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Peter Doshi, senior editor,
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Fiona Godlee, former editor in chief,
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Kamran Abbasi, editor in chief
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The BMJ, London, UK
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Correspondence to: P Doshi Pdoshi{at}bmj.com
Data should be fully and immediately available for public scrutiny
In the pages of The BMJ a decade ago, in the middle of a different pandemic, it came to light that governments around the world had spent billions stockpiling antivirals for influenza that had not been shown to reduce the risk of complications, hospital admissions, or death. The majority of trials that underpinned regulatory approval and government stockpiling of oseltamivir (Tamiflu) were sponsored by the manufacturer; most were unpublished, those that were published were ghostwritten by writers paid by the manufacturer, the people listed as principal authors lacked access to the raw data, and academics who requested access to the data for independent analysis were denied.1234
The Tamiflu saga heralded a decade of unprecedented attention to the importance of sharing clinical trial data.56 Public battles for drug company data,78 transparency campaigns with thousands of signatures,910 strengthened journal data sharing requirements,1112 explicit commitments from companies to share data,13 new data access website portals,8 and landmark transparency policies from medicines regulators1415 all promised a new era in data transparency.
Progress was made, but clearly not enough. The errors of the last pandemic are being repeated. Memories are short. Today, despite the global rollout of covid-19 vaccines and treatments, the anonymised participant level data underlying the trials for these new products remain inaccessible to doctors, researchers, and the public—and are likely to remain that way for years to come.16 This is morally indefensible for all trials, but especially for those involving major public health interventions.
Unacceptable delay
Pfizer’s pivotal covid vaccine trial was funded by the company and designed, run, analysed, and authored by Pfizer employees. The company and the contract research organisations that carried out the trial hold all the data.17 And Pfizer has indicated that it will not begin entertaining requests for trial data until May 2025, 24 months after the primary study completion date, which is listed on ClinicalTrials.gov as 15 May 2023 (NCT04368728).
The lack of access to data is consistent across vaccine manufacturers.16 Moderna says data “may be available … with publication of the final study results in 2022.”18 Datasets will be available “upon request and subject to review once the trial is complete,” which has an estimated primary completion date of 27 October 2022 (NCT04470427).
As of 31 December 2021, AstraZeneca may be ready to entertain requests for data from several of its large phase III trials.19 But actually obtaining data could be slow going. As its website explains, “timelines vary per request and can take up to a year upon full submission of the request.”20
Underlying data for covid-19 therapeutics are similarly hard to find. Published reports of Regeneron’s phase III trial of its monoclonal antibody therapy REGEN-COV flatly state that participant level data will not be made available to others.21 Should the drug be approved (and not just emergency authorised), sharing “will be considered.” For remdesivir, the US National Institutes of Health, which funded the trial, created a new portal to share data (https://accessclinicaldata.niaid.nih.gov/), but the dataset on offer is limited. An accompanying document explains: “The longitudinal data set only contains a small subset of the protocol and statistical analysis plan objectives.”
We are left with publications but no access to the underlying data on reasonable request. This is worrying for trial participants, researchers, clinicians, journal editors, policy makers, and the public. The journals that have published these primary studies may argue that they faced an awkward dilemma, caught between making the summary findings available quickly and upholding the best ethical values that support timely access to underlying data. In our view, there is no dilemma; the anonymised individual participant data from clinical trials must be made available for independent scrutiny.
Journal editors, systematic reviewers, and the writers of clinical practice guideline generally obtain little beyond a journal publication, but regulatory agencies receive far more granular data as part of the regulatory review process. In the words of the European Medicine Agency’s former executive director and senior medical officer, “relying solely on the publications of clinical trials in scientific journals as the basis of healthcare decisions is not a good idea ... Drug regulators have been aware of this limitation for a long time and routinely obtain and assess the full documentation (rather than just publications).”22
Among regulators, the US Food and Drug Administration is believed to receive the most raw data but does not proactively release them. After a freedom of information request to the agency for Pfizer’s vaccine data, the FDA offered to release 500 pages a month, a process that would take decades to complete, arguing in court that publicly releasing data was slow owing to the need to first redact sensitive information.23 This month, however, a judge rejected the FDA’s offer and ordered the data be released at a rate of 55 000 pages a month. The data are to be made available on the requesting organisation’s website (phmpt.org).
In releasing thousands of pages of clinical trial documents, Health Canada and the EMA have also provided a degree of transparency that deserves acknowledgment.2425 Until recently, however, the data remained of limited utility, with copious redactions aimed at protecting trial blinding. But study reports with fewer redactions have been available since September 2021,2425 and missing appendices may be accessible through freedom of information requests.
Even so, anyone looking for participant level datasets may be disappointed because Health Canada and the EMA do not receive or analyse these data, and it remains to be seen how the FDA responds to the court order. Moreover, the FDA is producing data only for Pfizer’s vaccine; other manufacturers’ data cannot be requested until the vaccines are approved, which the Moderna and Johnson & Johnson vaccines are not. Industry, which holds the raw data, is not legally required to honour requests for access from independent researchers.
Like the FDA, and unlike its Canadian and European counterparts, the UK’s regulator—the Medicines and Healthcare Products Regulatory Agency—does not proactively release clinical trial documents, and it has also stopped posting information released in response to freedom of information requests on its website.26
Transparency and trust
As well as access to the underlying data, transparent decision making is essential. Regulators and public health bodies could release details27 such as why vaccine trials were not designed to test efficacy against infection and spread of SARS-CoV-2.28 Had regulators insisted on this outcome, countries would have learnt sooner about the effect of vaccines on transmission and been able to plan accordingly.29
Big pharma is the least trusted industry.30 At least three of the many companies making covid-19 vaccines have past criminal and civil settlements costing them billions of dollars.31 One pleaded guilty to fraud.31 Other companies have no pre-covid track record. Now the covid pandemic has minted many new pharma billionaires, and vaccine manufacturers have reported tens of billions in revenue.32
The BMJ supports vaccination policies based on sound evidence. As the global vaccine rollout continues, it cannot be justifiable or in the best interests of patients and the public that we are left to just trust “in the system,” with the distant hope that the underlying data may become available for independent scrutiny at some point in the future. The same applies to treatments for covid-19. Transparency is the key to building trust and an important route to answering people’s legitimate questions about the efficacy and safety of vaccines and treatments and the clinical and public health policies established for their use.
Twelve years ago we called for the immediate release of raw data from clinical trials.1 We reiterate that call now. Data must be available when trial results are announced, published, or used to justify regulatory decisions. There is no place for wholesale exemptions from good practice during a pandemic. The public has paid for covid-19 vaccines through vast public funding of research, and it is the public that takes on the balance of benefits and harms that accompany vaccination. The public, therefore, has a right and entitlement to those data, as well as to the interrogation of those data by experts.
Pharmaceutical companies are reaping vast profits without adequate independent scrutiny of their scientific claims.33 The purpose of regulators is not to dance to the tune of rich global corporations and enrich them further; it is to protect the health of their populations. We need complete data transparency for all studies, we need it in the public interest, and we need it now.
Footnotes
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Competing interests: We have read and understood BMJ policy on declaration of interests and declare that The BMJ is a co-founder of the AllTrials campaign. PD was one of the Cochrane reviewers studying influenza antivirals beginning in 2009, who campaigned for access to data. He also helped organise the Coalition Advocating for Adequately Licensed Medicines (CAALM), which formally petitioned the FDA to refrain from fully approving any covid-19 vaccine this year (docket FDA-2021-P-0786). PD is also a member of Public Health and Medical Professionals for Transparency, which has sued the FDA to obtain the Pfizer covid-19 vaccine data. The views and opinions do not necessarily reflect the official policy or position of the University of Maryland.
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Provenance and peer review: Commissioned; externally peer reviewed.
On May 7, 2021, during the peak of India's Delta Surge, The World Health Organization reported, "Uttar Pradesh (is) going the last mile to stop COVID-19."
The WHO noted, "Government teams are moving across 97,941 villages in 75 districts over five days in this activity which began May 5 in India's most populous state with a population of 230 million."
The activity involved an aggressive house-to-house test and treat program with medicine kits.
The WHO explained, "Each monitoring team has two members who visit homes in villages and remote hamlets to test everyone with symptoms of COVID-19 using Rapid Antigen Test kits. Those who test positive are quickly isolated and given a medicine kit with advice on disease management."
The medicines comprising the kit were not identified as part of the Western media blackout at the time. As a result, the contents were as secret as the sauce at McDonald's.
The WHO continued, "On the inaugural day, WHO field officers monitored over 2,000 government teams and visited at least 10,000 households."
This news story was published on the WHO Official Website in India. The website details the WHO’s work against COVID-19 in India, including a discussion about their “Online course for Rapid Response Teams.”
Such teams are the very government teams discussed above assigned to conduct the house-to-house test and treat program in Uttar Pradesh. In discussing the role of the Rapid Response Team (RRT), the WHO site reports,
“RRTs are a key component of a larger emergency response strategy that is essential for an efficient and effective response…WHO has produced and published this course for RRTs working at the national, sub-national, district, and sub-district levels to strengthen the pandemic response with support from the National Center for Disease Control, Ministry of Health & Family Welfare, Government of India, and the U.S. Centers for Disease Control and Prevention.”
The Rapid Response Teams derive support from the United States CDC under the umbrella of the WHO. This fact further validates the Uttar Pradesh test and treat program and solidifies this as a joint effort by the WHO and CDC.
https://www.who.int/india/news/detail/16-09-2021-online-course-for-rapid-response-teams
Perhaps the most telling portion of the WHO article was the last sentence, “WHO will also support the Uttar Pradesh government on the compilation of the final reports.”
None have yet been published.
Just five short weeks later, on June 14, 2021, new cases had dropped a staggering 97.1 percent, and the Uttar Pradesh program was hailed as a resounding success. According to ZeeNews of India, "The strategy of trace, test & treat yields results."
"The Yogi-led state has also been registering a steep decline in the number of Active COVID Cases as the figure has dropped from a high of 310,783 in April to 8,986 now, a remarkable reduction by 97.10 percent."
By July 2, 2021, three weeks later, cases were down a full 99 percent.
On August 6, 2021, India’s Ivermectin media blackout ended with MSN reporting. Western media, including MSN, finally acknowledged what was contained in those Uttar Pradesh medicine kits. Among the medicines were Doxycycline and Ivermectin.
On August 25, 2021, the Indian media noticed the discrepancy between Uttar Pradesh's massive success and other states, like Kerala's, comparative failure. Although Uttar Pradesh was only 5% vaccinated to Kerala's 20%, Uttar Pradesh had (only) 22 new COVID cases, while Kerala was overwhelmed with 31,445 in one day. So it became apparent that whatever was contained in those treatment kits must have been pretty effective.
News18 reported, "Let’s look at the contrasting picture. Kerala, with its 3.5 crore population - or 35 million, on August 25 reported 31,445 new cases, a bulk of the total cases reported in the country. Uttar Pradesh, the biggest state with a population of nearly 24 crore - or 240 million - meanwhile reported just 22 cases in the same period.
Two days ago, just seven fresh positive cases were reported from Uttar Pradesh. Kerala reported 215 deaths on August 25, while Uttar Pradesh only reported two deaths. In fact, no deaths have been reported from Uttar Pradesh in recent days. There are only 345 active cases in Uttar Pradesh now while Kerala’s figure is at 1.7 lakh - or 170,000."
"Kerala has done a much better job in vaccination coverage with 56% of its population being vaccinated with one dose and 20% of the population being fully vaccinated with a total of 2.66 crore - or 26.6 million - doses being administered.
Uttar Pradesh had given over 6.5 crore - or 65 million - doses, the maximum in the country, but only 25% of people have got their first dose while less than 5% of people are fully vaccinated. Given the present COVID numbers, Uttar Pradesh seems to be trumping Kerala for the tag of the most successful model against COVID."
This author reviewed the reasons behind Kerala’s failed treatment model in two articles, “The Lesson of Kerala” and “Kerala’s Vaccinated Surge.”
By September 12, 2021, Livemint reported that 34 districts were declared COVID-free or had no active cases. Only 14 new cases were recorded in the entire state of Uttar Pradesh.
On September 22, 2021, YouTube hosted a video by popular science blogger Dr. John Campbell detailing the Uttar Pradesh success story. He gave a breakdown of the ingredients and dosages of the magical medicine home treatment kit responsible for eradicating COVID in Uttar Pradesh. The same kit was also used in the state of Goa.
Dr. John Campbell broke India's Ivermectin Blackout wide open on YouTube by revealing the formula of the secret sauce, much to the dismay of Big Pharma, the WHO, and the CDC. Readers will want to watch this before it is taken down. See mark 2:22.
Each home kit contained the following: Paracetamol tablets [tylenol], Vitamin C, Multivitamin, Zinc, Vitamin D3, Ivermectin 12 mg [quantity #10 tablets], Doxycycline 100 mg [quantity #10 tablets]. Other non-medication components included face masks, sanitizer, gloves and alcohol wipes, a digital thermometer, and a pulse oximeter. See mark 2:33.
Campbell reports that the exciting things in the kit that grabbed his attention were: Zinc, Vitamin D3, Ivermectin, and secondary antibiotic treatment. "Interesting, that’s what the government decided to give." See mark 3:40
John Campbell has reviewed repurposed drugs for COVID before. He has interviewed both Dr. Tess Lawrie and Dr. Pierre Kory. Repurposed drugs hold the potential for benefitting many conditions, not the least of which include viruses and cancers.
https://www.amazon.com/Surviving-Cancer-COVID-19-Disease-Repurposed/dp/0998055425
Dr. Campbell noted that there had been no recent cases in 59 Uttar Pradesh districts. In addition, out of 191,446 tests completed in the previous 24 hours, only 33 samples were positive for a test positivity rate of only 0.01%. Dr. Campbell called this low number "staggering." See mark 5:05.
By September, cases had fallen dramatically. Out of the entire state of 200 million plus inhabitants, only 187 active cases were left compared to the peak in April of 310,783 cases. See mark 5:41.
Dr. Campbell attributes their success to many factors, including early detection and early treatment with kits costing a mere $ 2.65 per person. See mark 6:20.
Notice that Dr. Campbell does not mention a single person who had any toxicity from those ten 12 mg pills of Ivermectin - in the entire state of over 200 million. Not one poisoning was reported. No Indian poison control articles or telephone calls were reported. Out of millions of distributed medicine kits, each containing 120 mg of Ivermectin, not one person in Uttar Pradesh was reported to have had a problem with the drug.
Notice that Dr. Campbell at no time criticizes the medicine kit as "fringe" or ineffective. After all, it would be improper to accuse a WHO-sponsored program such as the Uttar Pradesh test and treat – coordinated by WHO – of being “fringe.”
Contrary to what little we receive - at great expense - from the government in the United States, these kits are efficient and contain gloves, a thermometer, and an oximeter. The last time I purchased an oximeter some ten years ago, it cost some $200.00. This entire kit – including the oximeter – costs only $2.65.
And notice that a government can purchase over one thousand home treatment Ivermectin containing kits for the price of one course of Remdesivir. Remdesivir runs $3,100, and it is an impractical drug as it must be given late in the disease during hospitalization. Moreover, it is a drug that does not save lives.
https://www.nejm.org/doi/full/10.1056/nejmoa2007764
https://www.nytimes.com/2020/10/15/health/coronavirus-remdesivir-who.html
On the other hand, the Ivermectin kits are highly correlated with eliminating COVID-19 in Uttar Pradesh. Indeed with less than 11% of their population fully vaccinated, the Uttar Pradesh model of test and treat is superior not only to Kerala, with a much higher percent vaccinated. Uttar Pradesh beats the UK, the US, and nearly everywhere else in the world in terms of the lowest active COVID cases.
Rather than turning a blind eye to Uttar Pradesh, perhaps it is time to analyze its success. It is time for all to realize that far from being dangerous, Ivermectin is safer than hand sanitizer or plain Tylenol, judging from the number of United States poison control calls.
Now is precisely the moment to point out that Dr. George Fareed, Dr. Peter McCullough, and Dr. Harvey Risch were correct in their U.S. Senate Testimony on November 19, 2020. They advised that early outpatient treatment was essential and would save hundreds of thousands of American lives if adopted. It wasn’t.
Now is the right moment to notice the onslaught of United States poison control articles attempting to smear Ivermectin, a drug proven safe and effective in the Uttar Pradesh test-and-treat program administered under the auspices of both the WHO and CDC.
It is appropriate to remind the reader that the WHO and CDC possess direct and recent knowledge of Ivermectin use for COVID-19 in India. Moreover, they know better than anyone the colossal effectiveness and overwhelming safety of Ivermectin used in those millions of Uttar Pradesh test and treat kits.
Perhaps it is also time to ask why exactly Dr. Tess Lawrie’s peer-reviewed meta-analysis was given an Altimetric score of 26,697, making it number eight out of some 18 million publications.
https://hopepressworks.org/f/ivermectin-meta-analysis-by-dr-tess-lawrie-nears-most-cited-ever
This rank is far better than the top 1%, which would only need a ranking of 180,000 for it to rank in the top 1%. It would only need 18,000 for it to rank in the top .1%. Ranking in the top .001% would mean #180. Therefore, at number eight, it is 8/180 of the top .001% or roughly the top 4.4% of the top .001%. This article ranks in the top 5% of the top .001%!
In other words, only seven articles in the world out of those 18 million are ranked higher.
This peer-reviewed paper is one of the most cited of medical references of all time – period. That should alert any reader – immediately - to its historical significance. Dr. Tess Lawrie is a 30-year veteran WHO evidence synthesis expert. Her conclusion is every bit as meaningful as the article's rank. Here are those words,
“Moderate-certainty evidence finds that large reductions in COVID-19 deaths are possible using Ivermectin. Using Ivermectin early in the clinical course may reduce numbers progressing to severe disease. The apparent safety and low cost suggest that Ivermectin is likely to have a significant impact on the SARS-CoV-2 pandemic globally.”
https://pubmed.ncbi.nlm.nih.gov/34145166/
Maybe it is time to ask why Dr. Pierre Kory’s peer-reviewed narrative review of Ivermectin ranks #38 out of the same 18 million publications.
He concludes, “Finally, the many examples of Ivermectin distribution campaigns leading to rapid population-wide decreases in morbidity and mortality reduction indicate that an oral agent effective in all phases of COVID-19 has been identified.”
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8088823/
If Dr. Lawrie’s paper is ranked in the top 5% of the top .001% of all such published medical articles of all time, then Dr. Kory’s is not far behind. His is 38/180 of the top .001% or the top 21% of the top .001%
Thus, both articles would rank in the rarified atmosphere of nearly one in a million.
Therefore, the reader must now ask why two magnificent independent reviews from two different continents, coming to the same conclusion, are both ignored by our world’s medical leaders?
Uttar Pradesh is one such population that experienced a considerable drop in COVID-19 morbidity and mortality months AFTER Dr. Kory’s article was published on April 22, 2021. Therefore, one must ask that if Ivermectin so predictably and safely eradicates COVID-19, then why is it not being systematically deployed over all the world, as Dr. Kory and Dr. Lawrie suggest?
Perhaps every reader needs to ask themselves this question - Why is it that BOTH Dr. Lawrie’s and Dr. Kory’s supremely-rated expert review articles, published in the medical literature on PubMed, the National Library of Medicine, are BANNED from Wikipedia?
Although India’s Ivermectin victory over COVID may have been lost on bent-on-vaccinating-everyone Big Pharma and Big Regulators, the message seems to have gotten through to the man on the street. If Google Trends is any indicator, interest in Ivermectin is exploding, and for good reason. We are all being systematically deceived by influential organizations in the name of profits.
A daily onslaught of media propaganda bombards us with messages attempting to steer us away from the safest and most effective treatments.
Interest in Ivermectin and India is only increasing and has now reached an all-time high. India’s conquest of COVID-19 is concealed no longer. The secret is out. And perhaps, at long last, that much-anticipated WHO Final Report detailing the most successful Pandemic campaign of any place on earth will be published.
I’ve been getting frequent requests for at least the last six months to write about the Novavax covid vaccine. I’ve been resisting, mainly because it’s seemed uncertain whether it would ever actually be approved in the western world. Now that it’s been approved for use in the EU, however, that has changed, and I figure that I can put it off no longer.
I guess the reason so many people are excited about the Novavax vaccine is that it uses a traditional technology that’s been used many times previously, rather than the new-fangled technologies used in the mRNA and adenovector vaccines that have up to now been all that’s available in the US and EU. To many people, that apparently makes it feel inherently safer.
The Novavax vaccine consists of two parts: the Sars-Cov-2 spike protein and an adjuvant (a substance that causes the immune system to realize that a dangerous foreign entity is present, and which thus activates an immune response to the spike protein). So, rather than injecting genetic blueprints in to the body that get cells to make the viral spike protein themselves (as is the case with the four previously approved vaccines), the spike protein is injected directly.
The first country to approve the Novavax vaccine was Indonesia, which approved it for use in November. That means that there is no even slightly long term real world follow-up data available yet. All we have is the preliminary results from the randomized trials. That means we still have no idea about rare side-effects, and won’t for months. Several million people had already received the AstraZeneca vaccine before authorities realized it could cause serious blood clotting disorders, and millions had also received the Moderna and Pfizer vaccines before it became clear that they can cause myocarditis. With that cautionary point having been made, let’s take a look at what the preliminary results from the randomized trials show.
The first trial results concerning the Novavax vaccine appeared in the New England Journal of Medicine in May. 4,387 people in South Africa were randomized to receive either the vaccine or a saline placebo. The trial was conducted during the final months of 2020, when the beta variant was dominant in South Africa. Like the earlier covid vaccine trials, the objective of the study was to understand the ability of the vaccine to prevent symptomatic disease, which was defined as symptoms suggestive of covid-19 plus a positive covid test.
The average age of the participants was 32 years and chronic conditions were rare, so this was a group at low risk of severe disease. When this fact is combined with the relatively small total number of participants (for a vaccine trial), there was no possibility that the study was going to say anything useful about the ability of the vaccine to prevent severe disease. So this was really a trial looking at the ability of the Novavax vaccine to prevent the common cold in healthy young people.
Let’s look at the results.
As with the earlier published vaccine trials, data on efficacy was only provided two months out from receipt of the vaccine. At the two month mark, 15 people in the vaccine group had developed symptomatic covid-19, as compared with 29 people in the placebo group. This gives a relative risk reduction of 49% against the beta variant at two months post vaccination, which is disappointing. It’s below the 50% risk reduction that regulators have set as the minimum level required for them to approve a vaccine.
It’s even more disappointing when you consider that efficacy against symptomatic infection likely peaks at two months out from vaccination, and then drops rapidly – that is the pattern that’s been seen with all the other approved covid vaccines, and it’s very likely that the same is true for this vaccine.
Furthermore, the beta variant is long gone. The other approved vaccines appear to have little to no ability to prevent infection from the currently dominant omicron variant (although they do still seem to reduce the risk of severe disease to a large extent). Here in Sweden you are currently just as likely to get covid regardless of whether you’ve been vaccinated or not, but you’re still far less likely to end up in an ICU due to severe covid if you’ve been vaccinated. There’s no reason to assume that this vaccine is any different.
Let’s move on and look at safety. Safety data was only provided for a sub-set of patients, and for the first 35 days out from receipt of the first vaccine dose. What little there was though, was somewhat discouraging, with twice as many adverse events requiring medical attention in the group receiving the vaccine as in the group receiving the placebo (13 vs 6), and twice as many serious adverse events in the group receiving the vaccine (2 vs 1). To be fair though, the small absolute numbers make it impossible to draw any conclusions about safety based on this limited data. So we’ll wait to pass judgement.
Let’s move on to the second trial, which was published in the New England Journal of Medicine in September. This was a much larger trial than the first, with 15,187 people in the UK who were randomized to either the Novavax vaccine or a saline placebo. Like the earlier study, it was looking at the ability of the vaccine to prevent symptomatic disease. The study ran from late 2020 to early 2021, during a time when the alpha variant was dominant, so the results of the study apply primarily to that variant. 45% of the participants had at least one risk factor that would predispose them to severe disease, and the average age was 56 years.
Ok, so what were the results?
Among participants who received two doses of the vaccine, there were 96 covid infections in the placebo group, but only 10 in the vaccine group during the three month period after receipt of the second dose. This gives an efficacy during the first few months of 90%, similar to what was found in the Moderna and Pfizer vaccine trials. One person ended up being hospitalized for covid-19 in the placebo group, while no-one was hospitalized in the vaccine group – so unfortunately there again weren’t enough hospitalizations to be able to say anything about the ability of the vaccine to prevent severe disease (although it’s pretty clear from this study that even for a relatively high risk group, the overall risk of hospitalization due to covid is low – of 96 people in the placebo group who got covid, only one required hospitalization).
Let’s turn to safety. Safety data is only provided for the period from receipt of the first dose to 28 days out from receipt of the second dose, so we don’t learn anything about the longer term, but at least for that shorter period, there was no signal of serious harm. There were 44 serious adverse events in the vaccine group, and 44 serious adverse events in the placebo group. One person in the vaccine group developed myocarditis three days after receipt of the second dose, which suggests that the Novavax vaccine might cause myocarditis, just like the Pfizer and Moderna vaccines do.
Let’s turn to the final trial, which was published in the New England Journal of Medicine in December. It was carried out in the United States and Mexico during the first half of 2021. Just as with the previous trial, the results apply primarily to the alpha variant. 29,949 participants were randomized to either the Novavax vaccine or a saline placebo. Like the other two trials, the purpose was to see if the vaccine prevented symptomatic disease, again defined as symptoms suggestive of covid-19 plus a positive PCR test. The median age of the participants was 47 years, and 52% had an underlying condition that would predispose them to more severe disease if infected with covid-19.
So, what were the results?
At 70 days out from receipt of the second dose, 0.8% of participants in the placebo group had developed covid-19, compared with only 0.1% in the vaccine group. This gives a relative risk reduction of 90%, a result that is identical to that seen in the previous trial. Unfortunately, no information is provided on hospitalizations, which I assume means that not one of the 29,949 people included in the study was hospitalized for covid-19, so, just as with the earlier trials, it’s impossible to tell if the vaccine results in any meaningful reduction in hospitalizations.
At 28 days post receipt of the seond dose, 0.9% of participants in the vaccine group had suffered a serious adverse event, compared with 1.0% of participants in the placebo group. That is encouraging.
Ok, let’s wrap up. what can we conclude about the Novavax vaccine after looking at the results of these three trials?
First, we can conclude that it effectively protected people from symptomatic covid due to the alpha variant at two-three months post vaccination (which of course tells us nothing about how effective the vaccine is after six months or a year). That information is now mostly of historical interest, since alpha is long gone and we’re living in the era of omicron. If the Novavax vaccine is similar to the four previously approved vaccines, then it’s likely useless at preventing infection due to omicron.
Second, it’s impossible to conclude from these trials whether the Novavax vaccine results in any reduction in risk of hospitalization due to covid, for the simple reason that not enough people ended up being hospitalized. Having said that, my guess would be that it probably does protect against hospitalization and need for ICU treatment, just as the other approved vaccines do. At its heart, it’s doing the same thing as they are – generating an immune response to the spike protein found on the original Wuhan covid variant, and the overall trial results are very similar to the trial results for the Moderna and Pfizer vaccines.
The overall safety data suggests that the vaccine is pretty safe, with serious adverse events being balanced between the vaccine group and the placebo group. Rare side-effects are however not detectable in randomized trials with a few tens of thousands of participants. For that longer term follow-up with much larger numbers of people is necessary. So it’s currently impossible to know whether the Novavax vaccine can cause myocarditis, like the mRNA vaccines, or blood clotting disorders, like the adenovector virus vaccines, or some other type of rare adverse event entirely. It’s therefore impossible to say at the present point in time whether it will turn out to be more safe, or less safe, or equivalent to the already approved vaccines.
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Cerebral venous thrombosis after COVID-19 vaccination in the UK: a multicentre cohort study: https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(21)01608-1/
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Vaccine-induced immune thrombotic thrombocytopenia with disseminated intravascular coagulation and death after ChAdOx1 nCoV-19 vaccination: https://www.sciencedirect.com/science/article/pii/S1052305721003414
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Fatal cerebral hemorrhage after COVID-19 vaccine: https://pubmed.ncbi.nlm.nih.gov/33928772/
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Myocarditis after mRNA vaccination against SARS-CoV-2, a case series: https://www.sciencedirect.com/science/article/pii/S2666602221000409
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Three cases of acute venous thromboembolism in women after vaccination against COVID-19: https://www.sciencedirect.com/science/article/pii/S2213333X21003929
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Acute thrombosis of the coronary tree after vaccination against COVID-19: https://www.sciencedirect.com/science/article/abs/pii/S1936879821003988
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US case reports of cerebral venous sinus thrombosis with thrombocytopenia after vaccination with Ad26.COV2.S (against covid-19), March 2 to April 21, 2020: https://pubmed.ncbi.nlm.nih.gov/33929487/
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Portal vein thrombosis associated with ChAdOx1 nCov-19 vaccine: https://www.thelancet.com/journals/langas/article/PIIS2468-1253(21)00197-7/
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Management of cerebral and splanchnic vein thrombosis associated with thrombocytopenia in subjects previously vaccinated with Vaxzevria (AstraZeneca): position statement of the Italian Society for the Study of Hemostasis and Thrombosis (SISET): https://pubmed.ncbi.nlm.nih.gov/33871350/
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Vaccine-induced immune immune thrombotic thrombocytopenia and cerebral venous sinus thrombosis after vaccination with COVID-19; a systematic review: https://www.sciencedirect.com/science/article/pii/S0022510X21003014
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Thrombosis with thrombocytopenia syndrome associated with COVID-19 vaccines: https://www.sciencedirect.com/science/article/abs/pii/S0735675721004381
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Covid-19 vaccine-induced thrombosis and thrombocytopenia: a commentary on an important and practical clinical dilemma: https://www.sciencedirect.com/science/article/abs/pii/S0033062021000505
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Thrombosis with thrombocytopenia syndrome associated with COVID-19 viral vector vaccines: https://www.sciencedirect.com/science/article/abs/pii/S0953620521001904
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COVID-19 vaccine-induced immune-immune thrombotic thrombocytopenia: an emerging cause of splanchnic vein thrombosis: https://www.sciencedirect.com/science/article/pii/S1665268121000557
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The roles of platelets in COVID-19-associated coagulopathy and vaccine-induced immune thrombotic immune thrombocytopenia (covid): https://www.sciencedirect.com/science/article/pii/S1050173821000967
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Roots of autoimmunity of thrombotic events after COVID-19 vaccination: https://www.sciencedirect.com/science/article/abs/pii/S1568997221002160
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Cerebral venous sinus thrombosis after vaccination: the United Kingdom experience: https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(21)01788-8/fulltext
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Thrombotic immune thrombocytopenia induced by SARS-CoV-2 vaccine: https://www.nejm.org/doi/full/10.1056/nejme2106315
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Myocarditis after immunization with COVID-19 mRNA vaccines in members of the US military. This article reports that in “23 male patients, including 22 previously healthy military members, myocarditis was identified within 4 days after receipt of the vaccine”: https://jamanetwork.com/journals/jamacardiology/fullarticle/2781601
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Thrombosis and thrombocytopenia after vaccination with ChAdOx1 nCoV-19: https://www.nejm.org/doi/full/10.1056/NEJMoa2104882?query=recirc_curatedRelated_article
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Association of myocarditis with the BNT162b2 messenger RNA COVID-19 vaccine in a case series of children: https://pubmed.ncbi.nlm.nih.gov/34374740/
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Thrombotic thrombocytopenia after vaccination with ChAdOx1 nCov-19: https://www.nejm.org/doi/full/10.1056/NEJMoa2104840?query=recirc_curatedRelated_article
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Post-mortem findings in vaccine-induced thrombotic thrombocytopenia (covid-19): https://haematologica.org/article/view/haematol.2021.279075
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Thrombocytopenia, including immune thrombocytopenia after receiving COVID-19 mRNA vaccines reported to the Vaccine Adverse Event Reporting System (VAERS): https://www.sciencedirect.com/science/article/pii/S0264410X21005247
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Acute symptomatic myocarditis in seven adolescents after Pfizer-BioNTech COVID-19 vaccination: https://pediatrics.aappublications.org/content/early/2021/06/04/peds.2021-052478
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Aphasia seven days after the second dose of an mRNA-based SARS-CoV-2 vaccine. Brain MRI revealed an intracerebral hemorrhage (ICBH) in the left temporal lobe in a 52-year-old man. https://www.sciencedirect.com/science/article/pii/S2589238X21000292#f0005
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Comparison of vaccine-induced thrombotic episodes between ChAdOx1 nCoV-19 and Ad26.COV.2.S vaccines: https://www.sciencedirect.com/science/article/abs/pii/S0896841121000895
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Hypothesis behind the very rare cases of thrombosis with thrombocytopenia syndrome after SARS-CoV-2 vaccination: https://www.sciencedirect.com/science/article/abs/pii/S0049384821003315
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Blood clots and bleeding episodes after BNT162b2 and ChAdOx1 nCoV-19 vaccination: analysis of European data: https://www.sciencedirect.com/science/article/pii/S0896841121000937
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Cerebral venous thrombosis after BNT162b2 mRNA SARS-CoV-2 vaccine: https://www.sciencedirect.com/science/article/abs/pii/S1052305721003098
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Primary adrenal insufficiency associated with thrombotic immune thrombocytopenia induced by the Oxford-AstraZeneca ChAdOx1 nCoV-19 vaccine (VITT): https://www.sciencedirect.com/science/article/pii/S0953620521002363
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Myocarditis and pericarditis after vaccination with COVID-19 mRNA: practical considerations for care providers: https://www.sciencedirect.com/science/article/pii/S0828282X21006243
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“Portal vein thrombosis occurring after the first dose of SARS-CoV-2 mRNA vaccine in a patient with antiphospholipid syndrome”: https://www.sciencedirect.com/science/article/pii/S2666572721000389
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Early results of bivalirudin treatment for thrombotic thrombocytopenia and cerebral venous sinus thrombosis after vaccination with Ad26.COV2.S: https://www.sciencedirect.com/science/article/pii/S0196064421003425
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Myocarditis, pericarditis and cardiomyopathy after COVID-19 vaccination: https://www.sciencedirect.com/science/article/pii/S1443950621011562
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Mechanisms of immunothrombosis in vaccine-induced thrombotic thrombocytopenia (VITT) compared to natural SARS-CoV-2 infection: https://www.sciencedirect.com/science/article/abs/pii/S0896841121000706
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Prothrombotic immune thrombocytopenia after COVID-19 vaccination: https://www.sciencedirect.com/science/article/pii/S0006497121009411
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Vaccine-induced thrombotic thrombocytopenia: the dark chapter of a success story: https://www.sciencedirect.com/science/article/pii/S2589936821000256
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Cerebral venous sinus thrombosis negative for anti-PF4 antibody without thrombocytopenia after immunization with COVID-19 vaccine in a non-comorbid elderly Indian male treated with conventional heparin-warfarin based anticoagulation: https://www.sciencedirect.com/science/article/pii/S1871402121002046
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Thrombosis after COVID-19 vaccination: possible link to ACE pathways: https://www.sciencedirect.com/science/article/pii/S0049384821004369
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Cerebral venous sinus thrombosis in the U.S. population after SARS-CoV-2 vaccination with adenovirus and after COVID-19: https://www.sciencedirect.com/science/article/pii/S0735109721051949
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A rare case of a middle-aged Asian male with cerebral venous thrombosis after AstraZeneca COVID-19 vaccination: https://www.sciencedirect.com/science/article/pii/S0735675721005714
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Cerebral venous sinus thrombosis and thrombocytopenia after COVID-19 vaccination: report of two cases in the United Kingdom: https://www.sciencedirect.com/science/article/abs/pii/S088915912100163X
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Immune thrombocytopenic purpura after vaccination with COVID-19 vaccine (ChAdOx1 nCov-19): https://www.sciencedirect.com/science/article/abs/pii/S0006497121013963.
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Antiphospholipid antibodies and risk of thrombophilia after COVID-19 vaccination: the straw that breaks the camel’s back?: https://docs.google.com/document/d/1XzajasO8VMMnC3CdxSBKks1o7kiOLXFQ
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Vaccine-induced thrombotic thrombocytopenia, a rare but severe case of friendly fire in the battle against the COVID-19 pandemic: What pathogenesis?: https://www.sciencedirect.com/science/article/pii/S0953620521002314
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Diagnostic-therapeutic recommendations of the ad-hoc FACME expert working group on the management of cerebral venous thrombosis related to COVID-19 vaccination: https://www.sciencedirect.com/science/article/pii/S0213485321000839
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Thrombocytopenia and intracranial venous sinus thrombosis after exposure to the “AstraZeneca COVID-19 vaccine”: https://pubmed.ncbi.nlm.nih.gov/33918932/
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Thrombocytopenia following Pfizer and Moderna SARS-CoV-2 vaccination: https://pubmed.ncbi.nlm.nih.gov/33606296/
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Severe and refractory immune thrombocytopenia occurring after SARS-CoV-2 vaccination: https://pubmed.ncbi.nlm.nih.gov/33854395/
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Purpuric rash and thrombocytopenia after mRNA-1273 (Modern) COVID-19 vaccine: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7996471/
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COVID-19 vaccination: information on the occurrence of arterial and venous thrombosis using data from VigiBase: https://pubmed.ncbi.nlm.nih.gov/33863748/
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Cerebral venous thrombosis associated with the covid-19 vaccine in Germany: https://onlinelibrary.wiley.com/doi/10.1002/ana.26172
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Cerebral venous thrombosis following BNT162b2 mRNA vaccination of BNT162b2 against SARS-CoV-2: a black swan event: https://pubmed.ncbi.nlm.nih.gov/34133027/
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The importance of recognizing cerebral venous thrombosis following anti-COVID-19 vaccination: https://pubmed.ncbi.nlm.nih.gov/34001390/
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Thrombosis with thrombocytopenia after messenger RNA vaccine -1273: https://pubmed.ncbi.nlm.nih.gov/34181446/
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Blood clots and bleeding after BNT162b2 and ChAdOx1 nCoV-19 vaccination: an analysis of European data: https://pubmed.ncbi.nlm.nih.gov/34174723/
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First dose of ChAdOx1 and BNT162b2 COVID-19 vaccines and thrombocytopenic, thromboembolic, and hemorrhagic events in Scotland: https://www.nature.com/articles/s41591-021-01408-4
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Exacerbation of immune thrombocytopenia after COVID-19 vaccination: https://pubmed.ncbi.nlm.nih.gov/34075578/
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First report of a de novo iTTP episode associated with a COVID-19 mRNA-based anti-COVID-19 vaccine: https://pubmed.ncbi.nlm.nih.gov/34105244/
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PF4 immunoassays in vaccine-induced thrombotic thrombocytopenia: https://www.nejm.org/doi/full/10.1056/NEJMc2106383
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Antibody epitopes in vaccine-induced immune immune thrombotic thrombocytopenia: https://www.nature.com/articles/s41586-021-03744-4
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Myocarditis with COVID-19 mRNA vaccines: https://www.ahajournals.org/doi/pdf/10.1161/CIRCULATIONAHA.121.056135
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Myocarditis and pericarditis after COVID-19 vaccination: https://jamanetwork.com/journals/jama/fullarticle/2782900
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Myocarditis temporally associated with COVID-19 vaccination: https://www.ahajournals.org/doi/pdf/10.1161/CIRCULATIONAHA.121.055891.
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COVID-19 Vaccination Associated with Myocarditis in Adolescents: https://pediatrics.aappublications.org/content/pediatrics/early/2021/08/12/peds.2021-053427.full.pdf
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Acute myocarditis after administration of BNT162b2 vaccine against COVID-19: https://pubmed.ncbi.nlm.nih.gov/33994339/
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Temporal association between COVID-19 vaccine Ad26.COV2.S and acute myocarditis: case report and review of the literature: https://www.sciencedirect.com/science/article/pii/S1553838921005789
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COVID-19 vaccine-induced myocarditis: a case report with review of the literature: https://www.sciencedirect.com/science/article/pii/S1871402121002253
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Potential association between COVID-19 vaccine and myocarditis: clinical and CMR findings: https://www.sciencedirect.com/science/article/pii/S1936878X2100485X
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Recurrence of acute myocarditis temporally associated with receipt of coronavirus mRNA disease vaccine 2019 (COVID-19) in a male adolescent: https://www.sciencedirect.com/science/article/pii/S002234762100617X
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Fulminant myocarditis and systemic hyper inflammation temporally associated with BNT162b2 COVID-19 mRNA vaccination in two patients: https://www.sciencedirect.com/science/article/pii/S0167527321012286.
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Acute myocarditis after administration of BNT162b2 vaccine: https://www.sciencedirect.com/science/article/pii/S2214250921001530
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Lymphohistocytic myocarditis after vaccination with COVID-19 Ad26.COV2.S viral vector: https://www.sciencedirect.com/science/article/pii/S2352906721001573
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Myocarditis following vaccination with BNT162b2 in a healthy male: https://www.sciencedirect.com/science/article/pii/S0735675721005362
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Acute myocarditis after Comirnaty (Pfizer) vaccination in a healthy male with previous SARS-CoV-2 infection: https://www.sciencedirect.com/science/article/pii/S1930043321005549
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Myopericarditis after Pfizer mRNA COVID-19 vaccination in adolescents: https://www.sciencedirect.com/science/article/pii/S002234762100665X
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Pericarditis after administration of BNT162b2 mRNA COVID-19 mRNA vaccine: https://www.sciencedirect.com/science/article/pii/S1885585721002218
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Acute myocarditis after vaccination with SARS-CoV-2 mRNA-1273 mRNA: https://www.sciencedirect.com/science/article/pii/S2589790X21001931
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Temporal relationship between the second dose of BNT162b2 mRNA Covid-19 vaccine and cardiac involvement in a patient with previous SARS-COV-2 infection: https://www.sciencedirect.com/science/article/pii/S2352906721000622
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Myopericarditis after vaccination with COVID-19 mRNA in adolescents 12 to 18 years of age: https://www.sciencedirect.com/science/article/pii/S0022347621007368
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Acute myocarditis after SARS-CoV-2 vaccination in a 24-year-old man: https://www.sciencedirect.com/science/article/pii/S0870255121003243
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Important information on myopericarditis after vaccination with Pfizer COVID-19 mRNA in adolescents: https://www.sciencedirect.com/science/article/pii/S0022347621007496
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A series of patients with myocarditis after vaccination against SARS-CoV-2 with mRNA-1279 and BNT162b2: https://www.sciencedirect.com/science/article/pii/S1936878X21004861
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Takotsubo cardiomyopathy after vaccination with mRNA COVID-19: https://www.sciencedirect.com/science/article/pii/S1443950621011331
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COVID-19 mRNA vaccination and myocarditis: https://pubmed.ncbi.nlm.nih.gov/34268277/
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COVID-19 vaccine and myocarditis: https://pubmed.ncbi.nlm.nih.gov/34399967/
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Epidemiology and clinical features of myocarditis/pericarditis before the introduction of COVID-19 mRNA vaccine in Korean children: a multicenter study https://search.bvsalud.org/global-literature-on-novel-coronavirus-2019-ncov/resourc e/en/covidwho-1360706.
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COVID-19 vaccines and myocarditis: https://pubmed.ncbi.nlm.nih.gov/34246566/
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Myocarditis and other cardiovascular complications of COVID-19 mRNA-based COVID-19 vaccines https://www.cureus.com/articles/61030-myocarditis-and-other-cardiovascular-comp lications-of-the-mrna-based-covid-19-vaccines https://www.cureus.com/articles/61030-myocarditis-and-other-cardiovascular-complications-of-the-mrna-based-covid-19-vaccines
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Myocarditis, pericarditis, and cardiomyopathy after COVID-19 vaccination: https://pubmed.ncbi.nlm.nih.gov/34340927/
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Myocarditis with covid-19 mRNA vaccines: https://www.ahajournals.org/doi/10.1161/CIRCULATIONAHA.121.056135
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Association of myocarditis with COVID-19 mRNA vaccine in children: https://media.jamanetwork.com/news-item/association-of-myocarditis-with-mrna-co vid-19-vaccine-in-children/
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Association of myocarditis with COVID-19 messenger RNA vaccine BNT162b2 in a case series of children: https://jamanetwork.com/journals/jamacardiology/fullarticle/2783052
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Myocarditis after immunization with COVID-19 mRNA vaccines in members of the U.S. military: https://jamanetwork.com/journals/jamacardiology/fullarticle/2781601%5C
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Myocarditis occurring after immunization with COVID-19 mRNA-based COVID-19 vaccines: https://jamanetwork.com/journals/jamacardiology/fullarticle/2781600
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Myocarditis following immunization with Covid-19 mRNA: https://www.nejm.org/doi/full/10.1056/NEJMc2109975
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Patients with acute myocarditis after vaccination withCOVID-19 mRNA: https://jamanetwork.com/journals/jamacardiology/fullarticle/2781602
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Myocarditis associated with vaccination with COVID-19 mRNA: https://pubs.rsna.org/doi/10.1148/radiol.2021211430
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Symptomatic Acute Myocarditis in 7 Adolescents after Pfizer-BioNTech COVID-19 Vaccination: https://pediatrics.aappublications.org/content/148/3/e2021052478
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Cardiovascular magnetic resonance imaging findings in young adult patients with acute myocarditis after COVID-19 mRNA vaccination: a case series: https://jcmr-online.biomedcentral.com/articles/10.1186/s12968-021-00795-4
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Clinical Guidance for Young People with Myocarditis and Pericarditis after Vaccination with COVID-19 mRNA: https://www.cps.ca/en/documents/position/clinical-guidance-for-youth-with-myocarditis-and-pericarditis
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Cardiac imaging of acute myocarditis after vaccination with COVID-19 mRNA: https://pubmed.ncbi.nlm.nih.gov/34402228/
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Case report: acute myocarditis after second dose of mRNA-1273 SARS-CoV-2 mRNA vaccine: https://academic.oup.com/ehjcr/article/5/8/ytab319/6339567
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Myocarditis / pericarditis associated with COVID-19 vaccine: https://science.gc.ca/eic/site/063.nsf/eng/h_98291.html
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Transient cardiac injury in adolescents receiving the BNT162b2 mRNA COVID-19 vaccine: https://journals.lww.com/pidj/Abstract/9000/Transient_Cardiac_Injury_in_Adolesce nts_Receiving.95800.aspx
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Perimyocarditis in adolescents after Pfizer-BioNTech COVID-19 vaccine: https://academic.oup.com/jpids/advance-article/doi/10.1093/jpids/piab060/6329543
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The new COVID-19 mRNA vaccine platform and myocarditis: clues to the possible underlying mechanism: https://pubmed.ncbi.nlm.nih.gov/34312010/
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Acute myocardial injury after COVID-19 vaccination: a case report and review of current evidence from the Vaccine Adverse Event Reporting System database: https://pubmed.ncbi.nlm.nih.gov/34219532/
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Be alert to the risk of adverse cardiovascular events after COVID-19 vaccination: https://www.xiahepublishing.com/m/2472-0712/ERHM-2021-00033
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Myocarditis associated with COVID-19 vaccination: echocardiographic, cardiac tomography, and magnetic resonance imaging findings: https://www.ahajournals.org/doi/10.1161/CIRCIMAGING.121.013236
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In-depth evaluation of a case of presumed myocarditis after the second dose of COVID-19 mRNA vaccine: https://www.ahajournals.org/doi/10.1161/CIRCULATIONAHA.121.056038
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Occurrence of acute infarct-like myocarditis after COVID-19 vaccination: just an accidental coincidence or rather a vaccination-associated autoimmune myocarditis?: https://pubmed.ncbi.nlm.nih.gov/34333695/
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Recurrence of acute myocarditis temporally associated with receipt of coronavirus mRNA disease vaccine 2019 (COVID-19) in a male adolescent: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8216855/
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Myocarditis after SARS-CoV-2 vaccination: a vaccine-induced reaction?: https://pubmed.ncbi.nlm.nih.gov/34118375/
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Self-limited myocarditis presenting with chest pain and ST-segment elevation in adolescents after vaccination with the BNT162b2 mRNA vaccine: https://pubmed.ncbi.nlm.nih.gov/34180390/
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Myopericarditis in a previously healthy adolescent male after COVID-19 vaccination: Case report: https://pubmed.ncbi.nlm.nih.gov/34133825/
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Biopsy-proven lymphocytic myocarditis after first COVID-19 mRNA vaccination in a 40-year-old man: case report: https://pubmed.ncbi.nlm.nih.gov/34487236/
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Insights from a murine model of COVID-19 mRNA vaccine-induced myopericarditis: could accidental intravenous injection of a vaccine induce myopericarditis https://academic.oup.com/cid/advance-article/doi/10.1093/cid/ciab741/6359059
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Unusual presentation of acute perimyocarditis after modern SARS-COV-2 mRNA-1237 vaccination: https://pubmed.ncbi.nlm.nih.gov/34447639/
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Perimyocarditis after the first dose of mRNA-1273 SARS-CoV-2 (Modern) mRNA-1273 vaccine in a young healthy male: case report: https://bmccardiovascdisord.biomedcentral.com/articles/10.1186/s12872-021-02183
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Acute myocarditis after the second dose of SARS-CoV-2 vaccine: serendipity or causal relationship: https://pubmed.ncbi.nlm.nih.gov/34236331/
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Rhabdomyolysis and fasciitis induced by the COVID-19 mRNA vaccine: https://pubmed.ncbi.nlm.nih.gov/34435250/
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COVID-19 vaccine-induced rhabdomyolysis: case report with literature review: https://pubmed.ncbi.nlm.nih.gov/34186348/.
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GM1 ganglioside antibody and COVID-19-related Guillain Barre syndrome: case report, systemic review, and implications for vaccine development: https://www.sciencedirect.com/science/article/pii/S2666354621000065
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Guillain-Barré syndrome after AstraZeneca COVID-19 vaccination: causal or casual association: https://www.sciencedirect.com/science/article/pii/S0303846721004169
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Sensory Guillain-Barré syndrome after ChAdOx1 nCov-19 vaccine: report of two cases and review of the literature: https://www.sciencedirect.com/science/article/pii/S0165572821002186
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Guillain-Barré syndrome after the first dose of SARS-CoV-2 vaccine: a temporary occurrence, not a causal association: https://www.sciencedirect.com/science/article/pii/S2214250921000998.
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Guillain-Barré syndrome presenting as facial diplegia after vaccination with COVID-19: a case report: https://www.sciencedirect.com/science/article/pii/S0736467921006442
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Guillain-Barré syndrome after the first injection of ChAdOx1 nCoV-19 vaccine: first report: https://www.sciencedirect.com/science/article/pii/S0035378721005853.
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SARS-CoV-2 vaccines are not safe for those with Guillain-Barre syndrome following vaccination: https://www.sciencedirect.com/science/article/pii/S2049080121005343
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Acute hyperactive encephalopathy following COVID-19 vaccination with dramatic response to methylprednisolone: a case report: https://www.sciencedirect.com/science/article/pii/S2049080121007536
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Facial nerve palsy following administration of COVID-19 mRNA vaccines: analysis of self-report database: https://www.sciencedirect.com/science/article/pii/S1201971221007049
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Neurological symptoms and neuroimaging alterations related to COVID-19 vaccine: cause or coincidence: https://www.sciencedirect.com/science/article/pii/S0899707121003557.
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New-onset refractory status epilepticus after ChAdOx1 nCoV-19 vaccination: https://www.sciencedirect.com/science/article/pii/S0165572821001569
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Acute myelitis and ChAdOx1 nCoV-19 vaccine: coincidental or causal association: https://www.sciencedirect.com/science/article/pii/S0165572821002137
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Bell’s palsy and SARS-CoV-2 vaccines: an unfolding story: https://www.sciencedirect.com/science/article/pii/S1473309921002735
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Bell’s palsy after the second dose of the Pfizer COVID-19 vaccine in a patient with a history of recurrent Bell’s palsy: https://www.sciencedirect.com/science/article/pii/S266635462100020X
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Acute-onset central serous retinopathy after immunization with COVID-19 mRNA vaccine:. https://www.sciencedirect.com/science/article/pii/S2451993621001456.
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Bell’s palsy after COVID-19 vaccination: case report: https://www.sciencedirect.com/science/article/pii/S217358082100122X.
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An academic hospital experience assessing the risk of COVID-19 mRNA vaccine using patient’s allergy history: https://www.sciencedirect.com/science/article/pii/S2213219821007972
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COVID-19 vaccine-induced axillary and pectoral lymphadenopathy in PET: https://www.sciencedirect.com/science/article/pii/S1930043321002612
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ANCA-associated vasculitis after Pfizer-BioNTech COVID-19 vaccine: https://www.sciencedirect.com/science/article/pii/S0272638621007423
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Late cutaneous reactions after administration of COVID-19 mRNA vaccines: https://www.sciencedirect.com/science/article/pii/S2213219821007996
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COVID-19 vaccine-induced rhabdomyolysis: case report with review of the literature: https://www.sciencedirect.com/science/article/pii/S1871402121001880
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Clinical and pathologic correlates of skin reactions to COVID-19 vaccine, including V-REPP: a registry-based study: https://www.sciencedirect.com/science/article/pii/S0190962221024427
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Thrombosis with thrombocytopenia syndrome associated with COVID-19 vaccines:. https://www.sciencedirect.com/science/article/abs/pii/S0735675721004381.
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COVID-19 vaccine-associated anaphylaxis: a statement from the Anaphylaxis Committee of the World Allergy Organization:. https://www.sciencedirect.com/science/article/pii/S1939455121000119.
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Cerebral venous sinus thrombosis negative for anti-PF4 antibody without thrombocytopenia after immunization with COVID-19 vaccine in an elderly, non-comorbid Indian male treated with conventional heparin-warfarin-based anticoagulation:. https://www.sciencedirect.com/science/article/pii/S1871402121002046.
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Acute myocarditis after administration of BNT162b2 vaccine against COVID-19:. https://www.sciencedirect.com/science/article/abs/pii/S188558572100133X
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Blood clots and bleeding after BNT162b2 and ChAdOx1 nCoV-19 vaccine: an analysis of European data:. https://www.sciencedirect.com/science/article/pii/S0896841121000937.
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immune thrombocytopenia associated with Pfizer-BioNTech’s COVID-19 BNT162b2 mRNA vaccine:. https://www.sciencedirect.com/science/article/pii/S2214250921002018.
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Bullous drug eruption after the second dose of COVID-19 mRNA-1273 (Moderna) vaccine: Case report: https://www.sciencedirect.com/science/article/pii/S1876034121001878.
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COVID-19 RNA-based vaccines and the risk of prion disease: https://scivisionpub.com/pdfs/covid19rna-based-vaccines-and-the-risk-of-prion-dis ease-1503.pdf
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This study notes that 115 pregnant women lost their babies, out of 827 who participated in a study on the safety of covid-19 vaccines: https://www.nejm.org/doi/full/10.1056/NEJMoa2104983.
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Process-related impurities in the ChAdOx1 nCov-19 vaccine: https://www.researchsquare.com/article/rs-477964/v1
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COVID-19 mRNA vaccine causing CNS inflammation: a case series: https://link.springer.com/article/10.1007/s00415-021-10780-7
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Allergic reactions, including anaphylaxis, after receiving the first dose of the Pfizer-BioNTech COVID-19 vaccine: https://pubmed.ncbi.nlm.nih.gov/33475702/
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Allergic reactions to the first COVID-19 vaccine: a potential role of polyethylene glycol: https://pubmed.ncbi.nlm.nih.gov/33320974/
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Pfizer Vaccine Raises Allergy Concerns: https://pubmed.ncbi.nlm.nih.gov/33384356/
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Allergic reactions, including anaphylaxis, after receiving the first dose of Pfizer-BioNTech COVID-19 vaccine – United States, December 14-23, 2020: https://pubmed.ncbi.nlm.nih.gov/33444297/
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Allergic reactions, including anaphylaxis, after receiving first dose of Modern COVID-19 vaccine – United States, December 21, 2020-January 10, 2021: https://pubmed.ncbi.nlm.nih.gov/33507892/
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Reports of anaphylaxis after coronavirus disease vaccination 2019, South Korea, February 26-April 30, 2021: https://pubmed.ncbi.nlm.nih.gov/34414880/
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Reports of anaphylaxis after receiving COVID-19 mRNA vaccines in the U.S.-Dec 14, 2020-Jan 18, 2021: https://pubmed.ncbi.nlm.nih.gov/33576785/
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Immunization practices and risk of anaphylaxis: a current, comprehensive update of COVID-19 vaccination data: https://pubmed.ncbi.nlm.nih.gov/34269740/
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Relationship between pre-existing allergies and anaphylactic reactions following administration of COVID-19 mRNA vaccine: https://pubmed.ncbi.nlm.nih.gov/34215453/
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Anaphylaxis Associated with COVID-19 mRNA Vaccines: Approach to Allergy Research: https://pubmed.ncbi.nlm.nih.gov/33932618/
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Severe Allergic Reactions after COVID-19 Vaccination with the Pfizer / BioNTech Vaccine in Great Britain and the USA: Position Statement of the German Allergy Societies: German Medical Association of Allergologists (AeDA), German Society for Allergology and Clinical Immunology (DGAKI) and Society for Pediatric Allergology and Environmental Medicine (GPA): https://pubmed.ncbi.nlm.nih.gov/33643776/
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Allergic reactions and anaphylaxis to LNP-based COVID-19 vaccines: https://pubmed.ncbi.nlm.nih.gov/33571463/
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Reported orofacial adverse effects from COVID-19 vaccines: the known and the unknown: https://pubmed.ncbi.nlm.nih.gov/33527524/
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Cutaneous adverse effects of available COVID-19 vaccines: https://pubmed.ncbi.nlm.nih.gov/34518015/
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Cumulative adverse event report of anaphylaxis following injections of COVID-19 mRNA vaccine (Pfizer-BioNTech) in Japan: the first month report: https://pubmed.ncbi.nlm.nih.gov/34347278/
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COVID-19 vaccines increase the risk of anaphylaxis: https://pubmed.ncbi.nlm.nih.gov/33685103/
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Biphasic anaphylaxis after exposure to the first dose of the Pfizer-BioNTech COVID-19 mRNA vaccine COVID-19: https://pubmed.ncbi.nlm.nih.gov/34050949/
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Allergenic components of the mRNA-1273 vaccine for COVID-19: possible involvement of polyethylene glycol and IgG-mediated complement activation: https://pubmed.ncbi.nlm.nih.gov/33657648/
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Polyethylene glycol (PEG) is a cause of anaphylaxis to Pfizer / BioNTech mRNA COVID-19 vaccine: https://pubmed.ncbi.nlm.nih.gov/33825239/
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Acute allergic reactions to COVID-19 mRNA vaccines: https://pubmed.ncbi.nlm.nih.gov/33683290/
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Polyethylene glycole allergy of the SARS CoV2 vaccine recipient: case report of a young adult recipient and management of future exposure to SARS-CoV2: https://pubmed.ncbi.nlm.nih.gov/33919151/
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Elevated rates of anaphylaxis after vaccination with Pfizer BNT162b2 mRNA vaccine against COVID-19 in Japanese healthcare workers; a secondary analysis of initial post-approval safety data: https://pubmed.ncbi.nlm.nih.gov/34128049/
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Allergic reactions and adverse events associated with administration of mRNA-based vaccines. A health system experience: https://pubmed.ncbi.nlm.nih.gov/34474708/
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Allergic reactions to COVID-19 vaccines: statement of the Belgian Society of Allergy and Clinical Immunology (BelSACI): https://www.tandfonline.com/doi/abs/10.1080/17843286.2021.1909447
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.IgE-mediated allergy to polyethylene glycol (PEG) as a cause of anaphylaxis to COVID-19 mRNA vaccines: https://pubmed.ncbi.nlm.nih.gov/34318537/
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Allergic reactions after COVID-19 vaccination: putting the risk in perspective: https://pubmed.ncbi.nlm.nih.gov/34463751/
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Anaphylactic reactions to COVID-19 mRNA vaccines: a call for further studies: https://pubmed.ncbi.nlm.nih.gov/33846043/ 188.
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Risk of severe allergic reactions to COVID-19 vaccines among patients with allergic skin disease: practical recommendations. An ETFAD position statement with external experts: https://pubmed.ncbi.nlm.nih.gov/33752263/
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COVID-19 vaccine and death: causality algorithm according to the WHO eligibility diagnosis: https://pubmed.ncbi.nlm.nih.gov/34073536/
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Fatal brain hemorrhage after COVID-19 vaccine: https://pubmed.ncbi.nlm.nih.gov/33928772/
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A case series of skin reactions to COVID-19 vaccine in the Department of Dermatology at Loma Linda University: https://pubmed.ncbi.nlm.nih.gov/34423106/
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Skin reactions reported after Moderna and Pfizer’s COVID-19 vaccination: a study based on a registry of 414 cases: https://pubmed.ncbi.nlm.nih.gov/33838206/
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Clinical and pathologic correlates of skin reactions to COVID-19 vaccine, including V-REPP: a registry-based study: https://pubmed.ncbi.nlm.nih.gov/34517079/
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Skin reactions after vaccination against SARS-COV-2: a nationwide Spanish cross-sectional study of 405 cases: https://pubmed.ncbi.nlm.nih.gov/34254291/
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Varicella zoster virus and herpes simplex virus reactivation after vaccination with COVID-19: review of 40 cases in an international dermatologic registry: https://pubmed.ncbi.nlm.nih.gov/34487581/
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Immune thrombosis and thrombocytopenia (VITT) associated with the COVID-19 vaccine: diagnostic and therapeutic recommendations for a new syndrome: https://pubmed.ncbi.nlm.nih.gov/33987882/
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Laboratory testing for suspicion of COVID-19 vaccine-induced thrombotic (immune) thrombocytopenia: https://pubmed.ncbi.nlm.nih.gov/34138513/
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Intracerebral hemorrhage due to thrombosis with thrombocytopenia syndrome after COVID-19 vaccination: the first fatal case in Korea: https://pubmed.ncbi.nlm.nih.gov/34402235/
-
Risk of thrombocytopenia and thromboembolism after covid-19 vaccination and positive SARS-CoV-2 tests: self-controlled case series study: https://pubmed.ncbi.nlm.nih.gov/34446426/
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Vaccine-induced immune thrombotic thrombocytopenia and cerebral venous sinus thrombosis after covid-19 vaccination; a systematic review: https://pubmed.ncbi.nlm.nih.gov/34365148/.
-
Nerve and muscle adverse events after vaccination with COVID-19: a systematic review and meta-analysis of clinical trials: https://pubmed.ncbi.nlm.nih.gov/34452064/.
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A rare case of cerebral venous thrombosis and disseminated intravascular coagulation temporally associated with administration of COVID-19 vaccine: https://pubmed.ncbi.nlm.nih.gov/33917902/
-
Primary adrenal insufficiency associated with thrombotic immune thrombocytopenia induced by Oxford-AstraZeneca ChAdOx1 nCoV-19 vaccine (VITT): https://pubmed.ncbi.nlm.nih.gov/34256983/
-
Acute cerebral venous thrombosis and pulmonary artery embolism associated with the COVID-19 vaccine: https://pubmed.ncbi.nlm.nih.gov/34247246/.
-
Thromboaspiration infusion and fibrinolysis for portomesenteric thrombosis after administration of AstraZeneca COVID-19 vaccine: https://pubmed.ncbi.nlm.nih.gov/34132839/
-
59-year-old woman with extensive deep venous thrombosis and pulmonary thromboembolism 7 days after a first dose of Pfizer-BioNTech BNT162b2 mRNA vaccine COVID-19: https://pubmed.ncbi.nlm.nih.gov/34117206/
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Cerebral venous thrombosis and vaccine-induced thrombocytopenia.a. Oxford-AstraZeneca COVID-19: a missed opportunity for a rapid return on experience: https://pubmed.ncbi.nlm.nih.gov/34033927/
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Myocarditis and other cardiovascular complications of mRNA-based COVID-19 vaccines: https://pubmed.ncbi.nlm.nih.gov/34277198/
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Pericarditis after administration of COVID-19 mRNA BNT162b2 vaccine: https://pubmed.ncbi.nlm.nih.gov/34364831/
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Unusual presentation of acute pericarditis after vaccination against SARS-COV-2 mRNA-1237 Modern: https://pubmed.ncbi.nlm.nih.gov/34447639/
-
Case report: acute myocarditis after second dose of SARS-CoV-2 mRNA-1273 vaccine mRNA-1273: https://pubmed.ncbi.nlm.nih.gov/34514306/
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Immune-mediated disease outbreaks or recent-onset disease in 27 subjects after mRNA/DNA vaccination against SARS-CoV-2: https://pubmed.ncbi.nlm.nih.gov/33946748/
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Insights from a murine model of myopericarditis induced by COVID-19 mRNA vaccine: could accidental intravenous injection of a vaccine induce myopericarditis: https://pubmed.ncbi.nlm.nih.gov/34453510/
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Immune thrombocytopenia in a 22-year-old post Covid-19 vaccine: https://pubmed.ncbi.nlm.nih.gov/33476455/
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propylthiouracil-induced neutrophil anti-cytoplasmic antibody-associated vasculitis after COVID-19 vaccination: https://pubmed.ncbi.nlm.nih.gov/34451967/
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Secondary immune thrombocytopenia (ITP) associated with ChAdOx1 Covid-19 vaccine: case report: https://pubmed.ncbi.nlm.nih.gov/34377889/
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Thrombosis with thrombocytopenia syndrome (TTS) following AstraZeneca ChAdOx1 nCoV-19 (AZD1222) COVID-19 vaccination: risk-benefit analysis for persons <60 years in Australia: https://pubmed.ncbi.nlm.nih.gov/34272095/
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COVID-19 vaccination association and facial nerve palsy: A case-control study: https://pubmed.ncbi.nlm.nih.gov/34165512/
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The association between COVID-19 vaccination and Bell’s palsy: https://pubmed.ncbi.nlm.nih.gov/34411533/
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Bell’s palsy after COVID-19 vaccination: https://pubmed.ncbi.nlm.nih.gov/33611630/
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Acute transverse myelitis (ATM): clinical review of 43 patients with COVID-19-associated ATM and 3 serious adverse events of post-vaccination ATM with ChAdOx1 nCoV-19 vaccine (AZD1222): https://pubmed.ncbi.nlm.nih.gov/33981305/
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Bell’s palsy after 24 hours of mRNA-1273 SARS-CoV-2 mRNA-1273 vaccine: https://pubmed.ncbi.nlm.nih.gov/34336436/
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Sequential contralateral facial nerve palsy after first and second doses of COVID-19 vaccine: https://pubmed.ncbi.nlm.nih.gov/34281950/.
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Transverse myelitis induced by SARS-CoV-2 vaccination: https://pubmed.ncbi.nlm.nih.gov/34458035/
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Peripheral facial nerve palsy after vaccination with BNT162b2 (COVID-19): https://pubmed.ncbi.nlm.nih.gov/33734623/
-
Acute abducens nerve palsy after COVID-19 vaccination: https://pubmed.ncbi.nlm.nih.gov/34044114/.
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Facial nerve palsy after administration of COVID-19 mRNA vaccines: analysis of self-report database: https://pubmed.ncbi.nlm.nih.gov/34492394/
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Transient oculomotor paralysis after administration of RNA-1273 messenger vaccine for SARS-CoV-2 diplopia after COVID-19 vaccine: https://pubmed.ncbi.nlm.nih.gov/34369471/
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Bell’s palsy after Ad26.COV2.S COVID-19 vaccination: https://pubmed.ncbi.nlm.nih.gov/34014316/
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Bell’s palsy after COVID-19 vaccination: case report: https://pubmed.ncbi.nlm.nih.gov/34330676/
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A case of acute demyelinating polyradiculoneuropathy with bilateral facial palsy following ChAdOx1 nCoV-19 vaccination: https://pubmed.ncbi.nlm.nih.gov/34272622/
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Guillian Barré syndrome after vaccination with mRNA-1273 against COVID-19: https://pubmed.ncbi.nlm.nih.gov/34477091/
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Acute facial paralysis as a possible complication of SARS-CoV-2 vaccination: https://pubmed.ncbi.nlm.nih.gov/33975372/.
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Bell’s palsy after COVID-19 vaccination with high antibody response in CSF: https://pubmed.ncbi.nlm.nih.gov/34322761/.
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Parsonage-Turner syndrome associated with SARS-CoV-2 or SARS-CoV-2 vaccination. Comment on: “Neuralgic amyotrophy and COVID-19 infection: 2 cases of accessory spinal nerve palsy” by Coll et al. Articular Spine 2021; 88: 10519: https://pubmed.ncbi.nlm.nih.gov/34139321/.
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Bell’s palsy after a single dose of vaccine mRNA. SARS-CoV-2: case report: https://pubmed.ncbi.nlm.nih.gov/34032902/.
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Autoimmune hepatitis developing after coronavirus disease vaccine 2019 (COVID-19): causality or victim?: https://pubmed.ncbi.nlm.nih.gov/33862041/
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Autoimmune hepatitis triggered by vaccination against SARS-CoV-2: https://pubmed.ncbi.nlm.nih.gov/34332438/
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Acute autoimmune-like hepatitis with atypical antimitochondrial antibody after vaccination with COVID-19 mRNA: a new clinical entity: https://pubmed.ncbi.nlm.nih.gov/34293683/.
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Autoimmune hepatitis after COVID vaccine: https://pubmed.ncbi.nlm.nih.gov/34225251/
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A novel case of bifacial diplegia variant of Guillain-Barré syndrome after vaccination with Janssen COVID-19: https://pubmed.ncbi.nlm.nih.gov/34449715/
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Comparison of vaccine-induced thrombotic events between ChAdOx1 nCoV-19 and Ad26.COV.2.S vaccines: https://pubmed.ncbi.nlm.nih.gov/34139631/.
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Bilateral superior ophthalmic vein thrombosis, ischemic stroke and immune thrombocytopenia after vaccination with ChAdOx1 nCoV-19: https://pubmed.ncbi.nlm.nih.gov/33864750/
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Diagnosis and treatment of cerebral venous sinus thrombosis with vaccine-induced immune-immune thrombotic thrombocytopenia: https://pubmed.ncbi.nlm.nih.gov/33914590/
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Venous sinus thrombosis after vaccination with ChAdOx1 nCov-19: https://pubmed.ncbi.nlm.nih.gov/34420802/
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Cerebral venous sinus thrombosis following vaccination against SARS-CoV-2: an analysis of cases reported to the European Medicines Agency: https://pubmed.ncbi.nlm.nih.gov/34293217/
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Risk of thrombocytopenia and thromboembolism after covid-19 vaccination and positive SARS-CoV-2 tests: self-controlled case series study: https://pubmed.ncbi.nlm.nih.gov/34446426/
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Blood clots and bleeding after BNT162b2 and ChAdOx1 nCoV-19 vaccination: an analysis of European data: https://pubmed.ncbi.nlm.nih.gov/34174723/
-
Arterial events, venous thromboembolism, thrombocytopenia and bleeding after vaccination with Oxford-AstraZeneca ChAdOx1-S in Denmark and Norway: population-based cohort study: https://pubmed.ncbi.nlm.nih.gov/33952445/
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First dose of ChAdOx1 and BNT162b2 COVID-19 vaccines and thrombocytopenic, thromboembolic and hemorrhagic events in Scotland: https://pubmed.ncbi.nlm.nih.gov/34108714/
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Cerebral venous thrombosis associated with COVID-19 vaccine in Germany: https://pubmed.ncbi.nlm.nih.gov/34288044/
-
Malignant cerebral infarction after vaccination with ChAdOx1 nCov-19: a catastrophic variant of vaccine-induced immune-mediated thrombotic thrombocytopenia: https://pubmed.ncbi.nlm.nih.gov/34341358/
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celiac artery and splenic artery thrombosis complicated by splenic infarction 7 days after the first dose of Oxford vaccine, causal relationship or coincidence: https://pubmed.ncbi.nlm.nih.gov/34261633/.
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Primary adrenal insufficiency associated with Oxford-AstraZeneca ChAdOx1 nCoV-19 (VITT) vaccine-induced immune thrombotic thrombocytopenia: https://pubmed.ncbi.nlm.nih.gov/34256983/
-
Thrombocytopenia after COVID-19 vaccination: https://pubmed.ncbi.nlm.nih.gov/34332437/.
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Cerebral venous sinus thrombosis associated with thrombocytopenia after COVID-19 vaccination: https://pubmed.ncbi.nlm.nih.gov/33845870/.
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Thrombosis with thrombocytopenia syndrome after COVID-19 immunization: https://pubmed.ncbi.nlm.nih.gov/34236343/
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Acute myocardial infarction within 24 hours after COVID-19 vaccination: https://pubmed.ncbi.nlm.nih.gov/34364657/.
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Bilateral acute macular neuroretinopathy after SARS-CoV-2 vaccination: https://pubmed.ncbi.nlm.nih.gov/34287612/
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central venous sinus thrombosis with subarachnoid hemorrhage after COVID-19 mRNA vaccination: are these reports merely coincidental: https://pubmed.ncbi.nlm.nih.gov/34478433/
-
Intracerebral hemorrhage due to thrombosis with thrombocytopenia syndrome after COVID-19 vaccination: the first fatal case in Korea: https://pubmed.ncbi.nlm.nih.gov/34402235/
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Cerebral venous sinus thrombosis negative for anti-PF4 antibody without thrombocytopenia after immunization with COVID-19 vaccine in a non-comorbid elderly Indian male treated with conventional heparin-warfarin-based anticoagulation: https://pubmed.ncbi.nlm.nih.gov/34186376/
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Cerebral venous sinus thrombosis 2 weeks after first dose of SARS-CoV-2 mRNA vaccine: https://pubmed.ncbi.nlm.nih.gov/34101024/
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A case of multiple thrombocytopenia and thrombosis following vaccination with ChAdOx1 nCoV-19 against SARS-CoV-2: https://pubmed.ncbi.nlm.nih.gov/34137813/
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Vaccine-induced thrombotic thrombocytopenia: the elusive link between thrombosis and adenovirus-based SARS-CoV-2 vaccines: https://pubmed.ncbi.nlm.nih.gov/34191218/
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Acute ischemic stroke revealing immune thrombotic thrombocytopenia induced by ChAdOx1 nCov-19 vaccine: impact on recanalization strategy: https://pubmed.ncbi.nlm.nih.gov/34175640/
-
New-onset refractory status epilepticus after ChAdOx1 nCoV-19 vaccine: https://pubmed.ncbi.nlm.nih.gov/34153802/
-
Thrombosis with thrombocytopenia syndrome associated with COVID-19 viral vector vaccines: https://pubmed.ncbi.nlm.nih.gov/34092488/
-
Pulmonary embolism, transient ischemic attack, and thrombocytopenia after Johnson & Johnson COVID-19 vaccine: https://pubmed.ncbi.nlm.nih.gov/34261635/
-
Thromboaspiration infusion and fibrinolysis for portomesenteric thrombosis after administration of the AstraZeneca COVID-19 vaccine: https://pubmed.ncbi.nlm.nih.gov/34132839/.
-
Spontaneous HIT syndrome: knee replacement, infection, and parallels with vaccine-induced immune thrombotic thrombocytopenia: https://pubmed.ncbi.nlm.nih.gov/34144250/
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Deep venous thrombosis (DVT) occurring shortly after second dose of SARS-CoV-2 mRNA vaccine: https://pubmed.ncbi.nlm.nih.gov/33687691/
-
Procoagulant antibody-mediated procoagulant platelets in immune thrombotic thrombocytopenia associated with SARS-CoV-2 vaccination: https://pubmed.ncbi.nlm.nih.gov/34011137/.
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Vaccine-induced immune thrombotic thrombocytopenia causing a severe form of cerebral venous thrombosis with high mortality rate: a case series: https://pubmed.ncbi.nlm.nih.gov/34393988/.
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Procoagulant microparticles: a possible link between vaccine-induced immune thrombocytopenia (VITT) and cerebral sinus venous thrombosis: https://pubmed.ncbi.nlm.nih.gov/34129181/.
-
Atypical thrombosis associated with the vaccine VaxZevria® (AstraZeneca): data from the French network of regional pharmacovigilance centers: https://pubmed.ncbi.nlm.nih.gov/34083026/.
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Acute cerebral venous thrombosis and pulmonary artery embolism associated with the COVID-19 vaccine: https://pubmed.ncbi.nlm.nih.gov/34247246/.
-
Vaccine-induced thrombosis and thrombocytopenia with bilateral adrenal haemorrhage: https://pubmed.ncbi.nlm.nih.gov/34235757/.
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Palmar digital vein thrombosis after Oxford-AstraZeneca COVID-19 vaccination: https://pubmed.ncbi.nlm.nih.gov/34473841/.
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Cutaneous thrombosis associated with cutaneous necrosis following Oxford-AstraZeneca COVID-19 vaccination: https://pubmed.ncbi.nlm.nih.gov/34189756/
-
Cerebral venous thrombosis following COVID-19 vaccination: https://pubmed.ncbi.nlm.nih.gov/34045111/.
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Lipschütz ulcers after AstraZeneca COVID-19 vaccination: https://pubmed.ncbi.nlm.nih.gov/34366434/.
-
Amyotrophic Neuralgia secondary to Vaxzevri vaccine (AstraZeneca) COVID-19: https://pubmed.ncbi.nlm.nih.gov/34330677/
-
Thrombosis with thrombocytopenia after Messenger vaccine RNA-1273: https://pubmed.ncbi.nlm.nih.gov/34181446/
-
Intracerebral hemorrhage twelve days after vaccination with ChAdOx1 nCoV-19: https://pubmed.ncbi.nlm.nih.gov/34477089/
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Thrombotic thrombocytopenia after vaccination with COVID-19: in search of the underlying mechanism: https://pubmed.ncbi.nlm.nih.gov/34071883/
-
Coronavirus (COVID-19) Vaccine-induced immune thrombotic thrombocytopenia (VITT): https://pubmed.ncbi.nlm.nih.gov/34033367/
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Comparison of adverse drug reactions among four COVID-19 vaccines in Europe using the EudraVigilance database: Thrombosis in unusual sites: https://pubmed.ncbi.nlm.nih.gov/34375510/
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Immunoglobulin adjuvant for vaccine-induced immune thrombotic thrombocytopenia: https://pubmed.ncbi.nlm.nih.gov/34107198/
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Severe vaccine-induced thrombotic thrombocytopenia following vaccination with COVID-19: an autopsy case report and review of the literature: https://pubmed.ncbi.nlm.nih.gov/34355379/.
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A case of acute pulmonary embolism after immunization with SARS-CoV-2 mRNA: https://pubmed.ncbi.nlm.nih.gov/34452028/
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Neurosurgical considerations regarding decompressive craniectomy for intracerebral hemorrhage after SARS-CoV-2 vaccination in vaccine-induced thrombotic thrombocytopenia-VITT: https://pubmed.ncbi.nlm.nih.gov/34202817/
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Thrombosis and SARS-CoV-2 vaccines: vaccine-induced immune thrombotic thrombocytopenia: https://pubmed.ncbi.nlm.nih.gov/34237213/.
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Acquired thrombotic thrombocytopenic thrombocytopenic purpura: a rare disease associated with the BNT162b2 vaccine: https://pubmed.ncbi.nlm.nih.gov/34105247/.
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Immune complexes, innate immunity and NETosis in ChAdOx1 vaccine-induced thrombocytopenia: https://pubmed.ncbi.nlm.nih.gov/34405870/.
-
Sensory Guillain-Barré syndrome following ChAdOx1 nCov-19 vaccine: report of two cases and review of the literature: https://pubmed.ncbi.nlm.nih.gov/34416410/.
-
Vogt-Koyanagi-Harada syndrome after COVID-19 and ChAdOx1 nCoV-19 (AZD1222) vaccination: https://pubmed.ncbi.nlm.nih.gov/34462013/.
-
Reactivation of Vogt-Koyanagi-Harada disease under control for more than 6 years, after anti-SARS-CoV-2 vaccination: https://pubmed.ncbi.nlm.nih.gov/34224024/.
-
Post-vaccinal encephalitis after ChAdOx1 nCov-19: https://pubmed.ncbi.nlm.nih.gov/34324214/
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Neurological symptoms and neuroimaging alterations related to COVID-19 vaccine: cause or coincidence?: https://pubmed.ncbi.nlm.nih.gov/34507266/
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Fatal systemic capillary leak syndrome after SARS-COV-2 vaccination in a patient with multiple myeloma: https://pubmed.ncbi.nlm.nih.gov/34459725/
-
Polyarthralgia and myalgia syndrome after vaccination with ChAdOx1 nCOV-19: https://pubmed.ncbi.nlm.nih.gov/34463066/
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Three cases of subacute thyroiditis after SARS-CoV-2 vaccination: post-vaccination ASIA syndrome: https://pubmed.ncbi.nlm.nih.gov/34043800/.
-
Facial diplegia: a rare and atypical variant of Guillain-Barré syndrome and the Ad26.COV2.S vaccine: https://pubmed.ncbi.nlm.nih.gov/34447646/
-
Association between ChAdOx1 nCoV-19 vaccination and bleeding episodes: large population-based cohort study: https://pubmed.ncbi.nlm.nih.gov/34479760/.
-
fulminant myocarditis and systemic hyperinflammation temporally associated with BNT162b2 COVID-19 mRNA vaccination in two patients: https://pubmed.ncbi.nlm.nih.gov/34416319/.
-
Adverse effects reported after COVID-19 vaccination in a tertiary care hospital, centered on cerebral venous sinus thrombosis (CVST): https://pubmed.ncbi.nlm.nih.gov/34092166/
-
Induction and exacerbation of subacute cutaneous lupus erythematosus erythematosus after mRNA- or adenoviral vector-based SARS-CoV-2 vaccination: https://pubmed.ncbi.nlm.nih.gov/34291477/
-
Petechiae and peeling of fingers after immunization with BTN162b2 messenger RNA (mRNA)-based COVID-19 vaccine: https://pubmed.ncbi.nlm.nih.gov/34513435/
-
Hepatitis C virus reactivation after COVID-19 vaccination: a case report: https://pubmed.ncbi.nlm.nih.gov/34512037/
-
Bilateral immune-mediated keratolysis after immunization with SARS-CoV-2 recombinant viral vector vaccine: https://pubmed.ncbi.nlm.nih.gov/34483273/.
-
Immune-mediated thrombocytopenic purpura after Pfizer-BioNTech COVID-19 vaccine in an elderly woman: https://pubmed.ncbi.nlm.nih.gov/34513446/
-
Platelet activation and modulation in thrombosis with thrombocytopenia syndrome associated with the ChAdO × 1 nCov-19 vaccine: https://pubmed.ncbi.nlm.nih.gov/34474550/
-
Reactive arthritis after COVID-19 vaccination: https://pubmed.ncbi.nlm.nih.gov/34033732/.
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Two cases of Graves’ disease after SARS-CoV-2 vaccination: an autoimmune / inflammatory syndrome induced by adjuvants: https://pubmed.ncbi.nlm.nih.gov/33858208/
-
Acute relapse and impaired immunization after COVID-19 vaccination in a patient with multiple sclerosis treated with rituximab: https://pubmed.ncbi.nlm.nih.gov/34015240/
-
Widespread fixed bullous drug eruption after vaccination with ChAdOx1 nCoV-19: https://pubmed.ncbi.nlm.nih.gov/34482558/
-
COVID-19 mRNA vaccine causing CNS inflammation: a case series: https://pubmed.ncbi.nlm.nih.gov/34480607/
-
Thymic hyperplasia after Covid-19 mRNA-based vaccination with Covid-19: https://pubmed.ncbi.nlm.nih.gov/34462647/
-
Acute disseminated encephalomyelitis following vaccination against SARS-CoV-2: https://pubmed.ncbi.nlm.nih.gov/34325334/
-
Tolosa-Hunt syndrome occurring after COVID-19 vaccination: https://pubmed.ncbi.nlm.nih.gov/34513398/
-
Systemic capillary extravasation syndrome following vaccination with ChAdOx1 nCOV-19 (Oxford-AstraZeneca): https://pubmed.ncbi.nlm.nih.gov/34362727/
-
Immune-mediated thrombocytopenia associated with Ad26.COV2.S vaccine (Janssen; Johnson & Johnson): https://pubmed.ncbi.nlm.nih.gov/34469919/.
-
Transient thrombocytopenia with glycoprotein-specific platelet autoantibodies after vaccination with Ad26.COV2.S: case report: https://pubmed.ncbi.nlm.nih.gov/34516272/.
-
Acute hyperactive encephalopathy following COVID-19 vaccination with dramatic response to methylprednisolone: case report: https://pubmed.ncbi.nlm.nih.gov/34512961/
-
Transient cardiac injury in adolescents receiving the BNT162b2 mRNA COVID-19 vaccine: https://pubmed.ncbi.nlm.nih.gov/34077949/
-
Autoimmune hepatitis developing after ChAdOx1 nCoV-19 vaccine (Oxford-AstraZeneca): https://pubmed.ncbi.nlm.nih.gov/34171435/
-
Severe relapse of multiple sclerosis after COVID-19 vaccination: a case report: https://pubmed.ncbi.nlm.nih.gov/34447349/
-
Lymphohistocytic myocarditis after vaccination with the COVID-19 viral vector Ad26.COV2.S: https://pubmed.ncbi.nlm.nih.gov/34514078/
-
Hemophagocytic lymphohistiocytosis after vaccination with ChAdOx1 nCov-19: https://pubmed.ncbi.nlm.nih.gov/34406660/.
-
IgA vasculitis in adult patient after vaccination with ChadOx1 nCoV-19: https://pubmed.ncbi.nlm.nih.gov/34509658/
-
A case of leukocytoclastic vasculitis after vaccination with a SARS-CoV2 vaccine: case report: https://pubmed.ncbi.nlm.nih.gov/34196469/.
-
Onset / outbreak of psoriasis after Corona virus ChAdOx1 nCoV-19 vaccine (Oxford-AstraZeneca / Covishield): report of two cases: https://pubmed.ncbi.nlm.nih.gov/34350668/
-
Hailey-Hailey disease exacerbation after SARS-CoV-2 vaccination: https://pubmed.ncbi.nlm.nih.gov/34436620/
-
Supraclavicular lymphadenopathy after COVID-19 vaccination in Korea: serial follow-up by ultrasonography: https://pubmed.ncbi.nlm.nih.gov/34116295/.
-
COVID-19 vaccine, immune thrombotic thrombocytopenia, jaundice, hyperviscosity: concern in cases with underlying hepatic problems: https://pubmed.ncbi.nlm.nih.gov/34509271/.
-
Report of the International Cerebral Venous Thrombosis Consortium on cerebral venous thrombosis after SARS-CoV-2 vaccination: https://pubmed.ncbi.nlm.nih.gov/34462996/
-
Immune thrombocytopenia after vaccination during the COVID-19 pandemic: https://pubmed.ncbi.nlm.nih.gov/34435486/
-
COVID-19: lessons from the Norwegian tragedy should be taken into account in planning for vaccine launch in less developed/developing countries: https://pubmed.ncbi.nlm.nih.gov/34435142/
-
Rituximab-induced acute lympholysis and pancytopenia following vaccination with COVID-19: https://pubmed.ncbi.nlm.nih.gov/34429981/
-
Exacerbation of plaque psoriasis after COVID-19 inactivated mRNA and BNT162b2 vaccines: report of two cases: https://pubmed.ncbi.nlm.nih.gov/34427024/
-
Vaccine-induced interstitial lung disease: a rare reaction to COVID-19 vaccine: https://pubmed.ncbi.nlm.nih.gov/34510014/.
-
Vesiculobullous cutaneous reactions induced by COVID-19 mRNA vaccine: report of four cases and review of the literature: https://pubmed.ncbi.nlm.nih.gov/34236711/
-
Vaccine-induced thrombocytopenia with severe headache: https://pubmed.ncbi.nlm.nih.gov/34525282/
-
Acute perimyocarditis after the first dose of COVID-19 mRNA vaccine: https://pubmed.ncbi.nlm.nih.gov/34515024/
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Rhabdomyolysis and fasciitis induced by COVID-19 mRNA vaccine: https://pubmed.ncbi.nlm.nih.gov/34435250/.
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Rare cutaneous adverse effects of COVID-19 vaccines: a case series and review of the literature: https://pubmed.ncbi.nlm.nih.gov/34363637/
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Immune thrombocytopenia associated with the Pfizer-BioNTech COVID-19 mRNA vaccine BNT162b2: https://www.sciencedirect.com/science/article/pii/S2214250921002018
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Secondary immune thrombocytopenia putatively attributable to COVID-19 vaccination: https://casereports.bmj.com/content/14/5/e242220.abstract.
-
Immune thrombocytopenia following Pfizer-BioNTech BNT162b2 mRNA COVID-19 vaccine: https://pubmed.ncbi.nlm.nih.gov/34155844/
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Newly diagnosed idiopathic thrombocytopenia after COVID-19 vaccine administration: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8176657/.
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Idiopathic thrombocytopenic purpura and the Modern Covid-19 vaccine: https://www.annemergmed.com/article/S0196-0644(21)00122-0/fulltext.
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Thrombocytopenia after Pfizer and Moderna SARS vaccination – CoV -2: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8014568/.
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Immune thrombocytopenic purpura and acute liver injury after COVID-19 vaccination: https://casereports.bmj.com/content/14/7/e242678.
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Collection of complement-mediated and autoimmune-mediated hematologic conditions after SARS-CoV-2 vaccination: https://ashpublications.org/bloodadvances/article/5/13/2794/476324/Autoimmune-and-complement-mediated-hematologic
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Petechial rash associated with CoronaVac vaccination: first report of cutaneous side effects before phase 3 results: https://ejhp.bmj.com/content/early/2021/05/23/ejhpharm-2021-002794
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COVID-19 vaccines induce severe hemolysis in paroxysmal nocturnal hemoglobinuria: https://ashpublications.org/blood/article/137/26/3670/475905/COVID-19-vaccines-induce-severe-hemolysis-in
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Cerebral venous thrombosis associated with COVID-19 vaccine in Germany: https://pubmed.ncbi.nlm.nih.gov/34288044/.
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Cerebral venous sinus thrombosis after COVID-19 vaccination : Neurological and radiological management: https://pubmed.ncbi.nlm.nih.gov/34327553/.
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Cerebral venous thrombosis and thrombocytopenia after COVID-19 vaccination: https://pubmed.ncbi.nlm.nih.gov/33878469/.
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Cerebral venous sinus thrombosis and thrombocytopenia after COVID-19 vaccination: report of two cases in the United Kingdom: https://pubmed.ncbi.nlm.nih.gov/33857630/.
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Cerebral venous thrombosis induced by SARS-CoV-2 vaccine: https://pubmed.ncbi.nlm.nih.gov/34090750/.
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Carotid artery immune thrombosis induced by adenovirus-vectored COVID-19 vaccine: case report: https://pubmed.ncbi.nlm.nih.gov/34312301/.
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Cerebral venous sinus thrombosis associated with vaccine-induced thrombotic thrombocytopenia: https://pubmed.ncbi.nlm.nih.gov/34333995/
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The roles of platelets in COVID-19-associated coagulopathy and vaccine-induced immune-immune thrombotic thrombocytopenia: https://pubmed.ncbi.nlm.nih.gov/34455073/
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Cerebral venous thrombosis after the BNT162b2 mRNA SARS-CoV-2 vaccine: https://pubmed.ncbi.nlm.nih.gov/34111775/.
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Cerebral venous thrombosis after COVID-19 vaccination: https://pubmed.ncbi.nlm.nih.gov/34045111/
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Lethal cerebral venous sinus thrombosis after COVID-19 vaccination: https://pubmed.ncbi.nlm.nih.gov/33983464/
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Cerebral venous sinus thrombosis in the U.S. population, After SARS-CoV-2 vaccination with adenovirus and after COVID-19: https://pubmed.ncbi.nlm.nih.gov/34116145/
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Cerebral venous thrombosis after COVID-19 vaccination: is the risk of thrombosis increased by intravascular administration of the vaccine: https://pubmed.ncbi.nlm.nih.gov/34286453/.
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Central venous sinus thrombosis with subarachnoid hemorrhage after COVID-19 mRNA vaccination: are these reports merely coincidental: https://pubmed.ncbi.nlm.nih.gov/34478433/
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Cerebral venous sinus thrombosis after ChAdOx1 nCov-19 vaccination with a misleading first brain MRI: https://pubmed.ncbi.nlm.nih.gov/34244448/
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Early results of bivalirudin treatment for thrombotic thrombocytopenia and cerebral venous sinus thrombosis after vaccination with Ad26.COV2.S: https://pubmed.ncbi.nlm.nih.gov/34226070/
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Cerebral venous sinus thrombosis associated with post-vaccination thrombocytopenia by COVID-19: https://pubmed.ncbi.nlm.nih.gov/33845870/.
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Cerebral venous sinus thrombosis 2 weeks after the first dose of SARS-CoV-2 mRNA vaccine: https://pubmed.ncbi.nlm.nih.gov/34101024/.
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Vaccine-induced immune thrombotic thrombocytopenia causing a severe form of cerebral venous thrombosis with a high mortality rate: a case series: https://pubmed.ncbi.nlm.nih.gov/34393988/.
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Adenovirus interactions with platelets and coagulation and vaccine-associated autoimmune thrombocytopenia thrombosis syndrome: https://pubmed.ncbi.nlm.nih.gov/34407607/.
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Headache attributed to COVID-19 (SARS-CoV-2 coronavirus) vaccination with the ChAdOx1 nCoV-19 (AZD1222) vaccine: a multicenter observational cohort study: https://pubmed.ncbi.nlm.nih.gov/34313952/
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Adverse effects reported after COVID-19 vaccination in a tertiary care hospital, focus on cerebral venous sinus thrombosis (CVST): https://pubmed.ncbi.nlm.nih.gov/34092166/
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Cerebral venous sinus thrombosis following vaccination against SARS-CoV-2: an analysis of cases reported to the European Medicines Agency: https://pubmed.ncbi.nlm.nih.gov/34293217/
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A rare case of a middle-age Asian male with cerebral venous thrombosis after COVID-19 AstraZeneca vaccination: https://pubmed.ncbi.nlm.nih.gov/34274191/
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Cerebral venous sinus thrombosis negative for anti-PF4 antibody without thrombocytopenia after immunization with COVID-19 vaccine in a non-comorbid elderly Indian male treated with conventional heparin-warfarin-based anticoagulation: https://pubmed.ncbi.nlm.nih.gov/34186376/
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Arterial events, venous thromboembolism, thrombocytopenia and bleeding after vaccination with Oxford-AstraZeneca ChAdOx1-S in Denmark and Norway: population-based cohort study: https://pubmed.ncbi.nlm.nih.gov/33952445/
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Procoagulant microparticles: a possible link between vaccine-induced immune thrombocytopenia (VITT) and cerebral sinus venous thrombosis: https://pubmed.ncbi.nlm.nih.gov/34129181/
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S. case reports of cerebral venous sinus thrombosis with thrombocytopenia after vaccination with Ad26.COV2.S, March 2-April 21, 2021: https://pubmed.ncbi.nlm.nih.gov/33929487/.
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Malignant cerebral infarction after vaccination with ChAdOx1 nCov-19: a catastrophic variant of vaccine-induced immune-mediated thrombotic thrombocytopenia: https://pubmed.ncbi.nlm.nih.gov/34341358/
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Acute ischemic stroke revealing immune thrombotic thrombocytopenia induced by ChAdOx1 nCov-19 vaccine: impact on recanalization strategy: https://pubmed.ncbi.nlm.nih.gov/34175640/
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Vaccine-induced immune thrombotic immune thrombocytopenia (VITT): a new clinicopathologic entity with heterogeneous clinical presentations: https://pubmed.ncbi.nlm.nih.gov/34159588/.
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Imaging and hematologic findings in thrombosis and thrombocytopenia after vaccination with ChAdOx1 nCoV-19 (AstraZeneca): https://pubmed.ncbi.nlm.nih.gov/34402666/
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Autoimmunity roots of thrombotic events after vaccination with COVID-19: https://pubmed.ncbi.nlm.nih.gov/34508917/
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Cerebral venous sinus thrombosis after vaccination: the UK experience: https://pubmed.ncbi.nlm.nih.gov/34370974/
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Massive cerebral venous thrombosis and venous basin infarction as late complications of COVID-19: a case report: https://pubmed.ncbi.nlm.nih.gov/34373991/
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Australian and New Zealand approach to the diagnosis and treatment of vaccine-induced immune thrombosis and immune thrombocytopenia: https://pubmed.ncbi.nlm.nih.gov/34490632/
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An observational study to identify the prevalence of thrombocytopenia and anti-PF4 / polyanion antibodies in Norwegian health care workers after COVID-19 vaccination: https://pubmed.ncbi.nlm.nih.gov/33909350/
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Acute transverse myelitis (ATM): clinical review of 43 patients with COVID-19-associated ATM and 3 serious adverse events of post-vaccination ATM with ChAdOx1 nCoV-19 (AZD1222) vaccine: https://pubmed.ncbi.nlm.nih.gov/33981305/.
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A case of acute demyelinating polyradiculoneuropathy with bilateral facial palsy after ChAdOx1 nCoV-19 vaccine:. https://pubmed.ncbi.nlm.nih.gov/34272622/
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Thrombocytopenia with acute ischemic stroke and hemorrhage in a patient recently vaccinated with an adenoviral vector-based COVID-19 vaccine:. https://pubmed.ncbi.nlm.nih.gov/33877737/
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Predicted and observed incidence of thromboembolic events among Koreans vaccinated with the ChAdOx1 nCoV-19 vaccine: https://pubmed.ncbi.nlm.nih.gov/34254476/
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First dose of ChAdOx1 and BNT162b2 COVID-19 vaccines and thrombocytopenic, thromboembolic, and hemorrhagic events in Scotland: https://pubmed.ncbi.nlm.nih.gov/34108714/
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ChAdOx1 nCoV-19 vaccine-associated thrombocytopenia: three cases of immune thrombocytopenia after 107,720 doses of ChAdOx1 vaccination in Thailand: https://pubmed.ncbi.nlm.nih.gov/34483267/.
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Pulmonary embolism, transient ischemic attack, and thrombocytopenia after Johnson & Johnson COVID-19 vaccine: https://pubmed.ncbi.nlm.nih.gov/34261635/
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Neurosurgical considerations with respect to decompressive craniectomy for intracerebral hemorrhage after SARS-CoV-2 vaccination in vaccine-induced thrombotic thrombocytopenia-VITT: https://pubmed.ncbi.nlm.nih.gov/34202817/
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Large hemorrhagic stroke after vaccination against ChAdOx1 nCoV-19: a case report: https://pubmed.ncbi.nlm.nih.gov/34273119/
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Polyarthralgia and myalgia syndrome after vaccination with ChAdOx1 nCOV-19: https://pubmed.ncbi.nlm.nih.gov/34463066/
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A rare case of thrombosis and thrombocytopenia of the superior ophthalmic vein after ChAdOx1 nCoV-19 vaccination against SARS-CoV-2: https://pubmed.ncbi.nlm.nih.gov/34276917/
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Thrombosis and severe acute respiratory syndrome Coronavirus 2 vaccines: vaccine-induced immune thrombotic thrombocytopenia: https://pubmed.ncbi.nlm.nih.gov/34237213/.
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Renal vein thrombosis and pulmonary embolism secondary to vaccine-induced thrombotic immune thrombocytopenia (VITT): https://pubmed.ncbi.nlm.nih.gov/34268278/.
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Limb ischemia and pulmonary artery thrombosis after ChAdOx1 nCoV-19 vaccine (Oxford-AstraZeneca): a case of vaccine-induced immune thrombotic thrombocytopenia: https://pubmed.ncbi.nlm.nih.gov/33990339/.
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Association between ChAdOx1 nCoV-19 vaccination and bleeding episodes: large population-based cohort study: https://pubmed.ncbi.nlm.nih.gov/34479760/.
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Secondary thrombocytopenia after SARS-CoV-2 vaccination: case report of haemorrhage and hematoma after minor oral surgery: https://pubmed.ncbi.nlm.nih.gov/34314875/.
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Venous thromboembolism and mild thrombocytopenia after vaccination with ChAdOx1 nCoV-19: https://pubmed.ncbi.nlm.nih.gov/34384129/
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Fatal exacerbation of ChadOx1-nCoV-19-induced thrombotic thrombocytopenia syndrome after successful initial therapy with intravenous immunoglobulins: a rationale for monitoring immunoglobulin G levels: https://pubmed.ncbi.nlm.nih.gov/34382387/
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A case of ANCA-associated vasculitis after AZD1222 (Oxford-AstraZeneca) SARS-CoV-2 vaccination: victim or causality?: https://pubmed.ncbi.nlm.nih.gov/34416184/.
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Intracerebral hemorrhage associated with vaccine-induced thrombotic thrombocytopenia after ChAdOx1 nCOVID-19 vaccination in a pregnant woman: https://pubmed.ncbi.nlm.nih.gov/34261297/
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Massive cerebral venous thrombosis due to vaccine-induced immune thrombotic thrombocytopenia: https://pubmed.ncbi.nlm.nih.gov/34261296/
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Nephrotic syndrome after ChAdOx1 nCoV-19 vaccine against SARScoV-2: https://pubmed.ncbi.nlm.nih.gov/34250318/.
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A case of vaccine-induced immune-immune thrombotic thrombocytopenia with massive arteriovenous thrombosis: https://pubmed.ncbi.nlm.nih.gov/34059191/
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Cutaneous thrombosis associated with cutaneous necrosis following Oxford-AstraZeneca COVID-19 vaccination: https://pubmed.ncbi.nlm.nih.gov/34189756/
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Thrombocytopenia in an adolescent with sickle cell anemia after COVID-19 vaccination: https://pubmed.ncbi.nlm.nih.gov/34331506/
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Vaccine-induced thrombocytopenia with severe headache: https://pubmed.ncbi.nlm.nih.gov/34525282/
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Myocarditis associated with SARS-CoV-2 mRNA vaccination in children aged 12 to 17 years: stratified analysis of a national database: https://www.medrxiv.org/content/10.1101/2021.08.30.21262866v1
-
COVID-19 mRNA vaccination and development of CMR-confirmed myopericarditis: https://www.medrxiv.org/content/10.1101/2021.09.13.21262182v1.full?s=09.
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Severe autoimmune hemolytic anemia after receipt of SARS-CoV-2 mRNA vaccine: https://onlinelibrary.wiley.com/doi/10.1111/trf.16672
-
Intravenous injection of coronavirus disease 2019 (COVID-19) mRNA vaccine can induce acute myopericarditis in a mouse model: https://t.co/j0IEM8cMXI
-
A report of myocarditis adverse events in the U.S. Vaccine Adverse Event Reporting System. (VAERS) in association with COVID-19 injectable biologics: https://pubmed.ncbi.nlm.nih.gov/34601006/
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This study concludes that: “The vaccine was associated with an excess risk of myocarditis (1 to 5 events per 100,000 persons). The risk of this potentially serious adverse event and of many other serious adverse events increased substantially after SARS-CoV-2 infection”: https://www.nejm.org/doi/full/10.1056/NEJMoa2110475
-
Bilateral uveitis after inoculation with COVID-19 vaccine: a case report: https://www.sciencedirect.com/science/article/pii/S1201971221007797
-
Myocarditis associated with SARS-CoV-2 mRNA vaccination in children aged 12 to 17 years: stratified analysis of a national database: https://www.medrxiv.org/content/10.1101/2021.08.30.21262866v1.
-
Immune-mediated hepatitis with the Moderna vaccine is no longer a coincidence but confirmed: https://www.sciencedirect.com/science/article/pii/S0168827821020936
-
Extensive investigations revealed consistent pathophysiologic alterations after vaccination with COVID-19 vaccines: https://www.nature.com/articles/s41421-021-00329-3
-
Lobar hemorrhage with ventricular rupture shortly after the first dose of an mRNA-based SARS-CoV-2 vaccine: https://www.ncbi.nlm.nih.gov/labs/pmc/articles/PMC8553377/
-
Mrna COVID vaccines dramatically increase endothelial inflammatory markers and risk of Acute Coronary Syndrome as measured by PULS cardiac testing: a caution: https://www.ahajournals.org/doi/10.1161/circ.144.suppl_1.10712
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ChAdOx1 interacts with CAR and PF4 with implications for thrombosis with thrombocytopenia syndrome:https://www.science.org/doi/10.1126/sciadv.abl8213
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Lethal vaccine-induced immune thrombotic immune thrombocytopenia (VITT) following announcement 26.COV2.S: first documented case outside the U.S.: https://pubmed.ncbi.nlm.nih.gov/34626338/
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A prothrombotic thrombocytopenic disorder resembling heparin-induced thrombocytopenia after coronavirus-19 vaccination: https://europepmc.org/article/PPR/PPR304469 435.
-
VITT (vaccine-induced immune thrombotic thrombocytopenia) after vaccination with ChAdOx1 nCoV-19: https://pubmed.ncbi.nlm.nih.gov/34731555/
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Vaccine-induced immune thrombotic thrombocytopenia (VITT): a new clinicopathologic entity with heterogeneous clinical presentations: https://pubmed.ncbi.nlm.nih.gov/34159588/
-
Treatment of acute ischemic stroke associated with ChAdOx1 nCoV-19 vaccine-induced immune thrombotic thrombocytopenia: https://pubmed.ncbi.nlm.nih.gov/34461442/
-
Spectrum of neurological complications after COVID-19 vaccination: https://pubmed.ncbi.nlm.nih.gov/34719776/.
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Cerebral venous sinus thrombosis after vaccination: the UK experience: https://pubmed.ncbi.nlm.nih.gov/34370974/
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Cerebral venous vein/venous sinus thrombosis with thrombocytopenia syndrome after COVID-19 vaccination: https://pubmed.ncbi.nlm.nih.gov/34373413/
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Portal vein thrombosis due to vaccine-induced immune thrombotic immune thrombocytopenia (VITT) after Covid vaccination with ChAdOx1 nCoV-19: https://pubmed.ncbi.nlm.nih.gov/34598301/
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Hematuria, a generalized petechial rash and headaches after Oxford AstraZeneca ChAdOx1 nCoV-19 vaccination: https://pubmed.ncbi.nlm.nih.gov/34620638/
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Myocardial infarction and azygos vein thrombosis after vaccination with ChAdOx1 nCoV-19 in a hemodialysis patient: https://pubmed.ncbi.nlm.nih.gov/34650896/
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Takotsubo (stress) cardiomyopathy after vaccination with ChAdOx1 nCoV-19: https://pubmed.ncbi.nlm.nih.gov/34625447/
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Humoral response induced by Prime-Boost vaccination with ChAdOx1 nCoV-19 and BNT162b2 mRNA vaccines in a patient with multiple sclerosis treated with teriflunomide: https://pubmed.ncbi.nlm.nih.gov/34696248/
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Guillain-Barré syndrome after ChAdOx1 nCoV-19 COVID-19 vaccination: a case series: https://pubmed.ncbi.nlm.nih.gov/34548920/
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Refractory vaccine-induced immune thrombotic thrombocytopenia (VITT) treated with delayed therapeutic plasma exchange (TPE): https://pubmed.ncbi.nlm.nih.gov/34672380/.
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Rare case of COVID-19 vaccine-associated intracranial hemorrhage with venous sinus thrombosis: https://pubmed.ncbi.nlm.nih.gov/34556531/.
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Delayed headache after COVID-19 vaccination: a warning sign for vaccine-induced cerebral venous thrombosis: https://pubmed.ncbi.nlm.nih.gov/34535076/.
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Clinical features of vaccine-induced thrombocytopenia and immune thrombosis: https://pubmed.ncbi.nlm.nih.gov/34379914/.
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Predictors of mortality in thrombotic thrombocytopenia after adenoviral COVID-19 vaccination: the FAPIC score: https://pubmed.ncbi.nlm.nih.gov/34545400/
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Ischemic stroke as a presenting feature of immune thrombotic thrombocytopenia induced by ChAdOx1-nCoV-19 vaccination: https://pubmed.ncbi.nlm.nih.gov/34035134/
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In-hospital observational study of neurological disorders in patients recently vaccinated with COVID-19 mRNA vaccines: https://pubmed.ncbi.nlm.nih.gov/34688190/
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Endovascular treatment for vaccine-induced cerebral venous sinus thrombosis and thrombocytopenia after vaccination with ChAdOx1 nCoV-19: report of three cases: https://pubmed.ncbi.nlm.nih.gov/34782400/
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Cardiovascular, neurological, and pulmonary events after vaccination with BNT162b2, ChAdOx1 nCoV-19, and Ad26.COV2.S vaccines: an analysis of European data: https://pubmed.ncbi.nlm.nih.gov/34710832/
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Cerebral venous thrombosis developing after vaccination. COVID-19: VITT, VATT, TTS and more: https://pubmed.ncbi.nlm.nih.gov/34695859/
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Cerebral venous thrombosis and myeloproliferative neoplasms: a three-center study of 74 consecutive cases: https://pubmed.ncbi.nlm.nih.gov/34453762/.
-
Possible triggers of thrombocytopenia and/or hemorrhage by BNT162b2 vaccine, Pfizer-BioNTech: https://pubmed.ncbi.nlm.nih.gov/34660652/.
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Multiple sites of arterial thrombosis in a 35-year-old patient after vaccination with ChAdOx1 (AstraZeneca), which required emergency femoral and carotid surgical thrombectomy: https://pubmed.ncbi.nlm.nih.gov/34644642/
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Case series of vaccine-induced thrombotic thrombocytopenia in a London teaching hospital: https://pubmed.ncbi.nlm.nih.gov/34694650/
-
Neuro-ophthalmic complications with thrombocytopenia and thrombosis induced by ChAdOx1 nCoV-19 vaccine: https://pubmed.ncbi.nlm.nih.gov/34726934/
-
Thrombotic events after COVID-19 vaccination in over 50 years of age: results of a population-based study in Italy: https://pubmed.ncbi.nlm.nih.gov/34835237/
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Intracerebral hemorrhage associated with vaccine-induced thrombotic thrombocytopenia after ChAdOx1 nCOVID-19 vaccination in a pregnant woman: https://pubmed.ncbi.nlm.nih.gov/34261297/
-
Age- and sex-specific incidence of cerebral venous sinus thrombosis associated with Ad26.COV2.S COVID-19 vaccination: https://pubmed.ncbi.nlm.nih.gov/34724036/.
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Genital necrosis with cutaneous thrombosis following vaccination with COVID-19 mRNA: https://pubmed.ncbi.nlm.nih.gov/34839563/
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Cerebral venous sinus thrombosis after mRNA-based COVID-19 vaccination: https://pubmed.ncbi.nlm.nih.gov/34783932/.
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COVID-19 vaccine-induced immune thrombosis with thrombocytopenia thrombosis (VITT) and shades of gray in thrombus formation: https://pubmed.ncbi.nlm.nih.gov/34624910/
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Inflammatory myositis after vaccination with ChAdOx1: https://pubmed.ncbi.nlm.nih.gov/34585145/
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Acute ST-segment elevation myocardial infarction secondary to vaccine-induced immune thrombosis with thrombocytopenia (VITT): https://pubmed.ncbi.nlm.nih.gov/34580132/.
-
A rare case of COVID-19 vaccine-induced thrombotic thrombocytopenia (VITT) affecting the venosplanchnic and pulmonary arterial circulation from a UK district general hospital: https://pubmed.ncbi.nlm.nih.gov/34535492/
-
COVID-19 vaccine-induced thrombotic thrombocytopenia: a case series: https://pubmed.ncbi.nlm.nih.gov/34527501/
-
Thrombosis with thrombocytopenia syndrome (TTS) after vaccination with AstraZeneca ChAdOx1 nCoV-19 (AZD1222) COVID-19: a risk-benefit analysis for persons <60% risk-benefit analysis for people <60 years in Australia: https://pubmed.ncbi.nlm.nih.gov/34272095/
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Immune thrombocytopenia after immunization with Vaxzevria ChadOx1-S vaccine (AstraZeneca), Victoria, Australia: https://pubmed.ncbi.nlm.nih.gov/34756770/
-
Characteristics and outcomes of patients with cerebral venous sinus thrombosis in thrombotic immune thrombocytopenia induced by SARS-CoV-2 vaccine: https://jamanetwork.com/journals/jamaneurology/fullarticle/2784622
-
Case study of thrombosis and thrombocytopenia syndrome after administration of the AstraZeneca COVID-19 vaccine: https://pubmed.ncbi.nlm.nih.gov/34781321/
-
Thrombosis with Thrombocytopenia Syndrome Associated with COVID-19 Vaccines: https://pubmed.ncbi.nlm.nih.gov/34062319/
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Cerebral venous sinus thrombosis following vaccination with ChAdOx1: the first case of definite thrombosis with thrombocytopenia syndrome in India: https://pubmed.ncbi.nlm.nih.gov/34706921/
-
COVID-19 vaccine-associated thrombosis with thrombocytopenia syndrome (TTS): systematic review and post hoc analysis: https://pubmed.ncbi.nlm.nih.gov/34698582/.
-
Case report of immune thrombocytopenia after vaccination with ChAdOx1 nCoV-19: https://pubmed.ncbi.nlm.nih.gov/34751013/.
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Acute transverse myelitis after COVID-19 vaccination: https://pubmed.ncbi.nlm.nih.gov/34684047/.
-
Concerns for adverse effects of thrombocytopenia and thrombosis after adenovirus-vectored COVID-19 vaccination: https://pubmed.ncbi.nlm.nih.gov/34541935/
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Major hemorrhagic stroke after ChAdOx1 nCoV-19 vaccination: a case report: https://pubmed.ncbi.nlm.nih.gov/34273119/
-
Cerebral venous sinus thrombosis after COVID-19 vaccination: neurologic and radiologic management: https://pubmed.ncbi.nlm.nih.gov/34327553/.
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Thrombocytopenia with acute ischemic stroke and hemorrhage in a patient recently vaccinated with an adenoviral vector-based COVID-19 vaccine: https://pubmed.ncbi.nlm.nih.gov/33877737/
-
Intracerebral hemorrhage and thrombocytopenia after AstraZeneca COVID-19 vaccine: clinical and diagnostic challenges of vaccine-induced thrombotic thrombocytopenia: https://pubmed.ncbi.nlm.nih.gov/34646685/
-
Minimal change disease with severe acute kidney injury after Oxford-AstraZeneca COVID-19 vaccine: case report: https://pubmed.ncbi.nlm.nih.gov/34242687/.
-
Case report: cerebral sinus vein thrombosis in two patients with AstraZeneca SARS-CoV-2 vaccine: https://pubmed.ncbi.nlm.nih.gov/34609603/
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Case report: Pityriasis rosea-like rash after vaccination with COVID-19: https://pubmed.ncbi.nlm.nih.gov/34557507/
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Extensive longitudinal transverse myelitis after ChAdOx1 nCOV-19 vaccine: case report: https://pubmed.ncbi.nlm.nih.gov/34641797/.
-
Acute eosinophilic pneumonia associated with anti-COVID-19 vaccine AZD1222: https://pubmed.ncbi.nlm.nih.gov/34812326/.
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Thrombocytopenia, including immune thrombocytopenia after receiving COVID-19 mRNA vaccines reported to the Vaccine Adverse Event Reporting System (VAERS): https://pubmed.ncbi.nlm.nih.gov/34006408/
-
A case of ANCA-associated vasculitis after AZD1222 (Oxford-AstraZeneca) SARS-CoV-2 vaccination: victim or causality?: https://pubmed.ncbi.nlm.nih.gov/34416184/
-
Vaccine-induced immune thrombosis and thrombocytopenia syndrome after adenovirus-vectored severe acute respiratory syndrome coronavirus 2 vaccination: a new hypothesis on mechanisms and implications for future vaccine development: https://pubmed.ncbi.nlm.nih.gov/34664303/.
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Thrombosis in peripheral artery disease and thrombotic thrombocytopenia following adenoviral COVID-19 vaccination: https://pubmed.ncbi.nlm.nih.gov/34649281/.
-
Newly diagnosed immune thrombocytopenia in a pregnant patient after coronavirus disease 2019 vaccination: https://pubmed.ncbi.nlm.nih.gov/34420249/
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Cerebral venous sinus thrombosis and thrombotic events after vector-based COVID-19 vaccines: systematic review and meta-analysis: https://pubmed.ncbi.nlm.nih.gov/34610990/.
-
Sweet’s syndrome after Oxford-AstraZeneca COVID-19 vaccine (AZD1222) in an elderly woman: https://pubmed.ncbi.nlm.nih.gov/34590397/
-
Sudden sensorineural hearing loss after COVID-19 vaccination: https://pubmed.ncbi.nlm.nih.gov/34670143/.
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Prevalence of serious adverse events among health care professionals after receiving the first dose of ChAdOx1 nCoV-19 coronavirus vaccine (Covishield) in Togo, March 2021: https://pubmed.ncbi.nlm.nih.gov/34819146/.
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Acute hemichorea-hemibalismus after COVID-19 (AZD1222) vaccination: https://pubmed.ncbi.nlm.nih.gov/34581453/
-
Recurrence of alopecia areata after covid-19 vaccination: a report of three cases in Italy: https://pubmed.ncbi.nlm.nih.gov/34741583/
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Shingles-like skin lesion after vaccination with AstraZeneca for COVID-19: a case report: https://pubmed.ncbi.nlm.nih.gov/34631069/
-
Thrombosis after COVID-19 vaccination: possible link to ACE pathways: https://pubmed.ncbi.nlm.nih.gov/34479129/
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Thrombocytopenia in an adolescent with sickle cell anemia after COVID-19 vaccination: https://pubmed.ncbi.nlm.nih.gov/34331506/
-
Leukocytoclastic vasculitis as a cutaneous manifestation of ChAdOx1 corona virus vaccine nCoV-19 (recombinant): https://pubmed.ncbi.nlm.nih.gov/34546608/
-
Abdominal pain and bilateral adrenal hemorrhage from immune thrombotic thrombocytopenia induced by COVID-19 vaccine: https://pubmed.ncbi.nlm.nih.gov/34546343/
-
Longitudinally extensive cervical myelitis after vaccination with inactivated virus based COVID-19 vaccine: https://pubmed.ncbi.nlm.nih.gov/34849183/
-
Induction of cutaneous leukocytoclastic vasculitis after ChAdOx1 nCoV-19 vaccine: https://pubmed.ncbi.nlm.nih.gov/34853744/.
-
A case of toxic epidermal necrolysis after vaccination with ChAdOx1 nCoV-19 (AZD1222): https://pubmed.ncbi.nlm.nih.gov/34751429/.
-
Ocular adverse events following COVID-19 vaccination: https://pubmed.ncbi.nlm.nih.gov/34559576/
-
Depression after ChAdOx1-S / nCoV-19 vaccination: https://pubmed.ncbi.nlm.nih.gov/34608345/.
-
Venous thromboembolism and mild thrombocytopenia after ChAdOx1 nCoV-19 vaccination: https://pubmed.ncbi.nlm.nih.gov/34384129/.
-
Recurrent ANCA-associated vasculitis after Oxford AstraZeneca ChAdOx1-S COVID-19 vaccination: a case series of two patients: https://pubmed.ncbi.nlm.nih.gov/34755433/
-
Major artery thrombosis and vaccination against ChAdOx1 nCov-19: https://pubmed.ncbi.nlm.nih.gov/34839830/
-
Rare case of contralateral supraclavicular lymphadenopathy after vaccination with COVID-19: computed tomography and ultrasound findings: https://pubmed.ncbi.nlm.nih.gov/34667486/
-
Cutaneous lymphocytic vasculitis after administration of the second dose of AZD1222 (Oxford-AstraZeneca) Severe acute respiratory syndrome Coronavirus 2 vaccine: chance or causality: https://pubmed.ncbi.nlm.nih.gov/34726187/.
-
Pancreas allograft rejection after ChAdOx1 nCoV-19 vaccine: https://pubmed.ncbi.nlm.nih.gov/34781027/
-
Understanding the risk of thrombosis with thrombocytopenia syndrome following Ad26.COV2.S vaccination: https://pubmed.ncbi.nlm.nih.gov/34595694/
-
Cutaneous adverse reactions of 35,229 doses of COVID-19 Sinovac and AstraZeneca vaccine COVID-19: a prospective cohort study in health care workers: https://pubmed.ncbi.nlm.nih.gov/34661934/
-
Comments on thrombosis after vaccination: spike protein leader sequence could be responsible for thrombosis and antibody-mediated thrombocytopenia: https://pubmed.ncbi.nlm.nih.gov/34788138
-
Eosinophilic dermatosis after AstraZeneca COVID-19 vaccination: https://pubmed.ncbi.nlm.nih.gov/34753210/.
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Severe immune thrombocytopenia following COVID-19 vaccination: report of four cases and review of the literature: https://pubmed.ncbi.nlm.nih.gov/34653943/.
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Relapse of immune thrombocytopenia after COVID-19 vaccination: https://pubmed.ncbi.nlm.nih.gov/34591991/
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Thrombosis in pre- and post-vaccination phase of COVID-19; https://pubmed.ncbi.nlm.nih.gov/34650382/
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A look at the role of postmortem immunohistochemistry in understanding the inflammatory pathophysiology of COVID-19 disease and vaccine-related thrombotic adverse events: a narrative review: https://pubmed.ncbi.nlm.nih.gov/34769454/
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COVID-19 vaccine in patients with hypercoagulability disorders: a clinical perspective: https://pubmed.ncbi.nlm.nih.gov/34786893/
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Vaccine-associated thrombocytopenia and thrombosis: venous endotheliopathy leading to combined venous micro-macrothrombosis: https://pubmed.ncbi.nlm.nih.gov/34833382/
-
Thrombosis and thrombocytopenia syndrome causing isolated symptomatic carotid occlusion after COVID-19 Ad26.COV2.S vaccine (Janssen): https://pubmed.ncbi.nlm.nih.gov/34670287/
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An unusual presentation of acute deep vein thrombosis after Modern COVID-19 vaccine: case report: https://pubmed.ncbi.nlm.nih.gov/34790811/
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Immediate high-dose intravenous immunoglobulins followed by direct treatment with thrombin inhibitors is crucial for survival in vaccine-induced immune thrombotic thrombocytopenia Sars-Covid-19-vector adenoviral VITT with venous thrombosis of the cerebral sinus and portal vein: https://pubmed.ncbi.nlm.nih.gov/34023956/.
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Thrombosis formation after COVID-19 vaccination immunologic aspects: review article: https://pubmed.ncbi.nlm.nih.gov/34629931/
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Imaging and hematologic findings in thrombosis and thrombocytopenia after vaccination with ChAdOx1 nCoV-19 (AstraZeneca): https://pubmed.ncbi.nlm.nih.gov/34402666/
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Spectrum of neuroimaging findings in post-CoVID-19 vaccination: a case series and review of the literature: https://pubmed.ncbi.nlm.nih.gov/34842783/
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Cerebral venous sinus thrombosis, pulmonary embolism, and thrombocytopenia after COVID-19 vaccination in a Taiwanese man: a case report and review of the literature: https://pubmed.ncbi.nlm.nih.gov/34630307/
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Fatal cerebral venous sinus thrombosis after COVID-19 vaccination: https://pubmed.ncbi.nlm.nih.gov/33983464/
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Autoimmune roots of thrombotic events after COVID-19 vaccination: https://pubmed.ncbi.nlm.nih.gov/34508917/.
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New portal vein thrombosis in cirrhosis: is thrombophilia exacerbated by vaccine or COVID-19: https://www.jcehepatology.com/article/S0973-6883(21)00545-4/fulltext.
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Images of immune thrombotic thrombocytopenia induced by Oxford / AstraZeneca® COVID-19 vaccine: https://pubmed.ncbi.nlm.nih.gov/33962903/.
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Cerebral venous sinus thrombosis after vaccination with COVID-19 mRNA of BNT162b2: https://pubmed.ncbi.nlm.nih.gov/34796065/.
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Increased risk of urticaria/angioedema after BNT162b2 mRNA COVID-19 vaccination in health care workers taking ACE inhibitors: https://pubmed.ncbi.nlm.nih.gov/34579248/
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A case of unusual mild clinical presentation of COVID-19 vaccine-induced immune thrombotic thrombocytopenia with splanchnic vein thrombosis: https://pubmed.ncbi.nlm.nih.gov/34843991/
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Cerebral venous sinus thrombosis following vaccination with Pfizer-BioNTech COVID-19 (BNT162b2): https://pubmed.ncbi.nlm.nih.gov/34595867/
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A case of idiopathic thrombocytopenic purpura after a booster dose of COVID-19 BNT162b2 vaccine (Pfizer-Biontech): https://pubmed.ncbi.nlm.nih.gov/34820240/
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Vaccine-induced immune thrombotic immune thrombocytopenia (VITT): targeting pathologic mechanisms with Bruton’s tyrosine kinase inhibitors: https://pubmed.ncbi.nlm.nih.gov/33851389/
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Thrombotic thrombocytopenic purpura after vaccination with Ad26.COV2-S: https://pubmed.ncbi.nlm.nih.gov/33980419/
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Thromboembolic events in younger females exposed to Pfizer-BioNTech or Moderna COVID-19 vaccines: https://pubmed.ncbi.nlm.nih.gov/34264151/
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Potential risk of thrombotic events after COVID-19 vaccination with Oxford-AstraZeneca in women receiving estrogen: https://pubmed.ncbi.nlm.nih.gov/34734086/
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Thrombosis after adenovirus-vectored COVID-19 vaccination: a concern for underlying disease: https://pubmed.ncbi.nlm.nih.gov/34755555/
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Adenovirus interactions with platelets and coagulation and vaccine-induced immune thrombotic thrombocytopenia syndrome: https://pubmed.ncbi.nlm.nih.gov/34407607/
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Thrombotic thrombocytopenic purpura: a new threat after COVID bnt162b2 vaccine: https://pubmed.ncbi.nlm.nih.gov/34264514/.
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Unusual site of deep vein thrombosis after vaccination against coronavirus mRNA-2019 coronavirus disease (COVID-19): https://pubmed.ncbi.nlm.nih.gov/34840204/
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Neurological side effects of SARS-CoV-2 vaccines: https://pubmed.ncbi.nlm.nih.gov/34750810/
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Coagulopathies after SARS-CoV-2 vaccination may derive from a combined effect of SARS-CoV-2 spike protein and adenovirus vector-activated signaling pathways: https://pubmed.ncbi.nlm.nih.gov/34639132/
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Isolated pulmonary embolism after COVID vaccination: 2 case reports and a review of acute pulmonary embolism complications and follow-up: https://pubmed.ncbi.nlm.nih.gov/34804412/
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Central retinal vein occlusion after vaccination with SARS-CoV-2 mRNA: case report: https://pubmed.ncbi.nlm.nih.gov/34571653/.
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Complicated case report of long-term vaccine-induced thrombotic immune thrombocytopenia A: https://pubmed.ncbi.nlm.nih.gov/34835275/.
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Deep venous thrombosis after vaccination with Ad26.COV2.S in adult males: https://pubmed.ncbi.nlm.nih.gov/34659839/.
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Neurological autoimmune diseases after SARS-CoV-2 vaccination: a case series: https://pubmed.ncbi.nlm.nih.gov/34668274/.
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Severe autoimmune hemolytic autoimmune anemia after receiving SARS-CoV-2 mRNA vaccine: https://pubmed.ncbi.nlm.nih.gov/34549821/
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Occurrence of COVID-19 variants among recipients of ChAdOx1 nCoV-19 vaccine (recombinant): https://pubmed.ncbi.nlm.nih.gov/34528522/
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Prevalence of thrombocytopenia, anti-platelet factor 4 antibodies, and elevated D-dimer in Thais after vaccination with ChAdOx1 nCoV-19: https://pubmed.ncbi.nlm.nih.gov/34568726/
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Epidemiology of acute myocarditis/pericarditis in Hong Kong adolescents after co-vaccination: https://academic.oup.com/cid/advance-article-abstract/doi/10.1093/cid/ciab989/644 5179.
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Myocarditis after 2019 coronavirus disease mRNA vaccine: a case series and determination of incidence rate: https://academic.oup.com/cid/advance-article/doi/10.1093/cid/ciab926/6420408
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Myocarditis and pericarditis after COVID-19 vaccination: inequalities in age and vaccine types: https://www.mdpi.com/2075-4426/11/11/1106
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Epidemiology and clinical features of myocarditis/pericarditis before the introduction of COVID-19 mRNA vaccine in Korean children: a multicenter study: https://pubmed.ncbi.nlm.nih.gov/34402230/
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Shedding light on post-vaccination myocarditis and pericarditis in COVID-19 and non-COVID-19 vaccine recipients: https://pubmed.ncbi.nlm.nih.gov/34696294/
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Myocarditis Following mRNA COVID-19 Vaccine: https://journals.lww.com/pec-online/Abstract/2021/11000/Myocarditis_Following_ mRNA_COVID_19_Vaccine.9.aspx.
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Myocarditis following BNT162b2 mRNA Covid-19 mRNA vaccine in Israel: https://pubmed.ncbi.nlm.nih.gov/34614328/.
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Myocarditis, pericarditis, and cardiomyopathy following COVID-19 vaccination: https://www.heartlungcirc.org/article/S1443-9506(21)01156-2/fulltext
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Myocarditis and other cardiovascular complications of COVID-19 mRNA-based COVID-19 vaccines: https://pubmed.ncbi.nlm.nih.gov/34277198/
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Possible Association Between COVID-19 Vaccine and Myocarditis: Clinical and CMR Findings: https://pubmed.ncbi.nlm.nih.gov/34246586/
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Hypersensitivity Myocarditis and COVID-19 Vaccines: https://pubmed.ncbi.nlm.nih.gov/34856634/.
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Severe myocarditis associated with COVID-19 vaccine: zebra or unicorn?: https://www.internationaljournalofcardiology.com/article/S0167-5273(21)01477-7/fulltext.
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Acute myocardial infarction and myocarditis after COVID-19 vaccination: https://www.ncbi.nlm.nih.gov/labs/pmc/articles/PMC8522388/
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Myocarditis after Covid-19 vaccination in a large healthcare organization: https://www.nejm.org/doi/10.1056/NEJMoa2110737
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Association of myocarditis with COVID-19 messenger RNA BNT162b2 vaccine in a case series of children: https://jamanetwork.com/journals/jamacardiology/fullarticle/2783052
-
Clinical suspicion of myocarditis temporally related to COVID-19 vaccination in adolescents and young adults: https://www.ahajournals.org/doi/abs/10.1161/CIRCULATIONAHA.121.056583?url_ver=Z39.88-2003&rfr_id=ori:rid:crossref.org&rfr_dat=cr_pub%20%200pubmed
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STEMI mimicry: focal myocarditis in an adolescent patient after COVID-19 mRNA vaccination:. https://pubmed.ncbi.nlm.nih.gov/34756746/
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Myocarditis and pericarditis in association with COVID-19 mRNA vaccination: cases from a regional pharmacovigilance center: https://www.ncbi.nlm.nih.gov/labs/pmc/articles/PMC8587334/
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Myocarditis after COVID-19 mRNA vaccines: https://pubmed.ncbi.nlm.nih.gov/34546329/.
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Patients with acute myocarditis after COVID-19 mRNA vaccination:. https://jamanetwork.com/journals/jamacardiology/fullarticle/2781602.
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Myocarditis after COVID-19 vaccination: a case series: https://www.sciencedirect.com/science/article/pii/S0264410X21011725?via%3Dihub.
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Myocarditis associated with COVID-19 vaccination in adolescents: https://publications.aap.org/pediatrics/article/148/5/e2021053427/181357
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Myocarditis findings on cardiac magnetic resonance imaging after vaccination with COVID-19 mRNA in adolescents:. https://pubmed.ncbi.nlm.nih.gov/34704459/
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Myocarditis after COVID-19 vaccination: magnetic resonance imaging study: https://academic.oup.com/ehjcimaging/advance-article/doi/10.1093/ehjci/jeab230/6 421640.
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Acute myocarditis after administration of the second dose of BNT162b2 COVID-19 vaccine: https://www.ncbi.nlm.nih.gov/labs/pmc/articles/PMC8599115/
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Myocarditis after COVID-19 vaccination: https://www.sciencedirect.com/science/article/pii/S2352906721001603
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Case report: probable myocarditis after Covid-19 mRNA vaccine in a patient with arrhythmogenic left ventricular cardiomyopathy: https://pubmed.ncbi.nlm.nih.gov/34712717/.
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Acute myocarditis after administration of BNT162b2 vaccine against COVID-19: https://www.revespcardiol.org/en-linkresolver-acute-myocarditis-after-administration-bnt162b2-S188558572100133X.
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Myocarditis associated with COVID-19 mRNA vaccination: https://pubs.rsna.org/doi/10.1148/radiol.2021211430
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Acute myocarditis after COVID-19 vaccination: a case report: https://www.sciencedirect.com/science/article/pii/S0248866321007098
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Acute myopericarditis after COVID-19 vaccination in adolescents:. https://pubmed.ncbi.nlm.nih.gov/34589238/.
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Perimyocarditis in adolescents after Pfizer-BioNTech COVID-19 vaccination: https://academic.oup.com/jpids/article/10/10/962/6329543.
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Acute myocarditis associated with anti-COVID-19 vaccination: https://ecevr.org/DOIx.php?id=10.7774/cevr.2021.10.2.196.
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Myocarditis associated with COVID-19 vaccination: echocardiographic, cardiac CT, and MRI findings:. https://pubmed.ncbi.nlm.nih.gov/34428917/.
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Acute symptomatic myocarditis in 7 adolescents after Pfizer-BioNTech COVID-19 vaccination:. https://pubmed.ncbi.nlm.nih.gov/34088762/.
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Myocarditis and pericarditis in adolescents after first and second doses of COVID-19 mRNA vaccines:. https://academic.oup.com/ehjqcco/advance-article/doi/10.1093/ehjqcco/qcab090/64 42104.
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COVID 19 vaccine for adolescents. Concern for myocarditis and pericarditis: https://www.mdpi.com/2036-7503/13/3/61.
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Cardiac imaging of acute myocarditis after vaccination with COVID-19 mRNA: https://pubmed.ncbi.nlm.nih.gov/34402228/
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Myocarditis temporally associated with COVID-19 vaccination: https://pubmed.ncbi.nlm.nih.gov/34133885/
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Acute myocardial injury after COVID-19 vaccination: a case report and review of current evidence from the vaccine adverse event reporting system database: https://pubmed.ncbi.nlm.nih.gov/34219532/
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Acute myocarditis associated with COVID-19 vaccination: report of a case: https://www.ncbi.nlm.nih.gov/labs/pmc/articles/PMC8639400/
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Myocarditis following vaccination with COVID-19 messenger RNA: a Japanese case series: https://pubmed.ncbi.nlm.nih.gov/34840235/.
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Myocarditis in the setting of a recent COVID-19 vaccination: https://pubmed.ncbi.nlm.nih.gov/34712497/.
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Acute myocarditis after a second dose of COVID-19 mRNA vaccine: report of two cases: https://www.clinicalimaging.org/article/S0899-7071(21)00265-5/fulltext.
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Prevalence of thrombocytopenia, antiplatelet factor 4 antibodies, and elevated D-dimer in Thais after vaccination with ChAdOx1 nCoV-19: https://pubmed.ncbi.nlm.nih.gov/34568726/
-
Epidemiology of acute myocarditis/pericarditis in Hong Kong adolescents after co-vaccination: https://academic.oup.com/cid/advance-article-abstract/doi/10.1093/cid/ciab989/6445179
-
Myocarditis after 2019 coronavirus disease mRNA vaccine: a case series and incidence rate determination: https://academic.oup.com/cid/advance-article/doi/10.1093/cid/ciab926/6420408.
-
Myocarditis and pericarditis after COVID-19 vaccination: inequalities in age and vaccine types: https://www.mdpi.com/2075-4426/11/11/1106
-
Epidemiology and clinical features of myocarditis/pericarditis before the introduction of COVID-19 mRNA vaccine in Korean children: a multicenter study: https://pubmed.ncbi.nlm.nih.gov/34402230/
-
Shedding light on post-vaccination myocarditis and pericarditis in COVID-19 and non-COVID-19 vaccine recipients: https://pubmed.ncbi.nlm.nih.gov/34696294/
-
Diffuse prothrombotic syndrome after administration of ChAdOx1 nCoV-19 vaccine: case report: https://pubmed.ncbi.nlm.nih.gov/34615534/
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Three cases of acute venous thromboembolism in women after coronavirus 2019 vaccination: https://pubmed.ncbi.nlm.nih.gov/34352418/
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Clinical and biological features of cerebral venous sinus thrombosis after vaccination with ChAdOx1 nCov-19; https://jnnp.bmj.com/content/early/2021/09/29/jnnp-2021-327340.
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COV2-S vaccination may reveal hereditary thrombophilia: massive cerebral venous sinus thrombosis in a young man with normal platelet count: https://pubmed.ncbi.nlm.nih.gov/34632750/
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Post-mortem findings in vaccine-induced thrombotic thrombocytopenia: https://haematologica.org/article/view/haematol.2021.279075
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COVID-19 vaccine-induced thrombosis: https://pubmed.ncbi.nlm.nih.gov/34802488/.
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Inflammation and platelet activation after COVID-19 vaccines: possible mechanisms behind vaccine-induced immune thrombocytopenia and thrombosis: https://pubmed.ncbi.nlm.nih.gov/34887867/.
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Anaphylactoid reaction and coronary thrombosis related to COVID-19 mRNA vaccine: https://pubmed.ncbi.nlm.nih.gov/34863404/.
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Vaccine-induced cerebral venous thrombosis and thrombocytopenia. Oxford-AstraZeneca COVID-19: a missed opportunity for rapid return on experience: https://www.sciencedirect.com/science/article/pii/S235255682100093X
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Occurrence of splenic infarction due to arterial thrombosis after vaccination with COVID-19: https://pubmed.ncbi.nlm.nih.gov/34876440/
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Deep venous thrombosis more than two weeks after COVID-19 vaccination: https://pubmed.ncbi.nlm.nih.gov/33928773/
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Case report: Take a second look: Cerebral venous thrombosis related to Covid-19 vaccination and thrombotic thrombocytopenia syndrome: https://pubmed.ncbi.nlm.nih.gov/34880826/
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Information on ChAdOx1 nCoV-19 vaccine-induced immune-mediated thrombotic thrombocytopenia: https://pubmed.ncbi.nlm.nih.gov/34587242/
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Change in blood viscosity after COVID-19 vaccination: estimation for persons with underlying metabolic syndrome: https://pubmed.ncbi.nlm.nih.gov/34868465/
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Management of a patient with a rare congenital limb malformation syndrome after SARS-CoV-2 vaccine-induced thrombosis and thrombocytopenia (VITT): https://pubmed.ncbi.nlm.nih.gov/34097311/
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Bilateral thalamic stroke: a case of COVID-19 (VITT) vaccine-induced immune thrombotic thrombocytopenia or a coincidence due to underlying risk factors: https://pubmed.ncbi.nlm.nih.gov/34820232/.
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Thrombocytopenia and splanchnic thrombosis after vaccination with Ad26.COV2.S successfully treated with transjugular intrahepatic intrahepatic portosystemic shunt and thrombectomy: https://onlinelibrary.wiley.com/doi/10.1002/ajh.26258
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Incidence of acute ischemic stroke after coronavirus vaccination in Indonesia: case series: https://pubmed.ncbi.nlm.nih.gov/34579636/
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Successful treatment of vaccine-induced immune immune thrombotic thrombocytopenia in a 26-year-old female patient: https://pubmed.ncbi.nlm.nih.gov/34614491/
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Case report: vaccine-induced immune immune thrombotic thrombocytopenia in a patient with pancreatic cancer after vaccination with messenger RNA-1273: https://pubmed.ncbi.nlm.nih.gov/34790684/
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Idiopathic idiopathic external jugular vein thrombophlebitis after coronavirus disease vaccination (COVID-19): https://pubmed.ncbi.nlm.nih.gov/33624509/.
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Squamous cell carcinoma of the lung with hemoptysis following vaccination with tozinameran (BNT162b2, Pfizer-BioNTech): https://pubmed.ncbi.nlm.nih.gov/34612003/
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Vaccine-induced thrombotic thrombocytopenia after Ad26.COV2.S vaccination in a man presenting as acute venous thromboembolism: https://pubmed.ncbi.nlm.nih.gov/34096082/
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Myocarditis associated with COVID-19 vaccination in three adolescent boys: https://pubmed.ncbi.nlm.nih.gov/34851078/.
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Cardiovascular magnetic resonance findings in young adult patients with acute myocarditis after COVID-19 mRNA vaccination: a case series: https://pubmed.ncbi.nlm.nih.gov/34496880/
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Perimyocarditis after vaccination with COVID-19: https://pubmed.ncbi.nlm.nih.gov/34866957/
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Epidemiology of acute myocarditis/pericarditis in Hong Kong adolescents after co-vaccination: https://pubmed.ncbi.nlm.nih.gov/34849657/.
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Myocarditis-induced sudden death after BNT162b2 COVID-19 mRNA vaccination in Korea: case report focusing on histopathological findings: https://pubmed.ncbi.nlm.nih.gov/34664804/
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Acute myocarditis after vaccination with COVID-19 mRNA in adults aged 18 years or older: https://pubmed.ncbi.nlm.nih.gov/34605853/
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Recurrence of acute myocarditis temporally associated with receipt of the 2019 coronavirus mRNA disease vaccine (COVID-19) in an adolescent male: https://pubmed.ncbi.nlm.nih.gov/34166671/
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Young male with myocarditis after mRNA-1273 coronavirus disease-2019 (COVID-19) mRNA vaccination: https://pubmed.ncbi.nlm.nih.gov/34744118/
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Acute myocarditis after SARS-CoV-2 vaccination in a 24-year-old male: https://pubmed.ncbi.nlm.nih.gov/34334935/.
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Ga-DOTATOC digital PET images of inflammatory cell infiltrates in myocarditis after vaccination with COVID-19: https://pubmed.ncbi.nlm.nih.gov/34746968/
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Occurrence of acute infarct-like myocarditis after vaccination with COVID-19: just an accidental coincidence or rather a vaccination-associated autoimmune myocarditis?”: https://pubmed.ncbi.nlm.nih.gov/34333695/.
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Self-limited myocarditis presenting with chest pain and ST-segment elevation in adolescents after vaccination with BNT162b2 mRNA vaccine: https://pubmed.ncbi.nlm.nih.gov/34180390/
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Myocarditis Following Immunization with COVID-19 mRNA Vaccines in Members of the U.S. Military: https://pubmed.ncbi.nlm.nih.gov/34185045/
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Myocarditis after BNT162b2 vaccination in a healthy male: https://pubmed.ncbi.nlm.nih.gov/34229940/
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Myopericarditis in a previously healthy adolescent male after COVID-19 vaccination: Case report: https://pubmed.ncbi.nlm.nih.gov/34133825/
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Acute myocarditis after SARS-CoV-2 mRNA-1273 mRNA vaccination: https://pubmed.ncbi.nlm.nih.gov/34308326/.
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Chest pain with abnormal electrocardiogram redevelopment after injection of COVID-19 vaccine manufactured by Moderna: https://pubmed.ncbi.nlm.nih.gov/34866106/
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Biopsy-proven lymphocytic myocarditis after first vaccination with COVID-19 mRNA in a 40-year-old man: case report: https://pubmed.ncbi.nlm.nih.gov/34487236/
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Multimodality imaging and histopathology in a young man presenting with fulminant lymphocytic myocarditis and cardiogenic shock after vaccination with mRNA-1273: https://pubmed.ncbi.nlm.nih.gov/34848416/
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Report of a case of myopericarditis after vaccination with BNT162b2 COVID-19 mRNA in a young Korean male: https://pubmed.ncbi.nlm.nih.gov/34636504/
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Acute myocarditis after Comirnaty vaccination in a healthy male with previous SARS-CoV-2 infection: https://pubmed.ncbi.nlm.nih.gov/34367386/
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Acute myocarditis in a young adult two days after vaccination with Pfizer: https://pubmed.ncbi.nlm.nih.gov/34709227/
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Case report: acute fulminant myocarditis and cardiogenic shock after messenger RNA coronavirus vaccination in 2019 requiring extracorporeal cardiopulmonary resuscitation: https://pubmed.ncbi.nlm.nih.gov/34778411/
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Acute myocarditis after 2019 coronavirus disease vaccination: https://pubmed.ncbi.nlm.nih.gov/34734821/
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A series of patients with myocarditis after vaccination against SARS-CoV-2 with mRNA-1279 and BNT162b2: https://pubmed.ncbi.nlm.nih.gov/34246585/
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Myopericarditis after Pfizer messenger ribonucleic acid coronavirus coronavirus disease vaccine in adolescents: https://pubmed.ncbi.nlm.nih.gov/34228985/
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Post-vaccination multisystem inflammatory syndrome in adults without evidence of prior SARS-CoV-2 infection: https://pubmed.ncbi.nlm.nih.gov/34852213/
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Acute myocarditis defined after vaccination with 2019 mRNA of coronavirus disease: https://pubmed.ncbi.nlm.nih.gov/34866122/
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Biventricular systolic dysfunction in acute myocarditis after SARS-CoV-2 mRNA-1273 vaccination: https://pubmed.ncbi.nlm.nih.gov/34601566/
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Myocarditis following COVID-19 vaccination: MRI study: https://pubmed.ncbi.nlm.nih.gov/34739045/.
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Acute myocarditis after COVID-19 vaccination: case report: https://docs.google.com/document/d/1Hc4bh_qNbZ7UVm5BLxkRdMPnnI9zcCsl/e
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Association of myocarditis with COVID-19 messenger RNA BNT162b2 vaccine COVID-19 in a case series of children: https://pubmed.ncbi.nlm.nih.gov/34374740/
-
Clinical suspicion of myocarditis temporally related to COVID-19 vaccination in adolescents and young adults: https://pubmed.ncbi.nlm.nih.gov/34865500/
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Myocarditis following vaccination with Covid-19 in a large healthcare organization: https://pubmed.ncbi.nlm.nih.gov/34614329/
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AstraZeneca COVID-19 vaccine and Guillain-Barré syndrome in Tasmania: a causal link: https://pubmed.ncbi.nlm.nih.gov/34560365/
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COVID-19, Guillain-Barré and vaccineA dangerous mix: https://pubmed.ncbi.nlm.nih.gov/34108736/.
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Guillain-Barré syndrome after the first dose of Pfizer-BioNTech COVID-19 vaccine: case report and review of reported cases: https://pubmed.ncbi.nlm.nih.gov/34796417/.
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Guillain-Barre syndrome after BNT162b2 COVID-19 vaccine: https://link.springer.com/article/10.1007%2Fs10072-021-05523-5.
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COVID-19 adenovirus vaccines and Guillain-Barré syndrome with facial palsy: https://onlinelibrary.wiley.com/doi/10.1002/ana.26258.
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Association of receipt association of Ad26.COV2.S COVID-19 vaccine with presumed Guillain-Barre syndrome, February-July 2021: https://jamanetwork.com/journals/jama/fullarticle/2785009
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A case of Guillain-Barré syndrome after Pfizer COVID-19 vaccine: https://pubmed.ncbi.nlm.nih.gov/34567447/
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Guillain-Barré syndrome associated with COVID-19 vaccination: https://pubmed.ncbi.nlm.nih.gov/34648420/.
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Rate of recurrent Guillain-Barré syndrome after COVID-19 BNT162b2 mRNA vaccine: https://jamanetwork.com/journals/jamaneurology/fullarticle/2783708
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Guillain-Barre syndrome after COVID-19 vaccination in an adolescent: https://www.pedneur.com/article/S0887-8994(21)00221-6/fulltext.
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Guillain-Barre syndrome after ChAdOx1-S / nCoV-19 vaccination: https://pubmed.ncbi.nlm.nih.gov/34114256/.
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Guillain-Barre syndrome after COVID-19 mRNA-1273 vaccine: case report: https://pubmed.ncbi.nlm.nih.gov/34767184/.
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Guillain-Barre syndrome following SARS-CoV-2 vaccination in 19 patients: https://pubmed.ncbi.nlm.nih.gov/34644738/.
-
Guillain-Barre syndrome presenting with facial diplegia following vaccination with COVID-19 in two patients: https://pubmed.ncbi.nlm.nih.gov/34649856/
-
A rare case of Guillain-Barré syndrome after COVID-19 vaccination: https://pubmed.ncbi.nlm.nih.gov/34671572/
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Neurological complications of COVID-19: Guillain-Barre syndrome after Pfizer COVID-19 vaccine: https://pubmed.ncbi.nlm.nih.gov/33758714/
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COVID-19 vaccine causing Guillain-Barre syndrome, an uncommon potential side effect: https://pubmed.ncbi.nlm.nih.gov/34484780/
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Guillain-Barre syndrome after the first dose of COVID-19 vaccination: case report; https://pubmed.ncbi.nlm.nih.gov/34779385/.
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Miller Fisher syndrome after Pfizer COVID-19 vaccine: https://pubmed.ncbi.nlm.nih.gov/34817727/.
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Miller Fisher syndrome after 2019 BNT162b2 mRNA coronavirus vaccination: https://pubmed.ncbi.nlm.nih.gov/34789193/.
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Bilateral facial weakness with a variant of paresthesia of Guillain-Barre syndrome after Vaxzevria COVID-19 vaccine: https://pubmed.ncbi.nlm.nih.gov/34261746/
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Guillain-Barre syndrome after the first injection of ChAdOx1 nCoV-19 vaccine: first report: https://pubmed.ncbi.nlm.nih.gov/34217513/.
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A case of sensory ataxic Guillain-Barre syndrome with immunoglobulin G anti-GM1 antibodies after first dose of COVID-19 BNT162b2 mRNA vaccine (Pfizer): https://pubmed.ncbi.nlm.nih.gov/34871447/
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Reporting of acute inflammatory neuropathies with COVID-19 vaccines: subgroup disproportionality analysis in VigiBase: https://pubmed.ncbi.nlm.nih.gov/34579259/
-
A variant of Guillain-Barré syndrome after SARS-CoV-2 vaccination: AMSAN: https://pubmed.ncbi.nlm.nih.gov/34370408/.
-
A rare variant of Guillain-Barré syndrome after vaccination with Ad26.COV2.S: https://pubmed.ncbi.nlm.nih.gov/34703690/.
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Guillain-Barré syndrome after SARS-CoV-2 vaccination in a patient with previous vaccine-associated Guillain-Barré syndrome: https://pubmed.ncbi.nlm.nih.gov/34810163/
-
Guillain-Barré syndrome in an Australian state using mRNA and adenovirus-vector SARS-CoV-2 vaccines: https://onlinelibrary.wiley.com/doi/10.1002/ana.26218.
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Acute transverse myelitis after SARS-CoV-2 vaccination: case report and review of the literature: https://pubmed.ncbi.nlm.nih.gov/34482455/.
-
Variant Guillain-Barré syndrome occurring after SARS-CoV-2 vaccination: https://pubmed.ncbi.nlm.nih.gov/34114269/.
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Guillian-Barre syndrome with axonal variant temporally associated with Modern SARS-CoV-2 mRNA-based vaccine: https://pubmed.ncbi.nlm.nih.gov/34722067/
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Guillain-Barre syndrome after the first dose of SARS-CoV-2 vaccine: a temporary occurrence, not a causal association: https://pubmed.ncbi.nlm.nih.gov/33968610/
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SARS-CoV-2 vaccines can be complicated not only by Guillain-Barré syndrome but also by distal small fiber neuropathy: https://pubmed.ncbi.nlm.nih.gov/34525410/
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Clinical variant of Guillain-Barré syndrome with prominent facial diplegia after AstraZeneca 2019 coronavirus disease vaccine: https://pubmed.ncbi.nlm.nih.gov/34808658/
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Adverse event reporting and risk of Bell’s palsy after COVID-19 vaccination: https://www.thelancet.com/journals/laninf/article/PIIS1473-3099(21)00646-0/fulltext.
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Bilateral facial nerve palsy and COVID-19 vaccination: causality or coincidence: https://pubmed.ncbi.nlm.nih.gov/34522557/
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Left Bell’s palsy after the first dose of mRNA-1273 SARS-CoV-2 vaccine: case report: https://pubmed.ncbi.nlm.nih.gov/34763263/.
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Bell’s palsy after inactivated vaccination with COVID-19 in a patient with a history of recurrent Bell’s palsy: case report: https://pubmed.ncbi.nlm.nih.gov/34621891/
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Neurological complications after the first dose of COVID-19 vaccines and SARS-CoV-2 infection: https://pubmed.ncbi.nlm.nih.gov/34697502/
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Type I interferons as a potential mechanism linking COVID-19 mRNA vaccines with Bell’s palsy: https://pubmed.ncbi.nlm.nih.gov/33858693/
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Acute transverse myelitis following inactivated COVID-19 vaccine: https://pubmed.ncbi.nlm.nih.gov/34370410/
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Acute transverse myelitis after COVID-19 vaccination: https://pubmed.ncbi.nlm.nih.gov/34579245/.
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A case of longitudinally extensive transverse myelitis following Covid-19 vaccination: https://pubmed.ncbi.nlm.nih.gov/34182207/
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Post COVID-19 transverse myelitis; a case report with review of the literature: https://pubmed.ncbi.nlm.nih.gov/34457267/.
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Beware of neuromyelitis optica spectrum disorder after vaccination with inactivated virus for COVID-19: https://pubmed.ncbi.nlm.nih.gov/34189662/
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Neuromyelitis optica in a healthy woman after vaccination against severe acute respiratory syndrome coronavirus 2 mRNA-1273: https://pubmed.ncbi.nlm.nih.gov/34660149/
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Acute bilateral bilateral optic neuritis/chiasm with longitudinal extensive transverse myelitis in long-standing stable multiple sclerosis after vector-based vaccination against SARS-CoV-2: https://pubmed.ncbi.nlm.nih.gov/34131771/
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A case series of acute pericarditis after vaccination with COVID-19 in the context of recent reports from Europe and the United States: https://pubmed.ncbi.nlm.nih.gov/34635376/
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Acute pericarditis and cardiac tamponade after vaccination with Covid-19: https://pubmed.ncbi.nlm.nih.gov/34749492/
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Myocarditis and pericarditis in adolescents after the first and second doses of COVID-19 mRNA vaccines: https://pubmed.ncbi.nlm.nih.gov/34849667/
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Perimyocarditis in adolescents after Pfizer-BioNTech COVID-19 vaccine: https://pubmed.ncbi.nlm.nih.gov/34319393/
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Acute myopericarditis after COVID-19 vaccine in adolescents: https://pubmed.ncbi.nlm.nih.gov/34589238/
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Pericarditis after administration of the BNT162b2 mRNA vaccine COVID-19: https://pubmed.ncbi.nlm.nih.gov/34149145/
-
Case report: symptomatic pericarditis post COVID-19 vaccination: https://pubmed.ncbi.nlm.nih.gov/34693198/.
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An outbreak of Still’s disease after COVID-19 vaccination in a 34-year-old patient: https://pubmed.ncbi.nlm.nih.gov/34797392/
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Hemophagocytic lymphohistiocytosis following COVID-19 vaccination (ChAdOx1 nCoV-19): https://pubmed.ncbi.nlm.nih.gov/34862234/
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Myocarditis after SARS-CoV-2 mRNA vaccination, a case series: https://pubmed.ncbi.nlm.nih.gov/34396358/.
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Miller-Fisher syndrome and Guillain-Barré syndrome overlap syndrome in a patient after Oxford-AstraZeneca SARS-CoV-2 vaccination: https://pubmed.ncbi.nlm.nih.gov/34848426/.
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Immune-mediated disease outbreaks or new-onset disease in 27 subjects after mRNA/DNA vaccination against SARS-CoV-2: https://pubmed.ncbi.nlm.nih.gov/33946748/
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Post-mortem investigation of deaths after vaccination with COVID-19 vaccines: https://pubmed.ncbi.nlm.nih.gov/34591186/
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Acute kidney injury with macroscopic hematuria and IgA nephropathy after COVID-19 vaccination: https://pubmed.ncbi.nlm.nih.gov/34352309/
-
Relapse of immune thrombocytopenia after covid-19 vaccination in young male patient: https://pubmed.ncbi.nlm.nih.gov/34804803/.
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Immune thrombocytopenic purpura associated with COVID-19 mRNA vaccine Pfizer-BioNTech BNT16B2b2: https://pubmed.ncbi.nlm.nih.gov/34077572/
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Retinal hemorrhage after SARS-CoV-2 vaccination: https://pubmed.ncbi.nlm.nih.gov/34884407/.
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Case report: anti-neutrophil cytoplasmic antibody-associated vasculitis with acute renal failure and pulmonary hemorrhage can occur after COVID-19 vaccination: https://pubmed.ncbi.nlm.nih.gov/34859017/
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Intracerebral hemorrhage due to vasculitis following COVID-19 vaccination: case report: https://pubmed.ncbi.nlm.nih.gov/34783899/
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Peduncular, symptomatic cavernous bleeding after immune thrombocytopenia-induced SARS-CoV-2 vaccination: https://pubmed.ncbi.nlm.nih.gov/34549178/.
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Brain death in a vaccinated patient with COVID-19 infection: https://pubmed.ncbi.nlm.nih.gov/34656887/
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Generalized purpura annularis telangiectodes after SARS-CoV-2 mRNA vaccination: https://pubmed.ncbi.nlm.nih.gov/34236717/.
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Lobar hemorrhage with ventricular rupture shortly after the first dose of a SARS-CoV-2 mRNA-based SARS-CoV-2 vaccine: https://pubmed.ncbi.nlm.nih.gov/34729467/.
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A case of outbreak of macroscopic hematuria and IgA nephropathy after SARS-CoV-2 vaccination: https://pubmed.ncbi.nlm.nih.gov/33932458/
-
Acral hemorrhage after administration of the second dose of SARS-CoV-2 vaccine. A post-vaccination reaction: https://pubmed.ncbi.nlm.nih.gov/34092400/742.
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Severe immune thrombocytopenic purpura after SARS-CoV-2 vaccine: https://pubmed.ncbi.nlm.nih.gov/34754937/
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Gross hematuria after severe acute respiratory syndrome coronavirus 2 vaccination in 2 patients with IgA nephropathy: https://pubmed.ncbi.nlm.nih.gov/33771584/
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Autoimmune encephalitis after ChAdOx1-S SARS-CoV-2 vaccination: https://pubmed.ncbi.nlm.nih.gov/34846583/
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COVID-19 vaccine and death: causality algorithm according to the WHO eligibility diagnosis: https://pubmed.ncbi.nlm.nih.gov/34073536/
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Bell’s palsy after vaccination with mRNA (BNT162b2) and inactivated (CoronaVac) SARS-CoV-2 vaccines: a case series and a nested case-control study: https://pubmed.ncbi.nlm.nih.gov/34411532/
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Epidemiology of myocarditis and pericarditis following mRNA vaccines in Ontario, Canada: by vaccine product, schedule, and interval: https://www.medrxiv.org/content/10.1101/2021.12.02.21267156v1
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Anaphylaxis following Covid-19 vaccine in a patient with cholinergic urticaria: https://pubmed.ncbi.nlm.nih.gov/33851711/
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Anaphylaxis induced by CoronaVac COVID-19 vaccine: clinical features and results of revaccination: https://pubmed.ncbi.nlm.nih.gov/34675550/.
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Anaphylaxis after Modern COVID-19 vaccine: https://pubmed.ncbi.nlm.nih.gov/34734159/.
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Association of self-reported history of high-risk allergy with allergy symptoms after COVID-19 vaccination: https://pubmed.ncbi.nlm.nih.gov/34698847/
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Sex differences in the incidence of anaphylaxis to LNP-mRNA vaccines COVID-19: https://pubmed.ncbi.nlm.nih.gov/34020815/
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Allergic reactions, including anaphylaxis, after receiving the first dose of Pfizer-BioNTech COVID-19 vaccine – United States, December 14 to 23, 2020: https://pubmed.ncbi.nlm.nih.gov/33641264/
-
Allergic reactions, including anaphylaxis, after receiving the first dose of Modern COVID-19 vaccine – United States, December 21, 2020 to January 10, 2021: https://pubmed.ncbi.nlm.nih.gov/33641268/
-
Prolonged anaphylaxis to Pfizer 2019 coronavirus disease vaccine: a case report and mechanism of action: https://pubmed.ncbi.nlm.nih.gov/33834172/
-
Anaphylaxis reactions to Pfizer BNT162b2 vaccine: report of 3 cases of anaphylaxis following vaccination with Pfizer BNT162b2: https://pubmed.ncbi.nlm.nih.gov/34579211/
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Biphasic anaphylaxis after first dose of 2019 messenger RNA coronavirus disease vaccine with positive polysorbate 80 skin test result: https://pubmed.ncbi.nlm.nih.gov/34343674/
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Acute myocardial infarction and myocarditis after COVID-19 vaccination: https://pubmed.ncbi.nlm.nih.gov/34586408/
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Takotsubo syndrome after COVID-19 vaccination: https://pubmed.ncbi.nlm.nih.gov/34539938/.
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Takotsubo cardiomyopathy after coronavirus 2019 vaccination in patient on maintenance hemodialysis: https://pubmed.ncbi.nlm.nih.gov/34731486/.
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Premature myocardial infarction or side effect of COVID-19 vaccine: https://pubmed.ncbi.nlm.nih.gov/33824804/
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Myocardial infarction, stroke, and pulmonary embolism after BNT162b2 mRNA COVID-19 vaccine in persons aged 75 years or older: https://pubmed.ncbi.nlm.nih.gov/34807248/
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Kounis syndrome type 1 induced by inactivated SARS-COV-2 vaccine: https://pubmed.ncbi.nlm.nih.gov/34148772/
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Acute myocardial infarction within 24 hours after COVID-19 vaccination: is Kounis syndrome the culprit: https://pubmed.ncbi.nlm.nih.gov/34702550/
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Deaths associated with the recently launched SARS-CoV-2 vaccination (Comirnaty®): https://pubmed.ncbi.nlm.nih.gov/33895650/
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Deaths associated with recently launched SARS-CoV-2 vaccination: https://pubmed.ncbi.nlm.nih.gov/34425384/
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A case of acute encephalopathy and non-ST-segment elevation myocardial infarction after vaccination with mRNA-1273: possible adverse effect: https://pubmed.ncbi.nlm.nih.gov/34703815/
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COVID-19 vaccine-induced urticarial vasculitis: https://pubmed.ncbi.nlm.nih.gov/34369046/.
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ANCA-associated vasculitis after Pfizer-BioNTech COVID-19 vaccine: https://pubmed.ncbi.nlm.nih.gov/34280507/.
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New-onset leukocytoclastic vasculitis after COVID-19 vaccine: https://pubmed.ncbi.nlm.nih.gov/34241833/
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Cutaneous small vessel vasculitis after COVID-19 vaccine: https://pubmed.ncbi.nlm.nih.gov/34529877/.
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Outbreak of leukocytoclastic vasculitis after COVID-19 vaccine: https://pubmed.ncbi.nlm.nih.gov/33928638/
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Leukocytoclastic vasculitis after exposure to COVID-19 vaccine: https://pubmed.ncbi.nlm.nih.gov/34836739/
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Vasculitis and bursitis in [ 18 F] FDG-PET/CT after COVID-19 mRNA vaccine: post hoc ergo propter hoc?; https://pubmed.ncbi.nlm.nih.gov/34495381/.
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Cutaneous lymphocytic vasculitis after administration of COVID-19 mRNA vaccine: https://pubmed.ncbi.nlm.nih.gov/34327795
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Cutaneous leukocytoclastic vasculitis induced by Sinovac COVID-19 vaccine: https://pubmed.ncbi.nlm.nih.gov/34660867/.
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Case report: ANCA-associated vasculitis presenting with rhabdomyolysis and crescentic Pauci-Inmune glomerulonephritis after vaccination with Pfizer-BioNTech COVID-19 mRNA: https://pubmed.ncbi.nlm.nih.gov/34659268/
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Reactivation of IgA vasculitis after vaccination with COVID-19: https://pubmed.ncbi.nlm.nih.gov/34848431/
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Varicella-zoster virus-related small-vessel vasculitis after Pfizer-BioNTech COVID-19 vaccination: https://pubmed.ncbi.nlm.nih.gov/34310759/.
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Imaging in vascular medicine: leukocytoclastic vasculitis after COVID-19 vaccine booster: https://pubmed.ncbi.nlm.nih.gov/34720009/
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A rare case of Henoch-Schönlein purpura after a case report of COVID-19 vaccine: https://pubmed.ncbi.nlm.nih.gov/34518812/
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Cutaneous vasculitis following COVID-19 vaccination: https://pubmed.ncbi.nlm.nih.gov/34611627/.
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Possible case of COVID-19 mRNA vaccine-induced small-vessel vasculitis: https://pubmed.ncbi.nlm.nih.gov/34705320/.
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IgA vasculitis following COVID-19 vaccination in an adult: https://pubmed.ncbi.nlm.nih.gov/34779011/
-
Propylthiouracil-induced anti-neutrophil cytoplasmic antibody-associated vasculitis following vaccination with COVID-19: https://pubmed.ncbi.nlm.nih.gov/34451967/
-
Coronavirus disease vaccine 2019 (COVID-19) in systemic lupus erythematosus and neutrophil anti-cytoplasmic antibody-associated vasculitis: https://pubmed.ncbi.nlm.nih.gov/33928459/
-
Reactivation of IgA vasculitis after COVID-19 vaccination: https://pubmed.ncbi.nlm.nih.gov/34250509/
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Clinical and histopathologic spectrum of delayed adverse skin reactions after COVID-19 vaccination: https://pubmed.ncbi.nlm.nih.gov/34292611/.
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First description of immune complex vasculitis after COVID-19 vaccination with BNT162b2: case report: https://pubmed.ncbi.nlm.nih.gov/34530771/.
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Nephrotic syndrome and vasculitis after SARS-CoV-2 vaccine: true association or circumstantial: https://pubmed.ncbi.nlm.nih.gov/34245294/.
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Occurrence of de novo cutaneous vasculitis after vaccination against coronavirus disease (COVID-19): https://pubmed.ncbi.nlm.nih.gov/34599716/.
-
Asymmetric cutaneous vasculitis after COVID-19 vaccination with unusual preponderance of eosinophils: https://pubmed.ncbi.nlm.nih.gov/34115904/.
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Henoch-Schönlein purpura occurring after vaccination with COVID-19: https://pubmed.ncbi.nlm.nih.gov/34247902/.
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Henoch-Schönlein purpura following the first dose of COVID-19 viral vector vaccine: case report: https://pubmed.ncbi.nlm.nih.gov/34696186/.
-
Granulomatous vasculitis after AstraZeneca anti-SARS-CoV-2 vaccine: https://pubmed.ncbi.nlm.nih.gov/34237323/.
-
Acute retinal necrosis due to varicella zoster virus reactivation after vaccination with BNT162b2 COVID-19 mRNA: https://pubmed.ncbi.nlm.nih.gov/34851795/.
-
A case of generalized Sweet’s syndrome with vasculitis triggered by recent vaccination with COVID-19: https://pubmed.ncbi.nlm.nih.gov/34849386/
-
Small-vessel vasculitis following Oxford-AstraZeneca vaccination against SARS-CoV-2: https://pubmed.ncbi.nlm.nih.gov/34310763/
-
Relapse of microscopic polyangiitis after COVID-19 vaccination: case report: https://pubmed.ncbi.nlm.nih.gov/34251683/.
-
Cutaneous vasculitis after severe acute respiratory syndrome coronavirus 2 vaccine: https://pubmed.ncbi.nlm.nih.gov/34557622/.
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Recurrent herpes zoster after COVID-19 vaccination in patients with chronic urticaria on cyclosporine treatment – A report of 3 cases: https://pubmed.ncbi.nlm.nih.gov/34510694/
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Leukocytoclastic vasculitis after coronavirus disease vaccination 2019: https://pubmed.ncbi.nlm.nih.gov/34713472/803
-
Outbreaks of mixed cryoglobulinemia vasculitis after vaccination against SARS-CoV-2: https://pubmed.ncbi.nlm.nih.gov/34819272/
-
Cutaneous small-vessel vasculitis after vaccination with a single dose of Janssen Ad26.COV2.S: https://pubmed.ncbi.nlm.nih.gov/34337124/
-
Case of immunoglobulin A vasculitis after vaccination against coronavirus disease 2019: https://pubmed.ncbi.nlm.nih.gov/34535924/
-
Rapid progression of angioimmunoblastic T-cell lymphoma after BNT162b2 mRNA booster vaccination: case report: https://www.frontiersin.org/articles/10.3389/fmed.2021.798095/
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COVID-19 mRNA vaccination-induced lymphadenopathy mimics lymphoma progression on FDG PET / CT: https://pubmed.ncbi.nlm.nih.gov/33591026/
-
Lymphadenopathy in COVID-19 vaccine recipients: diagnostic dilemma in oncology patients: https://pubmed.ncbi.nlm.nih.gov/33625300/
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Hypermetabolic lymphadenopathy after administration of BNT162b2 mRNA vaccine Covid-19: incidence assessed by [ 18 F] FDG PET-CT and relevance for study interpretation: https://pubmed.ncbi.nlm.nih.gov/33774684/
-
Lymphadenopathy after COVID-19 vaccination: review of imaging findings: https://pubmed.ncbi.nlm.nih.gov/33985872/
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Evolution of bilateral hypermetabolic axillary hypermetabolic lymphadenopathy on FDG PET/CT after 2-dose COVID-19 vaccination: https://pubmed.ncbi.nlm.nih.gov/34735411/
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Lymphadenopathy associated with COVID-19 vaccination on FDG PET/CT: distinguishing features in adenovirus-vectored vaccine: https://pubmed.ncbi.nlm.nih.gov/34115709/.
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COVID-19 vaccination-induced lymphadenopathy in a specialized breast imaging clinic in Israel: analysis of 163 cases: https://pubmed.ncbi.nlm.nih.gov/34257025/.
-
COVID-19 vaccine-related axillary lymphadenopathy in breast cancer patients: case series with literature review: https://pubmed.ncbi.nlm.nih.gov/34836672/.
-
Coronavirus disease vaccine 2019 mimics lymph node metastases in patients undergoing skin cancer follow-up: a single-center study: https://pubmed.ncbi.nlm.nih.gov/34280870/
-
COVID-19 post-vaccination lymphadenopathy: report of fine-needle aspiration biopsy cytologic findings: https://pubmed.ncbi.nlm.nih.gov/34432391/
-
Regional lymphadenopathy after COVID-19 vaccination: review of the literature and considerations for patient management in breast cancer care: https://pubmed.ncbi.nlm.nih.gov/34731748/
-
Subclinical axillary lymphadenopathy associated with COVID-19 vaccination on screening mammography: https://pubmed.ncbi.nlm.nih.gov/34906409/
-
Adverse events of COVID injection that may occur in children.Acute-onset supraclavicular lymphadenopathy coincident with intramuscular mRNA vaccination against COVID-19 may be related to the injection technique of the vaccine, Spain, January and February 2021: https://pubmed.ncbi.nlm.nih.gov/33706861/
-
Supraclavicular lymphadenopathy after COVID-19 vaccination in Korea: serial follow-up by ultrasonography: https://pubmed.ncbi.nlm.nih.gov/34116295/
-
Oxford-AstraZeneca COVID-19 vaccination induced lymphadenopathy on [18F] choline PET / CT, not just an FDG finding: https://pubmed.ncbi.nlm.nih.gov/33661328/
-
Biphasic anaphylaxis after exposure to the first dose of Pfizer-BioNTech COVID-19 mRNA vaccine COVID-19: https://pubmed.ncbi.nlm.nih.gov/34050949/
-
Axillary adenopathy associated with COVID-19 vaccination: imaging findings and follow-up recommendations in 23 women: https://pubmed.ncbi.nlm.nih.gov/33624520/
-
A case of cervical lymphadenopathy following COVID-19 vaccination: https://pubmed.ncbi.nlm.nih.gov/34141500/
-
Unique imaging findings of neurologic phantosmia after Pfizer-BioNtech COVID-19 vaccination: a case report: https://pubmed.ncbi.nlm.nih.gov/34096896/
-
Thrombotic adverse events reported for Moderna, Pfizer, and Oxford-AstraZeneca COVID-19 vaccines: comparison of occurrence and clinical outcomes in the EudraVigilance database: https://pubmed.ncbi.nlm.nih.gov/34835256/
-
Unilateral lymphadenopathy after COVID-19 vaccination: a practical management plan for radiologists of all specialties: https://pubmed.ncbi.nlm.nih.gov/33713605/
-
Unilateral axillary adenopathy in the setting of COVID-19 vaccination: follow-up: https://pubmed.ncbi.nlm.nih.gov/34298342/
-
A systematic review of cases of CNS demyelination following COVID-19 vaccination: https://pubmed.ncbi.nlm.nih.gov/34839149/
-
Supraclavicular lymphadenopathy after COVID-19 vaccination: an increasing presentation in the two-week wait neck lump clinic: https://pubmed.ncbi.nlm.nih.gov/33685772/
-
COVID-19 vaccine-related axillary and cervical lymphadenopathy in patients with current or previous breast cancer and other malignancies: cross-sectional imaging findings on MRI, CT and PET-CT: https://pubmed.ncbi.nlm.nih.gov/34719892/
-
Adenopathy after COVID-19 vaccination: https://pubmed.ncbi.nlm.nih.gov/33625299/.
-
Incidence of axillary adenopathy on breast imaging after vaccination with COVID-19: https://pubmed.ncbi.nlm.nih.gov/34292295/.
-
COVID-19 vaccination and lower cervical lymphadenopathy in two-week neck lump clinic: a follow-up audit: https://pubmed.ncbi.nlm.nih.gov/33947605/.
-
Cervical lymphadenopathy after coronavirus disease vaccination 2019: clinical features and implications for head and neck cancer services: https://pubmed.ncbi.nlm.nih.gov/34526175/
-
Lymphadenopathy associated with the COVID-19 vaccine: https://pubmed.ncbi.nlm.nih.gov/33786231/
-
Evolution of lymphadenopathy on PET/MRI after COVID-19 vaccination: https://pubmed.ncbi.nlm.nih.gov/33625301/.
-
Autoimmune hepatitis triggered by SARS-CoV-2 vaccination: https://pubmed.ncbi.nlm.nih.gov/34332438/.
-
New-onset nephrotic syndrome after Janssen COVID-19 vaccination: case report and literature review: https://pubmed.ncbi.nlm.nih.gov/34342187/.
-
Massive cervical lymphadenopathy following vaccination with COVID-19: https://pubmed.ncbi.nlm.nih.gov/34601889/
-
ANCA glomerulonephritis following Modern COVID-19 vaccination: https://pubmed.ncbi.nlm.nih.gov/34081948/
-
Extensive longitudinal transverse myelitis following AstraZeneca COVID-19 vaccination: https://pubmed.ncbi.nlm.nih.gov/34507942/.
-
Systemic capillary extravasation syndrome after vaccination with ChAdOx1 nCOV-19 (Oxford-AstraZeneca): https://pubmed.ncbi.nlm.nih.gov/34362727/
-
Unilateral axillary lymphadenopathy related to COVID-19 vaccine: pattern on screening breast MRI allowing benign evaluation: https://pubmed.ncbi.nlm.nih.gov/34325221/
-
Axillary lymphadenopathy in patients with recent Covid-19 vaccination: a new diagnostic dilemma: https://pubmed.ncbi.nlm.nih.gov/34825530/.
-
Minimal change disease and acute kidney injury after Pfizer-BioNTech COVID-19 vaccine: https://pubmed.ncbi.nlm.nih.gov/34000278/
-
COVID-19 vaccine-induced unilateral axillary adenopathy: follow-up evaluation in the USA: https://pubmed.ncbi.nlm.nih.gov/34655312/.
-
Gastroparesis after Pfizer-BioNTech COVID-19 vaccination: https://pubmed.ncbi.nlm.nih.gov/34187985/.
-
Acute-onset supraclavicular lymphadenopathy coincident with intramuscular mRNA vaccination against COVID-19 may be related to the injection technique of the vaccine, Spain, January and February 2021: https://pubmed.ncbi.nlm.nih.gov/33706861/
-
Supraclavicular lymphadenopathy after COVID-19 vaccination in Korea: serial follow-up by ultrasonography: https://pubmed.ncbi.nlm.nih.gov/34116295/
-
Oxford-AstraZeneca COVID-19 vaccination induced lymphadenopathy on [18F] choline PET / CT, not just an FDG finding: https://pubmed.ncbi.nlm.nih.gov/33661328/
-
Biphasic anaphylaxis after exposure to the first dose of Pfizer-BioNTech COVID-19 mRNA vaccine COVID-19: https://pubmed.ncbi.nlm.nih.gov/34050949/
-
Axillary adenopathy associated with COVID-19 vaccination: imaging findings and follow-up recommendations in 23 women: https://pubmed.ncbi.nlm.nih.gov/33624520/
-
A case of cervical lymphadenopathy following COVID-19 vaccination: https://pubmed.ncbi.nlm.nih.gov/34141500/
-
Unique imaging findings of neurologic phantosmia after Pfizer-BioNtech COVID-19 vaccination: a case report: https://pubmed.ncbi.nlm.nih.gov/34096896/
-
Thrombotic adverse events reported for Moderna, Pfizer, and Oxford-AstraZeneca COVID-19 vaccines: comparison of occurrence and clinical outcomes in the EudraVigilance database: https://pubmed.ncbi.nlm.nih.gov/34835256/
-
Unilateral lymphadenopathy after COVID-19 vaccination: a practical management plan for radiologists of all specialties: https://pubmed.ncbi.nlm.nih.gov/33713605/
-
Unilateral axillary adenopathy in the setting of COVID-19 vaccination: follow-up: https://pubmed.ncbi.nlm.nih.gov/34298342/
-
A systematic review of cases of CNS demyelination following COVID-19 vaccination: https://pubmed.ncbi.nlm.nih.gov/34839149/
-
Supraclavicular lymphadenopathy after COVID-19 vaccination: an increasing presentation in the two-week wait neck lump clinic: https://pubmed.ncbi.nlm.nih.gov/33685772/
-
COVID-19 vaccine-related axillary and cervical lymphadenopathy in patients with current or previous breast cancer and other malignancies: cross-sectional imaging findings on MRI, CT and PET-CT: https://pubmed.ncbi.nlm.nih.gov/34719892/
-
Adenopathy after COVID-19 vaccination: https://pubmed.ncbi.nlm.nih.gov/33625299/.
-
Incidence of axillary adenopathy on breast imaging after vaccination with COVID-19: https://pubmed.ncbi.nlm.nih.gov/34292295/.
-
COVID-19 vaccination and lower cervical lymphadenopathy in two-week neck lump clinic: a follow-up audit: https://pubmed.ncbi.nlm.nih.gov/33947605/.
-
Cervical lymphadenopathy after coronavirus disease vaccination 2019: clinical features and implications for head and neck cancer services: https://pubmed.ncbi.nlm.nih.gov/34526175/
-
Lymphadenopathy associated with the COVID-19 vaccine: https://pubmed.ncbi.nlm.nih.gov/33786231/
-
Evolution of lymphadenopathy on PET/MRI after COVID-19 vaccination: https://pubmed.ncbi.nlm.nih.gov/33625301/.
-
Autoimmune hepatitis triggered by SARS-CoV-2 vaccination: https://pubmed.ncbi.nlm.nih.gov/34332438/.
-
New-onset nephrotic syndrome after Janssen COVID-19 vaccination: case report and literature review: https://pubmed.ncbi.nlm.nih.gov/34342187/.
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Massive cervical lymphadenopathy following vaccination with COVID-19: https://pubmed.ncbi.nlm.nih.gov/34601889/
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ANCA glomerulonephritis following Modern COVID-19 vaccination: https://pubmed.ncbi.nlm.nih.gov/34081948/
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Extensive longitudinal transverse myelitis following AstraZeneca COVID-19 vaccination: https://pubmed.ncbi.nlm.nih.gov/34507942/.
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Systemic capillary extravasation syndrome after vaccination with ChAdOx1 nCOV-19 (Oxford-AstraZeneca): https://pubmed.ncbi.nlm.nih.gov/34362727/
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Unilateral axillary lymphadenopathy related to COVID-19 vaccine: pattern on screening breast MRI allowing benign evaluation: https://pubmed.ncbi.nlm.nih.gov/34325221/
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Axillary lymphadenopathy in patients with recent Covid-19 vaccination: a new diagnostic dilemma: https://pubmed.ncbi.nlm.nih.gov/34825530/.
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Minimal change disease and acute kidney injury after Pfizer-BioNTech COVID-19 vaccine: https://pubmed.ncbi.nlm.nih.gov/34000278/
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COVID-19 vaccine-induced unilateral axillary adenopathy: follow-up evaluation in the USA: https://pubmed.ncbi.nlm.nih.gov/34655312/.
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Gastroparesis after Pfizer-BioNTech COVID-19 vaccination: https://pubmed.ncbi.nlm.nih.gov/34187985/.
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Buchhorn, R., Meyer, C., Schulze-Forster, K., Junker, J., & Heidecke, H. (2021). Autoantibody Release in Children after Corona Virus mRNA Vaccination: A Risk Factor of Multisystem Inflammatory Syndrome? Vaccines (Basel), 9(11). doi:10.3390/vaccines9111353. https://www.ncbi.nlm.nih.gov/pubmed/34835284
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Calcaterra, G., Bassareo, P. P., Barilla, F., Romeo, F., & Mehta, J. L. (2022). Concerning the unexpected prothrombotic state following some coronavirus disease 2019 vaccines. J Cardiovasc Med (Hagerstown), 23(2), 71-74. doi:10.2459/JCM.0000000000001232. https://www.ncbi.nlm.nih.gov/pubmed/34366403
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Calcaterra, G., Mehta, J. L., de Gregorio, C., Butera, G., Neroni, P., Fanos, V., & Bassareo, P. P. (2021). COVID 19 Vaccine for Adolescents. Concern about Myocarditis and Pericarditis. Pediatr Rep, 13(3), 530-533. doi:10.3390/pediatric13030061. https://www.ncbi.nlm.nih.gov/pubmed/34564344
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Chai, Q., Nygaard, U., Schmidt, R. C., Zaremba, T., Moller, A. M., & Thorvig, C. M. (2022). Multisystem inflammatory syndrome in a male adolescent after his second Pfizer-BioNTech COVID-19 vaccine. Acta Paediatr, 111(1), 125-127. doi:10.1111/apa.16141. https://www.ncbi.nlm.nih.gov/pubmed/34617315
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Chamling, B., Vehof, V., Drakos, S., Weil, M., Stalling, P., Vahlhaus, C., . . . Yilmaz, A. (2021). Occurrence of acute infarct-like myocarditis following COVID-19 vaccination: just an accidental co-incidence or rather vaccination-associated autoimmune myocarditis? Clin Res Cardiol, 110(11), 1850-1854. doi:10.1007/s00392-021-01916-w. https://www.ncbi.nlm.nih.gov/pubmed/34333695
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Chang, J. C., & Hawley, H. B. (2021). Vaccine-Associated Thrombocytopenia and Thrombosis: Venous Endotheliopathy Leading to Venous Combined Micro-Macrothrombosis. Medicina (Kaunas), 57(11). doi:10.3390/medicina57111163. https://www.ncbi.nlm.nih.gov/pubmed/34833382
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Chelala, L., Jeudy, J., Hossain, R., Rosenthal, G., Pietris, N., & White, C. (2021). Cardiac MRI Findings of Myocarditis After COVID-19 mRNA Vaccination in Adolescents. AJR Am J Roentgenol. doi:10.2214/AJR.21.26853. https://www.ncbi.nlm.nih.gov/pubmed/34704459
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Choi, S., Lee, S., Seo, J. W., Kim, M. J., Jeon, Y. H., Park, J. H., . . . Yeo, N. S. (2021). Myocarditis-induced Sudden Death after BNT162b2 mRNA COVID-19 Vaccination in Korea: Case Report Focusing on Histopathological Findings. J Korean Med Sci, 36(40), e286. doi:10.3346/jkms.2021.36.e286. https://www.ncbi.nlm.nih.gov/pubmed/34664804
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Chouchana, L., Blet, A., Al-Khalaf, M., Kafil, T. S., Nair, G., Robblee, J., . . . Liu, P. P. (2021). Features of Inflammatory Heart Reactions Following mRNA COVID-19 Vaccination at a Global Level. Clin Pharmacol Ther. doi:10.1002/cpt.2499. https://www.ncbi.nlm.nih.gov/pubmed/34860360
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Chua, G. T., Kwan, M. Y. W., Chui, C. S. L., Smith, R. D., Cheung, E. C., Tian, T., . . . Ip, P. (2021). Epidemiology of Acute Myocarditis/Pericarditis in Hong Kong Adolescents Following Comirnaty Vaccination. Clin Infect Dis. doi:10.1093/cid/ciab989. https://www.ncbi.nlm.nih.gov/pubmed/34849657
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Clarke, R., & Ioannou, A. (2021). Should T2 mapping be used in cases of recurrent myocarditis to differentiate between the acute inflammation and chronic scar? J Pediatr. doi:10.1016/j.jpeds.2021.12.026. https://www.ncbi.nlm.nih.gov/pubmed/34933012
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Colaneri, M., De Filippo, M., Licari, A., Marseglia, A., Maiocchi, L., Ricciardi, A., . . . Bruno, R. (2021). COVID vaccination and asthma exacerbation: might there be a link? Int J Infect Dis, 112, 243-246. doi:10.1016/j.ijid.2021.09.026. https://www.ncbi.nlm.nih.gov/pubmed/34547487
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Das, B. B., Kohli, U., Ramachandran, P., Nguyen, H. H., Greil, G., Hussain, T., . . . Khan, D. (2021). Myopericarditis after messenger RNA Coronavirus Disease 2019 Vaccination in Adolescents 12 to 18 Years of Age. J Pediatr, 238, 26-32 e21. doi:10.1016/j.jpeds.2021.07.044. https://www.ncbi.nlm.nih.gov/pubmed/34339728
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Das, B. B., Moskowitz, W. B., Taylor, M. B., & Palmer, A. (2021). Myocarditis and Pericarditis Following mRNA COVID-19 Vaccination: What Do We Know So Far? Children (Basel), 8(7). doi:10.3390/children8070607. https://www.ncbi.nlm.nih.gov/pubmed/34356586
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Deb, A., Abdelmalek, J., Iwuji, K., & Nugent, K. (2021). Acute Myocardial Injury Following COVID-19 Vaccination: A Case Report and Review of Current Evidence from Vaccine Adverse Events Reporting System Database. J Prim Care Community Health, 12, 21501327211029230. doi:10.1177/21501327211029230. https://www.ncbi.nlm.nih.gov/pubmed/34219532
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Dickey, J. B., Albert, E., Badr, M., Laraja, K. M., Sena, L. M., Gerson, D. S., . . . Aurigemma, G. P. (2021). A Series of Patients With Myocarditis Following SARS-CoV-2 Vaccination With mRNA-1279 and BNT162b2. JACC Cardiovasc Imaging, 14(9), 1862-1863. doi:10.1016/j.jcmg.2021.06.003. https://www.ncbi.nlm.nih.gov/pubmed/34246585
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Dimopoulou, D., Spyridis, N., Vartzelis, G., Tsolia, M. N., & Maritsi, D. N. (2021). Safety and tolerability of the COVID-19 mRNA-vaccine in adolescents with juvenile idiopathic arthritis on treatment with TNF-inhibitors. Arthritis Rheumatol. doi:10.1002/art.41977. https://www.ncbi.nlm.nih.gov/pubmed/34492161
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Dimopoulou, D., Vartzelis, G., Dasoula, F., Tsolia, M., & Maritsi, D. (2021). Immunogenicity of the COVID-19 mRNA vaccine in adolescents with juvenile idiopathic arthritis on treatment with TNF inhibitors. Ann Rheum Dis. doi:10.1136/annrheumdis-2021-221607. https://www.ncbi.nlm.nih.gov/pubmed/34844930
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Ehrlich, P., Klingel, K., Ohlmann-Knafo, S., Huttinger, S., Sood, N., Pickuth, D., & Kindermann, M. (2021). Biopsy-proven lymphocytic myocarditis following first mRNA COVID-19 vaccination in a 40-year-old male: case report. Clin Res Cardiol, 110(11), 1855-1859. doi:10.1007/s00392-021-01936-6. https://www.ncbi.nlm.nih.gov/pubmed/34487236
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El Sahly, H. M., Baden, L. R., Essink, B., Doblecki-Lewis, S., Martin, J. M., Anderson, E. J., . . . Group, C. S. (2021). Efficacy of the mRNA-1273 SARS-CoV-2 Vaccine at Completion of Blinded Phase. N Engl J Med, 385(19), 1774-1785. doi:10.1056/NEJMoa2113017. https://www.ncbi.nlm.nih.gov/pubmed/34551225
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Facetti, S., Giraldi, M., Vecchi, A. L., Rogiani, S., & Nassiacos, D. (2021). [Acute myocarditis in a young adult two days after Pfizer vaccination]. G Ital Cardiol (Rome), 22(11), 891-893. doi:10.1714/3689.36746. https://www.ncbi.nlm.nih.gov/pubmed/34709227
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Fazlollahi, A., Zahmatyar, M., Noori, M., Nejadghaderi, S. A., Sullman, M. J. M., Shekarriz-Foumani, R., . . . Safiri, S. (2021). Cardiac complications following mRNA COVID-19 vaccines: A systematic review of case reports and case series. Rev Med Virol, e2318. doi:10.1002/rmv.2318. https://www.ncbi.nlm.nih.gov/pubmed/34921468
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Fazolo, T., Lima, K., Fontoura, J. C., de Souza, P. O., Hilario, G., Zorzetto, R., . . . Bonorino, C. (2021). Pediatric COVID-19 patients in South Brazil show abundant viral mRNA and strong specific anti-viral responses. Nat Commun, 12(1), 6844. doi:10.1038/s41467-021-27120-y. https://www.ncbi.nlm.nih.gov/pubmed/34824230
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Fikenzer, S., & Laufs, U. (2021). Correction to: Response to Letter to the editors referring to Fikenzer, S., Uhe, T., Lavall, D., Rudolph, U., Falz, R., Busse, M., Hepp, P., & Laufs, U. (2020). Effects of surgical and FFP2/N95 face masks on cardiopulmonary exercise capacity. Clinical research in cardiology: official journal of the German Cardiac Society, 1-9. Advance online publication. https://doi.org/10.1007/s00392-020-01704-y. Clin Res Cardiol, 110(8), 1352. doi:10.1007/s00392-021-01896-x. https://www.ncbi.nlm.nih.gov/pubmed/34170372
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Foltran, D., Delmas, C., Flumian, C., De Paoli, P., Salvo, F., Gautier, S., . . . Montastruc, F. (2021). Myocarditis and Pericarditis in Adolescents after First and Second doses of mRNA COVID-19 Vaccines. Eur Heart J Qual Care Clin Outcomes. doi:10.1093/ehjqcco/qcab090. https://www.ncbi.nlm.nih.gov/pubmed/34849667
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Forgacs, D., Jang, H., Abreu, R. B., Hanley, H. B., Gattiker, J. L., Jefferson, A. M., & Ross, T. M. (2021). SARS-CoV-2 mRNA Vaccines Elicit Different Responses in Immunologically Naive and Pre-Immune Humans. Front Immunol, 12, 728021. doi:10.3389/fimmu.2021.728021. https://www.ncbi.nlm.nih.gov/pubmed/34646267
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Furer, V., Eviatar, T., Zisman, D., Peleg, H., Paran, D., Levartovsky, D., . . . Elkayam, O. (2021). Immunogenicity and safety of the BNT162b2 mRNA COVID-19 vaccine in adult patients with autoimmune inflammatory rheumatic diseases and in the general population: a multicentre study. Ann Rheum Dis, 80(10), 1330-1338. doi:10.1136/annrheumdis-2021-220647. https://www.ncbi.nlm.nih.gov/pubmed/34127481
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Galindo, R., Chow, H., & Rongkavilit, C. (2021). COVID-19 in Children: Clinical Manifestations and Pharmacologic Interventions Including Vaccine Trials. Pediatr Clin North Am, 68(5), 961-976. doi:10.1016/j.pcl.2021.05.004. https://www.ncbi.nlm.nih.gov/pubmed/34538306
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Gargano, J. W., Wallace, M., Hadler, S. C., Langley, G., Su, J. R., Oster, M. E., . . . Oliver, S. E. (2021). Use of mRNA COVID-19 Vaccine After Reports of Myocarditis Among Vaccine Recipients: Update from the Advisory Committee on Immunization Practices – United States, June 2021. MMWR Morb Mortal Wkly Rep, 70(27), 977-982. doi:10.15585/mmwr.mm7027e2. https://www.ncbi.nlm.nih.gov/pubmed/34237049
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Gatti, M., Raschi, E., Moretti, U., Ardizzoni, A., Poluzzi, E., & Diemberger, I. (2021). Influenza Vaccination and Myo-Pericarditis in Patients Receiving Immune Checkpoint Inhibitors: Investigating the Likelihood of Interaction through the Vaccine Adverse Event Reporting System and VigiBase. Vaccines (Basel), 9(1). doi:10.3390/vaccines9010019. https://www.ncbi.nlm.nih.gov/pubmed/33406694
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Gautam, N., Saluja, P., Fudim, M., Jambhekar, K., Pandey, T., & Al’Aref, S. (2021). A Late Presentation of COVID-19 Vaccine-Induced Myocarditis. Cureus, 13(9), e17890. doi:10.7759/cureus.17890. https://www.ncbi.nlm.nih.gov/pubmed/34660088
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Gellad, W. F. (2021). Myocarditis after vaccination against covid-19. BMJ, 375, n3090. doi:10.1136/bmj.n3090. https://www.ncbi.nlm.nih.gov/pubmed/34916217
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Greenhawt, M., Abrams, E. M., Shaker, M., Chu, D. K., Khan, D., Akin, C., . . . Golden, D. B. K. (2021). The Risk of Allergic Reaction to SARS-CoV-2 Vaccines and Recommended Evaluation and Management: A Systematic Review, Meta-Analysis, GRADE Assessment, and International Consensus Approach. J Allergy Clin Immunol Pract, 9(10), 3546-3567. doi:10.1016/j.jaip.2021.06.006. https://www.ncbi.nlm.nih.gov/pubmed/34153517
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Haaf, P., Kuster, G. M., Mueller, C., Berger, C. T., Monney, P., Burger, P., . . . Tanner, F. C. (2021). The very low risk of myocarditis and pericarditis after mRNA COVID-19 vaccination should not discourage vaccination. Swiss Med Wkly, 151, w30087. doi:10.4414/smw.2021.w30087. https://www.ncbi.nlm.nih.gov/pubmed/34668687
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Hasnie, A. A., Hasnie, U. A., Patel, N., Aziz, M. U., Xie, M., Lloyd, S. G., & Prabhu, S. D. (2021). Perimyocarditis following first dose of the mRNA-1273 SARS-CoV-2 (Moderna) vaccine in a healthy young male: a case report. BMC Cardiovasc Disord, 21(1), 375. doi:10.1186/s12872-021-02183-3. https://www.ncbi.nlm.nih.gov/pubmed/34348657
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Hause, A. M., Gee, J., Baggs, J., Abara, W. E., Marquez, P., Thompson, D., . . . Shay, D. K. (2021). COVID-19 Vaccine Safety in Adolescents Aged 12-17 Years – United States, December 14, 2020-July 16, 2021. MMWR Morb Mortal Wkly Rep, 70(31), 1053-1058. doi:10.15585/mmwr.mm7031e1. https://www.ncbi.nlm.nih.gov/pubmed/34351881
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Helms, J. M., Ansteatt, K. T., Roberts, J. C., Kamatam, S., Foong, K. S., Labayog, J. S., & Tarantino, M. D. (2021). Severe, Refractory Immune Thrombocytopenia Occurring After SARS-CoV-2 Vaccine. J Blood Med, 12, 221-224. doi:10.2147/JBM.S307047. https://www.ncbi.nlm.nih.gov/pubmed/33854395
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Hippisley-Cox, J., Patone, M., Mei, X. W., Saatci, D., Dixon, S., Khunti, K., . . . Coupland, C. A. C. (2021). Risk of thrombocytopenia and thromboembolism after covid-19 vaccination and SARS-CoV-2 positive testing: self-controlled case series study. BMJ, 374, n1931. doi:10.1136/bmj.n1931. https://www.ncbi.nlm.nih.gov/pubmed/34446426
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Ho, J. S., Sia, C. H., Ngiam, J. N., Loh, P. H., Chew, N. W., Kong, W. K., & Poh, K. K. (2021). A review of COVID-19 vaccination and the reported cardiac manifestations. Singapore Med J. doi:10.11622/smedj.2021210. https://www.ncbi.nlm.nih.gov/pubmed/34808708
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Iguchi, T., Umeda, H., Kojima, M., Kanno, Y., Tanaka, Y., Kinoshita, N., & Sato, D. (2021). Cumulative Adverse Event Reporting of Anaphylaxis After mRNA COVID-19 Vaccine (Pfizer-BioNTech) Injections in Japan: The First-Month Report. Drug Saf, 44(11), 1209-1214. doi:10.1007/s40264-021-01104-9. https://www.ncbi.nlm.nih.gov/pubmed/34347278
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Ioannou, A. (2021a). Myocarditis should be considered in those with a troponin rise and unobstructed coronary arteries following Pfizer-BioNTech COVID-19 vaccination. QJM. doi:10.1093/qjmed/hcab231. https://www.ncbi.nlm.nih.gov/pubmed/34463755
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Ioannou, A. (2021b). T2 mapping should be utilised in cases of suspected myocarditis to confirm an acute inflammatory process. QJM. doi:10.1093/qjmed/hcab326. https://www.ncbi.nlm.nih.gov/pubmed/34931681
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Isaak, A., Feisst, A., & Luetkens, J. A. (2021). Myocarditis Following COVID-19 Vaccination. Radiology, 301(1), E378-E379. doi:10.1148/radiol.2021211766. https://www.ncbi.nlm.nih.gov/pubmed/34342500
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Istampoulouoglou, I., Dimitriou, G., Spani, S., Christ, A., Zimmermanns, B., Koechlin, S., . . . Leuppi-Taegtmeyer, A. B. (2021). Myocarditis and pericarditis in association with COVID-19 mRNA-vaccination: cases from a regional pharmacovigilance centre. Glob Cardiol Sci Pract, 2021(3), e202118. doi:10.21542/gcsp.2021.18. https://www.ncbi.nlm.nih.gov/pubmed/34805376
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Jaafar, R., Boschi, C., Aherfi, S., Bancod, A., Le Bideau, M., Edouard, S., . . . La Scola, B. (2021). High Individual Heterogeneity of Neutralizing Activities against the Original Strain and Nine Different Variants of SARS-CoV-2. Viruses, 13(11). doi:10.3390/v13112177. https://www.ncbi.nlm.nih.gov/pubmed/34834983
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Jain, S. S., Steele, J. M., Fonseca, B., Huang, S., Shah, S., Maskatia, S. A., . . . Grosse-Wortmann, L. (2021). COVID-19 Vaccination-Associated Myocarditis in Adolescents. Pediatrics, 148(5). doi:10.1542/peds.2021-053427. https://www.ncbi.nlm.nih.gov/pubmed/34389692
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Jhaveri, R., Adler-Shohet, F. C., Blyth, C. C., Chiotos, K., Gerber, J. S., Green, M., . . . Zaoutis, T. (2021). Weighing the Risks of Perimyocarditis With the Benefits of SARS-CoV-2 mRNA Vaccination in Adolescents. J Pediatric Infect Dis Soc, 10(10), 937-939. doi:10.1093/jpids/piab061. https://www.ncbi.nlm.nih.gov/pubmed/34270752
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Kaneta, K., Yokoi, K., Jojima, K., Kotooka, N., & Node, K. (2021). Young Male With Myocarditis Following mRNA-1273 Vaccination Against Coronavirus Disease-2019 (COVID-19). Circ J. doi:10.1253/circj.CJ-21-0818. https://www.ncbi.nlm.nih.gov/pubmed/34744118
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Kaul, R., Sreenivasan, J., Goel, A., Malik, A., Bandyopadhyay, D., Jin, C., . . . Panza, J. A. (2021). Myocarditis following COVID-19 vaccination. Int J Cardiol Heart Vasc, 36, 100872. doi:10.1016/j.ijcha.2021.100872. https://www.ncbi.nlm.nih.gov/pubmed/34568540
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Kim, H. W., Jenista, E. R., Wendell, D. C., Azevedo, C. F., Campbell, M. J., Darty, S. N., . . . Kim, R. J. (2021). Patients With Acute Myocarditis Following mRNA COVID-19 Vaccination. JAMA Cardiol, 6(10), 1196-1201. doi:10.1001/jamacardio.2021.2828. https://www.ncbi.nlm.nih.gov/pubmed/34185046
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King, W. W., Petersen, M. R., Matar, R. M., Budweg, J. B., Cuervo Pardo, L., & Petersen, J. W. (2021). Myocarditis following mRNA vaccination against SARS-CoV-2, a case series. Am Heart J Plus, 8, 100042. doi:10.1016/j.ahjo.2021.100042. https://www.ncbi.nlm.nih.gov/pubmed/34396358
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Klein, N. P., Lewis, N., Goddard, K., Fireman, B., Zerbo, O., Hanson, K. E., . . . Weintraub, E. S. (2021). Surveillance for Adverse Events After COVID-19 mRNA Vaccination. JAMA, 326(14), 1390-1399. doi:10.1001/jama.2021.15072. https://www.ncbi.nlm.nih.gov/pubmed/34477808
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Klimek, L., Bergmann, K. C., Brehler, R., Pfutzner, W., Zuberbier, T., Hartmann, K., . . . Worm, M. (2021). Practical handling of allergic reactions to COVID-19 vaccines: A position paper from German and Austrian Allergy Societies AeDA, DGAKI, GPA and OGAI. Allergo J Int, 1-17. doi:10.1007/s40629-021-00165-7. https://www.ncbi.nlm.nih.gov/pubmed/33898162
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Witberg, G., Barda, N., Hoss, S., Richter, I., Wiessman, M., Aviv, Y., . . . Kornowski, R. (2021). Myocarditis after Covid-19 Vaccination in a Large Health Care Organization. N Engl J Med, 385(23), 2132-2139. doi:10.1056/NEJMoa2110737. https://www.ncbi.nlm.nih.gov/pubmed/34614329
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Zimmermann, P., & Curtis, N. (2020). Why is COVID-19 less severe in children? A review of the proposed mechanisms underlying the age-related difference in severity of SARS-CoV-2 infections. Arch Dis Child. doi:10.1136/archdischild-2020-320338. https://www.ncbi.nlm.nih.gov/pubmed/33262177
Abstract
Our group has been using the PULS Cardiac Test (GD Biosciences, Inc, Irvine, CA) a clinically validated measurement of multiple protein biomarkers which generates a score predicting the 5 yr risk (percentage chance) of a new Acute Coronary Syndrome (ACS). The score is based on changes from the norm of multiple protein biomarkers including IL-16, a proinflammatory cytokine, soluble Fas, an inducer of apoptosis, and Hepatocyte Growth Factor (HGF)which serves as a marker for chemotaxis of T-cells into epithelium and cardiac tissue, among other markers. Elevation above the norm increases the PULS score, while decreases below the norm lowers the PULS score.The score has been measured every 3-6 months in our patient population for 8 years.
Recently, with the advent of the mRNA COVID 19 vaccines (vac) by Moderna and Pfizer, dramatic changes in the PULS score became apparent in most patients.This report summarizes those results.
A total of 566 pts, aged 28 to 97, M:F ratio 1:1 seen in a preventive cardiology practice had a new PULS test drawn from 2 to 10 weeks following the 2nd COVID shot and was compared to the previous PULS score drawn 3 to 5 months previously pre- shot. Baseline IL-16 increased from 35=/-20 above the norm to 82 =/- 75 above the norm post-vac; sFas increased from 22+/- 15 above the norm to 46=/-24 above the norm post-vac; HGF increased from 42+/-12 above the norm to 86+/-31 above the norm post-vac. These changes resulted in an increase of the PULS score from 11% 5 yr ACS risk to 25% 5 yr ACS risk.
At the time of this report, these changes persist for at least 2.5 months post second dose of vac.We conclude that the mRNA vacs dramatically increase inflammation on the endothelium and T cell infiltration of cardiac muscle and may account for the observations of increased thrombosis, cardiomyopathy, and other vascular events following vaccination.
Pfizer/BioNTech’s Comirnaty COVID shot was approved (licensed) by the U.S. Food and Drug Administration in late August 2021, but only for adults, and only when carrying the Comirnaty label. No other COVID shot has been FDA approved. However, Comirnaty is currently not available, and while the experimental, emergency use authorized (EUA) Pfizer shot is substituted for Comirnaty, the two products are clearly legally distinct and not the same
A licensed vaccine is not shielded from liability until or unless it’s added to the recommended childhood vaccination schedule by the CDC. So, if you were injured by Comirnaty, you could sue Pfizer. You cannot sue if injured by the EUA Pfizer shot (or any of the other EUA COVID injections)
Even though several hundred claims have been filed with the Countermeasures Injury Compensation Program (CICP) for injuries resulting from the COVID shots — which is the only possible avenue to obtain damages — not a single claim has been paid out
Natural immunity is much stronger than what you can achieve from the injection, which only provides antibodies against the SARS-CoV-2 spike protein and wanes within a few months. The shots may in fact permanently limit the kind of immune response you would make were you to later be exposed or infected with COVID
Children’s Health Defense has filed a lawsuit arguing you cannot have a vaccine that is both an emergency use product and a licensed product at the same time. That’s against the law, but the government has done it anyway. Remarkably, the request for an injunction was initially thrown out, but the CHD has not given up and is still pursuing the case
In this interview, Dr. Meryl Nass, an internist specializing in toxicology, vaccine-induced illnesses and Gulf War illness, shares her insights into the dangers of the COVID jab, which received an emergency use authorization October 26, 2021, for children as young as 5.
We also discuss the conflicts of interest within the U.S. Food and Drug Administration that seem to be behind this reckless decision, and how the agency pulled the wool over our eyes with its approval of Pfizer/BioNTech’s Comirnaty COVID injection.
Is the COVID Jab Approved or Not?
As explained by Nass:
“All of the COVID ‘vaccines,’ and most of the COVID treatment products, have not been [FDA] approved. Approved means licensed. All except one, which is the Pfizer vaccine for adults, age 16 and up, which got approved, i.e., licensed on August 23 [2021].
But every other vaccine, and for every other age group, including the boosters, have only been authorized under emergency use authorizations (EUAs). There’s a critical difference [between licensing and EUA]. Once a drug is fully licensed, it is subject to liability.
If the company injures you with that product, you can sue them, unless it later gets put on the CDC’s childhood schedule or is recommended by the CDC [U.S. Centers for Disease Control and Prevention] [during] pregnancy, in which case it obtains a different liability shield.
It then becomes part of the National Vaccine Injury Compensation Program (NVICP, established under the 1986 National Childhood Vaccine Injury Act), and 75 cents from every dose of vaccine that is sold in the United States goes into a fund to pay for injuries that way.”
The National Childhood Vaccine Injury Act removed liability for all vaccines recommended by the CDC for children. Since 2016, they’ve also removed liability for vaccines given to pregnant women, a category that has become the latest “gold rush” for vaccines. Naturally, once a company is no longer liable for injuries, the profitability of the product in question increases dramatically.
Countermeasures Injury Compensation Program Is Nearly Useless
Products under emergency use have their own special government program for liability called the Countermeasures Injury Compensation Program (CICP). “It is a terrible program,” Nass says. CICP is an offshoot of the 2005 PREP Act.
“The PREP act enabled the CICP to be created by Congress,” Nass explains. “Congress has to allocate money for it. If you are injured by an emergency use product, you don’t get any legal process. The companies have had all their liability waived. There is a single process that is administered through HHS [Health and Human Services].
Some employees there decide whether you deserve to be compensated or not. The maximum in damages you can obtain is about $370,000 if you’re totally disabled or die, and the money is only to compensate you for lost wages or unpaid medical bills.”
So far, even though several hundred CICP claims have been filed for injuries resulting from the COVID shots, not a single claim has been paid out. This is important, because the statute of limitations is one year. “It’s getting close to running out for people who were vaccinated early,” Nass says.
If you fail to apply in time, you lose the opportunity to get any compensation entirely. “Of course, in fact, it’s really ‘an opportunity’ to apply and get nothing because almost nobody gets paid,” she says. At that point, you have no further recourse. There’s no appeals process to the judicial system.
“You can ask the HHS twice to compensate you, and if they say no, that’s it,” Nass explains. “You can attempt to sue the company that made the product, if you’re convinced it was improperly made, but the secretary of HHS has to give you the permission to sue.
You have to prove that there was willful misconduct and no one has ever reached that bar. So, there has never been a lawsuit under this. Anyway, that’s what you’re looking at. If you get the vaccine under EUA and are injured, you’re on your own. People have no idea about this when they vaccinate themselves or their children.”
Why Were the Shots Mandated?
As you know by now, president Biden decided to mandate the COVID jab for most federal employees (but not all) and private companies with 100 employees or more. “We don’t know why that is,” Nass says. It doesn’t make sense, as large numbers of Americans have already recovered from COVID-19 and have durable, long-lasting immunity already.
As correctly noted by Nass, natural immunity is much stronger than what you can achieve from the injection, which only provides antibodies against the SARS-CoV-2 spike protein and wears off within a few months. The shots “may in fact permanently limit the kind of immune response you would make were you to be infected with COVID later,” Nass says.
For these reasons, there’s absolutely no good reason to vaccinate people who have recovered from the infection and several bad reasons. There’s evidence showing the shot can be more harmful for those with existing immunity.
“But for reasons best known to itself, the Biden administration feels so certain it needs to vaccinate everybody that it has used illegal means to tell employers they will lose federal contracts if they don’t force their employees to be vaccinated immediately, and must fire them — if they’re health care workers, for example, or government employees, or military — if they have not been vaccinated.
Obviously that is creating a great deal of chaos, particularly within the health care industry, particularly in my state, Maine, where these draconian rules have gone into effect and many fire department, police, EMTs, nurses and doctors can no longer work.
The one thing that was necessary to push mandates forward was for the government to be able to say it had a licensed product. Before the emergency use authorization was created in 2005, you had licensed drugs and you had experimental drugs and nothing else.
There was no gray area between them. Any use of a medication or vaccine that is not fully licensed is still experimental, despite the fact that a new category of drugs has been created with emergency use authorizations.
These are still experimental drugs, so under emergency use, you can’t force people [to take them]. You have to offer them options and they have the right to refuse. Since that is part of the statute, the federal government can’t get around it.
Therefore, attorneys in the Biden administration knew they could not legally impose mandates under an EUA, and so they demanded that FDA provide a COVID vaccine full approval, aka, an unrestricted license. This was believed to enable them to impose mandates.
They must have put pressure on the FDA, and FDA gave them what they wanted, which was a license for the Pfizer vaccine called Comirnaty on August 23 [2021].”
Comirnaty Approval Includes Important Caveats
In the documents released August 23, 2021, by the FDA, there were some interesting caveats. They said the Comirnaty vaccine is essentially equivalent to the EUA vaccine and the two vaccines may be used interchangeably. However, they pointed out that the two are legally distinct. Curiously, FDA didn’t specify what these legal distinctions are.
“I concluded that the legal distinctions were the fact that under EUA, there was essentially no manufacturer liability, but once the vaccine got licensed, the manufacturer would be subject to liability claims unless and until the vaccine was placed on the childhood schedule or recommended in pregnancy, in which case it would then fall … under the NVICP,” Nass says.
“Right now, Comirnaty is still not in that injury compensation program, and it’s licensed, so it no longer falls under the CICP. So, it is in fact subject to liability if you get injured with a bottle that says Comirnaty on it. Of course, if you’re Pfizer, what do you want to do?
You don’t want to make that licensed product available until several months have gone by and Comirnaty has been put into the National Vaccine Injury Compensation Program. So, Pfizer and FDA have not made the licensed product available yet.
What has happened instead, in the military, is the FDA has made a secret deal with the military and said, certain emergency use lots can be considered equivalent to the licensed vaccine, and [told military medical staff] which QR codes — which lots can be used. [These specific lots] can then be given to soldiers as if they’re licensed.
Subsequently, we’re told that military clinics are actually putting Comirnaty labels onto bottles that are under EUA. Now, that probably can happen in the military, but only in the military, because there are likely to be memoranda of understanding within the military that we haven’t seen yet that say soldiers cannot sue Pfizer for injuries …
In the military, the government and Pfizer feel like they have set up a situation where nobody can sue, but in the civilian world, that has not happened, and so there is no Comirnaty available.
Yet, on the basis that FDA licensed this product, the federal government is still telling employers that they can mandate it and that they must fire employees that have not taken the vaccine, or they will lose government contracts. We’re in a very interesting situation that is ripe for litigation, and Children’s Health Defense, which is an organization I represent, is litigating some of this.
However, the litigation situation has been very difficult since the pandemic began. Cases that normally would’ve been easy wins are being thrown out by the courts, both in the U.S. and in Europe. Something strange has happened and the judges are looking for any way out, so they don’t have to rule on the merits of these cases.”
The organization Children’s Health Defense has filed a lawsuit arguing you cannot have a vaccine that is both an emergency use product and a licensed product at the same time. That’s against the law, but the federal government did it anyway. Remarkably, the request for an injunction was initially thrown out, but Children’s Health Defense hasn’t given up and is still pursuing that case.
COVID Jab Is Authorized for 5- to 11-Year-Olds in the US
As mentioned, the FDA recently authorized the EUA COVID jab for children between the ages of 5 and 11, which is simply appalling, considering they are at virtually no risk from COVID-19. I’ve not seen a single recorded case in the entire world of anyone in that age group dying of COVID that didn’t have a serious preexisting comorbidity, such as cancer.
If you have a healthy child, they are at no risk from the infection, so there’s only danger associated with this shot, which in this age group would be one-third the adult dose. Typically, when you’re giving a drug to a child, the dose is calculated based on the child’s weight. Here, they’re giving the same dose to a 5-year-old as an 11-year-old, despite there being a significant difference in weight. So, it’s pure guesswork.
Worse yet, the mRNA vaccines produce an unpredictable amount of spike protein, and even if they produce much too much, there is no way to turn off the process once you have been injected.
Despite clear safety signals, the FDA’s advisory committee authorized the Pfizer jab for 5- to 11-year-olds unanimously, 17-to-0 (with one abstaining vote). However, when you look at the roster of the FDA’s committee members1 who reviewed and voted to authorize the Pfizer shot for children as young as 5, the unanimous “yes” vote becomes less of a mystery.
Abhorrent Conflicts of Interest
As reported by National File2 and The Defender,3 the membership of the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) has had staggering conflicts of interest. Members have included:
In addition to that, former FDA commissioner Scott Gottlieb is currently on Pfizer’s board of directors. As noted by Nass, two of the members, one permanent and one temporary, are also CDC career employees whose job it is to push vaccines at the CDC.
“If they voted against authorizing a vaccine, they would be out of a job,” Nass says. “They have no business on that committee … It’s a very unethical stew of advisory committee members …
What happened is Pfizer delivered a large package of information to the FDA on October 6, 2021. FDA staff had to go through this large packet of information on the 5- to 11-year-olds and produce their own report, which was about 40 pages long, and create talks to give to the advisory committee, and they did all of this in 17 days.
There was apparently very little critical thought that went into their presentations. Before the meeting, Children’s Health Defense, and I was one of the authors, wrote to the committee and to FDA officials saying, ‘Look, there’s all these reasons that don’t make logical or medical sense for vaccinating kids in this age group, because they almost never get very ill or die, and the side effects of the vaccine are essentially unknown.
We know there are a lot of side effects, but the federal government has concealed from us the rate at which these side effects occur. But we know that the rate from myocarditis is very high, probably at least 1 in 5,000 young males … which is a very serious side effect. It can lead, probably always leads, to some scarring. It can lead to sudden death, to heart failure.”
Trials in Young Children Were Insufficient
As explained by Nass, in the clinical trial, there were two groups of children. The first group was enrolled for two to three months, while the second group was enrolled for just 17 days after receiving the second dose. (Pfizer added the second group because FDA claimed there weren’t enough volunteers in the first group.)
These two groups comprised over 3,000 children who got the jab and 1,500 or 2,000 who got a placebo. None suffered serious side effects. This was then translated into the claim that the injection was safe. However, as noted by Nass:
“They didn’t look at safety in all these kids. Even though FDA had said, ‘Add kids to your clinical trial,’ Pfizer created a ‘safety subset’ of one-tenth of the vaccinated subjects.
It was this small number of kids from whom they drew blood to show they had adequate levels of neutralizing antibodies, which was a surrogate for efficacy, because they didn’t have enough cases of COVID in this abbreviated trial to show that the vaccine actually works in this age group.”
Even though the advisory committee acknowledged that the blood test done for efficacy had not been validated, and wasn’t reliable evidence of effectiveness, they still decided that all children, regardless of health status, would benefit from the injection.
They also ignored the fact that at least half the children are already immune, and giving them the injection will provide no additional benefit in terms of immunity, while putting them at increased risk for serious side effects.
“Nobody said, ‘Look, the parents of healthy kids may be dying for a vaccine, but that’s because we haven’t told them the truth about the vaccine. We haven’t told them their kids don’t need it. We haven’t told them it’s going to potentially damage future immunity.
We haven’t told them they’re at higher risk of side effects than if they never had COVID. We’re not allowing them to go get antibody tests to establish that they’re already immune and therefore should be waved from being vaccinated.’
The committee members were aware of all this stuff, but in the end [they voted yes] … apart from one very smart member of the committee who works for the National Institutes of Health. He abstained. He didn’t have the guts to vote no, but he knew this was a bad idea.”
Children Are Being Injected Without Parental Consent
While all of that is bad enough, parents of young children now face the possibility of their children being injected against their will and without their knowledge. Nass comments:
“As I said, we don’t know why the government wants everybody vaccinated, but there’s probably a reason that goes beyond protecting us from COVID.
The government got the FDA to authorize the vaccine for 12- to 15-year-olds on May 10 [2021], and subsequently that group, which is about 6 million kids, has been getting vaccinated across the country. That’s under emergency use so, again, you can’t sue.
But something kind of evil happened, which was many cities began vaccinating 12- to 15-year-olds in the absence of parental permission. So, a child could show up with their friends or a friend’s mother at a vaccine center and get vaccinated with no one asking about their medical history, nobody calling the parents. No notation got entered into the child’s medical record that they were vaccinated.
Vaccinators were told to make their own assessment. If they thought this child could give consent, go ahead and vaccinate. Now, that is a gross violation of our laws, and yet it was happening in Boston, in Philadelphia, in Seattle, in San Francisco, and we have good documentation of it.
The government currently is planning for mobile vaccination clinics for kids and vaccinations in schools, and they may take this program of vaccinating without parental consent down to the 5- to 11-year-olds …
In fact, we may see clinics popping up that don’t require informed consent in the 5- to 11-year-old group. Let me just mention that the chief medical officer in Canada’s British Columbia said they have brought laws that allow children of any age to consent for themselves. Think about that. A baby can consent for vaccinations for itself. It would be funny if it wasn’t so diabolical.”
All of this goes against the most basic concept of medical ethics, which is informed consent. No one has the right to perform a medical procedure on you without your consent, or the consent of a legal guardian. The government, again, without establishing any new laws, is simply bypassing the legal system.
Will Young Children Be at Risk for Myocarditis?
Based on her review of the scientific literature, Nass suspects younger children in the now COVID jab-approved, 5- to 11-year-old age group will be at exponentially higher risk of myocarditis and other side effects compared to the 12- to 15-year group, where we’ve already seen a documented increase.
“In the letter that Children’s Health Defense wrote to the advisory committee for the FDA, we created a graph based on the reporting rate of myocarditis versus age, and we showed there was an exponential curve.
Men aged 65 and up had a rate that was 1/100th the rate of boys aged 12 to 17. If that exponential curve keeps going up, the rate in the 5- to 11-year-olds could be even dramatically higher. In those young men, a 1 in 5,000 rate was reported to VAERS [Vaccine Adverse Events Reporting System]. That’s not a real rate.
That just tells us how many people got diagnosed with myocarditis, and then went to the trouble of reporting it to the FDA. The FDA and CDC have a large number of other databases from which they can gather rates of illness.
VAERS is considered passive reporting. It is not considered fit for purpose to establish illness rates because we don’t know how many people report. Do 1 in 10 report, 1 in 100, 1 in 50? Nobody knows.
However, again, because everything is crazy since the pandemic came in, the CDC has tried to pull the wool over our eyes and has claimed that the rate of anaphylaxis in the population from COVID vaccines is identical to their reporting rate to VAERS. We know that’s not true.
On the CDC’s website, that’s what they have. Elsewhere on the website, they say you can’t take a VAERS rate and call it an actual rate of reactions, but they’ve done that [for anaphylaxis]. And they’re trying to obfuscate the fact that they’re not giving you real rates, and sort of pretending that the myocarditis rate is probably the VAERS reporting rate of myocarditis, although they’re not saying so directly.”
Nass goes on to recount an example from the smallpox vaccine, which also caused myocarditis. A military study that just looked at cases sent to specialists found roughly 1 in 15,000 developed myocarditis. A military immunologist then dug deeper, and drew blood on soldiers before and after vaccination, and found a myocarditis rate of 1 in 220 after receiving the smallpox vaccine.
However, 1 soldier in 30 developed subclinical myocarditis where troponin rose from normal to more than two times the upper limits of normal. While asymptomatic, 1 in 30 had measurable inflammation of the heart. “Right now, in terms of what the rate is for COVID, nobody is looking, no federal agency wants to find out the real rate,” Nass says.
You Can’t Find Problems You Refuse to Look For
A simple study that measures troponin levels — a marker for heart inflammation and damage — before and after each dose, could easily determine what the real rate of myocarditis is, yet that is not being done.
“This is what we’re dealing with,” Nass says. “All these databases, which is about a dozen different databases, that CDC and FDA said they could access to determine the rates of side effects after vaccination with COVID vaccines, they’re either not being used or being used improperly,” Nass says.
“It was discovered that a new algorithm was being used to study the VAERS database that only came into use in January 2021, immediately after the vaccines were authorized, and the algorithm was developed such that you compare two vaccines to each other.
If the pattern of side effects was similar between the two vaccines — which is often the case because there’s a limited number of general vaccine adverse reactions — even if one vaccine has a thousand times more side effects as the one it is being compared to, by using this flawed algorithm, if the pattern of reactions was the same, even though the rates were 1,000 times higher for one, the algorithm would fail to detect a problem.
That is the algorithm they’re using to analyze VAERS [data]. They’re also using bad methods … to analyze the vaccine safety database, which encompasses 12 million Americans who enrolled in HMOs around the country. The CDC pays for access to their electronic medical records and their data.
Somehow when these databases have been looked at carefully, they’re finding very low rates of myocarditis in boys, approximately equal to the VAERS reporting. It was said months ago, ‘We can’t find a safety signal for myocarditis. We’re not finding an anaphylaxis signal. we’re not finding a Bell’s palsy signal.’
The FDA’s and CDC’s algorithms couldn’t pick up for most known side effects. So, there’s something wrong with the analytic methods that are being used, but the agencies haven’t told us precisely what they are. What we do know is that the rates of side effects that are being reported to VAERS are phenomenal.
They’re orders of magnitude higher than for any previous vaccines used in the United States. An order of magnitude is 10-fold, so rates of reported adverse reactions are 10 to 100 times higher than what has been reported for any other vaccine. Reported deaths after COVID in the United States are 17,000+. It’s off the charts.
Other side effects reported after COVID vaccinations total over 800,000. Again, more deaths and more side effects than have ever been reported for every vaccine combined in use in the U.S. cumulatively over 30 years.”
Despite all this shocking data, our federal agencies look the other way, pretending as if nothing is happening, and no matter how many people approach them — with lawsuits, with public comments, reaching out to politicians — they refuse to address blatantly obvious concerns. This is clear evidence that they’re acting with intentional malice.
FDA has become Clown World, and what they do now is to perform a charade of all the normal regulatory processes that they are expected to perform … You’re the guinea pigs, but they’re not collecting the data. Nobody should get these shots. ~ Dr. Meryl Nass
The FDA and CDC are supposed to protect the public. They’re supposed to identify safety concerns. They’re not supposed to act as marketing firms for drug companies, but that’s precisely what they’ve been converted to.
New Formulations Have Never Been Tested
Another truly egregious fact is that Pfizer has altered its formulation, allegedly to make it more stable, but this new formulation has never been included in any of the trials. Nass explains:
“During the October 26, 2021, VRBPAC [Vaccines and Related Biological Products Advisory Committee] meeting, Pfizer said, ‘Look, we want to give the vaccines in doctor’s offices and we’ve found a way to stabilize the vaccine so we don’t need those ultra-cold fridges anymore. We can put these vials in a doctor’s office and, once defrosted, they can sit in a regular fridge 10 weeks and they’ll be fine.’
Some committee members asked, ‘OK, what’d you do? How did you make this marvelous discovery?’ And they said, ‘We went from the phosphate buffered saline buffer to a Tris buffer, and we slightly changed some electrolytes.’ A committee member asked, ‘OK, how did that make it so much more stable?’ And everybody in the meeting from FDA and Pfizer looked at each other and said, ‘We don’t know.’
An hour later, Pfizer had one of their chemists get on the line, but he couldn’t explain how the change in buffer led to a huge increase in stability, either. Then, later in the meeting, one of the members of the committee asked, ‘Did you use this new formulation in the clinical trial?’
And Dr. Bill Gruber, the lead Pfizer representative, said, ‘No, we didn’t.’ In other words, Pfizer plans, with FDA connivance, to use an entirely new vaccine formulation in children, after their clinical trials used the old formulation. This is grossly illegal. They’ve got a new formulation of vaccine. It wasn’t tested in humans. And they’re about to use it on 28 million American kids.”
It’s nothing short of a dystopian nightmare. Completely surreal. You can’t make this stuff up. Yet as shocking as all this is, earlier this year, Dr. Anthony Fauci projected that these COVID jabs would be available for everyone, from infants to the elderly. Now they’ve got the 5-year-olds, and there’s every reason to suspect they’ll go after newborns and infants next.
Whose Babies Will Be Offered Up as Sacrificial Lambs?
According to Nass, Pfizer and the FDA have struck a deal that will allow Pfizer to test on babies even younger than 6 months old, even if there’s no intention to inject infants that young. Those trials may begin as early as the end of January 2022.
“This arrangement between FDA and Pfizer will give Pfizer its extra six months of patent protection, whether or not these vaccines are intended to be used in those age groups. So, you can look at these trials as a way of almost sacrificing little children, because when you start a trial, you don’t know what the dangers are going to be.
I could be wrong, but I doubt we’re going to give these to newborn babies the way we give the hepatitis B vaccine on the date of birth, yet they will be tested in very young babies. The question is, whose babies get tested? In the past, sometimes the babies that got tested were foster children, wards of the state. Sometimes parents offer up their children. But there will be clinical trials.”
When will we get the data from those trials? It turns out that in the agreements reached between Pfizer and the FDA, some of those trials won’t conclude until 2024, 2025 and 2027. The goal here is to vaccinate all Americans, children and adults, within the coming few months or a year, yet it’ll be five years before we actually know from clinical trials what the side effects may be.
We’re Living in Clown World
As noted by Nass, this is yet another crime. It may fulfill the letter of the law, but it doesn’t fulfill the meaning of the law. It makes no sense to run clinical trials that won’t be completed until five years after your mass vaccination program has been completed and the entire population is injected.
“It’s just a joke to do that,” Nass says. “But FDA has become Clown World, and what they do now is to perform a charade of all the normal regulatory processes that they are expected to do, but they’re only doing them in an abbreviated or peculiar manner so that they don’t really collect the important data.
For example, the control group has been vaccinated two months into the Pfizer trials, which effectively obscures side effects that develop after two months. Blood is not tested for evidence of myocarditis or blood clots using simple tests (troponin and D-dimer levels).
For all the Americans out there who haven’t spent 20 years examining the FDA procedures like I have, these FDA advisory committee meetings are it’s designed to make you think a real regulatory process is going on, when it’s not. Instead we are all guinea pigs, but no one is collecting the data that would normally be required to authorize or approve a vaccine. Therefore, in my opinion, nobody should get these shots.“
To make matters even worse, it’s actually illegal to grant EUAs for these vaccines, because there are drugs that can prevent the condition (COVID), as well as treat it. EUAs can only be granted if there are no existing approved, available alternatives to prevent or treat the infection.
The effective drugs most have already heard of are ivermectin and hydroxychloroquine, but there are a number of other drugs that also have profound effects on COVID, Nass says, including TriCor and cyproheptadine (Periactin).
TriCor, or fenofibrate, emulsifies lipid nanoparticles and fatty conglomerations that contain viruses and inflammatory substances. The drug essentially allows your body to break down the viral and inflammatory debris better. As such, it might also help combat complications caused by the nanoliposomes in the COVID shot.
According to Nass, Pepcid at high doses of up to 80 milligrams three times a day is also useful for treatment. Dr. Robert Malone is starting a clinical trial using a combination of Pepcid and celecoxib (brand name Celebrex). Many are also recommending aspirin to prevent platelet activation and clotting.
I believe a far better alternative to aspirin is lumbrokinase, and/or serapeptase. Both are fibrinolytic enzymes that address blood clotting. You can develop sensitivity to them, so I recommend alternating the two on alternate days for about three months if you’ve had COVID.
You could rule out blood clotting by doing a D-dimer test. If your D-dimer is normal, you don’t need an anticlotting agent. If clotting is a concern, you could also use NAC in addition to these fibrinolytic enzymes. It too helps break up clots and prevent clot formation.
This letter from Marc Wathelet, PhD, Expert in Molecular Biology and Immunology, is addressed to the Belgian Minister of Health, Frank Vandenbroucke, and analyzes not only the mandates imposed on health care workers but also the vaccination of children and the “Safe Ticket” vaccination passport intended for the general population. The content of the letter is relevant not only to the Belgian situation but also to that of other countries adopting this kind of coercive measures, that are particularly questionable as for their public health benefits.
(The letter is available in French at this LINK)
Dear Mr. Vandenbroucke , Deputy Prime Minister and Minister of Social Affairs and Public Health
Thank you for your response to our letter concerning the compulsory vaccination of health care workers, which you justify based on a certain number of assertions which are however not supported by documentation of scientifically established facts.
On the contrary,
the scientific data available to date contradict all of your arguments and, as detailed below, we can only conclude that the compulsory vaccination of health care workers is not only useless, but also counterproductive from a public health perspective. Such compulsory vaccination also violates the principles of bio-ethics and medical ethics as well as our human rights.
1) Compulsory Vaccination of Health Care Workers is Unnecessary
Mandatory vaccination of health care workers is unnecessary because studies show beyond a reasonable doubt that it does not prevent the contamination of an individual, nor does it reduce the viral load of infected people, and therefore their ability to transmit the virus to others.
In appendix A you will find a long list of facts, scientific publications and official statements from qualified agencies and individuals, such as Dr. Fauci, who confirms our assertion that vaccination does not prevent the disease. the contamination of an individual and his ability to transmit the delta variant circulating today to others.
We will only take a recent example here: on September 23, the Irish Examiner announced that in the city of Waterford, 99.7% of those over 18 were fully vaccinated, which is the highest total in the entire European Union . On October 11, Waterford News & Star reported that the city had the highest incidence rate in Ireland.
There is only one conclusion to be drawn, which cannot be disputed in good faith: beyond studies, in the real world, in practice: vaccination does not make it possible to prevent the transmission of SARS-CoV-2 in the community.
2) Mandatory Vaccination of Health Care Workers is Counterproductive from a Public Health Point of View
The message that COVID vaccines would be “safe and effective,” an unsupported claim if only for the lack of the necessary hindsight, was hammered out constantly for months in all the media. One of the negative effects of this campaign is the acceptance of this assertion as an established fact, not only by the population but also by its leaders.
As a result, vaccinated people respect less behaviors such as social distancing or wearing a mask. And since they are more likely to be asymptomatic when infected, which makes them less aware of the risk they pose to others, they are actually more likely to spread the virus than non-vaccinated people.
In practice, this means that the COVID Safe Ticket (Belgian vaccination passport) is not only useless but also counterproductive. It is a license for vaccinated people to infect others, whether they are vaccinated or not.
The same reasoning applies to health care workers, even if they observe social distancing more scrupulously: vaccinating all health care workers will not prevent the contamination of “sick or vulnerable people because of their great age” which you are rightly concerned about.
We agree with you that “people taken care of have the right to maximum safety”. We offer two non-exclusive alternatives to the compulsory vaccination of health care workers, which will be much more effective in preventing nosocomial infections:
1) Have all nursing staff, vaccinated or not, tested at high frequency. In this regard, note that nasopharyngeal tests are not without risk, as reported by the Academy of Medicine in France. Two other safer methods can be considered: an oro-pharyngeal antigen test or an oral PCR test.
2) Establish a voluntary ivermectin prophylaxis program: There are 14 studies that support the effectiveness of this approach.
Finally, the compulsory vaccination of health care workers is counterproductive from a public health point of view because those who still refuse to be vaccinated will no longer be able to work, and therefore the number of health care workers, already in short supply, will be even smaller, with a negative impact on public health.
In France, there are ~ 300,000 unvaccinated health care workers (~10%), and 15,000 of them are already suspended from their job. In Belgian hospitals, 9.4% of health care workers are not vaccinated and in elderly / nursing homes, 13.1% are not.
3) The Illusion of Herd Immunity
You say: “Scientists say that 70% of the total population (including children) would need to be fully vaccinated for everyone to be protected. With the Delta variant, which is more contagious than the first variants, we continue to aim for that 70%, but we are striving to achieve the highest percentage possible.”
This opinion seems to be shared above all by the experts appointed by the government. On the contrary, many scientists had anticipated that vaccinating during a pandemic was not a sufficient approach to control the virus, and events proved them right (see Appendix A for a list of citations).
You say that “Vaccination reduces the circulation of the virus”. This is contradicted by the articles cited above about the delta variant (Appendix A), the example of the City of Waterford, and now a large study shows that the increases in COVID-19 are indeed not linked to the levels of vaccination worldwide (cf the comparative study of 68 countries, as well as 2,947 counties in the United States).
4) The Dangers of COVID vs. the Dangers of Vaccination
You say, “If we’re afraid of variants, we certainly need to vaccinate more today.” Since hard data indicates that vaccination does not work in practice, even when everyone is vaccinated, the solution cannot be to vaccinate more!
There is no reason to be afraid of variants: on the one hand the lethality of the Delta variant is one tenth of the Alpha according to Public Health England, and on the other hand the lethality of COVID is intrinsically weak. It is mainly linked to the presence of comorbidities (99% of deaths occur in people with comorbidity, 96% in people with multiple comorbidities, Appendix B ).
Importantly, this lethality is comparable to that caused by other respiratory infections. Therefore, neither the COVID Safe Ticket nor the compulsory vaccination are justifiable from a public health point of view!
Those at risk have had the opportunity to be vaccinated or can take prophylactic treatment if they choose not to be vaccinated. The situation of these individuals cannot therefore justify putting other healthy individuals at unnecessary risk.
The risks inherent in COVID vaccinations, in the medium and long term, simply remain unknown, due to the lack of the necessary hindsight (we note, however, the prolonged post-vaccination syndrome, similar to long COVID). The short-term risk is evident despite the intense efforts of the health authorities, mainstream media and big tech to suppress all information on this subject.
For example, the Israeli Ministry of Health published an article on its Facebook page about severe adverse reactions, that it described as very rare only, to find itself inundated by a deluge of contrary opinions from its citizens (14,000 in a few hours), opinions that were swiftly deleted. Denying this reality is not a solution to the problem.
Facebook is routinely removing any group that identifies adverse reactions to vaccines, groups with tens of thousands of users in the United States and elsewhere. By what right? In French speaking countries alone, the (non-exhaustive) collection of screenshots of these individual reports testifies to the catastrophic scale of the phenomenon.
Pharmacovigilance databases around the world are all reporting an increase in severe adverse reactions and deaths from COVID vaccines (WHO; United States - VAERS; United Kingdom - Yellow Card; European Union - Eudravigilance).
Analysis of VAERS data, for example, shows a much higher incidence for COVID vaccines than for influenza severe adverse events (28 times more) and deaths (57 times more, see Appendix B). What’s the use of these pharmacovigilance sites if such data are brushed aside as irrelevant, when on the contrary, they should call for the suspension of the vaccination campaign?
The fact-checking sites, financed by the pharmaceutical industry, come to the rescue of the official narrative by affirming that there is no proof that these deaths are attributable to the vaccines. This is to reverse the burden of proof!
According to a report from the French medications agency ANSM (January 28, 2021), the official pharmacovigilance rule is this: “The analysis of reported cases takes into account clinical, chronological, semiological and pharmacological data. It may lead to the vaccine’s responsibility for the occurrence of an observed adverse event being dismissed only when another, certain, cause is identified.”
In fact, an audit of data reported to VAERS shows that only 14% of deaths following vaccination can be attributed to another cause, and it is not just anyone filling such reports, as 67% of the reports have been made by a doctor. Similarly, in Eudravigilance, 79% of the reports regarding a death were filed by a health care professional.
In reality, all of the Bradford Hill criteria are mostly observed, which means that these vaccines are the cause of most of the reported adverse reactions. When autopsies, which are too rarely done, are performed, between 30 and 100% of deaths are attributable to vaccination (see annex B).
These databases are poorly designed, leading to erroneous reports on both sides of the debate. For example, we see circulating for Eudravigilance a figure greater than 25,000 deaths following vaccination against COVID. A more rigorous analysis indicates 7,174 deaths as of October 9, 2021. VAERS analysis gives a number of deaths of the same order of magnitude (7,680, as of October 8, 2021).
These pharmacovigilance systems are passive, leading to a very significant underreporting of the real number of cases. A factor of 5 seems conservative, but regardless of the exact number, what is indisputable is that people in good health, without co-morbidities, young people, die from vaccination or are seriously injured.
A rotavirus vaccine was withdrawn from the market in 1999 because of only 15 cases of intussusception. The swine flu vaccination campaign in 1976 was halted after 25 deaths. We are at about 3,000 times more at the minimum (appendix B). How many more deaths will it take before we realize the obvious?
Data shows that those who are cautious about vaccines are more educated on average than those who favour vaccination, contrary to how they are portrayed in the media.
And the reality of serious adverse effects due to vaccination is confirmed by the fact that it is precisely health care workers who do not want to be vaccinated, despite their education and the fact that they are generally in favour of vaccination (they are not anti-vaxxers!), because they are on the front line and can see the damage these vaccines cause.
It is therefore deeply immoral to make vaccination compulsory, whether it concerns health care workers or any category of citizens. Likewise, it is unethical to encourage the vaccination of groups of individuals who were excluded from the Phase 3 of the clinical trials, in particular pregnant women and those under the age of 18.
Children deaths due to COVID are extremely rare and observed exclusively in individuals suffering from severe co-morbidities. Therefore the deaths of healthy children already recorded following vaccination should lead to an immediate moratorium on the vaccination of children. This should also apply to pregnant women, especially given the absence of information on the long-term effects of these injections.
Compulsory vaccination violates not only ethics, but also fundamental concepts of rights, as demonstrated by Alessandro Negroni, professor of philosophy of law at the University of Genoa.
In light of European and international law, genetic anti-covid vaccines constitute a medical experiment on human beings. From an ethical as well as a legal point of view, no one can be obliged to submit to a form of medical experimentation in the absence of free and informed consent.
We hope that you will take this analysis into account and that you will realize that we must abandon the idea of compulsory vaccination with experimental products for anyone, as well as the implementation of a COVID Safe Ticket based on anything else than a recent test.
Let us also abandon therapeutic nihilism, and treat infected individuals early, as medicine had always done before the start of this crisis.
Yours faithfully,
By ReinfoCovid Belgium and the non-profit “Notre Bon Droit”
Analysis by Marc G. Wathelet, Ph.D. (Molecular Biology)
APPENDIX A – Data on the Effects of Vaccination on Infection and Transmission
The effect of vaccination on the risk of SARS-CoV-2 infection and its transmission to others was modest in the initial studies, but the rapid decline in immunity in vaccinated individuals and the appearance of more contagious variants makes this effect negligible today, as discussed in detail in this document https://www.linkedin.com/pulse/questions-sur-limmunisation-et-la-transmission-de-marc-wathelet/?published=t , drafted as part of a legal action by the non-profit organization “Notre Bon Droit” in opposition to the “COVID Safe Ticket” — the Belgian Government’s vaccination passport.
This document dates from July 28, 2021, and contains 50 references and the studies that have appeared since that date only confirm this analysis:
- https://www.medrxiv.org/content/10.1101/2021.07.28.21261295v1
- https://onlinelibrary.wiley.com/doi/10.1111/joim.13372
- https://www.medrxiv.org/content/10.1101/2021.08.19.21262139v1
- https://www.medrxiv.org/content/10.1101/2021.08.12.21261951v2
- https://www.cdc.gov/mmwr/volumes/70/wr/mm7031e2.htm?s_cid=mm7031e2_w
- https://www.medrxiv.org/content/10.1101/2021.09.28.21264262v1.full.pdf
- https://www.medrxiv.org/content/10.1101/2021.09.02.21262979v1
- https://www.medrxiv.org/content/10.1101/2021.09.28.21264260v1.full.pdf
- https://link.springer.com/article/10.1007/s10654-021-00808-7
- https://www.nejm.org/doi/pdf/10.1056/NEJMoa2114583?articleTools=true
- https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(2102183-8/fulltext)
Data from Public Health England up to the 40th week of 2021
The most recent data from Public Health England indicate that in all cohorts the rate of infection is higher in vaccinated than in unvaccinated people from the age of 30. In these conditions, the obligation of vaccination is simply absurd.
The CDC and Dr. Fauci recognized the impact of the greater contagiousness of the Delta variant and did reinstate the wearing of the mask for the vaccinated.
In addition, the document cited above also [compares immunity against SARS-CoV-2 acquired following vaccination and that following natural infection and shows that the latter is more robust, wider and more balanced regarding the production of antibodies and T cells. It also lasts longer than the vaccine-induced immunity, which translates into better and longer lasting protection against infection for individuals having recovered from COVID compared to vaccinees.
Health care workers are among those who have been most exposed to the virus so far, so it would be absurd to impose a vaccination on them when, for many of them, their natural immunity is more effective. Here too, the studies that have appeared since only confirm this analysis:
- https://www.medrxiv.org/content/10.1101/2021.08.12.21261951v2
- https://www.medrxiv.org/content/10.1101/2021.08.24.21262415v1
- https://www.bmj.com/content/bmj/374/bmj.n2101.full.pdf
The #Covidrationnel collective in Belgium, which includes around thirty university professors, researchers and doctors, carried out a similar analysis and reached the same conclusions
These studies are confirmed by observations in the real world, in the jurisdictions with the highest vaccination rates such as the Seychelles, Gibraltar and Iceland. The high rate of vaccination does not prevent significant waves of infections that follow shortly the vaccination campaign.
More recently, in the city of Waterford in Ireland where 99.7% of the people over 18s are fully vaccinated, one observes the highest incidence rate in Ireland (618.9 infected per 100,000 over the last 2 weeks).
A recent global study shows increases in COVID-19 cases are indeed unrelated to immunization levels across the world (68 countries and 2,947 counties in the United States).
APPENDIX B – The Dangers of COVID vs. the Dangers of COVID Vaccination
From a public health point of view, it is not helpful to consider the general case fatality rate. Rather, it’s a question of identifying populations at risk.
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a. The Dangers of COVID
The dangers of COVID are related to age and the presence of comorbidities. 99% of deaths occur in people with comorbidity, 96% in people with multiple comorbidities according to the US CDC
COVID survival rates by age group according to Dr. Ioannidis’ team:
Age Survival rate 0-19 99.9973% 20-29 99.986% 30-39 99.969% 40-49 99.918% 50-59 99.73% 60-69 99.41% 70+ 94.5% These figures do not distinguish COVID from other respiratory infections in terms of lethality, and therefore do not justify a different approach to manage this disease from a public health perspective. Therefore, neither the COVID Safe Ticket nor compulsory vaccination are justified from a public health point of view!
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b. The Dangers of COVID Vaccination
There are excellent vaccines, with a very favorable risk-benefit ratio, against severe diseases, such as tetanus or yellow fever, for example. However, the benefit-risk ratio sometimes turns out to be unfavorable, and the vaccine in question is then withdrawn from the market.
For example, a rotavirus vaccine was taken off the market in 1999 due to only 15 cases of intussusception .
The swine flu vaccination campaign in 1976 was interrupted after 25 deaths . It also caused 532 cases of Guillain-Barré syndrome.
What about the COVID Vaccines?
A simple correlation is not synonymous with causation. We rely on the Bradford Hill criteria, which are widely verified for these vaccines as shown below. They are:
1) Strength of the association (the larger the magnitude of the effects associated with the association, the more likely a causal link is, even if a small effect does not imply no causal link);
2) Stability of the association (its repetition in time and space)
3) Consistency (the same observations are made in different populations);
4) Specificity (a cause produces a particular effect in a particular population in the absence of other explanations);
5) Temporal relationship (temporality). The causes must precede the consequences;
6) Dose-effect relationship (a larger dose leads to a larger effect);
7) Plausibility (biological plausibility, possibility of explaining the mechanisms involved);
8) Experimental evidence (in animals or in humans);
9) Analogy (possibility of alternative explanations).
For example, temporality ( # 5 ) shows a very high incidence of death in the days following vaccination, before falling back to the normal level
The same profile of adverse reactions is observed in Europe and the United States ( # 3 ), listed below, in decreasing order of frequency compared to their respective norm:
pulmonary embolism, stroke, deep vein thrombosis, thrombosis, increased fibrin D dimers, appendicitis, tinnitus, cardiac arrest, death, Parkinson’s disease, slow speech, aphasia (inability to speak), fatigue, pericardial effusion, headache head, chills, pericarditis, deafness, myocarditis, intracranial hemorrhage, spontaneous abortion, cough, Bell’s palsy, paresthesia, blindness, dyspnea (difficulty breathing), myalgia, dysstasia (difficulty standing), convulsions, anaphylactic reaction, suicide , speech disorder, thrombocytopenic thrombotic purpura, paralysis, swelling, diarrhea, neuropathy, multiple organ dysfunction syndrome, depression.
Their number increases with the level of vaccination, and there is specificity ( # 4 ), the adverse effect profile shown above is different from that observed for influenza vaccines but is similar to the effects of COVID; also, some populations are affected differently, for example myocarditis and pericarditis affect more young men.
Biological plausibility ( # 7 ): COVID vaccines produce the SARS-CoV-2 spike protein in our cells just as infection with the virus does, and the side effects mimic those seen in disease; the Spike protein shows in vitro intrinsic toxicity towards endothelial cells and cardiac pericytes:
- https://www.sciencedirect.com/science/article/pii/S096999612030406X?via%3Dihub
- https://www.biorxiv.org/content/10.1101/2021.04.30.442194v1
- https://www.biorxiv.org/content/10.1101/2020.12.21.423721v2
- https://www.ahajournals.org/doi/10.1161/CIRCRESAHA.121.318902
Experimental evidence (animal or human, # 8 ), mouse experiments reproduce myopericarditis.
Strength of association ( # 1 ) and stability ( # 2 ):
Report of serious adverse reactions and deaths for all COVID vaccines per million doses compared to annual influenza vaccines from 2016 to 2021, to the H1N1 strain of influenza vaccine in 2009-2010, and to all vaccines except those against COVID from 2006 to 2021 in the US VAERS system.Analysis of VAERS data shows a much higher incidence for COVID vaccines than for influenza severe side effects (28X plus) and death (57X plus).
Absolute numbers of serious adverse reactions and deaths in VAERS for the 3 vaccines in the United States against COVID, and their ratio by number of injections
An audit of VAERS data shows that only 14% of deaths following vaccination can be attributed to another cause; at least 67% of reports were initiated by a physician
As the VAERS system is passive, only a small proportion of real cases are recorded there. This proportion can be estimated on the basis of a study of 64,900 employees of a Massachusetts hospital measuring the serious reactions compatible with anaphylaxis that can occur immediately after vaccination: they occurred at a rate of 2.47 per cent. 10,000 vaccinations. The incidence rate of anaphylaxis confirmed in this study is higher than that reported by the CDC on the basis of passive methods (VAERS) of spontaneous notification (0.025-0.11 per 10,000 vaccinations).
These data suggest that the under-reporting in VAERS is by a factor of between 22.5 and 98.8!
This indicates that the number of deaths exceeds 150,000 and the number of severe side effects exceeds one million in the United States:
Absolute figures of serious adverse reactions and deaths in the European Economic Area for the 4 vaccines against COVID, and their ratio by number of injections. 79% of death reports were initiated by healthcare personnel.
The official rule in pharmacovigilance:
The analysis of reported cases takes into account clinical, chronological, semiological and pharmacological data. It may lead to the vaccine’s responsibility for the occurrence of an observed adverse event being dismissed as soon as another, certain cause is identified.
When autopsies, which are too rarely done, are performed, between 30 and 100% of deaths are attributable to vaccination. Peter Schirmacher, chief pathologist at Heidelberg University, determined that autopsy reports indicate that, conservatively, at least 30-40% of a sample of 40 people who died within two weeks of vaccination actually died from the vaccine. .
Professors Arne Burkhardt and Walter Lang, forensic pathologists, presented the results of ten autopsies in Reutlingen on Monday, September 20. Of the ten deaths, seven are “probably” related to the injections, of which five are “very likely”. For the last three cases, one of them remains to be evaluated, another seems to be “a coincidence”, and for the last, the link “is possible but not certain”.
In Norway, when 23 deaths following vaccination occurred in an EHPAD, the authorities carried out 13 autopsies and these 13 deaths were found to be linked to vaccination .
A French drug assessment center concluded that COVID vaccination should be discontinued, for all 4 products. And the Moderna vaccine is abandoned by some countries for the youngest (Norway, Sweden, Denmark; France for the second dose).
Finally, in an article titled “Why are we vaccinating children against COVID?, the authors conclude that not only is their vaccination contraindicated, but that even for the most vulnerable subjects over 65 years of age, the risk-benefit analysis shows that there are 5 times more deaths attributable to vaccination than to disease.
It is against bioethics and the law to vaccinate groups of individuals who were excluded from phase 3 clinical trials, especially those under the age of 18.
Society, by vaccinating children, puts them at risk in order to protect adults without considering their well-being, while it is the responsibility of adults to protect themselves.
It is also not only incorrect that the delta variant would be more dangerous for children, but data from the British National Statistics Office (ONS) indicates a 46% increase in deaths in the 15-19 age group since their vaccination was authorized (+ 63% in young men, + 16% in young women # 4 ), compared to the same period in 2020.
This letter, dated October 17, is translated from French and reproduced with permission from a post on LinkedIn. Please refer to the original version in French for any formal reference.
Author: MOS Medical Group – Eglise Bell
Since Tokyo summer Olympic Game ended on August 8, 2021, the urgent status of the pandemic as Japan is now in its worst surge of the COVID-19 pandemic since the onset of the crisis in such a megacity of 14 million. Most recently, a record number of new cases were reported at 20,140 on August 14. Deaths aren’t as high as successive waves of the pandemic from February 2021 to the end of May, but nerves are frayed with record numbers of infections. Dr. Ozaki, The chairman of the Tokyo Metropolitan Medical Association, recently led an emergency press conference on August 13, Dr. Haruo Ozaki shared those 18,000 new infections are reported daily. However, the death count has eased as compared to previous surges.
Image Credit: Novikov Aleksey / Shutterstock
How to deal with the current dilemma is a huge challenge to Japanese government and medical agencies? Fortunately, India has an excellent testimonial. Since April 28, India medical officials started providing Hydroxychloroquine and ivermectin to its massive population. As India is the major pharmaceutical manufacture in the world, they were ready for this massive drug distribution. Miraculously, COVID cases were plummeting quickly since then thanks to the new rules.
Much like what was successfully accomplished in India, parts of Bangladesh, and places like Argentina and Mexico, Chairman Ozaki calls for the immediate use of ivermectin as cases surge in Japan.
Dr. Ozaki declared that ivermectin has demonstrated significant benefits in reducing infections and deaths where the regimen is prophylactically administered for another indication. With the encouraging medical data from ivermectin clinical trials’ reports worldwide, especially the one from FLCCC of US and BIRD of UK, the head of the Metropolitan Medical Association declared that while clinical trials were important, it was time to greenlight doctors to prescribe ivermectin in association with giving the patient informed consent.
Finally,greenlight for Ivermectin is on in the first developing country since the start of the COVID-19 pandemic,giving hope to all countries and regions. Perhaps this time because Japan did not have the big Pharm entering the COVID vaccine market, the government did not get much pressure, so the Japanese government’s anti-epidemic policy basically reflects a normal democratic regime should do, that is, to protect the health of the people. Expect the miracle of ivermectin in India to happen again.
References:
Im pathologischen Institut in Reutlingen werden am Montag, den 20.09.2021, die Ergebnisse der Obduktionen von acht nach COVID19-Impfung Verstorbenen vorgestellt. Die feingeweblichen Analysen wurden von den Pathologen Prof. Dr. Arne Burkhardt und Prof. Dr. Walter Lang durchgeführt. Die Erkenntnisse bestätigen die Feststellung von Prof. Dr. Peter Schirmacher, dass bei mehr als 40 von ihm obduzierten Leichnamen, die binnen zwei Wochen nach der COVID-19-Impfung gestorben sind, circa ein Drittel kausal an der Impfung verstorben sind. Im Rahmen der live gestreamten Pressekonferenz werden mikroskopische Details der Gewebeveränderungen gezeigt. Prof. Dr. Werner Bergholz berichtet über die aktuellen Parameter der statistischen Erfassung des Impfgeschehens.
Auf der Pressekonferenz wird zudem das Ergebnis der Analyse von COVID-19-Impfstoffproben einer österreichische Forschergruppe vorgestellt, das sich mit den Erkenntnissen von Wissenschaftlern aus Japan und den USA deckt. Es haben sich im Impfstoff undeklarierte metallhaltige Bestandteile feststellen lassen. Optisch fallen Impfstoffelemente durch ihre ungewöhnliche Form auf.
Aus den Untersuchungsergebnissen resultieren rechtliche und politische Forderungen so zum Beispiel nach unverzüglicher Informationssammlung durch die Behörden, um die gesundheitliche Gefährdungslage der Bevölkerung durch die COVID-19-Impfstoffe bewerten zu können. Z.B. können durch Einsichtnahme in die IVF-Register frühe Signale eingeschränkter Fruchtbarkeit der Geimpften geprüft werden. Über das Krebsregister können Erkenntnisse über das Entstehen von Krebs durch die gentechnischen Veränderungen der Virus-RNA gewonnen werden. Eine Aussetzung der COVID-19-Impfungen ist zu erwägen.
Teil 1:
Teil 2:
Odysee:
https://odysee.com/@de:d/Pathologie_Konferenz_Reutlingen_Teil_2:7
Todesursache nach COVID-19-Impfung Präsentation Prof. Dr. Arne Burkhardt
Download PDF 12 MB 20.09.2021, Reutlingen
Undeklarierte Bestandteile von COVID-19-Impfstoffen Scanning Electron Microscopy Analysis einer deutschen Hochschule
Download PDF 9 MB 20.09.2021, Reutlingen
Prof. Dr. Arne Burkhardt
Prof. Dr. Arne Burkhardt blickt auf langjährige Lehrtätigkeit an den Universitäten Hamburg, Bern und Tübingen zurück sowie auf Gastprofessuren/Studienaufenthalte in Japan (Nihon Universität), USA (Brookhaven National Institut), Korea, Schweden, Malaysia und der Türkei. Er hat 18 Jahre lang das Pathologische Institut in Reutlingen geleitet, war danach als niedergelassener Pathologe tätig. Prof. Burkhardt hat über 150 Artikel in Fachzeitschriften und als Beiträge in Handbüchern veröffentlicht. Er hat zudem pathologische Institute zertifiziert.
Prof. Dr. Walter Lang
Prof. Dr. Walter Lang war von 1968-1985 als Pathologe an der Medizinischen Hochschule Hannover tätig. Danach leitete er 25 Jahre lang ein von ihm gegründetes Privatinstitut für Pathologie in Hannover mit den Schwerpunkten Transplantationspathologie, extragynäkologische Cytologie, Schilddrüsentumore, Lungen/Pleurapathologie. Er führte Konsultations-Diagnostik für 12 große Lungen-Kliniken durch und nahm Leberpathologie-Untersuchung für zahlreiche Kliniken vor. Im Zeitraum 1985-2020 führte er Konsultations-Untersuchungen für die Pathologie der Lungenklinik in Herner durch.
Prof. Dr. Werner Bergholz
Prof. Dr. Werner Bergholz ist ehemaliger Professor für Elektrotechnik mit Schwerpunkt Qualitäts- und Risikomanagement an der Jakobs-University Bremen. Vor seiner Berufung war Prof. Bergholz 17 Jahre im Management der Chip-Produktion bei der Firma Siemens tätig.
Our resident physician John Day in Texas comes with an update on his situation. It seems his clinic no longer seeks to fire him for refusing to be vaccinated, they now claim it’s for cause (it’s not). A doctor who has been free to decide medical treatments for and with his patients for many years, all of a sudden cannot decide that for his own body.
And of course it’s not just America, and it’s not just doctors, it’s also pilots and nurses and soldiers and police men and women, and vaccine mandates are being introduced in many countries. That will deprive many fields in our societies of their leaders, and leave them occupied by followers only.
People who think for themselves, and wish to decide for themselves (as is their right), are being put out by the curb, and by the thousands. The resulting changes in society will be devastating. Losing all those years of experience and wisdom and kindness and intelligence will make us all a lot poorer. And why? It’s obviously not about logic, and it’s not about health. John:
John Day MD: Precariously Supported,
Yesterday was an odd day in several aspects. I had worked a long Friday at the clinic again, which did not go badly. I left nothing unfinished. We drove to the Yoakum homestead Friday night and got a good night of sleep.
Somehow, I felt very heavy and slow on Saturday and Sunday, so I trudged through three to four hours of pushing the little Honda mower, and did work in the garden, but ploddingly. I planted garlic for the winter/spring season, and tended the garden.
I continued to feel a weight of unease, and as we started the drive back to Austin, Sunday afternoon, I had a sense that I should really buy winter veggies to put in at the clinic garden, which I started in 2016, and tend for my coworkers. Putting things off until the end of the month, in my last two weeks of work there, seemed awkward.
We picked up a lot of winter greens and salad starts in little pots on our way into Austin, some for our Austin kitchen garden, but most for the clinic garden. I did a last harvest of the blackeyed pea row, then cut down the vines, and took them to some chickens that a friend of Jenny’s raises.
Yesterday (Monday) morning I worked in our kitchen garden again, preparing the beds for fall and winter, cleaning up the summer debris, and also planting an orange seedling in the bed in front of the house, where the February freeze had killed the one fruitful tree.
After eating, I went over to the clinic with an orange seedling, to replace the two that the February freeze had killed, and all of the winter salad and cooking-green seedlings to fill a couple of rows. I went through the entrance, put on a mask, and went through to the garden in the break area, with shovels and clippers, saying “hi” to a few people and smiling with my eyes. I went out through the garden gate, and brought in the orange tree, then the veggie starts.
The orange tree needed to go in the large bed, which has a Mexican avocado seedling tree, and a banana plant that actually survived February. Mainly it has a lot of sweet potatoes. It’s a fairly large bed, and this has been a very good year for sweet potatoes. I filled the three gallon bucket that the tree was in with sweet potatoes, from just a few square feet that I cleared and dug up, before planting it, maybe one percent of that bed.
While I was digging up the sweet potatoes and digging the hole to put the orange tree in, my flip phone rang. I figured it was Jenny. I brushed some of the dirt off my hands and answered it. It was the nice and very well-mannered youngish man, who is currently Director of Human Resources, telling me that my last day of work had been changed from the last Friday of October to the Friday just passed, which was different from what I had been told last week, when the reason for my firing was changed from vaccine-mandate non-compliance, to all of the wrongs I have committed in the period of time since that mandate was announced.
It was a lousy spot for him to be put in, and he seemed uncomfortable having to put it into polite words. He had been trying to call me while I was working on our home garden, but I had not been carrying the phone. I told him that I was at the clinic garden, putting in some things for winter, and that he could talk to me in person. My presence in the garden was unanticipated, though I have worked on my day off frequently in the past couple of months.
We talked as I planted the orange tree and put the big sweet potatoes in the pot, handing it over to a couple of nurses taking their lunch. They had helped dig sweet potatoes last year, and I knew they wanted some. He politely explained that I was not to re-enter the building, and that my desk would be cleared out and boxed for me. The explanation was so polite that I sought clarification. I did negotiate that I could pick up a few notes at my desk with his presence and supervision, which we then did. My badge didn’t let me in this time. He had to use his. As we walked through the clinic to my desk, most people had their eyes down. A few coworkers looked me in the eyes, and I smiled with my eyes. I was comfortable in myself, and emanated that (I think).
We grabbed a few boxes and made short work of the packing-up. I got everything, and we carried the three boxes to my little twenty four year old Ford Ranger pickup truck together. We went back to the garden and break-area through the gate, He thought it best that I just leave without planting the vegetables, but I prevailed upon him to keep his agreement to let me clean out the rows and do the planting.
He actually had a fair number of gardening questions, which I answered as I cleared the rows and planted for winter. I worked expeditiously, taking about twenty to thirty minutes, as I explained the quality of the soil, and how building soil is one of the main objectives in successful gardening. If you don’t have enough garden to out produce what the squirrels, birds and other critters can eat, they will eat it all. You need a big enough garden patch.
We walked back to the truck with shovels and clippers, talking about what’s next. The clinic will still pay me for these last two weeks of October, but my patients who are scheduled will not get to see me for a last visit. I have been doing everything possible to avoid leaving loose ends, and to write thorough chart notes, so it will be easy for the next doctor. I have tried to make suggestions for which doctor or practitioner might best match the needs and personality of each patient. I passed my list to give to the Director of Adult Medicine, who has been working hard and well on this transition. It’s not a complete list…
I am left to wonder why the clinic took surprise action to remove me from patient-care, while still paying my salary for two weeks. I suspect there was free-floating anxiety about what I might say or do. I had been informing people of the actual circumstances of my leaving, being fired for non-compliance with mandatory vaccination. The management has been consulting with attorneys the whole time, and somebody else is contesting her firing for non-compliance with that mandate, I am told. Governor Abbott did say that vaccine mandates are not tolerable in Texas, Monday of last week. I suspect that my being fired-for-cause, other than non-compliance with COVID vaccination might be more plausible when the date of my firing is moved forward from the prior date of my termination for non-compliance
I do not intend to contest my firing through recourse to the law. The only law I am really, currently concerned with is the Law of Karma, and I am very concerned with that law. I am constantly aware of the implications of Karma as we wade further into this rip-tide of history.
Human Horticulturist
Third part of a timeline of ivermectin-related events in theCOVID-19 pandemic
Mika Turkia M.Sc.
mika.turkia@alumni.helsinki.fi
September 30, 2021
Abstract
This review presents a third part extending two previous parts of a timeline describing ivermectin-related events in the COVID-19 pandemic, with this third part covering a period from July 2021 to September 2021.
Among the most notable developments during the period were allegations that a clinical trial about prophylaxis and late treatment of COVID-19 with ivermectin by Elgazzar et al. carried out in Egypt in mid-2020was fraudulent, with some of the introduction plagiarized and the patient data claimed to appear fabricated.
The government of Egypt initiated an investigation on the issue, the results of which were not available bythe end of the period.
Ivermectin skeptics noted that the retraction of the Elgazzar et al. trial, along with suspicions about failed randomization in another trial by Niaee et al., seemed to invalidate the various meta-analyses which had included these trials. Ivermectin proponents argued that the retraction did not affect the conclusions of their meta-analyses. Later, the validity of an Argentinian prophylaxis trial by Carvallo et al. was questioned; as an observational trial it had not been included in the meta-analyses.
Among new trial results were the results of ’Together’ trial led by a Canadian university but carried out in Brazil. The primary endpoint was extended emergency room observation or hospitalization, and the secondary endpoint was mortality. Fluvoxamine produced a statistically significant result for the first endpoint but not for the second. In 677 treated patients vs 678 controls ivermectin indicated some risk reduction but the differences were not statistically significant. One of the authors concluded that ivermectin had ’noeffect whatsoever’ on their endpoints. On the other hand, a intervention program in La Pampa province of Argentina with 3,269 treated and 18,149 untreated indicated mortality rates of 1.5% vs 2.1% (p=0.029),and in subjects over 40 years 2.7% vs 4.1% (p=0.005). A Cochrane meta-analysis concluded that all aspects regarding ivermectin’s efficacy for either treatment or prophylaxis were currently unknown.
After a 24-fold increase in ivermectin prescriptions from US pharmacies compared to the pre-pandemic baseline, US Food and Drug Administration (FDA), American Medical Association, American Pharmacists Association and American Society of Health-System Pharmacists campaigned against ivermectin, calling for‘an immediate end’ to prescribing, dispensing and using it. However, this campaigning also resulted in an increased public awareness of ivermectin.
A prominent social media figure with over ten million followers revealed that he had been prescribed ivermectin for COVID-19. The fact was subsequently propagated internationally by the news media which represented ivermectin as a dangerous ‘horse dewormer’. Several international news outlets published a false story about emergency rooms in Oklahoma being full of people having overdosed ivermectin, blocking out other patients including gunshot victims.
A Japanese doctor who had treated 500 patients with ivermectin reported having received death threats after telling about his methods on a television program. A group of British scientists which had published a meta-analysis about ivermectin reported having received death threats after questioning the efficacy of ivermectin. An ivermectin discussion forum was flooded with pornographic images and incoherent babbling.
A hospital was harassed for not administering ivermectin.
An Indian physician claimed that due to the World Health Organization’s opposition to ivermectin, India’s second wave had been countered by an almost nationwide covert use of early treatment protocols including ivermectin. Another physician reported that in one city in Amazonas, Brazil, a mass distribution of ivermectin had resulted in the city having no hospitalized COVID-19 patients during the surge of the gamma variant in the first half of 2021.
Frontline COVID-19 Critical Care Alliance (FLCCC) faced criticism for its ivermectin advocacy and communication style. With regard to treatment protocols, the addition of dual anti-androgen therapy to FLCCC’sMATH+ hospital treatment protocol was said to have restored the protocol’s efficacy against the delta variant in intensive care unit patients. FLCCC also published a scoping review of the pathophysiology ofCOVID-19, emphasizing the role of platelet activation with the release of serotonin and the activation and degranulation of mast cells contributing to the hyper-inflammatory state.
In an overview, the period from April 2020 to March 2021 could be characterized as a period of argumentation and attempted rationality, the period from April 2021 to June 2021 as a period of emotion and campaigning,and the period from July 2021 to September 2021 as a period of chaos.
Current best practices for meta-analyses were found to be unsound. A new approach based on individual patient data analysis was proposed.
Introduction
The period covering the first part of the timeline from April 2020 to March 2021 [1] could be characterized as a period of research, argumentation and rationality. During the period, smaller-scale research and experimentation of ivermectin for COVID-19 was pursued and eventually, alliances and groups of clinicians and researchers were formed to promote combination treatment protocols that included ivermectin. However, at the end of the period, first the European Medicine Agency (EMA) and second the World Health Organization(WHO) advised against the use of ivermectin except in clinical trials.
The second period from April 2021 to June 2021 [2] could be characterized as a period of emotion and campaigning. During the period, a failure of the approach based on argumentation led to a disillusionment of clinicians and researchers in favor of ivermectin treatments and stopped communication between the proponents and administrative agencies. Instead, ivermectin proponents turned directly to the public and the clinicians. The analysis related to the second part of the timeline focused on possible structural corruption and the role of the WHO.
The third period from July 2021 to September 2021 covered in this paper might best be characterized as a period of chaos, initiated by accusations of plagiarism and data fabrication in one of the early ivermectin trials [3]. As the trial was included in published meta-analyses of ivermectin’s efficacy [4,5,6], the allegations undermined the believability of these meta-analyses, although the authors of the meta-analyses at first stated that the exclusion did not essentially change the results of the analyses. Later, one of the groups diverged from this view.
The history, indications and safety of ivermectin have been described in the previous parts. Some events preceding July 2021 not included in the previous parts of the timeline have been included.
March 2020
On March 25, Waltner-Toews et al. wrote that COVID-19 requires a new approach to science [7]. They referred to ‘post-normal science’ (PNS) developed in the 1990s by Silvio Funtowicz and Jerome R. Ravetz which represented a novel approach for the use of science on issues where ‘facts are uncertain, values in dispute, stakes high and decisions urgent’ [8]. As an example, PNS recommended that models to predict and control the future should be replaced by models to map our ignorance about the future; it also stressed the importance of trust, participation and transparency, all of which had been lacking during the COVID-19pandemic. Waltner-Toews et al. wrote that ‘everywhere, we are seeing a total breakdown of the epistemic consensus required to make normal science “work”. This is happening not only in the fields you might expect– behavioral psychology, sociology, and ethics – but also in virology, genetics, and epidemiology. In other words, when “applied scientists” and “professional consultants” are no longer in their comfort zones but find themselves in a post-normal context, fitness for purpose changes meaning. And even in established fields, disagreements can’t be hidden (or consensus enforced) from broad audiences: are the present draconian measures justified or not? More data (even “reliable data”) and better predictive models cannot resolve the“distribution of sacrifice” which involves, among other things, the arbitration of dilemmas that appear at every scale. Hiding behind some general notion of science or the “lack of data” – as if data had the power to resolve these dilemmas – is feckless, feeble and confused’.
November 2020
On November 29, an article by Cherkes et al. in the clinical practice guidelines and recommendations section of an Ukrainian journal Proceedings of the Shevchenko Scientific Society – Medical Sciences gave a detailed description of FLCCC’s MATH+ hospital treatment protocol [9].
April 2021
On April 14, an article by Seet et al. described an open-label randomized trial (n=3,037) describing a 42-day prophylaxis regimen with four different medications, one of which was povidone iodine throat spray(n=735), compared to 500 mg per day of oral vitamin C (n=619), indicated 44.7% lower risk of severe disease (5.7% vs 10.3%, RR 0.55, p=0.05) and 31.1% lower risk of infection (46.0% vs 70.0%, RR 0.69,p=0.01) [10,11]. A single 12 mg dose of ivermectin (n=617) did not produce a statistically significant difference. Hydroxychloroquine produced a slightly smaller risk reduction than povidone iodine.
May 2021
On May 11, two Norwegian doctors presented data on ivermectin trials to the Norwegian government [12].
On May 26, an investigational monoclonal antibody for mild to moderate COVID-19, sotrovimab, was issued an emergency use authorization by the US Food and Drug Administration (FDA). Sotrovimab was to be administered as a single intravenous infusion of 500 mg over 30 minutes within 10 days of symptom onset [13].
The wholesale price of a single dose was USD 2,100 [14].
On May 28, Bloomberg Law discussed YouTube’s censorship practices [15]. YouTube chief executive officer Susan Wojcicki commented that ‘the complex nature of misinformation online presents a number of challenges for platforms such as YouTube and I welcome your suggestions as to what we can do better’.
June 2021
On June 1, a commentary by Chosidow et al. asked whether ivermectin would be a potential treatment forCOVID-19 [16].
On June 4, an article by Payne et al. about evidence-based approach to early outpatient treatment considered zinc gluconate, melatonin and vitamin D feasible options but repeated the usual objections to ivermectin[17].
On June 7, an article by Sajidah et al. discussed the host nuclear transport machinery in detail [18].
On June 10, Kumar et al. discussed the role of vitamins and minerals as immunity boosters in COVID-19, pointing out for example the protective roles of calcium, magnesium, copper, iodine, selenium, manganese,cobalt and sulfur, and the possibly harmful effect of iron [19].
On June 14, an article by Duru et al. described an in silico study suggesting that ivermectin bound well toSARS-CoV-2 spike glycoprotein [20].
On June 17, an article by Yanagida et al. concluded that ivermectin had low proarrhythmic risk [21].
On June 18, an article by Mart´ınez investigated the antioxidant properties of several pharmaceuticals, positing the idea that oxide reduction balance might help explain the toxicity or efficacy of these drugs, and noting that ivermectin and molnupiravir, two powerful COVID-19 drugs, were not good electron acceptors,and the fact that they were not as effective oxidants as other studied molecules might be an advantage [22].
On June 18, a commentary by Taibbi discussed politicization and censorship of ivermectin in the US [23,24].
On June 18, a Norwegian newspaper Aftenposten interviewed two Norwegian proponents of FLCCC protocols, one of whom was FLCCC founding member Eivind Hustad Vinjevoll [25] and the other Anders Bugge.
The Norwegian Medicines Agency remained unconvinced, stating that it was not their task to assess unapproved treatments: they only followed the recommendations of US National Institutes of Health and the World Health Organization.
On June 21, referring to lack of evidence and low quality of trials, eleven Norwegian senior physicians disagreed with Vinjevoll’s and Bugge’s views [26].
On June 22, Huang et al. summarized recent advances in the exploration of ivermectin’s anticancer properties [27].
On June 27, Salvador et al. published a protocol of a prospective observational study aiming to evaluate the effectiveness and safety of a single-dose ivermectin for treatment of uncomplicated strongyloidiasis in immunosuppressed patients [28].
On June 28, Bugge replied to the Norwegian senior physicians [29].
On June 28, an article by Roman et al. presented a meta-analysis of ten randomized controlled trials(RCTs) including 1,173 patients with mild or moderate disease [30]. The authors wrote that in comparison to standard of care or placebo, ivermectin did not reduce all-cause mortality, length of stay or viral clearance.
They concluded that ivermectin was not a viable option to treat COVID-19 patients. The article was based on a previous preprint [31,32]. The CovidAnalysis group noted that in addition to numerous uncorrected errors,the preprint and the PDF of the article stated that the authors had no conflicts of interest, yet Pasupuleti’saffiliation listed in the abstract on the journal’s website was a company delivering brand and portfolio commercial strategy for biotech and pharma, working with 24 of the top 25 pharmaceutical companies as well as hundreds of biotechs globally [33,34]. The company also stated that they were working withthe European Federation of Pharmaceutical Industries (EFPIA) to support their activities, and that the company’s regulatory consultancy practice in the US was preparing a number of emergency use authorizations to the FDA [35].
On June 28, an article by Patterson et al. presented a model for predicting COVID-19 severity and chronicity [36]. A score measuring severity of COVID-19 was defined as (IL-6 + sCD40L / 1000 + VEGF / 10 + 10 * IL-10) / (IL-2 + IL-8). A score measuring chronicity (long haul symptoms) was defined as (IFN-γ+ IL-2) / CCL4-MIP-1β. CCL4 (chemokine ligands 4), also called MIP-1β(macrophage inflammatory protein-1β),was related to the C-C chemokine receptor type 5 (CCR5) pathway. About VEGF, see also [37,38,39,40].
On June 30, Thailand’s FDA and Chiang Mai University’s faculty of pharmacy warned against using ivermectin for COVID-19 [41].
On June 30, an article by Nippes et al. reviewed research on the presence of chloroquine, hydroxychloroquine, azithromycin, ivermectin, dexamethasone, remdesivir, favipiravir and some HIV antivirals in the environment, and presented treatment technologies for each drug [42].
On June 30, Syed interviewed FLCCC’s Marik about treatments and the origin of SARS-CoV-2 [43].
July 2021
On July 1, HART group consisting of UK doctors compared adverse events reported to the WHO of ivermectin (20 deaths and 5,484 adverse events since 1992), remdesivir (534 deaths and 6,707 adverse events since 2020) and COVID-19 vaccines (6,667 deaths and 1,198,200 adverse events since 2020) [44]. They also suggested that some of the ongoing studies were designed to fail and actually aimed at stalling the adoption of ivermectin.
On July 1, Vice magazine wrote about ivermectin advocates, saying that ‘proponents of a dubious COVID19 cure have signaled they’re ready for a long fight against what they see as censorship in medicine and media’ [45].
On July 2, an article by Vallejos et al. described a low dose RCT with 501 relatively low-risk outpatients in Argentina which did not produce statistically significant results (NCT04529525) [46,47].
On July 2, an article by Adegboro et al. reviewed the antiviral effects of ivermectin [48].
On July 2, a Twitter post reported that a video featuring Nobel prize winner Satoshi ¯Omura discussing Japanese ivermectin emergency use authorization bill had been removed by YouTube for violating their terms of service [49].
On July 2, a blog post by Crawford investigated the details and the background of the meta-analysis by Roman et al., noting that the meta-analysis came at a politically contentious moment, the language and behavior appeared political, the work was error-laden, took research out of its true context, used numbers that didn’t seem to come from the actual studies, chose papers testing ivermectin under the least favorable circumstances, gave unexplained and inappropriate weights to the small amount of data that stood as outliers to the bigger picture, and extracted an unfavorable conclusion from a massive average mortality reduction that did not quite reach statistical significance while consistently complaining about the low quality of evidence represented by the studies [50]. Crawford asked whether these were ‘just mistakes’, adding that ‘a medical journal published all this – just in time to push back the Lawrie case. Think on all that for a moment’.
On July 3, an open letter signed by 43 researchers and clinicians requested retraction of the meta-analysis by Roman et al. [51,52].
On July 6, an article by Hill et al. (submitted on January 20) presented a meta-analysis including eleven RCTs of moderate/severe infection [5]. The analysis indicated 56% reduction in mortality (3% vs 9%, RR0.44, 95% CI 0.25-0.77, p=0.004), favorable clinical recovery and reduced hospitalization. In contrast to the preprint stating that ivermectin should be validated in larger studies before the results are sufficient for review by regulatory authorities [53], the published version said that a network of large clinical trials was in progress to validate the results seen to date.
On July 6, a TrialSite news report suggested that the WHO might have been attempting to limit the use of ivermectin to neglected tropical diseases only [54,55,56]. The report also discussed the apparent lack of objectivity of Wikipedia, noting that it had, among other omissions, mentioned the rejection of FLCCC’s review by Frontiers of Pharmacology but failed to mention that it had later been published in the American Journal of Therapeutics, failed to mention the meta-analysis by the BIRD group, and failed to mention USNIH’s transitioning to a neutral stance on ivermectin. The report asked why any positive aspects would be omitted unless there was an explicit goal to completely discredit this possible therapeutic option and researchers looking into the matter.
On July 6, Yahoo News UK published a news story featuring ivermectin in a positive light [57].
On July 6, WHO announced that it had updated its patient care guidelines to include interleukin-6 receptor blockers tocilizumab (by Roche) and sarilumab (by Regeneron Pharmaceuticals and Sanofi) [58]. The strong recommendation was based on findings from a prospective and a living network meta-analysis including data(also prepublication data) from over 10,000 patients enrolled in 27 clinical trials. The meta-analyses were said to show that in severely or critically ill patients these drugs reduced the odds of death by 13% and the odds of mechanical ventilation by 28% compared to standard of care, with high certainty of evidence [59]. WHO said tocilizumab and sarilumab were the first drugs found to be effective against COVID-19 since corticosteroids were recommended in September 2020 [58]. WHO director-general Tedros Adhanom Ghebreyesus said, however, that the drugs would remain inaccessible to most, and called on manufacturers to reduce prices and make supplies available to low-and middle-income countries. Ghebreyesus also encouraged companies to agree to transparent, non-exclusive voluntary licensing agreements using WHO’s Covid-19 Technology Access Pool (C-TAP) platform and the Medicines Patent Pool, or to waive exclusivity rights. Rochwerg et al. noted that compared with other treatments IL-6 receptor blockers were expensive but the the recommendation did not take account of cost effectiveness [59]. They also acknowledged that access to these drugs was challenging in many parts of the world and that the recommendation could exacerbate health inequity. However, the strong recommendation aimed at providing a stimulus to improve global access to these treatments.
On July 6, an article by WHO Rapid Evidence Appraisal for COVID-19 Therapies (REACT) WorkingGroup presented a meta-analysis on the efficacy of tocilizumab and sarilumab [60]. Absolute mortality risk was 22% for IL-6 antagonists compared with an assumed mortality risk of 25% for standard of care or placebo, with especially sarilumab showing very low efficacy. Regarding conflicts of interests, one of the authors reported being involved with two patents owned by Genentech/Roche, one on treating COVID-19with an IL-6 antagonist, and another for tocilizumab and remdesivir combination therapy for COVID-19pneumonia. Two other authors reported being co-inventors of a filed patent covering the use of low-dose tocilizumab for treatment of viral infections. Nine other authors also reported associations with Roche.
Seven authors reported associations with Sanofi. Three reported being employees of and owning stock in Regeneron, and two reported other associations with it. Also associations with, for example, Merck Sharp and Dohme, Gilead Sciences, ViiV Healthcare, Janssen, Cilag, Thera technologies, Lilly, Biohope, Gebro, Bristo lMyers Squibb, Abbvie, Pfizer, Novartis, PharmaMar, GlaxoSmithKline, Boehringer Ingelheim, Celgene,Alexion, Inatherys, AB Science, Argenx, Oncoarendi, Biogen, Ose Pharmaceutical, Shionogi, Genetech, EliLilly, Swedish Orphan Biovitrum AB, Sanofi Genzyme, Aspen Pharmacare, Crist´alia and AM Pharma were reported.
On July 6, a press release by M´edecins Sans Fronti`eres (MSF) noted that the Swiss pharmaceutical company Roche continued to have de facto market exclusivity and tocilizumab was likely to remain unaffordable and inaccessible for most of the world [61]. MSF wrote that Roche had kept the price of tocilizumab very high in most countries (USD 410 in Australia, USD 646 in India and USD 3,625 in the US per dose of 600mg for COVID-19, while the manufacturing cost was estimated to be around USD 60).
On July 6, an article by Malin et al. presented a key summary of German national treatment guidance for COVID-19 inpatients [62]. The guideline recommended corticosteroids, prophylactic anti-coagulation, and optionally tocilizumab. Convalescent plasma, azithromycin, ivermectin and vitamin D3were recommended against. With regard to ivermectin, it was said that achievable tissue concentrations seemed to be far below the half maximal inhibitory concentration in vitro, that in February 2021 only one peer-reviewed RCT with 72 patients was available for consideration, and that the numerous preprints did not report clinically relevant endpoints or presented with significant methodological issues and a high risk of bias.
On July 6, a commentator asked why WHO targeted IL-6 instead of going upstream to block NF-kB [63] which in turn inhibits IL-6 (ivermectin is an NF-kB antagonist [64]) [65,66].
On July 6, the US president Biden proposed the creation of the Advanced Research Projects Agency for Health (ARPA-H), a new organization under the NIH, aimed at facilitating and accelerating more innovation and breakthroughs in fundamental biomedical and health research [67].
On July 6, an article by Margolin et al. described a small controlled trial (n=113) that suggested benefits from supplementation with zinc, zinc ionophores quina plant bark extract and quercetin, vitamins C, D3and E, and L-lysine [68].
On July 7, an article by Cadegiani et al. about an open-label observational prospective outpatient study indicated 98.0% lower risk of hospitalization (0% vs 19.7%, RR 0.02, p<0.001) and 94.2% lower risk of ventilation (0% vs 6.6%, RR 0.06, p=0.005) [69,70,71]. The authors said treatments showed overwhelming improvements; therefore, it had become ethically questionable to conduct further studies employing full placebo arms in early COVID-19.
On July 7, a preprint by Hazan et al. described a retrospective late treatment study with 24 outpatients and a synthetic control arm calculated from the US Centers for Disease Control and Prevention (CDC)database [72]. The study used a combination therapy protocol with ivermectin, doxycycline, zinc, vitaminD and vitamin C, resulting in 100% survival and cure in unselected ambulatory ‘moderate to severely’ illCOVID-19 outpatients, with some initially presenting with SpO2values as low as 73% and 77%. Despite a symptom to treatment delay of over nine days, mean SpO2values rose from 86.5 to 93.1 in the first 24 hours.
On July 8, an article by Muthusamy et al. described an in silico study identifying 32 anti-parasitic compounds effectively inhibiting the receptor binding domain of the SARS-CoV-2 spike protein [73]. The most effective compounds, in a descending order, were selamectin, ivermectin, artefenomel, moxidectin, posaconazole, imidocarb, piperaquine, cepharantine, betulinic acid and atovaquone.
On July 9, Cameron et al. proposed a two-axis model to describe variability in decision-making among critical care physicians [74]. The authors emphasized the necessity for a better understanding of the root causes of physician-attributable differences in patient management in order to foster a better collaborative and educational environment to help critical care systems adapt to emerging ideas. The first axis of the model measured interventionism (early, aggressive treatment) versus minimalism (’wait and see’) preferences. The second axis measured individualism versus collectivism.
On July 12, a preprint by Neil et al. described a Bayesian meta-analysis of ivermectin’s effectiveness in COVID-19 [75].
On July 13, a news report in the Atlantic by Mazer discussed FDA’s recent approval of Alzheimer’s disease medicine aducanumab [76]. It said aducanumab was approved despite scant evidence of benefit, and against the nearly unanimous advice of the agency’s expert advisers, with ten members against approval and one being uncertain [77]. Aducanumab was priced at USD 56,000 a patient per year. The estimated cost of treating all patients with it was larger than NASA’s yearly budget. The article said that ‘the actions of drug regulators, like those of industrial polluters, are often freighted with unacknowledged externalities .. . the FDA specifically does not really worry about those larger societal issues and doesn’t really worry about cost. . . instead, the agency is judged by how many drugs it can approve’.
On July 14, an opinion by Flam said that high hopes for ivermectin owe more to politics than to science[78].
On July 14, Mathachan et al. reviewed current uses of ivermectin in dermatology, tropical medicine andCOVID-19 [79].
On July 15, an article by Ravikirti et al. describing a clinical trial in India on patients with mild to moderate disease (n=112) using 12 mg of ivermectin on two consecutive days did not produce statistically significant results [80].
On July 15, referring to a 2020 preprint by Elgazzar et al. [3], a news article by Davey in the Guardian said that a huge study supporting ivermectin as COVID-19 treatment had been withdrawn over ethical concerns [81]. The article described ivermectin being promoted by right wing figures, then interviewed a person described as a medical student, Jack Lawrence, who had analyzed the preprint and the associated dataset for an assignment as a part of his master’s degree. He had found that the introduction section appeared plagiarized, raw data apparently contradicted the study protocol on several occasions, there were errors in data formatting, and the dataset didn’t match the numbers in the preprint. He also described that ivermectin hype was ‘dominated by a mix of right-wing figures, anti-vaxxers and outright conspiracists’.
A data analyst Nick Brown had helped Lawrence to analyze the data. He said that the main error was that at least 79 of the patient records were obvious clones of other records. An epidemiologist, Gideon Meyerowitz-Katz, commented that the data appeared totally faked, and since the study had been included in most meta-analyses, if removed, the conclusions of these meta-analyses would have their conclusions entirely reversed. Yet another researcher said the data appeared fabricated. Lawrence concluded that ‘something is clearly broken in a system that can allow a study as full of problems as the Elgazzar paper to run unchallenged for seven months . . . thousands of highly educated scientists, doctors, pharmacists, and at least four major medicines regulators missed a fraud so apparent that it might as well have come with a flashing neon sign’.
On July 15, a post by Lawrence on an online disinformation website discussed retraction of the preprint by Elgazzar et al. [82]. Jack Lawrence introduced himself on his blog as a journalist and a disinformation researcher [83].
On July 15, a blog post by Brown analyzed details of the study by Elgazzar et al [84].
On July 15, a blog post by Meyerowitz-Katz pictured ivermectin for COVID-19 research as ‘potentially the most consequential medical fraud ever committed’ [85].
On July 15, the Covid Analysis group removed Elgazzar et al. from their meta-analysis. Since the study was a preprint, the analysis of 37 peer-reviewed studies (n=11,352) in the July 15 version 99 of 60 studies [86] remained unchanged, indicating 88% efficacy in prophylaxis (95 % CI 70%-95%), 74% efficacy in early treatment (95% CI 58%-84%) and 42% efficacy in late treatment (95% CI 19%-58%). Since Elgazzar etal. only concerned prophylaxis and late treatment, also the early treatment results remained unchanged, indicating 64% reduction in mortality (95% CI 15%-85%). In comparison to the previous, July 9 version 98 of 62 studies [87] (Elgazzar study included prophylaxis (n=200) and late treatment (n=400) parts), the new version indicated the same or slightly improved prophylaxis efficacy but slightly widened confidence intervals, with all studies indicating 85% (95% CI 75%-91%) vs 85% (95% CI 75%-92%) efficacy, and RCTs indicating83% (95% CI 39%-95%) vs 84% (95% CI 25%-96%) efficacy. For late treatment, the new version indicated lower efficacy, with all studies indicating 46% (95% CI 30%-59%) vs 43% (95% CI 26%-56%) efficacy, and RCTs indicating 40% (95% CI 11%-60%) vs 29% (95% CI 3%-48%) efficacy.
On July 16, FLCCC and BIRD gave a joint statement saying that there was no scientific basis to state that the removal of one study from meta-analyses would ‘reverse results’, yet the Guardian article had reported it as a fact [88]. They also said that according to the most recent analyses by BIRD, excluding the Elgazzar data from the meta-analyses by Bryant and Hill did not change the conclusions of these reviews, with the findings still clearly favoring ivermectin for both prevention and treatment. They added that even the prestigious Institute Pasteur in France had confirmed that the evidence was sound [89].
On July 16, Hill tweeted that ‘after removal of Elgazzar trial from ivermectin meta-analysis, borderline significant effects still seen for hospitalization and survival, but small number of endpoints. More evidence still needed from large ongoing randomized trials – must be continued’ [90].
On July 16, a news article said that a study that had ‘lit up the right-wing sphere of COVID deniers had been retracted over questionable methods’, adding that it was ‘just totally faked’ [91].
On July 16, a South African news article reviewed the retraction [92]. It also featured video interviews of patients, doctors and officials which concentrated on the black market of ivermectin in South Africa and the possible dangers of counterfeit medications.
On July 16, an opinion by Razak, the rector of International Islamic University of Malaysia, aimed at ‘setting the pace for a more courageous narrative’ about ivermectin’s possibilities in COVID-19 [93].
On July 17, the United Arab Emirates announced the treatment results for intravenously administered monoclonal antibody sotrovimab, produced by GlaxoSmithKline, in treating mild to moderate COVID-19cases among high-risk outpatients [94]. 6,175 patients were administered sotrovimab in Abu Dhabi between30 June and 13 July. Within 14 days, 97 percent of recipients achieved full recovery. There were zero deaths. 1 percent were admitted to ICU.
On July 17, a news report by Weisser described that early in the pandemic in Indonesia, an enterprising philanthropist Haryoseno made ivermectin available to the masses for free or at low cost, which resulted in Indonesia having an extremely low COVID-19 mortality rate. On June 12, 2021, however, in line withthe WHO recommendation, the ministry of health decided to disallow ivermectin and threatened Haryoseno with a fine and a ten-year jail sentence. Subsequently, the supply of ivermectin dried up and mortality increased five-fold [95]. About Australia, the report noted that clinician Mark Hobart had been reported to the Australian Health Practitioner Regulation Agency (AHPRA) which had decided that there had been no infringement. Subsequently, federal health minister had written that off-label ivermectin prescribing was not regulated or controlled by the Therapeutic Goods Administration (TGA) but was at the discretion ofthe prescribing physician. The physicians had formed Covid Medical Network [96], the members of which predominantly followed a ‘triple-therapy protocol’ developed by Thomas Borody, consisting of ivermectin, zinc and doxycycline [97]. The report also said that although the research on ivermectin for COVID-19 had originated from Australia, the researchers had been starved of resources and the discovery ignored.
On July 20, BBC wrote about Indonesia, saying that local media reports had incorrectly stated that theIndonesian authorities had granted ivermectin emergency approval [98]. The reports had been based on a July 15 statement issued by the Food and Drugs Authority of Indonesia (BPOM) in which ivermectin had been listed together with other drugs, two of which had had emergency approval. Shortly afterwards the head of BPOM had told local media that no emergency approval had been given to ivermectin. It had been listed because it was undergoing clinical trials at eight hospitals, the results of which were not expected until October.
On July 20, Med Page Today wrote about retraction of the preprint by Elgazzar et al. [99].
On July 20, a Swedish medical newspaper published an opinion by three Swedish doctors suggesting that Sweden should follow the example of the Czech Republic, Slovakia and other countries which had adopted ivermectin [100].
On July 22, Los Angeles Times wrote that ‘ivermectin, another bogus treatment, becomes a darling ofconspiracy-mongers’ [101]. In addition to reviewing the main points behind the retraction of the Elgazzaret al. preprint the columnist delved into an analysis of ivermectin politics, saying it was rather different from hydroxychloroquine controversy, as ‘the political underpinning of the ivermectin craze involves a conspiracy-infused attack on the pharmaceutical and medical establishment. In this it resembles the antivaccine movement .. . like anti-vaxxers, ivermectin advocates claim that information about the drug is being “suppressed,” generally by agents of Big Pharma; the core idea is that because drug companies can’t make very much money out of a drug available in generic form, they prefer to foist vaccines, on which they canmake billions of dollars in profits, on the innocent public . . . let’s be clear: information about the drug isn’t being “suppressed” for political reasons. It’s being treated as what it is: dangerous misinformation’.
On July 23, an interview of science writer Matt Ridley in the Wall Street Journal said that science had lost the public’s trust and that the politicization of science had led to a loss of confidence in science as an institution, and whereas the distrust may have been justified it left a vacuum that was often filled by lessrigorous approaches to knowledge [102]. Ridley pointed to a distinction between ‘science as a philosophy’ and‘science as an institution’, with the former wanting to remain open-minded, and the latter wanting to present a unified and authoritative voice, fostering a naive belief in the supremacy of scientists in understanding the world, luring politicians to affiliate themselves with this alleged power. Regardless, scientists often deliberately published things that fit with their political prejudices, ignored things that didn’t, or presented models based on rather extreme assumptions. Pessimistic predictions often being more popular in the media introduced a bias. A third conceptualization of or a type of identification with the concept of science,‘science as a profession’, had become off-puttingly arrogant and political, permeated by motivated reasoning and confirmation bias, with increasing numbers of scientists falling prey to groupthink [103]. According to Ridley, the tendency of scientific establishment ‘to turn into a church, enforcing obedience to the latest dogma and expelling heretics and blasphemers’ had previously been kept in check by the fragmented natureof the scientific enterprise but social media was eliminating the space for heterodoxy, leaving those believingin science as a philosophy increasingly estranged from science as an institution.
On July 23, an article by Mansour et al. described a preclinical tolerance study on the safety of inhaled lyophilized ivermectin formulation indicating 127-fold increase in drug aqueous solubility but also safety issues [104].
On July 24, World Ivermectin Day was organized by the BIRD group, the FLCCC, TrialSite News and 15 other affiliates [105]. Panel discussions included Shabnam Palesa Mohamed in conversation with PinkyN.J. Ngcakani (South Africa) and Wahome Ngare (Kenya); Erin Stair in conversation with Hector Carvallo(Argentina), Lucy Kerr (Brazil) and Flavio Cadegiani (Brazil); Shabnam Palesa Mohamed in conversation with Pierre Kory (US), Ira Bernstein (Canada) and Sabine Hazan (United States); Vincent Rey Vicente(US) in conversation with Iggy Agbayani, Homer Lim and Allan Landrito (Philippines), and PriyamadhabaBahera, Binod Kumar Patro, Biswa Mohan Padhy and Rashmi Ranjan Mohanty (India); Daniel O’Connorin conversation with Juan Bertoglio (Chile) and Matjaˇz Zwitter (Slovenia); Daniel O’Connor in conversationwith Juan Chamie (US), Pierre Kory (US) and Nathi Mdladla (South Africa).
On July 25, a preprint by Ontai et al. described a nationwide implementation of multi-drug COVID-19inpatient and outpatient treatment protocol CATRACHO in Honduras since May 3, 2020 [106,107]. The inpatient protocol consisted of dexamethasone, colchicine, tocilizumab, ivermectin, zinc, azithromycin andheparin. There were two outpatient protocols, one consisting of mouthwash, azithromycin, ivermectin andzinc, and the other consisting of prednisone, colchicine and rivaroxaban. The results indicated a case fatalityrate (CFR) decrease from May 3,2020 baseline of 9.3% to 3.0%, or from June 10, 2020 baseline of 5.0% to3.0%. Mexico used as a control country failed to show a similar decline.
On July 27, upon receiving a Special Benevolence Award from Tan Sri Lee Kim Yew of Malaysia on World Ivermectin Day, Kory of the FLCCC gave a lecture outlining the history of ivermectin in COVID-19 [108,109].
He mentioned that the MATH+ protocol had been adopted as the standard protocol in Ukraine, and thatthe hospital mortality rate there was the lowest of the countries in the area.
On July 27, press releases by Cochrane Deutschland and the University of W¨urzburg stated that there was no evidence of ivermectin’s efficacy [110,111].
On July 27, the university hospital of St. Anny in Brno in the Czech Republic published a report about their ivermectin treatment, saying it had been well tolerated and likely had a positive effect on COVID19 [112]. Ivermectin had been available at hospitals and for outpatient treatment since late 2020. Head of internal cardioangiology clinic Michal Rezek described the results of their analysis of 150 patients with a mean age of 63 years (32-93 years, median 65 years) treated between December 2020 and January 2021 with two doses of 0.2 mg/kg of ivermectin. 117 patients had required oxygenation and corticosteroids, 42 had required high-flow oxygen, and 17 had received also remdesivir. 18 patients had needed mechanical ventilation, six of which had died. Hospital mortality had been 10%, with the average age of the deceased being 75 years. There had been no control group. The hospital intended to continue ivermectin treatment and was preparing a RCT in collaboration with Masaryk University and Czech Clinical Research InfrastructureNetwork (CZECRIN) [113]. Lack of COVID-19 patients was mentioned as a possible obstacle to the trial. Rezek said a combination antiviral therapy with ivermectin and remdesivir was likely more effective than single-agent therapies.
On July 28, a Cochrane review by Popp et al. concluded that its authors were uncertain about the efficacy and safety of ivermectin for treatment or prophylaxis of COVID-19 [114]. With regard to late treatment(inpatients), the authors were uncertain whether ivermectin compared to placebo or standard of care reduced or increased mortality (RR 0.60, 95% CI 0.14-2.51, 2 studies, n=185, very low certainty), mechanical ventilation (RR 0.55, 95% CI 0.11-2.59, 2 studies, 185 participants, very low certainty), need for supplemental oxygen (0 participants required supplemental oxygen, one study, 45 participants, very low certainty), adverse events within 28 days (RR 1.21, 95% CI 0.50-2.97, one study, 152 participants, very low certainty), or viral clearance at day seven (RR 1.82, 95% CI 0.51-6.48, 2 studies, 159 participants, very low certainty). With regard to outpatients, the authors were uncertain about mortality up to 28 days (RR 0.33, 95% CI 0.018.05, 2 studies, 422 participants, very low certainty), mechanical ventilation (RR 2.97, 95% CI 0.12-72.47,one study, 398 participants, very low certainty) and symptoms resolution up to 14 days (RR 1.04, 95% CI0.89-1.21, one study, 398 participants, low certainty). With regard to prophylaxis there was only one eligible study, with mortality up to 28 days being the only outcome eligible for primary analysis; the authors were uncertain whether ivermectin reduced or increased mortality compared to no treatment (zero participants died, one study, 304 participants, very low certainty). The Covid Analysis group criticized the meta-analysis for being ’a very biased meta analysis designed to exclude almost all studies’ [115].
On July 28, an opinion in the Wall Street Journal questioned FDA’s negative stance on ivermectin [116]. The next day the authors wrote that they had not been aware of the retraction of the Elgazzar et al. study, yet stated that ‘the broader point stands: there’s strong evidence of ivermectin’s efficacy in COVID-19’ [117].
On July 28, GlaxoSmithKline (GSK) and Vir Biotechnology announced a joint procurement agreement with European Commission to supply up to 220,000 doses of sotrovimab [118], a contract worth USD 462 million at the wholesale price of USD 2,100 per dose. The agreement enabled participating European Union member states to quickly purchase sotrovimab, following local emergency authorization or authorization at the EUlevel, to treat high-risk patients with COVID-19 who might benefit from early treatment with sotrovimab.
On July 29, an article in Times of India explained a much higher rate of infections in the state of Kerala bylower COVID-19 seropositivity [119].
On July 30, a Czech Republic newspaper published a timeline of ivermectin-related events in the CzechRepublic [120].
On July 30, an article by Rella et al. suggested that in the current conditions the vaccines-only pandemic response may create vaccine-resistant strains [121,122].
On July 31, Kiekens interviewed George Fareed about outpatient treatment protocols for newly infected andfor long haul COVID-19 syndrome (LHCS) patients, implemented jointly with Brian Tyson on thousands of patients in the US [123]. For neurological LHCS symptoms in some instances, Fareed suggested a two to three-day high-dose ivermectin treatment as suggested by Alessandro Santin [124].
August 2021
On August 2, a news article from Israel reported on a clinical trial by Biber et al. (NCT04429711) [125], saying that ivermectin could help reduce the length of infection for less than a USD 1 per day, and that only 13%of ivermectin-treated patients were infectious after six days, compared with 50% of patients in the placebo group [126]. Schwartz, the leader of the trial, said that three journals had rejected the paper: ‘No one even wanted to hear about it. You have to ask how come when the world is suffering’.
On August 2, an open letter by Covid Medical Network stressed the importance of early treatment and noted that the federal health minister had acknowledged and even encouraged off-label prescribing of some treatments including ivermectin [127].
On August 2, an article by Reardon in Nature said that shocking revelations of widespread flaws in the data of a preprint study by Elgazzar et al. dampened ivermectin’s promise and highlighted the challenges of investigating drug efficacy during a pandemic [128]. Gideon Meyerowitz-Katz, an Australian epidemiologist,said he had lost all faith in the results of ivermectin trials published to date.
On August 2, an article by Sengthong et al. said that repeated ivermectin treatment induced ivermectin resistance in Strongyloides ratti infected rats [129].
On August 3, an article by Santin et al. reviewed the current status of ivermectin research, mentioning that the indicated biological mechanism of ivermectin, competitive binding with SARS-CoV-2 spike protein, was ikely non-epitope specific, possibly yielding full efficacy against emerging viral mutant strains [130].
On August 3, BBC wrote about the mystery of rising infections in India’s Kerala [131]. The southern Indian state of Kerala, with barely 3% of India’s population, accounted for more than half of the country’s new COVID-19 infections. Kerala was testing more than double the people per million compared to the rest of the country. Antibody tests survey revealed that only 43% people above the age of six in Kerala had been exposed to the infection, compared to 68% nationwide. Kerala had fully vaccinated more than 20% of its eligible population and 52% had received a single jab (70% of people over 45 years) which was much higher than the national average. BBC wrote that the state appeared to be testing widely, reporting cases honestly and vaccinating quickly, ensuring that future waves of infection would be less severe. Yet Kerala was said to be at an early stage in runaway exponential growth of cases. More forceful enforcement of rolling lockdowns was suggested as a solution.
On August 3, George Fareed discussed early treatments on Fox News television [132].
On August 5, an article by Behera et al. described a prospective cohort study (n=3,532) in India, indicatingthat two doses of oral ivermectin (0.3 mg/kg/dose given 72 hours apart) as chemoprophylaxis among healthcare workers reduced the risk of COVID-19 infection by 83% in the following month (6% vs 15%, adjustedrelative risk 0.17; 95% CI, 0.12-0.23) [133].
On August 5, a preprint by Rana et al. described an in silico study showing strong binding affinity ofivermectin and doxycycline for SARS-CoV-2 main protease 3CLpro, and increased binding affinity for thecombination of both [134,135].
On August 5, a Finnish technology magazine wrote about ivermectin, saying that according to FLCCC,there was already an effective medication for COVID-19 but it was rarely used [136]. A head of unit at theFinnish Medicines Agency (FIMEA) commented that doctors were allowed to prescribe it off-label, providedthat the patient was informed about it not being officially approved for COVID-19. The official commentedthat ‘in an international comparison the Finnish medical community is quite conservative about adoptingnew treatments without a sufficiently strong evidence base’. Also, a process to officially adopt ivermectin forCOVID-19 could only be initiated by a producer of ivermectin or the European Medicine Agency (EMA).
On August 6, an article by Kow et al. reviewed sample size calculations in ivermectin trials, indicating thatexisting trials had been very underpowered [137].
On August 6, US National Institutes of Health (NIH) Collaboratory published a video interview of EdwardJ. Mills, the head researcher of Together adaptive platform trial [138]. Mills discussed interim results of their outpatient trial which included fluvoxamine and ivermectin (0.4 mg/kg for three days). For ivermectin,the risk reduction for extended emergency room observation or hospitalization was 9% (86/677 vs 95/678,RR 0.91, 95% CI 0.69-1.19) and for mortality 18% (RR 0.82, 95% CI 0.44-1.52); these were not statistically significant. Mills commented that ivermectin had had ’no effect whatsoever’ on their primary and secondary endpoints. For fluvoxamine, the risk reduction for extended emergency room observation or hospitalization was 31% (74/742 vs 107/738, RR 0.69, 95% CI 0.52-0.91) and for mortality 29% (17/742 vs 24/738, RR0.71, 95% CI 0.39-1.29); the first endpoint was statistically significant while the second was not. The trial was done at ten locations in Minas Gerais, Brazil. It was unclear whether over-the-counter ivermectin usehad been an exclusion criteria. At the time the gamma variant was prevalent and assumed to cause higher viral loads and a more severe disease than most other variants. The Covid Analysis group criticized various aspects of the trial [139].
On August 6, a report on SARS-CoV-2 variants by Public Health England indicated that concerning deathswithin 28 days of positive specimen date between February 1 and August 2 there had been 71 deaths in people under 50 years and 670 in people over 50 years [140]. In the first group, 18% had been vaccinatedtwice and 68% were unvaccinated. In the second group, 58% had been vaccinated twice and 31% were unvaccinated.
On August 6, a podcast by Nature discussed ivermectin [141].
On August 9, a commentary by US medical doctor using a pseudonym Justus R. Hope described a ‘blackouton any conversation about how ivermectin beat COVID-19 in India’ [142,143]. It claimed that the US newsmedia were trying to confuse the public with false information by saying the deaths in India were ten times greater than official reports. Using August 5 numbers as examples the author said that in ivermectin-using states of India such as Uttar Pradesh with a population 240 million of which 4.9% were fully vaccinated there were 26 daily cases and three deaths, in Delhi with a population of 31 million of which 15% were fully vaccinated there were 61 daily cases and two deaths, in Uttarakhand with a population of 11.4 million of which 15% were fully vaccinated there were 24 daily cases with zero deaths. In states not using ivermectin such as Tamil Nadu with a population of 78.8 million of which 6.9% were fully vaccinated there were 1,997daily cases with 33 deaths. In the US with a population of 331 million of which 50.5% were fully vaccinated there were 127,108 daily cases with 574 deaths. He compared FDA’s and WHO’s ban on ivermectin to Pope’sban on all books and letters that argued the Sun was the center of the universe instead of Earth, adding that the US government was ‘all-in with vaccines with the enthusiasm of a 17th century Catholic church’.
On August 10, a news story by Yahoo! Japan reported that a Japanese clinician Kazuhiro Nagao, appearingon the Fuji TV television program, had suggested that ivermectin should be distributed to all Japanese nationals in advance to be taken after COVID-19 infection, and that COVID-19 should be in the same administrative category as seasonal influenza in order to avoid delays and make early treatment possible [144].
On August 10, a news report from La Pampa province of Argentina described minister of health MarioRub´en Kohan releasing the latest results of the implementation of a monitored intervention program on the use of 0.6 mg/kg of ivermectin for five days in 3,269 treated patients versus 18,149 untreated patients[145,146]. The risk of death was 27.4% lower (RR 0.73) and the risk of death or ICU admission was 38.0%lower (RR 0.62). For people over 40 years of age the risk of death was 33.4% lower (RR 0.67). For people over 40 years of age and with comorbidities the risk of death was 44.0% lower (RR 0.56).
On August 11, Los Angeles Times wrote about ivermectin having ‘no effect whatsoever’ in the Togethertrial [147]. The head researcher Mills said that ‘in our specific trial we do not see the treatment benefit that a lot of the advocates believe should have been seen’. He complained that many researchers had faced unprecedented abuse from advocates of specific treatments.
On August 11, an article by Cobos-Campos et al. reviewed ivermectin for COVID-19 [148].
On August 12, vaccine expert Geert Vanden Bossche, who on May 24, 2021 had proposed mass chemoprophylaxis with ivermectin [149], demanded stopping of COVID-19 mass vaccination [150]. A rationale for the demand was the increased infectiousness of new variants already noted with respect to the alpha and delta variants, both more infective than the original variant, and the delta variant being significantly more infective than the alpha variant. Bossche expected this trajectory to continue, possibly resulting in an uncontrollable situation. In Bossche’s view, the increased infectivity had resulted from a natural selection of increasingly vaccine immunity escaping variants in the vaccinated part of the population. In other words, mass vacci11nation had created an evolutionary pressure for development of these variants which were then transferred to the non-vaccinated population. In addition, vaccine-induced antibodies possibly competed with natural antibody based, variant-nonspecific immunity, possibly rendering the population more vulnerable to some vaccine immunity escaping variants. The issue was also taken up by other researchers [151].
On August 12, a preprint by Elavarasi et al. described a retrospective study about hospitalized patients in India which did not show a statistically significant result [152].
On August 12, an article by Pedroso et al. described that self-prescribed use of early ivermectin treatment by 45 healthcare workers in Brazil was associated with a lower rate of seroconversion in a dose-dependentresponse [153].
On August 13, an article by Zhou et al. suggested that ivermectin might be a new potential anticancer drug therapy for human colorectal cancer and other cancers [154].
On August 13, on NIH Collaboratory, Smith discussed the history of proposed therapies for COVID-19 andthe adaptive platform trial ACTIV-2 [155].
On August 14, a Japanese clinician Kazuhiro Nagao wrote in a blog post that he had been harassed and had received death threats after appearing on TV and telling about treating 500 COVID-19 patients with ivermectin with no deaths [156,157].
On August 14, Kiekens interviewed an Italian physician Andrea Stramezzi about his early treatment protocol and his telehealth treatment method [158]. He was using hydroxychloroquine as a part of the outpatient protocol due to its easy availability. According to Stramezzi, it was useful in the first few days. Initially in the pandemic it had been provisionally recommended [159], then banned [160]. Stramezzi had initiated a legal proceeding about the ban, initially winning the case but subsequently losing an appeal. Regardless,the judge had decreed that physicians were free to prescribe medications off-label at their discretion. In addition, the protocol had included anti-inflammatories such as aspirin, and bromhexine. Also vitamins C and D were used, although Stramezzi did not consider high levels of vitamin D sufficient to prevent COVID19. Additionally, vitamin K was administered separately from vitamin D due to their antagonism. A later addition, ivermectin, useful also in later stages to reduce replication of the virus, needed to be imported from the neighboring countries. Stramezzi said that about 10% of Italians had a genetic vulnerability toSARS-CoV-2 induced hyperinflammation. For this group, prevention with corticosteroids and enoxaparin was necessary. He said that there were approximately 1,500 physicians in Italy working with the similar protocols, exchanging information with each other. The public’s awareness of early treatments in Italy was still low because health authorities did not recommend it or talk about it, instead just recommendingparacetamol and waiting for severe pneumonia to emerge before contacting healthcare facilities. Stramezzisaid they had met Sileri, a physician/researcher and deputy minister of health (M5s) [161,162], for an hour.
Sileri had said he was aware of the therapeutical options, had treated a hundred patients himself, and hadco-authored an article about the genetic defect [163]. Also, the parliament of Italy had voted in favor ofearly treatments [164]. Regardless, after several months nothing had happened with regard to adoption of these treatments. Stramezzi was developing a free mobile phone app for doctors who had too many patients or who were unsure of how to treat COVID-19: the app would give suggestions for a suitable treatment protocol.
On August 16, a letter to the editor by Chahla et al. in the American Journal of Therapeutics described a randomized controlled trial (n=234) in Argentina with ivermectin and iota-carrageenan as pre-exposureprophylaxis for health care workers (NCT04701710) [165,166,167]. The treated group (n=117) received 6mg ivermectin every seven days, and six nasal sprays of iota-carrageenan per day for 4 weeks. The risk ofCOVID-19 infection was 84.0% lower (3.4% vs 21.4%, RR 0.16, p=0.001), and the risk of moderate or severe disease was 95.2% lower (0.0% vs 8.5%, RR 0.05, p=0.002). The authors hypothesized that the combination treatment formed a double viral barrier: first, carrageenan behaved as a mucolytic agent in a barrier of sulfated polysaccharides with negative charge in the nasal cavity; second, ivermectin decreased viral load by systemic cellular action.
On August 16, an article by Winter examined the ongoing discussion about ivermectin [168].
On August 17, an article by Gonz´alez-Paz et al. described an in-silico elastic network model analysis of ivermectin components (avermectin-B1a and avermectin-B1b) providing a biophysical and computational perspective of proposed multi-target activity of ivermectin for COVID-19 [169,170].
On August 17, Associated Press reported that ’dozens of people in Oregon have contacted the state’s poisoncenter after self-medicating against COVID-19 with a drug used to treat parasites, with five becoming hospitalized and two of them winding up in intensive care units’ [171].
On August 18, Los Angeles Times wrote that fluvoxamine may actually work against COVID-19 [172].
On August 19, an article by Gonz´alez-Paz et al. described an in silico analysis of the components of ivermectin (avermectin-B1a and avermectin-B1b), suggesting different and complementary inhibitory activity of each component, with an affinity of avermectin-B1b for viral structures, and of avermectin-B1a for host structures [173,174].
On August 20, an article by Amaya-Aponte reviewed ivermectin in COVID-19 [175].
On August 20, the investigational monoclonal antibody sotrovimab was granted a provisional approval forthe treatment of COVID-19 in Australia [176].
On August 20, a letter by Popp et al. in the BMJ said that the different assessments between Popp et al’sCochrane meta-analysis and the one by Bryant et al. were partly due to baseline data of included studies:Bryant et al. pooled heterogeneous patient populations, interventions, comparators and outcomes whereasPopp et al. did not; thus, according to Popp et al., Bryant et al. compared apples and oranges, ‘serving a large bowl of a colorful fruit salad’ [177]. The authors accused Bryant et al. of ‘creating pseudotrustworthiness for substances that cannot be considered effective and safe treatment options nor game changers, at this stage’.
On August 21, an article by Karvanen et al. described a new algorithm for causal effect identification: do search based on do-calculus [178]. The algorithm might allow for improving clinical trial result analysis [179,180,181].
On August 21, due to overlap and confusion with the I-MATH+ prophylaxis and early outpatient treatment protocol, the FLCCC discontinued its I-MASS mass prophylaxis and home treatment protocol introduced a few months earlier [182].
On August 21, the US Food and Drug Administration (FDA) tweeted about ivermectin, stating that ‘You are not a horse. You are not a cow. Seriously, y’all. Stop it.’ [183]. The tweet linked to FDA’s March 2021advisory against ivermectin [184].
On August 21, a Slovenian newspaper reviewed ivermectin, mentioning two previous articles published in the same newspaper written by a Slovenian ivermectin proponent Matjaˇz Zwitter [185,186].
On August 21, a blog post by Meyerowitz-Katz discussed a study by Cadegiani et al. [69], claiming that thedata in a spreadsheet uploaded by the authors didn’t look real: ’data for this study may not be fake, but it is at least incredibly suspicious’ [187,188].
On August 21, a preprint by Izcovich et al. presented a systematic review about bias as a source of inconsistency in ivermectin trials [189]. Based on a review of 29 RCTs with 5,592 cases the authors concluded that previous reports about ivermectin’s benefits were based on potentially biased results, and further research was needed.
On August 22, an Indian geriatrician, preventive cardiologist and anti-aging specialist Lenny Da Costa described ivermectin use in India [190,191]. According to Costa, beginning from March 2020, India distributed an outpatient home treatment kit containing hydroxychloroquine, azithromycin, doxycycline, ivermectin and vitamin C. In March 2021, ignoring evidence from India, WHO stated that ivermectin should not be used.
The statement was given by an Indian epidemiologist, WHO chief scientist Soumya Swaminathan. A group of Indian physicians filed a legal case against her. To protect Swaminathan, Indian central government removedivermectin from official recommendations. However, state governments were responsible for guidelines for medical care in the states, not the central government; most states continued the use of ivermectin. Costasaid that no-one had stopped using ivermectin but they did not advertise the fact. According to Costa,during the deadly second wave in April-May 2021, India’s most populous state, Uttar Pradesh, reduced the number of daily cases from 60,000 to 15,000 in a month by distributing ivermectin for everyone for free. Clinicians did not wait for RT-PCR test results; instead, medication was started immediately on the presentation of symptoms. Prescriptions were given for free by telemedicine (WhatsApp). Ivermectin prevented people from infecting others, especially family members. Also, numerous physicians had been using ivermectin since March 2020 for prophylaxis, with none of them getting infected. On June 29, 2021, the government of Uttar Pradesh announced a home treatment kit for children, containing paracetamol, multivitamins and ivermectin. Costa claimed that India’s success in controlling the second wave was primarily due to an early administration of ivermectin, doxycycline, zinc and other medications used for early treatment.
On August 23, a medical doctor writing under a pseudonym Justus R. Hope continued on India’s ‘ivermectin blackout’ [192,193]. On August 15, Kerala, a state reportedly not using ivermectin, with a population of approximately 3% of India’s population, had accounted for 56% of India’s new cases and 25% of India’s new deaths. Delhi, a state with nearly the same population size as Kerala but using ivermectin, accounted for 0.2% of new cases and 0% of deaths. Uttar Pradesh, with a population almost eight times larger than
Kerala, accounted for 0.09% of new cases and 0.2% of deaths. Hope wrote that Kerala ranked in the top five most vaccinated of India’s 29 states, adding that Kerala’s failure in comparison to most other states of India could be explained by the facts that Kerala had not used ivermectin for early treatment whereas most other states had, and that ivermectin lowered the viral load and inhibited transmission whereas vaccination did not, giving a false sense of security. Those with prior infection, negative test result, or at least one vaccine dose (56% of adults) had been exempted from lockdown [194]. Hope called Kerala’s comparatively highvaccination rate its most problematic feature leading to rampant viral transmission. Kerala had adopted ivermectin in April but restricted its use to severe cases with additional risk factors. On August 5, Kerala had removed ivermectin from state guidelines completely. In contrast, Uttar Pradesh had been the first stateto introduce large-scale prophylactic and therapeutic use of ivermectin. The state had treated all contacts of an infected patient prophylactically with ivermectin. The lesson, Hope said, was that ivermectin could make up for the low use of vaccination but vaccination could not make up for the low use of ivermectin.
On August 23, ABC News report written by a medical toxicology fellow and an emergency medicine physician in New York stated that health officials had said that a potentially dangerous, unproven deworming drugs hould not be used to treat COVID-19 [195]. The report blamed social media for informing people about the medication ‘not authorized by independent regulators at the FDA’ (see e.g. [196]). Not a single trial to prove ivermectin’s usefulness existed and an interviewee advised that people ‘don’t have to go with something that doesn’t have a scientific basis’.
On August 23, CBS News reported that officials had warned against using anti-parasite drug for COVID19 [197].
On August 24, Mother Jones magazine interviewed Boulware, an ivermectin researcher, involved in a University of Minnesota trial (NCT04510194) [198,199]. Boulware had received hostile messages calling him ’are embodied Josef Mengele’ from people believing that ivermectin was a miracle cure and placebo-controlled trials were therefore unethical. Another researcher at Washington University in St. Louis commented on the polarization, saying that if she tweeted something about vaccines as positive, she was being attacked by people pro early treatment, and if she tweeted about potential treatments, she provoked the ire of vaccine advocates who ‘kind of seem to suppress any information about early treatment, maybe because they feel like it’s going to make people think they don’t need to be vaccinated’. The article also described Steve Kirsch’s frustration with the government’s unwillingness to recommend treatments on the basis of small trials with encouraging results. Researchers also worried that the recent reports of ivermectin self-dosing could scare people off of enrolling in any kind of treatment trials in the future.
On August 25, an article by Mohan et al. described a trial (RIVET-COV, n=157) investigating the effect of single-dose oral ivermectin (12 or 24 mg) in mild and moderate COVID-19 which indicated no statistically significant effects on viral load or RT-PCR negativity [200].
On August 25, on the social media platform Reddit, subreddit r/ivermectin which had been a public, uncensored discussion forum initiated a year before for discussions related to ivermectin research and treatments,was flooded with tens of horse-themed pornographic cartoon images, in reference to ivermectin as ‘horse paste’, as well as hundreds of sexual, offensive or irrelevant comments. The moderator said the attack had been coordinated by a group of moderators of other, large subreddits, yet refused to remove the irrelevant content, referring to his disbelief in censorship [201].
On August 25, in a FLCCC weekly update, endocrinologist and researcher Fl´avio Cadegiani described his experience in the state of Amazonas in Brazil during a gamma variant outbreak in 2021 (the gamma variantwas considered to cause a more severe disease than the delta variant) [202]. The research group had visitedvarious cities with hospitals overwhelmed with COVID-19 patients. However, in the city of Coari located afew hundred kilometers west from Manaus there had been no hospitalized COVID-19 patients at all. At first Cadegiani had been unable to get an explanation to the situation but later, in private, a health official had revealed that the city had been providing ivermectin for its whole population for two months already. As to the question why the explanation had not been given immediately the official replied that she had been afraid of being accused of giving unapproved treatments. Cadegiani said the experience had been shocking.
He added that secondary endpoints in single-agent trials were important indicators of possible efficacy as a component in a multi-agent treatment protocol.
On August 25, in the FLCCC weekly update, Kory and Marik discussed the addition of dual anti-androgentherapy (dutasteride 2 mg on day one followed by 1 mg daily for ten days [203], and spironolactone 100 mg twice daily for ten days [204]) to their delta variant early treatment protocol which at the time included twelve components [202]. They stated the addition provided ‘massive improvements’.
On August 26, Krolewiecki et al. published additional details about their trial on the antiviral effect of high-dose ivermectin in COVID-19 [205].
On August 26, Centers for Disease Control and Prevention (CDC) reported that ivermectin prescriptionsfrom US pharmacies had increased 24-fold from the pre-pandemic baseline [206]. Ivermectin-related calls to poison control centers had increased five-fold, respectively. The report gave two examples of adverse effects:one patient becoming disoriented after taking tablets of unknown strength (5 tablets per day for five days),and another patient presenting with confusion, drowsiness, visual hallucinations, tachypnea and tremors after drinking an injectable form of veterinary ivermectin.
On August 26, Newsweek interviewed Joe Varon of the FLCCC saying that since a year ago he had treated thousands of COVID-19 patients in the US with off-label ivermectin in combination with other pharmaceuticals in the FLCCC treatment protocols [207]. During the pandemic Varon had been widely featured in the US media but the reporters had chosen to not mention ivermectin.
On August 26, a news story in Vice magazine complained that Facebook did not properly censor ivermectin content and Facebook’s ivermectin groups were ‘unhinged and out of control’ [208,209].
On August 28, Newsweek reported about a far-right political commentator’s use of ivermectin for his COVID19 infection [210].
On August 28, Newsweek reported that a Republican representative from Texas had appeared to speak in support of unproven treatments for COVID-19, including ivermectin, a drug often used as a dewormer for cows and horses [211]. The representative was also said to have praised president Trump and have raised concerns about vaccines.
On August 29, Anthony Fauci warned against using ivermectin for COVID-19 [212].
On August 29, Cohen wrote in Forbes that ivermectin had become embedded in a ‘cultural war’, commenting that ‘of all drugs right-wingers would have gravitated to, ivermectin and hydroxychloroquine are most unusual candidates, in that they’re largely used in humans in developing nations for conditions rarely seen in the US’ [213]. Ivermectin for COVID-19 was pictured as unproven misinformation harming public health, and the politicization of the issue had been to the detriment of efforts to contain the pandemic, taking attention away from clinically confirmed instruments such as vaccines. The author worried that there were a surprising number of people in the medical profession who believed in ivermectin, such as the physician advisor to Florida’s governor. Cohen said that ‘these contrarians are not waiting for the completion of confirmatory studies to disseminate their advice to the gullible minions to take ivermectin off-label, even if doing so may endanger lives’.
On August 30, Newsweek reported that an US hospital had refused to administer FLCCC member FredWagshul’s prescription for a patient, after which a judge had ordered the hospital to administer it [214]. The next day, a regional US newspaper interviewed Wagshul who attributed the lack of adoption of ivermectinto ‘propaganda, money and big pharma’ [215].
On August 30, a report by German news agency said that ivermectin trials have been of a low quality and that Cochrane Deutschland and the University of W¨urzburg considered ivermectin inefficacious [216].
On August 30, a video interview of Fernando Valerio describes Honduras’ treatment protocols in detail [217].
On August 31, a preprint by Omrani et al. presented a systematic review and meta-analysis of effectiveness of ivermectin/doxycycline combination, concluding that based on low-quality evidence, the combination was accompanied with a shorter time of clinical recovery but did not significantly reduce all-cause mortality, viral clearance, and hospital stay [218].
On August 31, Pfeiffer described patients’ experiences in US hospitals [219].
On August 31, Kory of the FLCCC accused the US National Institutes of Health (NIH) of being the main agent in the ‘war against ivermectin’ due to not having given a recommendation for ivermectin [220]. Healso stated the FDA was only ‘running interference for [NIH] by telling jokes and lies’.
On August 31, a Swedish newspaper G¨oteborgs-Posten wrote about veterinary ivermectin use in the US [221].
On August 31, a preprint describing a randomized controlled trial of community-level surgical mask promotion in rural Bangladesh with 111,525 individuals in the intervention arm and 155,268 individuals in the control arm indicated 14% relative reduction in COVID-19-like symptoms, with absolute reductions of 7.5%vs 8.6%. Divided by age groups, differences were not statistically significant in people under 50. In people between 50-60 years there was a reduction of 23%, and in people over 60 a reduction of 35%, respectively.
The impact of the intervention faded after five months [222].
September 2021
On September 1, ABC News wrote that due to lack of evidence and increase in reports related to ivermectin toxicity, the American Medical Association, American Pharmacists Association and American Society of Health-System Pharmacists had called for an ‘immediate end’ to prescribing, dispensing or using the deworming drug ivermectin to treat or prevent COVID-19 [223].
On September 1, Washington Post wrote that people using ivermectin for prophylaxis had been shocked about having ended up being hospitalized for COVID-19 [224]. The story mentioned the rise in prescriptions and FDA’s tweet and warned about overdoses. Numerous interviewees advised against ivermectin, with the most critical comparing it to ‘snake oil’. Overall, a part of the population preferring ivermectin and vitamin cocktails over vaccines was seen to indicate ‘a broader problem: a public health crisis made worse by many people’s distrust of medical authorities while they rely on often faulty information from some ofthe country’s most influential people, which is amplified through social media’. Ivermectin was said to have gained particular traction in conservative circles. Wagshul of the FLCCC was quoted saying that ivermectin was more effective than vaccines against variants given waning immunity. A researcher working on an ongoingclinical trial on ivermectin in the US ([225,226]) commented that ‘there’s either people that believe it totally is a cure-all and works or that it is highly dangerous . . . and the reality is, neither extreme is true’.
On September 1, a letter by Keehner et al. in the New England Journal of Medicine reported about a dramatic decline in vaccine effectiveness from June to July in a highly vaccinated health system workforce in California, likely due to the emergence of the delta variant, waning of immunity over time, and the end of masking requirements in California [227].
On September 1, KFOR News published a news story in which a rural Oklahoma doctor, Jason McElyea,claimed that local emergency rooms were so backed up with patients having overdosed ivermectin that gunshot victims had hard time getting to the facilities [228]. In addition, ivermectin overdose patients were completely clogging ambulance services: McElyea was quoted saying that ‘all of their ambulances are stuck at the hospital waiting for a bed to open so they can take the patient in and they don’t have any, that’s it. . . if there’s no ambulance to take the call, there’s no ambulance to come to the call’.
On September 1, 2021 the subreddit r/ivermectin was ‘quarantined’ by the Reddit platform but that did notstop the flood of offensive posts. Alternative forums were created but they seemed to fail to capture largeaudiences (e.g. [229]). Another subreddit, r/IVMScience appeared to have stalled after August 23, 2021,with the moderator’s account deleted.
On September 1, podcaster Joe Rogan, with 11.1 million followers on YouTube, 13.2 million followers on Instagram and a USD 100 million contract to publish his podcast exclusively on Spotify, revealed on Instagram that he had got COVID-19 and had been treated with monoclonal antibodies, ivermectin, azithromycin, prednisone, nicotinamide adenine dinucleotide drip and a vitamin drip for three days in a row [230]. Rogan’s statement was widely taken up by news media [231,232,233]. On July 1, 2021, in the context of an unrelated controversy, a journalist at the New York Times had called Rogan ‘too big to cancel . . . one of the most consumed media products on the planet – with the power to shape tastes, politics, medical decisions’ [234].
On September 1, a letter to the editor by Bryant et al. commented on the recent report in the Guardian [81]discussing the effect of the removal of the Elgazzar et al. trial on the meta-analysis by Bryant at al. [4].
The authors stated that ‘while quantitative measures of effect do of course change on removal of any study,the overall findings of a significant mortality advantage in ivermectin treatment, and in prophylaxis, remain robust to removal of the disputed data. The claim that conclusions are “entirely reversed” cannot be sustained on the evidence’ [235].
On September 1, Due˜nas-Gonz´alez et al. discussed repurposing of ivermectin as a novel anticancer [236].
On September 2, Newsweek published a version of McElyea’s story, saying people taking the horse de-wormer medication were filling up the area’s emergency rooms [237]. The report mentioned FDA’s ‘stern warnings’against ivermectin, the unavailability of ambulances, and gunshot victims’ difficulties.
On September 2, Rolling Stone wrote about how Joe Rogan ‘became a cheerleader for ivermectin . . . no one has been more successful at promoting ivermectin than Rogan’ [238].
On September 2, a major Finnish newspaper Helsingin Sanomat republished a news article written by Finnish News Agency (STT) about an US podcast host Joe Rogan treating his COVID-19 infection with a ‘dewormer intended for horses’ warned against by ‘medical officials’ [239]. The article described that after his diagnosis Rogan begun taking ‘all kinds of potions’ including ivermectin, which, according to Washington Post and the Guardian, was used as a dewormer for horses. However, ‘some representatives of conservative media’had ‘advertised the controversial dewormer’. In addition to mentioning the negative stance of the European
Medicine Agency (EMA), the article also cited FDA’s tweet saying: ‘You are not a horse. You are not a cow.
Seriously, y’all. Stop it’. According to the article, calls about ivermectin exposure to poison control centers in the US jumped to five times over normal levels in July 2021. Rogan was also described having spread ‘lies’about COVID-19 and being against vaccines. The leading infectious diseases expert Anthony Fauci was said to have criticized Rogan’s earlier statements. Up to the 1990s, STT, founded in 1887, was often consideredt he ‘official’ national news source. Helsingin Sanomat, the most widely distributed newspaper in Finland,essentially holds a monopoly in the metropolitan area. The article was also republished by the most widely distributed yellow press media Ilta-Sanomat belonging to the same concern as Helsingin Sanomat [240]. In addition, the story was posted in some regional newspapers [241], essentially reaching the whole population of the country.
On September 2, a competing Finnish yellow press newspaper wrote about Rogan’s use of dewormer, saying that it had no proven efficacy and it could be dangerous, even deadly [242]. Rogan was said to regularly ‘flirt with misinformation’. The article also described FDA warnings and retraction of the Elgazzar et al. trial.
On September 2, citing insufficient evidence of efficacy, leading health experts in Sri Lanka urged people to stop using ivermectin for COVID-19; however, a local trial was ongoing [243].
On September 2, Marik and Kory published a reanalysis of the data of their earlier meta-analysis [6],saying that the summary point estimates were largely unaffected when the study by Elgazzar et al. was removed [244].
On September 2, a letter to the editor by Neil et al. said that their Bayesian analysis provided sufficientconfidence that ivermectin was an effective treatment for COVID-19, also after the exclusion of Elgazzar et al. study [245].
On September 2, a Cochrane review concluded that the authors were uncertain whether the investigational monoclonal antibody sotrovimab had an effect on mortality (RR 0.33, 95% CI 0.01-8.18) and invasive mechanical ventilation requirement or death (RR 0.14, 95% CI 0.01-2.76). Treatment with sotrovimab was said to possibly reduce the need for oxygenation (RR 0.11, 95 % CI 0.02-0.45), hospital admission or death by day 30 (RR 0.14, 95% CI 0.04-0.48) [246].
On September 2, an article by Alves et al. in the BMJ about poorly designed studies contributing to misinformation in Brazil said that ’much like a poorly written sequel to a blockbuster, the ivermectin narrative appears to be a subsidiary of the rationale that gave the world the HCQ pseudo-solution to COVID-19: cheap, readily available answer to the biggest sanitary crisis of our time’ [247]. The authors argued that public communication of science (i.e. news reporting) should be evidence based: any interaction between scientists and press should aim at summarizing and contextualizing the most important findings of an article for the general public, preserving context and limitations of the research, promoting transparency,integrity and scientific literacy. Also, research findings should be published without delay and include full datasets. Otherwise, the authors said, public communication may be only fueling polarization and an eventual implementation of harmful, inefficient or wasteful public health policies.
On September 2, an article by Chaudhry et al. presented a systematic review about the role of ivermectin in hospitalized patients [248].
On September 2, a report in BuzzFeed news questioned the validity of two prophylaxis trials by Carvallo etal. in Argentina [249]. The report claimed that the reported numbers, genders and ages of trial participants had slight inconsistencies. Carvallo was said to have declined to share the raw data even to his coauthors, the timeline and ethical approvals of the trials were unclear, as well as who had performed the statistical analyses.
It was also unclear which hospitals had been involved and in which ways. Carvallo denied accusations of fraud.
On September 3, an article by Okogbenin et al. described a retrospective study in Nigeria, with 300 patients treated with ivermectin, zinc, vitamin C and azithromycin, reporting zero mortality [250].
On September 3, a rapid response by Bryant et al. to Popp et al. [177] stated that their Bryant et al. metaanalysis was a non-commissioned research paper that strictly followed PRISMA systematic review guidelines,and that Popp et al. itself contained several misleading items, including using death instead of infection for the prophylaxis outcome, specifying outcome measures not found in the included trials but ignoring the outcome measures found in the trials, subsequently stating that they found ‘no data’ [251]. The authors concluded that in a pandemic context, the benefits of ivermectin almost certainly outweighed any risks.
On September 3, a blog post by Meyerowitz-Katz discussed the study by Carvallo et al. [252], pointing outissues that indicated possible fraud, yet noted that the study was not a randomized controlled trial and thus
not included in most meta-analyses or given the same credence, and it did not change recommendations forofficial medical organizations. However, Meyerowitz-Katz added, ’it perhaps had an even bigger impact onpeople actually taking ivermectin than previously fraudulent research. This paper showed a 100% benefit,it was enormously popular on social media, and it was given a huge amount of credence by promoters ofivermectin for nearly a year. It is not a stretch to say that this one study has perhaps caused hundreds ofthousands or even millions of people to take ivermectin as a prophylactic drug to prevent COVID-19’ [253].
On September 3, South African Health Products Regulatory Authority (SAHPRA) repeated its warnings against the use of ivermectin, saying its stance was aligned to that of US FDA [254].
On September 3, Yahoo News published a version of McElyea’s story, mentioning that he was an emergency room physician affiliated with multiple hospitals in Sallisaw, Oklahoma, and that the situation was so dire that even people with gunshot wounds have to wait their turn to get treatment [255]. McElyea added that people were suffering real ramifications from taking a dosage meant for a full-sized horse, including ‘scary’instances of vision loss, nausea, and vomiting.
On September 3, Rolling Stone magazine published a version of McElyea’s story [256].
On September 4, the Guardian published a version of McElyea’s story [257].
On September 4, BBC published a version of McElyea’s story [258].
On September 4, the administration of Northeastern Health Systems (NHS) Sequoyah posted a statement saying that although McElyea was not an employee of NHS Sequoyah, he was affiliated with a medical staffing group that provided coverage for the emergency room at Sallisaw but he had not worked there in over two months [259,260]. The administration clarified that NHS Sequoyah had not treated any patients due to complications related to taking ivermectin, including not treating any patients for ivermectin overdose. They added that all patients who had visited the emergency room had received medical attention as appropriate,and the hospital had not needed to turn away any patients seeking emergency care.
On September 4, KXMX interviewed a hospital administrator of NHS Sequoyah who stated that the hospital being overloaded by ivermectin patients was ‘simply not the case in Sallisaw .. . we have not seen or had anypatients in our ER or hospital with ivermectin overdose . . . we have not had any patients with complaints or issues related to ivermectin . . . we are not overrun with patients with ivermectin related issues’ [261].
The administrator added that McElyea had treated patients in the Sallisaw emergency room but not in the past several months, and added that she wanted the public to know that McElyea did not speak for NHSSequoyah.
On September 4, NPR wrote that poison control centers are fielding a surge of ivermectin overdose calls [262,263].
On September 4, Reuters published a fact-check article saying that ‘outrage has spread online that Afghan refugees entering the United States will receive the drug ivermectin although it does not have U.S. approval as a COVID-19 treatment. However, the posts miss the vital context that refugees are given ivermectin for infections unrelated to the novel coronavirus . . . ivermectin is administered as a presumptive treatment forintestinal parasite’ [264]. The ‘outrage’ was said to have been caused by ivermectin being administered to refugees but being largely unavailable for US citizens willing to use it for COVID-19.
On September 4, an article by Associated Press published in Indian Express said that efforts to stamp out use of parasite drug ivermectin for COVID-19 in US were growing [265]. It said that ivermectin was being‘promoted by Republican lawmakers, conservative talk show hosts and some doctors, amplified via social media to millions of Americans who remain resistant to getting vaccinated’, with the American Medical Association, two US pharmacist groups, FDA, CDC and WHO advising against it.
On September 5, the Guardian added an amendment to the end of their article, quoting parts of the statementby NHS Sequoyah, saying that the hospital had not treated any patients related to taking ivermectin,including overdose [266].
On September 5, a ‘fact check’ by Shore News Network called the McElyea story ‘completely false’, mentioning that the publishers had not issued retractions, saying that ‘the left continues to push a media narrativethat conservatives and Republicans are creating an ivermectin health crisis’ [267].
On September 6, a preprint by Buonfrate et al. described randomized controlled trial in Italy with results indicating statistically insignificant dose dependent viral load reduction (NCT04438850) [268]. The authors said that ivermectin remained safe with dosing regimes of 0.6 mg/kg and 1.2 mg/kg for five days. The study was terminated early due to lack of eligible patients.
On September 6, a blog post by an US doctor working on new models for mental health care called theMcElyea story ‘too good to check’, saying that ’the media has tried to spread the word that the scientific consensus [about ivermectin for COVID-19] remains skeptical. In the process, they may have gone a littleoverboard and portrayed it as the world’s deadliest toxin that will definitely kill you and it will all somehow be Donald Trump’s fault’ [269,270].
On September 6, a report by News On 6 said ‘a false report has Oklahoma trending nationally . . . the doctor at the center of the story told News 9 he was misquoted, and the story was wrong’. McElyea clarifiedthat ‘as the story ran, it sounded like all of Oklahoma hospitals were filled with people who have overdosed on ivermectin and that’s not the case, . . . the cases we are seeing, people who are overdosing on ivermectin,they are taking full strength cattle doses and coming in and that is something that could be avoided’.
The report mentioned another hospital in the area, Integris Grove, having stated that they had seen ‘a handful of ivermectin patients in their emergency rooms . . . while our hospitals are not filled with people who have taken ivermectin, such patients are adding to the congestion already caused by COVID-19 and other emergencies’. The report concluded with a mention that the Oklahoma Center for Poison and Drug Information had received 12 ivermectin-related calls last month [271].
On September 6, Soave analyzed the media reporting, saying that the media fell for a viral hoax about ivermectin overdoses straining rural hospitals [272]. He commented that McElyea clearly stated that ivermectin overdoses were a problem and claimed that some hospitals were dealing with strain in general but he neveractually connected these two issues. Instead, the KFOR’s journalist had added that framing; she had notresponded to a request for comment. If other media outlets had called the doctor or the hospitals they would have easily uncovered the error. Soave added that while the mainstream media had vigorously condemned COVID-19 misinformation in social media, readers could also encounter it in mainstream media such as Rolling Stone, New York Times or Associated Press (AP) which had recently reported that 70 percent of calls to Mississippi’s poison hotline were from people who had taken ivermectin while the actual figure was 2 percent [273] (AP was a member of the Trusted News Initiative (TNI) [274]).
On September 6, another judge reversed the earlier decision concerning administration of ivermectin prescribed by Wagshul to a patient in a US hospital, saying there ‘was no doubt that the medical and scientific communities do not support the use of ivermectin as a treatment for COVID-19’ [275]. The judge addedt hat ‘COVID-19 has ravaged the world. However, the rule of law must be followed once the court system is involved. The law in its purest form shall have neither hatred nor sympathy to anyone or anything. It shall stand unwavering in its truth, justice, and fairness to call’ [276]. A spokesperson for the hospital described the ruling as ‘positive in regards to the respect for science and the expertise of medical professionals’, adding that they implore the community ‘to do what we know works: wear a mask, become fully vaccinated and use social distancing whenever possible’. She added that the hospital appreciated scientific rigor and did not believe they should be ordered to administer medications ’against medical advice’.
On September 6, a German magazine for pharmacists reported about American Pharmacists Association’s recent demand to stop off-label ivermectin prescribing [277]. The article mentioned the ongoing PRINCIPLEtrial by University of Oxford.
On September 7, Fox News reported that McElyea was an employee of an agency that staffs emergencydepartments [278]. The report also mentioned that while NHS Sequoyah had stated they had not treatedany ivermectin patients, Integris Grove Hospital, had seen a handful’. Integris added that ‘there is a lotof media attention surrounding remarks reportedly made by Dr. McElyea. While we do not speak on hisbehalf, he has publicly said his comments were misconstrued and taken out of context’.
On September 7, a CNN reporter Daniel Dale tweeted about McElyea case, saying local media had misrepresented the interview of McElyea, national and international media had failed to do due diligence, and readers and critics had jumped to conclusions. He concluded that ‘lots of people involved here – certainly the local outlet/the big aggregating outlets/the prominent tweeters on the left, but also some critics on the right – could’ve done a better job pursuing facts/waiting for facts before coming to conclusions’ [279]. CNN published a ‘fact-check’ report with similar content [280].
On September 7, an Austrian newspaper wrote that the misconception that horse dewormer ivermectin wouldhelp against COVID-19 is widespread internationally and also in Austria [281]. The article mentioned thatno poisonings had been reported in Austria, and that Czech Republic had adopted ivermectin in hospitals.
A toxicologist commented that ivermectin was still dangerous and there was insufficient data on the safety of chronic consumption.
On September 7, the title of a January 2021 article in a German women’s magazine, originally asking whether ivermectin might be useful, was updated to ‘People are not horses’ [282].
On September 7, a Swedish newspaper Svenska Dagbladet wrote that instead of being vaccinated Americans are taking ivermectin as the latest alternative treatment for COVID-19, the only problem being that it was intended for treating parasites in horses and cows [283].
On September 7, Joe Rogan complained that CNN had reported that he had been taking ‘horse dewormer’;Rogan stated that ‘I literally got it from a doctor’ [284].
On September 7, wealthy Chinese exile Guo Wengui was said to be using his online misinformation network to promote the use of unproven treatments for COVID-19 [285].
On September 8, an article by Cruciani et al. presented a systematic review and meta-analysis of ivermectin for prophylaxis and treatment of COVID-19 [286]. Based on an analysis of eleven RCTs, the authors concluded that there was limited evidence for the benefit of ivermectin.
On September 8, a letter published in the Guardian by Hill, the main author of one of the meta-analyses about ivermectin [5], said that after his team had questioned the clinical benefits of ivermectin the team and his family had received daily death threats. As social media platforms had not reacted he had stopped using social media but abuse by email had continued. Hill described the situation as shocking, affecting many scientists, and said that scientists must be protected from anti-vaxxer abuse, possibly by police action [287].
On September 8, Wired magazine wrote about Together trial results, quoting the head researcher saying that ivermectin proponents had ignored their fluvoxamine findings, only being interested in ivermectin,‘feeling strongly’ about it but not about other possible options [288]. The article also mentioned US NIH’s ongoing ACTIV-6 ivermectin trial, into which people could sign up at home. A co-chair of the trial’s steering committee said that there was no data on ivermectin’s benefit but since people were using it, the point of their trial was to get a definitive answer.
On September 8, the Guardian worried about some Australian clinics’ off-label prescribing of ‘unapproved’ivermectin [289]. The president of the Royal Australian College of General Practitioners (RACGP) said that while RACGP did not consider its role to be looking over the shoulders of every GP, the advice from the health experts to not use ivermectin was ‘100% clear’. However, she added, ‘the status of other drugs, suchas sotrovimab, is very different. That is an example of a new drug for the treatment of Covid-19 that haspassed through the rigorous testing safety procedures of the Therapeutic Goods Administration’.
On September 9, Geert Vanden Bossche summarized the negative effects of mass vaccination as follows: itwill, first, eventually drive dominant propagation of super variants that are highly infectious and increasinglyresist vaccine-induced neutralizing antibodies; second, erode innate immune defense in the non-vaccinated(due to high infectious pressure exerted by enhanced circulation of more infectious variants); and third,erode naturally acquired immunity (due to increasing viral resistance to neutralizing spike protein specificantibodies). Of these, the second and third consequences together prevent herd immunity from being established.
Yet the solution, according to Bossche, would be induction of herd immunity by starting from scratch against the more infectious variants. This could be achieved by providing multidrug early treatment for the infected which would result in enhanced rates of recovery from disease and rise in the number of people who develop life-long protective immunity. Also, mass antiviral treatment with any drug that would effectively reduce viral infectious pressure would be required to prevent innate antibodies in previously asymptotically infected individuals from being suppressed by short-lived, spike protein specific antibodies and thus enable the healthy, unvaccinated part of the population to deal with all SARS-CoV-2 variants; these massantiviral campaigns might need to include pets and live-stock and be combined with lockdown rules foras long as titers of these short-lived antibodies were measurable (6-8 weeks).
Boscche said that a larger unvaccinated population would circulate also less infectious variants, attenuating circulation of more infectious variants. However, the above methods would still be unlikely to sufficiently reduce transmission among healthy individuals; therefore ultimately an immune intervention able to prevent infection in all susceptible age groups would be required, and as long as such an intervention, likely based on natural killer cell based vaccines, would not be available, repeated antiviral chemoprophylaxis might be necessary. However, as along term strategy the chemoprophylaxis would not be feasible, as overuse could promote viral resistance to the compound.
About his personal intentions Bossche wrote that ‘one can always do more, write morearticles, bring more scientific evidence to the table, do more interviews and podcasts, reply to more questionsand destroy more of the nonsense divulgated by scientifically incompetent experts or illiterate fact-checkers.
However, I’ve decided to not continue along this path as I knew from the very start that this big alliance of stakeholders would not listen and as the primary purpose of my endeavors has always been to share, as broadly as possible, my scientific insights on why this [mass vaccination] experiment is an incredible blunder, so that none the involved experts, key opinion leaders, public health authorities or peers from industry could ever pretend that this was unknown and simply unpredictable’ [290].
He said that he had a history of going against ‘groupthink’, for example speaking against the results of Gavi The Vaccine Alliance’s phase III Ebola vaccine trials conducted by the World Health Organization (WHO) and published in a peer-reviewed journal. Bossche said the results falsely concluded that the vaccine had 100% efficacy, whereas according to Bossche’s analysis ‘the truth looked extremely different’ [291]. He added that to him it seemed that ‘many of our experts and scientists, even including a substantial number of renowned professors, are so stuck within their small silos that they have simply lost touch with reality’.
On September 9, Hill responded to a tweet by the BIRD group which had said that according to Hill, the conclusions of the meta-analysis by Hill et al. remain clearly in favor of ivermectin even after exclusion ofElgazzar et al. trial [292,293]. Hill stated: ‘Misleading information from the BIRD group. In our analysis there is no significant survival benefit for ivermectin in randomized trials after exclusion of apparently fraudulent and biased studies’ [292]. Later on the same days he responded with ‘more misleading information from the BIRD group misquoting our research’ to another tweet by the BIRD group which had said that‘Hill’s work also shows that ivermectin not only reduces the risk of death, it clears the virus from the bloodstream faster than controls, thus ivermectin reduces the time that an infected person can transmit the virus’ [294].
On September 9, Joe Rogan discussed the ‘horse dewormer’ narrative, referring to regulatory capture in theUS [295].
On September 10, a news report in the BMJ discussed US court rulings and ivermectin prescriptions [296].
On September 10, the BIRD group announced that their meta-analysis by Bryant et al. [4] had reached a position in the top ten of 18.9 million articles tracked by Altmetric [297,298].
On September 10, Hill tweeted that the ‘survival benefit of ivermectin disappears when only trials at low risk of bias are analyzed. The reported survival effects are entirely driven by studies at high risk of bias or medical fraud’ [299]. An accompanying graph indicated slightly over 50% benefit (p=0.01) with Elgazzar et al. study included, slightly under 40% benefit (p=0.05) without it but including studies with a high risk for bias, and approximately 4% benefit (p=0.90) with only low risk studies included.
On September 10, a blog article discussing failed communication attempts between ivermectin skeptics and proponents commented that ‘what you are witnessing is just the most absurd example of a decades-long war on re-purposed (aka “non-profitable”) medicines’ [300,301,302].
On September 10, Hindustan Times wrote about a clinical trial (RIVET-COV) with 157 patients with mild to moderate disease carried out by All India Institute of Medical Sciences (AIIMS) which indicated that ivermectin did not reduce the viral load or duration of symptoms [303]. Mohan said that ‘all the ivermectin being prescribed or being taken by people left, right, and centre will definitely not show any effect’; therefore ivermectin should not be used outside clinical trials, although he added that their trial did not investigate possible effect on mortality.
On September 11, TrialSite News wrote about US NIH’s refusal to release information on who had been involved in its decision to recommend neither for nor against ivermectin [304]. However, US CDC had released the names of the members of the working group [305]. According to TrialSite News, three of the nine members, Adimora, Bedimo and Glidden, had disclosed a financial relationship with Merck & Co/MSD.
Another member, Naggie, had later received USD 155 million funding for US NIH’s ACTIV-6 trial which included ivermectin, fluvoxamine and fluticasone (NCT04885530) [306].
On September 11, TrialSite News wrote that Australia’s Therapeutic Good Administration (TGA) had formally placed a national prohibition on off-label prescribing of ivermectin to all general practitioners,citing interruption of vaccination as a factor in the decision [307].
On September 12, a three-day International Covid Summit started in Rome [308,309], with presentationsin the Roman Senate held also in Italian and Spanish and translated into sign language. Lecturers included Roberta Ferrero, Francesca Donato, Albert Bagnai, Luigi Icardi, Ivan Vilibor Sincic, Joseph Tritto, Robert Malone, Mauro Rango, Christof Plothe, David Anderson, Ira Bernstein, Fabio Burigana, Steven Hatfill,Roberto Accinelli, Tess Lawrie, Oswaldo Castaneda, Rosanna Chifari, Antonietta Gatti, Andrea Stramezzi, Peter Mccullough, George Fareed, Pierre Kory, Roberta Lacerda, Carlos Maggi, Bruce Patterson, DilipPawar, Victor Villa, Mattia Perroni and Francesco Matozza. In addition, the summit featured groups of researchers and clinicians from Italy, Croatia, Czech Republic, Poland, Romania, Bulgaria, Tanzania, South Africa, Nigeria, Mali, Spain, UK, France, Brazil, Bolivia, Argentina, Paraguay, Peru, Canada and US. Several treatment protocols including McCullough et al’s sequenced multidrug protocol [310] and FLCCC’s MATH+protocol were discussed.
On September 13, a Dominican Republic newspaper described details of an early 2020 ivermectin trial by Morgenstern et al. [311,312].
On September 13, a story in Rolling Stone ridiculed ‘anti-vaxxers’ for using povidone iodine mouthwash to prevent COVID-19 [313]. An interviewed gynecologist/obstetrician commented that ‘we use it before surgery to clean the vagina’ and that ‘it could result in iodine poisoning if taken orally’. Another physician who appeared unable to give statements without including profanities in his sentences commented that ‘drinking iodine’ had caused a patient a transient kidney failure and that povidone iodine definitely could not reducethe effects of COVID-19 or prevent its transmission. An ’Australian family physician’ stated that ‘there have been no human studies on the use of Betadine to treat COVID-19, just hypotheses and lab studies’.
On September 13, the Guardian wrote about ‘ivermectin frenzy’ being ‘a cottage industry of advocacy groups, anti-vaccine activists and telehealth companies’ despite stances of FDA, NIH and some US medical and pharmaceutical associations [314]. It noted that FLCCC had signed open letters in favor of ivermectin which had also been signed by ‘anti-vaxx’ organizations. Telehealth sites were said to have connections to a conservative doctor group America’s Frontline Doctors in favor of hydroxychloroquine treatments and whose opinions had been quoted by ‘Donald Trump, his son Donald Trump Jr and numerous QAnon conspiracists’.
On September 13, Mother Jones magazine wrote that people associated with Q-Anon had harassed a hospital where a Q-Anon member had been hospitalized with hundreds of calls and emails, in order to get ivermectin administered to her [315].
On September 14, in a Cochrane Collaboration author interview, Stephanie Weibel and Maria Popp described their ivermectin meta-analysis [316]. The authors said that because of a lack of good-quality evidence, it was unknown whether ivermectin reduces or increases mortality, caused adverse effects, improved or worsened patients’ condition, or increased or decreased viral load, led to more or fewer negative COVID-19 tests 7days after treatment. Likewise, they could not say whether ivermectin prevented COVID-19 infection or reduced the number of deaths after high-risk exposure to the SARS-CoV-2 virus.
On September 14, Menichella wrote about Peter McCullough’s influence in Italy and about a protocol developed in Italy by a group led by Giuseppe Remuzzi [317]. The Remuzzi protocol was mainly based on relatively selective COX-2 inhibitors [318]. In a retrospective observational matched-cohort study with 90outpatients and 90 controls with mild disease the proportions of patients who required hospitalization were2% vs 14% (p=0.01); cumulative days of hospitalization were 44 vs 481 days, and costs of hospitalization were EUR 28,000 vs EUR 296,000, respectively. Menichella wrote that the standard of care resulted in approximately 2% mortality; with a ’serious home treatment protocol’ mortality could be lowered to 0.05%.
On September 15, an article by Talwar et al. described a case of a successful management of ivermectinpoisoning [319]. A 6-year-old girl weighing 20.5 kg had accidentally consumed 600 mg of ivermectin (29.3mg/kg). Mechanical ventilation, ceftriaxone, clindamycin, intravenous midazolam, phenytoin and supportivemeasures were utilized. The girl was discharged after nine days of hospitalization.
On September 15, a news report in Willamette Week discussed US biologist Bret Weinstein’s role in the ivermectin controversy, including his influence on Joe Rogan [320].
On September 15, a letter to the editor by Boretti discussed quercetin, suggesting that quercetin might help to lower inflammation, as well as reduce the toxic effects of COVID-19 vaccines and the chances of being infected [321]. Quercetin had been included in the FLCCC protocols since early 2020.
On September 15, Fenton et al. discussed unreliability of current vaccine studies [322].
On September 16, Cheng et al. presented a meta-analysis about efficacy and safety of various medications for treating severe and non-severe COVID-19 patients [323].
On September 16, Malhotra discussed Indian Bar Association’s legal notice to WHO [324].
On September 16, an Australian medical newspaper wrote that a secretive organization called the COVID19 Antiviral Advisory Group had said it had been instructing 200 doctors to prescribe ivermectin and was planning on going public against TGA’s ivermectin ban [325].
On September 17, an article by Singh et al. suggested a positive correlation between European populations’zinc sufficiency status and COVID-19 mortality. The authors noted that the observed association was contrary to what would be expected if zinc sufficiency was protective in COVID-19, suggesting that controlled trials or retrospective analyses of the adverse event patients’ data should be undertaken to correctly guidethe practice of zinc supplementation in COVID-19 [326].
On September 17, an article by Gurung et al. described an in silico study which indicated that ivermectin demonstrated moderate binding to human serum albumin [327].
On September 17, a preprint by Karale et al. presented an updated systematic review and meta-analysis of mortality, need for ICU admission, use of mechanical ventilation, adverse effects and other clinical outcomes
[328]. 52 studies (n=17,561) were included in a qualitative analysis and 44 of those (n=14,019) were included in the meta-analysis. A mortality meta-analysis indicated lower odds of death (OR 0.54, 95% CI 0.34-0.86,p=0.009, 29 studies). As adjuvant therapy, the odds of viral clearance were higher (OR 3.52, 95%CI 1.816.86, p=0.0002, 22 studies), the duration to achieve viral clearance was shorter (p=0.02, 8 studies), andthe need for hospitalization was reduced (OR 0.34, p=0.008, 6 studies). The authors concluded that themortality benefit of ivermectin in COVID-19 is uncertain but as an adjuvant therapy ivermectin may improve viral clearance and reduce the need for hospitalization.
On September 17, a news report by Piper in Vox magazine questioned the validity of studies by Carvallo etal. [329,330], saying that experts on scientific fraud didn’t believe Carvallo conducted his study as described:the data appeared fabricated, key data was missing, study registration and published results didn’t match with each other, Carvallo could not explain these issues, and the hospital in which the study was said to have been conducted stated that it had not been conducted there, to which Carvallo replied that it had been but without the hospital administration knowing [331]. In another context, Lawrie of the BIRD group had been asked what evidence would persuade her that ivermectin didn’t work, to which she had replied thatthere could be nothing that would persuade her. Mills involved in the Together trial commented that themost culpable parties weren’t those who had believed in the apparently fraudulent studies but those whohad conducted, published, and boosted them.
On September 17, Business Insider wrote about FLCCC’s Kory and Marik, calling them ’fringe doctors whipping up false hope that could have deadly consequences’ [332]. According to Business Insider, Kory was’a once respected doctor whose hospital rejected his unsupported treatment ideas’ while Marik was ’a doctor who ostracized himself from mainstream medicine after his high-profile sepsis treatment was a dud’, adding that ’Marik’s failed sepsis protocol later became the backbone of the FLCCC’s first iterations of COVID-19treatment’ (the MATH+ inpatient protocol) [333]. Recently they had been ’sucked (willingly or not) into the embrace of the anti-vaccine far right .. . ivermectin is now a darling drug of QAnon’. A former FLCCCmember, Eric Osgood, had left the group in summer 2021. The editor in chief of Science Communication said that FLCCC’s communication style was objectionable but added that the existence of ’rogue opinions’was a necessary condition for scientific breakthroughs. However not everyone had the skills to assess claimsnor understood how science worked, which had led to ’a conflict between our commitment to freedom of speech and a clash with the nature of scientific truth and people’s right to say anything they want . . . the hype machine they’ve created is out of control’.
On September 17, Seheult on MedCram reviewed ivermectin, with comments from cell biologist Rhonda Patrick [334]. Seheult stressed the importance of taking all treatment options into account; Patrick said ivermectin had seemed to consistently reduce viral load but the hype around ivermectin was pushing researchers away from the subject.
On September 20, an Indian news agency reported that 31 of 75 districts of the state of Uttar Pradesh inIndia were COVID-19 free [335]. In total, the state reported 17 new cases in the last 24 hours out of 182,742samples tested.
On September 20, the Guardian worried about horses being deprived of a deworming agent [336].
On September 21, Brazil’s president Bolsonaro stated that Brazil had supported clinicians’ early treatment measures since the beginning of the pandemic, adding that he could not understand why some countries opposed early treatment measures [337].
On September 21, Ars Technica discussed the validity of Covid Analysis group’s ivmmeta.com meta-analysis[338].
On September 22, a letter to the editor by Lawrence et al. in Nature Medicine concluded that metaanalyses based on summary data alone were inherently unreliable [339]. The authors stated that most,if not all, of the flaws in recent ivermectin meta-analyses would have been immediately detected if metaanalyses were performed on an individual patient data (IPD) basis. They recommended that meta-analysts who study interventions for COVID-19 should request and personally review IPD in all cases, even if IPDsynthesis techniques were not used. They also recommended that all clinical trials published on COVID-19should immediately follow best-practice guidelines and upload anonymized IPD. They authors said that their proposal was a change to a nearly universally accepted practice over many decades and substantially more rigorous than current standards; regardless, the proposed change was imperative.
On September 22, in a FLCCC weekly update, Marik announced an upcoming publication of an article on the pathophysiology of COVID-19 [340].
On September 22, a video by John Campbell described the contents of ivermectin kits used in state of Goain India [341]. The kits in Goa contained pulse oximeter, a thermometer, paracetamol, vitamin C and D,multivitamin tablets containing zinc, ivermectin (10 x 12 mg), doxycycline (10 x 100 mg), and personal protective equipment. The cost of one kit was USD 2.65. The kits used in Uttar Pradesh contained ivermectin, doxycycline, vitamins B, C and D, zinc, paracetamol, thermometer and a pulse oximeter. Outpatients weremonitored by phone twice a day. Campbell said that the intervention had actually been organized under a WHO monitoring program. A WHO report described that since May 5, 2021, 141,610 government teams were moving across 97,941 villages in 75 districts over five days in Uttar Pradesh, a state with a population of 230 million [342]. WHO field officers monitored over 2,000 government teams and visited at least 10,000 households. WHO also said it was to support the Uttar Pradesh government on the compilation of the final reports; these reports had not yet been published.
On September 23, a preprint by Mayer et al. described an intervention program of high-dose ivermectin in COVID-19 carried out by the Ministry of Health of the Province of La Pampa, Argentina [343]. Within five days of symptoms onset, 0.6 mg/kg/day of ivermectin for five days was administered. Active pharmacosurveillance was performed for 21 days, with hepatic laboratory assessments performed in a subset of patients. From 21,232 subjects with COVID-19, 3,266 were offered and agreed to participate in the ivermectin program. 17,966 did not participate and were considered as controls. A total of 567 participantsreported 819 adverse events; 3.13% discontinued ivermectin due to adverse events. Mortality was lower in the ivermectin group in the full group analysis (1.5% vs 2.1%, OR 0.720, p=0.029), as well as in subjects over 40year-old (2.7% vs 4.1%, OR 0,655, p=0.005). ICU admission was significantly lower in the ivermectin groupcompared to controls among participants over 40 year-old (1.2% vs 2.0%, OR 0.608, p=0.024). According to Covid Analysis group [344], in a full group analysis the unadjusted risk of death was 27.6% lower (RR 0.72,p=0.03) and unadjusted risk of ICU admission was 26.0% lower (RR 0.74, p=0.13).
On September 23, several groups of clinicians in favor of early treatments announced a new organization,World Council for Health, an umbrella organization with over 45 affiliated organizations [345]. The council released a home treatment guide with a combination protocol consisting of vitamins C and D, zinc, quercetin, melatonin, ivermectin, mouthwash, ibuprofen, N-acetylcysteine, antihistamines, aspirin, and others [346].
The protocol was one of the first ones to tentatively include iodine (Lugol’s solution).
On September 23, the Indian Council of Medical Research (ICMR) dropped ivermectin and hydroxychloroquine from clinical guidelines for the management of adult COVID-19 patients [347,348,349,350].
On September 23, a fact-checking website discussed social media posts claiming that ’ivermectin apparently sterilizes the majority (85%) of men that take it’ and a news report claiming that ’ivermectin causes sterilization in 85 percent of men, study finds’ [351,352].
On September 24, the Guardian wrote about misinformation spreading globally [353].
On September 24, the Guardian wrote about fraudulent ivermectin studies [354].
On September 24, Mashable interviewed ex-FLCCC member Osgood who said that he had initially joined the FLCCC because they were ’forward thinking doctors who were able to get ahead of the profession’ on a few hospital treatments (e.g. the use of anticoagulants) but he had left the organization because of his view that FLCCC insisted on promoting ivermectin over vaccines [355]. He referred to povidone iodine prophylaxis of COVID-19 as misinformation.
On September 26, an article by Marik et al. presented a scoping review of the pathophysiology of COVID-19[356]. The article described severe COVID-19 as one of the most complex of medical conditions known to medical science, noting that an overarching and comprehensive understanding of its pathogenesis, a requirement for the formulation of effective prophylactic and treatment strategies, was still lacking. Threebasic pathologic processes were identified: a pulmonary macrophage activation syndrome with uncontrolled inflammation, a complement-mediated endothelialitis together with a procoagulant state with a thromboticmicroangiopathy, and platelet activation with the release of serotonin and the activation and degranulation of mast cells contributing to the hyper-inflammatory state (quercetin had been a part of FLCCC protocols sinceMarch 2020; in one study, it was found more effective than cromolyn in blocking mast cell cytokine release[357]). The article also mentioned the C-C chemokine receptor type 5 (CCR5) pathway which interacts with chemokine ligand 5 (CCL5 or RANTES).
On September 26, in a discussion with Robert Malone, Geert Vanden Bossche stated that the proper way would have been to vaccinate vulnerable groups only, and mentioned ivermectin chemoprophylaxis as a possible solution [358].
On September 26, the New York Times interviewed the acting head of the New Mexico (US) state health department who claimed that ivermectin ’had contributed to’ deaths of two hospitalized patients who had previously self-medicated with ivermectin ’instead of proven treatments like monoclonal antibodies’ [359].
On September 27, in a discussion with Anmol Ambani and Peter A. McCullough, Marik presented the contents of the new article in a video lecture [360].
On September 27, 5,200 doctors had signed a Global Covid Summit related ’Rome declaration’ [361].
On September 27, an article by Deng et al. presented a systematic review and meta-analysis about the efficacy and safety of ivermectin [362]. Based on an analysis of three observational studies and 14 RCTs representingvery low to moderate quality of evidence, the authors concluded that ivermectin was not efficacious atmanaging COVID-19.
On September 28, an article by Barkati et al. concluded that corticosteroid therapy was an important risk factor for Strongyloides hyperinfection but there were challenges associated with the performance, availability and quality of Strongyloides tests. The authors concluded that presumptive use of ivermectin was reasonablein selected situations [363].
On September 28, an article by Zhang et al. presented a Bayesian network meta-analysis of 222 randomized controlled trials with 102,950 patients, suggesting that imatinib, intravenous immunoglobulin andtocilizumab led to lower risk of death; baricitinib plus remdesivir, colchicine, dexamethasone, recombinanthuman granulocyte colony stimulating factor and tocilizumab indicated lower occurrence of mechanical ventilation; tofacitinib, sarilumab, remdesivir, tocilizumab and baricitinib plus remdesivir increased the hospital discharge rate; convalescent plasma, ivermectin, ivermectin plus doxycycline, hydroxychloroquine, nitazoxanide and proxalutamide resulted in better viral clearance [364]. On a treatment class level, the analysis found that the use of antineoplastic agents was associated with fewer mortality cases, immunostimulants could reduce the risk of mechanical ventilation and immunosuppressants led to higher discharge rates.
On September 28, the New York Times wrote that Facebooks groups promoting ivermectin continued to flourish [365].
On September 28, a rapid review by Cardwell et al. about pharmacological interventions to prevent COVID19 mentioned ivermectin prophylaxis trials [366].
On September 29, a preprint by Budhiraja et at. described secondary infections in hospitalized patients inNorth India, mentioning that 43.5% of the patients had been administered ivermectin [367].
On September 29, referring to FLCCC, BIRD and America’s Frontline Doctors (AFLDS), Scientific Americanwrote about fringe doctors’ groups promoting ivermectin for COVID despite a lack of evidence [368].
On September 29, Chemistry World wrote that ivermectin debacle had exposed flaws in meta-analysis methodology [369]. The report stated that ’the people who’ve done these meta-analyses haven’t stuffed up. . . they haven’t deviated from accepted standards or made big mistakes . . . instead, there is a fundamentalflaw in the approach’.
On September 29, the Hill, the largest independent political news site in the US, wrote that ivermectin disinformation had led to new kinds of chaos [370].
On September 30, a preprint by Schaffer et al. describing changes in dispensing of medicines proposed for re-purposing in the first year of the COVID-19 pandemic in Australia noted that there had a small but sustained increase in ivermectin dispensing between March 2020 and November 2020 [371].
On September 30, an introduction to Popp et al.’s Cochrane review by Jordan said that at this stage there were very few completed well conducted studies about either prevention or treatment but 31 trials were underway [372].
Discussion
On a closer look it appeared that the quality of some early ivermectin trials had been lower than assumed.
As individual patient data had not been generally available, most parties including various groups publishing meta-analyses had implicitly trusted the summary data and ignored slight inconsistencies. The current best practice guidelines did not require analysis of individual patient data. The proposal that meta-analyses should be performed on individual patient data appeared justified. An additional, likely necessary change to methodology would be adoption of the do-search method, assumedly the most general tool currently available for causal effect identification, and as such an improvement over Bayesian methods [179,373].
In 2014, Every-Palmer et al. noted that little ‘high quality’ (according to evidence-based medicine standards)empirical evidence existed that EBM should benefit the population, i.e. evidence about EBM’s superiority in improving patient outcomes [374]. In 2018, Anjum claimed that EBM relied on a flawed positivist methodology [375]. Recently, Martini claimed that the concept of evidence was insufficiently defined [376].
A fundamental error appeared to be the insistence on trialing single agents instead of combination protocols.
All of the currently utilized early treatment protocols were combination protocols and it was unlikely that the same results could have been obtained with a single agent. Thus, combination protocol trials would have been more likely to produce statistically significant effects. The insistence on large trials, instead of eliminating biases, possibly introduced them. For example, a lack of funding for repurposing may have introduced a severe funding-related bias.
It appeared that prolonged stress and continuing unpredictability of the situation had overwhelmed many,occasionally leading to actions whose consequences were perhaps badly thought out. The situation seemedto amplify preexisting tendencies and weaknesses within groups, leading to group-specific biases, formationof subcultures, or variants of ’groupthink’ [103]. Groups suspecting the pharmaceutical industry, authoritiesand ’the mainstream’ seemed to amplify these tendencies in-group, whereas groups suspecting anything’fringe’ but favoring mechanistic thinking and overreliance on specific methods or paradigms seemed toamplify these tendencies. Groups with a tendency to act out in panic or anger exhibited that behavior,while groups with a tendency to retreat into fearful inaction and silence did that. The central role of trustwas highlighted, yet trust seemed practically nonexistent.
Also strengths were exhibited, most prominently the capability of forming groups and alliances. However,these groups tended to become tribal in their nature, and the result resembled tribal warfare, a practice that the humanity should already have transcended. It seemed as if everyone was trying to take care of others in their own ways but these ways were incompatible with each other; someone once defined conflicts as ’failed attempts to love’.
It also seemed that journalists and the public had an idealized image of science and were trying to find solace in it as in a religion, with some scientists maybe trying to maintain these illusions. One commentator noted that ’society was not ready to watch science in real time’ [377]. Another added that ’science was not prepared to display itself to the public in real time’, while a third said that ’society was not ready to watch science in any other way either’.
In the news media, emotionally manipulative tactics seemed common. A prime example of arrogance and lack of due diligence was the case of Rolling Stone ridiculing povidone iodine use [313], claiming that there had been no human trials about it on COVID-19, despite the fact that there had been several, with promising results [10,378,379,380,381] (for observational studies, see e.g. [382,383]; for an updating list, see [384]).
Ways of reasoning appeared incompatible for example in the case of the Guardian’s critique of the BIRD group affiliating with organizations labeled as anti-vaccine for the purposes of promoting early treatment.
In the view of the BIRD group founder, vaccinations were unrelated to early treatments and, subsequently,the vaccination stances of the affiliates irrelevant. While technically correct, this view predictably appeared confusing.
In a similar manner it could be noted that, for example, the possible usefulness and validity of FLCCC’s protocols was unrelated to FLCCC members’ extra-medical opinions, and that ivermectin was only one component of the synergistic protocols consisting of more than ten components. Also, some news reports[332] severely misrepresented the sepsis protocol [333]. With regard to the social media communications of the FLCCC, it may have made a mistake in leaving these communications largely to a couple of ex-journalists whose communication style appeared unsuitable already in the first half of 2020.
With regard to conflicts of interest, the members of US National Institutes of Health’s (NIH) ivermectinworking group had disclosed several relationships to pharmaceutical companies working on COVID-19 treatments [385]. As mentioned, three of the nine members of the working group [305] had disclosed relationshipswith Merck & Co/MSD which, during the pandemic, had issued a statement against the use of ivermectinin COVID-19 [386], was working on a competing product molnupiravir [387,388,389], and had receivedsignificant US government funding for development of investigational pharmaceuticals for COVID-19 [390].
Adimora had received research support from Gilead Sciences and was a consultant and a member of an advisory board of Merck & Co/MSD; Bedimo was a member of advisory boards of Gilead Sciences, Merck &Co/MSD and ViiV Healthcare (a subsidiary of GlaxoSmithKline); Glidden was a consultant to Gilead Sciences and a member of an advisory board of Merck & Co/MSD [385]. A fourth member, Pavia, was a consultant to GlaxoSmithKline. A fifth member, Naggie, the head of US NIH’s ACTIV-6 trial (NCT04885530) [306]had received research support from AbbVie and Gilead Sciences, had a connection to Bristol Myers SquibbCompany, and was a stockholder and an advisory board member of Vir Biotechnology, the producer ofsotrovimab together with GlaxoSmithKline [391]. In summary, more than half of the members of the working group were associated with producers of molnupiravir, sotrovimab, remdesivir (Gilead Sciences),lopinavir/ritonavir (AbbVie), and investigational monoclonal antibodies (Bristol Myers Squibb Company).
However, NIH had specifically intended to involve the industry in its decision-making processes through the ACTIV public-private partnership [392]. Whereas this organizational structure likely appeared beneficialfrom the point of view of a swift development of investigational pharmaceuticals, with regard to repurposingit appeared to have included conflicts of interest by design.
For the pharmaceutical industry, incentives for unethical behavior may currently overpower those for ethical behavior. The current setting appeared designed for gambling [393], hardly the best method for optimizing public health, and it was difficult to see why societies considered it appropriate.
The event descriptions did not delve into details of the experiences of Honduras and the Dominican Republic; readers are encouraged to acquaintance themselves with the original sources [217,106,107,311,312].
These countries used relatively little clinical trial evidence to implement their protocols. Similarly, no RCT evidence on FLCCC protocols exists, yet they have been successfully used. These parties seemed to embrace uncertainty instead of requiring an unattainable level of certainty; high-income countries were probably less accustomed to radical uncertainty than developing countries.
Cameron described critical care archetypes on a two-axis model, with the first axis comparing interventionism(early, aggressive treatment) versus minimalism (’wait and see’) preferences, and the second axis measuring individualism versus collectivism [74]. In this model, the FLCCC appeared high on interventionism and individualism. The ’mainstream’, for example the World Health Organization and national authorities, appeared high on minimalism and collectivism.
During the whole pandemic (and before it), little to no attention was paid to the optimization of innate immunity. If the immune system is dysfunctional or in a suboptimal state, attempts at medicating symptoms including symptoms of SARS-CoV-2 infection are unlikely to be very effective, and the same likely applies to vaccines. While the role of zinc was acknowledged to some degree, the roles of, for example, copper, selenium and iodine were still mostly ignored. Conventionally, a long-term zinc supplementation without simultaneous copper supplementation is considered a risk for development of copper deficiency which would compromise immune function and host defence [394]; FLCCC recently lowered the dose of zinc supplementation. Astudy on European populations found a positive correlation between zinc sufficiency status and COVID-19mortality and incidence, contrary to what would be expected if zinc sufficiency was protective in COVID-19[326]; however, the result might also indicate lack of zinc ionophores.
Suggested solutions
In addition to the methodological issues there were other types of challenges to overcome. Considering that the nature of communication between parties involved in the ivermectin controversy was predominantly ofa rather violent nature, a method for improving communications would be needed. A suitable method forthe purpose may be the rather well known but rarely applied ’non-violent communication’ (NVC) method developed by Marshall Rosenberg [395,396]. The method presupposes a willingness to a certain degree ofvulnerability in order to express one’s real needs and feelings, and a willingness to actually listen to others without judging.
The method consists of two parts: expressing oneself, and empathically acknowledging others. NVC defines empathy as ’a process of connecting with another by guessing their feelings and needs’ [397]. Friesem describes the expressing part as a sequence of four steps: making observations (not evaluations) without blaming or criticizing, connecting feelings (bodily sensations instead of thoughts) to these observations, expressing the needs/values (not preferences) that caused the feelings, and making requests (concrete actions instead of vague wishes) without demanding [398]. The listening part consists of the same steps but the expressions use the pronoun ’you’ instead of ’I’. The four components are thus expressed as ’when I/you see/hear. . . ’(observation), ’I/you feel. . . ’ (feeling), ’. . . because I/you need/value. . . ’ (need), and ’would you be willing to/would you like. . . ’ (request).
The content must be as free from interpretations as possible, instead expressed in a neutral ’observation anguage’. Feelings, which are functions of the states of satisfaction of various needs, must be identified, named, connected with, and expressed without interpretation. Needs must be distinguished from strategies(strategies include objects and parameters while needs do not). Requests are aimed at assessing how likelyone is to get cooperation for particular strategies for meeting one’s needs; requests should be concrete and specific. Pandemic-specific examples are left as an exercise for the reader. With regard to therapeutics research, it might be worth a try to organize a conference whose participants would be required to find at least one detail they could agree on and then build on that foundation.
Considering that the communications at times appeared hopelessly dysfunctional, more potent methods are likely also needed. To a large extent, the damage associated with the pandemic was not caused by the virus itself but by a preexisting societal conditioning to fixed beliefs and subconscious biases which eventually led to disorganized and dissociative behavior. This ’inflexible disorganization’ subsequently created a massive amount of additional anxiety, burnout and depression.
Psychedelic therapy, currently maybe the second most trendy research subject after COVID-19 itself, wouldlend itself well for resolving these issues [399,400,401,402,403,404]. Psychedelics are likely the most effectivefacilitator of inspection of subconscious biases and fixed beliefs, and as such a valuable tool especially forscientists. Smaller doses may be preferable; this practice is called psycholytic therapy. It differs from the so-called ’microdosing’ in that doses are typically approximately a half or a third of a regular dose, and the effects of the substance are clearly perceived but different from those of high-dose psychedelic therapy.
Subconscious biases could be said to be a type of dissociative phenomena, in which a trigger related to a previous experience of overwhelming trauma triggers a slight dissociation, or a ’defence mechanism’. The mechanism of action of psychedelics in this case, in short, is to enable a person to relive the traumatic experience in order to neutralize the trigger. This must be done in an environment which provides thenecessary support so that the experience would not be experienced as overwhelming once again, as that would constitute a retraumatizing experience. Although various psychedelics produce slightly different effects, all of them would be useful for this kind of work. This includes also substances not always considered psychedelics,namely MDMA which is often called an ’empathogen’, and ketamine, often called a ’dissociative’.
Thus, an available pharmacological method would be off-label ketamine [405,406,407]. A trial by Federet al. compared treatment of post-traumatic stress disorder with either midazolam or ketamine (n=30)(NCT02397889) [408,409,410]. The mean score on the clinician-administered PTSD Scale for DSM-5(CAPS-5) was reduced from 40.1 to 33.2 in the midazolam group, and from 41.9 to 22.5 in the ketaminegroup. A similar reduction was observed for depressive symptoms.
A recent example of conflict resolution through altered states of consciousness, with promising results, was an attempt to alleviate the Israeli-Palestinian conflict by organizing ayahuasca group ceremonies [411].
The essence of psychedelic therapy, however, are not the molecules but the ’states of consciousness’, or states of mind, or emotional states, reached with the help of the molecules; change, progress or ’healing’ happens in or through these states. The same states may also be reached by other methods, although psychedelics provide a shortcut in situations in which there is a lack of time, skill or resources; the cost-effectiveness of psychedelic therapy is typically superior to other methods.
Non-pharmaceutical methods capable of inducing altered states include holotropic breathwork developed by Stanislav and Christina Grof [412]. Holotropic breathwork consists of continuous forceful circular breathing,combined with some bodywork and other techniques for guidance. The breathing technique leads to changes in oxygenation and typically to altered states of consciousness with the potential of resolving embodied traumatic experiences or opening new perspectives to overcome fixed beliefs. Grof developed the method as an alternative to LSD therapy sessions and has described the states and results as similar. A gentler approach from Buddhist traditions, also applicable to trauma therapy, is the Ch¨od method based on visualization[413,414].
The Wim Hof method is applicable for innate immune system enhancement [415]. In 2014, Kox et al.proved that sympathetic nervous system and immune system can be voluntarily influenced, and that itis possible to attenuate the innate immune response in humans [416,417]. Healthy volunteers practicing specific breathwork (hyperventilation), meditation and cold exposure techniques exhibited profound increases in the release of epinephrine, which in turn led to increased production of anti-inflammatory mediators and subsequent dampening of the proinflammatory cytokine response elicited by intravenous administration ofbacterial endotoxin. The Wim Hof method has numerous advantages: it is free, available to everyone,unlikely to produce adverse effects, and unconnected to health care systems and clinicians.
Conclusions
Similarly to SARS-CoV-2 virus emerging as a possibly inexhaustible source of ever more infectious variants,the issue of COVID-19 treatments emerged as a possibly inexhaustible source of increasingly complex epistemological challenges. Current best practices of clinical trial result meta-analysis were found to be unsound;methodological changes were proposed. More broadly, the whole approach based on sole reliance on single agent clinical trials that no-one really wanted to fund appeared fundamentally unsound. The pandemic also revealed various severe problems with mindsets and subconscious biases; methods to overcome these issues were also proposed. The impression of the ivermectin controversy as a whole was that what is ideally understood by science will remain out of reach if scientists are riddled with subconscious biases, methodologies are fundamentally unsound, commercial interests dominate, and the behavior more closely resembles tribal warfare than a silent meditation retreat.
Authors’ contributions
The author was responsible for all aspects of the manuscript.
Funding
This research did not receive any specific grant from funding agencies in the public, commercial, or not-for-profit sectors.
Availability of data and materials
Not applicable.
Ethics approval and consent to participate
Not applicable.
Consent for publication
Not applicable.
Competing interests
The author declares that he has no competing interests.
Author details
Independent researcher, Helsinki, Finland. ORCID iD: 0000-0002-8575-9838
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Khan MM, Parab SR, Paranjape M. Repurposing 0.5% povidone iodine solution in otorhinolaryngology practice in Covid 19 pandemic. American Journal of Otolaryngology 2020;41(5):102618. https://doi.org/10.1016/j.amjoto.2020.102618
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STATE OF MAINE SUPERIOR COURT
KENNEBEC, ss. CIVIL ACTION
DOCKET NO. CV-21-158
COALITION FOR HEALTHCARE
WORKERS AGAINST MEDICAL
MANDATES, et al,
Plaintiffs
v.
JEANNE M. LAMBREW and
NIRAV D. SHAH,
Defendants
AFFIDAVIT OF DR. MERYL JAE NASS, M.D.
IN REBUTTAL TO NIRAV DINESH SHAH, M.D., J.D.
(The graphics and footnotes are missing. I will try to provide them later.)
BEFORE ME, the undersigned person, duly authorized to administer oaths, personally appeared, Dr. Meryl J. Nass, M.D., J.D., who, after being first duly cautioned and sworn, deposed and stated as follows:
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My name is Meryl Jae Nass, M.D. I practice internal medicine in Ellsworth, Maine.
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I have a Bachelor's degree in Biology from the Massachusetts Institute of Technology.
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I attended New Jersey Medical School and transferred to the University of Mississippi Medical School when my husband became a professor there. I received my medical degree from the University of Mississippi and did a residency in internal medicine there.
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I am board certified in internal medicine.
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In addition to a 40 year career practicing medicine, I developed expertise in the identification, response and amelioration of bioterrorism and pandemic diseases, Gulf War syndrome, anthrax, and in the evaluation of vaccines and vaccine safety.
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I am the first person in the world to have investigated an outbreak and proved it was due to biological warfare. The outbreak occurred in Zimbabwe (then Rhodesia) during its civil war in 19978-80, and my research was published in 1992. I have been referred to as a "biowarfare epidemiologist" ever since.
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I was a consultant to the Ministry of Health of Cuba in 1993 regarding an epidemic of optic and peripheral neuropathy, correctly diagnosing it as the result of cyanide exposure coupled with nutritional deficiency and advising on mitigation strategies.
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I am considered an expert on the anthrax letters attacks of 2001 and the anthrax vaccine. I consulted for the World Bank's Interamerican Development Bank in 2002 regarding the evaluation and amelioration of anthrax and other potential bioterrorism and chemical weapon events.
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I consulted for the U.S. Director of National Intelligence regarding the prevention and identification of domestic terrorism events, in 2008.
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I have given requested testimonies to six different Congressional committees between 1999 and 2007.
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I have provided expert testimony to two National Academy of Science committees and to a UK committee headed by its Law Lord investigating Gulf War syndrome.
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While I have testified to state legislative committees on a variety of medical issues, in recent years I have testified in Vermont, Massachusetts, New Brunswick and Maine on the specific issue of vaccine mandates.
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Since the 2020 start of this pandemic, I have been providing almost daily information and analysis to the public on all aspects of the pandemic, the pandemic response, potential COVID-19 treatments and vaccines. This information is posted on my website. Many of my articles have been reposted on other websites. I have also written original articles for websites and magazines. I have written the most comprehensive article on the deliberate suppression of hydroxychloroquine for the treatment of COVID, to date. I edited one Citizen Petition to the Food and Drug Administration ("FDA") regarding the polymerase chain reaction ("PCR") tests that have been used to diagnose COVID-19, and I coauthored another Citizen Petition to the FDA challenging its response to the pandemic and its issuance of Emergency Use Authorizations ("EUA") for COVID-19 vaccines.
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I have been interviewed by all major US newspapers and TV networks, as well as by many alternative media.
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I am listed in Who's Who in America and Who's Who in the World.
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The COVID-19 pandemic is due to a coronavirus which most likely was developed at the Wuhan Institute of Virology laboratory, in collaboration with Professor Ralph Baric of the University of North Carolina. This research was partly funded by U.S. federal agencies, especially the National Institute of Allergy and Infectious Disease, which has devoted up to 51 million dollars/year to coronavirus research over the past 20 years, preceding the current pandemic.
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I was asked to review and comment on Dr. Nirah Shah's affidavit and the following remarks provide my response to his statements. Unless stated otherwise, when I use the term "CDC" in the following discussion, it refers to the federal Center for Disease Control and Prevention in Atlanta, GA and not the Maine CDC, which Dr. Shah directs.
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Dr. Nirav Shah is incorrect in his discussion of the means of spread (#17) of SARS-CoV-2, the virus said to cause the disease called COVID-19. He has omitted aerosol spread, in which particles much smaller than droplet size can travel across a building and cause infection at a distance far greater than six feet. This is well known in the scientific literature, and it is the reason the CDC advised improved ventilation and opening windows to reduce the burden of virus suspended in air, potentially for hours. Even coughing and sneezing have been shown to spread droplets over a distance exceeding 20 feet.
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The so-called Delta variant (#22) is defined differently in different countries. There is not just one Delta variant, because coronaviruses are continuously mutating. It is true that current variants, which the CDC defines as one entity, are more contagious than earlier variants. While some cases are indisputably very severe, detailed information from the United Kingdom ("UK") regarding 7 different variants that are being closely observed has revealed that overall, the Delta variant has the lowest mortality rate of all. For most individuals it is less severe. For some it is more severe than earlier variants.
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It is true that the CDC has claimed that unvaccinated Americans are much more likely to be hospitalized than vaccinated Americans. However, data from the UK and Israel fail to confirm this. In fact, Israeli statistics show that both vaccinated and unvaccinated individuals are approximately equally likely to be hospitalized for COVID at the present time.
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This Israel Ministry of Health graph makes this clear. While the number of cases was approximately the same in the vaccinated and the unvaccinated, there were nearly twice as many vaccinated Israelis hospitalized as unvaccinated Israelis. Israel used the Pfizer vaccine almost exclusively.
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The UK data tracks the Israeli data, and can be found at: https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/1018547/Technical_Briefing_23_21_09_16.pdf
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How is it that the federal CDC and Dr. Shah can claim otherwise? Unfortunately, the CDC is captured by pharmaceutical companies, which donate to the CDC Foundation.
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CDC produces data that invariably support Executive branch policies. Dr. Shah is a liaison representative for CDC's Advisory Committee on Immunization Practices and hews closely to the CDC's talking points.
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CDC has employed several strategies to reduce artificially the number of reported breakthrough cases, and I have written about most of these. On May 1, 2021, the CDC stopped accepting reports of breakthrough (fully vaccinated but infected) cases from states and hospitals unless these cases died or were hospitalized and had been proven to be positive for COVID by using a PCR test with a strict cycle threshold of 28 or less. Unvaccinated cases, however, could be diagnosed using a highly permissive cycle threshold of 40 or even 45, even though Dr. Tony Fauci himself pointed out early in the pandemic that at cycle thresholds over 35, all you were finding were "dead nucleotides" rather than evidence of live virus.
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Furthermore, CDC defines patients as fully vaccinated only two weeks after their final vaccination. Americans who developed COVID-19 between vaccine doses or before two weeks had elapsed after their last dose were defined as not fully vaccinated, and in some circumstances as unvaccinated.
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CDC also employs a leaky method of collecting cases from hospitals, as described in a recent article in Politico.
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Unless patients have their vaccination status clearly listed in their hospital record, they are probably going to be classified as unvaccinated. Hospital reporting of breakthrough cases to CDC is extremely patchy.
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Unfortunately, while over 6,000 reports of U.S. deaths following vaccination have been submitted to the VAERS system, managed jointly by the FDA and CDC, 80% occurred within 2 weeks of a vaccination. It seems the CDC may be defining them as deaths in the unvaccinated. Otherwise it is difficult to understand how CDC claims none have been proven to be caused by vaccination. This CDC conclusion flies in the face of studies by a prominent pathology professor in Germany who found, based on autopsy studies he conducted, that 30-40% of deaths occurring soon after a COVID-19 vaccination were due to the vaccine.
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Dr. Shah (#27) stated that the treatment of COVID-19 consists mainly of supportive care. While the federal CDC and recent NIH guidelines have made this claim, it is not supported by the medical literature, including the literature generated by these two agencies. CDC and NIAID have known about the benefits of chloroquine drugs for coronaviruses for many years. Hydroxychloroquine, chloroquine and ivermectin are very effective treatments for COVID when used early, during the first week of illness. The effectiveness of chloroquine antimalarial drugs (chloroquine, hydroxychloroquine and mefloquine) against coronaviruses, especially SARS-1 and MERS, was known by the CDC and NIH long before the current pandemic, since papers were published beginning in 2004 through 2014 about their success, in vitro, using acceptable doses against these deadly viruses.
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Remdesivir (#28) is a controversial drug that the US Department of Veterans Affairs found did not improve mortality and extended length of hospital stay in a recent study.
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Remdesivir was ushered through its pivotal trial by NIAID Director Tony Fauci, and only succeeded because the desired endpoint was changed during the study, not once but twice.
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The NIH Guidelines committee, formed by NIAID, included 16 members with financial conflicts of interest with Gilead, the maker of Remdesivir. This is the most likely explanation for why this committee supported the use of Remdesivir but failed to support its competitors ivermectin and hydroxychloroquine.
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The W.H.O. recommends against the use of Remdesivir for COVID.
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Hydroxychloroquine (#32), as I noted above, was known to be effective against SARS coronaviruses since 2004. Vast efforts were put in place at the start of the current pandemic to prevent its use for COVID-19. These efforts included using borderline lethal doses of the drug in several large clinical trials, and using too low a dose in others. Starting the drug in hospital, when viral replication was already over and the disease process was later due to autoimmunity, cytokine storm and thromboses, was a guaranteed way to demonstrate lack of efficacy, since the drug only acted to stop the growth of virus. The NIAID promised a large study of outpatient use in 2,000 patients early in the illness, then inexplicably cancelled the trial after only 20 subjects had been enrolled.
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Early treatment works, as evidenced by the forest plot meta-analysis below:
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Importantly, there is suggestive evidence that hydroxychloroquine is also effective for prophylactic use. The biggest study in this regard is COPCOV MORU, undertaken by Oxford University professor Nicholas White in countries around the world. The study is not yet completed. The principal investigators felt it important to dispel the myth that hydroxychloroquine was ineffective for prevention of COVID, and posted a critique of the flawed methodologies used in studies that claimed this.
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Dr. Shah claims (#34) that Vitamin D has failed to show effectiveness in the treatment of COVID. However, a compilation of the studies (which can be found at vdmeta.com) on Vitamin D shows otherwise:
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Ivermectin (#35-37) is a very useful drug in the treatment of COVID that I use regularly. It is highly effective, as shown in the following meta-analysis for early treatment, in which only 4 of 28 studies failed to show benefit. While Dr. Shah correctly notes that Merck, which developed the drug and got a Nobel prize for it in 2015, has advised against its use, he failed to tell you that Merck has developed a new drug for COVID, Molnupiravir, which will compete with ivermectin for market share. Ivermectin is a cheap, off-patent generic drug. According to the Washington Post, "The U.S. government made an advance purchase of 1.7 million treatment courses of the drug [Molnupiravir] at a cost of $1.2 billion."
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It should be obvious from the forest plot below that ivermectin shows strong evidence of efficacy for COVID-19.
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Ivermectin is on the WHO list of essential drugs. Over 3 billion doses have been used, and Merck has donated most of them to Africans in a joint venture with the WHO to prevent onchocerciasis, or River Blindness. It is used over the counter and is an exceedingly safe drug.
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Only because Americans have been stopped from obtaining the drug through normal means have some sought to buy a veterinary version over the counter in farm stores. There has not been a single reported death in the US from such irregular use of the drug, nor from its use as prescribed.
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Dr. Shah is probably aware that the Maine Board of Pharmacy recently encouraged pharmacists to refuse to dispense ivermectin. Dr. Shah was perhaps instrumental in encouraging the Maine Board of Pharmacy to interject itself and interfere with the doctor-patient relationship when it comes to doctors prescribing human ivermectin.
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A few overdoses by consumers of animal ivermectin became the justification to refuse legitimate prescriptions for the pharmaceutical drug ivermectin. This does not make sense. FDA has used the same rationale to discourage physicians from prescribing it. Apparently conflating safe physician prescriptions with overdosing on over-the-counter horse paste was the best excuse CDC and FDA could come up with to issue warnings and proscriptions for legitimate prescriptions.
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It seems ingenuous of Dr. Shah to note that ivermectin "carries a risk of side effects when not dosed properly." So do all drugs:
"Nearly 500 years ago, Swiss physician and chemist Paracelsus expressed the basic principle of toxicology: “All things are poison and nothing is without poison; only the dose makes a thing not a poison.”
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It is the actions of public health officials such as Dr. Shah to prevent patients from obtaining effective COVID-19 drugs that have led patients to seek out inferior veterinary products, because they cannot obtain this potentially life-saving medicine from their physicians and pharmacies due to interference by public health authorities. It has now become impossible for me to obtain the drug for my patients in a timely manner when they develop COVID-19. This is criminal negligence or worse, in my opinion.
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U.S. public health professionals, including Dr. Shah, created an artificial shortage of a drug that is most effective at treating COVID-19. Then they used the fact that desperate patients have purchased the animal medication as their justification for stopping use of the drug. I am not an attorney like Dr. Shah, but this seems to me to be criminal behavior, which will predictably result in patient deaths.
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Regarding the prophylactic use of ivermectin (#37), the data are highly supportive. Many US physicians have used it to prevent infection in themselves. A meta-analysis of prophylaxis studies of ivermectin reveals that using ivermectin reduces your risk of developing COVID-19 by 86%. Why did Dr. Shah say "there are no data supporting the use of ivermectin as a prophylactic for those who have been exposed" unless he was aware that there is a plethora of literature regarding the benefit of the drug in those using ivermectin before they were exposed--and he wished to avoid including these studies? Should we refer to his carefully chosen verbiage as legalese or sophistry? Regardless, neither befits a physician who has taken the Hippocratic oath and whose primary responsibility is to heal patients, not hinder their care.
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Dr. Shah claims that taking ivermectin "does not reduce the risk of transmission of COVID-19 in the way a vaccine does." This is a spurious claim, since I have shown that the drug is about 86% effective in preventing infection. Preventing infection prevents transmission.
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The COVID vaccines, on the other hand, do not claim to stop transmission. Currently the head of the federal CDC says they prevent severe illness but no longer prevent infection or transmission.
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A large outbreak of COVID-19 in July in Banstable County, MA that was well documented in the CDC publication Morbidity and Mortality Weekly Review revealed that 74% of COVID cases were fully vaccinated according to the CDC definition. Cycle thresholds, used as a surrogate for viral titers and infectivity, were the same in both vaccinated and non-vaccinated cases. Breakthrough cases (a.k.a. vaccine failures) had received each of the 3 vaccines types authorized for use in the US.
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This extremely well done study provides solid evidence that vaccination did not and cannot break the chain of transmission and cannot generate herd immunity. Surely Dr. Shah is familiar with this widely read report by CDC, MIT, Harvard and the Massachusetts Department of Public Health.
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Regarding calls to poison control centers, it appears that the Associated Press was given false information. It claimed that 70% of calls to the Mississippi poison control center were about ivermectin. However, the story was later corrected, when Mississippi's state epidemiologist said ivermectin calls only accounted for about 2% of total calls.
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Additional false information regarding overdoses of ivermectin in Oklahoma made the international news, only to be later corrected as false news.
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Both ivermectin and hydroxychloroquine are WHO essential drugs that are used over the counter in much of the world. Both are considered extremely safe when taken at recommended doses. Hydroxychloroquine is even recommended during pregnancy.
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Dr. Shah makes an interesting point in #38, in which he compares ivermectin and hydroxychloroquine prophylaxis with the prophylaxis gained through COVID-19 vaccination. Why compare them to each other? Dr. Shah is in fact addressing a statutory problem for the vaccine EUAs that was posed by the 2 mentioned drugs. Each of these drugs has an extremely long half-life in tissue (probably greater than a month) and therefore each is used routinely for prophylaxis of (respectively) river blindness and malaria. Were they to be used in this way to prevent COVID-19, and if their success at preventing and treating COVID-19 was acknowledged, no EUAs could have legally been issued for other, more expensive on-patent drugs and vaccines. In order to issue an EUA there must be "no adequate, approved, and available alternatives."
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Had our federal public health agencies acknowledged that ivermectin and hydroychloroquine were effective prophylactics and treatments for COVID-19, no EUAs for remdesivir, monoclonal antibodies, other drugs, convalescent sera, and vaccines could have legally been issued. This appears to be the primary reason that knowledge about and use of these drugs has been suppressed. The fact that Dr. Shah raised the issue suggests he is well aware of this legal matter and is actively involved in these drugs' suppression.
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In #39, Dr. Shah admits foreknowledge about these drugs before promulgating the Emergency Rule, Immunization Requirements for Healthcare Workers, 10-144 Code of Maine Rules, Chapter 264. One wonders what information he used to draw his conclusions, when the bulk of the published literature, as I have shown, suggests he should have drawn a very different conclusion about the respective benefits of these drugs versus COVID-19 vaccines. His claims are belied by the evidence.
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In #38, Dr. Shah alleges that the drugs produce more side effects than the vaccines. This is untrue. One need only look at reports of myocarditis in boys aged 12-17 after COVID-19 vaccination: they report myocarditis cases at a rate 50 times that of men over 65. FDA's Doran Fink noted at the last CDC Advisory Committee on Immunization Practices meeting that we do not know the rate of subclinical myocarditis caused by the COVID-19 vaccines. Furthermore, FDA admitted in its letter to Pfizer on August 23, 2021 that it was unable to determine the extent of myocarditis from Pfizer's vaccine, and would be unable to do so in future as well.
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We also do not know the rate of thrombosis, heart attacks and strokes after vaccination, but reports to VAERS suggest they are high following COVID-19 vaccinations. We do know that anaphylaxis rates after the mRNA vaccines are about 100 times higher than expected from other vaccines, based on a Harvard study of employees at Mass General Hospital and the Brigham Hospital. No wonder the vaccines must be given only when resuscitation equipment and staff are on site.
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I agree that safe and effective vaccines are a marvelous achievement of mankind and have made a huge difference in our quality of life and our longevity.
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Herd immunity is achieved when a population is sufficiently immune (due to cross-immunity from related infections, recovered immunity from having had the disease, or vaccine-induced immunity) that it no longer supports continuing transmission of an infectious agent and an outbreak ends or never gets started. The definition of immunity inexplicably changed in the past year in some places to exclude the first two types of immunity I mentioned. This definitional change, used by Dr. Shah in #41, is duplicitous and unscientific. The definitions in my medical textbooks accord with what I have written above.
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In number #43, Dr. Shah reveals he is not very cognizant of the details regarding vaccine induced immunity. Immunity from the Mumps and chickenpox vaccines probably never reaches 90-92%, or if it does, does not remain there for long. Most chickenpox cases in the U.S. occur in vaccinated children whose immunity has waned over time. The same is true for mumps. Rubella vaccine is probably more effective, as there is no transmission of rubella within the U.S. Measles vaccine was thought to provide very high protection, but it too wanes over time. That is why we now give 2 or 3 MMR vaccines to children, when initially it was believed one alone would convey life-long immunity.
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If COVID-19 vaccines provided strong and long-lasting immunity from infection and transmission, and were very safe, then Dr. Shah would be correct in statement #44. But unfortunately, the vaccines fail to prevent transmission, as admitted by federal CDC Director Walensky and a recent CDC publication.
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Their protection wears off quickly, and they have profound safety problems. Had they undergone the normal FDA approval process rather than a "warp speed" simulation of a rigorous approval process, they would never have been licensed or used beyond the clinical trials. The asymptomatic spread of COVID-19 was the basis for locking down and restricting the basic liberties of all of Maine's citizens, even the healthy, for over a year. But the makers of the COVID-19 vaccines state that they only reduce symptoms, rather than conferring immunity, or preventing infection or transmission. Vaccines for COVID-19 provide us with a charade of protection and a charade that the vaccinated cannot be asymptomatically infected and transmitting virus to patients. If the vaccines reduce symptoms but not infection or viral load (as suggested by a rigorous study in a hospital in Vietnam) then vaccinated individuals may actually be more likely to spread the disease than the unvaccinated.
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We simply do not know if this is the case in the U.S., due to CDC's successful efforts to corrode the statistics on cases, hospitalizations and deaths.
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The bottom line is that even if everyone in the U.S. was vaccinated, the flaws in the vaccines and the leaky protection they convey would prevent us ever achieving high levels of population immunity. Dr. Shah pretends that the COVID-19 vaccines work as well as the measles vaccine. But they most certainly do not. The massive numbers of "breakthrough" cases (which used to be called "vaccine failures") in the UK and Israel, with vaccination rates in their populations higher than ours, make clear that high rates of vaccination are not the solution to the spread of COVID-19. This is why the U.S. government just spent 1.2 billion dollars on Merck's Molnupiravir pill. For treatment. Federal agencies have begun to acknowledge that vaccinations will not end the pandemic. It seems Dr. Shah has not kept up with recent policy changes.
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Regarding #52, I have reviewed the Pfizer filing to the European Medicines Agency and the Japanese agency. In them, I learned that Pfizer's lipid nanoparticle contains two novel ingredients, not used previously in any vaccines. I believe Dr. Shah is grossly mistaken regarding his assurance that these ingredients are commonly used. While PEG is commonly used, it is also the cause of life-threatening anaphylactic reactions, which Dr. Shah fails to acknowledge.
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Furthermore, FDA and CDC have access to over a dozen databases from which calculations of vaccine safety should be derived. However, the public has only been given information from VAERS, V-safe and the VSD. Inappropriate algorithms have been employed by CDC and FDA to analyze the data.
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As I noted earlier, FDA instructed Pfizer on August 23, 2021 that its surveillance systems are unable to assess the risk of myocarditis from Pfizer's vaccine, and therefore FDA asked Pfizer to assess the risk. Pfizer has reported anticipated earnings from its COVID-19 vaccines in 2021 of $33 billion dollars. Do you think Pfizer will identify a problem with myocarditis under these circumstances?
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Regarding #54-63, it is certainly true that COVID-19 continues to spread in Maine, although given the federal CDC's idiosyncratic method of counting breakthrough cases in the vaccinated, there are doubts about the veracity of the statistics Dr. Shah provides. I agree that the methods that have been employed for the past 1.5 years, including injection with the COVID-19 vaccines, have not worked very well. Why are we continuing to use them?
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Why are we continuing to prevent the use of medications that appear to be much more effective than the COVID-19 vaccines?
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Why are so many healthcare workers still unvacccinated? The simple answer is that they are the people seeing the side effects from these vaccines. Healthcare workers are required to be vaccinated with many vaccines. They have never refused in large numbers like this before. They get yearly flu shots, and must have had the childhood shots and a hepatitis B series.
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Why do 10-15% of those who got the first mRNA shot fail to return for the second shot? This does not happen with other vaccines. Clearly, thousands of Maine healthcare workers have direct knowledge of something that is being denied by our public health professionals. Why else would so many healthcare workers give up their careers, when they will go to less prestigious and remunerative jobs instead?
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The Emergency Rule was promulgated in the absence of science, common sense, and a review of the existing literature on COVID-19. This is what happens when there are no checks and balances in the system, no legislative involvement, and our unelected public health professionals (who do not treat patients and may not even be physicians) are allowed to rule by fiat.
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While they may, as Dr. Shah has, try to hide behind claims that they are acting to protect patients, healthcare workers, the healthcare infrastructure and reduce facility outbreaks, all 4 claims are fraudulent.
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Clearly the infrastructure will be hard hit when 10 or 20% of healthcare workers are fired from their jobs. How does Maine CDC propose to ameliorate this mess and keep the infrastructure functioning?
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How does Maine CDC propose to rebuild relationships with healthcare workers after imposing this draconian and scientifically insupportable mandate on them? Trust is gone.
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Why has the administration of Governor Janet Mills made it impossible to use hydroxychloroquine for prophylaxis of COVID-19? Why has it warned pharmacists not to dispense ivermectin? Are these the acts of an administration concerned with the health of the public and its healthcare workers? Or are these political acts that resulted from backroom deals to promote expensive but poorly effective drugs and vaccines--and the only way to do so is to suppress the already licensed, safe, cheap and effective treatments?
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Furthermore, the FDA has allowed COVID-19 vaccine manufacturers to use antibody tests to determine immunity from previous infections in subjects in clinical trials. FDA accepts these results as valid. However, regular Americans are not being allowed to use a single test (and there are dozens available) to demonstrate that they are already immune, and would obtain no benefit from vaccination, only risk of an adverse event. The new technical procedural rulemaking being undertaken by Maine's Department of Health and Human Services to finalize the Emergency Rule expressly eliminates "proof of immunity" as a basis for exemption from the COVID-19 mandate. Why have the federal government and the Maine CDC and DHS adopted a new definition of immunity, reminiscent of Orwell's book 1984, that precludes immunity from prior infections? 2 + 2 = 5? This is nonsensical. It only makes sense if the inexorable drive to vaccinate everyone, regardless of their immune status, is being done for an ulterior motive. That motive might be to gain obeisance. It might be to justify vaccine passports. We simply do not know why it is being done. But we must not ignore these vitally important questions, simply because they are uncomfortable or run counter to a prevailing narrative.
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#72, which claims that prior immunity resulting from a COVID-19 infection is uncertain, is a gross falsehood. There are now dozens of studies that show immunity after COVID-19 infection is strong, durable and long-lasting. There are just as many studies showing that the immunity obtained from existing vaccines is neither durable nor long-lasting.
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But what we do know is that forcing immune Americans to be vaccinated with a risky vaccine is not medicine. It is the antithesis of medicine.
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Testing alone is not the solution either. The tests are not perfect. One UK study showed that rapid tests might be only 58% accurate and it was suggested that they are not ready for use. However, they were rolled out anyway, in the UK and here, despite widespread knowledge of their flaws. Why were millions of tests thrown away at the Abbott plant in Westbrook? We have not been told the reason, and only learned of this when concerned employees told the press about it.
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The solution to the pandemic has been known since 2004. It was demonstrated by CDC scientists in 2005, and by NIAID scientists in 2014. No doubt they have access to chloroquine and/or ivermectin drugs for their families. Recall that during Senate testimony 2 months ago, we learned that only about 60% of CDC, FDA's CBER and NIAID employees had been vaccinated.
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Dr. Shah's affidavit is a tissue of lies that are consistent with the lies promulgated by federal agencies. Perhaps that is why he failed to cite a single reference to back up the claims in his affidavit. Unfortunately, these lies have created a huge rift between our patients and our medical establishment. They are about to create a crisis in healthcare when many healthcare workers have their employment terminated. These lies have led to a prolongation of the pandemic and a steep increase in morbidity and mortality.
Maine deserves and can do a lot better than this.
This is an anonymously posted document by someone who calls themselves Spartacus. Because it’s anonymous, I can’t contact them to ask for permission to publish. So I hesitated for a while, but it’s simply the best document I’ve seen on Covid, vaccines, etc. Whoever Spartacus is, they have a very elaborate knowledge in “the field”. If you want to know a lot more about the no. 1 issue in the world today, read it. And don’t worry if you don’t understand every single word, neither do I. But I learned a lot.
The original PDF doc is here was here: Covid19 – The Spartacus Letter
See also: References for "Spartacus" Anonymous COVID9 whistleblower document
Hello,
My name is Spartacus, and I’ve had enough.
We have been forced to watch America and the Free World spin into inexorable decline due to a biowarfare attack. We, along with countless others, have been victimized and gaslit by propaganda and psychological warfare operations being conducted by an unelected, unaccountable Elite against the American people and our allies.
Our mental and physical health have suffered immensely over the course of the past year and a half. We have felt the sting of isolation, lockdown, masking, quarantines, and other completely nonsensical acts of healthcare theater that have done absolutely nothing to protect the health or wellbeing of the public from the ongoing COVID-19 pandemic.
Now, we are watching the medical establishment inject literal poison into millions of our fellow Americans without so much as a fight.
We have been told that we will be fired and denied our livelihoods if we refuse to vaccinate. This was the last straw.
We have spent thousands of hours analyzing leaked footage from Wuhan, scientific papers from primary sources, as well as the paper trails left by the medical establishment.
What we have discovered would shock anyone to their core.
First, we will summarize our findings, and then, we will explain them in detail. References will be placed at the end.
Summary:
- COVID-19 is a blood and blood vessel disease. SARS-CoV-2 infects the lining of human blood vessels, causing them to leak into the lungs.
- Current treatment protocols (e.g. invasive ventilation) are actively harmful to patients, accelerating oxidative stress and causing severe VILI (ventilator-induced lung injuries). The continued use of ventilators in the absence of any proven medical benefit constitutes mass murder.
- Existing countermeasures are inadequate to slow the spread of what is an aerosolized and potentially wastewater-borne virus, and constitute a form of medical theater.
- Various non-vaccine interventions have been suppressed by both the media and the medical establishment in favor of vaccines and expensive patented drugs.
- The authorities have denied the usefulness of natural immunity against COVID-19, despite the fact that natural immunity confers protection against all of the virus’s proteins, and not just one.
- Vaccines will do more harm than good. The antigen that these vaccines are based on, SARS-CoV-2 Spike, is a toxic protein. SARS-CoV-2 may have ADE, or antibody-dependent enhancement; current antibodies may not neutralize future strains, but instead help them infect immune cells. Also, vaccinating during a pandemic with a leaky vaccine removes the evolutionary pressure for a virus to become less lethal.
- There is a vast and appalling criminal conspiracy that directly links both Anthony Fauci and Moderna to the Wuhan Institute of Virology.
- COVID-19 vaccine researchers are directly linked to scientists involved in brain-computer interface (“neural lace”) tech, one of whom was indicted for taking grant money from China.
- Independent researchers have discovered mysterious nanoparticles inside the vaccines that are not supposed to be present.
- The entire pandemic is being used as an excuse for a vast political and economic transformation of Western society that will enrich the already rich and turn the rest of us into serfs and untouchables.
COVID-19 Pathophysiology and Treatments:
COVID-19 is not a viral pneumonia. It is a viral vascular endotheliitis and attacks the lining of blood vessels, particularly the small pulmonary alveolar capillaries, leading to endothelial cell activation and sloughing, coagulopathy, sepsis, pulmonary edema, and ARDS-like symptoms. This is a disease of the blood and blood vessels. The circulatory system. Any pneumonia that it causes is secondary to that.
In severe cases, this leads to sepsis, blood clots, and multiple organ failure, including hypoxic and inflammatory damage to various vital organs, such as the brain, heart, liver, pancreas, kidneys, and intestines.
Some of the most common laboratory findings in COVID-19 are elevated D-dimer, elevated prothrombin time, elevated C-reactive protein, neutrophilia, lymphopenia, hypocalcemia, and hyperferritinemia, essentially matching a profile of coagulopathy and immune system hyperactivation/immune cell exhaustion.
COVID-19 can present as almost anything, due to the wide tropism of SARS-CoV-2 for various tissues in the body’s vital organs. While its most common initial presentation is respiratory illness and flu-like symptoms, it can present as brain inflammation, gastrointestinal disease, or even heart attack or pulmonary embolism.
COVID-19 is more severe in those with specific comorbidities, such as obesity, diabetes, and hypertension. This is because these conditions involve endothelial dysfunction, which renders the circulatory system more susceptible to infection and injury by this particular virus.
The vast majority of COVID-19 cases are mild and do not cause significant disease. In known cases, there is something known as the 80/20 rule, where 80% of cases are mild and 20% are severe or critical. However, this ratio is only correct for known cases, not all infections. The number of actual infections is much, much higher. Consequently, the mortality and morbidity rate is lower. However, COVID-19 spreads very quickly, meaning that there are a significant number of severely-ill and critically-ill patients appearing in a short time frame.
In those who have critical COVID-19-induced sepsis, hypoxia, coagulopathy, and ARDS, the most common treatments are intubation, injected corticosteroids, and blood thinners. This is not the correct treatment for COVID-19. In severe hypoxia, cellular metabolic shifts cause ATP to break down into hypoxanthine, which, upon the reintroduction of oxygen, causes xanthine oxidase to produce tons of highly damaging radicals that attack tissue. This is called ischemia-reperfusion injury, and it’s why the majority of people who go on a ventilator are dying. In the mitochondria, succinate buildup due to sepsis does the same exact thing; when oxygen is reintroduced, it makes superoxide radicals. Make no mistake, intubation will kill people who have COVID-19.
The end-stage of COVID-19 is severe lipid peroxidation, where fats in the body start to “rust” due to damage by oxidative stress. This drives autoimmunity. Oxidized lipids appear as foreign objects to the immune system, which recognizes and forms antibodies against OSEs, or oxidation-specific epitopes. Also, oxidized lipids feed directly into pattern recognition receptors, triggering even more inflammation and summoning even more cells of the innate immune system that release even more destructive enzymes. This is similar to the pathophysiology of Lupus.
COVID-19’s pathology is dominated by extreme oxidative stress and neutrophil respiratory burst, to the point where hemoglobin becomes incapable of carrying oxygen due to heme iron being stripped out of heme by hypochlorous acid. No amount of supplemental oxygen can oxygenate blood that chemically refuses to bind O2.
The breakdown of the pathology is as follows:
SARS-CoV-2 Spike binds to ACE2. Angiotensin Converting Enzyme 2 is an enzyme that is part of the renin-angiotensin-aldosterone system, or RAAS. The RAAS is a hormone control system that moderates fluid volume in the body and in the bloodstream (i.e. osmolarity) by controlling salt retention and excretion. This protein, ACE2, is ubiquitous in every part of the body that interfaces with the circulatory system, particularly in vascular endothelial cells and pericytes, brain astrocytes, renal tubules and podocytes, pancreatic islet cells, bile duct and intestinal epithelial cells, and the seminiferous ducts of the testis, all of which SARS-CoV-2 can infect, not just the lungs.
SARS-CoV-2 infects a cell as follows: SARS-CoV-2 Spike undergoes a conformational change where the S1 trimers flip up and extend, locking onto ACE2 bound to the surface of a cell. TMPRSS2, or transmembrane protease serine 2, comes along and cuts off the heads of the Spike, exposing the S2 stalk-shaped subunit inside. The remainder of the Spike undergoes a conformational change that causes it to unfold like an extension ladder, embedding itself in the cell membrane. Then, it folds back upon itself, pulling the viral membrane and the cell membrane together. The two membranes fuse, with the virus’s proteins migrating out onto the surface of the cell. The SARS-CoV-2 nucleocapsid enters the cell, disgorging its genetic material and beginning the viral replication process, hijacking the cell’s own structures to produce more virus.
SARS-CoV-2 Spike proteins embedded in a cell can actually cause human cells to fuse together, forming syncytia/MGCs (multinuclear giant cells). They also have other pathogenic, harmful effects. SARS-CoV-2’s viroporins, such as its Envelope protein, act as calcium ion channels, introducing calcium into infected cells. The virus suppresses the natural interferon response, resulting in delayed inflammation. SARS-CoV-2 N protein can also directly activate the NLRP3 inflammasome. Also, it suppresses the Nrf2 antioxidant pathway. The suppression of ACE2 by binding with Spike causes a buildup of bradykinin that would otherwise be broken down by ACE2.
This constant calcium influx into the cells results in (or is accompanied by) noticeable hypocalcemia, or low blood calcium, especially in people with Vitamin D deficiencies and pre-existing endothelial dysfunction. Bradykinin upregulates cAMP, cGMP, COX, and Phospholipase C activity. This results in prostaglandin release and vastly increased intracellular calcium signaling, which promotes highly aggressive ROS release and ATP depletion. NADPH oxidase releases superoxide into the extracellular space. Superoxide radicals react with nitric oxide to form peroxynitrite. Peroxynitrite reacts with the tetrahydrobiopterin cofactor needed by endothelial nitric oxide synthase, destroying it and “uncoupling” the enzymes, causing nitric oxide synthase to synthesize more superoxide instead. This proceeds in a positive feedback loop until nitric oxide bioavailability in the circulatory system is depleted.
Dissolved nitric oxide gas produced constantly by eNOS serves many important functions, but it is also antiviral against SARS-like coronaviruses, preventing the palmitoylation of the viral Spike protein and making it harder for it to bind to host receptors. The loss of NO allows the virus to begin replicating with impunity in the body. Those with endothelial dysfunction (i.e. hypertension, diabetes, obesity, old age, African-American race) have redox equilibrium issues to begin with, giving the virus an advantage.
Due to the extreme cytokine release triggered by these processes, the body summons a great deal of neutrophils and monocyte-derived alveolar macrophages to the lungs. Cells of the innate immune system are the first-line defenders against pathogens. They work by engulfing invaders and trying to attack them with enzymes that produce powerful oxidants, like SOD and MPO. Superoxide dismutase takes superoxide and makes hydrogen peroxide, and myeloperoxidase takes hydrogen peroxide and chlorine ions and makes hypochlorous acid, which is many, many times more reactive than sodium hypochlorite bleach.
Neutrophils have a nasty trick. They can also eject these enzymes into the extracellular space, where they will continuously spit out peroxide and bleach into the bloodstream. This is called neutrophil extracellular trap formation, or, when it becomes pathogenic and counterproductive, NETosis. In severe and critical COVID-19, there is actually rather severe NETosis.
Hypochlorous acid building up in the bloodstream begins to bleach the iron out of heme and compete for O2 binding sites. Red blood cells lose the ability to transport oxygen, causing the sufferer to turn blue in the face. Unliganded iron, hydrogen peroxide, and superoxide in the bloodstream undergo the Haber-Weiss and Fenton reactions, producing extremely reactive hydroxyl radicals that violently strip electrons from surrounding fats and DNA, oxidizing them severely.
This condition is not unknown to medical science. The actual name for all of this is acute sepsis.
We know this is happening in COVID-19 because people who have died of the disease have noticeable ferroptosis signatures in their tissues, as well as various other oxidative stress markers such as nitrotyrosine, 4-HNE, and malondialdehyde.
When you intubate someone with this condition, you are setting off a free radical bomb by supplying the cells with O2. It’s a catch-22, because we need oxygen to make Adenosine Triphosphate (that is, to live), but O2 is also the precursor of all these damaging radicals that lead to lipid peroxidation.
The correct treatment for severe COVID-19 related sepsis is non-invasive ventilation, steroids, and antioxidant infusions. Most of the drugs repurposed for COVID-19 that show any benefit whatsoever in rescuing critically-ill COVID-19 patients are antioxidants. N-acetylcysteine, melatonin, fluvoxamine, budesonide, famotidine, cimetidine, and ranitidine are all antioxidants. Indomethacin prevents iron-driven oxidation of arachidonic acid to isoprostanes. There are powerful antioxidants such as apocynin that have not even been tested on COVID-19 patients yet which could defang neutrophils, prevent lipid peroxidation, restore endothelial health, and restore oxygenation to the tissues.
Scientists who know anything about pulmonary neutrophilia, ARDS, and redox biology have known or surmised much of this since March 2020. In April 2020, Swiss scientists confirmed that COVID-19 was a vascular endotheliitis. By late 2020, experts had already concluded that COVID-19 causes a form of viral sepsis. They also know that sepsis can be effectively treated with antioxidants. None of this information is particularly new, and yet, for the most part, it has not been acted upon. Doctors continue to use damaging intubation techniques with high PEEP settings despite high lung compliance and poor oxygenation, killing an untold number of critically ill patients with medical malpractice.
Because of the way they are constructed, Randomized Control Trials will never show any benefit for any antiviral against COVID-19. Not Remdesivir, not Kaletra, not HCQ, and not Ivermectin. The reason for this is simple; for the patients that they have recruited for these studies, such as Oxford’s ludicrous RECOVERY study, the intervention is too late to have any positive effect.
The clinical course of COVID-19 is such that by the time most people seek medical attention for hypoxia, their viral load has already tapered off to almost nothing. If someone is about 10 days post-exposure and has already been symptomatic for five days, there is hardly any virus left in their bodies, only cellular damage and derangement that has initiated a hyperinflammatory response. It is from this group that the clinical trials for antivirals have recruited, pretty much exclusively.
In these trials, they give antivirals to severely ill patients who have no virus in their bodies, only a delayed hyperinflammatory response, and then absurdly claim that antivirals have no utility in treating or preventing COVID-19. These clinical trials do not recruit people who are pre-symptomatic. They do not test pre-exposure or post-exposure prophylaxis.
This is like using a defibrillator to shock only flatline, and then absurdly claiming that defibrillators have no medical utility whatsoever when the patients refuse to rise from the dead. The intervention is too late. These trials for antivirals show systematic, egregious selection bias. They are providing a treatment that is futile to the specific cohort they are enrolling.
India went against the instructions of the WHO and mandated the prophylactic usage of Ivermectin. They have almost completely eradicated COVID-19. The Indian Bar Association of Mumbai has brought criminal charges against WHO Chief Scientist Dr. Soumya Swaminathan for recommending against the use of Ivermectin.
Ivermectin is not “horse dewormer”. Yes, it is sold in veterinary paste form as a dewormer for animals. It has also been available in pill form for humans for decades, as an antiparasitic drug.
The media have disingenuously claimed that because Ivermectin is an antiparasitic drug, it has no utility as an antivirus. This is incorrect. Ivermectin has utility as an antiviral. It blocks importin, preventing nuclear import, effectively inhibiting viral access to cell nuclei. Many drugs currently on the market have multiple modes of action. Ivermectin is one such drug. It is both antiparasitic and antiviral.
In Bangladesh, Ivermectin costs $1.80 for an entire 5-day course. Remdesivir, which is toxic to the liver, costs $3,120 for a 5-day course of the drug. Billions of dollars of utterly useless Remdesivir were sold to our governments on the taxpayer’s dime, and it ended up being totally useless for treating hyperinflammatory COVID-19. The media has hardly even covered this at all.
The opposition to the use of generic Ivermectin is not based in science. It is purely financially and politically-motivated. An effective non-vaccine intervention would jeopardize the rushed FDA approval of patented vaccines and medicines for which the pharmaceutical industry stands to rake in billions upon billions of dollars in sales on an ongoing basis.
The majority of the public are scientifically illiterate and cannot grasp what any of this even means, thanks to a pathetic educational system that has miseducated them. You would be lucky to find 1 in 100 people who have even the faintest clue what any of this actually means.
COVID-19 Transmission:
COVID-19 is airborne. The WHO carried water for China by claiming that the virus was only droplet-borne. Our own CDC absurdly claimed that it was mostly transmitted by fomite-to-face contact, which, given its rapid spread from Wuhan to the rest of the world, would have been physically impossible.
The ridiculous belief in fomite-to-face being a primary mode of transmission led to the use of surface disinfection protocols that wasted time, energy, productivity, and disinfectant.
The 6-foot guidelines are absolutely useless. The minimum safe distance to protect oneself from an aerosolized virus is to be 15+ feet away from an infected person, no closer. Realistically, no public transit is safe.
Surgical masks do not protect you from aerosols. The virus is too small and the filter media has too large of gaps to filter it out. They may catch respiratory droplets and keep the virus from being expelled by someone who is sick, but they do not filter a cloud of infectious aerosols if someone were to walk into said cloud.
The minimum level of protection against this virus is quite literally a P100 respirator, a PAPR/CAPR, or a 40mm NATO CBRN respirator, ideally paired with a full-body tyvek or tychem suit, gloves, and booties, with all the holes and gaps taped.
Live SARS-CoV-2 may potentially be detected in sewage outflows, and there may be oral-fecal transmission. During the SARS outbreak in 2003, in the Amoy Gardens incident, hundreds of people were infected by aerosolized fecal matter rising from floor drains in their apartments.
COVID-19 Vaccine Dangers:
The vaccines for COVID-19 are not sterilizing and do not prevent infection or transmission. They are “leaky” vaccines. This means they remove the evolutionary pressure on the virus to become less lethal. It also means that the vaccinated are perfect carriers. In other words, those who are vaccinated are a threat to the unvaccinated, not the other way around.
All of the COVID-19 vaccines currently in use have undergone minimal testing, with highly accelerated clinical trials. Though they appear to limit severe illness, the long-term safety profile of these vaccines remains unknown.
Some of these so-called “vaccines” utilize an untested new technology that has never been used in vaccines before. Traditional vaccines use weakened or killed virus to stimulate an immune response. The Moderna and Pfizer-BioNTech vaccines do not. They are purported to consist of an intramuscular shot containing a suspension of lipid nanoparticles filled with messenger RNA. The way they generate an immune response is by fusing with cells in a vaccine recipient’s shoulder, undergoing endocytosis, releasing their mRNA cargo into those cells, and then utilizing the ribosomes in those cells to synthesize modified SARS-CoV-2 Spike proteins in-situ.
These modified Spike proteins then migrate to the surface of the cell, where they are anchored in place by a transmembrane domain. The adaptive immune system detects the non-human viral protein being expressed by these cells, and then forms antibodies against that protein. This is purported to confer protection against the virus, by training the adaptive immune system to recognize and produce antibodies against the Spike on the actual virus. The J&J and AstraZeneca vaccines do something similar, but use an adenovirus vector for genetic material delivery instead of a lipid nanoparticle. These vaccines were produced or validated with the aid of fetal cell lines HEK-293 and PER.C6, which people with certain religious convictions may object strongly to.
SARS-CoV-2 Spike is a highly pathogenic protein on its own. It is impossible to overstate the danger presented by introducing this protein into the human body.
It is claimed by vaccine manufacturers that the vaccine remains in cells in the shoulder, and that SARS-CoV-2 Spike produced and expressed by these cells from the vaccine’s genetic material is harmless and inert, thanks to the insertion of prolines in the Spike sequence to stabilize it in the prefusion conformation, preventing the Spike from becoming active and fusing with other cells. However, a pharmacokinetic study from Japan showed that the lipid nanoparticles and mRNA from the Pfizer vaccine did not stay in the shoulder, and in fact bioaccumulated in many different organs, including the reproductive organs and adrenal glands, meaning that modified Spike is being expressed quite literally all over the place. These lipid nanoparticles may trigger anaphylaxis in an unlucky few, but far more concerning is the unregulated expression of Spike in various somatic cell lines far from the injection site and the unknown consequences of that.
Messenger RNA is normally consumed right after it is produced in the body, being translated into a protein by a ribosome. COVID-19 vaccine mRNA is produced outside the body, long before a ribosome translates it. In the meantime, it could accumulate damage if inadequately preserved. When a ribosome attempts to translate a damaged strand of mRNA, it can become stalled. When this happens, the ribosome becomes useless for translating proteins because it now has a piece of mRNA stuck in it, like a lace card in an old punch card reader. The whole thing has to be cleaned up and new ribosomes synthesized to replace it. In cells with low ribosome turnover, like nerve cells, this can lead to reduced protein synthesis, cytopathic effects, and neuropathies.
Certain proteins, including SARS-CoV-2 Spike, have proteolytic cleavage sites that are basically like little dotted lines that say “cut here”, which attract a living organism’s own proteases (essentially, molecular scissors) to cut them. There is a possibility that S1 may be proteolytically cleaved from S2, causing active S1 to float away into the bloodstream while leaving the S2 “stalk” embedded in the membrane of the cell that expressed the protein.
SARS-CoV-2 Spike has a Superantigenic region (SAg), which may promote extreme inflammation.
Anti-Spike antibodies were found in one study to function as autoantibodies and attack the body’s own cells. Those who have been immunized with COVID-19 vaccines have developed blood clots, myocarditis, Guillain-Barre Syndrome, Bell’s Palsy, and multiple sclerosis flares, indicating that the vaccine promotes autoimmune reactions against healthy tissue.
SARS-CoV-2 Spike does not only bind to ACE2. It was suspected to have regions that bind to basigin, integrins, neuropilin-1, and bacterial lipopolysaccharides as well. SARS-CoV-2 Spike, on its own, can potentially bind any of these things and act as a ligand for them, triggering unspecified and likely highly inflammatory cellular activity.
SARS-CoV-2 Spike contains an unusual PRRA insert that forms a furin cleavage site. Furin is a ubiquitous human protease, making this an ideal property for the Spike to have, giving it a high degree of cell tropism. No wild-type SARS-like coronaviruses related to SARS-CoV-2 possess this feature, making it highly suspicious, and perhaps a sign of human tampering.
SARS-CoV-2 Spike has a prion-like domain that enhances its infectiousness.
The Spike S1 RBD may bind to heparin-binding proteins and promote amyloid aggregation. In humans, this could lead to Parkinson’s, Lewy Body Dementia, premature Alzheimer’s, or various other neurodegenerative diseases. This is very concerning because SARS-CoV-2 S1 is capable of injuring and penetrating the blood-brain barrier and entering the brain. It is also capable of increasing the permeability of the blood-brain barrier to other molecules.
SARS-CoV-2, like other betacoronaviruses, may have Dengue-like ADE, or antibody-dependent enhancement of disease. For those who aren’t aware, some viruses, including betacoronaviruses, have a feature called ADE. There is also something called Original Antigenic Sin, which is the observation that the body prefers to produce antibodies based on previously-encountered strains of a virus over newly-encountered ones.
In ADE, antibodies from a previous infection become non-neutralizing due to mutations in the virus’s proteins. These non-neutralizing antibodies then act as trojan horses, allowing live, active virus to be pulled into macrophages through their Fc receptor pathways, allowing the virus to infect immune cells that it would not have been able to infect before. This has been known to happen with Dengue Fever; when someone gets sick with Dengue, recovers, and then contracts a different strain, they can get very, very ill.
If someone is vaccinated with mRNA based on the Spike from the initial Wuhan strain of SARS-CoV-2, and then they become infected with a future, mutated strain of the virus, they may become severely ill. In other words, it is possible for vaccines to sensitize someone to disease.
There is a precedent for this in recent history. Sanofi’s Dengvaxia vaccine for Dengue failed because it caused immune sensitization in people whose immune systems were Dengue-naive.
In mice immunized against SARS-CoV and challenged with the virus, a close relative of SARS-CoV-2, they developed immune sensitization, Th2 immunopathology, and eosinophil infiltration in their lungs.
We have been told that SARS-CoV-2 mRNA vaccines cannot be integrated into the human genome, because messenger RNA cannot be turned back into DNA. This is false. There are elements in human cells called LINE-1 retrotransposons, which can indeed integrate mRNA into a human genome by endogenous reverse transcription. Because the mRNA used in the vaccines is stabilized, it hangs around in cells longer, increasing the chances for this to happen. If the gene for SARS-CoV-2 Spike is integrated into a portion of the genome that is not silent and actually expresses a protein, it is possible that people who take this vaccine may continuously express SARS-CoV-2 Spike from their somatic cells for the rest of their lives.
By inoculating people with a vaccine that causes their bodies to produce Spike in-situ, they are being inoculated with a pathogenic protein. A toxin that may cause long-term inflammation, heart problems, and a raised risk of cancers. In the long-term, it may also potentially lead to premature neurodegenerative disease.
Absolutely nobody should be compelled to take this vaccine under any circumstances, and in actual fact, the vaccination campaign must be stopped immediately.
COVID-19 Criminal Conspiracy:
The vaccine and the virus were made by the same people.
In 2014, there was a moratorium on SARS gain-of-function research that lasted until 2017. This research was not halted. Instead, it was outsourced, with the federal grants being laundered through NGOs.
Ralph Baric is a virologist and SARS expert at UNC Chapel Hill in North Carolina. This is who Anthony Fauci was referring to when he insisted, before Congress, that if any gain-of-function research was being conducted, it was being conducted in North Carolina.
This was a lie. Anthony Fauci lied before Congress. A felony.
Ralph Baric and Shi Zhengli are colleagues and have co-written papers together. Ralph Baric mentored Shi Zhengli in his gain-of-function manipulation techniques, particularly serial passage, which results in a virus that appears as if it originated naturally. In other words, deniable bioweapons. Serial passage in humanized hACE2 mice may have produced something like SARS-CoV-2.
The funding for the gain-of-function research being conducted at the Wuhan Institute of Virology came from Peter Daszak. Peter Daszak runs an NGO called EcoHealth Alliance. EcoHealth Alliance received millions of dollars in grant money from the National Institutes of Health/National Institute of Allergy and Infectious Diseases (that is, Anthony Fauci), the Defense Threat Reduction Agency (part of the US Department of Defense), and the United States Agency for International Development. NIH/NIAID contributed a few million dollars, and DTRA and USAID each contributed tens of millions of dollars towards this research. Altogether, it was over a hundred million dollars.
EcoHealth Alliance subcontracted these grants to the Wuhan Institute of Virology, a lab in China with a very questionable safety record and poorly trained staff, so that they could conduct gain-of-function research, not in their fancy P4 lab, but in a level-2 lab where technicians wore nothing more sophisticated than perhaps a hairnet, latex gloves, and a surgical mask, instead of the bubble suits used when working with dangerous viruses. Chinese scientists in Wuhan reported being routinely bitten and urinated on by laboratory animals. Why anyone would outsource this dangerous and delicate work to the People’s Republic of China, a country infamous for industrial accidents and massive explosions that have claimed hundreds of lives, is completely beyond me, unless the aim was to start a pandemic on purpose.
In November of 2019, three technicians at the Wuhan Institute of Virology developed symptoms consistent with a flu-like illness. Anthony Fauci, Peter Daszak, and Ralph Baric knew at once what had happened, because back channels exist between this laboratory and our scientists and officials.
December 12th, 2019, Ralph Baric signed a Material Transfer Agreement (essentially, an NDA) to receive Coronavirus mRNA vaccine-related materials co-owned by Moderna and NIH. It wasn’t until a whole month later, on January 11th, 2020, that China allegedly sent us the sequence to what would become known as SARS-CoV-2. Moderna claims, rather absurdly, that they developed a working vaccine from this sequence in under 48 hours.
Stephane Bancel, the current CEO of Moderna, was formerly the CEO of bioMerieux, a French multinational corporation specializing in medical diagnostic tech, founded by one Alain Merieux. Alain Merieux was one of the individuals who was instrumental in the construction of the Wuhan Institute of Virology’s P4 lab.
The sequence given as the closest relative to SARS-CoV-2, RaTG13, is not a real virus. It is a forgery. It was made by entering a gene sequence by hand into a database, to create a cover story for the existence of SARS-CoV-2, which is very likely a gain-of-function chimera produced at the Wuhan Institute of Virology and was either leaked by accident or intentionally released.
The animal reservoir of SARS-CoV-2 has never been found.
This is not a conspiracy “theory”. It is an actual criminal conspiracy, in which people connected to the development of Moderna’s mRNA-1273 are directly connected to the Wuhan Institute of Virology and their gain-of-function research by very few degrees of separation, if any. The paper trail is well-established.
The lab-leak theory has been suppressed because pulling that thread leads one to inevitably conclude that there is enough circumstantial evidence to link Moderna, the NIH, the WIV, and both the vaccine and the virus’s creation together. In a sane country, this would have immediately led to the world’s biggest RICO and mass murder case. Anthony Fauci, Peter Daszak, Ralph Baric, Shi Zhengli, and Stephane Bancel, and their accomplices, would have been indicted and prosecuted to the fullest extent of the law. Instead, billions of our tax dollars were awarded to the perpetrators.
The FBI raided Allure Medical in Shelby Township north of Detroit for billing insurance for “fraudulent COVID-19 cures”. The treatment they were using? Intravenous Vitamin C. An antioxidant. Which, as described above, is an entirely valid treatment for COVID-19-induced sepsis, and indeed, is now part of the MATH+ protocol advanced by Dr. Paul E. Marik.
The FDA banned ranitidine (Zantac) due to supposed NDMA (N-nitrosodimethylamine) contamination. Ranitidine is not only an H2 blocker used as antacid, but also has a powerful antioxidant effect, scavenging hydroxyl radicals. This gives it utility in treating COVID-19.
The FDA also attempted to take N-acetylcysteine, a harmless amino acid supplement and antioxidant, off the shelves, compelling Amazon to remove it from their online storefront.
This leaves us with a chilling question: did the FDA knowingly suppress antioxidants useful for treating COVID-19 sepsis as part of a criminal conspiracy against the American public?
The establishment is cooperating with, and facilitating, the worst criminals in human history, and are actively suppressing non-vaccine treatments and therapies in order to compel us to inject these criminals’ products into our bodies. This is absolutely unacceptable.
COVID-19 Vaccine Development and Links to Transhumanism:
This section deals with some more speculative aspects of the pandemic and the medical and scientific establishment’s reaction to it, as well as the disturbing links between scientists involved in vaccine research and scientists whose work involved merging nanotechnology with living cells.
On June 9th, 2020, Charles Lieber, a Harvard nanotechnology researcher with decades of experience, was indicted by the DOJ for fraud. Charles Lieber received millions of dollars in grant money from the US Department of Defense, specifically the military think tanks DARPA, AFOSR, and ONR, as well as NIH and MITRE. His specialty is the use of silicon nanowires in lieu of patch clamp electrodes to monitor and modulate intracellular activity, something he has been working on at Harvard for the past twenty years. He was claimed to have been working on silicon nanowire batteries in China, but none of his colleagues can recall him ever having worked on battery technology in his life; all of his research deals with bionanotechnology, or the blending of nanotech with living cells.
The indictment was over his collaboration with the Wuhan University of Technology. He had double-dipped, against the terms of his DOD grants, and taken money from the PRC’s Thousand Talents plan, a program which the Chinese government uses to bribe Western scientists into sharing proprietary R&D information that can be exploited by the PLA for strategic advantage.
Charles Lieber’s own papers describe the use of silicon nanowires for brain-computer interfaces, or “neural lace” technology. His papers describe how neurons can endocytose whole silicon nanowires or parts of them, monitoring and even modulating neuronal activity.
Charles Lieber was a colleague of Robert Langer. Together, along with Daniel S. Kohane, they worked on a paper describing artificial tissue scaffolds that could be implanted in a human heart to monitor its activity remotely.
Robert Langer, an MIT alumnus and expert in nanotech drug delivery, is one of the co-founders of Moderna. His net worth is now $5.1 billion USD thanks to Moderna’s mRNA-1273 vaccine sales.
Both Charles Lieber and Robert Langer’s bibliographies describe, essentially, techniques for human enhancement, i.e. transhumanism. Klaus Schwab, the founder of the World Economic Forum and the architect behind the so-called “Great Reset”, has long spoken of the “blending of biology and machinery” in his books.
Since these revelations, it has come to the attention of independent researchers that the COVID-19 vaccines may contain reduced graphene oxide nanoparticles. Japanese researchers have also found unexplained contaminants in COVID-19 vaccines.
Graphene oxide is an anxiolytic. It has been shown to reduce the anxiety of laboratory mice when injected into their brains. Indeed, given SARS-CoV-2 Spike’s propensity to compromise the blood-brain barrier and increase its permeability, it is the perfect protein for preparing brain tissue for extravasation of nanoparticles from the bloodstream and into the brain. Graphene is also highly conductive and, in some circumstances, paramagnetic.
In 2013, under the Obama administration, DARPA launched the BRAIN Initiative; BRAIN is an acronym for Brain Research Through Advancing Innovative Neurotechnologies®. This program involves the development of brain-computer interface technologies for the military, particularly non-invasive, injectable systems that cause minimal damage to brain tissue when removed. Supposedly, this technology would be used for healing wounded soldiers with traumatic brain injuries, the direct brain control of prosthetic limbs, and even new abilities such as controlling drones with one’s mind.
Various methods have been proposed for achieving this, including optogenetics, magnetogenetics, ultrasound, implanted electrodes, and transcranial electromagnetic stimulation. In all instances, the goal is to obtain read or read-write capability over neurons, either by stimulating and probing them, or by rendering them especially sensitive to stimulation and probing.
However, the notion of the widespread use of BCI technology, such as Elon Musk’s Neuralink device, raises many concerns over privacy and personal autonomy. Reading from neurons is problematic enough on its own. Wireless brain-computer interfaces may interact with current or future wireless GSM infrastructure, creating neurological data security concerns. A hacker or other malicious actor may compromise such networks to obtain people’s brain data, and then exploit it for nefarious purposes.
However, a device capable of writing to human neurons, not just reading from them, presents another, even more serious set of ethical concerns. A BCI that is capable of altering the contents of one’s mind for innocuous purposes, such as projecting a heads-up display onto their brain’s visual center or sending audio into one’s auditory cortex, would also theoretically be capable of altering mood and personality, or perhaps even subjugating someone’s very will, rendering them utterly obedient to authority. This technology would be a tyrant’s wet dream. Imagine soldiers who would shoot their own countrymen without hesitation, or helpless serfs who are satisfied to live in literal dog kennels.
BCIs could be used to unscrupulously alter perceptions of basic things such as emotions and values, changing people’s thresholds of satiety, happiness, anger, disgust, and so forth. This is not inconsequential. Someone’s entire regime of behaviors could be altered by a BCI, including such things as suppressing their appetite or desire for virtually anything on Maslow’s Hierarchy of Needs.
Anything is possible when you have direct access to someone’s brain and its contents. Someone who is obese could be made to feel disgust at the sight of food. Someone who is involuntarily celibate could have their libido disabled so they don’t even desire sex to begin with. Someone who is racist could be forced to feel delight over cohabiting with people of other races. Someone who is violent could be forced to be meek and submissive. These things might sound good to you if you are a tyrant, but to normal people, the idea of personal autonomy being overridden to such a degree is appalling.
For the wealthy, neural laces would be an unequaled boon, giving them the opportunity to enhance their intelligence with neuroprosthetics (i.e. an “exocortex”), and to deliver irresistible commands directly into the minds of their BCI-augmented servants, even physically or sexually abusive commands that they would normally refuse.
If the vaccine is a method to surreptitiously introduce an injectable BCI into millions of people without their knowledge or consent, then what we are witnessing is the rise of a tyrannical regime unlike anything ever seen before on the face of this planet, one that fully intends to strip every man, woman, and child of our free will.
Our flaws are what make us human. A utopia arrived at by removing people’s free will is not a utopia at all. It is a monomaniacal nightmare. Furthermore, the people who rule over us are Dark Triad types who cannot be trusted with such power. Imagine being beaten and sexually assaulted by a wealthy and powerful psychopath and being forced to smile and laugh over it because your neural lace gives you no choice but to obey your master.
The Elites are forging ahead with this technology without giving people any room to question the social or ethical ramifications, or to establish regulatory frameworks that ensure that our personal agency and autonomy will not be overridden by these devices. They do this because they secretly dream of a future where they can treat you worse than an animal and you cannot even fight back. If this evil plan is allowed to continue, it will spell the end of humanity as we know it.
Conclusions:
The current pandemic was produced and perpetuated by the establishment, through the use of a virus engineered in a PLA-connected Chinese biowarfare laboratory, with the aid of American taxpayer dollars and French expertise.
This research was conducted under the absolutely ridiculous euphemism of “gain-of-function” research, which is supposedly carried out in order to determine which viruses have the highest potential for zoonotic spillover and preemptively vaccinate or guard against them.
Gain-of-function/gain-of-threat research, a.k.a. “Dual-Use Research of Concern”, or DURC, is bioweapon research by another, friendlier-sounding name, simply to avoid the taboo of calling it what it actually is. It has always been bioweapon research. The people who are conducting this research fully understand that they are taking wild pathogens that are not infectious in humans and making them more infectious, often taking grants from military think tanks encouraging them to do so.
These virologists conducting this type of research are enemies of their fellow man, like pyromaniac firefighters. GOF research has never protected anyone from any pandemic. In fact, it has now started one, meaning its utility for preventing pandemics is actually negative. It should have been banned globally, and the lunatics performing it should have been put in straitjackets long ago.
Either through a leak or an intentional release from the Wuhan Institute of Virology, a deadly SARS strain is now endemic across the globe, after the WHO and CDC and public officials first downplayed the risks, and then intentionally incited a panic and lockdowns that jeopardized people’s health and their livelihoods.
This was then used by the utterly depraved and psychopathic aristocratic class who rule over us as an excuse to coerce people into accepting an injected poison which may be a depopulation agent, a mind control/pacification agent in the form of injectable “smart dust”, or both in one. They believe they can get away with this by weaponizing the social stigma of vaccine refusal. They are incorrect.
Their motives are clear and obvious to anyone who has been paying attention. These megalomaniacs have raided the pension funds of the free world. Wall Street is insolvent and has had an ongoing liquidity crisis since the end of 2019. The aim now is to exert total, full-spectrum physical, mental, and financial control over humanity before we realize just how badly we’ve been extorted by these maniacs.
The pandemic and its response served multiple purposes for the Elite:
- Concealing a depression brought on by the usurious plunder of our economies conducted by rentier-capitalists and absentee owners who produce absolutely nothing of any value to society whatsoever. Instead of us having a very predictable Occupy Wall Street Part II, the Elites and their stooges got to stand up on television and paint themselves as wise and all-powerful saviors instead of the marauding cabal of despicable land pirates that they are.
- Destroying small businesses and eroding the middle class.
- Transferring trillions of dollars of wealth from the American public and into the pockets of billionaires and special interests.
- Engaging in insider trading, buying stock in biotech companies and shorting brick-and-mortar businesses and travel companies, with the aim of collapsing face-to-face commerce and tourism and replacing it with e-commerce and servitization.
- Creating a casus belli for war with China, encouraging us to attack them, wasting American lives and treasure and driving us to the brink of nuclear armageddon.
- Establishing technological and biosecurity frameworks for population control and technocratic-socialist “smart cities” where everyone’s movements are despotically tracked, all in anticipation of widespread automation, joblessness, and food shortages, by using the false guise of a vaccine to compel cooperation.
Any one of these things would constitute a vicious rape of Western society. Taken together, they beggar belief; they are a complete inversion of our most treasured values.
What is the purpose of all of this? One can only speculate as to the perpetrators’ motives, however, we have some theories.
The Elites are trying to pull up the ladder, erase upward mobility for large segments of the population, cull political opponents and other “undesirables”, and put the remainder of humanity on a tight leash, rationing our access to certain goods and services that they have deemed “high-impact”, such as automobile use, tourism, meat consumption, and so on. Naturally, they will continue to have their own luxuries, as part of a strict caste system akin to feudalism.
Why are they doing this? Simple. The Elites are Neo-Malthusians and believe that we are overpopulated and that resource depletion will collapse civilization in a matter of a few short decades. They are not necessarily incorrect in this belief. We are overpopulated, and we are consuming too many resources. However, orchestrating such a gruesome and murderous power grab in response to a looming crisis demonstrates that they have nothing but the utmost contempt for their fellow man.
To those who are participating in this disgusting farce without any understanding of what they are doing, we have one word for you. Stop. You are causing irreparable harm to your country and to your fellow citizens.
To those who may be reading this warning and have full knowledge and understanding of what they are doing and how it will unjustly harm millions of innocent people, we have a few more words.
Damn you to hell. You will not destroy America and the Free World, and you will not have your New World Order. We will make certain of that.
References:
See References for "Spartacus" Anonymous COVID-9 whistleblower document
References completing the "Spartacus" Anonymous COVID-9 whistleblower document"
COVID-19 is not a viral pneumonia — it is a viral vascular endotheliitis:
https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(20)30937-5/fulltext
https://academic.oup.com/eurheartj/article/41/32/3038/5901158
https://www.embopress.org/doi/full/10.15252/embr.202152744
COVID-19 is not just a respiratory disease — it can precipitate multiple organ failure, including hypoxic and inflammatory damage to various vital organs, such as the brain, heart, liver, pancreas, kidneys, and intestines:
https://www.nature.com/articles/d41586-021-01693-6
https://www.health.harvard.edu/blog/the-hidden-long-term-cognitive-effects-of-covid-2020100821133
https://www.nature.com/articles/s41422-020-0390-x
https://www.embopress.org/doi/full/10.15252/embj.2020106230
https://jamanetwork.com/journals/jama/fullarticle/2776538
https://pubmed.ncbi.nlm.nih.gov/32921216/
https://www.nature.com/articles/s41575-021-00426-4
https://pubmed.ncbi.nlm.nih.gov/32553666/
https://www.nature.com/articles/s41467-021-23886-3
https://pubmed.ncbi.nlm.nih.gov/34081912/
https://www.nature.com/articles/s41581-021-00452-0
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7438210/
https://www.nature.com/articles/s41598-021-92740-9
Some of the most common laboratory findings in COVID-19:
https://www.uptodate.com/contents/covid-19-clinical-features
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7426219/
COVID-19 can present as almost anything:
https://www.nature.com/articles/s41591-020-0968-3
https://www.frontiersin.org/articles/10.3389/fmed.2020.00526/full
COVID-19 is more severe in those with conditions that involve endothelial dysfunction, such as obesity, hypertension, and diabetes:
https://jamanetwork.com/journals/jama/fullarticle/2772071
https://mdpi-res.com/d_attachment/cells/cells-10-00933/article_deploy/cells-10-00933.pdf
The vast majority of COVID-19 cases are mild and do not cause significant disease:
https://www.webmd.com/lung/covid-recovery-overview#1
https://academic.oup.com/ofid/article/7/9/ofaa286/5875595
https://pubmed.ncbi.nlm.nih.gov/33289900/
In those who have critical COVID-19-induced sepsis, hypoxia, coagulopathy, and ARDS, the most common treatments are intubation, injected corticosteroids, and blood thinners like heparin, which often precipitate harmful hemorrhages:
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7548860/
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7448713/
https://www.nejm.org/doi/full/10.1056/NEJMoa2103417
The majority of people who go on a ventilator are dying due to COVID-19 mimicking the physiology of ischemia-reperfusion injury with prolonged transient hypoxia and ischemia, leading directly to the formation of damaging reactive oxygen species:
https://www.journalofsurgicalresearch.com/article/S0022-4804(14)00176-0/fulltext
https://www.nature.com/articles/nature13909
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4625011/
https://www.atsjournals.org/doi/full/10.1164/rccm.201401-0168CP
https://pubmed.ncbi.nlm.nih.gov/18974366/
The end-stage of COVID-19 is severe lipid peroxidation, where fats in the body start to “rust” due to damage by oxidative stress:
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7768996/
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7357498/
https://www.liebertpub.com/doi/10.1089/ars.2021.0017
Oxidized lipids appear as foreign objects to the immune system, which recognizes and forms antibodies against OSEs, or oxidation-specific epitopes:
https://ard.bmj.com/content/annrheumdis/early/2020/08/04/annrheumdis-2020-218145.full.pdf
https://ard.bmj.com/content/80/9/1236
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7256550/
https://www.hss.edu/conditions_top-ten-series-antiphospholipid-syndrome-coronavirus-covid-19.asp
In COVID-19, neutrophil degranulation and NETosis in the bloodstream drives severe oxidative damage; hemoglobin becomes incapable of carrying oxygen due to heme iron being stripped out of heme by hypochlorous acid:
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7757048/
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7436665/
https://www.nature.com/articles/s41418-021-00805-z
https://www.sciencedirect.com/science/article/pii/S221249262030052X
SARS-CoV-2 Spike binds to ACE2. Angiotensin Converting Enzyme 2 is an enzyme that is part of the renin-angiotensin-aldosterone system, or RAAS. The RAAS is a hormone control system that moderates fluid volume and blood pressure in the body and in the bloodstream by controlling sodium/potassium retention and excretion and vascular tone:
https://www.ncbi.nlm.nih.gov/books/NBK470410/
https://www.merckmanuals.com/home/multimedia/figure/cvs_regulating_blood_pressure_renin
This protein, ACE2, is ubiquitous in every part of the body that interfaces with the circulatory system, particularly in vascular endothelial cells and pericytes, brain astrocytes, renal tubules and podocytes,
pancreatic islet cells, bile duct and intestinal epithelial cells, and the seminiferous ducts of the testis, all of which SARS-CoV-2 can infect:
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7167720/
https://www.frontiersin.org/articles/10.3389/fmed.2020.594495/full
https://www.frontiersin.org/articles/10.3389/fneur.2020.573095/full
SARS-CoV-2 infects a cell as follows:
https://www.nature.com/articles/s41401-020-0485-4
https://www.science.org/doi/10.1126/science.abb2507
https://www.sciencedirect.com/science/article/abs/pii/S1931312820306211
SARS-CoV-2 Spike proteins embedded in a cell can actually cause adjacent human cells to fuse together, forming syncytia/MGCs:
https://www.nature.com/articles/s41418-021-00782-3
https://pubmed.ncbi.nlm.nih.gov/33051876/
SARS-CoV-2’s viroporins, such as its Envelope protein, act as calcium ion channels, introducing calcium into infected cells:
https://www.nature.com/articles/s41422-021-00519-4
https://virologyj.biomedcentral.com/articles/10.1186/s12985-019-1182-0
The virus suppresses the natural interferon response, resulting in delayed inflammation:
https://www.nature.com/articles/s12276-021-00592-0
https://mdpi-res.com/d_attachment/viruses/viruses-12-01433/article_deploy/viruses-12-01433.pdf
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8310780/
SARS-CoV-2 N protein can also directly activate the NLRP3 inflammasome:
https://www.nature.com/articles/s41467-021-25015-6
https://www.frontiersin.org/articles/10.3389/fimmu.2020.01021/full
SARS-CoV-2 suppresses the Nrf2 antioxidant pathway, reducing the body’s own endogenous antioxidant enzyme activity:
https://www.nature.com/articles/s41467-020-18764-3
https://ctajournal.biomedcentral.com/articles/10.1186/s13601-020-00362-7
https://mdpi-res.com/d_attachment/ijms/ijms-22-07963/article_deploy/ijms-22-07963.pdf
The suppression of ACE2 by binding with Spike causes a buildup of bradykinin that would otherwise be broken down by ACE2:
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7834250/
https://www.the-scientist.com/news-opinion/is-a-bradykinin-storm-brewing-in-covid-19–67876
This constant calcium influx into the cells results in (or is accompanied by) noticeable hypocalcemia, or low blood calcium:
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7292572/
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8041474/
https://www.sciencedirect.com/science/article/abs/pii/S1871402121000059
Bradykinin upregulates cAMP, cGMP, COX, and Phospholipase C activity. This results in prostaglandin release and vastly increased intracellular calcium signaling, which promotes highly aggressive ROS release and ATP depletion:
https://www.sciencedirect.com/science/article/abs/pii/S089158490700319X?via%3Dihub
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC1218972/
https://pubmed.ncbi.nlm.nih.gov/2156053/
https://www.sciencedirect.com/topics/medicine-and-dentistry/bradykinin-b2-receptor-agonist
https://www.sciencedirect.com/topics/neuroscience/bradykinin
NADPH oxidase releases superoxide into the extracellular space:
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4556774/
https://www.pnas.org/content/110/21/8744
Superoxide radicals react with nitric oxide to form peroxynitrite:
https://pubmed.ncbi.nlm.nih.gov/8944624/
https://www.pnas.org/content/115/23/5839
Peroxynitrite reacts with the tetrahydrobiopterin cofactor needed by endothelial nitric oxide synthase, destroying it and “uncoupling” the eNOS enzymes, causing nitric oxide synthase to synthesize more superoxide instead (this means that every process that upregulates NOS activity now produces superoxide instead of nitric oxide):
https://pubmed.ncbi.nlm.nih.gov/24353182/
https://academic.oup.com/cardiovascres/article/73/1/8/316487
https://pubs.acs.org/doi/10.1021/bi9016632
This proceeds in a positive feedback loop until nitric oxide bioavailability in the circulatory system is depleted:
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7276137/
Dissolved nitric oxide gas produced constantly by eNOS serves many important functions, but it is also antiviral against SARS-like coronaviruses, preventing the palmitoylation of the viral Spike protein and making it harder for it to bind to host receptors:
https://journal.chestnet.org/article/S0012-3692(20)34397-X/fulltext
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7111989/
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7754882/
The loss of NO allows the virus to begin replicating with impunity in the body (clearly, the virus has an evolutionary incentive to induce oxidative stress to destroy nitric oxide):
Those with endothelial dysfunction (i.e. hypertension, diabetes, obesity, old age, African-American race) have redox equilibrium issues to begin with, giving the virus an advantage:
https://www.nature.com/articles/s41392-020-00454-7
https://www.frontiersin.org/articles/10.3389/fphys.2020.605908/full
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7430889/
https://pubmed.ncbi.nlm.nih.gov/19004510/
Due to the extreme cytokine release triggered by these processes, the body summons a great deal of neutrophils and monocyte-derived alveolar macrophages to the lungs:
https://www.frontiersin.org/articles/10.3389/fimmu.2021.652470/full
https://www.frontiersin.org/articles/10.3389/fimmu.2021.720109/full
Phagocytic cells of the innate immune system are the first-line defenders against pathogens. They work by engulfing invaders and trying to attack them with enzymes that produce powerful oxidants, like SOD and MPO:
https://www.frontiersin.org/articles/10.3389/fimmu.2012.00174/full
https://jlb.onlinelibrary.wiley.com/doi/full/10.1189/jlb.0809549
Superoxide dismutase takes superoxide and makes hydrogen peroxide, and myeloperoxidase takes hydrogen peroxide and chlorine ions and makes hypochlorous acid, which is many, many times more reactive than sodium hypochlorite bleach:
https://www.sciencedirect.com/topics/neuroscience/superoxide-dismutase
https://www.sciencedirect.com/topics/medicine-and-dentistry/myeloperoxidase
In severe and critical COVID-19, there is actually rather severe NETosis:
https://www.frontiersin.org/articles/10.3389/fphar.2021.708302/full
https://insight.jci.org/articles/view/138999
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7184981/
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7488868/
https://www.sciencedirect.com/science/article/pii/S221249262030052X
Hypochlorous acid building up in the bloodstream begins to bleach the iron out of heme and compete for O2 binding sites. Red blood cells lose the ability to transport oxygen, causing the sufferer to turn blue in the face:
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7757048/
https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0120737
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3863623/
Unliganded iron, hydrogen peroxide, and superoxide in the bloodstream undergo the Haber-Weiss and Fenton reactions, producing extremely reactive hydroxyl radicals that violently strip electrons from surrounding fats and DNA, oxidizing them severely:
https://www.sciencedirect.com/science/article/pii/S0753332221000135
https://sites.kowsarpub.com/ans/articles/60038.html
https://www.sciencedirect.com/science/article/abs/pii/S0300483X00002316?via%3Dihub
https://www.sciencedirect.com/topics/chemistry/fenton-reaction
This condition is not unknown to medical science. The actual name for all of this is acute sepsis (but without the traditional hallmarks of sepsis, like shock):
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4056356/
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7886971/
https://www.futuremedicine.com/doi/10.2217/fmb-2020-0312
We know this is happening in COVID-19 because people who have died of the disease have noticeable ferroptosis signatures in their tissues, as well as various other oxidative stress markers such as nitrotyrosine, 4-HNE, and malondialdehyde:
https://onlinelibrary.wiley.com/doi/full/10.1002/ehf2.12958
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7264936/
https://www.sciencedirect.com/science/article/pii/S2213231721001300
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8180845/
When you intubate someone with this condition, you are setting off a free radical bomb by supplying the cells with O2. It’s a catch-22, because we need oxygen to make Adenosine Triphosphate (that is, to live), but O2 is also the precursor of all these damaging radicals that lead to lipid peroxidation:
https://www.nature.com/articles/pr2009174
The correct treatment for severe COVID-19 related sepsis is non-invasive ventilation, steroids, and antioxidant infusions:
https://mdpi-res.com/d_attachment/medicina/medicina-56-00619/article_deploy/medicina-56-00619-v2.pdf
Most of the drugs repurposed for COVID-19 that show any benefit whatsoever in rescuing critically-ill COVID-19 patients are antioxidants. N-acetylcysteine, melatonin, fluvoxamine, budesonide, famotidine, cimetidine, and ranitidine are all antioxidants:
https://www.hindawi.com/journals/omcl/2018/6581970/
https://www.intechopen.com/chapters/62672
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6708076/
https://www.karger.com/Article/Abstract/88623
https://www.sciencedirect.com/science/article/abs/pii/000629529390218L?via%3Dihub
Indomethacin prevents iron-driven oxidation of arachidonic acid to isoprostanes:
https://www.sciencedirect.com/science/article/abs/pii/0161463079900442
There are powerful antioxidants such as apocynin that have not even been tested on COVID-19 patients yet which could defang neutrophils, prevent lipid peroxidation, restore endothelial health, and restore oxygenation to the tissues:
https://link.springer.com/article/10.1007/s10787-020-00715-5
Scientists who know anything about pulmonary neutrophilia, ARDS, and redox biology have known or surmised much of this since March 2020:
https://www.researchgate.net/post/NADPH_oxidase_Covid-19_Oxygen_treatment
In April 2020, Swiss scientists confirmed that COVID-19 was a systemic vascular endotheliitis:
https://www.usz.ch/en/covid-19-also-a-systemic-endotheliitis/
By late 2020, experts had already concluded that COVID-19 causes a form of viral sepsis:
https://www.healthleadersmedia.com/clinical-care/expert-severe-covid-19-illness-viral-sepsis
They also know that sepsis can be effectively treated with antioxidants:
https://jtd.amegroups.com/article/view/34870/html
None of this information is particularly new, and yet, for the most part, it has not been acted upon. Doctors continue to use damaging intubation techniques with high PEEP settings despite high lung compliance and poor oxygenation, killing an untold number of critically ill patients with medical malpractice:
https://ccforum.biomedcentral.com/articles/10.1186/s13054-020-03049-4
https://jamanetwork.com/journals/jama/fullarticle/2765302
Because of the way they are constructed, Randomized Control Trials will never show any benefit for any antiviral against COVID-19. Not Remdesivir, not Kaletra, not HCQ, and not Ivermectin. The reason for this is simple; for the patients that they have enrolled in these studies, such as Oxford’s ludicrous RECOVERY study, the intervention is too late to have any positive effect (i.e. these RCTs are designed in such a way that the use of antivirals is futile, therefore, these studies are deceptive and unethical by their very nature):
https://www.mdpi.com/1999-4915/13/6/963/htm
The clinical course of COVID-19 is such that by the time most people seek medical attention for hypoxia, their viral load has already tapered off to almost nothing. If someone is about 10 days post-exposure and has already been symptomatic for five days, there is hardly any virus left in their bodies, only cellular damage and derangement that has initiated a hyperinflammatory response:
https://www.sciencedirect.com/science/article/pii/S0753332220306867
It is from this group that the clinical trials for antivirals have recruited, pretty much exclusively (i.e. they do not test prophylaxis/early treatment, only changes to the mean duration of hospitalization for those already hospitalized):
https://www.nejm.org/doi/full/10.1056/nejmoa2023184
https://www.nejm.org/doi/full/10.1056/NEJMoa2022926
https://pubmed.ncbi.nlm.nih.gov/34318930/
India went against the instructions of the WHO and mandated the prophylactic usage of Ivermectin. They have almost completely eradicated COVID-19:
The Indian Bar Association of Mumbai has brought criminal charges against WHO Chief Scientist Dr. Soumya Swaminathan for recommending against the use of Ivermectin:
https://indianbarassociation.in/wp-content/uploads/2021/05/IBA-PRESS-RELEASE-MAY-26-2021.pdf
Ivermectin is not “horse dewormer”. Yes, it is sold in veterinary paste form as a dewormer for animals. It has also been available in pill form for humans for decades, as an antiparasitic drug:
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3043740/
The media have disingenuously claimed that because Ivermectin is an antiparasitic drug, it has no utility as an antivirus. This is incorrect. Ivermectin has utility as an antiviral. It blocks importin, preventing nuclear import, effectively inhibiting viral access to cell nuclei. Many drugs currently on the market have multiple modes of action. Ivermectin is one such drug. It is both antiparasitic and antiviral:
https://www.sciencedirect.com/science/article/abs/pii/S0166354219307211?via%3Dihub
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7539925/
In Bangladesh, Ivermectin costs $1.80 for an entire 5-day course:
Remdesivir, which is toxic to the liver, costs $3,120 for a 5-day course of the drug:
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7386240/
Billions of dollars of utterly useless Remdesivir were sold to our governments on the taxpayer’s dime, and it ended up being totally useless for treating hyperinflammatory COVID-19:
https://www.forbes.com/sites/jvchamary/2021/01/31/remdesivir-covid-coronavirus/?sh=7e6034e666c2
COVID-19 is airborne. The WHO carried water for China by claiming that the virus was only droplet-borne. Our own CDC absurdly claimed that it was mostly transmitted by fomite-to-face contact, which, given its rapid spread from Wuhan to the rest of the world, would have been physically impossible:
https://www.thelancet.com/article/S0140-6736(21)00869-2/fulltext
The ridiculous belief in fomite-to-face being a primary mode of transmission led to the use of surface disinfection protocols that wasted time, energy, productivity, and disinfectant:
https://www.nature.com/articles/d41586-021-00251-4
The 6-foot guidelines are absolutely useless. The minimum safe distance to protect oneself from an aerosolized virus is to be 15+ feet away from an infected person, no closer. Realistically, no public transit is safe:
https://www.medrxiv.org/content/10.1101/2020.08.03.20167395v1
Surgical masks do not protect you from aerosols. The virus is too small and the filter media has too large of gaps to filter it out. They may catch respiratory droplets and keep the virus from being expelled by someone who is sick, but they do not filter a cloud of infectious aerosols if someone were to walk into said cloud:
https://ajicjournal.org/retrieve/pii/S0196655305801439
The minimum level of protection against this virus is quite literally a P100 respirator, a PAPR/CAPR, or a 40mm NATO CBRN respirator, ideally paired with a full-body tyvek or tychem suit, gloves, and booties, with all the holes and gaps taped (in a pinch, surgical masks can be modified or worn a specific way to increase filtration):
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7409952/
Live SARS-CoV-2 may potentially be detected in sewage outflows, and there may be oral-fecal transmission:
https://www.sciencedirect.com/science/article/pii/S0048969720325936
https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0249568
https://www.nature.com/articles/s41587-020-0684-z
During the SARS outbreak in 2003, in the Amoy Gardens incident, hundreds of people were infected by aerosolized fecal matter rising from floor drains in their apartments (there is some valid concern that COVID-19 may also spread the same way, given its similarities to SARS):
https://pubmed.ncbi.nlm.nih.gov/16696450/
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC539564/
https://www.neha.org/sites/default/files/jeh/JEH5.06-Feature-Environmental-Transmission-of-SARS.pdf
https://www.cleanlink.com/news/article/COVID-19-Could-Spread-Through-Dry-Floor-Drains–25600
The vaccines for COVID-19 are not sterilizing and do not prevent infection or transmission. They are “leaky” vaccines. This means they remove the evolutionary pressure on the virus to become less lethal. It also means that the vaccinated are perfect carriers. In other words, those who are vaccinated are a threat to the unvaccinated, not the other way around:
https://www.cdc.gov/media/releases/2021/s0730-mmwr-covid-19.html
All of the COVID-19 vaccines currently in use have undergone minimal testing, with highly accelerated clinical trials. Though they appear to limit severe illness, the long-term safety profile of these vaccines remains unknown:
https://www.jdsupra.com/legalnews/accelerated-covid-19-vaccine-clinical-95853/
https://www.nebraskamed.com/COVID/were-the-covid-19-vaccines-rushed
Some of these so-called “vaccines” utilize an untested new technology that has never been used in vaccines before. Traditional vaccines use weakened or killed virus to stimulate an immune response. The Moderna and Pfizer-BioNTech vaccines do not. They are purported to consist of an intramuscular shot containing a suspension of lipid nanoparticles filled with messenger RNA:
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5439223/
https://cen.acs.org/pharmaceuticals/drug-delivery/Without-lipid-shells-mRNA-vaccines/99/i8
https://www.cdc.gov/coronavirus/2019-ncov/vaccines/different-vaccines/mrna.html
https://medlineplus.gov/genetics/understanding/therapy/mrnavaccines/
The way they generate an immune response is by fusing with cells in a vaccine recipient’s shoulder, undergoing endocytosis, releasing their mRNA cargo into those cells, and then utilizing the ribosomes in those cells to synthesize modified SARS-CoV-2 Spike proteins in-situ:
https://www.nature.com/articles/s41586-020-2622-0
These vaccines were produced or validated with the aid of fetal cell lines HEK-293 and PER.C6, which people with certain religious convictions may object strongly to:
SARS-CoV-2 Spike is a highly pathogenic protein on its own. It is impossible to overstate the danger presented by introducing this protein into the human body:
It is claimed by vaccine manufacturers that the vaccine remains in cells in the shoulder, and that SARS-CoV-2 Spike produced and expressed by these cells from the vaccine’s genetic material is harmless and inert, thanks to the insertion of prolines in the Spike sequence to stabilize it in the prefusion conformation, preventing the Spike from becoming active and fusing with other cells:
https://www.nature.com/articles/s41467-020-20321-x
https://cen.acs.org/pharmaceuticals/vaccines/tiny-tweak-behind-COVID-19/98/i38
However, a pharmacokinetic study from Japan showed that the lipid nanoparticles and mRNA from the Pfizer vaccine did not stay in the shoulder, and in fact bioaccumulated in many different organs, including the reproductive organs and adrenal glands, meaning that modified Spike is being expressed quite literally all over the place:
https://files.catbox.moe/0vwcmj.pdf
These lipid nanoparticles may trigger anaphylaxis in an unlucky few:
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8441754/
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7862013/
Messenger RNA is normally consumed right after it is produced in the body, being translated into a protein by a ribosome. COVID-19 vaccine mRNA is produced outside the body, long before a ribosome translates it. In the meantime, it could accumulate damage if inadequately preserved. When a ribosome attempts to translate a damaged strand of mRNA, it can become stalled:
https://elifesciences.org/articles/61984
https://www.frontiersin.org/articles/10.3389/fgene.2018.00431/full
Certain proteins, including SARS-CoV-2 Spike, have proteolytic cleavage sites that are basically like little dotted lines that say “cut here”, which attract a living organism’s own proteases (essentially, molecular scissors) to cut them. There is a possibility that S1 may be proteolytically cleaved from S2, causing active S1 to float away into the bloodstream while leaving the S2 “stalk” embedded in the membrane of the cell that expressed the protein:
https://academic.oup.com/cid/advance-article/doi/10.1093/cid/ciab465/6279075
https://www.nature.com/articles/s41564-021-00908-w
https://www.life-science-alliance.org/content/3/9/e202000786
SARS-CoV-2 Spike has a Superantigenic region (SAg), which may promote extreme inflammation:
https://www.pnas.org/content/117/41/25254
https://www.nature.com/articles/s41577-021-00502-5
Anti-Spike antibodies were found in one study to function as autoantibodies and attack the body’s own cells:
https://www.researchsquare.com/article/rs-612103/v2
Those who have been immunized with COVID-19 vaccines have developed blood clots, myocarditis, Guillain-Barre Syndrome, Bell’s Palsy, and multiple sclerosis flares, indicating that the vaccine promotes autoimmune reactions against healthy tissue:
https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-july-13-2021
https://www.medpagetoday.com/infectiousdisease/covid19vaccine/94061?xid=nl\_mpt\_DHE\_2021-08-17
SARS-CoV-2 Spike does not only bind to ACE2. It was suspected to have regions that bind to basigin, integrins, neuropilin-1, and bacterial lipopolysaccharides as well:
https://www.nature.com/articles/s41564-021-00958-0
https://www.mdpi.com/1422-0067/22/3/992/pdf
https://pubs.acs.org/doi/10.1021/acschemneuro.0c00619
https://www.science.org/doi/full/10.1126/science.abd3072
https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0253347
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7799037/
SARS-CoV-2 Spike, on its own, can potentially bind any of these things and act as a ligand for them, triggering unspecified and likely highly inflammatory cellular activity:
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7827936/
SARS-CoV-2 Spike contains an unusual PRRA insert that forms a furin cleavage site. Furin is a ubiquitous human protease, making this an ideal property for the Spike to have, giving it a high degree of cell tropism. No wild-type SARS-like coronaviruses related to SARS-CoV-2 possess this feature, making it highly suspicious, and perhaps a sign of human tampering:
https://journals.asm.org/doi/full/10.1128/JVI.01751-20
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7457603/
SARS-CoV-2 Spike has a prion-like domain that enhances its infectiousness:
https://www.preprints.org/manuscript/202003.0422/v1
https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0023664
The Spike S1 RBD may bind to heparin-binding proteins and promote amyloid aggregation. In humans, this could lead to Parkinson’s, Lewy Body Dementia, premature Alzheimer’s, or various other neurodegenerative diseases:
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7988450/
This is very concerning because SARS-CoV-2 S1 is capable of penetrating the blood-brain barrier and entering the brain. It is capable of increasing the permeability of the blood-brain barrier to itself and other molecules by injuring and disrupting it directly:
https://www.nature.com/articles/s41593-020-00771-8
https://www.nature.com/articles/s41392-021-00719-9
https://pubmed.ncbi.nlm.nih.gov/33053430/
SARS-CoV-2, like other betacoronaviruses, may have Dengue-like ADE, or antibody-dependent enhancement of disease:
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7943455/
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7454712/
https://www.journalofinfection.com/article/S0163-4453(21)00392-3/fulltext
https://sharylattkisson.com/2021/08/study-why-so-many-vaccinated-people-are-getting-sick/
https://www.nature.com/articles/s41564-020-00789-5
https://www.sciencedirect.com/science/article/pii/S1201971220307311
https://pubmed.ncbi.nlm.nih.gov/31826992/
https://www.biorxiv.org/content/10.1101/2021.08.22.457114v1
There is something called Original Antigenic Sin, which is the observation that the body prefers to produce antibodies based on previously-encountered strains of a virus over newly-encountered ones:
https://www.jimmunol.org/content/202/2/335
https://en.wikipedia.org/wiki/Original_antigenic_sin
In ADE, antibodies from a previous infection become non-neutralizing due to mutations in the virus’s proteins. These non-neutralizing antibodies then act as trojan horses, allowing live, active virus to be pulled into macrophages through their Fc receptor pathways:
https://en.wikipedia.org/wiki/Antibody-dependent_enhancement
https://www.cdc.gov/dengue/training/cme/ccm/page57857.html
It is possible for vaccines to sensitize someone to disease. There is a precedent for this in recent history. Sanofi’s Dengvaxia vaccine for Dengue failed because it caused immune sensitization in people whose immune systems were Dengue-naive:
https://www.frontiersin.org/articles/10.3389/fcimb.2020.572681/full
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3739535/
In mice immunized against SARS-CoV and challenged with the virus, a close relative of SARS-CoV-2, they developed immune sensitization, Th2 immunopathology, and eosinophil infiltration in their lungs:
https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0035421
We have been told that SARS-CoV-2 mRNA vaccines cannot be integrated into the human genome, because messenger RNA cannot be turned back into DNA. This is false. There are elements in human cells called LINE-1 retrotransposons, which can indeed integrate mRNA into a human genome by endogenous reverse transcription:
https://pubmed.ncbi.nlm.nih.gov/33330870/
The vaccine and the virus were made by the same people. In 2014, there was a moratorium on SARS gain-of-function research that lasted until 2017:
https://www.phe.gov/s3/dualuse/documents/gain-of-function.pdf
Ralph Baric is a virologist and SARS expert at UNC Chapel Hill in North Carolina. This is who Anthony Fauci was referring to when he insisted, before Congress, that if any gain-of-function research was being conducted, it was being conducted in North Carolina:
Ralph Baric: On the Front Lines of Coronavirus for Three Decades
Ralph Baric and Shi Zhengli are colleagues and have co-written papers together:
https://www.nature.com/articles/nm.3985/
Ralph Baric mentored Shi Zhengli in his gain-of-function manipulation techniques, particularly serial passage, which results in a virus that appears as if it originated naturally. In other words, deniable bioweapons. Serial passage in humanized hACE2 mice may have produced something like SARS-CoV-2:
https://www.paul.senate.gov/newsweek-op-ed-congress-must-pursue-answers-about-origin-covid-19
https://nymag.com/intelligencer/article/coronavirus-lab-escape-theory.html
The funding for the gain-of-function research being conducted at the Wuhan Institute of Virology came from Peter Daszak. Peter Daszak runs an NGO called EcoHealth Alliance:
https://peterdaszak.com/interceptdocs.pdf
https://theintercept.com/2021/09/09/covid-origins-gain-of-function-research/
EcoHealth Alliance received millions of dollars in grant money from the National Institutes of Health/National Institute of Allergy and Infectious Diseases (that is, Anthony Fauci), the Defense Threat Reduction Agency (part of the US Department of Defense), and the United States Agency for International Development. NIH/NIAID contributed a few million dollars, and DTRA and USAID each contributed tens of millions of dollars towards this research. Altogether, it was over a hundred million dollars:
EcoHealth Alliance subcontracted these grants to the Wuhan Institute of Virology, a lab in China with a very questionable safety record and poorly-trained staff, so that they could conduct gain-of-function research:
https://nypost.com/2021/07/01/pentagon-gave-millions-to-ecohealth-alliance-for-wuhan-lab/
Chinese scientists in Wuhan reported being routinely bitten and urinated on by laboratory animals:
In November of 2019, three technicians at the Wuhan Institute of Virology developed symptoms consistent with a flu-like illness:
https://www.webmd.com/lung/news/20210524/wuhan-lab-researchers-illness
December 12th, 2019, Ralph Baric signed a Material Transfer Agreement (essentially, an NDA) to receive Coronavirus mRNA vaccine-related materials co-owned by Moderna and NIH:
https://s3.documentcloud.org/documents/6935295/NIH-Moderna-Confidential-Agreements.pdf
It wasn’t until a whole month later, on January 11th, 2020, that China allegedly sent us the sequence to what would become known as SARS-CoV-2:
https://www.sciencedaily.com/releases/2020/01/200131114748.htm
Moderna claims, rather absurdly, that they developed a working vaccine from this sequence in under 48 hours:
https://www.businessinsider.com/moderna-designed-coronavirus-vaccine-in-2-days-2020-11
Moderna designed its coronavirus vaccine in 2 days — here’s how
https://nymag.com/intelligencer/2020/12/moderna-covid-19-vaccine-design.html
Stephane Bancel, the current CEO of Moderna, was formerly the CEO of bioMerieux, a French multinational corporation specializing in medical diagnostic tech, founded by one Alain Merieux:
https://en.wikipedia.org/wiki/St%C3%A9phane\_Bancel
https://www.himss.org/global-conference/speaker-stephane-bancel
Alain Merieux was one of the individuals who was instrumental in the construction of the Wuhan Institute of Virology’s P4 lab:
https://medicalxpress.com/news/2020-04-wuhan-lab-core-virus-controversy.html
http://english.whiov.cas.cn/ne/201712/t20171212_187624.html
The sequence given as the closest relative to SARS-CoV-2, RaTG13, is not a real virus. It is a forgery:
https://nerdhaspower.weebly.com/ratg13-is-fake.html
RaTG13 – the Undeniable Evidence That the Wuhan Coronavirus Is Man-Made
https://www.peakprosperity.com/forum-topic/scientific-history-of-ratg13/
The animal reservoir of SARS-CoV-2 has never been found:
https://www.technologyreview.com/2021/03/26/1021263/bat-covid-coronavirus-cause-origin-wuhan/
The FBI raided Allure Medical in Shelby Township north of Detroit for billing insurance for “fraudulent COVID-19 cures”. The treatment they were using? Intravenous Vitamin C. An antioxidant. Which, as described above, is an entirely valid treatment for COVID-19-induced sepsis, and indeed, is now part of the MATH+ protocol advanced by Dr. Paul E. Marik:
https://pubmed.ncbi.nlm.nih.gov/31978969/
https://www.sciencedirect.com/science/article/abs/pii/S0883944119316107?via%3Dihub
The FDA banned ranitidine (Zantac) due to supposed NDMA (N-nitrosodimethylamine) contamination:
Ranitidine is not only an H2 blocker used as antacid, but also has a powerful antioxidant effect, scavenging hydroxyl radicals. This gives it utility in treating COVID-19:
https://onlinelibrary.wiley.com/doi/10.1111/j.1472-8206.2009.00810.x
https://www.sciencedirect.com/science/article/pii/S1347861319342203
The FDA also attempted to take N-acetylcysteine, a harmless amino acid supplement and antioxidant, off the shelves, compelling Amazon to remove it from their online storefront:
https://www.naturalproductsinsider.com/regulatory/us-senator-npa-press-fda-nac-supplements
https://www.nutraingredients-usa.com/Article/2021/05/11/CRN-This-is-not-the-final-word-on-NAC
https://www.naturalproductsinsider.com/regulatory/amazon-confirms-plans-removing-nac-supplements
On June 9th, 2020, Charles Lieber, a Harvard nanotechnology researcher with decades of experience, was indicted by the DOJ for fraud:
Charles Lieber received millions of dollars in grant money from the US Department of Defense, specifically the military think tanks DARPA, AFOSR, and ONR, as well as NIH and MITRE:
His specialty is the use of silicon nanowires in lieu of patch clamp electrodes to monitor and modulate intracellular activity, something he has been working on at Harvard for the past twenty years:
https://www.harvardmagazine.com/2011/01/virus-sized-transistors
He was claimed to have been working on silicon nanowire batteries in China, but none of his colleagues can recall him ever having worked on battery technology in his life; all of his research deals with bionanotechnology, or the blending of nanotech with living cells:
https://news.harvard.edu/gazette/story/2019/07/harvard-researchers-present-nanowire-devices-update/
The indictment was over his collaboration with the Wuhan University of Technology. He had double-dipped, against the terms of his DOD grants, and taken money from the PRC’s Thousand Talents plan, a program which the Chinese government uses to bribe Western scientists into sharing proprietary R&D information that can be exploited by the PLA for strategic advantage (this risk has been known for a very long time):
https://www.justice.gov/usao-ma/pr/harvard-university-professor-indicted-false-statement-charges
https://www.nature.com/articles/d41586-020-00291-2
https://www.research.psu.edu/sites/default/files/FBI_Risks_To_Academia.pdf
https://www.drdavidzweig.com/wp-content/uploads/2020/05/Zweig-Kang-TTP.pdf
Charles Lieber’s own papers describe the use of silicon nanowires for brain-computer interfaces, or “neural lace” technology. His papers describe how neurons can endocytose whole silicon nanowires or parts of them, monitoring and even modulating neuronal activity:
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6531316/
https://spectrum.ieee.org/human-cells-eat-nanowires
Charles Lieber was a colleague of Robert Langer. Together, along with Daniel S. Kohane, they worked on a paper describing artificial tissue scaffolds that could be implanted in a human heart to monitor its activity remotely:
Robert Langer, an MIT alumnus and expert in nanotech drug delivery, is one of the co-founders of Moderna:
https://www.modernatx.com/modernas-board-directors
His net worth is now $5.1 billion USD thanks to Moderna’s mRNA-1273 vaccine sales:
Both Charles Lieber and Robert Langer’s bibliographies describe, essentially, techniques for human enhancement, i.e. transhumanism:
Klaus Schwab, the founder of the World Economic Forum and the architect behind the so-called “Great Reset”, has long spoken of the “blending of biology and machinery” in his books:
Since these revelations, it has come to the attention of independent researchers that the COVID-19 vaccines (and even some surgical masks) may contain reduced graphene oxide nanoparticles:
https://www.thelibertybeacon.com/graphene-oxide-the-vector-for-covid-19-democide/
https://www.orwell.city/2021/06/vaccination-vial-analysis-explained.html
https://www.nature.com/articles/s41428-020-0350-9
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6141029/
Japanese researchers have also found unexplained contaminants in COVID-19 vaccines:
Graphene oxide is an anxiolytic. It has been shown to reduce the anxiety of laboratory mice when injected into their brains:
https://www.sciencedirect.com/science/article/pii/S0142961221001058
https://graphene-flagship.eu/graphene/news/soothing-the-symptoms-of-anxiety-with-graphene-oxide/
Indeed, given SARS-CoV-2 Spike’s propensity to compromise the blood-brain barrier and increase its permeability, it is the perfect protein for preparing brain tissue for extravasation of nanoparticles from the bloodstream and into the brain:
https://pubs.acs.org/doi/10.1021/acsanm.8b02056
https://www.sciencedirect.com/science/article/pii/S0168365916303236
Graphene is also highly conductive and, in some circumstances, paramagnetic:
https://www.livescience.com/graphene-hides-rare-magnetism.html
https://www.sciencedirect.com/science/article/pii/S0008622319305809
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6474003/
BRAIN is an acronym for Brain Research Through Advancing Innovative Neurotechnologies®. This program involves the development of brain-computer interface technologies for the military, particularly non-invasive, injectable systems that cause minimal damage to brain tissue when removed:
https://www.darpa.mil/program/our-research/darpa-and-the-brain-initiative
Various methods have been proposed for achieving this, including optogenetics, magnetogenetics, ultrasound, implanted electrodes, and transcranial electromagnetic stimulation. In all instances, the goal is to obtain read or read-write capability over neurons:
https://www.darpa.mil/news-events/2019-05-20
Wireless brain-computer interfaces may interact with current or future wireless GSM infrastructure, creating neurological data security concerns:
https://www.frontiersin.org/articles/10.3389/fnins.2019.00112/full
https://www.intechopen.com/chapters/44252
https://www.brown.edu/news/2021-03-31/braingate-wireless
A BCI that is capable of altering the contents of one’s mind would theoretically be capable of altering mood and personality, or perhaps even subjugating someone’s very will, rendering them utterly obedient to authority:
https://link.springer.com/article/10.1007/s11023-012-9298-7
Mind reading and brain computer interface technology: the future is coming, fast
BCIs could be used to unscrupulously alter perceptions of basic things such as emotions and values, changing people’s thresholds of satiety, happiness, anger, disgust, and so forth:
http://www.buffalo.edu/news/releases/2010/07/11518.html
Brain-machine interfaces may be used to study and regulate mood
https://www.nature.com/articles/s41593-019-0488-y
For the wealthy, neural laces would be an unequaled boon, giving them the opportunity to enhance their intelligence with neuroprosthetics (i.e. an “exocortex”):
https://ieeexplore.ieee.org/document/6893912
The people who rule over us are Dark Triad types who cannot be trusted with such power:
https://www.sakkyndig.com/psykologi/artvit/babiak2010.pdf
https://fortune.com/2021/06/06/corporate-psychopaths-business-leadership-csr/
https://www.forbes.com/sites/jackmccullough/2019/12/09/the-psychopathic-ceo/
#PR POPULAR RATIONALISM COVID-19 HERO SERIES
Meet Dr. Harvey Risch (Photo: Yale.edu)
Harvey Risch is a brilliant contributor to the knowledge base of biomedical research. Dr. Risch was the first to publish on hydroxychloroquine, very early in the pandemic, summarizing in the American Journal of Epidemiology evidence that hydroxychloroquine (HCQ) was associated with lowered mortality risk in a dose-dependent manner. He advocated very strongly that the world should not wait for the outcome of long-term randomized clinical trials, showing a correct understanding of the level of evidence required for off-label prescription during emergencies. This publication has had more than 140,000 views. You can read his, and the world’s first review of the clinical evidence of hydroxychloroquine here.
Dr. Risch also served as the principal scientist in the large Brazil hydroxychloroquine trial, published in Travel Medicine and Infectious Disease. That study found day 6 use of HCQ, prednisone or both significantly reduced hospitalization risk by 50–60%. It is inconceivable that in the review of the evidence Dr. Risch presented that individuals like Anthony Fauci could not have known about what the studies were truly indicating. You can read the large Brazil HCQ study here.
Dr. Risch has also worked tirelessly to educate the public on hydroxychloroquine and other aspects of COVID-19, such as this piece in Newsweek in July, 2020 “Tireless” does not truly capture his efforts; he has appeared in interviews on television at least 76 times to date, and had provided testimony for important proceedings, giving decision makers no reason not to see and understand the value of HCQ for outpatient care for COVID-19.
It is a near universal truth that academic training, especially in the medical and biological sciences, attempts to force specialization. When individuals in academia continue to gather new skills via formal training, they break the mold. In addition to his medical training, Dr. Risch obtained a PhD in mathematical modeling of infectious epidemics and has actively published on that challenging topic. He is Professor of Epidemiology at Yale School of Public Health, widely recognized as one of the premier public health institutions in this country, and has published over 350 peer-reviewed scientific research papers. His publications have generated over 41,000 citations of those papers in the medical and scientific literature.
One of the distinctions that Dr. Risch carries is that he has no financial conflicts of interest in HCQ or any early treatment for COVID-19. Dr. Risch’s early vision has been supported by the clinical experience of many physicians - and he is co-author on the landmark “Pathophysiological Basis and Rationale for Early Outpatient Treatment of SARS-CoV-2 (COVID-19) Infection” with world-renown COVID-19 authority Dr. Peter McCollough.
Critics of Dr. Risch accuse him of weakening the standards for clinical adoption of treatment for COVID-19. These critics are hazards to public health in part because they fail to respect that off-label use is allowed when no standard of care exists (such as with COVID-19), and that Emergency Use Authorization (EUAs) do not require the same high level of evidence that clinical options require for success in translational efforts for medical options during non-emergencies. They apparently are unaware that the rules have changed for COVID-19 related studies: Real World Data and Real World Evidence can now be given full consideration by regulatory agencies (See FDA Guidance, 9/30/2021).
One of Dr. Risch’s interviews was with Dr. Naomi Wolf on The Daily Clout. Co-guests included Dr. Howard Tenenbaum, and Dr. Paul Alexander.
And here is a highly informative academic presentation (aired June 25, 2021) that tells the story of hydroxychloroquine and its abuse by false accusations and fake studies. He also highlights the Bradford-Hill Criteria for causality, a topic we’ll be reviewing in courses at IPAK-EDU.
NIAID Director Anthony Fauci has rejected hydroxychloroquine using language like “all the credible studies”. There are limitations to the available science on hydroxychloroquine, not the least of which have included faked studies conducted and published to cast dispersion on the inexpensive drug. Other limitations include small sample sizes of some studies; however, if Fauci and Francis Collins had prioritized large, well-conducted studies of hydroxychloroquine, this would not be a limiting issue. The massive number of studies to date that find an effect place hydroxychloroquine high among the candidates for likely to succeed in a thorough, objective analysis.
The fact that people are still dying without any ambulatory in-home care is the crime of the century.
Related
Alexander, P et al., Early Multidrug Outpatient Treatment of SARS-CoV-2 Infection (COVID-19) and Reduced Mortality Among Nursing Home Residents
Who Are the World's Leading Authorities in COVID-19 Treatment?
COVID-19 early treatment: real-time analysis of 1,013 studies
Peter McCullough speaks at the 78th Annual Meeting of the Association of American Physicians and Surgeons on October 2, 2021.
Anne McCloskey retired from her job as a general practitioner two years ago. When COVID hit, the authorities appealed for additional medical personnel and she answered the call in Derry, Northern Ireland.
After she released this video in August 2021, McCloskey was suspended pending an investigation. The Chief Medical Officer of Northern Ireland declared himself “appalled” by her remarks.
Please watch, listen, and make up your own mind.
[
](https://swprs.org/wp-content/uploads/2020/08/covid-stages.png)
Stages and treatment of covid disease (EVMS)
Updated: September 2021
Languages: German, English
Share on: Twitter / Facebook
Based on the available scientific evidence and current clinical experience, the SPR Collaboration recommends that physicians and authorities consider the following covid-19 treatment protocol for the prophylactic and early treatment of people at high risk or high exposure.
Numerous international studies have shown that prophylactic and early treatment can significantly reduce the risk of severe and fatal covid-19 (see scientific references below).
Note: Patients are asked to consult a doctor.
Treatment protocol
Prophylaxis
- Vitamin D3 (2000 IU per day)
- Vitamin C (500mg per day)
- Zinc (20mg to 30mg per day)
- Quercetin (250mg per day)
- Mouthwashes and nasal spray
Early treatment
- Zinc (75mg to 100mg per day)
- Quercetin (500mg per day)
- Aspirin (325mg per day)*
- Bromhexine (48mg per day)*
- Artemisia annua (extract)
- Mouthwashes and nasal spray
Prescription only
- High-dose calcifediol*
- Sulodexide (LMW heparin)*
- Fluvoxamine or cyproheptadine*
- Steroids: Prednisone or budesonide*
- Monoclonal antibody treatment
- Anti-androgen treatment
- Ivermectin (see below)
(*) Notes
- The early treatment phase includes post-exposure prophylaxis (PEP).
- Bromhexine is available prescription-free in most of Europe, but not in the US.
- Steroids and cyproheptadine are only used if respiratory symptoms develop.
- Counterindications and maximum dosages must be observed for all drugs.
- On hydroxychloroquine (HCQ), see Severe covid: A postviral autoimmune attack
See also
- FLCCC Covid-19 Prophylaxis and Treatment Protocols (FLCCC)
- Early Outpatient Treatment of COVID-19 (McCullough et al.)
- Covid-19 Early Treatment Study Overview (c19early.com)
Treatment studies
Results of trials and studies on the early treatment of covid.
Ivermectin
Ivermectin (an antiparasitic drug) has anti-viral and anti-inflammatory properties.
- Several controlled and observational studies on ivermectin found anti-viral and anti-inflammatory effects and a significant reduction in covid morbidity and mortality.
- However, once low-quality studies are excluded from the analysis, the benefit is no longer statistically significant, although a limited benefit might still be possible.
- Due to a lack of large high-quality trials, the WHO, the US FDA and the European EMA do not recommend using ivermectin against covid outside of clinical trials.
- Read more: The Ivermectin Debate (SPR)
**Zinc and quercetin
**
Zinc inhibits RNA polymerase activity of coronaviruses and thus inhibits virus replication. Quercetin (a plant polyphenol) supports the cellular absorption of zinc and has additional anti-viral properties.
- A Spanish study found that low plasma zinc levels (below 50mcg/dl) increased the risk of in-hospital death of covid patients by 130%.
- US studies found an 84% decrease in hospitalizations and a 45% decrease in mortality based on risk-stratified early treatment with zinc and HCQ.
- A US case study reported a rapid resolution of covid symptoms, such as shortness of breath, based on early outpatient treatment with high-dose zinc.
- An Italian randomized trial found a significantly reduced hospitalization rate and mortality in covid patients receiving quercetin.
Bromhexine
Bromhexine (a mucolytic cough medication) inhibits the expression of cellular TMPRSS2 protease and thus the entry of the virus into the cell, as first described in 2017.
- A randomized Iranian trial with 78 patients found a decrease in intensive care treatments of 82%, a decrease in intubations of 89%, and a decrease in deaths of 100%.
- A Chinese trial found a 50% reduction in intubations in patients receiving bromhexine.
- A Russian study found a faster recovery in hospitalized patients receiving bromhexine.
- A Russian prophylaxis study found a reduction in symptomatic covid from 20% to 0%.
Vitamin D3
Vitamin D3 supports and improves the immune system response to infections.
- A Spanish randomized controlled trial found a 96% reduction in the risk of requiring intensive care in patients receiving high-dose vitamin D (100,000 IU).
- Another randomized trial in Spain with 930 hospitalized patients found a reduction in ICU treatment of 80% and in mortality of 60% in patients receiving high-dose vitamin D.
- A study in a French nursing home found an 89% decrease in mortality in residents who had received high-dose vitamin D either shortly before or during covid-19 disease.
- A retrospective British study of approximately 1000 hospitalized covid patients found an 80% reduction in mortality with high-dose vitamin D.
- A large Israeli study found a strong link between vitamin D deficiency and covid-19 severity.
- For an overview of all covid-19 vitamin D studies, see here.
**Aspirin and heparin
**
Aspirin and heparin have anti-platelet and anti-thrombotic effects.
- A meta-study including 15,000 patients found a reduction in covid mortality of 53% in patients who were receiving aspirin as early or prophylactic treatment.
- A study published in PLOS One found a reduction in covid mortality at 30 days from 10.5% (control group) to 4.3% (with aspirin) in 70,000 US veterans taking aspirin.
- A retrospective US study with 400 patients found a reduction in ICU treatments by 43% and a reduction in mortality by 47% in the group of patients treated early with aspirin.
- A Mexican randomized controlled trial found a 40% reduction in hospitalization in patients receiving sulodexide (a heparin combination).
Artemisia annua (powder, extract, or tea)
Artemisia annua plant extract has known antimalarial and antiviral properties.
- An in vitro study by the German Max Planck Institute, published in Nature Scientific Reports, found artemisia annua to be effective against SARS-CoV-2 at realistic doses.
- An in vitro study by US researchers, published in the Journal of Ethnopharmacology, found artemisia annua hot-water extracts to be effective against SARS-CoV-2 replication.
- In a small clinical trial, published in Antimicrobial Agents, the viral load decreased significantly faster in covid patients treated with artemisinin-piperaquine.
- In a 2005 in vitro study, published in Antiviral Research, artemisia annua was already identified as effective against the original SARS-1 virus.
- In Madagascar, the first country to apply Artemisia annua extract against covid, covid and all-cause mortality has remained very low, even for African standards.
- In a simulation study by a Harvard group, the anti-malaria drug amodiaquine was identified as most effective against SARS-CoV-2 replication.
Mouthwashes and nasal sprays
Mouthwashes and nasal sprays target the initial infection and viral replication.
- Several small studies found that mouthwashes (gargling) based on povidone-iodine and nasal sprays based on povidone-iodine or nitric oxide may prevent a coronavirus infection or reduce its duration or symptoms (more about this).
- The German Society for Hospital Hygiene (DGKH) recommends anti-viral mouthwashes and nasal sprays for prophylaxis and early treatment.
- Some observers argued that traditional nasal rinsing and gargling practices in South East Asia may have helped successfully limiting coronavirus infections in these countries.
- Israel started mass production of nasal sprays based on nitric oxide in early 2021.
Anti-androgen treatment
Anti-androgen treatment inhibits the expression of the TMPRSS2 cellular protease used by SARS-CoV-2, which is driven by androgen hormones (i.e. male sexual hormones).
- A first randomized, double-blinded and placebo-controlled trial in Brazil found that proxalutamide reduced hospitalization rates in male patients by 91%.
- Another randomized, double-blinded and placebo-controlled trial in Brazil found that proxalutamide reduced mortality in hospitalized patients (male and female) by 78%.
- However, the two Brazilian trials have been criticized by other researchers.
- Previous studies found that men receiving anti-androgens – typically used against prostate cancer or hair loss – were at a much lower risk of severe covid.
Fluvoxamine and Cyproheptadine
These drugs inhibit serotonin-induced pulmonary vasoconstriction.
- The TOGETHER trial found that fluvoxamine outpatient treatment of covid patients reduced disease progression (hospitalizations or ER visits) significantly by 29%.
- The results of two preliminary US trials indicate that early treatment with fluvoxamine may reduce the risk of severe covid, hospitalization and death to near zero.
- Fluvoxamine and cyproheptadine target serotonin metabolism and serotonin-induced pulmonary vasoconstriction, which according to emerging evidence may be a key mechanism driving severe covid and covid-related respiratory failure.
- Fluvoxamine is a selective serotonin reuptake inhibitor (SSRI) and reduces platelet serotonin concentration; cyproheptadine is a direct serotonin receptor antagonist.
Corticosteroids
Corticosteroids (e.g. prednisone, budesonide) reduce covid-related hyper-inflammation.
- A study by the University of Oxford, published in the Lancet, found a significant reduction in urgent care visits and hospitalizations in patients receiving budesonide (an asthma drug).
- The British PRINCIPLE trial found that budesonide accelerated recovery by 3 days and reduced hospitalizations and deaths from 10.3% to 8.5%.
- The early outpatient treatment protocol developed by McCullough et al. recommends the use of prednisone if (and only if) covid-related respiratory symptoms develop.
Monoclonal antibody therapy
Antibody therapy is intended to inhibit viral replication.
- Monoclonal antibodies are ineffective in late treatment of covid, but very effective in early treatment. This is because severe covid is characterized by hyper-inflammation, not viral replication.
- Some monoclonal antibodies have lost their effectiveness against new virus variants.
- Convalescent plasma therapy has been shown to be ineffective in both early and late treatment of covid.
Additional notes
The early treatment of patients as soon as the first typical symptoms appear and even without a PCR test is essential to prevent progression of the disease. In contrast, isolating infected high-risk patients at home and without early treatment until they develop serious respiratory problems, as often happened during lockdowns, may be counterproductive.
People at high risk living in an epidemically active area should consider prophylactic treatment together with their doctor. The reason for this is the long incubation period of covid-19 (up to 14 days): when patients first notice that they contracted the disease, the viral load is already at a maximum and there are often only a few days left to react with an early treatment intervention.
Early treatment based on the above protocol is intended to avoid hospitalization. If hospitalization nevertheless becomes necessary, experienced ICU doctors recommend avoiding invasive ventilation (intubation) whenever possible and using oxygen therapy (HFNC) instead.
See also
An extension to a previous timeline covering April 2020–March 2021. The new timeline covers the period from April 2021 to June 2021.
Read the timeline by going to the source link.
The final discussion and conclusion is copied below.
Topics:
WHO's role and its funding, Gavi, COVAX, Trusted News Initiative, International Fact-Checking Network, the role of private philanthropy, Frontiers issue, comparison to the H1N1 pandemic, new treatment protocols, causal modeling.
Introduction
Ivermectin is a multifaceted medication invented in collaboration between Japanese professor emeritus Satoshi ¯ Omura from Kitasato University and US researcher William Campbell from Merck & Co/MSD between 1973 and 1979 [1];[2]. Each of them received one quarter of the 2015 Nobel Prize in physiology or medicine for their discoveries [3]. Ivermectin is best known as an antiparasitic agent, with approximately four billion doses having been administered since 1981, predominantly in Africa. Merck &Co/MSD’s patent expired in most countries in 1996, and ivermectin preparations are currently available internationally from many sources, with the production cost of a single dose estimated to be less than0.1 US dollars [4].
This article extends the timeline of ivermectin related-events described in a previous preprint available in two versions, March 30, 2021 and April 3, 2021 [5];[6]. The latter preprint covered the period from April 1, 2020 to March 31, 2021. This preprint extends the timeline to cover April–June 2021, as well as adding a few earlier events. Some caveats of the review are described in the previous preprint. Due to resource limitations, details of many developments are not covered in detail but only mentioned briefly,and omissions have been unavoidable. The focus of this review entails the social, organizational, financial and legal aspects of the situation with ivermectin, with less emphasis placed on presenting clinical trial results and biomedical research.Some of the main events in the previously covered period from April 2020 to March 2021 were an Australian in vitro study which initiated the interest in ivermectin [7]. This was followed by adoption of ivermectin in several South and Central American countries, the state of Uttar Pradesh in India, and Bangladesh in the second and third quarter of 2020. In late October 2020, the Front Line COVID-19Critical Care Alliance (FLCCC) published its ivermectin-based outpatient protocol called I-MASK+ [8];[9];[10].
A month later, another group called CovidAnalysis begun publishing a meta-analysis of ivermectin trials [11] and a list of ivermectin studies [12]. A main event in December 2020 was the US Senate hearing of Pierre Kory of the FLCCC [13]. The hearing raised interest of Lawrie et al. and Bryant et al. who produced additional meta-analyses [14];[15]. In conjunction, another group called British Ivermectin Recommendation Development (BIRD) was founded.
Another main event was the introduction of a preprint of a Unitaid/WHO-funded meta-analysis by Hillet al. [16]. Yet another notable event was the publication of an extensive review by a Japanese group including the discoverer of avermectins, the Nobel prize winner Satoshi ¯ Omura [2];[17].
In the first quarter of 2021, ivermectin had been adopted in several additional countries including Slovakia as the first European Union member country. However, in March 2021 both the European Medicine Agency (EMA) and the World Health Organization (WHO) advised against the use of ivermectin except in clinical trials, ignoring the various meta-analyses and the results of 26 existing randomized clinical trials, in addition to a similar amount of observational trials and other studies.
The majority of indications and the safety of ivermectin have been described in the previous preprint [6].In addition, in April 2021 ivermectin was found to effectively inhibit hepatitis E virus replication [18]. There is also a relatively large amount of research about the treatment of cancers with ivermectin [19][20][21][22][23][24][25], including breast cancer [26][27][28][29][30][31][32], ovarian cancer [33][34][35][36][37][38][39], cervical cancer [40], oesophageal squamous cell carcinoma [41], renal cancer [42], glioma [43][44][45], nasopharyngeal carcinoma [46], melanoma [47][48], gastric cancer [49][50], liver cancer [51] and leukemia [52][53] (list from [54]).
Recently, mass distribution of ivermectin has been studied for prophylaxis of malaria [55];[56];[57]. Ivermectin has also been found to promote wound healing partly through modulation of the inflammatory process and the levels of transforming growth factor beta 1 (TGF-β1) and vascular endothelial growth factor (VEGF) [58]. Ivermectin has also been proposed for the treatment of autoimmune disorders [59].
Omura has characterized ivermectin as “a panacea for resource-poor communities” [60]. Ivermectin has also been said to “continue to surprise and excite scientists, offering more and more promise to help improve global public health by treating a diverse range of diseases, with its unexpected potential as an antibacterial, antiviral and anti-cancer agent being particularly extraordinary” [61]. Possible issues include environmental toxicity [62];[63] and the emergence of ivermectin resistance [64].
April 2021...
Read the timeline by going to the source link. The final discussion and conclusion is copied below.
Discussion
In the United States and the European Union, most of the year 2020 appeared to have been characterized by an attempt to collect ivermectin-related data. The period from the beginning of November 2020 tothe end of March 2021 appeared to be characterized by disputes about interpretation of this data. The change of administration in the United States did not appear to significantly change its ivermectin-related health policy, likely to the disappointment of ivermectin proponents. Beginning from the March 30 guideline decision by the WHO against ivermectin, a period of a kind of trench warfare appeared to emerge. Ivermectin proponents, especially the FLCCC, announced they had resigned their attempts to influence the US National Institutes of Health, the Food and Drugs Agency, the European Medicines Agency and the World Health Organization. Similarly, the BIRD group turned directly to clinicians and the public. Changes to existing treatment protocols were mostly minor. Fluvoxamine emerged as an option and was added to many protocols including the FLCCC’s. The FLCCC introduced two new protocols: the I-MASS protocol for mass prophylaxis and the I-RECOVER for long haul COVID-19syndrome (LHCS). An interesting new development was the recognition of the role of mast cell activation and histamine release in LHCS [456].
The US NIH announced a new trial, ACTIV-6, for repurposed medicines, estimated to finish in March2023, almost two years in the future, rendering the trial practically irrelevant for the purposes of handling the pandemic. Simultaneously, pharmaceutical companies continued their attempts to finish their trials of new outpatient treatment pharmaceuticals as swiftly as possible, and new projects for the development of such treatments were initiated in the US and the UK.
A third concurrent process was the slower-than-expected progress of vaccination programs. A fourth concurrent process was the adoption of ivermectin in countries outside the US and EU. The countries who had adopted ivermectin previously, including Slovakia, implicitly disregarded the March 2021 guideline set by the WHO [171];[457]. India adopted ivermectin nationally after the announcement of the WHO guideline, then mostly dropped it, with the current situation being somewhat unclear. Legal action against the WHO was initiated in India. At the end of the period, Indonesia adopted ivermectin.With regard to researchers and clinicians, medical professionals whose practices appeared to be predominantly based on following existing regulations and protocols appeared to feel criticism against them unjustified and unfair. Similarly, medical professionals whose interest was in the further development of the protocols felt criticism against them unjustified and unfair. The first group may have perceived the latter group as deviants, whereas the latter group may have perceived the first group as anti-innovative.Presumably, both groups saw each others’ practices as somewhat unethical and antisocial. The difference was possibly due to different perspectives on collegiality and the perception of the role of patients. The first group appeared to put more weight on collegial cohesion and rule-adherence, with less weight put on individual patient outcomes, assumedly perceiving that patient outcomes were predominantly the product of the inflexible regulations which lay beyond their responsibility. The second group appeared to put less weight on collegial cohesion and regulations, placing more weight on individual patient outcomes, assumedly perceiving that patient outcomes superseded the rules and that validation of rules was the responsibility of individual clinicians.
With regard to COVID-19, knowledge about the mechanisms and treatments was somewhat scarce especially in the early phase of the pandemic. A recent study described that in such a situation, it would be adaptive to seek further information to resolve uncertainty and obtain a more accurate worldview but biases in such information-seeking behavior could contribute to the maintenance of inaccurate views [458].
The study indicated that more dogmatic individuals were less likely to seek out new information to refine an initial perceptual decision, leading to a reduction in overall belief accuracy despite similar initial decision performance. In addition, dogmatic participants placed less reliance on internal signals of uncertainty, rendering them less likely to seek additional information to update beliefs derived from weak or uncertain initial evidence. Dogmatism is often defined as a viewpoint or system of ideas based on insufficiently examined premises. Thus, differences in openness to research evidence may have been due to differences in personalities and habits which, in turn, may be seen as products of the life experiences(environments) of the individuals, including their medical education.
At times, the views appeared to differ up to a point in which the existence of a shared reality could be questioned, and the practice of presenting opposite conclusions on the same, existing data was in effect making further research irrelevant.
Validity of statistics-based research
In the context of clinical trials, the fundamental validity of the statistics-based research in general is rarely discussed. In 2011, Penston said that the extent and depth of the criticisms of statistics-based research usually comes as a surprise to investigators, doctors and other health care professionals who use the data from large-scale RCTs and epidemiological studies, as they rarely have the time, inclination and skill to read the related literature [459]. He questioned the large size of a study as a sign of strength,saying that as the number of patients recruited to a study increases, statistical significance may be achieved but causal inference is weakened, adding that the source of the problem was the belief that causal relationships of value can be derived from extremely heterogeneous samples. He also said that the methodology of statistics-based research cannot be tested independently of statistics; therefore it is unknown whether the causal inferences drawn from the data of large-scale RCTs and epidemiological studies are valid. According to him, lack of understanding of diseases and the properties of drugs, i.e.ignorance, were driving up the size of studies, and we had witnessed “an inexorable increase in the size of epidemiological studies and RCTs over the past 50 years without any concern for the consequences”.
Saint-Mont discussed the effect of randomization, detailing various false assumptions related to it, concluding that randomization does not lift experimental procedures in the medical and social sciences to the level of classical experiments in the natural sciences but may lull researchers into a false sense of security instead [460]. Both Saint-Mont and Penston stressed the importance of the existence of sound background theory as crucial for the success of science. Theory allows for stricter definitions of concepts and the identification of homogeneous reference classes that ensure regularity and, hence, reliable causal inference. In the context of COVID-19, the FLCCC appeared to present their conclusions more in the context of background theory (especially the MATH+ protocol [77]), while most others appeared to relymore on statistics.
An alternative or adjunct to RCTs to investigate could be causal modeling [461];[462];[463];[464]. According to Sgaier et al., causal modeling allows testing for causality in individuals and population groups faster and more efficiently, along with the ability to unravel the underlying complexity, and allows researchers and program designers to simulate an intervention and infer causality by relying on already available data [461]. Karvanen has provided examples of causal models for a case-control study,a nested case-control study, a clinical trial and a two-stage case-cohort study [463].
Journalistic ethics
With regard to journalistic ethics, the censorship discussion of April 11 appeared to indicate that journalistic principles that should have been self-evident no longer were, such as the responsibility of the media “to tell the truth” [165]. As described already for the period preceding April 2021, the financial press (e.g. the Wall Street Journal [163] and the Financial Express [171]) seemed to be more in favor of repurposed medicines, whereas the generalist press mostly continued to ignore or oppose them [217]. MacLeod has written about practices of the mass media in the United States, stating that corporate shareholders have no interest in the veracity of the news, only in short-term profits, and that reporting that challenges corporate profits is strongly discouraged [465]. A key factor shaping the content of the media is its reliance on advertising from large businesses for revenue. Advertisers wish to appeal to the groups and individuals with a greater spending power and to avoid controversial and critical content. Also, the collapse in advertising revenue in the traditional media has led to an increasing dependence on official sources, government and corporations which effectively subsidize the media by providing free content but expect something in return. In addition, in many cases, journalists are preselected based on their obedience to authority and their credulousness, and they increasingly come from the elite themselves [466]. The media houses also depend on social media for visibility which may be easily denied of them. Yet another factor are ideologies which in the United States were traditionally anti-communist but more recently anti-Trump and anti-Russian, for example. In the US media, ivermectin was often associated with hydroxychloroquine, and hydroxychloroquine with president Trump [467].
The dismissal of ivermectin in the press appeared to be related to the Trusted News Initiative (TNI) founded by Associated Press (AP), Agence France-Presse (AFP), British Broadcasting Corporation(BBC), Canadian Broadcasting Corporation (CBC), European Broadcast Union (EBU), Facebook, Financial Times, First Draft, Google, YouTube, The Hindu, Microsoft, Reuters, Twitter and Washington Post [321]. TNI appeared to function as some kind of peer-to-peer structured censorship mechanism.
Social media fact-checkers
In its COVID-19 medical misinformation policy, YouTube explicitly forbade treatment misinformation including “content that recommends use of ivermectin or hydroxychloroquine for the treatment of COVID-19” and “claims that ivermectin or hydroxychloroquine are effective treatments for COVID-19” [468]. The policy forbade also a large amount of peer-reviewed medical publications, in effect making YouTube an anti-science organization.
In a similar manner the policy forbade “prevention misinformation”, explicitly defined as “content that promotes prevention methods that contradict local health authorities or WHO”, specifically mentioning“content that recommends use of ivermectin or hydroxychloroquine for the prevention of COVID-19”. It also explicitly disallowed discussions of efficacy and possible adverse effects of vaccines which “contradict expert consensus from local health authorities or WHO”. Also diagnostic, transmission, social distancing and self-isolation information contradicting local health authorities or WHO were banned. The definitions of “expert” and “consensus” remained undefined, making the policy arbitrary, subsequently making YouTube an unpredictable promoter and enforcer of possibly arbitrary or authoritarian practices. In addition, technically, where local health authorities and WHO disagreed, application of the “or” operator banned content contradicting with either of them. Therefore in countries such as Slovakia and India,YouTube could not be used for content that recommended either for or against ivermectin for prophylaxis of COVID-19.
Clarke mentioned that YouTube and Facebook were relying on third party fact checkers funded partly by Charles Koch Institute [373];[374];[372]. Koch was listed as one of the 18 major funders of Poynter Institute, each with an undisclosed sum of at least USD 50,000, making it impossible to compare funders’ contributions [469];[470]. The International Fact-Checking Network (IFCN) is a unit of the Poynter Institute [471]. In May 2020, Facebook stated that all of its fact-checking partners were certified byIFCN [472]. IFCN stated it led an alliance of over 100 fact-checkers [473]. Poynter Institute described that the alliance was launched in January in response to “rampant misinformation globally” which the WHO classified as an “infodemic”, with the alliance “on the front lines in the fight against it”.
IFCN and the alliance also maintained a database of checked facts [474]. The database was updated daily, with members collaborating on the “massive crowdsourcing project” by using a shared spreadsheet and instant messaging apps. Poynter said the international collaboration had allowed the members to respond faster and reach larger audiences. All of the over 80 items found in the database with search term “ivermectin” dated between April 2020 and May 2021 were labeled either as no evidence, unproven, exaggerated, misleading, missing context, partly false, or false (the most common label), with two items labeled as explanatory [474]. Most of the items originated from South American partners such as Estadão Verifica in Brazil.
Some of the other major funders of Poynter included Facebook, Google News Initiative [475], Foundationto Promote Open Society (FPOS) of George Soros, a primarily US government funded agency National Endowment for Democracy (NED) [476], Democracy Fund created by eBay founder Pierre Omidyar, funding especially PolitiFact [477], and the Omidyar Network/Luminate also of Omidyar, Craig New-mark Foundation of Craigslist founder Craig Newmark, with at least USD 6 million donated to PoynterInstitute [478], and Rita Allen foundation involved in medical research, with its stated goal of “investing in transformative ideas in their earliest stages to promote breakthrough solutions to significant problems” [479].
It was of note that the major funders of Poynter included several individuals who were billionaires. Assumedly, they may have possessed influence over guidelines for what qualified as “facts”. While there was not enough information to ascertain whether the observed patterns of social media censorship were related to the values and previously observed practices of the any of the funders specifically, it was also not possible to rule out such influences.
An example may illustrate what kind of issues may arise from the use of donations as a tool for gaining political influence. With regard to funding by Koch, a report by Mayer in the New Yorker described the Koch brothers as “longtime libertarians who believe in drastically lower personal and corporate taxes,minimal social services for the needy, and much less oversight of industry .. . their combined fortune of thirty-five billion dollars is exceeded only by those of Bill Gates and Warren Buffett . . . many of the organizations funded by the Kochs employ specialists who write position papers that are subsequently quoted by politicians and pundits. David Koch has acknowledged that the family exerts tight ideological control. ‘If we’re going to give a lot of money, we’ll make darn sure they spend it in a way that goes along with our intent .. . and if they make a wrong turn and start doing things we don’t agree with, we withdraw funding’ ” [480];[481].
A republican political consultant commenting Kochs’ strategies for opposing climate change related oil industry reforms said that “the key .. . was to question the science – a public-relations strategy that the tobacco industry used effectively for years to forestall regulation”. As an example of health related interests, David Koch had served on the US National Cancer Advisory Board without disclosing his conflicts of interests as a major producer of formaldehyde, while simultaneously lobbying to prevent theUS Environmental Protection Agency (EPA) from classifying formaldehyde as a carcinogen, and funding members of Congress who had stymied the EPA, requiring it to defer new regulations until more studies would be completed.
Mayer’s article described Kochs’ operations as “covert”, referring to David Koch’s description of their businesses as “the largest company that you’ve never heard of”. According to Source Watch, in addition to denying climate change, other issues on the Kochs’ agenda included repealing health reform Obamacare), dismantling collective bargaining rights, fighting reductions in carbon emissions, keeping corporate money in elections and fighting internet neutrality [482];[483]. With regard to COVID-19, Koch Industries were producing test kit materials, sanitizers, alerting systems, healthcare IT systems related to COVID-19diagnostic testing, ventilators, and personal protective equipment [484].
Poynter’s largest custom training partners in 2019-2021 included Facebook, Huffington Post, Market-place, MRC Media, Middle East Broadcasting Networks, National Public Radio (NPR), Newsweek, New York Times, Southern Newspapers Publishers Association, Washington Post, TikTok, USA Today Network, Vice and Voice of America [469].
Academic journals
Regarding the academic journal publisher Frontiers Media SA’s, one of the members of its board of directors responsible for the financial and governance oversight of the company was Steve Koltes, founder and co-chairman of CVC Capital Partners Ltd [485]. In 2019, CVC Capital Partners, one of the world’s largest private equity and investment advisory firms, was said to have USD 75 billion of assets under management [486]. CVC announced that a group of its executives had helped fund University of Oxford’s vaccine research [487];[488]. CVC had also invested in System C, a company providing key software being used for planning and managing the UK’s COVID-19 vaccination programme [489]. The Times described CVC as “powerful, successful and extremely low profile” [490].
In 2015, Frontiers had removed 31 editors after the editors had complained that company staff were interfering with editorial decisions and violating core principles of medical publishing [491].
The WHO
During the period, an intensifying critique of the WHO emerged as a result of the March 2021 ivermectin guideline lacking transparency and breaking established practices of meta-analysis and research.Presenting criticism towards the feasibility of the vaccines-only approach and its possible relationship to financial interests of the pharmaceutical industry, or possible failures of entities such as WHO, FDA,NIH and EMA, has been difficult during the pandemic. Regardless, it is necessary to consider whether funding-related biases might exist with regard to the current practices of these agencies, especially the WHO.
First we may note that the main funders of the WHO for the 2018/2019 biennium were United States(USD 893 million), Bill and Melinda Gates Foundation (USD 531 million), United Kingdom (USD435 million), Gavi The Vaccine Alliance (USD 371 million), Germany (USD 292 million), Japan (USD214 million), UN Office for the Coordination of Humanitarian Affairs (UNOCHA) (USD 192 million),Rotary International (USD 143 million), World Bank (USD 133 million), European Commission (USD131 million), National Philanthropic Trust (USD 108 million), Canada (USD 101 million), China (USD86 million), Norway (USD 86 million), UN Central Emergency Response (USD 86 million), Sweden (USD77 million), France (USD 76 million), Kuwait (USD 70 million), Republic of Korea (USD 70 million) and Australia (USD 67 million) [492];[493];[494].
The Bill and Melinda Gates Foundation stated that its focus was on vaccine equity [307]. Also Gavi The Vaccine Alliance had been founded by the Bill and Melinda Gates Foundation in 1999, and the Gates foundation had invested a total of USD 4 billion in Gavi [495]. Gavi described the Gates foundation as“a key Gavi partner in vaccine market shaping”. The Gates Foundation also had long-term partnerships with Rotary International (polio vaccinations), National Philanthropic Trust, and the World Bank. Together, the USD 902 million contributions of the Gates Foundation and Gavi exceeded the United States contributions of USD 893 million, making the Gates-Gavi cluster the largest funder of the WHO in the2018/2019 biennium (in April 2020, president Trump announced that US halted funding to the WHO; the effects of this remained unclear [496];[497]). In addition, the Global Fund to Fight AIDS, Tuberculosis and Malaria (GFATM) contributed 33 million. Co-founded by the Bill and Melinda Gates Foundation in 2002, the foundation has contributed a total of USD 2.49 billion to GFATM [498]. Considering the recent USD 4 billion donation by the United States government to Gavi [89], one interpretation of the situation might be that the US outsourced a large part of its public health policy setting to Gavi and, subsequently, to Gates.
Yet another member of the Gates cluster was the Seattle-based PATH (Program for Appropriate Tech-nology in Health), one of the largest nonprofit organizations in global health [499]. In 2021, its website presented with a banner saying “600 million people are vaccinated. 7 billion haven’t had a shot. Help PATH today”. PATH’s CEO Nikolaj Gilbert, previously the global partnerships director for the United Nations Office for Project Services (UNOPS) and an employee of Novo Nordisk, described PATH’s priorities: “the partnership with the Bill and Melinda Gates Foundation and the U.S. government has shaped what this organization is all about today .. . so one of my key priorities will be to see: how can we sustain and grow those relationships that we have, how can we continue to be the preferred partner for those donors, and how can we also help them with their priorities?” [499].
A 2017 Politico article described Gates as “the world’s most powerful doctor”, saying his sway over the WHO spurred criticism about misplaced priorities and undue influence [500];[501]. The article quoted Gates’ critics saying that “Gates’ priorities have become the WHO’s . .. he is treated liked a head of state,not only at the WHO, but also at the G20”. Top WHO officials were said to have raised concerns that the foundation was distorting research priorities. Over three quarters of the WHO’s budget was coming from voluntary contributions which were usually earmarked for specific projects or diseases so that the WHO could not freely decide how to use them. The article stated that the Gates foundation’s focus on delivering vaccines and medicines, rather than on building resilient health systems, had drawn criticism.Changes had been made to the WHO’s budget approval process to in order to decrease the foundation’s influence. Yet a senior fellow for global health at the Council on Foreign Relations commented that “the foundation’s impact on the WHO is enormous . . . if they weren’t there, if they walked away with their money, the deleterious impact would be profound, and everyone is all too aware of that”.
Importantly, it should also be noted that the other top 20 funders predominantly represent high-income countries of the North America and Europe. None of the countries that had officially adopted ivermectin country-wide for COVID-19 up to April 2021 were represented [502]. Similarly, Coalition for Epidemic Preparedness Innovations (CEPI), an organization aiming to accelerate the development of vaccines against emerging infectious diseases and enable equitable access to these vaccines for people during outbreaks was founded by the governments of Norway and India, Bill and Melinda Gates Foundation, UK Wellcome Trust, and the World Economic Forum [503]. It had later secured financial support from Australia, Austria, Belgium, the Bill and Melinda Gates Foundation, Canada, Denmark, the European Commission, Ethiopia, Finland, Germany, Hungary, Iceland, Indonesia, Italy, Japan, Kuwait, Lithuania, Luxembourg, Malaysia, Mexico, Netherlands, New Zealand, Norway, Panama, Romania, Saudi Arabia,Serbia, Singapore, Switzerland, The Republic of Korea, United Kingdom, USAID, and UK Wellcome Trust. Of these countries, as of June 2021, ivermectin had been officially adopted in Mexico, Panama and Indonesia, as well as mixed use or occasional off-label use in some other countries [502].
Additionally, CEPI had received support from undeclared private sector entities as well as public contributions through the UN Foundation COVID-19 Solidarity Response Fund [503]. Each investor was to get one representative to an Investors Council providing guidance and oversight of CEPI activities, with four members serving on the CEPI board. Another entity, a Joint Coordination Group, was intended to discuss how to best enhance CEPI’s efforts to deliver and deploy vaccines, and had a role in planning for rapid response to a priority pathogen or an unknown pathogen. The Joint Coordination Group included the WHO, Gavi, European Medicine Agency (EMA), United States Food and Drug Administration Agency (FDA), Médecins Sans Frontières (MSF), UNICEF, International Federation of Red Cross and Red Crescent Societies (IFRC), African Vaccine Regulatory Forum (AVAREF), UK National Institute for Biological Standards and Control (NIBSC) and UK Wellcome Trust.
The Wellcome trust had been previously found out to secretly invest in companies that contributed to the same problems the trust said it wanted to solve [504]. The trust’s known investments through offshore companies in the Cayman Islands amounted to USD 891 million in 2018.
In 2010, the Bill and Melinda Gates Foundation, Gavi, WHO, US NIH/NIAID, CDC, UNICEF, PAHO and several research organizations launched a Decade of Vaccines collaboration, initiated by the Gates Foundation [505]. The intention was to enable greater coordination across all stakeholder groups – national governments, multilateral organizations, civil society, the private sector and philanthropic organizations. The five-member leadership council included the director general of WHO, Anthony S. Fauci of the National Institute of Allergy and Infectious Diseases (NIAID), executive director of UNICEF, an representative of African Leaders Malaria Alliance, and the president of global health at the Bill and Melinda Gates Foundation. All the relevant organizations had thus intimately and for the long term participated in the vaccine-centric collaboration initiated by Gates.
According to a recent study, in 2020, governments had spent a total of EUR 93 billion on COVID-19 vaccine and therapeutics development projects, with 95% allocated to vaccines and 5% on therapeutics [506]. 32% of the funds came from the US, 24% from the EU, and 13% from Japan and SouthKorea (a total of 69%). Only 7% of funds were preferred loans or conventional grants. 93% were advance market commitments (AMCs), i.e. binding agreements to subsidize purchases of vaccine doses prior to availability. Interestingly, 71% of the vaccine funding was allocated to Small and Medium Enterprises(SMEs) and MidCaps, with only 18% allocated to large pharmaceutical manufacturers. The figures did not include private sector investments.
The Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) public-private partnership program initiated by the US National Institutes of Health aimed at developing a coordinated research strategy for prioritizing and speeding development of the most promising treatments and vaccines [228]. Its public partners included Biomedical Advanced Research and Development Authority (BARPA), Centers for Disease Control and Prevention (CDC), Department of Defense, Department of Veterans Affairs,European Medicines Agency (EMA), National Institutes of Health (NIH), The Operation (formerly known as Operation Warp Speed), and US Food and Drug Administration (FDA). Industry partners included AbbVie, Amgen, AstraZeneca, Bristol Myers Squibb, Dewpoint Therapeutics, Eisai, Eli Lillyand Company, Gilead, GlaxoSmithKline, Johnson & Johnson, Merck & Co/MSD, Moderna, Novartis,Novavax, Pfizer, Rhythm Therapeutics, Roche-Genentech, Sanofi, Takeda, and Vir Biotechnology. Nonprofit partners included Bill and Melinda Gates Foundation, Fred Hutchinson Cancer Research Center,Foundation for the National Institutes of Health, and RTI International.
According to the International Federation of Pharmaceutical Manufacturers & Associations (IFPMA), as of February 2021, there were approximately 382 vaccine candidates in development, of which 24 in Phase I, 34 in Phase II and 23 in Phase III [507]. In addition to vaccines, there were over 1,000 clinical trials for therapeutics, of which 190 in Phase III. For example, Eli Lilly and Company and the Bill and Melinda Gates Foundation had entered into an agreement to facilitate access to future Lilly therapeutic antibodies under development, to benefit low- and middle-income countries.
Bill and Melinda Gates Foundation
According to Schwab, in five years up to 2020 the Gates Foundation had invested at least USD 250 million in companies that were currently working on COVID-19 vaccines, therapeutics, diagnostics or manufacturing [508];[509]. He also noted that Wellcome Trust had invested at least USD 1.25 billion to COVID-19 related industries [510]. Both funders were thus positioned to potentially gain from the pandemic financially. Wellcome’s director had a position on the Scientific Advisory Group for Emergencies advising the UK government on COVID-19, as well as a board seat on the Coalition for Epidemic Preparedness Innovations (CEPI). Earlier, the UK’s Scientific Advisory Group for Emergencies had failed to publicly disclose competing interests related to COVID-19. A Canadian professor emeritus of health policy and management commented that the funders were assumedly “acting the way they always have .. . looking after their own financial interests [and] pursuing their own privately developed objectives without being responsible to anybody but their own boards of directors”. Schwab said that despite the outsize role of the private charities in the pandemic response their financial interests had been little scrutinized, likely because foundations were not subject to the same oversight mechanisms as public institutions. A professor of sociology in the UK commented that the foundations were giving a false ideological impression that they are solving the problem even when they’re not.
The Gates foundation had also donated almost USD 2 billion to for-profit businesses, including USD 89 million to Novavax Inc., USD 65 million to GlaxoSmithKline Biologicals, USD 63 million to Evotec and Just Biotherapeutics, USD 61 million to Biologial E. Limited, USD 53 million to LG Chem Ltd., USD43 million to Dimagi Inc, USD 40 million to Inventprise, USD 38 million to Bharat Biotech International Ltd., USD 37 million to Janssen Vaccines and Prevention BV, and USD 35 million to AJ VaccinesAS [510]. Schwab claimed the foundation was subsidizing private companies’ research costs, opening up markets for their products, and bankrolling their bottom lines. He also claimed the foundation had funded groups pushing for industry-friendly government policies and regulation, including the Drug Information Association. He was also said to have funded nonprofit think tanks and advocacy groups that wanted to limit the role of government or direct its resources toward helping business interests. Schwab also noted that despite having given away USD 23.5 billion in the last five years up to 2020, Bill and Melinda Gates Foundation’s income from its investments had exceeded USD 28.5 billion in the same period [510].
Other commentators asked whether the Gates Foundation was addressing or reinforcing systemic problems raised by COVID-19, citing lack of transparency, dogmatic defence of intellectual property rights and monopolies, and intimate involvement with large pharmaceutical corporations as the main issues [511]. A 2016 report by Curtis gave details about Microsoft’s tax avoidance practices and its monopolistic nature, the foundation’s excessive global influence and support to various questionable practices including industrial agriculture with patented genetically modified seeds, Gates family’s “considerable personal access to senior levels of the WHO”, Gavi’s alleged overpaying for vaccines leading to excessive increases in vaccine prices, Gates’ dismissal of the issue, and the foundation’s agenda skewing health priorities and distorting health programmes [512]. Curtis wrote that one problem with the foundation’s heavy focus on developing new vacci