An anonymous tip from December of 2020 aged exceptionally well, with bad repercussions for the female fertility in girls born to both Covid-19 vaccinee parents.

Although it has been reported on by Igor Chudov a few days ago, I would like to add a bit more beef to this uncorroborated (so far) information, as it is the news no one wants to believe, but it deserves further investigation for the reasons outlined below.

The original Moderna insider tip from Dec. 2020, from two anonymous engineers working there, goes like this:

I'm an industrial engineer at Moderna and the other one of us is a process development engineer. I'm sure the same thing is happening with Pfizer-BioNTech. It was hard to put things together based on the small quantities of additions happening in manual step (highly unorthodox for a continuous process production). The explanation we got was highly sensitive trade secret adjuvants being added. Digging in deeper showed how sensitive it actually was. Most people's understanding of this novel vaccine type is that it works as follows:`

1. Make mRNA coding for S protein
2. Make lipid nanoparticle delivery system
3. Profit

How it actually works from what we've uncovered:

1. Make mRNA coding for S protein
2. Make mRNA coding for mutant versions of CYP19A1 and CDKN1B in smaller amounts
3. Make sure that while delivery system for (1) mostly ends up in liver, most of (2) ends up in the gonads
4. Make sure form and quantity of additive upregulating LINE-1 reverse transcription activity makes it hard to detect among legit adjuvants
5. Effects from (2) integrated by (4) are recessive; mildly oncogenic effects in vaccine recipients unlikely to be noticed for many years
6. (5) recessive but since most of population vaccinated, in next generation female offspring have premature ovarian failure

The beef of this tip is that, in addition to the mRNA code for S spike, the vaccine vials will contain additional mRNA that codes both for a mutant version of CYP19A1 and a mutant version of CDKN1B. Both these mutant proteins are implicated in the female infertility issues. From the advantage of hindsight in March 2022, this information is credible for the following reasons:

• The pharmacokinetics information of the LNPs in mRNA vaccines has been spilled by the Japanese only in May 2021. As it turned out, the LNPs with the mRNA in them do not stay at the injection site, as CDC and other agencies postulated. Instead, they accumulate in the liver and the gonads of the vaccinees in high concentrations. Surprise! So, the tipsters have been confirmed correct in this regard.

• The studies regarding LINE-1 enzymes being able to reverse transcribe the vaccine mRNA back into human DNA appeared much later as well:

  1. Reverse-transcribed SARS-CoV-2 RNA can integrate into the genome of cultured human cells and can be expressed in patient-derived tissues ( Jaenisch et al., 2021.05.21)
  2. Coronavirus gene findings are no cause for alarm, says leading scientist (ABS-CBN, 2021.01.30): The discovery by Professor Rudolf Jaenisch and researchers at the Massachusetts Institute of Technology, stirs up a hornet's nest because mRNA vaccines, including those made by Pfizer/ BioNTech and Moderna, operate in similar ways to the virus to trigger an immune response.
  3. Intracellular Reverse Transcription of Pfizer BioNTech COVID-19 mRNA Vaccine BNT162b2 In Vitro in Human Liver Cell Line (Aldn et al., 2022.02.25).
  4. Moderna finally cracks into gene editing with Metagenomi pact thanks to 'irresistible' data (Fierce Biotech, 2021.11.02): We finally know who Moderna has been courting behind the scenes to make the big jump into gene editing. The famed biotech has signed a research partnership with CRISPR gene editing company Metagenomi. Metagenomi will offer up access to its gene editing tools. The company recent unveiled data on its CRISPR-associated transposases system that can be used to "precisely integrate large DNA fragments into genomes", allowing for new editing techniques beyond the currently available technology.
  5. Metagenomi Presents New Findings on CRISPR-associated Transposases (CAST) that Allow for Targetable Genomic Integration of Large DNA Fragments (Metagenomi.co, 2021.05.14): Our research presented at ASGCT describes how our first-in-class programmable CAST gene editing system can be used to precisely integrate large fragments of DNA into target genomes and the potential of these systems in the development of both ex vivo and in vivo gene therapies. CRISPR-associated transposases can be reprogrammed to integrate at specific genomic sites using guide RNAs. Target genomes, eh? Transhumans, anyone? A.k.a. mutants?

  Another solid confirmation that the tipsters knew what they were talking about way before this information went public.

• As the reader Jeff C pointed out (and I quote verbatim from here on), the tipsters not only said that LINE-1 could facilitate reverse transcription but that the vaxx has a hidden additive that specifically upregulates LINE-1 (point #4). The Aldn et al. paper using the BioNTech vaxx clearly showed a high presence of LINE-1 when the vaxx was added that was not there in the control. So something about the vaxx significantly increases LINE-1 just like the tipster said. The fact that the tipster knew this before any of this was publicly known is pretty impressive. If you look back at the Covid virus reverse transcription study (Jaenisch et al - looked at Covid itself, not the vaxx) they artificially increased LINE-1 in the cells via transfection [To increase the likelihood of detecting rare integration events, we transfected HEK293T cells with LINE1 expression plasmids prior to infection with SARS-CoV-2]. That was a key criticism of the study in that it wasn't a real world case. This is in stark contrast to the vaxx study where LINE-1 increased solely due to the vaxx itself. Wasn't that the role of one of the "highly sensitive trade secret adjuvants being added", as hinted by the tipster?

• In Oct. 2021, a former Pfizer quality control manager and a whistleblower, Melissa Strickler, spilled beans on the unusual manufacturing process at the Pfizer Covid-19 vaccine plant in a series of interviews. Pfizer's processes for its vaccine are strangely deviating from usual norms. The compounding room has no idea what are the components they are mixing into the product. This secrecy about what goes into the vials is unprecedented. Furthermore, the vaccine manufacturers are not controlled by any independent bodies as to the quality control, the vials being shipped directly to the vaccine administration locations. This lends credence to the assertion that the mRNA vaccines may contain undisclosed constituents.

• The leak of EMA-Pfizer correspondence in Nov.-Dec. 2020, when EMA was working on Pfizer's vaccine authorization, revealed that EMA was concerned that the mRNA in the vaccine vials contains only 55% of the intended S spike code, the rest being truncated species blamed on the faults in the manufacturing process. Pfizer placated these concerns by pushing the S spike code proportion up to 75%, at least for the time being. After that, EMA stopped looking and declared the jabs kosher. More on this in my post Zeroing in on Gifts from Science to Humanity from Nov. 2021. So, another score for the tipsters - the jabs do contain some exogenous mRNA code that no one analyses or scrutinizes.

• If that is not enough, BigPharma, in collaboration with WHO and NIH, has a long tradition of adding undisclosed ingredients harming female fertility into the vaccines going all the way back to 1970s:

2017: HCG Found in WHO Tetanus Vaccine in Kenya Raises Concern in the Developing World. Baby-Killing Vaccine: Is It Being Stealth Tested?: During the early 1990s, the World Health Organization (WHO) has been overseeing massive vaccination campaigns against tetanus in a number of countries, among them Nicaragua, Mexico, and the Philippines. In October 1994, Human Life International (HLI) received a communication from its Mexican affiliate, the Comite Pro Vida de Mexico, regarding that country's anti-tetanus campaign. Suspicious of the campaign protocols, the Comite obtained several vials of the vaccine and had them analyzed by chemists. Some of the vials were found to contain human chorionic gonadotrophin (hCG), a naturally occurring hormone essential for maintaining a pregnancy. Here are the known facts concerning the tetanus vaccination campaigns in Mexico and the Philippines:

• Only women are vaccinated, and only the women between the ages of 15 and 45. (In Nicaragua the age range was 12-49).
• Human chorionic gonadotrophin (hCG) hormone has been found in the vaccines.
• The vaccination protocols call for multiple injections-three within three months and a total of five altogether. But, since tetanus vaccinations provide protection for ten years or more, why are multiple inoculations called for?

Allied with the WHO in the development of an anti-fertility vaccine (AFV) using hCG with tetanus and other carriers have been UNFPA, the UN Development Programme (UNDP), the World Bank, the Population Council, the Rockefeller Foundation, the All India Institute of Medical Sciences, and a number of universities, including Uppsala, Helsinki, and Ohio State.[5] The U.S. National Institute of Child Health and Human Development (part of NIH) was the supplier of the hCG hormone in some of the AFV experiments.

Again, a corroboration of the thrust of the allegations by the Moderna insiders.

• The strange, irrational drive to vaccinate every last person on Earth, especially children and pregrant women, with the untested and clearly dangerous injections is another huge red flag as to the true goals of the Covid-19 vaccination of the world population. Especially that the population control has been a holy grail for the eugenicist cabal since the 19th century, and in the form of vaccines, no less. Read my post Going for Jugular Take 2 - All Ducks in Row (Dec. 2021) for complete, more or less, disclosure.

• The new plant-based Canada-made non-mRNA vaccine still contains LNP material, for some inexplicable reason. Or should we suspect that it will also contain fertility-harming mRNA?

So, lots of indirect evidence that the Moderna insiders are trustworthy and that their whistle blowing deserves all the attention it can garner. In the form of vial analysis and vaccinee testing, for starters.

In the meantime, this post should serve as a fair warning and one of the elements on which to base your informed decision as to whether to accept any vaccine in 2022 and going onward. Or any injection, for that matter, from your caring health authorities and governments.

Continued in How Will We Know?

The COVID-19 pandemic is one of the most manipulated infectious disease events in history, characterized by official lies in an unending stream lead by government bureaucracies, medical associations, medical boards, the media, and international agencies.[3,6,57] We have witnessed a long list of unprecedented intrusions into medical practice, including attacks on medical experts, destruction of medical careers among doctors refusing to participate in killing their patients and a massive regimentation of health care, led by non-qualified individuals with enormous wealth, power and influence.

For the first time in American history a president, governors, mayors, hospital administrators and federal bureaucrats are determining medical treatments based not on accurate scientifically based or even experience based information, but rather to force the acceptance of special forms of care and “prevention”—including remdesivir, use of respirators and ultimately a series of essentially untested messenger RNA vaccines. For the first time in history medical treatment, protocols are not being formulated based on the experience of the physicians treating the largest number of patients successfully, but rather individuals and bureaucracies that have never treated a single patient—including Anthony Fauci, Bill Gates, EcoHealth Alliance, the CDC, WHO, state public health officers and hospital administrators.[23,38]

The media (TV, newspapers, magazines, etc), medical societies, state medical boards and the owners of social media have appointed themselves to be the sole source of information concerning this so-called “pandemic”. Websites have been removed, highly credentialed and experienced clinical doctors and scientific experts in the field of infectious diseases have been demonized, careers have been destroyed and all dissenting information has been labeled “misinformation” and “dangerous lies”, even when sourced from top experts in the fields of virology, infectious diseases, pulmonary critical care, and epidemiology. These blackouts of truth occur even when this information is backed by extensive scientific citations from some of the most qualified medical specialists in the world.[23] Incredibly, even individuals, such as Dr. Michael Yeadon, a retired ex-Chief Scientist, and vice-president for the science division of Pfizer Pharmaceutical company in the UK, who charged the company with making an extremely dangerous vaccine, is ignored and demonized. Further, he, along with other highly qualified scientists have stated that no one should take this vaccine.

Dr. Peter McCullough, one of the most cited experts in his field, who has successfully treated over 2000 COVID patients by using a protocol of early treatment (which the so-called experts completely ignored), has been the victim of a particularly vicious assault by those benefiting financially from the vaccines. He has published his results in peer reviewed journals, reporting an 80% reduction in hospitalizations and a 75% reduction in deaths by using early treatment.[44] Despite this, he is under an unrelenting series of attacks by the information controllers, none of which have treated a single patient.

Neither Anthony Fauci, the CDC, WHO nor any medical governmental establishment has ever offered any early treatment other than Tylenol, hydration and call an ambulance once you have difficulty breathing. This is unprecedented in the entire history of medical care as early treatment of infections is critical to saving lives and preventing severe complications. Not only have these medical organizations and federal lapdogs not even suggested early treatment, they attacked anyone who attempted to initiate such treatment with all the weapons at their disposal—loss of license, removal of hospital privileges, shaming, destruction of reputations and even arrest.[2]

A good example of this outrage against freedom of speech and providing informed consent information is the recent suspension by the medical board in Maine of Dr. Meryl Nass’ medical license and the ordering of her to undergo a psychiatric evaluation for prescribing Ivermectin and sharing her expertise in this field.[9,65] I know Dr, Nass personally and can vouch for her integrity, brilliance and dedication to truth. Her scientific credentials are impeccable. This behavior by a medical licensing board is reminiscent of the methodology of the Soviet KGB during the period when dissidents were incarcerated in psychiatric gulags to silence their dissent.

OTHER UNPRECEDENTED ATTACKS

Another unprecedented tactic is to remove dissenting doctors from their positions as journal editors, reviewers and retracting of their scientific papers from journals, even after these papers have been in print. Until this pandemic event, I have never seen so many journal papers being retracted— the vast majority promoting alternatives to official dogma, especially if the papers question vaccine safety. Normally a submitted paper or study is reviewed by experts in the field, called peer review. These reviews can be quite intense and nit picking in detail, insisting that all errors within the paper be corrected before publication. So, unless fraud or some other major hidden problem is discovered after the paper is in print, the paper remains in the scientific literature.

We are now witnessing a growing number of excellent scientific papers, written by top experts in the field, being retracted from major medical and scientific journals weeks, months and even years after publication. A careful review indicates that in far too many instances the authors dared question accepted dogma by the controllers of scientific publications—especially concerning the safety, alternative treatments or efficacy of vaccines.[12,63] These journals rely on extensive adverting by pharmaceutical companies for their revenue. Several instances have occurred where powerful pharmaceutical companies exerted their influence on owners of these journals to remove articles that in any way question these companies’ products.[13,34,35]

Worse still is the actual designing of medical articles for promoting drugs and pharmaceutical products that involve fake studies, so-called ghostwritten articles.[49,64] Richard Horton is quoted by the Guardian as saying “journals have devolved into information laundering operations for the pharmaceutical industry.”[13,63] Proven fraudulent “ghostwritten” articles sponsored by pharmaceutical giants have appeared regularly in top clinical journals, such as JAMA, and New England Journal of Medicine—never to be removed despite proven scientific abuse and manipulation of data.[49,63]

Ghostwritten articles involve using planning companies whose job it is to design articles containing manipulated data to support a pharmaceutical product and then have these articles accepted by high-impact clinical journals, that is, the journals most likely to affect clinical decision making of doctors. Further, they supply doctors in clinical practice with free reprints of these manipulated articles. The Guardian found 250 companies engaged in this ghostwriting business. The final step in designing these articles for publication in the most prestigious journals is to recruit well recognized medical experts from prestigious institutions, to add their name to these articles. These recruited medical authors are either paid upon agreeing to add their name to these pre- written articles or they do so for the prestige of having their name on an article in a prestigious medical journal.[11]

Of vital importance is the observation by experts in the field of medical publishing that nothing has been done to stop this abuse. Medical ethicists have lamented that because of this widespread practice “you can’t trust anything.” While some journals insist on disclosure information, most doctors reading these articles ignore this information or excuse it and several journals make disclosure more difficult by requiring the reader to find the disclosure statements at another location. Many journals do not police such statements and omissions by authors are common and without punishment.

As concerns the information made available to the public, virtually all the media is under the control of these pharmaceutical giants or others who are benefitting from this “pandemic”. Their stories are all the same, both in content and even wording. Orchestrated coverups occur daily and massive data exposing the lies being generated by these information controllers are hidden from the public. All data coming over the national media (TV, newspaper and magazines), as well as the local news you watch every day, comes only from “official” sources—most of which are lies, distortions or completely manufactured out of whole cloth—all aimed to deceive the public.

Television media receives the majority of its advertising budget from the international pharmaceutical companies—this creates an irresistible influence to report all concocted studies supporting their vaccines and other so-called treatments.[14] In 2020 alone the pharmaceutical industries spent 6.56 billion dollars on such advertising.[13,14] Pharma TV advertising amounted to 4.58 billion, an incredible 75% of their budget. That buys a lot of influence and control over the media. World famous experts within all fields of infectious diseases are excluded from media exposure and from social media should they in any way deviate against the concocted lies and distortions by the makers of these vaccines. In addition, these pharmaceutical companies spend tens of millions on social media advertising, with Pfizer leading the pack with $55 million in 2020.[14]

While these attacks on free speech are terrifying enough, even worse is the virtually universal control hospital administrators have exercised over the details of medical care in hospitals. These hirelings are now instructing doctors which treatment protocols they will adhere to and which treatments they will not use, no matter how harmful the “approved” treatments are or how beneficial the “unapproved” treatments are.[33,57]

Never in the history of American medicine have hospital administrators dictated to its physicians how they will practice medicine and what medications they can use. The CDC has no authority to dictate to hospitals or doctors concerning medical treatments. Yet, most physicians complied without the slightest resistance.

The federal Care Act encouraged this human disaster by offering all US hospitals up to 39,000 dollars for each ICU patient they put on respirators, despite the fact that early on it was obvious that the respirators were a major cause of death among these unsuspecting, trusting patients. In addition, the hospitals received 12,000 dollars for each patient that was admitted to the ICU—explaining, in my opinion and others, why all federal medical bureaucracies (CDC, FDA, NIAID, NIH, etc) did all in their power to prevent life- saving early treatments.[46] Letting patients deteriorate to the point they needed hospitalization, meant big money for all hospitals. A growing number of hospitals are in danger of bankruptcy, and many have closed their doors, even before this “pandemic”.[50] Most of these hospitals are now owned by national or international corporations, including teaching hospitals.[10]

It is also interesting to note that with the arrival of this “pandemic” we have witnessed a surge in hospital corporate chains buying up a number of these financially at-risk hospitals.[1,54] It has been noted that billions in Federal Covid aid is being used by these hospital giants to acquire these financially endangered hospitals, further increasing the power of corporate medicine over physician independence. Physicians expelled from their hospitals are finding it difficult to find other hospitals staffs to join since they too may be owned by the same corporate giant. As a result, vaccine mandate policies include far larger numbers of hospital employees. For example, Mayo Clinic fired 700 employees for exercising their right to refuse a dangerous, essentially untested experimental vaccine.[51,57] Mayo Clinic did this despite the fact that many of these employees worked during the worst of the epidemic and are being fired when the Omicron variant is the dominant strain of the virus, has the pathogenicity of a common cold for most and the vaccines are ineffective in preventing the infection.

In addition, it has been proven that the vaccinated asymptomatic person has a nasopharyngeal titer of the virus as high as an infected unvaccinated person. If the purpose of the vaccine mandate is to prevent viral spread among the hospital staff and patients, then it is the vaccinated who present the greatest risk of transmission, not the unvaccinated. The difference is that a sick unvaccinated person would not go to work, the asymptomatic vaccinated spreader will.

What we do know is that major medical centers, such as Mayo Clinic, receive tens of millions of dollars in NIH grants each year as well as monies from the pharmaceutical makers of these experimental “vaccines”. In my view, that is the real consideration driving these policies. If this could be proven in a court of law the administrators making these mandates should be prosecuted to the fullest extent of the law and sued by all injured parties.

The hospital bankruptcy problem has grown increasingly acute due to hospitals vaccine mandates and resulting large number of hospitals staff, especially nurses, refusing to be forcibly vaccinated.[17,51] This is all unprecedented in the history of medical care. Doctors within hospitals are responsible for the treatment of their individual patients and work directly with these patients and their families to initiate these treatments. Outside organizations, such as the CDC, have no authority to intervene in these treatments and to do so exposes the patients to grave errors by an organization that has never treated a single COVID-19 patient.

When this pandemic started, hospitals were ordered by the CDC to follow a treatment protocol that resulted in the deaths of hundreds of thousands of patients, most of whom would have recovered had proper treatments been allowed.[43,44] The majority of these deaths could have been prevented had doctors been allowed to use early treatment with such products as Ivermectin, hydroxy-chloroquine and a number of other safe drugs and natural compounds. It has been estimated, based on results by physicians treating the most covid patients successfully, that of the 800,000 people that we are told died from Covid, 640,000 could have not only been saved, but could have, in many cases, returned to their pre-infection health status had mandated early treatment with these proven methods been used. This neglect of early treatment constitutes mass murder. That means 160,000 would have actually died, far less than the number dying at the hands of bureaucracies, medical associations and medical boards that refused to stand up for their patients. According to studies of early treatment of thousands of patients by brave, caring doctors, seventy-five to eighty percent of the deaths could have been prevented.[43,44]

Incredibly, these knowledgeable doctors were prevented from saving these Covid-19 infected people. It should be an embarrassment to the medical profession that so many doctors mindlessly followed the deadly protocols established by the controllers of medicine.

One must also keep in mind that this event never satisfied the criteria for a pandemic. The World Health Organization changed the criteria to make this a pandemic. To qualify for a pandemic status the virus must have a high mortality rate for the vast majority of people, which it didn’t (with a 99.98% survival rate), and it must have no known existing treatments—which this virus had—in fact, a growing number of very successful treatments.

The draconian measures established to contain this contrived “pandemic” have never been shown to be successful, such as masking the public, lockdowns, and social distancing. A number of carefully done studies during previous flu seasons demonstrated that masks, of any kind, had never prevented the spread of the virus among the public.[60]

In fact, some very good studies suggested that the masks actually spread the virus by giving people a false sense of security and other factors, such as the observation that people were constantly breaking sterile technique by touching their mask, improper removal and by leakage of infectious aerosols around the edges of the mask. In addition masks were being disposed of in parking lots, walking trails, laid on tabletops in restaurants and placed in pockets and purses.

Within a few minutes of putting on the mask, a number of pathogenic bacteria can be cultured from the masks, putting the immune suppressed person at a high risk of bacterial pneumonia and children at a higher risk of meningitis.[16] A study by researchers at the University of Florida cultured over 11 pathogenic bacteria from the inside of the mask worn by children in schools.[40]

It was also known that children were at essentially no risk of either getting sick from the virus or transmitting it.

In addition, it was also known that wearing a mask for over 4 hours (as occurs in all schools) results in significant hypoxia (low blood oxygen levels) and hypercapnia (high CO2 levels), which have a number of deleterious effects on health, including impairing the development of the child’s brain.[4,72,52]

We have known that brain development continues long after the grade school years. A recent study found that children born during the “pandemic” have significantly lower IQs—yet school boards, school principals and other educational bureaucrats are obviously unconcerned.[18]

TOOLS OF THE INDOCTRINATION TRADE

The designers of this pandemic anticipated a pushback by the public and that major embarrassing questions would be asked. To prevent this, the controllers fed the media a number of tactics, one of the most commonly used was and is the “fact check” scam. With each confrontation with carefully documented evidence, the media “fact checkers” countered with the charge of “misinformation”, and an unfounded “conspiracy theory” charge that was, in their lexicon, “debunked”. Never were we told who the fact checkers were or the source of their “debunking” information—we were just to believe the “fact checkers”. A recent court case established under oath that facebook “fact checkers” used their own staff opinion and not real experts to check “facts”.[59] When sources are in fact revealed they are invariably the corrupt CDC, WHO or Anthony Fauci or just their opinion. Here is a list of things that were labeled as “myths” and “misinformation” that were later proven to be true.

• The asymptomatic vaccinated are spreading the virus equally as with unvaccinated symptomatic infected.

• The vaccines cannot protect adequately against new variants, such as Delta and Omicron.

• Natural immunity is far superior to vaccine immunity and is most likely lifelong.

• Vaccine immunity not only wanes after several months, but all immune cells are impaired for prolonged periods, putting the vaccinated at a high risk of all infections and cancer.

• COVID vaccines can cause a significant incidence of blood clots and other serious side effects

• The vaccine proponents will demand numerous boosters as each variant appears on the scene.

• Fauci will insist on the covid vaccine for small children and even babies.

• Vaccine passports will be required to enter a business, fly in a plane, and use public transportation

• There will be internment camps for the unvaccinated (as in Australia, Austria and Canada)

• The unvaccinated will be denied employment.

• There are secret agreements between the government, elitist institutions, and vaccine makers

• Many hospitals were either empty or had low occupancy during the pandemic.

• The spike protein from the vaccine enters the nucleus of the cell, altering cell DNA repair function.

• Hundreds of thousands have been killed by the vaccines and many times more have been permanently damaged.

• Early treatment could have saved the lives of most of the 700,000 who died.

• Vaccine-induced myocarditis (which was denied initially) is a significant problem and clears over a short period.

• Special deadly lots (batches) of these vaccines are mixed with the mass of other Covid-19 vaccines

Several of these claims by those opposing these vaccines now appear on the CDC website—most still identified as “myths”. Today, extensive evidence has confirmed that each of these so-called “myths” were in fact true. Many are even admitted by the “saint of vaccines”, Anthony Fauci. For example, we were told, even by our cognitively impaired President, that once the vaccine was released all the vaccinated people could take off their masks. Oops! We were told shortly afterward— the vaccinated have high concentrations (titers) of the virus in their noses and mouths (nasopharynx) and can transmit the virus to others in which they come into contact—especially their own family members. On go the masks once again— in fact double masking is recommended. The vaccinated are now known to be the main superspreaders of the virus and hospitals are filled with the sick vaccinated and people suffering from serious vaccine complications.[27,42,45]

Another tactic by the vaccine proponents is to demonize those who reject being vaccinated for a variety of reasons. The media refers to these critically thinking individuals as “anti-vaxxers”, “vaccine deniers”, “Vaccine resisters”, “murders”, “enemies of the greater good” and as being the ones prolonging the pandemic. I have been appalled by the vicious, often heartless attacks by some of the people on social media when a parent or loved one relates a story of the terrible suffering and eventual death, they or their loved one suffered as a result of the vaccines. Some psychopaths tweet that they are glad that the loved one died or that the dead vaccinated person was an enemy of good for telling of the event and should be banned. This is hard to conceptualize. This level of cruelty is terrifying, and signifies the collapse of a moral, decent, and compassionate society.

It is bad enough for the public to sink this low, but the media, political leaders, hospital administrators, medical associations and medical licensing boards are acting in a similar morally dysfunctional and cruel way.

LOGIC, REASONING, AND SCIENTIFIC EVIDENCE HAS DISAPPEARED IN THIS EVENT

Has scientific evidence, carefully done studies, clinical experience and medical logic had any effect on stopping these ineffective and dangerous vaccines? Absolutely not! The draconian efforts to vaccinate everyone on the planet continues (except the elite, postal workers, members of Congress and other insiders).[31,62]

In the case of all other drugs and previous conventional vaccines under review by the FDA, the otherwise unexplained deaths of 50 or less individuals would result in a halt in further distribution of the product, as happened on 1976 with the swine flu vaccine. With over 18,000 deaths being reported by the VAERS system for the period December 14, 2020 and December 31st, 2021 as well as 139,126 serious injuries (including deaths) for the same period there is still no interest in stopping this deadly vaccine program.[61] Worse, there is no serious investigation by any government agency to determine why these people are dying and being seriously and permanently injured by these vaccines.[15,67] What we do see is a continuous series of coverups and evasions by the vaccine makers and their promoters.

The war against effective cheap and very safe repurposed drugs and natural compounds, that have proven beyond all doubt to have saved millions of lives all over the world, has not only continued but has stepped up in intensity.[32,34,43]

Doctors are told they cannot provide these life-saving compounds for their patients and if they do, they will be removed from the hospital, have their medical license removed or be punished in many other ways. A great many pharmacies have refused to fill prescriptions for lvermectin or hydroxy- chloroquine, despite the fact that millions of people have taken these drugs safely for over 60 years in the case of hydroxy chloroquine and decades for Ivermectin.[33,36] This refusal to fill prescriptions is unprecedented and has been engineered by those wanting to prevent alternative methods of treatment, all based on protecting vaccine expansion to all. Several companies that make hydroxy chloroquine agreed to empty their stocks of the drug by donating them to the Strategic National Stockpile, making this drug far more difficult to get.[33] Why would the government do that when over 30 well-done studies have shown that this drug reduced deaths anywhere from 66% to 92% in other countries, such as India, Egypt, Argentina, France, Nigeria, Spain, Peru, Mexico, and others?[23]

The critics of these two life-saving drugs are most often funded by Bill Gates and Anthony Fauci, both of which are making millions from these vaccines.[48,15]

To further stop the use of these drugs, the pharmaceutical industry and Bill Gates/Anthony Fauci funded fake research to make the case that hydroxy chloroquine was a dangerous drug and could damage the heart.[34] To make this fraudulent case the researchers administered the sickest of covid patients a near lethal dose of the drug, in a dose far higher than used on any covid patient by Dr. Kory, McCullough and other “real”, and compassionate doctors, physicians who were actually treating covid patients.[23]

The controlled, lap-dog media, of course, hammered the public with stories of the deadly effect of hydroxy- chloroquine, all with a terrified look of fake panic. All these stories of ivermectin dangers were shown to be untrue and some of the stories were incredibly preposterous.[37,43]

The attack on Ivermectin was even more vicious than against hydroxy-chloroquine. All of this, and a great deal more is meticulously chronicled in Robert Kennedy, Jr’s excellent new book—The Real Anthony Fauci. Bill Gates, Big Pharma, and the Global War on Democracy and Public Health.[32] If you are truly concerned with the truth and with all that has occurred since this atrocity started, you must not only read, but study this book carefully. It is fully referenced and covers all topics in great detail. This is a designed human tragedy of Biblical proportions by some of the most vile, heartless, psychopaths in history.

Millions have been deliberately killed and crippled, not only by this engineered virus, but by the vaccine itself and by the draconian measures used by these governments to “control the pandemic spread”. We must not ignore the “deaths by despair” caused by these draconian measures, which can exceed hundreds of thousands. Millions have starved in third world countries as a result. In the United States alone, of the 800,000 who died, claimed by the medical bureaucracies, well over 600,000 of these deaths were the result of the purposeful neglect of early treatment, blocking the use of highly effective and safe repurposed drugs, such as hydroxy-chloroquine and Ivermectin, and the forced use of deadly treatments such as remdesivir and use of ventilators. This does not count the deaths of despair and neglected medical care caused by the lockdown and hospital measures forced on healthcare systems.

To compound all this, because of vaccine mandates among all hospital personnel, thousands of nurses and other hospital workers have resigned or been fired.[17,30,51] This has resulted in critical shortages of these vital healthcare workers and dangerous reductions of ICU beds in many hospitals. In addition, as occurred in the Lewis County Healthcare System, a specialty-hospital system in Lowville, N.Y., closed its maternity unit following the resignation of 30 hospital staff over the state’s disastrous vaccine mandate orders. The irony in all these cases of resignations is that the administrators unhesitatingly accepted these mass staffing losses despite rantings about suffering from short staffing during a “crisis”. This is especially puzzling when we learned that the vaccines did not prevent viral transmission and the present predominant variant is of extremely low pathogenicity.

DANGERS OF THE VACCINES ARE INCREASINGLY REVEALED BY SCIENCE

While most researchers, virologists, infectious disease researchers and epidemiologists have been intimidated into silence, a growing number of high integrity individuals with tremendous expertise have come forward to tell the truth—that is, that these vaccines are deadly.

Most new vaccines must go through extensive safety testing for years before they are approved. New technologies, such as the mRNA and DNA vaccines, require a minimum of 10 years of careful testing and extensive follow-up. These new so-called vaccines were “tested” for only 2 months and then the results of these safety test were and continue to be kept secret. Testimony before Senator Ron Johnson by several who participated in the 2 months study indicates that virtually no follow-up of the participants of the pre-release study was ever done.[67] Complains of complications were ignored and despite promises by Pfizer that all medical expenses caused by the “vaccines” would be paid by Pfizer, these individuals stated that none were paid.[66] Some medical expenses exceed 100,000 dollars.

As an example of the deception by Pfizer, and the other makers of mRNA vaccines, is the case of 12-year-old Maddie de Garay, who participated in the Pfizer vaccine pre-release safety study. At Sen. Johnson’s presentation with the families of the vaccine injured, her mother told of her child’s recurrent seizures, that she is now confined to a wheelchair, must be tube fed and suffers permanent brain damage. On the Pfizer safety evaluation submitted to the FDA her only side effect is listed as having a “stomachache”. Each person submitted similar horrifying stories.

The Japanese resorted to a FOIA (Freedom of Information Act) lawsuit to force Pfizer to release its secret biodistribution study. The reason Pfizer wanted it kept secret is that it demonstrated that Pfizer lied to the public and the regulatory agencies about the fate of the injected vaccine contents (the mRNA enclosed nano-lipid carrier). They claimed that it remained at the site of the injection (the shoulder), when in fact their own study found that it rapidly spread throughout the entire body by the bloodstream within 48 hours.

The study also found that these deadly nano-lipid carriers collected in very high concentrations in several organs, including the reproductive organs of males and females, the heart, the liver, the bone marrow, and the spleen (a major immune organ). The highest concentration was in the ovaries and the bone marrow. These nano-lipid carriers also were deposited in the brain.

Dr. Ryan Cole, a pathologist from Idaho reported a dramatic spike in highly aggressive cancers among vaccinated individuals, (not reported in the Media). He found a frighteningly high incidence of highly aggressive cancers in vaccinated individuals, especially highly invasive melanomas in young people and uterine cancers in women.[26] Other reports of activation of previously controlled cancers are also appearing among vaccinated cancer patients.[47] Thus far, no studies have been done to confirm these reports, but it is unlikely such studies will be done, at least studies funded by grants from the NIH.

The high concentration of spike proteins found in the ovaries in the biodistribution study could very well impair fertility in young women, alter menstruation, and could put them at an increased risk of ovarian cancer. The high concentration in the bone marrow, could also put the vaccinated at a high risk of leukemia and lymphoma. The leukemia risk is very worrisome now that they have started vaccinating children as young as 5 years of age. No long-term studies have been conducted by any of these makers of Covid-19 vaccines, especially as regards the risk of cancer induction. Chronic inflammation is intimately linked to cancer induction, growth and invasion and vaccines stimulate inflammation.

Cancer patients are being told they should get vaccinated with these deadly vaccines. This, in my opinion, is insane. Newer studies have shown that this type of vaccine inserts the spike protein within the nucleus of the immune cells (and most likely many cell types) and once there, inhibits two very important DNA repair enzymes, BRCA1 and 53BP1, whose duty it is to repair damage to the cell’s DNA.[29] Unrepaired DNA damage plays a major role in cancer.

There is a hereditary disease called xeroderma pigmentosum in which the DNA repair enzymes are defective. These ill-fated individuals develop multiple skin cancers and a very high incidence of organ cancer as a result. Here we have a vaccine that does the same thing, but to a less extensive degree.

One of the defective repair enzymes caused by these vaccines is called BRCA1, which is associated with a significantly higher incidence of breast cancer in women and prostate cancer in men.

It should be noted that no studies were ever done on several critical aspects of this type of vaccine.

• They have never been tested for long term effects

• They have never been tested for induction of autoimmunity

• They have never been properly tested for safety during any stage of pregnancy

• No follow-up studies have been done on the babies of vaccinated women

• There are no long-term studies on the children of vaccinated pregnant women after their birth (Especially as neurodevelopmental milestone occur).

• It has never been tested for effects on a long list of medical conditions:

  • Diabetes

  • Heart disease

  • Atherosclerosis

  • Neurodegenerative diseases

  • Neuropsychiatric effects

  • Induction of autism spectrum disorders and schizophrenia

  • Long term immune function

  • Vertical transmission of defects and disorders

  • Cancer

  • Autoimmune disorders

Previous experience with the flu vaccines clearly demonstrates that the safety studies done by researchers and clinical doctors with ties to pharmaceutical companies were essentially all either poorly done or purposefully designed to falsely show safety and coverup side effects and complications. This was dramatically demonstrated with the previously mentioned phony studies designed to indicate that hydroxy Chloroquine and Ivermectin were ineffective and too dangerous to use.[34,36,37] These fake studies resulted in millions of deaths and severe health disasters worldwide. As stated, 80% of all deaths were unnecessary and could have been prevented with inexpensive, safe repurposed medications with a very long safety history among millions who have taken them for decades or even a lifetime.[43,44]

It is beyond ironic that those claiming that they are responsible for protecting our health approved a poorly tested set of vaccines that has resulted in more deaths in less than a year of use than all the other vaccines combined given over the past 30 years. Their excuse when confronted was—“we had to overlook some safety measures because this was a deadly pandemic”.[28,46]

In 1986 President Reagan signed the National Childhood Vaccine Injury Act, which gave blanket protection to pharmaceutical makers of vaccines against injury litigation by families of vaccine injured individuals. The Supreme Court, in a 57-page opinion, ruled in favor of the vaccine companies, effectively allowing vaccine makers to manufacture and distribute dangerous, often ineffective vaccines to the population without fear of legal consequences. The court did insist on a vaccine injury compensation system which has paid out only a very small number of rewards to a large number of severely injured individuals. It is known that it is very difficult to receive these awards. According to the Health Resources and Services Administration, since 1988 the Vaccine Injury Compensation Program (VICP) has agreed to pay 3,597 awards among 19,098 vaccine injured individuals applying amounting to a total sum of $3.8 billion. This was prior to the introduction of the Covid-19 vaccines, in which the deaths alone exceed all deaths related to all the vaccines combined over a thirty-year period.

In 2018 President Trump signed into law the “right-to-try” law which allowed the use of experimental drugs and all unconventional treatments to be used in cases of extreme medical conditions. As we have seen with the refusal of many hospitals and even blanket refusal by states to allow Ivermectin, hydroxy-chloroquine or any other unapproved “official” methods to treat even terminal Covid-19 cases, these nefarious individuals have ignored this law.

Strangely, they did not use this same logic or the law when it came to Ivermectin and Hydroxy Chloroquine, both of which had undergone extensive safety testing by over 30 clinical studies of a high quality and given glowing reports on both efficacy and safety in numerous countries. In addition, we had a record of use for up to 60 years by millions of people, using these drugs worldwide, with an excellent safety record. It was obvious that a group of very powerful people in conjunction with pharmaceutical conglomerates didn’t want the pandemic to end and wanted vaccines as the only treatment option. Kennedy’s book makes this case using extensive evidence and citations.[14,32]

Dr. James Thorpe, an expert in maternal-fetal medicine, demonstrates that these covoid-19 vaccines given during pregnancy have resulted in a 50-fold higher incidence of miscarriage than reported with all other vaccines combined.[28] When we examine his graph on fetal malformations there was a 144-fold higher incidence of fetal malformation with the Covid-19 vaccines given during pregnancy as compared to all other vaccines combined. Yet, the American Academy of Obstetrics and Gynecology and the American College of Obstetrics and Gynecology endorse the safety of these vaccines for all stages of pregnancy and among women breast feeding their babies.

It is noteworthy that these medical specialty groups have received significant funding from Pfizer pharmaceutical company. The American College of Obstetrics and Gynecology, just in the 4th quarter of 2010, received a total of $11,000 from Pfizer Pharmaceutical company alone.[70] Funding from NIH grants are much higher.[20] The best way to lose these grants is to criticize the source of the funds, their products or pet programs. Peter Duesberg, because of his daring to question Fauci’s pet theory of AIDS caused by HIV virus, was no longer awarded any of the 30 grant applications he submitted after going public. Prior to this episode, as the leading authority on retroviruses in the world, he had never been turned down for an NIH grant.[39] This is how the “corrupted” system works, even though much of the grant money comes from our taxes.

HOT LOTS—DEADLY BATCHES OF THE VACCINES

A new study has now surfaced, the results of which are terrifying.[25] A researcher at Kingston University in London, has completed an extensive analysis of the VAERs data (a subdepartment of the CDC which collects voluntary vaccine complication data), in which he grouped reported deaths following the vaccines according to the manufacturer’s lot numbers of the vaccines. Vaccines are manufactured in large batches called lots. What he discovered was that the vaccines are divided into over 20,000 lots and that one out of every 200 of these batches (lots) is demonstrably deadly to anyone who receives a vaccine from that lot, which includes thousands of vaccine doses.

He examined all manufactured vaccines—Pfizer, Moderna, Johnson and Johnson (Janssen), etc. He found that among every 200 batches of the vaccine from Pfizer and other makers, one batch of the 200 was found to be over 50x more deadly than vaccines batches from other lots. The other vaccine lots (batches) were also causing deaths and disabilities, but nowhere near to this extent. These deadly batches should have appeared randomly among all “vaccines” if it was an unintentional event. However, he found that 5% of the vaccines were responsible for 90% of the serious adverse events, including deaths. The incidence of deaths and serious complications among these “hot lots” varied from over 1000% to several thousand percent higher than comparable safer lots. If you think this was by accident—think again. This is not the first time “hot lots” were, in my opinion, purposefully manufactured and sent across the nation—usually vaccines designed for children. In one such scandal, “hot lots” of a vaccine ended up all in one state and the damage immediately became evident. What was the manufacture’s response? It wasn’t to remove the deadly batches of the vaccine. He ordered his company to scatter the hot lots across the nation so that authorities would not see the obvious deadly effect.

All lots of a vaccine are numbered—for example Modera labels them with such codes as 013M20A. It was noted that the batch numbers ended in either 20A or 21A. Batches ending in 20A were much more toxic than the ones ending in 21A. The batches ending in 20A had about 1700 adverse events, versus a few hundred to twenty or thirty events for the 21A batches. This example explains why some people had few or no adverse events after taking the vaccine while others are either killed or severely and permanently harmed. To see the researcher’s explanation, go to https://www.bitchute.com/video/6xIYPZBkydsu/ In my opinion these examples strongly suggest an intentional alteration of the production of the “vaccine” to include deadly batches.

I have met and worked with a number of people concerned with vaccine safety and I can tell you they are not the evil anti-vaxxers you are told they are. They are highly principled, moral, compassionate people, many of which are top researchers and people who have studied the issue extensively. Robert Kennedy, Jr, Barbara Lou Fisher, Dr. Meryl Nass, Professor Christopher Shaw, Megan Redshaw, Dr. Sherri Tenpenny, Dr. Joseph Mercola, Neil Z. Miller, Dr. Lucija Tomjinovic, Dr. Stephanie Seneff, Dr. Steve Kirsch and Dr. Peter McCullough just to name a few. These people have nothing to gain and a lot to lose. They are attacked viciously by the media, government agencies, and elite billionaires who think they should control the world and everyone in it.

WHY DID FAUCI WANT NO AUTOPSIES OF THOSE WHO DIED AFTER VACCINATION?

There are many things about this “pandemic” that are unprecedented in medical history. One of the most startling is that at the height of the pandemic so few autopsies, especially total autopsies, were being done. A mysterious virus was rapidly spreading around the world, a selected group of people with weakened immune systems were getting seriously ill and many were dying and the one way we could rapidly gain the most knowledge about this virus—an autopsy, was being discouraged.

Guerriero noted that by the end of April, 2020 approximately 150,000 people had died, yet there were only 16 autopsies performed and reported in the medical literature.[24] Among these, only seven were complete autopsies, the remaining 9 being partial or by needle biopsy or incisional biopsy. Only after 170,000 deaths by Covid-19 and four months into the pandemic were the first series of autopsies actually done, that is, more than ten. And only after 280,000 deaths and another month, were the first large series of autopsies performed, some 80 in number.[22] Sperhake, in a call for autopsies to be done without question, noted that the first full autopsy reported in the literature along with photomicrographs appeared in a medico-legal journal from China in February 2020.[41,68] Sperhake expressed confusion as to why there was a reluctance to perform autopsies during the crisis, but he knew it was not coming from the pathologists. The medical literature was littered with appeals by pathologist for more autopsies to be performed.[58] Sperhake further noted that the Robert Koch Institute (The German health monitoring system) at least initially advised against doing autopsies. He also knew that at the time 200 participating autopsy institutions in the United States had done at least 225 autopsies among 14 states.

Some have claimed that this dearth of autopsies was based on the government’s fear of infection among the pathologists, but a study of 225 autopsies on Covid-19 cases demonstrated only one case of infection among the pathologist and this was concluded to have been an infection contracted elsewhere.[19] Guerriero ends his article calling for more autopsies with this observation: “Shoulder to shoulder, clinical and forensic pathologists overcame the obstructions of autopsy studies in Covid-19 victims and hereby generated valuable knowledge on the pathophysiology of the interaction between the SARS-CoV-2 and the human body, thus contributing to our understanding of the disease.”[24]

Suspicion concerning the worldwide reluctance of nations to allow full post mortem studies of Covid-19 victims may be based on the idea that it was more than by chance. There are at least two possibilities that stand out. First, those leading the progression of this “non-pandemic” event into a perceived worldwide “deadly pandemic”, were hiding an important secret that autopsies could document. Namely, just how many of the deaths were actually caused by the virus? To implement draconian measures, such as mandated mask wearing, lockdowns, destruction of businesses, and eventually mandated forced vaccination, they needed very large numbers of covid-19 infected dead. Fear would be the driving force for all these destructive pandemic control programs.

Elder et al in his study classified the autopsy findings into four groups.[22]

1. Certain Covid-19 death
2. Probably Covid-19 death
3. Possible Covid-19 death
4. Not associated with Covid-19, despite the positive test.

What possibly concerned or even terrified the engineers of this pandemic was that autopsies just might, and did, show that a number of these so-called Covid-19 deaths in truth died of their comorbid diseases. In the vast majority of autopsy studies reported, pathologists noted multiple comorbid conditions, most of which at the extremes of life could alone be fatal. Previously it was known that common cold viruses had an 8% mortality in nursing homes.

In addition, valuable evidence could be obtained from the autopsies that would improve clinical treatments and could possibly demonstrate the deadly effect of the CDC mandated protocols all hospitals were required to follow, such as the use of respirators and the deadly, kidney-destroying drug remdesivir. The autopsies also demonstrated accumulating medical errors and poor-quality care, as the shielding of doctors in intensive care units from the eyes of family members inevitably leads to poorer quality care as reported by several nurses working in these areas.[53-55]

As bad as all this was, the very same thing is being done in the case of Covid vaccine deaths—very few complete autopsies have been done to understand why these people died, that is, until recently. Two highly qualified researchers, Dr. Sucharit Bhakdi a microbiologist and highly qualified expert in infectious disease and Dr. Arne Burkhardt, a pathologist who is a widely published authority having been a professor of pathology at several prestigious institutions, recently performed autopsies on 15 people having died after vaccination. What they found explains why so many are dying and experiencing organ damage and deadly blood clots.[5]

They determined that 14 of the fifteen people died as a result of the vaccines and not of other causes. Dr. Burkhardt, the pathologist, observed widespread evidence of an immune attack on the autopsied individuals’ organs and tissues— especially their heart. This evidence included extensive invasion of small blood vessels with massive numbers of lymphocytes, which cause extensive cell destruction when unleashed. Other organs, such as the lungs and liver, were observed to have extensive damage as well. These findings indicate the vaccines were causing the body to attack itself with deadly consequences. One can easily see why Anthony Fauci, as well as public health officers and all who are heavily promoting these vaccines, publicly discouraged autopsies on the vaccinated who subsequently died. One can also see that in the case of vaccines, that were essentially untested prior to being approved for the general public, at least the regulatory agencies should have been required to carefully monitor and analyze all serious complications, and certainly deaths, linked to these vaccines. The best way to do that is with complete autopsies.

While we learned important information from these autopsies what is really needed are special studies of the tissues of those who have died after vaccination for the presence of spike protein infiltration throughout the organs and tissues. This would be critical information, as such infiltration would result in severe damage to all tissues and organs involved—especially the heart, the brain, and the immune system. Animal studies have demonstrated this. In these vaccinated individuals the source of these spike proteins would be the injected nanolipid carriers of the spike protein producing mRNA. It is obvious that the government health authorities and pharmaceutical manufacturers of these “vaccines” do not want these critical studies done as the public would be outraged and demand an end to the vaccination program and prosecution of the involved individuals who covered this up.

CONCLUSIONS

We are all living through one of the most drastic changes in our culture, economic system, as well as political system in our nation’s history as well as the rest of the world. We have been told that we will never return to “normal” and that a great reset has been designed to create a “new world order”. This has all been outlined by Klaus Schwab, head of the World Economic Forum, in his book on the “Great Reset”.[66] This book gives a great deal of insight as to the thinking of the utopians who are proud to claim this pandemic “crisis” as their way to usher in a new world. This new world order has been on the drawing boards of the elite manipulators for over a century.[73,74] In this paper I have concentrated on the devastating effects this has had on the medical care system in the United States, but also includes much of the Western world. In past papers I have discussed the slow erosion of traditional medical care in the United States and how this system has become increasingly bureaucratized and regimented.[7,8] This process was rapidly accelerating, but the appearance of this, in my opinion, manufactured “pandemic” has transformed our health care system over night.

As you have seen, an unprecedented series of events have taken place within this system. Hospital administrators, for example, assumed the position of medical dictators, ordering doctors to follow protocols derived not from those having extensive experience in treating this virus, but rather from a medical bureaucracy that has never treated a single COVID-19 patient. The mandated use of respirators on ICU Covid-19 patients, for example, was imposed in all medical systems and dissenting physicians were rapidly removed from their positions as caregivers, despite their demonstration of markedly improved treatment methods. Further, doctors were told to use the drug remdesivir despite its proven toxicity, lack of effectiveness and high complication rate. They were told to use drugs that impaired respiration and mask every patient, despite the patient’s impaired breathing. In each case, those who refused to abuse their patients were removed from the hospital and even faced a loss of license—or worse.

For the first time in modern medical history, early medical treatment of these infected patients was ignored nationwide. Studies have shown that early medical treatment was saving 80% of higher number of these infected people when initiated by independent doctors.[43,44] Early treatment could have saved over 640,000 lives over the course of this “pandemic”. Despite the demonstration of the power of these early treatments, the forces controlling medical care continued this destructive policy.

Families were not allowed to see their loved ones, forcing these very sick individuals in the hospitals to face their deaths alone. To add insult to injury, funerals were limited to a few grieving family members, who were not allowed to even sit together. All the while large stores, such as Walmart and Cosco were allowed to operate with minimal restrictions. Nursing home patients were also not allowed to have family visitations, again being forced to die a lonely death. All the while, in a number of states, the most transparent being in New York state, infected elderly were purposefully transferred from hospitals into nursing homes, resulting in a very high death rates of these nursing home residents. At the beginning of this “pandemic” over 50% of all death were occurring in nursing homes.

Throughout this “pandemic” we have been fed an unending series of lies, distortions and disinformation by the media, the public health officials, medical bureaucracies (CDC, FDA and WHO) and medical associations. Physicians, scientists, and experts in infectious treatments who formed associations designed to develop more effective and safer treatments, were regularly demonized, harassed, shamed, humiliated, and experience a loss of licensure, loss of hospital privileges and, in at least one case, ordered to have a psychiatric examination.[2,65,71]

Anthony Fauci was given essentially absolute control of all forms of medical care during this event, including insisting that drugs he profited from be used by all treating physicians. He ordered the use of masks, despite at first laughing at the use of masks to filter a virus. Governors, mayors, and many businesses followed his orders without question.

The draconian measures being used, masking, lockdowns, testing of the uninfected, use of the inaccurate PCR test, social distancing, and contact tracing had been shown previously to be of little or no use during previous pandemics, yet all attempts to reject these methods were to no avail. Some states ignored these draconian orders and had either the same or fewer cases, as well as deaths, as the states with the most strictly enforced measures. Again, no amount of evidence or obvious demonstration along these lines had any effect on ending these socially destructive measures. Even when entire countries, such as Sweden, which avoided all these measures, demonstrated equal rates of infections and hospitalization as nations with the strictest, very draconian measures, no policy change by the controlling institutions occurred. No amount of evidence changed anything.

Experts in the psychology of destructive events, such as economic collapses, major disasters and previous pandemics demonstrated that draconian measures come with an enormous cost in the form of “deaths of despair” and in a dramatic increase in serious psychological disorders. The effects of these pandemic measures on children’s neurodevelopment is catastrophic and to a large extent irreversible.

Over time tens of thousands could die as a result of this damage. Even when these predictions began to appear, the controllers of this “pandemic” continued full steam ahead. Drastic increases in suicides, a rise in obesity, a rise in drug and alcohol use, a worsening of many health measures and a terrifying rise in psychiatric disorders, especially depression and anxiety, were ignored by the officials controlling this event.

We eventually learned that many of the deaths were a result of medical neglect. Individuals with chronic medical conditions, diabetes, cancer, cardiovascular disease, and neurological diseases were no longer being followed properly in their clinics and doctor’s offices. Non-emergency surgeries were put on hold. Many of these patients chose to die at home rather than risk going to the hospitals and many considered hospitals “death houses”.

Records of deaths have shown that there was a rise in deaths among those aged 75 and older, mostly explained by Covid-19 infections, but for those between the ages of 65 to 74, deaths had been increasing well before the pandemic onset.[69] Between ages of 18 and aged 65 years, records demonstrate a shocking hike in non-Covid-19 deaths. Some of these deaths were explained by a dramatic increase in drug-related deaths, some 20,000 more than 2019. Alcohol related deaths also increased substantially, and homicides increased almost 30% in the 18 to 65-year group.

The head of the insurance company OneAmerica stated that their data indicated that the death rate for individuals aged 18 to 64 had increased 40% over the pre-pandemic period.[21] Scott Davidson, the company’s CEO, stated that this represented the highest death rate in the history of insurance records, which does extensive data collections on death rates each year. Davidson also noted that this high of a death rate increase has never been seen in the history of death data collection. Previous catastrophes of monumental extent increased death rates no more than 10 percent, 40% is unprecedented.

Dr. Lindsay Weaver, Indiana’s chief medical officer, stated that hospitalizations in Indiana are higher than at any point in the past five years. This is of critical importance since the vaccines were supposed to significantly reduce deaths, but the opposite has happened. Hospitals are being flooded with vaccine complications and people in critical condition from medical neglect caused by the lockdowns and other pandemic measures.[46,56]

A dramatic number of these people are now dying, with the spike occurring after the vaccines were introduced. The lies flowing from those who have appointed themselves as medical dictators are endless. First, we were told that the lockdown would last only two weeks, they lasted over a year. Then we were told that masks were ineffective and did not need to be worn. Quickly that was reversed. Then we were told the cloth mask was very effective, now it’s not and everyone should be wearing an N95 mask and before that that they should double mask. We were told there was a severe shortage of respirators, then we discover they are sitting unused in warehouses and in city dumps, still in their packing crates. We were informed that the hospitals were filled mostly with the unvaccinated and later found the exact opposite was true the world over. We were told that the vaccine was 95% effective, only to learn that in fact the vaccines cause a progressive erosion of innate immunity.

Upon release of the vaccines, women were told the vaccines were safe during all states of pregnancy, only to find out no studies had been done on safety during pregnancy during the “safety tests” prior to release of the vaccine. We were told that careful testing on volunteers before the EUA approval for public use demonstrated extreme safety of the vaccines, only to learn that these unfortunate subjects were not followed, medical complications caused by the vaccines were not paid for and the media covered this all up.[67] We also learned that the pharmaceutical makers of the vaccines were told by the FDA that further animal testing was unnecessary (the general public would be the Guinea pigs.) Incredibly, we were told that the Pfizer’s new mRNA vaccines had been approved by the FDA, which was a cleaver deception, in that another vaccine had approval (comirnaty) and not the one being used, the BioNTech vaccine. The approved comirnaty vaccine was not available in the United States. The national media told the public that the Pfizer vaccine had been approved and was no longer classed as experimental, a blatant lie. These deadly lies continue. It is time to stop this insanity and bring these people to justice.

Footnotes

How to cite this article: Blaylock RL. COVID UPDATE: What is the truth? Surg Neurol Int 2022;13:167.

Disclaimer

The views and opinions expressed in this article are those of the authors and do not necessarily reflect the official policy or position of the Journal or its management.

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Articles from Surgical Neurology International are provided here courtesy of Scientific Scholar

"If the radiance of a thousand suns were to burst at once into the sky, that would be like the splendor of the mighty one." "Now I am become Death, the destroyer of worlds”.

J. Robert Oppenheimer, Scientific director of the Manhattan Project (quoting from the Bhagavad Gita)

by Robert W. Malone MD, MS

Last January, Stew Peters decided to roll out the thesis that I have personal responsibility for the morbidity and mortality associated with the COVID-19 mRNA vaccines consequent to my pioneering work in developing the ideas and reduction to practice of using synthetic mRNA as a transient “gene therapy” method, with the entry level application being for vaccine purposes. This has been echoed by many angry social media detractors seeking to find someone to blame for the lies and adverse events that have been associated with these mRNA vaccines. Mindful of those critics, this Substack essay focuses on some of the differences between what was originally envisioned and the current molecules that are being injected into our bodies. The first section of the essay sets the stage by summarizing (for a general readership) how the whole idea of gene therapy was developed, and then describing how and why this lead to the idea of mRNA as a drug and as a method of generating a vaccine response. The second section gets quite technical, and provides detailed information intended for a scientific audience. The conclusion is written for a general audience.

Gene Therapy, Transhumanism, and the origins of mRNA as a drug or vaccine

The core idea captured in the original nine patents which stem from my work between 1987 and 1989 was that there are multiple key problems with the idea of permanent “gene therapy” as originally envisioned by Richard Roblin, PhD and academic Pediatrician Dr. Theodore Friedman in 1972. The modern embodiment of this concept can be found in the many writings from the WEF and others concerning “Transhumanism” and use of CRISPR/Cas9 gene editing technology. To really understand all of this requires a brief journey through the history and logic of “gene therapy”.

The January 2015 UC San Diego News center piece entitled “Friedman Recognized for Pioneering Gene Therapy Research: School of Medicine professor receives prestigious Japan Prize” nicely summarizes the underlying logic of “Gene Therapy” as envisioned by Friedman and Roblin.

“Though posed as a question, Friedmann and Roblin firmly believed the answer was yes, citing emergent thinking, new studies and growing data that suggested “good DNA” could be used to replace defective DNA in people with inherited conditions.

“In our view,” they wrote, “gene therapy may ameliorate some human genetic diseases in the future. For this reason, we believe that research directed at the development of techniques for gene therapy should continue.”

Though Friedmann said initial response to the paper was “not overwhelming,” it’s now commonly cited as a major milestone in the scientific beginnings of gene therapy research, though Friedmann said it was the Asilomar conference three years later (scientists set safety standards for recombinant DNA technology) where interest really “exploded.”

The idea of gene therapy, which quickly captured the public imagination, was fueled by its appealingly straightforward approach and what Friedmann has described as “obvious correctness”: Disarm a potentially pathogenic virus to make it benign. Stuff these viral particles with normal DNA. Then inject them into patients carrying abnormal genes, where they will deliver their therapeutic cargoes inside the defective target cells. In theory, the good DNA replaces or corrects the abnormal function of the defective genes, rendering previously impaired cells whole, normal and healthy. End of disease.”

Nice theory, what could possibly go wrong? The article continues-

“In 1968, Friedmann, working at the National Institutes of Health in Bethesda, Maryland with the late Jay Seegmiller (a founding faculty member of the School of Medicine) and others, showed that by adding foreign DNA to cultured cells from patients with Lesch-Nyhan syndrome, they could correct genetic defects that caused the rare but devastating neurological disorder. The condition was first described by William Nyhan, MD, a UC San Diego professor of pediatrics, and medical student Michael Lesch in 1964.

The feat was a powerful proof-of-concept, but subsequent efforts to advance the work to human clinical trials stalled. “We began to realize that it would be very complicated to take this idea and make it work in people,” Friedmann said, who joined the School of Medicine faculty in 1969.

In 1990, a 4-year-old girl with a congenital disease called adenoside deaminase (ADA) deficiency, which severely affects immunity and the ability to fight infections, became the first patient treated by gene therapy. White blood cells were taken from her, the normal ADA gene was inserted into them using an engineered and disabled virus and the cells re-injected. Despite initial claims of success, Friedmann said the experiment was eventually deemed a failure. The girl’s condition was not cured, and the research was found wanting.

A report commissioned by National Institutes of Health director Harold Varmus, MD, was highly critical of the entire gene therapy field and the ADA effort in particular, chiding investigators for creating a “mistaken and widespread perception of success.” Friedmann says he took the Varmus report “personally. I felt awful. It almost made me feel like I had been deceiving myself and my colleagues for more than two decades about the promise of gene therapy.” But he also knew there were “many more good people doing gene therapy research than rogues” and continued diligently and conscientiously to pursue his own research.

Nonetheless, media attention and hype about gene therapy continued to be rampant, fueled in part by over-enthusiastic opinions by some scientists. Things crashed in 1999 when an 18-year-old patient named Jesse Gelsinger, who suffered from a genetic disease of the liver, died during a clinical trial at the University of Pennsylvania. Gelsinger’s death was the first directly attributed to gene therapy. Subsequent investigations revealed numerous problems in the experimental design.”

The history of the Varmus report provides an early glimpse of the way things work at NIH and the US HHS. The Scientist appointed to head up the commission to review the science of “Gene Therapy” was none other than my graduate mentor Dr. Inder Verma, who had long been one of the leading proponents of gene therapy, and was subsequently forced to resign from the Salk Institute over a decades long record of what might most gently be called ethical lapses. But this was the scientist appointed by the overall Director of the NIH to “independently” investigate the scientific rigor and merits of the field. One hand washes the other.

What is awry with the original “gene therapy” concept? There are multiple issues, and here are a few-

1) Can you efficiently get genetic material (“polynucleotides”) into the nucleus of the majority of cells in the human body so that any genetic defects (or transhuman genetic improvements) can be made? In short, no. Human cells (and the immune system) have evolved many, many different mechanisms to resist modification by external polynucleotides. Otherwise we would already be overrun by various forms of parasitic DNA and RNA- viral and otherwise. This remains a major technical barrier, one which the “transhumanists” continue to overlook in their enthusiastic but naïve rush to play god with the human species. What are polynucleotides? Basically, the long chain polymers composed of four nucleotide bases (ATGC in the case of DNA, AUGC in the case of RNA) which carry all genetic information (that we know of) across time.

2) What about the immune system? Well, this was one of my breakthroughs way back in the late 1980s. What Ted (Friedman) originally envisioned was the simple idea that if a child had a genetic birth defect causing the body to produce a defective or not produce a critical protein (such as Lesch-Nyhan syndrome or Adenosine Deaminase Deficiency), this could be simply corrected by providing the “good gene” to complement the defect. What was not appreciated was that the immune systems of these children were “educated” during development to either recognize the “bad protein” as normal/self, or to not recognize the absent protein as normal/self. So, introduction of the “go od gene” into a person’s body would cause production of what was essentially a “foreign protein”, resulting in immunologic attack and killing of the cells which now have the ‘good gene”.

3) What happens when things go wrong and the “good gene/protein” is toxic? Well, in the current vaccine situation this is essentially the “Spike protein” problem. I get asked all the time “what can I do to eliminate the RNA vaccines from my body”, to which I have to answer – nothing. There is no technology that I know of which can eliminate these synthetic “mRNA-like” molecules from your body. The same is true for any of the many “gene therapy” methods currently being used. You just have to hope that your immune system will attack the cells that have taken up the polynucleotides and degrade (chew up) the offending large molecule that causes your cells to manufacture the toxic protein. Since virtually all current “gene therapy” methods are inefficient, and essentially deliver the genetic material randomly to a small subset of cells, there is no practical way to surgically remove the scattered, relatively rare transgenic cells. Clearance of genetically modified cells by the cellular immune system (T cells) is the only currently viable method to remove cells that have taken up the foreign genetic information (“transfection” in the case of mRNA or DNA, or “transduction” in the case of a viral vectored gene).

4) What happens if the “good gene” lands in a “bad place” in your genome? It turns out that the structure of our genome is highly evolved, and we are still relative neophytes in our current level of understanding. Despite having sequenced the human genome. The method of “insertional mutagenesis” (sticking genetic information in the form of viral DNA or other ways) has long been one of the leading methods to generate new insights into genetics – from fruit flies to frogs to fish to mice. When new DNA is inserted into chromosomes it can cause many unexpected things to happen. Like development of cancers, for example. This is why there is so much concern about the possibility that the mRNA-like polynucleotides used in the “RNA vaccines” may travel into the nucleus (where the DNA chromosomes reside) and insert or recombine with a cellular genome after reverse transcription (RNA-> DNA). Normally, with DNA-based gene therapy technologies, the FDA requires genotoxicity studies for this reason, but the FDA did not treat the “mRNA vaccine” technology as a gene therapy product.

Based on these risk considerations, the original idea behind using mRNA as a drug (for genetic therapeutic or vaccine purposes) was that mRNA is typically degraded quite rapidly once manufactured or released into a cell. mRNA stability is regulated by a number of genetic elements including the length of the “poly A tail”, but typically ranges from ½ to a couple of hours. Therefore, if natural or synthetic mRNA which is degraded by the usual enzymes is introduced into your body, it should only last for a very short time. And this has been the answer which Pfizer, BioNTech and Moderna have provided to physicians when asked “how long does the injected mRNA last after injection”.

But now we know that the “mRNA” from the Pfizer/BioNTech and Moderna vaccines which incorporates the synthetic nucleotide pseudouridine can persist in lymph nodes for at least 60 days after injection. This is not natural, and this is not really mRNA. These molecules have genetic elements similar to those of natural mRNA, but they are clearly far more resistant to the enzymes which normally degrade natural mRNA, seem to be capable of producing high levels of protein for extended periods, and seem to evade normal immunologic mechanisms for eliminating cells which produce foreign proteins which are not normally observed in the body.

Key findings from this seminal work by Katharina Röltgen et al include the following:

Regarding pseudouridine and mRNA

What is pseudouridine (shorthand symbol Ψ)? Pseudouridine is a modified nucleotide mRNA subunit that is prevalent in natural human mRNAs, and the biologic significance and regulation of the modification process is still being determined and understood. This modification occurs naturally in the cells of our body, in a highly regulated manner. This is in sharp contrast to the random incorporation of synthetic pseudouridine which occurs with the manufacturing process used for producing the Moderna and Pfizer/BioNTech (but not CureVac) COVID-19 “mRNA” vaccines. The “state of the art” of understanding of the biology of natural pseudouridine modifications is summarized circa late 2020 in this excellent review published in the journal Annual Review of Genetics by Erin K Borchardt et al. The open source version (not paywall protected) can be found here. Hang on, because we are about to dive into some serious immunology, molecular and cell biology.

Abstract as follows:

“Recent advances in pseudouridine detection reveal a complex pseudouridine landscape that includes messenger RNA and diverse classes of noncoding RNA in human cells. The known molecular functions of pseudouridine, which include stabilizing RNA conformations and destabilizing interactions with varied RNA-binding proteins, suggest that RNA pseudouridylation could have widespread effects on RNA metabolism and gene expression. Here, we emphasize how much remains to be learned about the RNA targets of human pseudouridine synthases, their basis for recognizing distinct RNA sequences, and the mechanisms responsible for regulated RNA pseudouridylation. We also examine the roles of noncoding RNA pseudouridylation in splicing and translation and point out the potential effects of mRNA pseudouridylation on protein production, including in the context of therapeutic mRNAs.”

A more recent (peer reviewed) publication in the journal Molecular Cell has shed light on some of the mechanisms of action associated with natural pseudouridine modification. It appears that, in the natural context, various highly regulated cellular enzymes (for example PUS1, PUS7, and RPUSD4) act on specific mRNAs and specific locations within those mRNAs while they are being made in the cell to modify the normal uridine nucleotide subunit to form pseudouridine. These modifications occur at locations associated with alternatively spliced RNA regions, are enriched near splice sites, and overlap with hundreds of binding sites for RNA-binding proteins. Latest data indicate that pre-mRNA pseudouridylation is used by human cells to regulate human gene expression via alternative pre-mRNA processing.

Relevant to the “mRNA” vaccines, the Borchardt review makes the following surprising statement, which is consistent with the Cell paper cited above which demonstrates that the synthetic “mRNA” being used for these vaccines persists in patient lymph node tissue for 60 days or longer-

“An exciting possibility is that regulated mRNA pseudouridylation controls mRNA metabolism in response to changing cellular conditions.”

That is a technically precise way of saying that incorporation of pseudouridine is one factor that controls how long an mRNA stays around in your body.

The review proceeds with the following alarming (from the context of the unregulated incorporation of Ψ into the molecules used for vaccine purposes) statement:

“The biological effects of Ψ must originate in chemical differences between U and Ψ, which primarily affect RNA backbone conformation and the stability of base pairs. Because Ψ can form stable pairs with G, C and U in addition to A, it has been proposed as a “universal” base pairing partner. Despite intensive study of the structural effects of Ψ on short, synthetic RNA oligos, it is currently impossible to predict the structural outcome of site-specific RNA pseudouridylation in longer RNAs. The systematic investigation of sequence-context effects on the stability of Ψ-containing duplexes is an important step towards accurate predictions. It will be important to determine the structural consequences of RNA pseudouridylation in cells, which is possible using improved methods to probe RNA structure in vivo.”

Furthermore,

“The effect of Ψ on the yield of functional protein depends strongly on the specific codons used. The mechanisms underlying this sequence dependence are unknown, highlighting how much remains to be understood about the translational consequences of mRNA pseudouridylation in cells.”

Finally, relevant to the immunosuppression being observed after multiple mRNA vaccine boosters (which is increasingly referred to as an acquired immunodeficiency syndrome or AIDS disease), Borchardt et al teach the following:

“Innate Immunity

Cells are equipped with innate immune sensors, including various Toll-like receptors (TLRs), retinoic acid inducible protein (RIG-I), and protein kinase R (PKR), which detect foreign nucleic acid. RNA modifications have been thought to provide a mechanism for discerning “self” RNA from non-self RNA, and indeed, incorporating RNA modifications, including pseudouridine, in foreign RNA allows for escape from innate immune detection. This makes RNA modification a powerful tool in the field of RNA therapeutics where RNAs must make it into cells without triggering an immune response, and remain stable long enough to achieve therapeutic goals. In addition, the presence of modified nucleosides in viral genomic RNA could contribute to immune evasion during infection.

TLRs Toll-Like Receptors (TLRs) are membrane-associated proteins which detect various pathogen associated molecular patterns (PAMPS) and subsequently stimulate production of proinflammatory cytokines. The RNA-sensing TLRs, TLR3, TLR7 and TLR8 reside within endosomal membranes. TLR3 recognizes dsRNA, while TLR7 and TLR8 recognize ssRNA. Upon target recognition, TLRs activate a signaling cascade that results in the expression of proinflammatory cytokines and interferon. In vitro transcribed RNA is immunostimulatory when transfected into HEK293 cells engineered to express either TLRs and inclusion of Ψ in the RNA suppressed this response (most pronounced for TLR7 and TLR8).

RIG-I Retinoic Acid Inducible Protein (RIG-I) is a cytosolic innate immune sensor responsible for detecting short stretches of dsRNA or ssRNA with either a 5′-triphosphate or 5′-disphosphate group (a feature common to various RNA viruses). Activation of RIG-I relieves its autoinhibition, releasing its CARD domains to interact with MAVS and set off a signaling cascade that ultimately results in expression of immune factors. Inclusion of Ψ in a 5′-triphosphate capped RNA abolishes activation of RIG-I, providing another mechanism for pseudouridine-mediated suppression of innate immune activation. Further, the polyU/UC region of the HCV genome is also potent activator of RIG-I and complete replacement of U with Ψ in this RNA fully abrogates downstream IFN-beta induction, despite RIG-I still binding to the modified RNA, but with reduced affinity. Durbin et al present biochemical evidence that RIG-I bound to pseudouridylated polyU/UC RNA fails to undergo the conformational changes necessary to activate downstream signaling.

PKR RNA-dependent Protein Kinase (PKR) is a cytosolic resident innate immune sensor. Upon detection of foreign RNA, PKR represses translation through phosphorylation of translation initiation factor eIF-2alpha. Molecules which activate PKR are varied, but include dsRNA formed intra- or inter-molecularly, and 5′ triphosphate groups. Inclusion of Ψ in various PKR substrates reduces PKR activation and downstream translation repression relative to unmodified RNAs. For example, a short 47-nt ssRNA potently activates PKR when synthesized with U but not with Ψ (~30-fold reduction with Ψ). Ψ also modestly reduced PKR activity when this short RNA was annealed to a complementary unmodified RNA 170. Likewise, in vitro transcribed, unmodified tRNA acted as much more potent activator of PKR than tRNAs transcribed with pseudouridine. It should be noted that it is unclear whether a fully pseudouridylated tRNA adopts canonical folding and what impact this may have on PKR recognition of this substrate. Finally, transfection of an unmodified mRNA caused a greater reduction in overall cellular protein synthesis in cell culture compared to the same mRNA fully pseudouridylated. Consistent with this result, fully pseudouridylated mRNA reduced PKR activation and subsequent phosphorylation of eIF-2alpha.”

Regarding the consequences for the use of mRNA as a drug for therapeutic or vaccine purposes, Borchardt et al conclude that

“Pseudouridine likely affects multiple facets of mRNA function, including reduced immune stimulation by several mechanisms, prolonged half-life of pseudouridine-containing RNA, as well as potentially deleterious effects of Ψ on translation fidelity and efficiency.”

Conclusion

Based on this information, it appears to me that the extensive random incorporation of pseudouridine into the synthetic mRNA-like molecules used for the Pfizer/BioNTech and Moderna SARS-CoV-2 vaccines may well account for much or all of the observed immunosuppression, DNA virus reactivation, and remarkable persistence of the synthetic “mRNA” molecules observed in lymph node biopsy tissues by Katharina Röltgen et al. Many of these adverse effects were reported by Kariko, Weissman et al in their 2008 paper “Incorporation of pseudouridine into mRNA yields superior nonimmunogenic vector with increased translational capacity and biological stability” and could have been anticipated by regulatory and toxicology professionals if they had bothered to consider these findings prior to allowing emergency use authorization and widespread (global) deployment of what is truly an immature and previously untested technology. Therefore, neither the FDA, NIH, CDC, nor BioNTech (which employs Dr. Kariko as a Vice President) nor Moderna can claim true ignorance. To my eyes, what we have seen is more appropriately classified as “willful ignorance”.

In conclusion, based on these data it is my opinion that the random and uncontrolled insertion of pseudouridine into the manufactured “mRNA”-like molecules administered to so many of us creates a population of polymers which may resemble natural mRNA, but which have a variety of properties which distinguish them in a variety of aspects which are clinically relevant. These characteristics and activities may account for many of the unusual effects, unusual stability, and striking adverse events associated with this new class of vaccines. These molecules are not natural mRNA, and they do not behave like natural mRNA.

The question that most troubles and perplexes me at this point is why the biological consequences of these modifications and associated clinical adverse effects were not thoroughly investigated before widespread administration of random pseudouridine-incorporating “mRNA”-like molecules to a global population. Biology, and particularly molecular biology, is highly complex and matrix-interrelated. Change one thing over here, and it is really hard to predict what might happen over there. That is why one must do rigorously controlled non-clinical and clinical research. Once again, it appears to me that the hubris of “elite” high status scientists, physicians and governmental “public health” bureaucrats has overcome common sense, well established regulatory norms have been disregarded, and patients have unnecessarily suffered as a consequence.

When will we ever learn.

Vaccine spike antigen and mRNA persist for two months in lymph node germinal centers... protein production of spike is higher than those of severely ill COVID-19 patients!

Immune imprinting, breadth of variant recognition and germinal center response in human SARS-CoV-2 infection and vaccination Cell. Published:January 24, 2022DOI:https://doi.org/10.1016/j.cell.2022.01.018

Highlights (per the journal)

• Vaccination confers broader IgG binding of variant RBDs than SARS-CoV-2 infection
• Imprinting from initial antigen exposures alters IgG responses to viral variants
• Histology of mRNA vaccinee lymph nodes shows abundant germinal centers
• Vaccine spike antigen and mRNA persist for weeks in lymph node germinal centers

The hidden highlight (lede) buried in this peer reviewed paper is that protein production of spike in people vaccinated with the Moderna or Pfizer vaccine is higher than those of severely ill COVID-19 patients! A person might ask, “How could that be?” In order to understand this, we must carefully analyze what the study shows.

This study asserts that the mRNA and the spike protein produced persists for weeks in lymph node germinal centers in human patients. Having worked with mRNA for decades, I can attest that this is highly unusual.

One very real hypothesis is that the substitution of pseudouridine for uridine to avoid the immune response is working so well that the mRNA is completely evading the normal clearance/degradation pathways. Hence, mRNA that is not being incorporated into cells at the injection site, is migrating to the lymph nodes (and throughout the body as the non-clinical Pfizer data suggest?) and continuing to express protein there. In this case, the cytotoxic protein antigen is spike. Spike protein can be detected for at least 60 days after administration of dose. Note that the duration of the protein expression was only tested for 60 days.

The spike protein, let’s review what it is and how it is being used (from the Daily Skeptic):

These new gene-based ‘vaccines’ are working in a completely novel way – nothing remotely resembling that of traditional vaccines. Given that pharmaceutical companies work competitively it was also somewhat of a surprise they took the same approach of targeting what has been termed the ‘spike protein’ of the SARS-CoV-2 virus.

This (spike) protein is nasty – sometimes being referred to as a ‘pathogenic protein’ – and is recognised as causing many of the awful pathologies associated with the disease of COVID-19. Logically you would inactivate or at least attenuate this nasty spike protein and develop a vaccine around the attenuated virus. But that’s not what was done. These ‘vaccines’ do not contain any of the offending virus at all but rather the gene sequence that causes the nasty spike protein to be made in the body. We have little idea how much of this nasty protein is produced or for how long it lasts after an injection of the gene sequence. Furthermore, stimulating the body’s own complex biological systems to produce the spike protein will mean that the amount of protein produced will vary from person to person. The idea is that the spike protein produced by the gene encoding it elicits a response by our immune system to produce antibodies directed against the spike. When the wild virus comes along and infects us the antibodies recognise the spike protein and attack it thus preventing its nasty effects. And it does, though as we have since learnt this approach isn’t very good at preventing infection or stopping its transmission. Are we perhaps clutching at straws too in claiming that these ‘vaccines’ are preventing serious disease and death? Have we not learnt anything over the past two years in treating Covid symptoms with conventional therapeutic drugs?

Knowing what we know about the spike protein in these vaccines, the study quantitatively measured spike protein levels in plasma after vaccination. Which, it turns out, are higher than the levels observed in a person with a severe COVID-19 infection. Just to write it, the fact that this only now being discovered or it it was known, released to the public is criminal in my opinion. This should have been characterized long ago, including prior to beginning human clinical trials.

That this has not been published or investigated more demonstrates the gross regulatory dereliction of duty by Pfizer, Biointech, Moderna, NIAID VRC and that whole crew. Using these vaccines, which include pseudouridine without fully understanding the implications and without the FDA requiring a complete pre-clinical toxicology regulatory package, including long-term follow-up, as is done with any other unique chemical or adjuvant additive is shocking. Then there is the novel use of the unique nano particles being used in these vaccines, which also were only marginally assessed, as shown by the Japanese Pfizer data.

Protein expression is not being turned off, because the immune response against the mRNA/pseudouridine complex is either not happening or is ineffective. It may also be that the mRNA/pseudouridine complex has a longer half-life than normal mRNA. The In either case, this is regulatory nightmare.

I do not know how to write this more strongly. This technology is immature. The WHO has approved six, more traditional vaccines, all of which the US government could license. These genetic vaccines are not the only option.

To note: The use of pseudouridine in these mRNA vaccines is not the only option. It has often been hypothesized that the reason Dr. Kariko added pseudouridine to the mRNA vaccine was to make an improvement to the original mRNA patents that I was an inventor on. An improvement to an existing patent allows commercialization of that patent. It is an old trick. Remember, that Curevac does not use pseudouridine in its formulation and it is not required or necessary for a significant immune response. In the next generation of mRNA vaccine experiments (hopefully done in an animal model), it is clear that the issues of adding pseudouridine need to be addressed prior to any more of these vaccines going into humans.

I know the following from the paper is long, but it is very important.

Prolonged detection of vaccine mRNA in LN GCs, and spike antigen in LN GCs and blood following SARS-CoV-2 mRNA vaccination

The biodistribution, quantity and persistence of vaccine mRNA and spike antigen after vaccination (with the Pfizer vaccine), and viral antigens after SARS-CoV-2 infection, are incompletely understood but are likely to be major determinants of immune responses. We performed in situ hybridization with control and SARS-CoV-2 vaccine mRNA-specific RNAScope probes in the core needle biopsies of the ipsilateral axillary LNs that were collected 7-60 days after 2nd dose of mRNA-1273 or BNT162b2 vaccination, and detected vaccine mRNA collected in the GCs of LNs on day 7, 16, and 37 post vaccination, with lower but still appreciable specific signal at day 60 (Figures 7A -7E). Only rare foci of vaccine mRNA were seen outside of GCs. Axillary LN core needle biopsie of non-vaccinees (n = 3) and COVID-19 patient specimens were negative for vaccine probe hybridization. Immunohistochemical staining for spike antigen in mRNA vaccinated patient LNs varied between individuals, but showed abundant spike protein in GCs 16 days post-2nd dose, with spike antigen still present as late as 60 days post-2nd dose. Spike antigen localized in a reticular pattern around the GC cells, similar to staining for follicular dendritic cell processes (Figure 7B). COVID-19 patient LNs showed lower quantities of spike antigen, but a rare GC had positive staining (Figure 7F). Immunohistochemical staining for N antigen in peribronchial LN secondary and primary follicles of COVID-19 patients (Figures 7F - 7I) was positive in 5 of the 7 patients, with a mean percentage of nucleocapsid-positive follicles of more than 25%.

Discussion One of the positive developments amid the global calamity of the SARS-CoV-2 pandemic has been the rapid design, production and deployment of a variety of vaccines, including remarkably effective mRNA vaccines encoding the viral spike (Baden et al., 2021; Polack et al., 2020). We find that BNT162b2 vaccination produces IgG responses to spike and RBD at concentrations as high as those of severely ill COVID-19 patients and follows a similar time course. Unlike infection, which stimulates robust but short-lived IgM and IgA responses, vaccination shows a pronounced bias for IgG production even at early time point

Read that again: Protein production of spike is higher than those of severely ill COVID-19 patients!

The paper also notes that the antibody response is IgG, not IgA or IgM. IgA and IgM antibodies produce a strong mucosal immune response needed for respiratory diseases, unlike IgG.

This Substack article has only skimmed the surface of the implications of this paper in terms of both the science and the malfeasance on the part of our government and pharmaceutical corporations. There is more to come on this issue.

To get to the full paper to download, click here.

Why Weren’t These Vaccines Put Through the Proper Safety Trials For Gene Technology, Asks a Former Pharmaceutical Research Scientist The Daily Skeptic 7 February 2022 by Dr. John D. Flack

This article by the daily skeptic does a great job at documenting that appropriate studies have not been done and even attempts to answer the question why:

Are we perhaps clutching at straws too in claiming that these ‘vaccines’ are preventing serious disease and death? Have we not learnt anything over the past two years in treating Covid symptoms with conventional therapeutic drugs?

Perhaps this has driven Big Pharma to pursue a new more profitable model based on protecting the healthy rather than treating the sick? Enter the era of the gene-based ‘vaccines’. The new technologies have had a long and difficult gestation period with several stillbirths. But perhaps their time had come with the ‘unprecedented’ virus from the East. A declared worldwide health emergency demanded a technological response, and it was there in waiting. But have we been blinded and duped by technology and lost sight of the end game of providing safe and effective medicines? Was it a judicious use of the PCR, rapid antigen test technology and information APP technology to drive the test and trace fiasco?

Was the gene technology ready to be used in a mass world-wide vaccination programme without a thorough examination of the potential problems of short- and long-term safety of this previously untested technology?

In my view, technocracy has trumped the sound principles, established over decades and centuries, of basic medical practice, immunology, virology, pharmaceutical sciences and public health generally. In the process, political democracy, personal freedoms, free speech and choice have been dangerously sidelined and even censored.

1. Peter Doshi, senior editor,

2. Fiona Godlee, former editor in chief,

3. Kamran Abbasi, editor in chief

4. The BMJ, London, UK

5. 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

• 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.

• Provenance and peer review: Commissioned; externally peer reviewed.

This key post in the Politics of Care series stems from an invite from Norman Fenton to give a lecture on December 6 to a group interested in the evidence swirling around vaccines. It is accompanied by The Handmaid’s Vaccine on RxISK, which gives a video of the talk, whose text and slides are below. The sound effects in the video are slightly mixed at one or two point and you might need the text to clarify the points made.

This talk is for all who are interested in evidence and how we generate it as well as for a group of people who are pro-vaccine, to the point of being volunteers in clinical trials, but who have ended up being harmed by them. They are the ones doing the science and demonstrating what science means – as I’ll explain – but their work is written off as misinformation.

The company handling of SSRI harms shows we came to classify real Evidence as misinformation. Many of the company tricks involved in this effort to persuade us the world is flat will be known to you but the brazenness with which they were deployed and the failure of physicians to spot what was going on may be new.

Slide 2

I have a doctorate in Serotonin Reuptake and was keen to try the SSRIs early on. Two men I put on Prozac became suicidal. Their problems cleared after stopping and re-emerged on starting another serotonin reuptake inhibitor and stopped again after stopping. See Creaney et al.

This is as clear a causal connection as you can get anywhere in science. I sent the cases to Lilly for comment and presented them in forums. No-one offered alternate explanations. Others reported similar cases during the year to publication of this article.

Slide 3

This rash of cases forced FDA to require Lilly to defend their drug. As my article came out, Lilly published this Beasley et al article in the BMJ. It came out on the same day the company presented their case at an FDA hearing – September 20, 1991 – stating:

• The plural of anecdote is not data
• It’s the disease not the drug
• Are you going to believe the misinformation or the science?
• It’s all the fault of the Church of Scientology (1991’s Anti-vaxxers).

The BMJ article shows more suicidal events on Prozac but the paper said these were not statistically significant and so there was no problem. FDA talked about heart-breaking cases reported to them but concluded the science didn’t link Prozac to the problem.

Slide 4

Here is Tony Hill, who created RCTs, saying 20 years later RCTs can help assess one of the 100 things a drug does – something we might be able to use for treatment purposes. This, by definition, means RCTs are not a good way to evaluate a drug. See Clinical Trials are not Safe.

Saying RCTs are not the way the truth and the light, these days, is like saying the Bible, the Koran or the US Constitution aren’t reliable.

Slide 5 Watch this.

Slide 6

In a depression trial, investigators focus intensely on one thing – does Prozac have an effect on mood. Pretty well everything else is ignored. The statistics we use don’t work unless there is an intense effort to collect everything we can about this one outcome.

And so, depression trials miss something that happens to almost everyone who takes an SSRI within 30 minutes of the first pill – your genitals go numb. You can search the RCTs on these drugs and all you will find is that perhaps 5% of people have sexual issues on these drugs.

Emotional numbing is another extremely common effect almost completely missed. This is how these drugs help. This is how these drugs might help someone diagnosed as depressed but the key point is that it is much more common than depression recovery.

Similarly in the vaccine trials, the common thing is a multiplicity of Spike protein effects – doing this we hope might help but if we are hypnotized by what is hoped for we will miss and have missed what these Spike proteins are actually doing.

If we just depend on RCTs, we end up knowing almost nothing about a drug.

The idea that an RCT shows there is a favourable Risk-Benefit ratio for a drug or vaccine can only hold true if the thing we are looking at is the commonest thing this vaccine does – like a parachute for instance. The commonest thing is a life saved and the Risk Benefit is favourable but we don’t need an RCT for parachutes.

If what we are hoping for is pretty rare – as in vaccine or SSRI trials – and in particular if we don’t know what we are missing, such as an obliteration of our ability to make love, perhaps for all time, then claiming a favourable Risk Benefit ratio is psychotic.

Slide 7

The first rating scale for behaviour was the Hamilton Rating Scale for Depression. An aid to make sure physicians checked on most of the things that might be abnormal in depression while they were interviewing a patient. An aid to help a doctor do an interview that would help the patient to live the life they wanted to live.

If you cleave to the checklist you will do very standardized but possibly disastrous interviews. For instance, on the Hamilton Scale, there is an item on suicide which could stem from the illness or from the drug – it needs a judgement call as to which of these is responsible. Ditto for sex, for sleep. Just checking yes for suicidality risks going badly wrong.

Checklists like these however became viewed as scientific instruments. They look better to hospital managers than DH asking about your daughter or partner. Without judgements, in medicine we call these diagnoses, rating scales are meaningless – other than to help a doctor to help you to live the life Pfizer want you to live.

Slide 8

The latest twist on this story are the rating scales for adverse events companies now run electronically which let people rate up to 12 things that happen after the vaccine – such as sore arm, headache, nausea etc. This ensures certain events become statistically significant – and are put forward as a result as the only things we know for sure happen on the vaccine. See Johanna Ryan’s work on Virtual Trials.

There is no area for people to contribute anything else – so reports of other adverse events end up coming from outside the trial and are viewed anecdotes – misinformation. Companies like Pfizer tally anecdotes. What else would you do with misinformation?

Slide 9

Here is Fluvoxamine, an SSRI supposedly good for Covid. There have been lots of dropouts in the trials done on this, enough to invalidate the trial.

Side effects though could be endorsed on pre-populated lists that included cough, fever, nausea etc but not suicidality, homicidality, sexual dysfunction or the other things this drug causes that were likely responsible for the huge dropout rate.

Many look to drugs like this as an alternate to vaccines. Some doctors advocate them as our Hi Tech versus Albert Bourla’s Hi Tech. There are lots of low tech things that might be more helpful like getting you off some of the Tech you’re on rather than throwing more Hi Tech at you.

As we throw Hi Tech at you, we miss the fact that RCTs convert poisons, from whose use we hope to bring some good, into sacraments – something that can only do good. Most believers figure having as many sacraments as you can daily is a good thing where its seems equally obvious to most of us that taking more than one poison at the same time is unlikely to be all that safe.

One more quirk is companies always want their Ugly Ducklings to have an I’m a Swan moment – thalidomide was the fourth most profitable drug in the US last year but will be pushed down to fifth by Albertine this year. Thalidomide is a drug that causes suicidality, sexual dysfunction and birth defects – just like the SSRIs including fluvoxamine.

Slide 10

For drug companies, rating scales ensure you do an interview that produces figures which are the most seductive way to get the patient on their drug. The interview helps you to help them to live the life Pfizer want them to live.

This is not just true for rating scales, it is true for any measure – peak flow rates, bone densities, blood pressure or lipids, or sugar. It may be important to do something about some figures, but the goal is to help people to live the life they want to live – not the life Pfizer want them to live.

A stopwatch can be a wonderful motivator to achieve a dream – it provides data from one fraction of our lives. If we remain on top of that fine – but what about weighing scales? Just after they were introduced we got the first descriptions of anorexia nervosa. In the 1920s, they had norms for ideal weight attached to them and eating disorders mushroomed. They migrated into our homes in the 1960s and eating disorders became epidemic.

It’s very difficult to ignore figures for weight. Without data from every other aspect of our lives at the same time, we risk being trapped by this one data source. We become neurotic.

Can we let bone densities remain thin, or lipid levels remain high? Yes, we can. You think of post-mortems as something that reveal what we died from – they more often reveal what we can live with.

Slide 11

Figures create risks and pharma makes money from treating risks rather than diseases. We are seduced into taking drugs when we are healthy.

The Covid dashboards are a great mechanism to generate perceptions of risk and fear. The vaccines of course treat risks – not disease.

The Meatloaf title Paradise by the Dashboard Light is what Pfizer sees but its Hell by the Dashboard Light for us – this now extends to the evaluation of lectures and ensures we pander to people rather than challenge them.

It’s extraordinary how little we have put into treating SARS-Cov, the disease in this case and its associated pneumonia. Curing diseases is not a good business model.

Slide 12 As Peter Drucker, the Guru of Marketing Science put it 50 years ago:

The goal of marketing is to make selling superfluous. The aim is to know and understand the customer so well that the product or service fits and sells itself.

Slide 13

Imipramine was the first antidepressant. It beats the later SSRIs in RCTs. It treats melancholia – they can’t. They are useless for severe depression. Melancholia comes with a high risk of suicide.

Imipramine was launched in 1958. A year later at a meeting in England, Danish psychiatrists made it clear that while it was a wonderful treatment it made some people suicidal.

Let’s do a thought RCT of imipramine versus placebo in melancholia. Even though it can cause suicide, we would expect it to reduce the number of suicides because it treats the condition. This RCT would be great evidence antidepressants do not cause suicide.

Slide 14

Here is the data on the trials in mild depression that brought the SSRIs to market – a doubling of suicidal events compared to placebo.

Slide 15

Imipramine looks the same in mild depressions. Now it too causes suicides. So RCTs tell us nothing about cause and effect – they can give us diametrically opposite answers. This is because these aren’t drug trials. They are Treatment Trials and in any clinical Trial, the condition confounds the effects of the drugs.

People evaluating drugs pre-RCTs knew this. When a patient becomes suicidal in a trial you have to use your judgement to work out what has happened but you are told not to.

Slide 16

This is true in every clinical situation where drugs and conditions cause superficially similar effects – diabetes and glitazones both cause heart failure, osteoporosis and bisphosphonates both cause fractures – and this makes it impossible for an algorithmic exercise as most RCTs are to establish what is happening.

Slide 17

Here is what a real drug trial looks like. Companies ran these studies in the 1980s and found that SSRIs make healthy volunteers suicidal, cause dependence and sexual dysfunction but we heard nothing about this when the drugs launched. These Trials enabled companies to game their Treatment Trials to hide these problems.

Vaccine trials are healthy volunteer trials.

Slide 18

This slide shows data straight from a 2006 GlaxoSmithKline paper. GSK’s SSRI paroxetine was in trouble – the RCTs data for Major Depressive Disorder seem to show paroxetine causes suicidal events. The real data are likely worse that GSK admit to here.

Slide 19

But never fear RCTs come to the rescue. GSK also did trials in people with Intermittent Brief Depressive Disorders – IBDD. These are borderline personality disorder to most people – patients who have suicidal events much more often than anyone else. But these patients can meet criteria for depression and could be entered into Depression RCTs.

Slide 20

Prozac in these patients didn’t work. Paroxetine didn’t either and had a 3-fold higher suicidal act rate than placebo. GSK then did another trial in a similar group of patients. Why?

The answer is here. Here are IBDD data from the two GSK trials. I have seen other data for these two trials which make paroxetine look worse but let’s stick with GSK’s story. We could even add 16 more events to the paroxetine arm and still get the same magical outcome

When you add the IBDD data to the MDD data – all of a sudden paroxetine doesn’t cause suicidal events it protects against them.

Something like this must happen in every treatment trial with heterogenous patients – back pain, breast cancer, diabetes, hypertension, osteoporosis, parkinson’s disease. We can use an effect a drug causes to hide an effect a drug causes.

RCTs are not a way to work out what is going on. Back pain trials will insist you use analgesics rather than antibiotics – which is wrong for the 10% of backpains caused by infections.

Slide 21

You’ve seen the son of this slide before. Here are the parents. In all AD RCTs there was a 2-week washout period during which patients were whipped off prior medicines. We now know this was a tricky thing to do – it gives lots of suicides – a bit like the two-week post vaccine period.

But companies argued as the patients were on nothing, all these events should be counted as placebo events – as the diagram here illustrates.

Slide 22

The Prozac 1991 paper had an increased number of suicidal events – but hey not statistically significant. Undo this maneuver –– and they are statistically significant.

Here are the paroxetine data presented to FDA. We’d prefer the figures for paroxetine to be better than placebo but what’s a fraction between friends.

Slide 23

Undo the washout maneuver and this is what the data looked like. FDA knew what was going on and that it breached regulations and did nothing. And these figures don’t look like a drug that should be approved without warnings.

Slide 24

When that was rumbled, companies changed the game. Patients terminated from their SSRI who went into withdrawal and became suicidal were viewed as placebo, while those who stopped placebo and were put on an SSRI and committed suicide were classified as a placebo suicide – on an intention to treat basis. Regulators didn’t ask questions.

Slide 25

Sylvia Plath committed suicide a week into an antidepressant – a common timeframe.

Slide 26

This advert is for the type of antidepressant she was given, an MAOI, featuring a space shuttle, aimed to giving doctors the impression this drug will get their patients into orbit faster.

Slide 27

Here is a space shuttle – the safest transport ever per million miles travelled – but not so safe if expressed in terms of exits from and entries back into earth’s atmosphere.

Rather than express suicidal events per patient exposed companies stuck to events per thousand patient years – having taken care to ensure some patients doing well remained in extended follow-up for months or years.

Slide 28

When the RCT data turned tricky and we got Black Box Warnings – companies turned to Real World Evidence – like national suicide rates. Here you see the claims for Norway which were typical of all Nordic countries – as SSRI use increased suicide rates fell – which is not compatible with the SSRI data.

If you look though suicide rates are going up with pre SSRI AD use until about 1988 – 3-4 years pre SSRI when they begin to fall.

Slide 29

Here is Norway again where you see suicide rates falling from 88 or so and what you see if them rising as autopsy rates rise and then falling in step – as ill-defined deaths fall and rise.

Slide 30 This is true for all the Nordic countries – See Reseland et al.

Slide 31

We routinely hear that SSRI use is escalating. It’s not – the same number of people go on them each year. The increase speaks to the growing numbers who are dependent on them.

Slide 32

This has implications for suicide rates – you are only likely to see an effect on an index like this during the first few years. In the case of vaccines, this years rate of myocarditis and thromboses will become the new normal – See Healy and Aldred 2005.

Slide 33

In 1999 I was asked to participate as a speaking at a company symposium in London – speakers would need to produce articles for a supplement. I said yes and soon after had an email with my article. It was a great Healy article saying the things Healy say in the way he says them with Healy references. No one who knew my stuff would pick it out as not mine.

I emailed back saying I figured on writing my own. There was surprise at the other end but they said okay. I sent it on to them and they said this is rather good but there are some important commercial messages in the other one – we’ll get Siegfried Kasper to put his name on it.

Here it is – only one word changed from the original paper – the name of author Kasper. Everybody in Vienna knows this but its done no harm to SK’s career. You can find materials saying you can trust doctors like Kasper because they have written a 1000 articles or more. Its still a great Healy article etc.

Slide 34

A year later I was in Pfizer’s archive where even the loo-paper was stamped confidential. I came across this working document – which was the articles on Pfizer’s SSRI Zoloft being managed by Current Medical Directions – a medical writing company.

Slide 35

Inside there are pages listing the articles published or in train on Zoloft for the anxious, the depressed, the young, the old etc – here you see the PTSD page.

You will see on the right – the articles were written for these essentially negative studies saying the drug worked wonderfully well. One would go to NEJM – the other to JAMA. And on the left – you see TBD – authors names are To Be Determined. Pfizer’s marketing department will work out who would be the best sales people for the drug.

This is not just a mental health issue. It holds for all treatments across medicine.

Slide 36

Here is the most famous RCT of all time. It has a distinguished authorship line and is in the journal with the highest impact factor in child psychiatry and says paroxetine works wonderfully well and is entirely safe for children who are depressed.

Slide 37

This internal GSK document from 1998 shows the company knew the trial had shown the drug didn’t work and proposed taking out the good bits of the data and publishing those which is the article you have seen. New York State took a fraud action against GSK on this basis who were also fined $3 billion which led to access to the trial data and what you are going to see next.

Slide 38 The full story is on Study329.org

Slide 39

Through this legal action we got access to company data no one ever sees. The efficacy data is pretty irrelevant, but it was still possible to show that no matter which way you cut the data paroxetine was not more efficacious than placebo.

Slide 40

The tricks used to hide the problems were the real interest in these data.

The original article had 10 pages. Regulators see an 800-page Clinical Study Report (CSR) plus nearly 5000 pages of appendices – these are notional they are there but no-one in MHRA or FDA will look at them. We saw these and a further 77,000 Clinical Record Form (CRF) pages.

Point 2 points to data that just didn’t get transcribed from the 77000 pages to the 5000 pages. Point 10 is patients on placebo got SSRIs – I can explain how. But I want to focus on the coding issues.

Slide 41

The psychiatric adverse events all got grouped in CNS or neurological events – into which the groupers also put headaches and dizziness. The dizziness was not neurological – it was cardiovascular because it this case the comparator drug lowers BP especially when used in double or triple the adult dose.

The effect of this was to drown out the signal from psychiatric adverse events. So there is an issue about grouping. We were sensitized to this by Elizabeth Loder, the BMJ editor handling out paper – which took over a year to publish with 7 review rounds and 7 reviewers – who objected to our every mention of headache. As it turned out was a headache-ologist, who was an opinion leader for GSK but above all was the wife of an attorney working in Ropes and Gray who had been the lawyers defending GSK against the $3 billion fine.

Slide 42

So here, leaving out headache and dizziness, in the lower bar you see the number of suicidal events in the Keller paper – once you decode them from emotional lability. In the middle bar, GSK revised this after being asked to do so by FDA when a fuss blew up. In the upper bar you see that we found more again – and there were more than we missed as I’m about to tell you.

Slide 43

How does this fit Co-Vaccines? Well, here you see Pfizer’s report of their adverse event data – a ton of them have disappeared into a higher order coding group called General Disorders. The crimson half of the bar shows you these are serious, potentially lethal. General Disorders is a meaningless group – it needs unpacking.

Slide 44

In a Pfizer trial, one man poured petrol over himself and set a match to it, intending to kill himself. He died 5 days later from his burns. His death was coded as burns. But the company had to write a Serious Adverse Events narrative and if you got to see that you could work out that he should have been coded as suicide.

Slide 45

Companies have found a way to get around this, as found out after Study 329 finished. Here is a young man on a street waving a gun. Its Kyle Rittenhouse. In Study 329 a boy of 15 was picked up out on the street waving a gun around and threatening to kill people. He was hospitalized and should therefore have had an SAE narrative but the company coded him as intercurrent illness.

Four children dropped out of Study 329 coded as intercurrent illness – all were taking paroxetine. Add them into the picture you have just seen and things look a lot worse.

What is intercurrent illness? This was almost certainly an adverse event on paroxetine but invoking an intercurrent illness that means you really should not have been entered into this study means there is no need to write a narrative. This loophole has been there for 25 years and FDA have not moved to close it.

Slide 46

We know Astra-Zeneca broke the blind and got rid of serious adverse events like the ones that happened to Bri Dressen – see New England J of Misinformation. Here you see intercurrent illnesses turning up in this same Astra-Zeneca trial.

Slide 47

Here you have Maddie de Garay who has been tube fed and needs a wheelchair since a few days after the second dose of Pfizer’s vaccine in their trial for 12-15 year olds. But the company says no serious vaccine-related adverse events happened in this trial. They claim she has hysteria and of course that antedates the trial and so the vaccine can’t have caused it.

Slide 48

Few people know that FDA approved paroxetine for children – here is part of FDA’s 2002 letter of approval to GSK. The key bit is typed up so you can read it. The date is important – the Keller paper was 2001.

You can see here GSK told FDA that Study 329 was negative and you see that FDA agreed to approve the drug on the back of three negative studies and also agreed that there was no need to mention this in the labelling. Why would FDA do this?

Slide 49

Here are the published results of adult trials of antidepressants nearly a decade earlier. The picture looks pretty good.

Slide 50

But as Erick Turner has shown, this is how these studies looked to FDA. A different picture. Companies don’t leave negative studies unpublished, they know FDA are happy to let them publish negative studies as positive.

Why? Did GSK tell FDA – if you tell the world Study 329 was negative, we might get sued for fraud – which they did and fined for $3 billion. FDA don’t feel inclined to blow this whistle and MHRA and EMA have even less incentive.

Slide 51

So here is Study 329 again. The author is not listed. In the case of trials done in children, pretty well the entire literature was company written. The mismatch between what articles claim and the data when we see is the greatest known divide in medicine but likely not atypical. Study 329 was a good and ethical trial compared to some of the current vaccine trials.

There are now 45 negative trials for antidepressants in minors – out of 45 trials done. Yet antidepressants appear now to be the second most commonly taken drugs by teenage girls.

Slide 52

In this New England J of Misinformation article, the first thing to note is the author is not listed here. Twenty of the 29 apparent authors are company people. Few are clinicians and none are likely to have seen anyone harmed.

Second the trial was run by I Con rather than Pfizer who subcontracted to Palladium Research, who subcontracted to Ventavia and we know Ventavia ran a shit-show.

Anyone with experience of company trials knows that it is worth looking at the centres involved because for instance in a trial of aripiprazole where there might be 33 centres with 30 producing results for the drug that would not get approval, but perhaps 3 in places FDA won’t visit that found every patient put on the drug did fabulously and every on placebo was seriously injured or died a horrible death and adding both together produces a result that can squeak by FDA.

There is scope to wonder if something similar happened in this trial.

What we do know is that more people died on vaccine than placebo and lots more people disappeared on vaccine and FDA’s current leadership for whatever reason would prefer to be dead before anyone gets access to the data and their correspondence with Pfizer.

Slide 53

Is there a House in the Doctor? The medical drama House was watched and loved by many. Dr House was good at solving puzzling clinical cases by pulling on the thread of some minor detail which led to the answer.

Doctors today have close to lost the ability to say an evident X causes an evident Y – largely down to the mantra that only RCT evidence tells us what a treatment does and we can’t believe the evident anymore. Wife shoots husband point blank in chest – did she kill him? Who knows. In perhaps 1 case in 100 he had a heart attack just beforehand – we need to pass the 100 cases on to those experts in CDC, FDA, EMA etc and let them work it out.

As a result docs report maybe 1 in 10 or 1 in 100 serious side effects to regulators who file these away and do nothing with them.

This is unlike airline pilots who also report near misses and refuse to fly if these reports are not taken into account – after all if the customer dies the pilot does too. This is not true of doctors.

Slide 54

There is a profound misapprehension of the role of a regulator. They are not part of the health apparatus. Their job , perhaps easier to see in the case of food, is to decide if this yellow stuff is butter or lard colored to look like butter. If butter – it is not their job to decide if this is good butter or not or if butter is good for us or not. Ditto with drugs – the role is just to tick a box if certain criteria are met.

They have no abilities to or training in establishing if a drug or vaccine causes a problem.

Slide 55

Here is Walter Raleigh getting his head chopped off. After the fact legal systems recognized the injustice of convicting someone based on hearsay and said cases could only be decided on the basis of evidence in the room that can examined and cross-examined.

The first thing MHRA do with any reports is to remove the names of doctors and patients. This converts them into hearsay, anedcotes, misinformation. It means no-one can decide if there is a link.

MHRA will say till the crack of doom they are looking to find causal needles in the haystack of reports but faced with a needle-stack they can’t seem to spot a needle.

The key to determining cause and effect is an encounter between a doctor and patient. All the data is there. After a first run through there is a chance to follow up when oddities about the data come to mind. Remove the possibility for an ongoing two-way encounter like this and you remove the ability to establish cause and effect.

Slide 56

The one tool regulators have with anonymized drug reports is proportional reporting rates but as Matthew Crawford pointed out you can’t even use this for VAERS because you need lots of drugs in the mix for this to work properly. Besides proportional reporting rates are a cop-out. They might look more scientific than interviewing someone but they aren’t.

Slide 57

If someone commits suicide on an SSRI, their doctor will be advised by their insurer not to say the drug caused it or say anything that might lead to a further legal case. Insurance is supposed to be a business that supports us to take risks but is not doing this here.

If the doctor breaks ranks and blames the drug, a coroner, who can say a street drug caused a death, has no box to tick to implicate a prescription drug in a death.

Media guidance equally ensures journalists cannot say the obvious – the drug caused the suicide if the coroner hasn’t done so – and all this will apply to vaccines also.

If the coroner goes rogue and writes to the regulator and intimates that the evident cause of death was the drug or vaccine, the regulator will check on what the doctor has said and if the doctor didn’t finger the drug or vaccine – they won’t.

If the case is so Evident that both doctor and coroner go rogue, as in the Alana Cutland case, the regulator will respond, as MHRA did, that we only have a handful of reports like this – not enough to let us work out what might have gone on.

Slide 58

In the TV series House, the hero pays heed to tiny things that don’t fit the pattern and after twists and turns finds how it all hangs together.

When a wife shoots her husband in front of Dr House these days he seems unable to work out what’s gone on. Ok the guy may have had a heart attack at the same time and she shot him afterwards out of spite at being cheated out of a pleasant moment but 99 times out a 100 it’s pretty simple, she killed him. House though has lost this plot.

Some great doctors encourage their colleagues to report adverse events to regulators – which makes the problem worse. Regulators will file these reports away until the crack of doom. Unless doctors have the courage to say – look I know what I have seen and the vaccine or the drug killed my patient, they make things worse.

Dr House can’t get his head around the fact that with drugs and vaccines we hope to bring good out of the use of a poison, and sometimes people get poisoned. We and he prefer the idea he is giving sacraments – things that can only do good.

F Scott Fitzgerald once said that a sophisticated mind can hold two contradictory things in mind at the same time and still function – doctors could do this once but can’t now.

Science challenges Muslims and Jews, Xtians and Atheists to leave their biases at the door and come to a consensus about the data. But as in a jury trial, sticking with the data we still have to come to a verdict. A judgement. A diagnosis. It is not the role of a regulator to make diagnoses or deliver verdicts.

A verdict has effects in the real world just as much as shooting someone. There are evident effects from shooting on a husband who dies, and equally evident effects on the wife being tried.

This is important but more important for all of us just now are the effects on the doctor or failing to make any verdict, and just as much failing to make the diagnosis they know or suspect is the right one.

This failure transforms them into Model Doctors – a shrunken replica of the real thing.

When treating a patient, following the evidence can’t mean doing what ghostwritten fraudulent articles say. It has to mean following the person in front of me and coming to a consensus view just as a jury would.

If there is a mismatch between that and the so-called evidence – well all the books say that’s what moves science forward.

Slide 60

See The Handmaid’s Vaccine on RxISK – and its message about Albert and Ursula, the happy couple you see here.

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.

NNTV, the standard policy tool that Pharma, the FDA, & CDC no longer want to talk about

A funny thing happened this afternoon. Not funny as in “haha”. More like funny as in, “ohhhhh that’s how the FDA rigs the process.”

I was reading the CDC’s “Guidance for Health Economics Studies Presented to the Advisory Committee on Immunization Practices (ACIP), 2019 Update” and I realized that the FDA’s woeful risk-benefit analysis in connection with Pfizer’s EUA application to jab children ages 5 to 11 violates many of the principles of the CDC’s Guidance document. The CDC “Guidance” document describes 21 things that every health economics study in connection with vaccines must do and the FDA risk-benefit analysis violated at least half of them.

Today I want to focus on a single factor: the Number Needed to Vaccinate (NNTV). In four separate places the CDC Guidance document mentions the importance of coming up with a Number Needed to Vaccinate (NNTV). I did not recall seeing an NNTV in the FDA risk-benefit document. So I checked the FDA’s risk-benefit analysis again and sure enough, there was no mention of an NNTV.

Because the FDA failed to provide an NNTV, I will attempt to provide it here.

First a little background. The Number Needed to Treat (NNT) in order to prevent a single case, hospitalization, ICU admission, or death, is a standard way to measure the effectiveness of any drug. It’s an important tool because it enables policymakers to evaluate tradeoffs between a new drug, a different existing drug, or doing nothing. In vaccine research the equivalent term is Number Needed to Vaccinate (NNTV, sometimes also written as NNV) in order to prevent a single case, hospitalization, ICU admission, or death (those are 4 different NNTVs that one could calculate).

Pharma HATES talking about NNTV and they hate talking about NNTV even more when it comes to COVID-19 vaccines because the NNTV is so ridiculously high that this vaccine could not pass any honest risk-benefit analysis.

Indeed about a year ago I innocently asked on Twitter what the NNTV is for coronavirus vaccines.

Pharma sent a swarm of trolls in to attack me and Pharma goons published hits pieces on me outside of Twitter to punish me for even asking the question. Of course none of the Pharma trolls provided an estimate of the NNTV for COVID-19 shots. That tells us that we are exactly over the target.

Various health economists have calculated a NNTV for COVID-19 vaccines.

• Ronald Brown, a health economist in Canada, estimated that the NNTV to prevent a single case of coronavirus is from 88 to 142.

• Others have calculated the NNTV to prevent a single case at 256.

• German and Dutch researchers, using a large (500k) data set from a field study in Israel calculated an NNTV between 200 and 700 to prevent one case of COVID-19 for the mRNA shot marketed by Pfizer. They went further and figured out that the “NNTV to prevent one death is between 9,000 and 100,000 (95% confidence interval), with 16,000 as a point estimate.”

You can see why Pharma hates this number so much (I can picture Pharma’s various PR firms sending out an “All hands on deck!” message right now to tell their trolls to attack this article). One would have to inject a lot of people to see any benefit and the more people who are injected the more the potential benefits are offset by the considerable side-effects from the shots.

Furthermore, the NNTV to prevent a single case is not a very meaningful measure because most people, particularly children, recover on their own (or even more quickly with ivermectin if treated early). The numbers that health policy makers should really want to know are the NNTV to prevent a single hospitalization, ICU admission, or death. But with the NNTV to prevent a single case already so high, and with significant adverse events from coronavirus vaccines averaging about 15% nationwide, Pharma and the FDA dare not calculate an NNTV for hospitalizations, ICU, and deaths, because then no one would ever take this product (bye bye $93 billion in annual revenue).

Increased all cause mortality in the Pfizer clinical trial of adults

As Bobby Kennedy explains, Pfizer’s clinical trial in adults showed alarming increases in all cause mortality in the vaccinated:

In Pfizer’s 6 month clinical trial in adults — there was 1 covid death out of 22,000 in the vaccine (“treatment”) group and 2 Covid deaths out of 22,000 in the placebo group (see Table s4). So NNTV = 22,000. The catch is there were 5 heart attack deaths in the vaccine group and only 1 in placebo group. So for every 1 life saved from Covid, the Pfizer vaccine kills 4 from heart attacks. All cause mortality in the 6 month study was 20 in vaccine group and 14 in placebo group. So a 42% all cause mortality increase among the vaccinated. The vaccine loses practically all efficacy after 6 months so they had to curtail the study. They unblinded and offered the vaccine to the placebo group. At that point the rising harm line had long ago intersected the sinking efficacy line.

Former NY Times investigative reporter Alex Berenson also wrote about the bad outcomes for the vaccinated in the Pfizer clinical trial in adults (here). Berenson received a lifetime ban from Twitter for posting Pfizer’s own clinical trial data.

Pfizer learned their lesson with the adult trial and so when they conducted a trial of their mRNA vaccine in children ages 5 to 11 they intentionally made it too small (only 2,300 participants) and too short (only followed up for 2 months) in order to hide harms.

Estimating an NNTV in children ages 5 to 11 using Pfizer’s own clinical trial data

All of the NNTV estimates above are based on data from adults. In kids the NNTV will be even higher (the lower the risk, the higher the NNTV to prevent a single bad outcome). Children ages 5 to 11 are at extremely low risk of death from coronavirus. In a meta-analysis combining data from 5 studies, Stanford researchers Cathrine Axfors and John Ioannidis found a median infection fatality rate (IFR) of 0.0027% in children ages 0-19. In children ages 5 to 11 the IFR is even lower. Depending on the study one looks at, COVID-19 is slightly less dangerous or roughly equivalent to the flu in children.

So how many children would need to be injected with Pharma’s mRNA shot in order to prevent a single hospitalization, ICU admission, or death?

Let’s examine Pfizer’s EUA application and the FDA’s risk-benefit analysis. By Pfizer’s own admission, there were zero hospitalization, ICU admissions, or deaths, in the treatment or control group in their study of 2,300 children ages 5 to 11.

So the Number Needed to Vaccinate in order to prevent a single hospitalization, ICU admission, or death, according to Pfizer’s own data, is infinity. ∞. Not the good kind of infinity as in God or love or time or the universe. This is the bad kind of infinity as in you could vaccinate every child age 5 to 11 in the U.S. and not prevent a single hospitalization, ICU admission, or death from coronavirus according to Pfizer’s own clinical trial data as submitted to the FDA. Of course Pfizer likes this kind of infinity because it means infinite profits. [Technically speaking the result is “undefined” because mathematically one cannot divide by zero, but you get my point.]

Estimating an NNTV and risk-benefit model in children ages 5 to 11 using the limited data that are available

Everyone knows that Pfizer was not even trying to conduct a responsible clinical trial of their mRNA shot in kids ages 5 to 11. Pfizer could have submitted to the FDA a paper napkin with the words “Iz Gud!” written in crayon and the VRBPAC would have approved the shot. They are all in the cartel together and they are all looking forward to their massive payoff/payday.

But let’s not be like Pharma. Instead, let’s attempt to come up with a best guess estimate based on real world data. Over time, others will develop a much more sophisticated estimate (for example, Walach, Klement, & Aukema, 2021 estimated an NNTV for 3 different populations based on “days post dose”). But for our purposes here I think there is a much easier way to come up with a ballpark NNTV estimate for children ages 5 to 11.

Here’s the benefits model:

• As of October 30, 2021, the CDC stated that 170 children ages 5 to 11 have died of COVID-19-related illness since the start of the pandemic. (That represents less than 0.1% of all coronavirus-related deaths nationwide even though children that age make up 8.7% of the U.S. population).

• The Pfizer mRNA shot only “works” for about 6 months (it increases risk in the first month, provides moderate protection in months 2 through 4 and then effectiveness begins to wane, which is why all of the FDA modeling only used a 6 month time-frame). So any modeling would have to be based on vaccine effectiveness in connection with the 57 (170/3) children who might otherwise have died of COVID-related illness during a 6-month period.

• At best, the Pfizer mRNA shot might be 80% effective against hospitalizations and death. That number comes directly from the FDA modeling (p. 32). I am bending over backwards to give Pfizer the benefit of considerable doubt because again, the Pfizer clinical trial showed NO reduction in hospitalizations or death in this age group. So injecting all 28,384,878 children ages 5 to 11 with two doses of Pfizer (which is what the Biden administration wants to do) would save, at most, 45 lives (0.8 effectiveness x 57 fatalities that otherwise would have occurred during that time period = 45).

• So then the NNTV to prevent a single fatality in this age group is 630,775 (28,384,878 / 45). But it’s a two dose regimen so if one wants to calculate the NNTV per injection the number doubles to 1,261,550. It’s literally the worst NNTV in the history of vaccination.

If you inject that many children, you certainly will have lots and lots of serious side effects including disability and death. So let’s look at the risk side of the equation.

Here’s the risk model:

• Because the Pfizer clinical trial has no useable data, I have to immuno-bridge from the nearest age group.

• 31,761,099 people (so just about 10% more people than in the 5 to 11 age bracket) ages 12 to 24 have gotten at least one coronavirus shot.

• The COVID-19 vaccine program has only existed for 10 months and younger people have only had access more recently (children 12 to 15 have had access for five months; since May 10) — so we’re looking at roughly the same observational time period as modeled above.

• During that time, there are 128 reports of fatal side effects following coronavirus mRNA injections in people 12 to 24. (That’s through October 22, 2021. There is a reporting lag though so the actual number of reports that have been filed is surely higher).

• Kirsch, Rose, and Crawford (2021) estimate that VAERS undercounts fatal reactions by a factor of 41 which would put the total fatal side effects in this age-range at 5,248. (Kirsch et al. represents a conservative estimate because others have put the underreporting factor at 100.)

• With potentially deadly side effects including myo- and pericarditis disproportionately impacting youth it is reasonable to think that over time the rate of fatal side effects from mRNA shots in children ages 5 to 11 might be similar to those in ages 12 to 24.

So, to put it simply, the Biden administration plan would kill 5,248 children via Pfizer mRNA shots in order to save 45 children from dying of coronavirus.

For every one child saved by the shot, another 117 would be killed by the shot.

The Pfizer mRNA shot fails any honest risk-benefit analysis in children ages 5 to 11.

Even under the best circumstances, estimating NNTV and modeling risk vs. benefits is fraught. In the current situation, with a new and novel bioengineered virus, where Pfizer’s data are intentionally underpowered to hide harms, and the FDA, CDC, & Biden Administration are doing everything in their power to push dangerous drugs on kids, making good policy decisions is even more difficult.

If the FDA or CDC want to calculate a different NNTV (and explain how they arrived at that number) I’m all ears. But we all know that the FDA refused to calculate an NNTV not because they forgot, but because they knew the number was so high that it would destroy the case for mRNA vaccines in children this age. Your move CDC — your own Guidance document states that you must provide this number.

Update: CDC finally mentions NNTV, but . . .

Toward the end of the six-hour CDC’s Advisory Committee on Immunization Practices (ACIP) Nov. 2 meeting where the committee voted to recommend Pfizer’s EUA vaccine for children 5 - 11, there was finally a mention of NNTV. It was on slide 36 of a presentation by CDC official D.r Sara Oliver. Unfortunately the CDC estimate was untethered from reality. I’ll explain:

Oliver claimed the NNTV to prevent a single case is 10, even though the best lower bound estimate is 88 and other estimates are 200 or higher (see calculations here and here).

Then she claimed the NNTV to prevent a single hospitalization is between 2,213 and 8,187. This is dishonest and a violation of scientific norms.

NNTV is calculated by dividing 1 by the Absolute Risk Reduction. There was no Absolute Risk Reduction in hospitalizations in the Pfizer clinical trial in kids 5 to 11, because no one was hospitalized in either the treatment or control group. 1/0 is “undefined” not 8,187.

Oliver made no estimate of NNTV to prevent a single COVID-19-related death because that is also undefined (again, there were no COVID-related deaths in the treatment or placebo group in the trial so the absolute risk reduction was zero).

Oliver also did not model injuries or deaths from the vaccine (she immuno-bridged from an older age group to show benefits but ignored the reported harms from the vaccine in the older age group).

I should also note that my estimates of NNTV were based on CDC data showing 170 deaths from COVID-19-related illness in kids ages 5 to 11 over the last 18 months (I got the number directly from the CDC COVID tracking website).

However at the ACIP meeting, the CDC said the number of children in this age group who have died of COVID-19-related illness is 94.

If 94 is the correct number to use, then the NNTV to prevent a single death from COVID-19 related illness in this age group would be 28,384,878 / 31 = 915,641. But it’s a two-dose regimen, so if one wants to calculate the NNTV-per-injection the number doubles to 1,831,282.

I imagine that at most, half of American parents will be foolish enough to inject this toxic product into their kids. At a 50% uptake rate, the ACIP decision to approve the Pfizer shot will likely kill 2,624 children via adverse reactions in order to potentially save 12 from COVID-19-related illness.

Now you know why the CDC did not release the meeting materials prior to the ACIP meeting — they could not stand up to any public scrutiny.

Update 11/05/21:

I see that El Gato Malo engaged in a similar set of calculations back in September when Pfizer first released its “results.” He faced the same challenges as I did — namely, there is no usable data from Pfizer and so one has to pull from others sources. He builds a steel man case (the most generous possible defense of the Pfizer product) and yet his results are still in line with mine (my numbers are higher though because I use a lower estimate of vaccine effectiveness and correct for VAERS underreporting). So again, even under the most generous assumptions, the Pfizer mRNA shot fails any honest risk benefit assessment in connection with children 5 to 11.

#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

Given the ever-changing narrative on COVID-19 vaccines, it is almost impossible for a layperson to understand exactly what is safe and what is part of the ongoing Phase 3 trials. A recent graphic found on the website of the School of Pharmacy at the University of Waterloo adds to that confusion, particularly given that mixing and matching of vaccines was NOT part of the original vaccine program.

Here is the graphic which is supposed to allow vaccine consumers to determine whether they are fully vaccinated:

Basically, the graphic is telling laypeople that they should not be getting the AstraZeneca vaccine as their second dose unless they received it as their first dose and that either the Pfizer or Moderna vaccines are suitable as a second dose if they received the AstraZeneca vaccine as their first dose.

Given that these vaccines are still being rolled out and that the final phase three trials for the stand-alone products (i.e. without mixing and matching) will not end until the following dates:

1.) Pfizer:

2.) AstraZeneca:

3.) Moderna:

...and that the medium- and long-term side effects and efficacy of each of the vaccines on a stand-alone basis have yet to be fully understood and shared with governments, public health officials and consumers, it is concerning that governments are basically allowing Big Pharma to continue their unprecedented vaccine experiment on humanity by both extending the period of time between doses far beyond what the manufacturer recommended and allowing the mixing and matching of COVID-19 vaccines all in the name of vaccinating as much of the world as possible as quickly as possible.

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We have a dedicated team of several hundred scientists and engineers solely focused on advancing Moderna's platform technology. They are organized around key disciplines and work in an integrated fashion to advance knowledge surrounding mRNA science and solve for challenges that are unique to mRNA drug development. Some of these disciplines include mRNA biology, chemistry, formulation & delivery, bioinformatics and protein engineering.

Our mRNA Medicines – The ‘Software of Life’

When we have a concept for a new mRNA medicine and begin research, fundamental components are already in place.

Generally, the only thing that changes from one potential mRNA medicine to another is the coding region – the actual genetic code that instructs ribosomes to make protein. Utilizing these instruction sets gives our investigational mRNA medicines a software-like quality. We also have the ability to combine different mRNA sequences encoding for different proteins in a single mRNA investigational medicine.

We are leveraging the flexibility afforded by our platform and the fundamental role mRNA plays in protein synthesis to pursue mRNA medicines for a broad spectrum of diseases.

Within a given modality, the base components are generally identical across development candidates - formulation, 5’ region and 3’ region. Only the coding region varies based on the protein/s the potential medicine is directing cells to produce.

Learn how our Research Engine and Early Development Engine are enabling us to fully maximize the promise of mRNA to meaningfully improve how medicines are discovered, developed and manufactured.

Overcoming Key Challenges

Using mRNA to create medicines is a complex undertaking and requires overcoming novel scientific and technical challenges. We need to get the mRNA into the targeted tissue and cells while evading the immune system. If the immune system is triggered, the resultant response may limit protein production and, thus, limit the therapeutic benefit of mRNA medicines. We also need ribosomes to think the mRNA was produced naturally, so they can accurately read the instructions to produce the right protein. And we need to ensure the cells express enough of the protein to have the desired therapeutic effect.

Our multidisciplinary platform teams work together closely to address these scientific and technical challenges. This intensive cross-functional collaboration has enabled us to advance key aspects of our platform and make significant strides to deliver mRNA medicines for patients.