“Have you no sense of decency?”

The recent Congressional hearings leading to a bloodbath of university presidents brings back memories from my teen-age years in the 1950s when everyone’s eyes were glued to the TV broadcast of the McCarthy hearings. And the student revolts incited by vicious college presidents trying to stifle academic freedom when it opposes foreign unjust wars awakens memories of the 1960s protests against the Vietnam War and the campus clampdowns confronting police violence.

I was the junior member of the “Columbia three” alongside Seymour Melman and my mentor Terence McCarthy (both of whom taught at Columbia’s Seeley Mudd School of Industrial Engineering; my job was mainly to handle publicity and publication). At the end of that decade, students occupied my office and all others at the New School’s graduate faculty in New York City – very peacefully, without disturbing any of my books and papers.
Only the epithets have changed.

The invective “Communist” has been replaced by “anti-Semite,” and the renewal of police violence on campus has not yet led to a Kent State-style rifle barrage against protesters. But the common denominators are all here once again. A concerted effort has been organized to condemn and even to punish today’s nationwide student uprisings against the genocide occurring in Gaza and the West Bank. Just as the House Unamerican Activities Committee (HUAC) aimed to end the careers of progressive actors, directors, professors and State Department officials unsympathetic to Chiang Kai-Shek or sympathetic to the Soviet Union from 1947 to 1975, today’s version aims at ending what remains of academic freedom in the United States.

The epithet of “communism” from 75 years ago has been updated to “anti-Semitism.” Senator Joe McCarthy of Wisconsin has been replaced by Elise Stefanik, House Republican from upstate New York, and Senator “Scoop” Jackson upgraded to President Joe Biden. Harvard University President Claudine Gay (now forced to resign), former University of Pennsylvania President Elizabeth Magill (also given the boot), and Massachusetts Institute of Technology President Sally Kornbluth were called upon to abase themselves by promising to accuse peace advocates critical of U.S. foreign policy of anti-Semitism.

The most recent victim was Columbia’s president Nemat “Minouche” Shafik, a cosmopolitan opportunist with trilateral citizenship who enforced neoliberal economic policy as a high-ranking official at the IMF (where she was no stranger to the violence of “IMF riots”) and the World Bank, and who brought her lawyers along to help her acquiesce in the Congressional Committee’s demands. She did that and more, all on her own. Despite being told not to by the faculty and student affairs committees, she called in the police to arrest peaceful demonstrators.

This radical trespass of police violence against peaceful demonstrators (the police themselves attested to their peacefulness) triggered sympathetic revolts throughout the United States, met with even more violent police responses at Emory College in Atlanta and California State Polytechnic, where cell phone videos were quickly posted on various media platforms.

Just as intellectual freedom and free speech were attacked by HUAC 75 years ago, academic freedom is now under attack at these universities. The police have trespassed onto school grounds to accuse students themselves of trespassing, with violence reminiscent of the demonstrations that peaked in May 1970 when the Ohio National Guard shot Kent State students singing and speaking out against America’s war in Vietnam.

Today’s demonstrations are in opposition to the Biden-Netanyahu genocide in Gaza and the West Bank. The more underlying crisis can be boiled down to the insistence by Benjamin Netanyahu that to criticize Israel is anti-Semitic. That is the “enabling slur” of today’s assault on academic freedom.

By “Israel,” Biden and Netanyahu mean specifically the right-wing Likud Party and its theocratic supporters aiming to create “a land without a [non-Jewish] people.” They assert that Jews owe their loyalty not to their current nationality (or humanity) but to Israel and its policy of driving the Gaza Strip’s millions of Palestinians into the sea by bombing them out of their homes, hospitals and refugee camps.

The implication is that to support the International Court of Justice’s accusations that Israel is plausibly committing genocide is an anti-Semitic act. Supporting the UN resolutions vetoed by the United States is anti-Semitic.

The claim is that Israel is defending itself and that protesting the genocide of the Palestinians in Gaza and the West Bank frightens Jewish students. But research by students at Columbia’s School of Journalism found that the complaints cited by the New York Times and other pro-Israeli media were made by non-students trying to spread the story that Israel’s violence was in self-defense.

The student violence has been by Israeli nationals. Columbia has a student-exchange program with Israel for students who finish their compulsory training with the Israeli Defense Forces. It was some of these exchange students who attacked pro-Gaza demonstrators, spraying them with Skunk, a foul-smelling indelible Israeli army chemical weapon that marks demonstrators for subsequent arrest, torture or assassination. The only students endangered were the victims of this attack. Columbia under Shafik did nothing to protect or help the victims.
The hearings to which she submitted speak for themselves. Columbia’s president Shafik was able to avoid the first attack on universities not sufficiently pro-Likud by having meetings outside of the country. Yet she showed herself willing to submit to the same brow-beating that had led her two fellow presidents to be fired, hoping that her lawyers had prompted her to submit in a way that would be acceptable to the committee.

I found the most demagogic attack to be that of Republican Congressman Rick Allen from Georgia, asking Dr. Shafik whether she was familiar with the passage in Genesis 12.3. As he explained” “It was a covenant that God made with Abraham. And that covenant was real clear. … ‘If you bless Israel, I will bless you. If you curse Israel, I will curse you.’ … Do you consider that to be a serious issue? I mean, do you want Columbia University to be cursed by [God of the Bible](http://1 https://m.youtube.com/watch?v=syPELLKpABI 2 https://stefanik.house.gov/2024/4/icymi-stefanik-secures-columbia-university-president-s-commitment-to-remove-antisemitic-professor-from-leadership-role 3 Nicholas Fandos, Stephanie Saul and Sharon Otterman, “Columbia’s President Tells Congress That Action Is Needed Against Antisemitism,” The New York Times, April 17, 2024., and “Columbia President Grilled During Congressional Hearing on Campus Antisemitism,” Jewish Journal, April 18, 2024. https://jewishjournal.com/news/united-states/370521/columbia-president-grilled-during-congressional-hearing-on-campus-antisemitism/#:~:text=Columbia%20President%20Grilled%20During%20Congressional%20Hearing%20on%20Campus%20Antisemitism 4 Miranda Nazzaro. “Netanyahu condemns ‘antisemitic mobs’ on US college campuses,” The Hill, April 24, 2024.)?”

Shafik smiled and was friendly all the way through this bible thumping, and replied meekly, “Definitely not.”
She might have warded off this browbeating question by saying, “Your question is bizarre. This is 2024, and America is not a theocracy. And the Israel of the early 1st century BC was not Netanyahu’s Israel of today.” She accepted all the accusations that Allen and his fellow Congressional inquisitors threw at her.

Her main nemesis was Elise Stefanik, Chair of the House Republican Conference, who is on the House Armed Services Committee, and the Committee on Education and the Workforce.

Congresswoman Stefanik: You were asked were there any anti-Jewish protests and you said ‘No’.

President Shafik: So the protest was not labeled as an anti-Jewish protest. It was labeled as an anti-Israeli government. But antisemitic incidents happened or antisemitic things were said. So I just wanted to finish.
Congresswoman Stefanik: And you are aware that in that bill, that got 377 Members out of 435 Members of Congress, condemns ‘from the river to the sea’ as antisemitic?

Dr. Shafik: Yes, I am aware of that.

Congresswoman Stefanik: But you don’t believe ‘from the river to the sea’ is antisemitic?

Dr. Shafik: We have already issued a statement to our community saying that language is hurtful and we would prefer not to hear it on our campus.

What an appropriate response to Stefanik’s browbeating might have been?

Shafik could have said, “The reason why students are protesting is against the Israeli genocide against the Palestinians, as the International Court of Justice has ruled, and most of the United Nations agree. I’m proud of them for taking a moral stand that most of the world supports but is under attack here in this room.”
Instead, Shafik seemed more willing than the leaders of Harvard or Penn to condemn and potentially discipline students and faculty for using the term “from the river to the sea, Palestine will be free.” She could have said that it is absurd to say that this is a call to eliminate Israel’s Jewish population, but is a call to give Palestinians freedom instead of being treated as Untermenschen.

Asked explicitly whether calls for genocide violate Columbia’s code of conduct, Dr. Shafik answered in the affirmative — “Yes, it does.” So did the other Columbia leaders who accompanied her at the hearing. They did not say that this is not at all what the protests are about. Neither Shafik nor any other of the university officials say, “Our university is proud of our students taking an active political and social role in protesting the idea of ethnic cleansing and outright murder of families simply to grab the land that they live on. Standing up for that moral principle is what education is all about, and what civilization’s all about.”

The one highlight that I remember from the McCarthy hearings was the reply by Joseph Welch, the U.S. Army’s Special Council, on June 9, 1954 to Republican Senator Joe McCarthy’s charge that one of Welch’s attorneys had ties to a Communist front organization. “Until this moment, senator,” Welch replied, “I think I never gauged your cruelty or your recklessness. … Have you no sense of decency, sir? At long last, have you left no sense of decency?”

The audience broke into wild applause. Welch’s put-down has echoed for the past 70 years in the minds of those who were watching television then (as I was, at age 15). A similar answer by any of the three other college presidents would have shown Stefanik to be the vulgarian that she is. But none ventured to stand up against the abasement.

The Congressional attack accusing opponents of genocide in Gaza as anti-Semites supporting genocide against the Jews is bipartisan. Already in December, Rep. Suzanne Bonamici (D-Ore.) helped cause Harvard and Penn’s presidents to be fired for their stumbling over her red-baiting. She repeated her question to Shafik on April 17: “Does calling for the genocide of Jews violate Columbia’s code of conduct?” Bonamici asked the four new Columbia witnesses. All responded: “Yes.”

That was the moment when they should have said that the students were not calling for genocide of the Jews, but seeking to mobilize opposition to genocide being committed by the Likud government against the Palestinians with President Biden’s full support.

During a break in the proceedings Rep. Stefanik told the press that “the witnesses were overheard discussing how well they thought their testimony was going for Columbia.” This arrogance is eerily reminiscent to the previous three university presidents who believed when walking out of the hearing that their testimony was acceptable. “Columbia is in for a reckoning of accountability. If it takes a member of Congress to force a university president to fire a pro-terrorist, antisemitic faculty chair, then Columbia University leadership is failing Jewish students and its academic mission,” added Stefanik. “No amount of overlawyered, overprepped, and over-consulted testimony is going to cover up for failure to act.”

Shafik could have pointedly corrected the implications by the House inquisitors that it was Jewish students who needed protection. The reality was just the opposite: The danger was from the Israeli IDF students who attacked the demonstrators with military Skunk, with no punishment by Columbia.

Despite being told not to by the faculty and student groups (which Shafik was officially bound to consult), she called in the police, who arrested 107 students, tied their hands behind their backs and kept them that way for many hours as punishment while charging them for trespassing on Columbia’s property. Shafik then suspended them from classes.

The clash between two kinds of Judaism: Zionist vs. assimilationist

A good number of these protestors being criticized were Jewish. Netanyahu and AIPAC have claimed – correctly, it seems – that the greatest danger to their current genocidal policies comes from the traditionally liberal Jewish middle-class population. Progressive Jewish groups have joined the uprisings at Columbia and other universities.
Early Zionism arose in late 19th-century Europe as a response to the violent pogroms killing Jews in Ukrainian cities such as Odessa and other Central European cities that were the center of anti-Semitism. Zionism promised to create a safe refuge. It made sense at a time when Jews were fleeing their countries to save their lives in countries that accepted them. They were the “Gazans” of their day.

After World War II and the horrors of the Holocaust, anti-Semitism became passé. Most Jews in the United States and other countries were being assimilated and becoming prosperous, most successfully in the United States. The past century has seen this success enable them to assimilate, while retaining the moral standard that ethnic and religious discrimination such as that which their forbears had suffered is wrong in principle.

Jewish activists were in the forefront of fighting for civil liberties, most visibly against anti-Black prejudice and violence in the 1960s and ‘70s, and against the Vietnam War. Many of my Jewish school friends in the 1950s bought Israel bonds, but thought of Israel as a socialist country and thought of volunteering to work on a kibbutz in the summer. There was no thought of antagonism, and I heard no mention of the Palestinian population when the phrase “a people without a land in a land without a people” was spoken.

But Zionism’s leaders have remained obsessed with the old antagonisms in the wake of Nazism’s murders of so many Jews. In many ways they have turned Nazism inside out, fearing a renewed attack from non-Jews. Driving the Arabs out of Israel and making it an apartheid state was just the opposite of what assimilationist Jews aimed at.

The moral stance of progressive Jews, and the ideal that Jews, blacks and members of all other religions and races should be treated equally, is the opposite of Israeli Zionism. In the hands of Netanyahu’s Likud Party and the influx of right-wing supporters, Zionism asserts a claim to set Jewish people apart from the rest of their national population, and even from the rest of the world, as we are seeing today.

Claiming to speak for all Jews, living and dead, Netanyahu asserts that to criticize his genocide and the Palestinian holocaust, the nakba, is anti-Semitic. This is the position of Stefanik and her fellow committee members. It is an assertion that Jews owe their first allegiance to Israel, and hence to its ethnic cleansing and mass murder since last October. President Biden also has labeled the student demonstrations “antisemitic protests.”

This claim in the circumstances of Israel’s ongoing genocide is causing more anti-Semitism than anyone since Hitler. If people throughout the world come to adopt Netanyahu’s and his cabinet’s definition of anti-Semitism, how many, being repulsed by Israel’s actions, will say, “If that is the case, then indeed I guess I’m anti-Semitic.”

Netanyahu’s slander against Judaism and what civilization should stand for

Netanyahu characterized the U.S. protests in an extremist speech on April 24 attacking American academic freedom.

What’s happening in America’s college campuses is horrific. Antisemitic mobs have taken over leading universities. They call for the annihilation of Israel, they attack Jewish students, they attack Jewish faculty. This is reminiscent of what happened in German universities in the 1930s. We see this exponential rise of antisemitism throughout America and throughout Western societies as Israel tries to defend itself against genocidal terrorists, genocidal terrorists who hide behind civilians.

It’s unconscionable, it has to be stopped, it has to be condemned and condemned unequivocally. But that’s not what happened. The response of several university presidents was shameful. Now, fortunately, state, local, federal officials, many of them have responded differently but there has to be more. More has to be done.

This is a call to make American universities into arms of a police state, imposing policies dictated by Israel’s settler state. That call is being funded by a circular flow: Congress gives enormous subsidies to Israel, which recycles some of this money back into the election campaigns of politicians willing to serve their donors. It is the same policy that Ukraine uses when it employs U.S. “aid” by setting up well-funded lobbying organizations to back client politicians.

What kind of student and academic protest expressions could oppose the Gaza and West Bank genocide without explicitly threatening Jewish students? How about “Palestinians are human being too!” That is not aggressive. To make it more ecumenical, one could add “And so are the Russians, despite what Ukrainian neo-Nazis say.”
I can understand why Israelis feel threatened by Palestinians. They know how many they have killed and brutalized to grab their land, killing just to “free” the land for themselves. They must think “If the Palestinians are like us, they must want to kill us, because of what we have done to them and there can never be a two-state solution and we can never live together, because this land was given to us by God.”

Netanyahu fanned the flames after his April 24 speech by raising today’s conflict to the level of a fight for civilization: “What is important now is for all of us, all of us who are interested and cherish our values and our civilization, to stand up together and to say enough is enough.”

Is what Israel is doing, and what the United Nations, the International Court of Justice and most of the Global Majority oppose, really “our civilization”? Ethnic cleansing, genocide and treating the Palestinian population as conquered and to be expelled as subhumans is an assault on the most basic principles of civilization.

Peaceful students defending that universal concept of civilization are called terrorists and anti-Semites – by the terrorist Israeli Prime Minister. He is following the tactics of Joseph Goebbels: The way to mobilize a population to fight the enemy is to depict yourself as under attack. That was the Nazi public relations strategy, and it is the PR strategy of Israel today – and of many in the American Congress, in AIPAC and many related institutions that proclaim a morally offensive idea of civilization as the ethnic supremacy of a group sanctioned by God.

The real focus of the protests is the U.S. policy that is backing Israel’s ethnic cleansing and genocide supported by last week’s foreign “aid.” It is also a protest against the corruption of Congressional politicians raising money from lobbyists representing foreign interests over those of the United States. Last week’s “aid” bill also backed Ukraine, that other country presently engaged in ethnic cleansing, where House members waved Ukrainian flags, not those of the United States. Shortly before that, one Congressman wore his Israeli army uniform into Congress to advertise his priorities.

Zionism has gone far beyond Judaism. I’ve read that there are nine Christian Zionists for every Jewish Zionist. It is as if both groups are calling for the End Time to arrive, while insisting that support for the United Nations and the International Court of Justice condemning Israel for genocide is anti-Semitic.

What CAN the students at Columbia ask for:

Students at Columbia and other universities have called for universities to disinvest in Israeli stocks, and also those of U.S. arms makers exporting to Israel. Given the fact that universities have become business organizations, I don’t think that this is the most practical demand at present. Most important, it doesn’t go to the heart of the principles at work.

What really is the big public relations issue is the unconditional U.S. backing for Israel come what may, with “anti-Semitism” the current propaganda epithet to characterize those who oppose genocide and brutal land grabbing.

They should insist on a public announcement by Columbia (and also Harvard and the University of Pennsylvania, who were equally obsequious to Rep. Stefanik) that they recognize that it is not anti-Semitic to condemn genocide, support the United Nations and denounce the U.S. veto.

They should insist that Columbia and the other universities making a sacrosanct promise not to call police onto academic grounds over issues of free speech.

They should insist that the president be fired for her one-sided support of Israeli violence against her students. In that demand they are in agreement with Rep. Stefanik’s principle of protecting students, and that Dr. Shafik must go.

But there is one class of major offenders that should be held up for contempt: the donors who try to attack academic freedom by using their money to influence university policy and turn universities away from the role in supporting academic freedom and free speech. The students should insist that university administrators – the unpleasant opportunists standing above the faculty and students – must not only refuse such pressure but should join in publicly expressing shock over such covert political influence.

The problem is that American universities have become like Congress in basing their policy on attracting contributions from their donors. That is the academic equivalent of the Supreme Court’s Citizens United ruling. Numerous Zionist funders have threatened to withdraw their contributions to Harvard, Columbia and other schools not following Netanyahu’s demands to clamp down on opponents of genocide and defenders of the United Nations. These funders are the enemies of the students at such universities, and both students and faculty should insist on their removal. Just as Dr. Shafik’s International Monetary Fund fell subject to its economists’ protest that there must be “No more Argentinas,” perhaps the Columbia students could chant “No More Shafiks.”

Image by Ivana Tomášková from Pixabay

The Vilification of Healthy People; Especially Children

Throughout the past several years apparently healthy people have been re-defined as being potential asymptomatic spreaders of a disease that can be lethal in high-risk individuals. The disease is known as the novel coronavirus disease that was first identified in 2019 (COVID-19). People around the world have been instilled with near-paralyzing fear that their family member, friend, neighbour and/or colleague who has no signs or symptoms can kill them by spreading severe acute respiratory syndrome-coronavirus-2 (SARS-CoV-2), which is the causative agent of COVID-19.

This paradigm that a person has no way of knowing who is safe to be around has formed the rationale for mass lockdowns, masking, and mandating ‘vaccines’ for which the initial clinical experiments are still ongoing. This has caused massive fracturing of relationships around the globe. Nobody has been spared. Families have split, best friendships that lasted decades ended abruptly, and colleagues lashed out.

We were told that everyone had to do their part to prevent hospitals from being overwhelmed. Those who felt healthy could not be trusted. Unbeknown to them they might have a wicked pathogen oozing out of their body. Healthy children who were at a statistical risk equivalent to zero of dying from COVID-19 would almost certainly kill their grandparents if they were not locked down, masked and ‘vaccinated’. Those who resisted lockdowns, masking, and mandating of so-called vaccines that could neither prevent the disease nor transmission of its causative agent have been treated like uncaring villains that are deserving of segregation. Remember this front page of one of Canada’s best-known newspapers that was published on August 26, 2021?…

The Prime Minister of Canada, Justin Trudeau, has been a classic example of a leader who has vigorously promoted this kind of hatred and division within his own country.

So, how did we get so far off-track with our response to COVID-19?

Why will future history books, if accurate, document this as the most mismanaged crisis of our time?

Most of the blame rests on the scientific and medical community allowing a very elegant scientific test to be chronically misused. This test is known as the ‘reverse transcriptase-polymerase chain reaction’ (RT-PCR).

Did we follow the science?

In court, I have often seen judges puzzled by the apparent contradictions in the scientific evidence being put forward by various experts. These judges often question how scientists can interpret the same data so differently. When it comes to the science underpinning COVID-19, published papers can be placed into two bins:

1. Those that are trustworthy because they are based on sound scientific methods.

2. Those that are untrustworthy because they are based on flawed scientific methods.

In the past several years science in bin 2 has become voluminous and has contributed excessively to the rationale for the so-called prevailing ‘COVID-19 narrative’. The problem is that the science in bin 2 cannot be properly interpreted because it is built on a fundamentally flawed foundation. Too many scientists failed to critically assess the methods used to generate the early COVID-19 data. This has resulted in this junk science to snowball out of control. The RT-PCR test is at the heart of this problem.

The House Built on Sand Must be Dismantled

If one goes back to the birth of COVID-19 science and critically assesses it, misusing the RT-PCR test jumps out as a key fundamental flaw that caused substantial overestimation of the number of cases of COVID-19 and erroneous labeling of healthy people as asymptomatic spreaders of a deadly disease. The only way to correct course and stop the avalanche of faulty COVID-19 science is to establish which papers can and cannot be trusted. Importantly, editors of scientific journals cannot allow any more COVID-19 ‘facts’ to be published unless the authors unequivocally demonstrate that their data are based on methods that have been implemented properly. Most notably, authors must demonstrate that their research methodologies have been appropriately calibrated such that their conclusions are justified.

Misuse of An Elegant Scientific Technique Has Plagued COVID-19 Science From the Very Beginning

To properly gauge the scope of an outbreak of an infectious disease, one first needs to accurately diagnose it. Diseases are diagnosed primarily based on two things:

1. Accurately detecting the presence of a pathogen using a laboratory-based test.

2. Detection of signs and/or symptoms consistent with the disease, which is usually done by a physician.

Symptoms are aspects of a disease that a person experiences but cannot be assessed easily by an observer. Examples include general malaise, pain, and a loss of appetite. In contrast, signs of illness can be objectively observed and documented by others, and include coughing, sneezing, or a fever that can measured with a thermometer. Often, symptoms precede the onset of signs of illness.

When it comes to defining what it means to be ‘asymptomatic’, there are three relevant scenarios:

1. A person who is not infected with a pathogen will never be at risk of developing the disease associated with that pathogen. These are healthy individuals who are asymptomatic by virtue of not having been infected. They cannot infect others.

2. A person can be infected with a potential pathogen but never develop symptoms of a disease because the causative agent fails to cause substantial harm in the body. In many cases, this might be because the immune system can respond rapidly and effectively. There have also been examples of people getting infected with SARS-CoV-2 but never apparently experiencing symptoms nor developing signs of COVID-19. Infection does not always result in disease. For example, billions of microbes, including many bacteria and viruses, live on and in our bodies without causing us harm. They have invaded our bodies but do not cause disease, even though some of them can cause serious disease in other people or even ourselves should they get into an inappropriate physiological location (e.g., some fecal bacteria entering a body via the oral route). Infected but asymptomatic (disease-free) people are also healthy (i.e., there is no impairment to their ability to function in their daily activities).

3. People who get infected and then progress to a diseased state always have a period in between when they are ‘asymptomatic’. Technically, these individuals that do eventually get sick are referred to as being ‘pre-symptomatic’. One does not know if a person is truly asymptomatic or pre-symptomatic until the typical incubation period for a pathogen has passed; this is the expected time from infection to the onset of symptoms in a susceptible person. A person who is infected and symptomatic can spread the causative agent of the disease to others.

When people have COVID-19, they experience obvious symptoms and signs also usually become apparent. This is the scenario that has been easy to manage throughout the declared COVID-19 pandemic. People who are sick have been asked to stay home. From a social hygiene perspective, it is my expert opinion that this should be encouraged for all the infectious diseases we live with. This would reduce infectious disease-related morbidities and mortalities.

In the context of COVID-19, most masking, isolation and vaccination policies around the world are predicated on the assumption that transmission of SARS-CoV-2 can be efficiently mediated by asymptomatic people who are transiently infected but never get COVID-19 and/or pre-symptomatic individuals. This is based on the assumption that SARS-CoV-2 can replicate to the point where a person who is not coughing or sneezing can expel a threshold dose required to potentially infect another person. Although this is theoretically possible and likely occurs rarely, it is incorrect to conclude that this is commonplace and a significant driver of the spread of COVID-19. This incorrect concept is based on an array of scientific studies that relied on RT-PCR testing that was inappropriately calibrated.

How to Define a Case of COVID-19

Cases of COVID-19 should only be determined as follows:

1. It should be a physician making the diagnosis.

2. It should be based on the presence of signs and symptoms that are consistent with the clinical definition of COVID-19.

3. The presence of symptoms and/or signs should be supported by laboratory results derived from properly calibrated tests that demonstrate the presence of SARS-CoV-2 virions. A virion is a single virus particle. Virions can be replication-competent; these are the only ones that can potentially infect another person and cause disease. Or they can be replication-incompetent; these ones can never spread to others and cause COVID-19.

Throughout the declared pandemic many so-called ‘cases’ of COVID-19 were incorrectly ‘diagnosed’. Cases, especially early in the declared pandemic, have been defined by individuals other than physicians, assumed based on signs and symptoms only, or exclusively based on a positive laboratory test result. The latter has been extremely common. This contradicts the World Health Organization, which noted that “Most PCR assays are indicated as an aid for diagnosis, therefore, health care providers must consider any result in combination with timing of sampling, specimen type, assay specifics, clinical observations, patient history, confirmed status of any contacts, and epidemiological information”.

The core definition, and all-too-often the sole definition of ‘cases’ of COVID-19 has been based on the use of a laboratory testing method referred to as ‘RT-PCR’. To understand how asymptomatic people were mislabeled as significant sources of transmission of SARS-CoV-2, one must first understand how RT-PCR testing should have been properly calibrated around the world.

A polymerase is a protein that can copy DNA, which is a genetic blueprint. So, the PCR method requires this genetic blueprint known as DNA to be present in order to work. If DNA is in a sample, when a scientist adds a polymerase, a few other ingredients, and then varies the temperature, new copies of tiny portions of the DNA will be made. With each ‘cycle’ that the PCR test is run, more copies of these fragments of the genetic blueprint will be made. Once a threshold number of copies appear in the sample, they can be detected. Think of it like a photocopier. From a great distance, you might not be able to tell if a single copy of a page has been made. However, once you have a stack of five hundred pages sitting on the output tray, you know for sure that the photocopier is churning out copies. In short, PCR is a method that scientists can use to determine whether a particular genetic blueprint is present in a sample.

The genetic blueprint for SARS-CoV-2 is not made of DNA. Instead, it is made of a related structure called ‘RNA’. Therefore, to use the PCR test to determine whether an RNA-based virus is present in a sample requires one additional step at the beginning. Specifically, a ‘reverse transcriptase’ is used to convert the RNA from SARS-CoV-2 into DNA, portions of which can then be detected with the PCR test. This is how the RT-PCR test is used to detect the presence of small pieces of the genetic material from SARS-CoV-2.

The Inappropriate Use of RT-PCR Testing Caused a Disconnect Between Laboratory Studies and ‘Real World’ Data

Laboratory studies suggested that asymptomatic individuals could potentially shed infectious SARS-CoV-2 one to two days before the onset of symptoms of COVID-19. However, the largest ‘real world’ study done to date looked at the prevalence of SARS-CoV-2 in ~10 million people in Wuhan, China and found no evidence of asymptomatic transmission. This typical disconnect in the results of laboratory-based studies and ‘real world’ data is due to the former types of experiments having relied on the use of uncalibrated or incorrectly calibrated RT-PCR tests. An RT-PCR test can only determine if tiny fragments of the genetic material from a virus is present in a sample. It can never indicate, on its own, whether that material is from virus particles that have the potential to infect and cause disease, or from replication-incompetent virions or even portions thereof that cannot cause disease.

Flawed RT-PCR Testing Caused Over-Diagnosis of COVID-19

On its own, a positive result on a RT-PCR test to detect SARS-CoV-2 is insufficient to diagnose COVID-19, yet this became routine in most parts of the world. In addition to the potential for false positive tests, true positive results can also be obtained from genomes of SARS-CoV-2 particles that are no longer infectious. An example of the latter would be an individual who has mounted an effective immune response and may have remnant replication-incompetent viral particles or partially degraded viral genetic material inside relatively long-lived white blood cells that have killed the virus. These cells are known as ‘phagocytes’ and are part of our immune system. Indeed, following clearance of SARS-CoV-2 from the body, full and/or partial genomes of SARS-CoV-2 can remain for up to several weeks. Phagocytosis (or ‘eating’) of SARS-CoV-2 is a mechanism to kill and remove the virus from the body. These phagocytic cells tend to hang on to these ‘killed’ virions so that they can activate other immunological effector cells, including B cells that produce the antibodies we have heard so much about. As such, these phagocytes can be a source of SARS-CoV-2 genomes that could be amplified by a PCR test. However, these genomes would not have the potential to cause COVID-19. Instead it would evidence that the infection has resolved or is resolving. Persistence of whole or partial genomes that are not associated with infectious particles is well-documented for a variety of other viruses, including measles, Middle East respiratory syndrome-coronavirus, and other coronaviruses. A positive RT-PCR test for the presence of SARS-CoV-2 should never be used, on its own, to define cases of COVID-19; and definitely should not be used to claim that someone has the potential to infect another person.

Building a Rock-Solid Foundation for COVID-19 Science:

The Gold Standard Functional Virology Assay that Should Always be Used to Calibrate RT-PCR Tests

A gold standard test for infectivity of a virus is a cell-based functional assay that determines the potential to replicate and cause cell death. The assay works like this: Cells that are stripped of their anti-viral properties are put into a dish and allowed to adhere to the bottom. The cells would typically cover the entire bottom of the dish. A scientist can look under a microscope to confirm the cells are healthy. A sample then gets added to the cells. If the sample contains replication-competent (i.e., potentially disease-causing) virions, these will infect and kill the cells. A day or two later, the scientist can check the cells under a microscope again. If they see what is called a ‘cytopathic effect’, which means the cells have died, this indicates that replication-competent virions were present. If there was no cytopathic effect, there were no replication-competent virions. Here are pictures from my research team that show how this virology test works…

…the cells on the left were not exposed to a replication-competent (infectious) virus. They remain happily adhered to the bottom of the dish. There was no cytopathic effect. The cells on the right were exposed to a replication-competent virus that infected and killed them. As the cells died, they rounded up and lost their ability to remain stuck to the bottom of the plate. This is a classic example of cytopathic effect. You can see how easy it is to use this test to determine whether a sample contains any infectious virions.

To calibrate a RT-PCR test for SARS-Cov-2, samples from nasopharyngeal swabs of a large array of people would be split into two; one for RT-PCR testing and the other for testing in the gold standard virology assay. Scientists would note the cycle threshold values from the RT-PCR test that are associated with evidence of replication-competent virions from the cellular virology assay versus those that did not cause a cytopathic effect. This allows a cycle threshold cut-off to be determined. Above this threshold, there is no evidence of replication-competent virions in samples from the nasopharyngeal swabs. This is the objective and proper way to calibrate a RT-PCR test when studying transmission of a virus. Without doing this, RT-PCR test results cannot be interpreted in a meaningful way, and they would lead to inappropriate conclusions, like asymptomatic people being spreaders of COVID-19.

Early in the declared COVID-19 pandemic the Public Health Agency of Canada appropriately performed this calibration of their RT-PCR test. For the test they were using, they identified a cycle threshold cut-off of 24 for declaring people to have the potential to infect others. If they had subsequently offered this service to support studies of the spread of COVID-19, only samples yielding a signal at 24 or fewer cycles would be declared to have evidence of potentially infectious SARS-CoV-2. However, with no explanation provided, this initial and appropriate way of calibrating the RT-PCR assay was not required for labs around the world that were studying transmission of SARS-CoV-2. In fact, cycle threshold cut-offs were arbitrarily assigned. As such, RT-PCR data used to determine global cases of COVID-19 have been highly unreliable.

Even so-called ‘fact-checkers’ of people who criticized the inappropriate designation of the RT-PCR as a stand-alone gold standard diagnostic test have had to admit that it cannot possibly distinguish between infectious and non-infectious virions or parts thereof. For example, a ‘fact check’ from Reuters concluded “PCR tests are being used widely in England to show that SARS-CoV-2 viral genetic material is present in the patient”. I bolded the relevant text. Indeed, RT-PCR tests are a valuable tool for determining whether portions of a virus’s genetic material are present in a sample. They cannot determine whether that genetic material is from a replication-competent virion that would have the potential to infect someone.

Positive RT-PCR tests for SARS-CoV-2 in asymptomatic people are almost universally based on high cycle threshold values, which raises the question of whether these individuals harbor infectious viral particles. The absence of a functional cell-based assay to prove infectivity renders results of asymptomatic testing impossible to interpret accurately. Indeed, the World Health Organization, agreeing with many health professionals around the world, has emphasized that spreading of SARS-CoV-2 by asymptomatic individuals is rare and an emphasis should be placed, therefore, on testing people with signs or symptoms of illness, not those who are apparently healthy.

In addition to the Canadian study that identified a cycle threshold of 24 as an appropriate cut-off for declaring samples positive for infectious SARS-CoV-2, other studies reported results of similar calibrations of other RT-PCR assays for SARS-CoV-2. They identified cycle threshold cut-offs of 22-27 and 30. Altogether, this suggests that tests with cycle threshold values above 22-30 are likely not indicative of the presence of replication-competent SARS-CoV-2.

The logical conclusion is that it is erroneous to declare samples with high cycle threshold values, especially those above 30, as being positive for infectious SARS-CoV-2. However, in many countries people were assumed to be infectious when their samples were declared positive using RT-PCR assays with cycle threshold cut-offs as high as 45 cycles. Such an unjustifiably high cut-off would have resulted in a substantial overestimation of cases of COVID-19 and would have led to erroneous labeling of asymptomatic people as potential spreaders of COVID-19.

Failure to Calibrate the RT-PCR Test Shows How a Representative Influential Scientific Study Incorrectly Concluded that Asymptomatic People Might be a Risk for Spreading COVID-19

The figure below shows results of a published study that claimed to depict the frequency at which asymptomatic people tested positive for SARS-CoV-2 relative to that observed for people with symptomatic infections. Specifically, graphs are shown from figure 2 of a paper published in the influential Journal of the American Medical Association - Internal Medicine. The argument being made was that the frequency at which asymptomatic people tested positive for SARS-CoV-2 was like that observed for people with symptomatic infections. However, the authors failed to calibrate their RT-PCR assay.

Following is the description the authors of the study provided in the methods section of their paper. The most important portion of this text is the last sentence, which is bolded.

“Specimen Collection and RT-PCR for SARS-CoV-2

The URT specimens were collected from both nasopharyngeal and oropharyngeal swabs obtained by trained medical staffs (physicians and nurses). For LRT specimens, participants were given instructions the night before to collect a first morning sputum (after gargling) in a specimen cup; RT-PCR assays for SARS-CoV-2 were performed using Allplex 2020-nCoV assay (Seegene, Seoul, ROK) to determine the presence of virus through the identification of 3 genetic markers: envelope (env) gene, RNA-dependent RNA polymerase (RdRp) gene, and nucleocapsid protein (N) gene. The cycle threshold (Ct) during RT-PCR testing refers to when the detection of viral amplicons occurs, it is inversely correlated with the amount of RNA present. A lower Ct value indicates large quantities of viral RNA. It was considered positive when the Ct values of all genes were less than 40 cycles.”

Remarkably, the authors applied an arbitrary cycle threshold of 40 to define a positive test result. Proper calibration of the test was not performed. I applied a new cycle threshold cut-off of 24, based on the published results of the Canadian study for calibrating a RT-PCR test for SARS-CoV-2. This is shown as a red dotted line on the graphs in the figure above. Symbols appearing in the light red rectangle above this line would be considered negative, in contrast to the positive designation that the authors had assigned. Remarkably, 99.7% of the people the authors declared to be harbouring infectious SARS-CoV-2 likely had no evidence of potentially infectious SARS-CoV-2 virions, had the test been properly calibrated. This represents a fatal flaw in this paper; one that negates its conclusion that “Isolation of asymptomatic patients may be necessary to control the spread of SARS-CoV-2”. It should also precipitate its retraction. Such a paper should never have been allowed to be published in the first place.

This highlights a fatal flaw that has been extremely common in publications throughout the declared pandemic that claimed asymptomatic people could be a significant source of transmission of SARS-CoV-2 that could cause COVID-19 in other people. Every paper making this claim should have the materials and methods section carefully evaluated to determine whether the cycle threshold cut-off for the RT-PCR assay was based on the appropriate calibration method or was selected arbitrarily.

Here is a list of other influential publications of original research studies that erroneously concluded that asymptomatic people might be significant sources of replication-competent SARS-CoV-2 virions. Most are based on fatally flawed RT-PCR testing and the remaining papers fail to disclose how they defined an ‘infection’. All of them should be retracted. None of their conclusions can be trusted…

1. Bai, Y. et al. Presumed Asymptomatic Carrier Transmission of COVID-19. Jama 323, 1406-1407 (2020).

2. Arons, M.M. et al. Presymptomatic SARS-CoV-2 Infections and Transmission in a Skilled Nursing Facility. The New England journal of medicine 382, 2081-2090 (2020).

3. Stock, A.D. et al. COVID-19 Infection Among Healthcare Workers: Serological Findings Supporting Routine Testing. Front Med (Lausanne) 7, 471 (2020).

4. Bi, Q. et al. Epidemiology and transmission of COVID-19 in 391 cases and 1286 of their close contacts in Shenzhen, China: a retrospective cohort study. The Lancet. Infectious diseases 20, 911-919 (2020).

5. Böhmer, M.M. et al. Investigation of a COVID-19 outbreak in Germany resulting from a single travel-associated primary case: a case series. The Lancet. Infectious diseases 20, 920-928 (2020).

6. Chan, J.F. et al. A familial cluster of pneumonia associated with the 2019 novel coronavirus indicating person-to-person transmission: a study of a family cluster. Lancet (London, England) 395, 514-523 (2020).

7. Van Vinh Chau, N. et al. The Natural History and Transmission Potential of Asymptomatic Severe Acute Respiratory Syndrome Coronavirus 2 Infection. Clinical infectious diseases : an official publication of the Infectious Diseases Society of America 71, 2679-2687 (2020).

8. Chaw, L. et al. Analysis of SARS-CoV-2 Transmission in Different Settings, Brunei. Emerging infectious diseases 26, 2598-2606 (2020).

9. Cheng, H.Y. et al. Contact Tracing Assessment of COVID-19 Transmission Dynamics in Taiwan and Risk at Different Exposure Periods Before and After Symptom Onset. JAMA internal medicine 180, 1156-1163 (2020).

10. Gao, M. et al. A study on infectivity of asymptomatic SARS-CoV-2 carriers. Respiratory medicine 169, 106026 (2020).

11. Gao, Y. et al. A cluster of the Corona Virus Disease 2019 caused by incubation period transmission in Wuxi, China. The Journal of infection 80, 666-670 (2020).

12. Guan, W.J. et al. Clinical Characteristics of Coronavirus Disease 2019 in China. The New England journal of medicine 382, 1708-1720 (2020).

13. He, X. et al. Temporal dynamics in viral shedding and transmissibility of COVID-19. Nat Med 26, 672-675 (2020).

14. Hodcroft, E.B. Preliminary case report on the SARS-CoV-2 cluster in the UK, France, and Spain. Swiss medical weekly 150 (2020).

15. Hoehl, S. et al. Evidence of SARS-CoV-2 Infection in Returning Travelers from Wuhan, China. The New England journal of medicine 382, 1278-1280 (2020).

16. Lauer, S.A. et al. The Incubation Period of Coronavirus Disease 2019 (COVID-19) From Publicly Reported Confirmed Cases: Estimation and Application. Annals of internal medicine 172, 577-582 (2020).

17. Li, R. et al. Substantial undocumented infection facilitates the rapid dissemination of novel coronavirus (SARS-CoV-2). Science (New York, N.Y.) 368, 489-493 (2020).

18. Li, C. et al. Asymptomatic and Human-to-Human Transmission of SARS-CoV-2 in a 2-Family Cluster, Xuzhou, China. Emerging infectious diseases 26, 1626-1628 (2020).

19. Liu, Y., Funk, S. & Flasche, S. The contribution of pre-symptomatic infection to the transmission dynamics of COVID-2019. Wellcome open research 5, 58 (2020).

20. Lu, X. et al. SARS-CoV-2 Infection in Children. The New England journal of medicine 382, 1663-1665 (2020).

21. Lu, S. et al. Alert for non-respiratory symptoms of coronavirus disease 2019 patients in epidemic period: A case report of familial cluster with three asymptomatic COVID-19 patients. Journal of medical virology 93, 518-521 (2021).

22. Luo, S.H. et al. A confirmed asymptomatic carrier of 2019 novel coronavirus. Chinese medical journal 133, 1123-1125 (2020).

23. Mizumoto, K., Kagaya, K., Zarebski, A. & Chowell, G. Estimating the asymptomatic proportion of coronavirus disease 2019 (COVID-19) cases on board the Diamond Princess cruise ship, Yokohama, Japan, 2020. Euro surveillance : bulletin Europeen sur les maladies transmissibles = European communicable disease bulletin 25 (2020).

24. Sun, K. et al. Transmission heterogeneities, kinetics, and controllability of SARS-CoV-2. Science (New York, N.Y.) 371 (2021).

25. Nishiura, H. et al. Estimation of the asymptomatic ratio of novel coronavirus infections (COVID-19). Int J Infect Dis 94, 154-155 (2020).

26. Nishiura, H., Linton, N.M. & Akhmetzhanov, A.R. Serial interval of novel coronavirus (COVID-19) infections. Int J Infect Dis 93, 284-286 (2020).

27. Pan, Y., Zhang, D., Yang, P., Poon, L.L.M. & Wang, Q. Viral load of SARS-CoV-2 in clinical samples. The Lancet. Infectious diseases 20, 411-412 (2020).

28. Pan, X. et al. Asymptomatic cases in a family cluster with SARS-CoV-2 infection. The Lancet. Infectious diseases 20, 410-411 (2020).

29. Park, S.Y. et al. Coronavirus Disease Outbreak in Call Center, South Korea. Emerging infectious diseases 26, 1666-1670 (2020).

30. Payne, D.C. et al. SARS-CoV-2 Infections and Serologic Responses from a Sample of U.S. Navy Service Members - USS Theodore Roosevelt, April 2020. MMWR. Morbidity and mortality weekly report 69, 714-721 (2020).

31. Kimball, A. et al. Asymptomatic and Presymptomatic SARS-CoV-2 Infections in Residents of a Long-Term Care Skilled Nursing Facility - King County, Washington, March 2020. MMWR. Morbidity and mortality weekly report 69, 377-381 (2020).

32. Qian, G. et al. COVID-19 Transmission Within a Family Cluster by Presymptomatic Carriers in China. Clinical infectious diseases : an official publication of the Infectious Diseases Society of America 71, 861-862 (2020).

33. Ran, L. et al. Risk Factors of Healthcare Workers With Coronavirus Disease 2019: A Retrospective Cohort Study in a Designated Hospital of Wuhan in China. Clinical infectious diseases : an official publication of the Infectious Diseases Society of America 71, 2218-2221 (2020).

34. Rosenberg, E.S. et al. COVID-19 Testing, Epidemic Features, Hospital Outcomes, and Household Prevalence, New York State-March 2020. Clinical infectious diseases : an official publication of the Infectious Diseases Society of America 71, 1953-1959 (2020).

35. Sakurai, A. et al. Natural History of Asymptomatic SARS-CoV-2 Infection. The New England journal of medicine 383, 885-886 (2020).

36. Samsami, M., Zebarjadi Bagherpour, J., Nematihonar, B. & Tahmasbi, H. COVID-19 Pneumonia in Asymptomatic Trauma Patients; Report of 8 Cases. Archives of academic emergency medicine 8, e46 (2020).

37. Tabata, S. et al. Clinical characteristics of COVID-19 in 104 people with SARS-CoV-2 infection on the Diamond Princess cruise ship: a retrospective analysis. The Lancet. Infectious diseases 20, 1043-1050 (2020).

38. Tong, Z.D. et al. Potential Presymptomatic Transmission of SARS-CoV-2, Zhejiang Province, China, 2020. Emerging infectious diseases 26, 1052-1054 (2020).

39. Treibel, T.A. et al. COVID-19: PCR screening of asymptomatic health-care workers at London hospital. Lancet (London, England) 395, 1608-1610 (2020).

40. Wei, W.E. et al. Presymptomatic Transmission of SARS-CoV-2 - Singapore, January 23-March 16, 2020. MMWR. Morbidity and mortality weekly report 69, 411-415 (2020).

41. Xu, J., Li, Y., Gan, F., Du, Y. & Yao, Y. Salivary Glands: Potential Reservoirs for COVID-19 Asymptomatic Infection. Journal of dental research 99, 989 (2020).

42. Yang, R., Gui, X. & Xiong, Y. Comparison of Clinical Characteristics of Patients with Asymptomatic vs Symptomatic Coronavirus Disease 2019 in Wuhan, China. JAMA network open 3, e2010182 (2020).

43. Yang, N. et al. In-flight transmission cluster of COVID-19: a retrospective case series. Infectious diseases (London, England) 52, 891-901 (2020).

44. Ye, F. et al. Delivery of infection from asymptomatic carriers of COVID-19 in a familial cluster. International journal of infectious diseases : IJID : official publication of the International Society for Infectious Diseases 94, 133-138 (2020).

45. Yu, P., Zhu, J., Zhang, Z. & Han, Y. A Familial Cluster of Infection Associated With the 2019 Novel Coronavirus Indicating Possible Person-to-Person Transmission During the Incubation Period. The Journal of infectious diseases 221, 1757-1761 (2020).

46. Zhang, J., Tian, S., Lou, J. & Chen, Y. Familial cluster of COVID-19 infection from an asymptomatic. Critical care (London, England) 24, 119 (2020).

47. Almadhi, M.A. et al. The high prevalence of asymptomatic SARS-CoV-2 infection reveals the silent spread of COVID-19. International journal of infectious diseases : IJID : official publication of the International Society for Infectious Diseases 105, 656-661 (2021).

48. Choi, A. et al. Symptomatic and Asymptomatic Transmission of SARS-CoV-2 in K-12 Schools, British Columbia, Canada April to June 2021. Microbiology spectrum, e0062222 (2022).

…these 48 papers represent most, if not all, of the peer-reviewed scientific evidence that has been used by most public health officials to mislabel asymptomatic people as sources of COVID-19-causing SARS-CoV-2. All of it is fatally flawed.

It was even concluded in a study that patients testing ‘positive’ with cycle threshold values above 33 could likely be discharged from hospitals. Such a recommendation would never be made if there was any evidence that these people harboured SARS-CoV-2 virions with the potential to infect others. So one must wonder why testing labs were allowed to arbitrarily pick cycle thresholds ranging from 38 to 45 as upper limits for defining the presence of infectious SARS-CoV-2.

Exclusive reliance on improperly calibrated RT-PCR testing as an indication of ‘infection’ has also led to the erroneous conclusion that post-symptomatic people may also need to be masked and/or isolated.

I have yet to see appropriate scientific evidence to justify the unusually high cycle threshold values being used in studies that label people as asymptomatic sources of COVID-19. In the absence of such data, there is no justification for masking, isolating or mandating experimental vaccine technologies for asymptomatic people.

Others have also criticized the exclusive use of RT-PCR tests in diagnosing COVID-19 and drawing conclusions about transmission in the absence of infectivity testing.

How RT-PCR Testing Should Have Been Used to Support Diagnoses of COVID-19

All labs should have been required to calibrate their RT-PCR test prior to providing any ‘real world’ data to public health officials that would be used to study the transmission of SARS-CoV-2. Use of the gold standard functional virology assay to do this calibration would have provided each lab with a strong objective rationale for their specific cycle threshold cut-off value when determining whether a person could have the potential to infect others. And this should have always been married to a clinical diagnosis rendered by a physician. As mentioned earlier, if this standard is applied retroactively to the COVID-19 scientific literature, it becomes obvious that much of it is untrustworthy.

Much of the Foundational COVID-19 Science is Fundamentally Flawed

RT-PCR testing has generally been misused during the declared COVID-19 pandemic due to failures to calibrate it properly. The result has been mislabeling asymptomatic people as significant potential sources for transmission of COVID-19. This, in turn, has resulted in inappropriate mandating of masking, isolation, and ‘vaccines’ for people who do not represent a genuine health risk to others. It has also taken the diagnostic expertise away from physicians and placed it in the hands of anonymous laboratory technicians.

Now, we are left with a mountain of COVID-19 science that cannot be interpreted properly. Scientists with integrity and the relevant expertise know that a substantial but undefined number of people that tested ‘positive for COVID-19’ never had the potential to spread SARS-CoV-2 to others and many of these also did not actually have the disease known as COVID-19.

Resolving the Apparent Conflicts in Evidence Presented by ‘Experts’

To judges who are puzzled by the differing interpretations of experts in their courts, the explanation is fairly simple. If you remove the fundamentally flawed science from expert reports, you will be left with trustworthy data that generally do not support what has been the prevailing narrative over the past several years. When scientists talk about following the overall weight of the scientific evidence, what we really mean is to follow the weight of the trustworthy scientific evidence. Do not get bedazzled by the numerous reports that have accumulated, often in ‘prestigious’ journals, that were based on flawed scientific methods. Don’t get distracted by the number of health ‘authorities’ that have blindly propagated this flawed science. Truth is not a democracy. It is not defined by a majority vote.

Harm to Public Trust in Science

The global propagation of poorly conducted science over the past several years has caused massive and irreparable harm. Children and teenagers took the brunt of this damage. They were given no choice. They had no voice. They became shields used in a conflict waged by adults who wielded faulty science like it was the gospel truth.

As a scientist with deep expertise in viral immunology, I am incredibly disheartened by the state of my scientific disciplines. My colleagues that sat in their ivory towers allowing junk science to justify crushing constitutional freedoms should be ashamed of themselves. I am proud of the relatively few who stood tall on a foundation of integrity and endured brutal treatment for the past couple of years. I can only hope that the harm done to public trust in the health sciences can be remedied.

Full paper - PDF 50 Pages Posted: 12 Sep 2022

• Kevin Bardosh
  University of Washington; University of Edinburgh - Edinburgh Medical School
• Allison Krug
  Artemis Biomedical Communications LLC
• Euzebiusz Jamrozik
  University of Oxford
• Trudo Lemmens
  University of Toronto - Faculty of Law
• Salmaan Keshavjee
  Harvard University - Harvard Medical School
• Vinay Prasad
  University of California, San Francisco (UCSF)
• Martin A. Makary
  Johns Hopkins University - Department of Surgery
• Stefan Baral
  John Hopkins University
• Tracy Beth Høeg
  Florida Department of Health; Sierra Nevada Memorial Hospital

Date Written: August 31, 2022

Abstract

Students at North American universities risk disenrollment due to third dose COVID-19 vaccine mandates. We present a risk-benefit assessment of boosters in this age group and provide five ethical arguments against mandates. We estimate that 22,000 - 30,000 previously uninfected adults aged 18-29 must be boosted with an mRNA vaccine to prevent one COVID-19 hospitalisation. Using CDC and sponsor-reported adverse event data, we find that booster mandates may cause a net expected harm: per COVID-19 hospitalisation prevented in previously uninfected young adults, we anticipate 18 to 98 serious adverse events, including 1.7 to 3.0 booster-associated myocarditis cases in males, and 1,373 to 3,234 cases of grade ≥3 reactogenicity which interferes with daily activities. Given the high prevalence of post-infection immunity, this risk-benefit profile is even less favourable. University booster mandates are unethical because: 1) no formal risk-benefit assessment exists for this age group; 2) vaccine mandates may result in a net expected harm to individual young people; 3) mandates are not proportionate: expected harms are not outweighed by public health benefits given the modest and transient effectiveness of vaccines against transmission; 4) US mandates violate the reciprocity principle because rare serious vaccine-related harms will not be reliably compensated due to gaps in current vaccine injury schemes; and 5) mandates create wider social harms. We consider counter-arguments such as a desire for socialisation and safety and show that such arguments lack scientific and/or ethical support. Finally, we discuss the relevance of our analysis for current 2-dose CCOVIDovid-19 vaccine mandates in North America.

Note: Funding: This paper was partially supported by a Wellcome Trust Society and Ethics fellowship awarded to KB (10892/B/15/ZE) and Wellcome Trust grants to EJ (216355, 221719, 203132).
Competing Interest Statement: We do not have any competing interests to declare.

Keywords: COVID-19 vaccines, mandates, ethics, young adults, risk-benefit analysis

Twice in the late winter and early spring of 2018, I climbed the stairs to the fourth floor of the Fisher Fine Arts Library, a Venetian-Gothic jewel box designed by Frank Furness as the main library of the University of Pennsylvania’s West Philadelphia campus in 1890. It had been years since I’d been inside the building whose open stacks of books I haunted in the early 1990s as a graduate student in the historic preservation program. It is there, for better or worse, that I learned about decoding symbols and interpreting diverse landscapes of industrialization and predatory finance.

I hold a crisp memory of my thesis advisor, a striking German woman with long white hair tucked into a tidy bun originally from the Palatinate who relocated to Oley, PA. We were walking down Walnut Street when she paused to look at me, put her hand on my shoulder, and tell me that one day I would see it; that my family would be protected because I could see it. Thirty years later the ability to sense worrisome artifacts lurking behind consensus reality is a burden I’d like to abandon, but I can’t. I’m still waiting for the upside. I don’t feel protected at all, and my family doesn’t understand me.

The account that follows isn’t about placing blame. I recognize we’re all caught in a terrible machine. Some of us are enmeshed more deeply than others. Some of us are more vulnerable than others. My ability to keep a roof over my head is intimately intertwined with the fate of Philadelphia’s largest private employer. If you believe the press releases, it is one of the best big employers in the nation. I am doing my best to complicate their contrived narratives. My lot is being a gad fly for Ben Franklin’s big project, the University of Pennsylvania.

I consider myself fortunate to have the stability to witness and tell the stories I tell. I harbor some guilt, because many people I care about don’t have that luxury. Still, there is nothing to do but forge ahead honing our skills, learning from our missteps, being human. Hanging back because we are afraid to fail is not an option. So, I choose to chip away at the foundation upon which my world rests with stories and felt dolls and dandelions. This anti-life egregore is nothing you can disarm by military force. Fritz Kunz and Piritim Sorokin were searching for the power of eros, the creative force of the universe. I’ll settle for a tonic of philia, affectionate love, appropriate to Philadelphia.

My significant other regularly points out this institution, one from which we both hold degrees, is not a monolithic presence. Rather it is more like a fractious collection of feuding fiefdoms. The right hand doesn’t know what the left hand is doing, which is exactly how systems of power like it. University culture is a civilizing force that rewards deep, narrow, often polarizing inquiry. Academic pecking orders are determined by books published, conference papers given, grants secured, patents filed, the robustness of one’s network. Virtuosos of cultivated ignorance are lauded; plausible deniability abounds. Behind ivy-covered walls chosen ones are conditioned to look to experts to define the contours of their character even as the system guts them and hollows their minds to make room for infusions of submission coding.

Look everywhere but inside your heart where you might unearth your moral compass. Ignore the elephants in the room as the acrid odor of dung fills your nostrils. The war on consciousness and natural life is well underway, but few retain sufficient clarity of thought or a firm enough backbone to call a spade a spade. Their boning knives are so sharp, and the cuts so deft, many victims never realize they’ve been gutted. That was me for decades – the good student, the good mom, the good co-worker, plowing ahead until a lattice of fine cracks began to widen revealing socially conditioned “goodness” to be a flimsy veneer under which a deep psychic wound festered.

And it wasn’t one wound, but many wounds. It was a pervasive network of woundedness, riddled with rot, and papered over with progressive social policy. The prognosis is not good. There’s not yet a cure for chronic domination disorder though symptoms may temporarily be alleviated through superficial social justice performances enacted even as most participants know deep inside nothing is actually meant to change. Cycles of harm run on repeat with increasing intensity, a perpetual gas-lit charade.

On that day, February 20, 2018, Neil Kleiman, NYU professor of “what works” government would be presenting on “A New City O/S.” At the time I was new to Twitter, and I distinctly remember tweeting the question, who decided to put behaviorists in charge of our cities? Who had ordered up this new operating system, which I now understand will be blockchain vending machine e-government tied to digital ID and smart sensor networks?

I grabbed a chair up front to record the presentation and got several pointed questions in at the end about social impact finance. As usual, the self-proclaimed experts seemed to know nothing about what was actually going on, upholding the ruse for an audience who would leave thinking they’d learned something when they were simply being managed through fanciful stories.

A lot more ...

I feel I’ve provided a pretty good tour of the University of Pennsylvania. I hope you have gained an understanding of how I see things – cagey financiers, delusional do-gooders, crafty policy makers, ambitious scientists, and digital storytellers each of whom is living their own drama where they hope to be the hero. So why have I taken you down this winding path? Well, I wanted to let you know that Zane Griffith Talley Cooper is the reason I chose to separate myself from Silicon Icarus.

I’d had some communication failures with Raul the previous month, and when I saw his story highlighting Cooper’s work in Greenland my heart dropped. Not because it wasn’t a well written piece or that rare earth mineral mining wasn’t a concern, but I knew that the Annenberg School of Communication, created by Sir Walter Nixon’s ambassador to England and heir to the Daily Racing Form / TV Guide fortune, was a mouthpiece for social impact propaganda. I’d written about it in 2018, including their push for blockchain media and sham social justice outlets. I’d sent Raul the link to, “Don’t Let the Impact Investors Capture the Non-Profit Activist Media,” a week or so prior to his article coming out.

I asked if we could have a conversation about Cooper, because the nature of his inclusion in the piece didn’t make sense to me. Nor did the shout-out given to him on Twitter. It was not the way Raul normally operated, and I pretty much read and uplifted every piece he’d written over the course of the year. I’m not one to let things fester. You may say I’m blunt or direct or even rude. I’ll own that. But I don’t play games, and people know where I stand.

I never got that conversation. The door was closed, a brief message exchange abruptly ended, and at that point I said I felt we were on different paths and it was probably appropriate to remove me as a contributor. Raul never opened the message I sent saying I hoped our paths would cross again, and that I wish him open pathways on his journey. I’m sure he will continue to do important work. I’d love to think impact finance will be a part of it, but it’s not the first time people I thought understood ended up pulling back and repositioning. As I said in the beginning of this post, this is not about assigning blame. I’m in this machine as deeply as anyone. I even have empathy for Zane Talley Griffith Cooper. It can’t be easy on the soul getting paid to study Web 3 while being expected to be an anti-imperialist in your academic circles. But he did do Beckett naked, so I suspect he’ll probably make it through.

https://www.zanegriffintalleycooper.com/pastzane/when-i-used-to-do-commercials-and-make-movies-sometimes

I stepped away from Silicon Icarus not because Raul interviewed Zane or wrote a piece I felt pulled punches, but because my request to talk about it was rejected. I didn’t have ten pages of thoughts when I made that ask, but there were things on my mind – serious things. To my way of thinking friends, real friends, should have enough trust and respect in one another to do the hard work of being human, which can be messy. Two years of support deserved better than ghosting, but we never know what it’s like to walk in another person’s shoes. I know he’s facing challenges. I don’t regret making that ask, because I wouldn’t be me if I hadn’t. The hardest part is not knowing if we ever were really friends, and that is the sickness of the Internet folks. It can be a real mind fuck.

But if the past few years have taught me anything, the universe operates according to purposeful if mysterious plans. I’ve had people arrive in my life to teach me and then abruptly leave. Still, we are all connected and so I will end with this passage from Louise Erdrich that I read this past week about waves. The waves are the key – periodicity, cycles, harmony. Edward Dewey knew some things. This paragraph is from “Books and Islands in Ojibwe Country,” page 64.

“Waves – On our way to visit the island and Eternal Sands we experience a confluence of shifting winds and waves. Tobasonakwut shows me how the waves are creating underwaves and counterwaves. The rough swells from the southeast are bouncing against the rocky shores, which he avoids. The wooded lands and shores will absorb the force of the waves and not send them back out to create confusion. Heading towards open water, we travel behind the farthest island, a wave cutter. We slice right into the waves when possible. But we are dealing with yesterday’s wind and a strong north wind and swells underneath the waves now proceeding from the wind that shifted, fresh, to the south. I think if what Tobasonakwut’s father said, “The creator is the lake and we are the waves on the lake.” The images of complexity and shifting mutability of human nature is very clear today.“

Perfect Louise.

Your words touch my heart.

I wish a wave cutter island for everyone who needs it right now – each and every one.

Hug your people.

You never know what tomorrow will bring.

Abstract

Introduction

In 2020, prior to COVID-19 vaccine rollout, the Brighton Collaboration created a priority list, endorsed by the World Health Organization, of potential adverse events relevant to COVID-19 vaccines. We adapted the Brighton Collaboration list to evaluate serious adverse events of special interest observed in mRNA COVID-19 vaccine trials.

Methods

Secondary analysis of serious adverse events reported in the placebo-controlled, phase III randomized clinical trials of Pfizer and Moderna mRNA COVID-19 vaccines in adults (NCT04368728 and NCT04470427), focusing analysis on Brighton Collaboration adverse events of special interest.

Results

Pfizer and Moderna mRNA COVID-19 vaccines were associated with an excess risk of serious adverse events of special interest of 10.1 and 15.1 per 10,000 vaccinated over placebo baselines of 17.6 and 42.2 (95 % CI −0.4 to 20.6 and −3.6 to 33.8), respectively. Combined, the mRNA vaccines were associated with an excess risk of serious adverse events of special interest of 12.5 per 10,000 vaccinated (95 % CI 2.1 to 22.9); risk ratio 1.43 (95 % CI 1.07 to 1.92). The Pfizer trial exhibited a 36 % higher risk of serious adverse events in the vaccine group; risk difference 18.0 per 10,000 vaccinated (95 % CI 1.2 to 34.9); risk ratio 1.36 (95 % CI 1.02 to 1.83). The Moderna trial exhibited a 6 % higher risk of serious adverse events in the vaccine group: risk difference 7.1 per 10,000 (95 % CI –23.2 to 37.4); risk ratio 1.06 (95 % CI 0.84 to 1.33). Combined, there was a 16 % higher risk of serious adverse events in mRNA vaccine recipients: risk difference 13.2 (95 % CI −3.2 to 29.6); risk ratio 1.16 (95 % CI 0.97 to 1.39).

Discussion

The excess risk of serious adverse events found in our study points to the need for formal harm-benefit analyses, particularly those that are stratified according to risk of serious COVID-19 outcomes. These analyses will require public release of participant level datasets.

Keywords

SARS-CoV-2COVID-19VaccinesCOVID-19 vaccinesmRNA vaccinesPfizer-BioNTech COVID-19 vaccine BNT162b2Moderna COVID-19 vaccine mRNA-1273NCT04368728NCT04470427Serious adverse eventsAdverse events of special interestBrighton CollaborationCoalition for Epidemic Preparedness InnovationsSafety Platform for Emergency vACcines

1. Introduction

In March 2020, the Brighton Collaboration and the Coalition for Epidemic Preparedness Innovations partnership, Safety Platform for Emergency vACcines (SPEAC), created and subsequently updated a “priority list of potential adverse events of special interest relevant to COVID-19 vaccine trials.” [1] The list comprises adverse events of special interest (AESIs) based on the specific vaccine platform, adverse events associated with prior vaccines in general, theoretical associations based on animal models, and COVID-19 specific immunopathogenesis. [1] The Brighton Collaboration is a global authority on the topic of vaccine safety and in May 2020, the World Health Organization’s Global Advisory Committee on Vaccine Safety endorsed and recommended the reporting of AESIs based on this priority list. To our knowledge, however, the list has not been applied to serious adverse events in randomized trial data.

We sought to investigate the association between FDA-authorized mRNA COVID-19 vaccines and serious adverse events identified by the Brighton Collaboration, using data from the phase III randomized, placebo-controlled clinical trials on which authorization was based. We consider these trial data against findings from post-authorization observational safety data. Our study was not designed to evaluate the overall harm-benefit of vaccination programs so far. To put our safety results in context, we conducted a simple comparison of harms with benefits to illustrate the need for formal harm-benefit analyses of the vaccines that are stratified according to risk of serious COVID-19 outcomes. Our analysis is restricted to the randomized trial data, and does not consider data on post-authorization vaccination program impact. It does however show the need for public release of participant level trial datasets.

2. Methods

Pfizer and Moderna each submitted the results of one phase III randomized trial in support of the FDA’s emergency use authorization of their vaccines in adults. Two reviewers (PD and RK) searched journal publications and trial data on the FDA’s and Health Canada’s websites to locate serious adverse event results tables for these trials. The Pfizer and Moderna trials are expected to follow participants for two years. Within weeks of the emergency authorization, however, the sponsors began a process of unblinding all participants who elected to be unblinded. In addition, those who received placebo were offered the vaccine. These self-selection processes may have introduced nonrandom differences between vaccinated and unvaccinated participants, thus rendering the post-authorization data less reliable. Therefore, to preserve randomization, we used the interim datasets that were the basis for emergency authorization in December 2020, approximately 4 months after trials commenced.

The definition of a serious adverse event (SAE) was provided in each trial’s study protocol and included in the supplemental material of the trial’s publication. [2], [3], [4] Pfizer and Moderna used nearly identical definitions, consistent with regulatory expectations. An SAE was defined as an adverse event that results in any of the following conditions: death; life-threatening at the time of the event; inpatient hospitalization or prolongation of existing hospitalization; persistent or significant disability/incapacity; a congenital anomaly/birth defect; medically important event, based on medical judgment.

In addition to journal publications, we searched the websites of the FDA (for advisory committee meeting materials) and Health Canada (for sections of the dossier submitted by sponsors to the regulator). [5] For the FDA website, we considered presentations by both the FDA and the sponsors. [6] Within each of these sources, we searched for SAE results tables that presented information by specific SAE type; we chose the most recent SAE table corresponding to the FDA’s requirement for a safety median follow-up time of at least 2 months after dose 2.

For each trial, we prepared blinded SAE tables (containing SAE types without results data). Using these blinded SAE tables, two clinician reviewers (JF and JE) independently judged whether each SAE type was an AESI. SAE types that matched an AESI term verbatim, or were an alternative diagnostic name for an AESI term, were included as an AESI. For all other SAE types, the reviewers independently judged whether that SAE type was likely to have been caused by a vaccine-induced AESI, based on a judgment considering the disease course, causative mechanism, and likelihood of the AESI to cause the SAE type. Disagreements were resolved through consensus; if consensus could not be reached, a third clinician reviewer (PW) was used to create a majority opinion. For each included SAE, we recorded the corresponding Brighton Collaboration AESI category and organ system. When multiple AESIs could potentially cause the same SAE, the reviewers selected the AESI that they judged to be the most likely cause based on classical clinical presentation of the AESI.

We used an AESI list derived from the work of Brighton Collaboration’s Safety Platform for Emergency vACcines (SPEAC) Project. This project created an AESI list which categorizes AESIs into three categories: those included because they are seen with COVID-19, those with a proven or theoretical association with vaccines in general, and those with proven or theoretical associations with specific vaccine platforms. The first version was produced in March 2020 based on experience from China. Following the second update (May 2020), the WHO Global Advisory Committee on Vaccine Safety (GACVS) adopted the list, and Brighton commenced a systematic review process “to ensure an ongoing understanding of the full spectrum of COVID-19 disease and modification of the AESI list accordingly.” [7] This resulted in three additional AESIs being added to the list in December 2020. The subsequent (and most recent fourth) update did not result in any additional AESIs being added to the list. [1].

We matched SAEs recorded in the trial against an expanded list of AESIs created by combining Brighton’s SPEAC COVID-19 AESI list with a list of 29 clinical diagnoses Brighton identified as “known to have been reported but not in sufficient numbers to merit inclusion on the AESI list.” [7] Sensitivity analysis was used to determine whether use of the original versus expanded list altered our results.

Risk ratios and risk differences between vaccine and placebo groups were calculated for the incidence of AESIs and SAEs. We excluded SAEs that were known efficacy outcomes (i.e. COVID-19), consistent with the approach Pfizer (but not Moderna) used in recording SAE data. The Pfizer study trial protocol states that COVID-19 illnesses and their sequelae consistent with the clinical endpoint definition were not to be reported as adverse events, “even though the event may meet the definition of an SAE.” [8] For unspecified reasons, Moderna included efficacy outcomes in their SAE tables, effectively reporting an all-cause SAE result. Because we did not have access to individual participant data, to account for the occasional multiple SAEs within single participants, we reduced the effective sample size by multiplying standard errors in the combined SAE analyses by the square root of the ratio of the number of SAEs to the number of patients with an SAE. This adjustment increased standard errors by 10 % (Pfizer) and 18 % (Moderna), thus expanding the interval estimates. We estimated combined risk ratios and risk differences for the two mRNA vaccines by averaging over the risks using logistic regression models which included indicators for trial and treatment group.

We used a simple harm-benefit framework to place our results in context, comparing risks of excess serious AESIs against reductions in COVID-19 hospitalization.

Read More ...

Highlights

• mRNA vaccines promote sustained synthesis of the SARS-CoV-2 spike protein.
• The spike protein is neurotoxic, and it impairs DNA repair mechanisms.
• Suppression of type I interferon responses results in impaired innate immunity.
• The mRNA vaccines potentially cause increased risk to infectious diseases and cancer.
• Codon optimization results in G-rich mRNA that has unpredictable complex effects.

Abstract

The mRNA SARS-CoV-2 vaccines were brought to market in response to the public health crises of Covid-19. The utilization of mRNA vaccines in the context of infectious disease has no precedent. The many alterations in the vaccine mRNA hide the mRNA from cellular defenses and promote a longer biological half-life and high production of spike protein. However, the immune response to the vaccine is very different from that to a SARS-CoV-2 infection. In this paper, we present evidence that vaccination induces a profound impairment in type I interferon signaling, which has diverse adverse consequences to human health. Immune cells that have taken up the vaccine nanoparticles release into circulation large numbers of exosomes containing spike protein along with critical microRNAs that induce a signaling response in recipient cells at distant sites. We also identify potential profound disturbances in regulatory control of protein synthesis and cancer surveillance. These disturbances potentially have a causal link to neurodegenerative disease, myocarditis, immune thrombocytopenia, Bell's palsy, liver disease, impaired adaptive immunity, impaired DNA damage response and tumorigenesis. We show evidence from the VAERS database supporting our hypothesis. We believe a comprehensive risk/benefit assessment of the mRNA vaccines questions them as positive contributors to public health.

Graphical abstract

"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.

Strictly regular use of ivermectin as prophylaxis for COVID-19 leads to a 90% reduction in COVID-19 mortality rate, in a dose-response manner: definitive results of a prospective observational study of a strictly controlled 223,128 population from a city-wide program in Southern Brazil.

1. Lucy Kerr, MD, ARDMS,
2. Fernando Baldi, PhD
3. Raysildo Barbosa Lôbo, PhD
4. Washington Luiz Olivato Assagra
5. Fernando Carlos Proença
6. Jennifer A. Hibberd, DDS, DPD, MRCDC
7. Juan J Chamie-Quintero
8. Pierre Kory, MD, MPA
9. Flavio A. Cadegiani, MD, MSc, PhD

Key-words: COVID-19, SARS-CoV-2, ivermectin, prophylaxis, prevention, coronavirus

Abstract

Background: Previously, we demonstrated that ivermectin use as prophylaxis for COVID-19 was associated with reductions in COVID-19 infection, hospitalization, and mortality rates, and in the risk of dying from COVID-19, irrespective of regularity and accumulated use of ivermectin, in an observational, prospectively obtained data from a strictly controlled city-wide program in a city in Southern Brazil (Itajaí, SC, Brazil) of of medically-based, optional use of ivermectin as prophylaxis for COVID-19.

In this study, our objective was to explore the data obtained from the program to evaluate whether the level of regularity of ivermectin use impacted in the reductions in these outcomes, aiming to determine if ivermectin showed a progressive dose-, regularity-response in terms of protection from COVID-19 and COVID-19 related outcomes.

Materials and methods:

This is a prospective observational study of the program mention above, that used ivermectin at a dose of 0.2mg/kg/day for two consecutive days, every 15 days. We obtained and analyzed the data regarding the accumulated dose of ivermectin use, in addition to age and comorbidities, to analyze the patterns of reduction of COVID-19 infection, hospitalization, and mortality rates, and risk of dying from COVID-19, according to the regularity and amount of ivermectin used in a 5-month period.

Following definitions of regularity, we considered as strictly regular subjects that used at least 180mg of ivermectin (180mg = 30 tablets), and as sporadic users subjects that used 60mg (= 10 tablets) or less during the 5-month period. Comparisons between subjects that did not use ivermectin and these two levels of regularity of ivermectin use were performed. Analysis of the intermediate levels of ivermectin use are present in the supplement appendix of this study.

To analyze hospitalization and mortality rates, we utilized the database of COVID-19 infections of all participants, from Itajaí and outside. To analyze COVID-19 infection rate and risk of dying from COVID-19 we utilized the Itajaí city database.

Propensity score matching (PSM) was employed, followed by multivariate adjusted analysis for residual differences (doubly adjusted analysis).

Results:

Of the 7,345 cases of COVID-19, 3,034 occurred in non-users, 1,627 in sporadic users, and 289 in strict users, while the remaining cases occurred in the intermediate levels of ivermectin use. Strict users were older (p < 0.0001) and non-significant higher prevalence of type 2 diabetes and hypertension.

COVID-19 infection rate was 39% lower among strict users [4.03% infection rate; risk ratio (RR), 0.61; 95% confidence interval (n = 289 in each group for both comparisons; 95%CI), 0.53 – 0.70; p < 0.0001] than in non-users (6.64% infection rate), and non-significant 11% reduction compared to sporadic users (4.54% infection rate) (n = 1,627 in each group; RR, 0.89; 95%CI 0.76 – 1.03; p = 0.11).

Hospitalization rate was reduced by 100% in strict users, compared to non-users and to sporadic users, both before and after PSM (RR, 0.00; 95%CI, not applicable; p < 0.0001).

After PSM, hospitalization rate was 35% lower among sporadic users than non-users (RR, 0.65; 95%CI, 0.44 – 0.70; p = 0.03).

In propensity score matched groups, multivariate-adjusted mortality rate was 90% lower in strict users compared to non-users (RR, 0.10, 95%CI, 0.02 – 0.45; p = 0.003) and 79% lower than in sporadic users (RR, 0.21; RR, 0.04 – 1.00; p = 0.05), while sporadic users had a 37% reduction in mortality rate compared to non-users (RR, 0.63; 95%CI, 0.41 – 0.99; p = 0.043).

Risk of dying from COVID-19 was 86% lower among strict users than non-users (RR, 0.14; 95%CI, 0.03 – 0.57; p = 0.006) and marginally significant, 72% lower than sporadic users (RR, 0.28; 95%CI, 0.07 – 1.18; p = 0.083), while sporadic users had a 51% reduction compared to non-users (RR, 0.49; 95%CI, 0.32 – 0.76; p = 0.001).

Conclusion:

Non-use of ivermectin was associated with a 10-times increase in mortality risk and 7-times increased risk of dying from COVID-19, compared to strictly regular use of ivermectin in a prospectively collected, strictly controlled population.

A progressive dose-response pattern was observed between level of ivermectin use and level of protection from COVID-19 related outcomes and consistent across different levels of ivermectin use.

I recently resigned from my position as full tenured professor at the University of Toronto. I am now professor emeritus, and before I turned sixty. Emeritus is generally a designation reserved for superannuated faculty, albeit those who had served their term with some distinction. I had envisioned teaching and researching at the U of T, full time, until they had to haul my skeleton out of my office. I loved my job. And my students, undergraduates and graduates alike, were positively predisposed toward me. But that career path was not meant to be. There were many reasons, including the fact that I can now teach many more people and with less interference online. But here’s a few more:

First, my qualified and supremely trained heterosexual white male graduate students (and I’ve had many others, by the way) face a negligible chance of being offered university research positions, despite stellar scientific dossiers. This is partly because of Diversity, Inclusivity and Equity mandates (my preferred acronym: DIE). These have been imposed universally in academia, despite the fact that university hiring committees had already done everything reasonable for all the years of my career, and then some, to ensure that no qualified “minority” candidates were ever overlooked. My students are also partly unacceptable precisely because they are my students. I am academic persona non grata, because of my unacceptable philosophical positions. And this isn’t just some inconvenience. These facts rendered my job morally untenable. How can I accept prospective researchers and train them in good conscience knowing their employment prospects to be minimal?

Second reason: This is one of many issues of appalling ideology currently demolishing the universities and, downstream, the general culture. Not least because there simply is not enough qualified BIPOC people in the pipeline to meet diversity targets quickly enough (BIPOC: black, indigenous and people of colour, for those of you not in the knowing woke). This has been common knowledge among any remotely truthful academic who has served on a hiring committee for the last three decades. This means we’re out to produce a generation of researchers utterly unqualified for the job. And we’ve seen what that means already in the horrible grievance studies “disciplines.” That, combined with the death of objective testing, has compromised the universities so badly that it can hardly be overstated. And what happens in the universities eventually colours everything. As we have discovered.

All my craven colleagues must craft DIE statements to obtain a research grant. They all lie (excepting the minority of true believers) and they teach their students to do the same. And they do it constantly, with various rationalizations and justifications, further corrupting what is already a stunningly corrupt enterprise. Some of my colleagues even allow themselves to undergo so-called anti-bias training, conducted by supremely unqualified Human Resources personnel, lecturing inanely and blithely and in an accusatory manner about theoretically all-pervasive racist/sexist/heterosexist attitudes. Such training is now often a precondition to occupy a faculty position on a hiring committee.

Need I point out that implicit attitudes cannot — by the definitions generated by those who have made them a central point of our culture — be transformed by short-term explicit training? Assuming that those biases exist in the manner claimed, and that is a very weak claim, and I’m speaking scientifically here. The Implicit Association test — the much-vaunted IAT, which purports to objectively diagnose implicit bias (that’s automatic racism and the like) is by no means powerful enough — valid and reliable enough — to do what it purports to do. Two of the original designers of that test, Anthony Greenwald and Brian Nosek, have said as much, publicly. The third, Professor Mahzarin Banaji of Harvard, remains recalcitrant. Much of this can be attributed to her overtly leftist political agenda, as well as to her embeddedness within a sub-discipline of psychology, social psychology, so corrupt that it denied the existence of left-wing authoritarianism for six decades after World War II. The same social psychologists, broadly speaking, also casually regard conservatism (in the guise of “system justification”) as a form of psychopathology.

Banaji’s continued countenancing of the misuse of her research instrument, combined with the status of her position at Harvard, is a prime reason we still suffer under the DIE yoke, with its baleful effect on what was once the closest we had ever come to truly meritorious selection. There are good reasons to suppose that DIE-motivated eradication of objective testing, such as the GRE for graduate school admission, will have deleterious effects on the ability of students so selected to master such topics as the statistics all social sciences (and medicine, for that matter) rely upon completely for their validity.

Furthermore, the accrediting boards for graduate clinical psychology training programs in Canada are now planning to refuse to accredit university clinical programs unless they have a “social justice” orientation. That, combined with some recent legislative changes in Canada, claiming to outlaw so-called “conversion therapy” (but really making it exceedingly risky for clinicians to do anything ever but agree always and about everything with their clients) have likely doomed the practice of clinical psychology, which always depended entirely on trust and privacy. Similar moves are afoot in other professional disciplines, such as medicine and law. And if you don’t think that psychologists, lawyers and other professionals are anything but terrified of their now woke governing professional colleges, much to everyone’s extreme detriment, you simply don’t understand how far this has all gone.

Just exactly what am I supposed to do when I meet a graduate student or young professor, hired on DIE grounds? Manifest instant skepticism regarding their professional ability? What a slap in the face to a truly meritorious young outsider. And perhaps that’s the point. The DIE ideology is not friend to peace and tolerance. It is absolutely and completely the enemy of competence and justice.

And for those of you who think that I am overstating the case, or that this is something limited in some trivial sense to the universities, consider some other examples: This report from Hollywood, cliched hotbed of “liberal” sentiment, for example, indicates just how far this has gone. In 2020, the Academy of Motion Picture Arts and Sciences (the Oscar people) embarked on a five-year plan (does that ring any historical bells?) “to diversify our organization and expand our definition of the best,” They did so in an attempt which included developing “new representation and inclusion standards for Oscars,” to, hypothetically, “better reflect the diversity of the movie-going audience.” What fruit has this initiative, offspring of the DIE ideology, borne? According to a recent article, penned by Peter Kiefer and Peter Savodnik, but posted on former NY Times’ journalist Bari Weiss’s Common Sense website (and Weiss left the Times, because of the intrusion of radical left ideology into that newspaper, just as Tara Henley did recently, vis a vis the CBC): “We spoke to more than 25 writers, directors, and producers — all of whom identify as liberal, and all of whom described a pervasive fear of running afoul of the new dogma. … How to survive the revolution? By becoming its most ardent supporter. … Suddenly, every conversation with every agent or head of content started with: Is anyone BIPOC attached to this?”

And this is everywhere — and if you don’t see it, your head is either in the sand or shoved somewhere far more unmentionable. CBS, for example, has literally mandated that every writers’ room be at least 40 per cent BIPOC in 2021 (50 per cent in 2022).

We are now at the point where race, ethnicity, “gender,” or sexual preference is first, accepted as the fundamental characteristic defining each person (just as the radical leftists were hoping) and second, is now treated as the most important qualification for study, research and employment.

Need I point out that this is insane ? Even the benighted New York Times has its doubts. A headline from August 11, 2021: Are Workplace Diversity Programs Doing More Harm than Good? In a word, yes. How can accusing your employees of racism etc. sufficient to require re-training (particularly in relationship to those who are working in good faith to overcome whatever bias they might still, in these modern, liberal times, manifest) be anything other than insulting, annoying, invasive, high-handed, moralizing, inappropriate, ill-considered, counterproductive, and otherwise unjustifiable?

And if you think DIE is bad, wait until you get a load of Environmental, Social and Governance (ESG) scores . Purporting to assess corporate moral responsibility, these scores, which can dramatically affect an enterprise’s financial viability, are nothing less than the equivalent of China’s damnable social credit system, applied to the entrepreneurial and financial world. CEOs: what in the world is wrong with you? Can’t you see that the ideologues who push such appalling nonsense are driven by an agenda that is not only absolutely antithetical to your free-market enterprise, as such, but precisely targeted at the freedoms that made your success possible? Can’t you see that by going along, sheep-like (just as the professors are doing; just as the artists and writers are doing) that you are generating a veritable fifth column within your businesses? Are you really so blind, cowed and cowardly? With all your so-called privilege?

And it’s not just the universities. And the professional colleges. And Hollywood. And the corporate world. Diversity, Inclusivity and Equity — that radical leftist Trinity — is destroying us. Wondering about the divisiveness that is currently besetting us? Look no farther than DIE. Wondering — more specifically — about the attractiveness of Trump? Look no farther than DIE. When does the left go too far? When they worship at the altar of DIE, and insist that the rest of us, who mostly want to be left alone, do so as well. Enough already. Enough. Enough.

Finally, do you know that Vladimir Putin himself is capitalizing on this woke madness? Anna Mahjar-Barducci at MEMRI.org covered his recent speech. I quote from the article’s translation: “The advocates of so-called ‘social progress’ believe they are introducing humanity to some kind of a new and better consciousness. Godspeed, hoist the flags, as we say, go right ahead. The only thing that I want to say now is that their prescriptions are not new at all. It may come as a surprise to some people, but Russia has been there already. After the 1917 revolution, the Bolsheviks, relying on the dogmas of Marx and Engels, also said that they would change existing ways and customs, and not just political and economic ones, but the very notion of human morality and the foundations of a healthy society. The destruction of age-old values, religion, and relations between people, up to and including the total rejection of family (we had that, too), encouragement to inform on loved ones — all this was proclaimed progress and, by the way, was widely supported around the world back then and was quite fashionable, same as today. By the way, the Bolsheviks were absolutely intolerant of opinions other than theirs.

“This, I believe, should call to mind some of what we are witnessing now. Looking at what is happening in a number of Western countries, we are amazed to see the domestic practices — which we, fortunately, have left, I hope — in the distant past. The fight for equality and against discrimination has turned into aggressive dogmatism bordering on absurdity, when the works of the great authors of the past — such as Shakespeare — are no longer taught at schools or universities, because their ideas are believed to be backward. The classics are declared backward and ignorant of the importance of gender or race. In Hollywood, memos are distributed about proper storytelling and how many characters of what color or gender should be in a movie. This is even worse than the agitprop department of the Central Committee of the Communist Party of the Soviet Union.”

This, from the head of the former totalitarian enterprise, against whom we fought a five decades’ long Cold War, risking the entire planet (in a very real manner). This, from the head of a country riven in a literally genocidal manner by ideas that Putin himself attributes to the progressives in the West, to the generally accepting audience of his once-burned (once (!)) twice-shy listeners.

And all of you going along with the DIE activists, whatever your reasons: this is on you. Professors. Cowering cravenly in pretence and silence. Teaching your students to dissimulate and lie. To get along. As the walls crumble. For shame. CEOs: signalling a virtue you don’t possess and shouldn’t want to please a minority who literally live their lives by displeasure. You’re evil capitalists, after all, and should be proud of it. At the moment, I can’t tell if you’re more reprehensibly timid even than the professors. Why the hell don’t you banish the human resource DIE upstarts back to the more-appropriately-named Personnel departments, stop them from interfering with the psyches of you and your employees, and be done with it? Musicians, artists, writers: stop bending your sacred and meritorious art to the demands of the propagandists before you fatally betray the spirit of your own intuition. Stop censoring your thought. Stop saying you will hire for your orchestral and theatrical productions for any reason other than talent and excellence. That’s all you have. That’s all any of us have.

He who sows the wind will reap the whirlwind. And the wind is rising.

Much more data and elaboration at original source.

• Statistically significant improvements are seen for mortality, ventilation, ICU admission, hospitalization, recovery, cases, and viral clearance. All remain significant after exclusions. 49 studies from 45 independent teams in 21 different countries show statistically significant improvements in isolation (37 primary outcome, 34 most serious outcome).
• Meta analysis using the most serious outcome shows 66% [53‑75%] and 83% [74‑89%] improvement for early treatment and prophylaxis, with similar results after exclusion based sensitivity analysis (excluding all GMK/BBC team studies), for primary outcomes, for peer-reviewed studies, and for RCTs.
• Results are very robust — in worst case exclusion sensitivity analysis 60 of 76 studies must be excluded to avoid finding statistically significant efficacy.
• While many treatments have some level of efficacy, they do not replace vaccines and other measures to avoid infection. Only 25% of ivermectin studies show zero events in the treatment arm.
• Multiple treatments are typically used in combination, which may be significantly more effective.
• Elimination of COVID-19 is a race against viral evolution. No treatment, vaccine, or intervention is 100% available and effective for all variants. All practical, effective, and safe means should be used, including treatments, as supported by Pfizer [Pfizer, TrialSiteNews]. Denying the efficacy of treatments increases mortality, morbidity, collateral damage, and endemic risk.

...

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.

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22. Thrombotic thrombocytopenia after vaccination with ChAdOx1 nCov-19: https://www.nejm.org/doi/full/10.1056/NEJMoa2104840?query=recirc_curatedRelated_article

23. Post-mortem findings in vaccine-induced thrombotic thrombocytopenia (covid-19): https://haematologica.org/article/view/haematol.2021.279075

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25. Acute symptomatic myocarditis in seven adolescents after Pfizer-BioNTech COVID-19 vaccination: https://pediatrics.aappublications.org/content/early/2021/06/04/peds.2021-052478

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78. Pericarditis after administration of BNT162b2 mRNA COVID-19 mRNA vaccine: https://www.sciencedirect.com/science/article/pii/S1885585721002218

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88. Epidemiology and clinical features of myocarditis/pericarditis before the introduction of COVID-19 mRNA vaccine in Korean children: a multicenter study https://search.bvsalud.org/global-literature-on-novel-coronavirus-2019-ncov/resourc e/en/covidwho-1360706.

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103. Cardiac imaging of acute myocarditis after vaccination with COVID-19 mRNA: https://pubmed.ncbi.nlm.nih.gov/34402228/

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105. Myocarditis / pericarditis associated with COVID-19 vaccine: https://science.gc.ca/eic/site/063.nsf/eng/h_98291.html

106. Transient cardiac injury in adolescents receiving the BNT162b2 mRNA COVID-19 vaccine: https://journals.lww.com/pidj/Abstract/9000/Transient_Cardiac_Injury_in_Adolesce nts_Receiving.95800.aspx

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108. The new COVID-19 mRNA vaccine platform and myocarditis: clues to the possible underlying mechanism: https://pubmed.ncbi.nlm.nih.gov/34312010/

109. Acute myocardial injury after COVID-19 vaccination: a case report and review of current evidence from the Vaccine Adverse Event Reporting System database: https://pubmed.ncbi.nlm.nih.gov/34219532/

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113. Occurrence of acute infarct-like myocarditis after COVID-19 vaccination: just an accidental coincidence or rather a vaccination-associated autoimmune myocarditis?: https://pubmed.ncbi.nlm.nih.gov/34333695/

114. Recurrence of acute myocarditis temporally associated with receipt of coronavirus mRNA disease vaccine 2019 (COVID-19) in a male adolescent: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8216855/

115. Myocarditis after SARS-CoV-2 vaccination: a vaccine-induced reaction?: https://pubmed.ncbi.nlm.nih.gov/34118375/

116. Self-limited myocarditis presenting with chest pain and ST-segment elevation in adolescents after vaccination with the BNT162b2 mRNA vaccine: https://pubmed.ncbi.nlm.nih.gov/34180390/

117. Myopericarditis in a previously healthy adolescent male after COVID-19 vaccination: Case report: https://pubmed.ncbi.nlm.nih.gov/34133825/

118. Biopsy-proven lymphocytic myocarditis after first COVID-19 mRNA vaccination in a 40-year-old man: case report: https://pubmed.ncbi.nlm.nih.gov/34487236/

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123. Rhabdomyolysis and fasciitis induced by the COVID-19 mRNA vaccine: https://pubmed.ncbi.nlm.nih.gov/34435250/

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144. Late cutaneous reactions after administration of COVID-19 mRNA vaccines: https://www.sciencedirect.com/science/article/pii/S2213219821007996

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154. COVID-19 RNA-based vaccines and the risk of prion disease: https://scivisionpub.com/pdfs/covid19rna-based-vaccines-and-the-risk-of-prion-dis ease-1503.pdf

155. This study notes that 115 pregnant women lost their babies, out of 827 who participated in a study on the safety of covid-19 vaccines: https://www.nejm.org/doi/full/10.1056/NEJMoa2104983.

156. Process-related impurities in the ChAdOx1 nCov-19 vaccine: https://www.researchsquare.com/article/rs-477964/v1

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159. Allergic reactions to the first COVID-19 vaccine: a potential role of polyethylene glycol: https://pubmed.ncbi.nlm.nih.gov/33320974/

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164. Reports of anaphylaxis after receiving COVID-19 mRNA vaccines in the U.S.-Dec 14, 2020-Jan 18, 2021: https://pubmed.ncbi.nlm.nih.gov/33576785/

165. Immunization practices and risk of anaphylaxis: a current, comprehensive update of COVID-19 vaccination data: https://pubmed.ncbi.nlm.nih.gov/34269740/

166. Relationship between pre-existing allergies and anaphylactic reactions following administration of COVID-19 mRNA vaccine: https://pubmed.ncbi.nlm.nih.gov/34215453/

167. Anaphylaxis Associated with COVID-19 mRNA Vaccines: Approach to Allergy Research: https://pubmed.ncbi.nlm.nih.gov/33932618/

168. Severe Allergic Reactions after COVID-19 Vaccination with the Pfizer / BioNTech Vaccine in Great Britain and the USA: Position Statement of the German Allergy Societies: German Medical Association of Allergologists (AeDA), German Society for Allergology and Clinical Immunology (DGAKI) and Society for Pediatric Allergology and Environmental Medicine (GPA): https://pubmed.ncbi.nlm.nih.gov/33643776/

169. Allergic reactions and anaphylaxis to LNP-based COVID-19 vaccines: https://pubmed.ncbi.nlm.nih.gov/33571463/

170. Reported orofacial adverse effects from COVID-19 vaccines: the known and the unknown: https://pubmed.ncbi.nlm.nih.gov/33527524/

171. Cutaneous adverse effects of available COVID-19 vaccines: https://pubmed.ncbi.nlm.nih.gov/34518015/

172. Cumulative adverse event report of anaphylaxis following injections of COVID-19 mRNA vaccine (Pfizer-BioNTech) in Japan: the first month report: https://pubmed.ncbi.nlm.nih.gov/34347278/

173. COVID-19 vaccines increase the risk of anaphylaxis: https://pubmed.ncbi.nlm.nih.gov/33685103/

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175. Allergenic components of the mRNA-1273 vaccine for COVID-19: possible involvement of polyethylene glycol and IgG-mediated complement activation: https://pubmed.ncbi.nlm.nih.gov/33657648/

176. Polyethylene glycol (PEG) is a cause of anaphylaxis to Pfizer / BioNTech mRNA COVID-19 vaccine: https://pubmed.ncbi.nlm.nih.gov/33825239/

177. Acute allergic reactions to COVID-19 mRNA vaccines: https://pubmed.ncbi.nlm.nih.gov/33683290/

178. Polyethylene glycole allergy of the SARS CoV2 vaccine recipient: case report of a young adult recipient and management of future exposure to SARS-CoV2: https://pubmed.ncbi.nlm.nih.gov/33919151/

179. Elevated rates of anaphylaxis after vaccination with Pfizer BNT162b2 mRNA vaccine against COVID-19 in Japanese healthcare workers; a secondary analysis of initial post-approval safety data: https://pubmed.ncbi.nlm.nih.gov/34128049/

180. Allergic reactions and adverse events associated with administration of mRNA-based vaccines. A health system experience: https://pubmed.ncbi.nlm.nih.gov/34474708/

181. Allergic reactions to COVID-19 vaccines: statement of the Belgian Society of Allergy and Clinical Immunology (BelSACI): https://www.tandfonline.com/doi/abs/10.1080/17843286.2021.1909447

182. .IgE-mediated allergy to polyethylene glycol (PEG) as a cause of anaphylaxis to COVID-19 mRNA vaccines: https://pubmed.ncbi.nlm.nih.gov/34318537/

183. Allergic reactions after COVID-19 vaccination: putting the risk in perspective: https://pubmed.ncbi.nlm.nih.gov/34463751/

184. Anaphylactic reactions to COVID-19 mRNA vaccines: a call for further studies: https://pubmed.ncbi.nlm.nih.gov/33846043/ 188.

185. Risk of severe allergic reactions to COVID-19 vaccines among patients with allergic skin disease: practical recommendations. An ETFAD position statement with external experts: https://pubmed.ncbi.nlm.nih.gov/33752263/

186. COVID-19 vaccine and death: causality algorithm according to the WHO eligibility diagnosis: https://pubmed.ncbi.nlm.nih.gov/34073536/

187. Fatal brain hemorrhage after COVID-19 vaccine: https://pubmed.ncbi.nlm.nih.gov/33928772/

188. A case series of skin reactions to COVID-19 vaccine in the Department of Dermatology at Loma Linda University: https://pubmed.ncbi.nlm.nih.gov/34423106/

189. Skin reactions reported after Moderna and Pfizer’s COVID-19 vaccination: a study based on a registry of 414 cases: https://pubmed.ncbi.nlm.nih.gov/33838206/

190. Clinical and pathologic correlates of skin reactions to COVID-19 vaccine, including V-REPP: a registry-based study: https://pubmed.ncbi.nlm.nih.gov/34517079/

191. Skin reactions after vaccination against SARS-COV-2: a nationwide Spanish cross-sectional study of 405 cases: https://pubmed.ncbi.nlm.nih.gov/34254291/

192. Varicella zoster virus and herpes simplex virus reactivation after vaccination with COVID-19: review of 40 cases in an international dermatologic registry: https://pubmed.ncbi.nlm.nih.gov/34487581/

193. Immune thrombosis and thrombocytopenia (VITT) associated with the COVID-19 vaccine: diagnostic and therapeutic recommendations for a new syndrome: https://pubmed.ncbi.nlm.nih.gov/33987882/

194. Laboratory testing for suspicion of COVID-19 vaccine-induced thrombotic (immune) thrombocytopenia: https://pubmed.ncbi.nlm.nih.gov/34138513/

195. Intracerebral hemorrhage due to thrombosis with thrombocytopenia syndrome after COVID-19 vaccination: the first fatal case in Korea: https://pubmed.ncbi.nlm.nih.gov/34402235/

196. Risk of thrombocytopenia and thromboembolism after covid-19 vaccination and positive SARS-CoV-2 tests: self-controlled case series study: https://pubmed.ncbi.nlm.nih.gov/34446426/

197. Vaccine-induced immune thrombotic thrombocytopenia and cerebral venous sinus thrombosis after covid-19 vaccination; a systematic review: https://pubmed.ncbi.nlm.nih.gov/34365148/.

198. Nerve and muscle adverse events after vaccination with COVID-19: a systematic review and meta-analysis of clinical trials: https://pubmed.ncbi.nlm.nih.gov/34452064/.

199. A rare case of cerebral venous thrombosis and disseminated intravascular coagulation temporally associated with administration of COVID-19 vaccine: https://pubmed.ncbi.nlm.nih.gov/33917902/

200. Primary adrenal insufficiency associated with thrombotic immune thrombocytopenia induced by Oxford-AstraZeneca ChAdOx1 nCoV-19 vaccine (VITT): https://pubmed.ncbi.nlm.nih.gov/34256983/

201. Acute cerebral venous thrombosis and pulmonary artery embolism associated with the COVID-19 vaccine: https://pubmed.ncbi.nlm.nih.gov/34247246/.

202. Thromboaspiration infusion and fibrinolysis for portomesenteric thrombosis after administration of AstraZeneca COVID-19 vaccine: https://pubmed.ncbi.nlm.nih.gov/34132839/

203. 59-year-old woman with extensive deep venous thrombosis and pulmonary thromboembolism 7 days after a first dose of Pfizer-BioNTech BNT162b2 mRNA vaccine COVID-19: https://pubmed.ncbi.nlm.nih.gov/34117206/

204. Cerebral venous thrombosis and vaccine-induced thrombocytopenia.a. Oxford-AstraZeneca COVID-19: a missed opportunity for a rapid return on experience: https://pubmed.ncbi.nlm.nih.gov/34033927/

205. Myocarditis and other cardiovascular complications of mRNA-based COVID-19 vaccines: https://pubmed.ncbi.nlm.nih.gov/34277198/

206. Pericarditis after administration of COVID-19 mRNA BNT162b2 vaccine: https://pubmed.ncbi.nlm.nih.gov/34364831/

207. Unusual presentation of acute pericarditis after vaccination against SARS-COV-2 mRNA-1237 Modern: https://pubmed.ncbi.nlm.nih.gov/34447639/

208. Case report: acute myocarditis after second dose of SARS-CoV-2 mRNA-1273 vaccine mRNA-1273: https://pubmed.ncbi.nlm.nih.gov/34514306/

209. Immune-mediated disease outbreaks or recent-onset disease in 27 subjects after mRNA/DNA vaccination against SARS-CoV-2: https://pubmed.ncbi.nlm.nih.gov/33946748/

210. Insights from a murine model of myopericarditis induced by COVID-19 mRNA vaccine: could accidental intravenous injection of a vaccine induce myopericarditis: https://pubmed.ncbi.nlm.nih.gov/34453510/

211. Immune thrombocytopenia in a 22-year-old post Covid-19 vaccine: https://pubmed.ncbi.nlm.nih.gov/33476455/

212. propylthiouracil-induced neutrophil anti-cytoplasmic antibody-associated vasculitis after COVID-19 vaccination: https://pubmed.ncbi.nlm.nih.gov/34451967/

213. Secondary immune thrombocytopenia (ITP) associated with ChAdOx1 Covid-19 vaccine: case report: https://pubmed.ncbi.nlm.nih.gov/34377889/

214. Thrombosis with thrombocytopenia syndrome (TTS) following AstraZeneca ChAdOx1 nCoV-19 (AZD1222) COVID-19 vaccination: risk-benefit analysis for persons <60 years in Australia: https://pubmed.ncbi.nlm.nih.gov/34272095/

215. COVID-19 vaccination association and facial nerve palsy: A case-control study: https://pubmed.ncbi.nlm.nih.gov/34165512/

216. The association between COVID-19 vaccination and Bell’s palsy: https://pubmed.ncbi.nlm.nih.gov/34411533/

217. Bell’s palsy after COVID-19 vaccination: https://pubmed.ncbi.nlm.nih.gov/33611630/

218. Acute transverse myelitis (ATM): clinical review of 43 patients with COVID-19-associated ATM and 3 serious adverse events of post-vaccination ATM with ChAdOx1 nCoV-19 vaccine (AZD1222): https://pubmed.ncbi.nlm.nih.gov/33981305/

219. Bell’s palsy after 24 hours of mRNA-1273 SARS-CoV-2 mRNA-1273 vaccine: https://pubmed.ncbi.nlm.nih.gov/34336436/

220. Sequential contralateral facial nerve palsy after first and second doses of COVID-19 vaccine: https://pubmed.ncbi.nlm.nih.gov/34281950/.

221. Transverse myelitis induced by SARS-CoV-2 vaccination: https://pubmed.ncbi.nlm.nih.gov/34458035/

222. Peripheral facial nerve palsy after vaccination with BNT162b2 (COVID-19): https://pubmed.ncbi.nlm.nih.gov/33734623/

223. Acute abducens nerve palsy after COVID-19 vaccination: https://pubmed.ncbi.nlm.nih.gov/34044114/.

224. Facial nerve palsy after administration of COVID-19 mRNA vaccines: analysis of self-report database: https://pubmed.ncbi.nlm.nih.gov/34492394/

225. Transient oculomotor paralysis after administration of RNA-1273 messenger vaccine for SARS-CoV-2 diplopia after COVID-19 vaccine: https://pubmed.ncbi.nlm.nih.gov/34369471/

226. Bell’s palsy after Ad26.COV2.S COVID-19 vaccination: https://pubmed.ncbi.nlm.nih.gov/34014316/

227. Bell’s palsy after COVID-19 vaccination: case report: https://pubmed.ncbi.nlm.nih.gov/34330676/

228. A case of acute demyelinating polyradiculoneuropathy with bilateral facial palsy following ChAdOx1 nCoV-19 vaccination: https://pubmed.ncbi.nlm.nih.gov/34272622/

229. Guillian Barré syndrome after vaccination with mRNA-1273 against COVID-19: https://pubmed.ncbi.nlm.nih.gov/34477091/

230. Acute facial paralysis as a possible complication of SARS-CoV-2 vaccination: https://pubmed.ncbi.nlm.nih.gov/33975372/.

231. Bell’s palsy after COVID-19 vaccination with high antibody response in CSF: https://pubmed.ncbi.nlm.nih.gov/34322761/.

232. Parsonage-Turner syndrome associated with SARS-CoV-2 or SARS-CoV-2 vaccination. Comment on: “Neuralgic amyotrophy and COVID-19 infection: 2 cases of accessory spinal nerve palsy” by Coll et al. Articular Spine 2021; 88: 10519: https://pubmed.ncbi.nlm.nih.gov/34139321/.

233. Bell’s palsy after a single dose of vaccine mRNA. SARS-CoV-2: case report: https://pubmed.ncbi.nlm.nih.gov/34032902/.

234. Autoimmune hepatitis developing after coronavirus disease vaccine 2019 (COVID-19): causality or victim?: https://pubmed.ncbi.nlm.nih.gov/33862041/

235. Autoimmune hepatitis triggered by vaccination against SARS-CoV-2: https://pubmed.ncbi.nlm.nih.gov/34332438/

236. Acute autoimmune-like hepatitis with atypical antimitochondrial antibody after vaccination with COVID-19 mRNA: a new clinical entity: https://pubmed.ncbi.nlm.nih.gov/34293683/.

237. Autoimmune hepatitis after COVID vaccine: https://pubmed.ncbi.nlm.nih.gov/34225251/

238. A novel case of bifacial diplegia variant of Guillain-Barré syndrome after vaccination with Janssen COVID-19: https://pubmed.ncbi.nlm.nih.gov/34449715/

239. Comparison of vaccine-induced thrombotic events between ChAdOx1 nCoV-19 and Ad26.COV.2.S vaccines: https://pubmed.ncbi.nlm.nih.gov/34139631/.

240. Bilateral superior ophthalmic vein thrombosis, ischemic stroke and immune thrombocytopenia after vaccination with ChAdOx1 nCoV-19: https://pubmed.ncbi.nlm.nih.gov/33864750/

241. Diagnosis and treatment of cerebral venous sinus thrombosis with vaccine-induced immune-immune thrombotic thrombocytopenia: https://pubmed.ncbi.nlm.nih.gov/33914590/

242. Venous sinus thrombosis after vaccination with ChAdOx1 nCov-19: https://pubmed.ncbi.nlm.nih.gov/34420802/

243. Cerebral venous sinus thrombosis following vaccination against SARS-CoV-2: an analysis of cases reported to the European Medicines Agency: https://pubmed.ncbi.nlm.nih.gov/34293217/

244. Risk of thrombocytopenia and thromboembolism after covid-19 vaccination and positive SARS-CoV-2 tests: self-controlled case series study: https://pubmed.ncbi.nlm.nih.gov/34446426/

245. Blood clots and bleeding after BNT162b2 and ChAdOx1 nCoV-19 vaccination: an analysis of European data: https://pubmed.ncbi.nlm.nih.gov/34174723/

246. Arterial events, venous thromboembolism, thrombocytopenia and bleeding after vaccination with Oxford-AstraZeneca ChAdOx1-S in Denmark and Norway: population-based cohort study: https://pubmed.ncbi.nlm.nih.gov/33952445/

247. First dose of ChAdOx1 and BNT162b2 COVID-19 vaccines and thrombocytopenic, thromboembolic and hemorrhagic events in Scotland: https://pubmed.ncbi.nlm.nih.gov/34108714/

248. Cerebral venous thrombosis associated with COVID-19 vaccine in Germany: https://pubmed.ncbi.nlm.nih.gov/34288044/

249. Malignant cerebral infarction after vaccination with ChAdOx1 nCov-19: a catastrophic variant of vaccine-induced immune-mediated thrombotic thrombocytopenia: https://pubmed.ncbi.nlm.nih.gov/34341358/

250. celiac artery and splenic artery thrombosis complicated by splenic infarction 7 days after the first dose of Oxford vaccine, causal relationship or coincidence: https://pubmed.ncbi.nlm.nih.gov/34261633/.

251. Primary adrenal insufficiency associated with Oxford-AstraZeneca ChAdOx1 nCoV-19 (VITT) vaccine-induced immune thrombotic thrombocytopenia: https://pubmed.ncbi.nlm.nih.gov/34256983/

252. Thrombocytopenia after COVID-19 vaccination: https://pubmed.ncbi.nlm.nih.gov/34332437/.

253. Cerebral venous sinus thrombosis associated with thrombocytopenia after COVID-19 vaccination: https://pubmed.ncbi.nlm.nih.gov/33845870/.

254. Thrombosis with thrombocytopenia syndrome after COVID-19 immunization: https://pubmed.ncbi.nlm.nih.gov/34236343/

255. Acute myocardial infarction within 24 hours after COVID-19 vaccination: https://pubmed.ncbi.nlm.nih.gov/34364657/.

256. Bilateral acute macular neuroretinopathy after SARS-CoV-2 vaccination: https://pubmed.ncbi.nlm.nih.gov/34287612/

257. central venous sinus thrombosis with subarachnoid hemorrhage after COVID-19 mRNA vaccination: are these reports merely coincidental: https://pubmed.ncbi.nlm.nih.gov/34478433/

258. Intracerebral hemorrhage due to thrombosis with thrombocytopenia syndrome after COVID-19 vaccination: the first fatal case in Korea: https://pubmed.ncbi.nlm.nih.gov/34402235/

259. Cerebral venous sinus thrombosis negative for anti-PF4 antibody without thrombocytopenia after immunization with COVID-19 vaccine in a non-comorbid elderly Indian male treated with conventional heparin-warfarin-based anticoagulation: https://pubmed.ncbi.nlm.nih.gov/34186376/

260. Cerebral venous sinus thrombosis 2 weeks after first dose of SARS-CoV-2 mRNA vaccine: https://pubmed.ncbi.nlm.nih.gov/34101024/

261. A case of multiple thrombocytopenia and thrombosis following vaccination with ChAdOx1 nCoV-19 against SARS-CoV-2: https://pubmed.ncbi.nlm.nih.gov/34137813/

262. Vaccine-induced thrombotic thrombocytopenia: the elusive link between thrombosis and adenovirus-based SARS-CoV-2 vaccines: https://pubmed.ncbi.nlm.nih.gov/34191218/

263. Acute ischemic stroke revealing immune thrombotic thrombocytopenia induced by ChAdOx1 nCov-19 vaccine: impact on recanalization strategy: https://pubmed.ncbi.nlm.nih.gov/34175640/

264. New-onset refractory status epilepticus after ChAdOx1 nCoV-19 vaccine: https://pubmed.ncbi.nlm.nih.gov/34153802/

265. Thrombosis with thrombocytopenia syndrome associated with COVID-19 viral vector vaccines: https://pubmed.ncbi.nlm.nih.gov/34092488/

266. Pulmonary embolism, transient ischemic attack, and thrombocytopenia after Johnson & Johnson COVID-19 vaccine: https://pubmed.ncbi.nlm.nih.gov/34261635/

267. Thromboaspiration infusion and fibrinolysis for portomesenteric thrombosis after administration of the AstraZeneca COVID-19 vaccine: https://pubmed.ncbi.nlm.nih.gov/34132839/.

268. Spontaneous HIT syndrome: knee replacement, infection, and parallels with vaccine-induced immune thrombotic thrombocytopenia: https://pubmed.ncbi.nlm.nih.gov/34144250/

269. Deep venous thrombosis (DVT) occurring shortly after second dose of SARS-CoV-2 mRNA vaccine: https://pubmed.ncbi.nlm.nih.gov/33687691/

270. Procoagulant antibody-mediated procoagulant platelets in immune thrombotic thrombocytopenia associated with SARS-CoV-2 vaccination: https://pubmed.ncbi.nlm.nih.gov/34011137/.

271. Vaccine-induced immune thrombotic thrombocytopenia causing a severe form of cerebral venous thrombosis with high mortality rate: a case series: https://pubmed.ncbi.nlm.nih.gov/34393988/.

272. Procoagulant microparticles: a possible link between vaccine-induced immune thrombocytopenia (VITT) and cerebral sinus venous thrombosis: https://pubmed.ncbi.nlm.nih.gov/34129181/.

273. Atypical thrombosis associated with the vaccine VaxZevria® (AstraZeneca): data from the French network of regional pharmacovigilance centers: https://pubmed.ncbi.nlm.nih.gov/34083026/.

274. Acute cerebral venous thrombosis and pulmonary artery embolism associated with the COVID-19 vaccine: https://pubmed.ncbi.nlm.nih.gov/34247246/.

275. Vaccine-induced thrombosis and thrombocytopenia with bilateral adrenal haemorrhage: https://pubmed.ncbi.nlm.nih.gov/34235757/.

276. Palmar digital vein thrombosis after Oxford-AstraZeneca COVID-19 vaccination: https://pubmed.ncbi.nlm.nih.gov/34473841/.

277. Cutaneous thrombosis associated with cutaneous necrosis following Oxford-AstraZeneca COVID-19 vaccination: https://pubmed.ncbi.nlm.nih.gov/34189756/

278. Cerebral venous thrombosis following COVID-19 vaccination: https://pubmed.ncbi.nlm.nih.gov/34045111/.

279. Lipschütz ulcers after AstraZeneca COVID-19 vaccination: https://pubmed.ncbi.nlm.nih.gov/34366434/.

280. Amyotrophic Neuralgia secondary to Vaxzevri vaccine (AstraZeneca) COVID-19: https://pubmed.ncbi.nlm.nih.gov/34330677/

281. Thrombosis with thrombocytopenia after Messenger vaccine RNA-1273: https://pubmed.ncbi.nlm.nih.gov/34181446/

282. Intracerebral hemorrhage twelve days after vaccination with ChAdOx1 nCoV-19: https://pubmed.ncbi.nlm.nih.gov/34477089/

283. Thrombotic thrombocytopenia after vaccination with COVID-19: in search of the underlying mechanism: https://pubmed.ncbi.nlm.nih.gov/34071883/

284. Coronavirus (COVID-19) Vaccine-induced immune thrombotic thrombocytopenia (VITT): https://pubmed.ncbi.nlm.nih.gov/34033367/

285. Comparison of adverse drug reactions among four COVID-19 vaccines in Europe using the EudraVigilance database: Thrombosis in unusual sites: https://pubmed.ncbi.nlm.nih.gov/34375510/

286. Immunoglobulin adjuvant for vaccine-induced immune thrombotic thrombocytopenia: https://pubmed.ncbi.nlm.nih.gov/34107198/

287. Severe vaccine-induced thrombotic thrombocytopenia following vaccination with COVID-19: an autopsy case report and review of the literature: https://pubmed.ncbi.nlm.nih.gov/34355379/.

288. A case of acute pulmonary embolism after immunization with SARS-CoV-2 mRNA: https://pubmed.ncbi.nlm.nih.gov/34452028/

289. Neurosurgical considerations regarding decompressive craniectomy for intracerebral hemorrhage after SARS-CoV-2 vaccination in vaccine-induced thrombotic thrombocytopenia-VITT: https://pubmed.ncbi.nlm.nih.gov/34202817/

290. Thrombosis and SARS-CoV-2 vaccines: vaccine-induced immune thrombotic thrombocytopenia: https://pubmed.ncbi.nlm.nih.gov/34237213/.

291. Acquired thrombotic thrombocytopenic thrombocytopenic purpura: a rare disease associated with the BNT162b2 vaccine: https://pubmed.ncbi.nlm.nih.gov/34105247/.

292. Immune complexes, innate immunity and NETosis in ChAdOx1 vaccine-induced thrombocytopenia: https://pubmed.ncbi.nlm.nih.gov/34405870/.

293. Sensory Guillain-Barré syndrome following ChAdOx1 nCov-19 vaccine: report of two cases and review of the literature: https://pubmed.ncbi.nlm.nih.gov/34416410/.

294. Vogt-Koyanagi-Harada syndrome after COVID-19 and ChAdOx1 nCoV-19 (AZD1222) vaccination: https://pubmed.ncbi.nlm.nih.gov/34462013/.

295. Reactivation of Vogt-Koyanagi-Harada disease under control for more than 6 years, after anti-SARS-CoV-2 vaccination: https://pubmed.ncbi.nlm.nih.gov/34224024/.

296. Post-vaccinal encephalitis after ChAdOx1 nCov-19: https://pubmed.ncbi.nlm.nih.gov/34324214/

297. Neurological symptoms and neuroimaging alterations related to COVID-19 vaccine: cause or coincidence?: https://pubmed.ncbi.nlm.nih.gov/34507266/

298. Fatal systemic capillary leak syndrome after SARS-COV-2 vaccination in a patient with multiple myeloma: https://pubmed.ncbi.nlm.nih.gov/34459725/

299. Polyarthralgia and myalgia syndrome after vaccination with ChAdOx1 nCOV-19: https://pubmed.ncbi.nlm.nih.gov/34463066/

300. Three cases of subacute thyroiditis after SARS-CoV-2 vaccination: post-vaccination ASIA syndrome: https://pubmed.ncbi.nlm.nih.gov/34043800/.

301. Facial diplegia: a rare and atypical variant of Guillain-Barré syndrome and the Ad26.COV2.S vaccine: https://pubmed.ncbi.nlm.nih.gov/34447646/

302. Association between ChAdOx1 nCoV-19 vaccination and bleeding episodes: large population-based cohort study: https://pubmed.ncbi.nlm.nih.gov/34479760/.

303. fulminant myocarditis and systemic hyperinflammation temporally associated with BNT162b2 COVID-19 mRNA vaccination in two patients: https://pubmed.ncbi.nlm.nih.gov/34416319/.

304. Adverse effects reported after COVID-19 vaccination in a tertiary care hospital, centered on cerebral venous sinus thrombosis (CVST): https://pubmed.ncbi.nlm.nih.gov/34092166/

305. Induction and exacerbation of subacute cutaneous lupus erythematosus erythematosus after mRNA- or adenoviral vector-based SARS-CoV-2 vaccination: https://pubmed.ncbi.nlm.nih.gov/34291477/

306. Petechiae and peeling of fingers after immunization with BTN162b2 messenger RNA (mRNA)-based COVID-19 vaccine: https://pubmed.ncbi.nlm.nih.gov/34513435/

307. Hepatitis C virus reactivation after COVID-19 vaccination: a case report: https://pubmed.ncbi.nlm.nih.gov/34512037/

308. Bilateral immune-mediated keratolysis after immunization with SARS-CoV-2 recombinant viral vector vaccine: https://pubmed.ncbi.nlm.nih.gov/34483273/.

309. Immune-mediated thrombocytopenic purpura after Pfizer-BioNTech COVID-19 vaccine in an elderly woman: https://pubmed.ncbi.nlm.nih.gov/34513446/

310. Platelet activation and modulation in thrombosis with thrombocytopenia syndrome associated with the ChAdO × 1 nCov-19 vaccine: https://pubmed.ncbi.nlm.nih.gov/34474550/

311. Reactive arthritis after COVID-19 vaccination: https://pubmed.ncbi.nlm.nih.gov/34033732/.

312. Two cases of Graves’ disease after SARS-CoV-2 vaccination: an autoimmune / inflammatory syndrome induced by adjuvants: https://pubmed.ncbi.nlm.nih.gov/33858208/

313. Acute relapse and impaired immunization after COVID-19 vaccination in a patient with multiple sclerosis treated with rituximab: https://pubmed.ncbi.nlm.nih.gov/34015240/

314. Widespread fixed bullous drug eruption after vaccination with ChAdOx1 nCoV-19: https://pubmed.ncbi.nlm.nih.gov/34482558/

315. COVID-19 mRNA vaccine causing CNS inflammation: a case series: https://pubmed.ncbi.nlm.nih.gov/34480607/

316. Thymic hyperplasia after Covid-19 mRNA-based vaccination with Covid-19: https://pubmed.ncbi.nlm.nih.gov/34462647/

317. Acute disseminated encephalomyelitis following vaccination against SARS-CoV-2: https://pubmed.ncbi.nlm.nih.gov/34325334/

318. Tolosa-Hunt syndrome occurring after COVID-19 vaccination: https://pubmed.ncbi.nlm.nih.gov/34513398/

319. Systemic capillary extravasation syndrome following vaccination with ChAdOx1 nCOV-19 (Oxford-AstraZeneca): https://pubmed.ncbi.nlm.nih.gov/34362727/

320. Immune-mediated thrombocytopenia associated with Ad26.COV2.S vaccine (Janssen; Johnson & Johnson): https://pubmed.ncbi.nlm.nih.gov/34469919/.

321. Transient thrombocytopenia with glycoprotein-specific platelet autoantibodies after vaccination with Ad26.COV2.S: case report: https://pubmed.ncbi.nlm.nih.gov/34516272/.

322. Acute hyperactive encephalopathy following COVID-19 vaccination with dramatic response to methylprednisolone: case report: https://pubmed.ncbi.nlm.nih.gov/34512961/

323. Transient cardiac injury in adolescents receiving the BNT162b2 mRNA COVID-19 vaccine: https://pubmed.ncbi.nlm.nih.gov/34077949/

324. Autoimmune hepatitis developing after ChAdOx1 nCoV-19 vaccine (Oxford-AstraZeneca): https://pubmed.ncbi.nlm.nih.gov/34171435/

325. Severe relapse of multiple sclerosis after COVID-19 vaccination: a case report: https://pubmed.ncbi.nlm.nih.gov/34447349/

326. Lymphohistocytic myocarditis after vaccination with the COVID-19 viral vector Ad26.COV2.S: https://pubmed.ncbi.nlm.nih.gov/34514078/

327. Hemophagocytic lymphohistiocytosis after vaccination with ChAdOx1 nCov-19: https://pubmed.ncbi.nlm.nih.gov/34406660/.

328. IgA vasculitis in adult patient after vaccination with ChadOx1 nCoV-19: https://pubmed.ncbi.nlm.nih.gov/34509658/

329. A case of leukocytoclastic vasculitis after vaccination with a SARS-CoV2 vaccine: case report: https://pubmed.ncbi.nlm.nih.gov/34196469/.

330. Onset / outbreak of psoriasis after Corona virus ChAdOx1 nCoV-19 vaccine (Oxford-AstraZeneca / Covishield): report of two cases: https://pubmed.ncbi.nlm.nih.gov/34350668/

331. Hailey-Hailey disease exacerbation after SARS-CoV-2 vaccination: https://pubmed.ncbi.nlm.nih.gov/34436620/

332. Supraclavicular lymphadenopathy after COVID-19 vaccination in Korea: serial follow-up by ultrasonography: https://pubmed.ncbi.nlm.nih.gov/34116295/.

333. COVID-19 vaccine, immune thrombotic thrombocytopenia, jaundice, hyperviscosity: concern in cases with underlying hepatic problems: https://pubmed.ncbi.nlm.nih.gov/34509271/.

334. Report of the International Cerebral Venous Thrombosis Consortium on cerebral venous thrombosis after SARS-CoV-2 vaccination: https://pubmed.ncbi.nlm.nih.gov/34462996/

335. Immune thrombocytopenia after vaccination during the COVID-19 pandemic: https://pubmed.ncbi.nlm.nih.gov/34435486/

336. COVID-19: lessons from the Norwegian tragedy should be taken into account in planning for vaccine launch in less developed/developing countries: https://pubmed.ncbi.nlm.nih.gov/34435142/

337. Rituximab-induced acute lympholysis and pancytopenia following vaccination with COVID-19: https://pubmed.ncbi.nlm.nih.gov/34429981/

338. Exacerbation of plaque psoriasis after COVID-19 inactivated mRNA and BNT162b2 vaccines: report of two cases: https://pubmed.ncbi.nlm.nih.gov/34427024/

339. Vaccine-induced interstitial lung disease: a rare reaction to COVID-19 vaccine: https://pubmed.ncbi.nlm.nih.gov/34510014/.

340. Vesiculobullous cutaneous reactions induced by COVID-19 mRNA vaccine: report of four cases and review of the literature: https://pubmed.ncbi.nlm.nih.gov/34236711/

341. Vaccine-induced thrombocytopenia with severe headache: https://pubmed.ncbi.nlm.nih.gov/34525282/

342. Acute perimyocarditis after the first dose of COVID-19 mRNA vaccine: https://pubmed.ncbi.nlm.nih.gov/34515024/

343. Rhabdomyolysis and fasciitis induced by COVID-19 mRNA vaccine: https://pubmed.ncbi.nlm.nih.gov/34435250/.

344. Rare cutaneous adverse effects of COVID-19 vaccines: a case series and review of the literature: https://pubmed.ncbi.nlm.nih.gov/34363637/

345. Immune thrombocytopenia associated with the Pfizer-BioNTech COVID-19 mRNA vaccine BNT162b2: https://www.sciencedirect.com/science/article/pii/S2214250921002018

346. Secondary immune thrombocytopenia putatively attributable to COVID-19 vaccination: https://casereports.bmj.com/content/14/5/e242220.abstract.

347. Immune thrombocytopenia following Pfizer-BioNTech BNT162b2 mRNA COVID-19 vaccine: https://pubmed.ncbi.nlm.nih.gov/34155844/

348. Newly diagnosed idiopathic thrombocytopenia after COVID-19 vaccine administration: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8176657/.

349. Idiopathic thrombocytopenic purpura and the Modern Covid-19 vaccine: https://www.annemergmed.com/article/S0196-0644(21)00122-0/fulltext.

350. Thrombocytopenia after Pfizer and Moderna SARS vaccination – CoV -2: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8014568/.

351. Immune thrombocytopenic purpura and acute liver injury after COVID-19 vaccination: https://casereports.bmj.com/content/14/7/e242678.

352. Collection of complement-mediated and autoimmune-mediated hematologic conditions after SARS-CoV-2 vaccination: https://ashpublications.org/bloodadvances/article/5/13/2794/476324/Autoimmune-and-complement-mediated-hematologic

353. Petechial rash associated with CoronaVac vaccination: first report of cutaneous side effects before phase 3 results: https://ejhp.bmj.com/content/early/2021/05/23/ejhpharm-2021-002794

354. COVID-19 vaccines induce severe hemolysis in paroxysmal nocturnal hemoglobinuria: https://ashpublications.org/blood/article/137/26/3670/475905/COVID-19-vaccines-induce-severe-hemolysis-in

355. Cerebral venous thrombosis associated with COVID-19 vaccine in Germany: https://pubmed.ncbi.nlm.nih.gov/34288044/.

356. Cerebral venous sinus thrombosis after COVID-19 vaccination : Neurological and radiological management: https://pubmed.ncbi.nlm.nih.gov/34327553/.

357. Cerebral venous thrombosis and thrombocytopenia after COVID-19 vaccination: https://pubmed.ncbi.nlm.nih.gov/33878469/.

358. Cerebral venous sinus thrombosis and thrombocytopenia after COVID-19 vaccination: report of two cases in the United Kingdom: https://pubmed.ncbi.nlm.nih.gov/33857630/.

359. Cerebral venous thrombosis induced by SARS-CoV-2 vaccine: https://pubmed.ncbi.nlm.nih.gov/34090750/.

360. Carotid artery immune thrombosis induced by adenovirus-vectored COVID-19 vaccine: case report: https://pubmed.ncbi.nlm.nih.gov/34312301/.

361. Cerebral venous sinus thrombosis associated with vaccine-induced thrombotic thrombocytopenia: https://pubmed.ncbi.nlm.nih.gov/34333995/

362. The roles of platelets in COVID-19-associated coagulopathy and vaccine-induced immune-immune thrombotic thrombocytopenia: https://pubmed.ncbi.nlm.nih.gov/34455073/

363. Cerebral venous thrombosis after the BNT162b2 mRNA SARS-CoV-2 vaccine: https://pubmed.ncbi.nlm.nih.gov/34111775/.

364. Cerebral venous thrombosis after COVID-19 vaccination: https://pubmed.ncbi.nlm.nih.gov/34045111/

365. Lethal cerebral venous sinus thrombosis after COVID-19 vaccination: https://pubmed.ncbi.nlm.nih.gov/33983464/

366. Cerebral venous sinus thrombosis in the U.S. population, After SARS-CoV-2 vaccination with adenovirus and after COVID-19: https://pubmed.ncbi.nlm.nih.gov/34116145/

367. Cerebral venous thrombosis after COVID-19 vaccination: is the risk of thrombosis increased by intravascular administration of the vaccine: https://pubmed.ncbi.nlm.nih.gov/34286453/.

368. Central venous sinus thrombosis with subarachnoid hemorrhage after COVID-19 mRNA vaccination: are these reports merely coincidental: https://pubmed.ncbi.nlm.nih.gov/34478433/

369. Cerebral venous sinus thrombosis after ChAdOx1 nCov-19 vaccination with a misleading first brain MRI: https://pubmed.ncbi.nlm.nih.gov/34244448/

370. Early results of bivalirudin treatment for thrombotic thrombocytopenia and cerebral venous sinus thrombosis after vaccination with Ad26.COV2.S: https://pubmed.ncbi.nlm.nih.gov/34226070/

371. Cerebral venous sinus thrombosis associated with post-vaccination thrombocytopenia by COVID-19: https://pubmed.ncbi.nlm.nih.gov/33845870/.

372. Cerebral venous sinus thrombosis 2 weeks after the first dose of SARS-CoV-2 mRNA vaccine: https://pubmed.ncbi.nlm.nih.gov/34101024/.

373. Vaccine-induced immune thrombotic thrombocytopenia causing a severe form of cerebral venous thrombosis with a high mortality rate: a case series: https://pubmed.ncbi.nlm.nih.gov/34393988/.

374. Adenovirus interactions with platelets and coagulation and vaccine-associated autoimmune thrombocytopenia thrombosis syndrome: https://pubmed.ncbi.nlm.nih.gov/34407607/.

375. Headache attributed to COVID-19 (SARS-CoV-2 coronavirus) vaccination with the ChAdOx1 nCoV-19 (AZD1222) vaccine: a multicenter observational cohort study: https://pubmed.ncbi.nlm.nih.gov/34313952/

376. Adverse effects reported after COVID-19 vaccination in a tertiary care hospital, focus on cerebral venous sinus thrombosis (CVST): https://pubmed.ncbi.nlm.nih.gov/34092166/

377. Cerebral venous sinus thrombosis following vaccination against SARS-CoV-2: an analysis of cases reported to the European Medicines Agency: https://pubmed.ncbi.nlm.nih.gov/34293217/

378. A rare case of a middle-age Asian male with cerebral venous thrombosis after COVID-19 AstraZeneca vaccination: https://pubmed.ncbi.nlm.nih.gov/34274191/

379. Cerebral venous sinus thrombosis negative for anti-PF4 antibody without thrombocytopenia after immunization with COVID-19 vaccine in a non-comorbid elderly Indian male treated with conventional heparin-warfarin-based anticoagulation: https://pubmed.ncbi.nlm.nih.gov/34186376/

380. Arterial events, venous thromboembolism, thrombocytopenia and bleeding after vaccination with Oxford-AstraZeneca ChAdOx1-S in Denmark and Norway: population-based cohort study: https://pubmed.ncbi.nlm.nih.gov/33952445/

381. Procoagulant microparticles: a possible link between vaccine-induced immune thrombocytopenia (VITT) and cerebral sinus venous thrombosis: https://pubmed.ncbi.nlm.nih.gov/34129181/

382. S. case reports of cerebral venous sinus thrombosis with thrombocytopenia after vaccination with Ad26.COV2.S, March 2-April 21, 2021: https://pubmed.ncbi.nlm.nih.gov/33929487/.

383. Malignant cerebral infarction after vaccination with ChAdOx1 nCov-19: a catastrophic variant of vaccine-induced immune-mediated thrombotic thrombocytopenia: https://pubmed.ncbi.nlm.nih.gov/34341358/

384. Acute ischemic stroke revealing immune thrombotic thrombocytopenia induced by ChAdOx1 nCov-19 vaccine: impact on recanalization strategy: https://pubmed.ncbi.nlm.nih.gov/34175640/

385. Vaccine-induced immune thrombotic immune thrombocytopenia (VITT): a new clinicopathologic entity with heterogeneous clinical presentations: https://pubmed.ncbi.nlm.nih.gov/34159588/.

386. Imaging and hematologic findings in thrombosis and thrombocytopenia after vaccination with ChAdOx1 nCoV-19 (AstraZeneca): https://pubmed.ncbi.nlm.nih.gov/34402666/

387. Autoimmunity roots of thrombotic events after vaccination with COVID-19: https://pubmed.ncbi.nlm.nih.gov/34508917/

388. Cerebral venous sinus thrombosis after vaccination: the UK experience: https://pubmed.ncbi.nlm.nih.gov/34370974/

389. Massive cerebral venous thrombosis and venous basin infarction as late complications of COVID-19: a case report: https://pubmed.ncbi.nlm.nih.gov/34373991/

390. Australian and New Zealand approach to the diagnosis and treatment of vaccine-induced immune thrombosis and immune thrombocytopenia: https://pubmed.ncbi.nlm.nih.gov/34490632/

391. An observational study to identify the prevalence of thrombocytopenia and anti-PF4 / polyanion antibodies in Norwegian health care workers after COVID-19 vaccination: https://pubmed.ncbi.nlm.nih.gov/33909350/

392. Acute transverse myelitis (ATM): clinical review of 43 patients with COVID-19-associated ATM and 3 serious adverse events of post-vaccination ATM with ChAdOx1 nCoV-19 (AZD1222) vaccine: https://pubmed.ncbi.nlm.nih.gov/33981305/.

393. A case of acute demyelinating polyradiculoneuropathy with bilateral facial palsy after ChAdOx1 nCoV-19 vaccine:. https://pubmed.ncbi.nlm.nih.gov/34272622/

394. Thrombocytopenia with acute ischemic stroke and hemorrhage in a patient recently vaccinated with an adenoviral vector-based COVID-19 vaccine:. https://pubmed.ncbi.nlm.nih.gov/33877737/

395. Predicted and observed incidence of thromboembolic events among Koreans vaccinated with the ChAdOx1 nCoV-19 vaccine: https://pubmed.ncbi.nlm.nih.gov/34254476/

396. First dose of ChAdOx1 and BNT162b2 COVID-19 vaccines and thrombocytopenic, thromboembolic, and hemorrhagic events in Scotland: https://pubmed.ncbi.nlm.nih.gov/34108714/

397. ChAdOx1 nCoV-19 vaccine-associated thrombocytopenia: three cases of immune thrombocytopenia after 107,720 doses of ChAdOx1 vaccination in Thailand: https://pubmed.ncbi.nlm.nih.gov/34483267/.

398. Pulmonary embolism, transient ischemic attack, and thrombocytopenia after Johnson & Johnson COVID-19 vaccine: https://pubmed.ncbi.nlm.nih.gov/34261635/

399. Neurosurgical considerations with respect to decompressive craniectomy for intracerebral hemorrhage after SARS-CoV-2 vaccination in vaccine-induced thrombotic thrombocytopenia-VITT: https://pubmed.ncbi.nlm.nih.gov/34202817/

400. Large hemorrhagic stroke after vaccination against ChAdOx1 nCoV-19: a case report: https://pubmed.ncbi.nlm.nih.gov/34273119/

401. Polyarthralgia and myalgia syndrome after vaccination with ChAdOx1 nCOV-19: https://pubmed.ncbi.nlm.nih.gov/34463066/

402. A rare case of thrombosis and thrombocytopenia of the superior ophthalmic vein after ChAdOx1 nCoV-19 vaccination against SARS-CoV-2: https://pubmed.ncbi.nlm.nih.gov/34276917/

403. Thrombosis and severe acute respiratory syndrome Coronavirus 2 vaccines: vaccine-induced immune thrombotic thrombocytopenia: https://pubmed.ncbi.nlm.nih.gov/34237213/.

404. Renal vein thrombosis and pulmonary embolism secondary to vaccine-induced thrombotic immune thrombocytopenia (VITT): https://pubmed.ncbi.nlm.nih.gov/34268278/.

405. Limb ischemia and pulmonary artery thrombosis after ChAdOx1 nCoV-19 vaccine (Oxford-AstraZeneca): a case of vaccine-induced immune thrombotic thrombocytopenia: https://pubmed.ncbi.nlm.nih.gov/33990339/.

406. Association between ChAdOx1 nCoV-19 vaccination and bleeding episodes: large population-based cohort study: https://pubmed.ncbi.nlm.nih.gov/34479760/.

407. Secondary thrombocytopenia after SARS-CoV-2 vaccination: case report of haemorrhage and hematoma after minor oral surgery: https://pubmed.ncbi.nlm.nih.gov/34314875/.

408. Venous thromboembolism and mild thrombocytopenia after vaccination with ChAdOx1 nCoV-19: https://pubmed.ncbi.nlm.nih.gov/34384129/

409. Fatal exacerbation of ChadOx1-nCoV-19-induced thrombotic thrombocytopenia syndrome after successful initial therapy with intravenous immunoglobulins: a rationale for monitoring immunoglobulin G levels: https://pubmed.ncbi.nlm.nih.gov/34382387/

410. A case of ANCA-associated vasculitis after AZD1222 (Oxford-AstraZeneca) SARS-CoV-2 vaccination: victim or causality?: https://pubmed.ncbi.nlm.nih.gov/34416184/.

411. Intracerebral hemorrhage associated with vaccine-induced thrombotic thrombocytopenia after ChAdOx1 nCOVID-19 vaccination in a pregnant woman: https://pubmed.ncbi.nlm.nih.gov/34261297/

412. Massive cerebral venous thrombosis due to vaccine-induced immune thrombotic thrombocytopenia: https://pubmed.ncbi.nlm.nih.gov/34261296/

413. Nephrotic syndrome after ChAdOx1 nCoV-19 vaccine against SARScoV-2: https://pubmed.ncbi.nlm.nih.gov/34250318/.

414. A case of vaccine-induced immune-immune thrombotic thrombocytopenia with massive arteriovenous thrombosis: https://pubmed.ncbi.nlm.nih.gov/34059191/

415. Cutaneous thrombosis associated with cutaneous necrosis following Oxford-AstraZeneca COVID-19 vaccination: https://pubmed.ncbi.nlm.nih.gov/34189756/

416. Thrombocytopenia in an adolescent with sickle cell anemia after COVID-19 vaccination: https://pubmed.ncbi.nlm.nih.gov/34331506/

417. Vaccine-induced thrombocytopenia with severe headache: https://pubmed.ncbi.nlm.nih.gov/34525282/

418. Myocarditis associated with SARS-CoV-2 mRNA vaccination in children aged 12 to 17 years: stratified analysis of a national database: https://www.medrxiv.org/content/10.1101/2021.08.30.21262866v1

419. COVID-19 mRNA vaccination and development of CMR-confirmed myopericarditis: https://www.medrxiv.org/content/10.1101/2021.09.13.21262182v1.full?s=09.

420. Severe autoimmune hemolytic anemia after receipt of SARS-CoV-2 mRNA vaccine: https://onlinelibrary.wiley.com/doi/10.1111/trf.16672

421. Intravenous injection of coronavirus disease 2019 (COVID-19) mRNA vaccine can induce acute myopericarditis in a mouse model: https://t.co/j0IEM8cMXI

422. A report of myocarditis adverse events in the U.S. Vaccine Adverse Event Reporting System. (VAERS) in association with COVID-19 injectable biologics: https://pubmed.ncbi.nlm.nih.gov/34601006/

423. This study concludes that: “The vaccine was associated with an excess risk of myocarditis (1 to 5 events per 100,000 persons). The risk of this potentially serious adverse event and of many other serious adverse events increased substantially after SARS-CoV-2 infection”: https://www.nejm.org/doi/full/10.1056/NEJMoa2110475

424. Bilateral uveitis after inoculation with COVID-19 vaccine: a case report: https://www.sciencedirect.com/science/article/pii/S1201971221007797

425. Myocarditis associated with SARS-CoV-2 mRNA vaccination in children aged 12 to 17 years: stratified analysis of a national database: https://www.medrxiv.org/content/10.1101/2021.08.30.21262866v1.

426. Immune-mediated hepatitis with the Moderna vaccine is no longer a coincidence but confirmed: https://www.sciencedirect.com/science/article/pii/S0168827821020936

427. Extensive investigations revealed consistent pathophysiologic alterations after vaccination with COVID-19 vaccines: https://www.nature.com/articles/s41421-021-00329-3

428. Lobar hemorrhage with ventricular rupture shortly after the first dose of an mRNA-based SARS-CoV-2 vaccine: https://www.ncbi.nlm.nih.gov/labs/pmc/articles/PMC8553377/

429. Mrna COVID vaccines dramatically increase endothelial inflammatory markers and risk of Acute Coronary Syndrome as measured by PULS cardiac testing: a caution: https://www.ahajournals.org/doi/10.1161/circ.144.suppl_1.10712

430. ChAdOx1 interacts with CAR and PF4 with implications for thrombosis with thrombocytopenia syndrome:https://www.science.org/doi/10.1126/sciadv.abl8213

431. Lethal vaccine-induced immune thrombotic immune thrombocytopenia (VITT) following announcement 26.COV2.S: first documented case outside the U.S.: https://pubmed.ncbi.nlm.nih.gov/34626338/

432. A prothrombotic thrombocytopenic disorder resembling heparin-induced thrombocytopenia after coronavirus-19 vaccination: https://europepmc.org/article/PPR/PPR304469 435.

433. VITT (vaccine-induced immune thrombotic thrombocytopenia) after vaccination with ChAdOx1 nCoV-19: https://pubmed.ncbi.nlm.nih.gov/34731555/

434. Vaccine-induced immune thrombotic thrombocytopenia (VITT): a new clinicopathologic entity with heterogeneous clinical presentations: https://pubmed.ncbi.nlm.nih.gov/34159588/

435. Treatment of acute ischemic stroke associated with ChAdOx1 nCoV-19 vaccine-induced immune thrombotic thrombocytopenia: https://pubmed.ncbi.nlm.nih.gov/34461442/

436. Spectrum of neurological complications after COVID-19 vaccination: https://pubmed.ncbi.nlm.nih.gov/34719776/.

437. Cerebral venous sinus thrombosis after vaccination: the UK experience: https://pubmed.ncbi.nlm.nih.gov/34370974/

438. Cerebral venous vein/venous sinus thrombosis with thrombocytopenia syndrome after COVID-19 vaccination: https://pubmed.ncbi.nlm.nih.gov/34373413/

439. Portal vein thrombosis due to vaccine-induced immune thrombotic immune thrombocytopenia (VITT) after Covid vaccination with ChAdOx1 nCoV-19: https://pubmed.ncbi.nlm.nih.gov/34598301/

440. Hematuria, a generalized petechial rash and headaches after Oxford AstraZeneca ChAdOx1 nCoV-19 vaccination: https://pubmed.ncbi.nlm.nih.gov/34620638/

441. Myocardial infarction and azygos vein thrombosis after vaccination with ChAdOx1 nCoV-19 in a hemodialysis patient: https://pubmed.ncbi.nlm.nih.gov/34650896/

442. Takotsubo (stress) cardiomyopathy after vaccination with ChAdOx1 nCoV-19: https://pubmed.ncbi.nlm.nih.gov/34625447/

443. Humoral response induced by Prime-Boost vaccination with ChAdOx1 nCoV-19 and BNT162b2 mRNA vaccines in a patient with multiple sclerosis treated with teriflunomide: https://pubmed.ncbi.nlm.nih.gov/34696248/

444. Guillain-Barré syndrome after ChAdOx1 nCoV-19 COVID-19 vaccination: a case series: https://pubmed.ncbi.nlm.nih.gov/34548920/

445. Refractory vaccine-induced immune thrombotic thrombocytopenia (VITT) treated with delayed therapeutic plasma exchange (TPE): https://pubmed.ncbi.nlm.nih.gov/34672380/.

446. Rare case of COVID-19 vaccine-associated intracranial hemorrhage with venous sinus thrombosis: https://pubmed.ncbi.nlm.nih.gov/34556531/.

447. Delayed headache after COVID-19 vaccination: a warning sign for vaccine-induced cerebral venous thrombosis: https://pubmed.ncbi.nlm.nih.gov/34535076/.

448. Clinical features of vaccine-induced thrombocytopenia and immune thrombosis: https://pubmed.ncbi.nlm.nih.gov/34379914/.

449. Predictors of mortality in thrombotic thrombocytopenia after adenoviral COVID-19 vaccination: the FAPIC score: https://pubmed.ncbi.nlm.nih.gov/34545400/

450. Ischemic stroke as a presenting feature of immune thrombotic thrombocytopenia induced by ChAdOx1-nCoV-19 vaccination: https://pubmed.ncbi.nlm.nih.gov/34035134/

451. In-hospital observational study of neurological disorders in patients recently vaccinated with COVID-19 mRNA vaccines: https://pubmed.ncbi.nlm.nih.gov/34688190/

452. Endovascular treatment for vaccine-induced cerebral venous sinus thrombosis and thrombocytopenia after vaccination with ChAdOx1 nCoV-19: report of three cases: https://pubmed.ncbi.nlm.nih.gov/34782400/

453. Cardiovascular, neurological, and pulmonary events after vaccination with BNT162b2, ChAdOx1 nCoV-19, and Ad26.COV2.S vaccines: an analysis of European data: https://pubmed.ncbi.nlm.nih.gov/34710832/

454. Cerebral venous thrombosis developing after vaccination. COVID-19: VITT, VATT, TTS and more: https://pubmed.ncbi.nlm.nih.gov/34695859/

455. Cerebral venous thrombosis and myeloproliferative neoplasms: a three-center study of 74 consecutive cases: https://pubmed.ncbi.nlm.nih.gov/34453762/.

456. Possible triggers of thrombocytopenia and/or hemorrhage by BNT162b2 vaccine, Pfizer-BioNTech: https://pubmed.ncbi.nlm.nih.gov/34660652/.

457. Multiple sites of arterial thrombosis in a 35-year-old patient after vaccination with ChAdOx1 (AstraZeneca), which required emergency femoral and carotid surgical thrombectomy: https://pubmed.ncbi.nlm.nih.gov/34644642/

458. Case series of vaccine-induced thrombotic thrombocytopenia in a London teaching hospital: https://pubmed.ncbi.nlm.nih.gov/34694650/

459. Neuro-ophthalmic complications with thrombocytopenia and thrombosis induced by ChAdOx1 nCoV-19 vaccine: https://pubmed.ncbi.nlm.nih.gov/34726934/

460. Thrombotic events after COVID-19 vaccination in over 50 years of age: results of a population-based study in Italy: https://pubmed.ncbi.nlm.nih.gov/34835237/

461. Intracerebral hemorrhage associated with vaccine-induced thrombotic thrombocytopenia after ChAdOx1 nCOVID-19 vaccination in a pregnant woman: https://pubmed.ncbi.nlm.nih.gov/34261297/

462. Age- and sex-specific incidence of cerebral venous sinus thrombosis associated with Ad26.COV2.S COVID-19 vaccination: https://pubmed.ncbi.nlm.nih.gov/34724036/.

463. Genital necrosis with cutaneous thrombosis following vaccination with COVID-19 mRNA: https://pubmed.ncbi.nlm.nih.gov/34839563/

464. Cerebral venous sinus thrombosis after mRNA-based COVID-19 vaccination: https://pubmed.ncbi.nlm.nih.gov/34783932/.

465. COVID-19 vaccine-induced immune thrombosis with thrombocytopenia thrombosis (VITT) and shades of gray in thrombus formation: https://pubmed.ncbi.nlm.nih.gov/34624910/

466. Inflammatory myositis after vaccination with ChAdOx1: https://pubmed.ncbi.nlm.nih.gov/34585145/

467. Acute ST-segment elevation myocardial infarction secondary to vaccine-induced immune thrombosis with thrombocytopenia (VITT): https://pubmed.ncbi.nlm.nih.gov/34580132/.

468. A rare case of COVID-19 vaccine-induced thrombotic thrombocytopenia (VITT) affecting the venosplanchnic and pulmonary arterial circulation from a UK district general hospital: https://pubmed.ncbi.nlm.nih.gov/34535492/

469. COVID-19 vaccine-induced thrombotic thrombocytopenia: a case series: https://pubmed.ncbi.nlm.nih.gov/34527501/

470. Thrombosis with thrombocytopenia syndrome (TTS) after vaccination with AstraZeneca ChAdOx1 nCoV-19 (AZD1222) COVID-19: a risk-benefit analysis for persons <60% risk-benefit analysis for people <60 years in Australia: https://pubmed.ncbi.nlm.nih.gov/34272095/

471. Immune thrombocytopenia after immunization with Vaxzevria ChadOx1-S vaccine (AstraZeneca), Victoria, Australia: https://pubmed.ncbi.nlm.nih.gov/34756770/

472. Characteristics and outcomes of patients with cerebral venous sinus thrombosis in thrombotic immune thrombocytopenia induced by SARS-CoV-2 vaccine: https://jamanetwork.com/journals/jamaneurology/fullarticle/2784622

473. Case study of thrombosis and thrombocytopenia syndrome after administration of the AstraZeneca COVID-19 vaccine: https://pubmed.ncbi.nlm.nih.gov/34781321/

474. Thrombosis with Thrombocytopenia Syndrome Associated with COVID-19 Vaccines: https://pubmed.ncbi.nlm.nih.gov/34062319/

475. Cerebral venous sinus thrombosis following vaccination with ChAdOx1: the first case of definite thrombosis with thrombocytopenia syndrome in India: https://pubmed.ncbi.nlm.nih.gov/34706921/

476. COVID-19 vaccine-associated thrombosis with thrombocytopenia syndrome (TTS): systematic review and post hoc analysis: https://pubmed.ncbi.nlm.nih.gov/34698582/.

477. Case report of immune thrombocytopenia after vaccination with ChAdOx1 nCoV-19: https://pubmed.ncbi.nlm.nih.gov/34751013/.

478. Acute transverse myelitis after COVID-19 vaccination: https://pubmed.ncbi.nlm.nih.gov/34684047/.

479. Concerns for adverse effects of thrombocytopenia and thrombosis after adenovirus-vectored COVID-19 vaccination: https://pubmed.ncbi.nlm.nih.gov/34541935/

480. Major hemorrhagic stroke after ChAdOx1 nCoV-19 vaccination: a case report: https://pubmed.ncbi.nlm.nih.gov/34273119/

481. Cerebral venous sinus thrombosis after COVID-19 vaccination: neurologic and radiologic management: https://pubmed.ncbi.nlm.nih.gov/34327553/.

482. Thrombocytopenia with acute ischemic stroke and hemorrhage in a patient recently vaccinated with an adenoviral vector-based COVID-19 vaccine: https://pubmed.ncbi.nlm.nih.gov/33877737/

483. Intracerebral hemorrhage and thrombocytopenia after AstraZeneca COVID-19 vaccine: clinical and diagnostic challenges of vaccine-induced thrombotic thrombocytopenia: https://pubmed.ncbi.nlm.nih.gov/34646685/

484. Minimal change disease with severe acute kidney injury after Oxford-AstraZeneca COVID-19 vaccine: case report: https://pubmed.ncbi.nlm.nih.gov/34242687/.

485. Case report: cerebral sinus vein thrombosis in two patients with AstraZeneca SARS-CoV-2 vaccine: https://pubmed.ncbi.nlm.nih.gov/34609603/

486. Case report: Pityriasis rosea-like rash after vaccination with COVID-19: https://pubmed.ncbi.nlm.nih.gov/34557507/

487. Extensive longitudinal transverse myelitis after ChAdOx1 nCOV-19 vaccine: case report: https://pubmed.ncbi.nlm.nih.gov/34641797/.

488. Acute eosinophilic pneumonia associated with anti-COVID-19 vaccine AZD1222: https://pubmed.ncbi.nlm.nih.gov/34812326/.

489. Thrombocytopenia, including immune thrombocytopenia after receiving COVID-19 mRNA vaccines reported to the Vaccine Adverse Event Reporting System (VAERS): https://pubmed.ncbi.nlm.nih.gov/34006408/

490. A case of ANCA-associated vasculitis after AZD1222 (Oxford-AstraZeneca) SARS-CoV-2 vaccination: victim or causality?: https://pubmed.ncbi.nlm.nih.gov/34416184/

491. Vaccine-induced immune thrombosis and thrombocytopenia syndrome after adenovirus-vectored severe acute respiratory syndrome coronavirus 2 vaccination: a new hypothesis on mechanisms and implications for future vaccine development: https://pubmed.ncbi.nlm.nih.gov/34664303/.

492. Thrombosis in peripheral artery disease and thrombotic thrombocytopenia following adenoviral COVID-19 vaccination: https://pubmed.ncbi.nlm.nih.gov/34649281/.

493. Newly diagnosed immune thrombocytopenia in a pregnant patient after coronavirus disease 2019 vaccination: https://pubmed.ncbi.nlm.nih.gov/34420249/

494. Cerebral venous sinus thrombosis and thrombotic events after vector-based COVID-19 vaccines: systematic review and meta-analysis: https://pubmed.ncbi.nlm.nih.gov/34610990/.

495. Sweet’s syndrome after Oxford-AstraZeneca COVID-19 vaccine (AZD1222) in an elderly woman: https://pubmed.ncbi.nlm.nih.gov/34590397/

496. Sudden sensorineural hearing loss after COVID-19 vaccination: https://pubmed.ncbi.nlm.nih.gov/34670143/.

497. Prevalence of serious adverse events among health care professionals after receiving the first dose of ChAdOx1 nCoV-19 coronavirus vaccine (Covishield) in Togo, March 2021: https://pubmed.ncbi.nlm.nih.gov/34819146/.

498. Acute hemichorea-hemibalismus after COVID-19 (AZD1222) vaccination: https://pubmed.ncbi.nlm.nih.gov/34581453/

499. Recurrence of alopecia areata after covid-19 vaccination: a report of three cases in Italy: https://pubmed.ncbi.nlm.nih.gov/34741583/

500. Shingles-like skin lesion after vaccination with AstraZeneca for COVID-19: a case report: https://pubmed.ncbi.nlm.nih.gov/34631069/

501. Thrombosis after COVID-19 vaccination: possible link to ACE pathways: https://pubmed.ncbi.nlm.nih.gov/34479129/

502. Thrombocytopenia in an adolescent with sickle cell anemia after COVID-19 vaccination: https://pubmed.ncbi.nlm.nih.gov/34331506/

503. Leukocytoclastic vasculitis as a cutaneous manifestation of ChAdOx1 corona virus vaccine nCoV-19 (recombinant): https://pubmed.ncbi.nlm.nih.gov/34546608/

504. Abdominal pain and bilateral adrenal hemorrhage from immune thrombotic thrombocytopenia induced by COVID-19 vaccine: https://pubmed.ncbi.nlm.nih.gov/34546343/

505. Longitudinally extensive cervical myelitis after vaccination with inactivated virus based COVID-19 vaccine: https://pubmed.ncbi.nlm.nih.gov/34849183/

506. Induction of cutaneous leukocytoclastic vasculitis after ChAdOx1 nCoV-19 vaccine: https://pubmed.ncbi.nlm.nih.gov/34853744/.

507. A case of toxic epidermal necrolysis after vaccination with ChAdOx1 nCoV-19 (AZD1222): https://pubmed.ncbi.nlm.nih.gov/34751429/.

508. Ocular adverse events following COVID-19 vaccination: https://pubmed.ncbi.nlm.nih.gov/34559576/

509. Depression after ChAdOx1-S / nCoV-19 vaccination: https://pubmed.ncbi.nlm.nih.gov/34608345/.

510. Venous thromboembolism and mild thrombocytopenia after ChAdOx1 nCoV-19 vaccination: https://pubmed.ncbi.nlm.nih.gov/34384129/.

511. Recurrent ANCA-associated vasculitis after Oxford AstraZeneca ChAdOx1-S COVID-19 vaccination: a case series of two patients: https://pubmed.ncbi.nlm.nih.gov/34755433/

512. Major artery thrombosis and vaccination against ChAdOx1 nCov-19: https://pubmed.ncbi.nlm.nih.gov/34839830/

513. Rare case of contralateral supraclavicular lymphadenopathy after vaccination with COVID-19: computed tomography and ultrasound findings: https://pubmed.ncbi.nlm.nih.gov/34667486/

514. Cutaneous lymphocytic vasculitis after administration of the second dose of AZD1222 (Oxford-AstraZeneca) Severe acute respiratory syndrome Coronavirus 2 vaccine: chance or causality: https://pubmed.ncbi.nlm.nih.gov/34726187/.

515. Pancreas allograft rejection after ChAdOx1 nCoV-19 vaccine: https://pubmed.ncbi.nlm.nih.gov/34781027/

516. Understanding the risk of thrombosis with thrombocytopenia syndrome following Ad26.COV2.S vaccination: https://pubmed.ncbi.nlm.nih.gov/34595694/

517. Cutaneous adverse reactions of 35,229 doses of COVID-19 Sinovac and AstraZeneca vaccine COVID-19: a prospective cohort study in health care workers: https://pubmed.ncbi.nlm.nih.gov/34661934/

518. Comments on thrombosis after vaccination: spike protein leader sequence could be responsible for thrombosis and antibody-mediated thrombocytopenia: https://pubmed.ncbi.nlm.nih.gov/34788138

519. Eosinophilic dermatosis after AstraZeneca COVID-19 vaccination: https://pubmed.ncbi.nlm.nih.gov/34753210/.

520. Severe immune thrombocytopenia following COVID-19 vaccination: report of four cases and review of the literature: https://pubmed.ncbi.nlm.nih.gov/34653943/.

521. Relapse of immune thrombocytopenia after COVID-19 vaccination: https://pubmed.ncbi.nlm.nih.gov/34591991/

522. Thrombosis in pre- and post-vaccination phase of COVID-19; https://pubmed.ncbi.nlm.nih.gov/34650382/

523. A look at the role of postmortem immunohistochemistry in understanding the inflammatory pathophysiology of COVID-19 disease and vaccine-related thrombotic adverse events: a narrative review: https://pubmed.ncbi.nlm.nih.gov/34769454/

524. COVID-19 vaccine in patients with hypercoagulability disorders: a clinical perspective: https://pubmed.ncbi.nlm.nih.gov/34786893/

525. Vaccine-associated thrombocytopenia and thrombosis: venous endotheliopathy leading to combined venous micro-macrothrombosis: https://pubmed.ncbi.nlm.nih.gov/34833382/

526. Thrombosis and thrombocytopenia syndrome causing isolated symptomatic carotid occlusion after COVID-19 Ad26.COV2.S vaccine (Janssen): https://pubmed.ncbi.nlm.nih.gov/34670287/

527. An unusual presentation of acute deep vein thrombosis after Modern COVID-19 vaccine: case report: https://pubmed.ncbi.nlm.nih.gov/34790811/

528. Immediate high-dose intravenous immunoglobulins followed by direct treatment with thrombin inhibitors is crucial for survival in vaccine-induced immune thrombotic thrombocytopenia Sars-Covid-19-vector adenoviral VITT with venous thrombosis of the cerebral sinus and portal vein: https://pubmed.ncbi.nlm.nih.gov/34023956/.

529. Thrombosis formation after COVID-19 vaccination immunologic aspects: review article: https://pubmed.ncbi.nlm.nih.gov/34629931/

530. Imaging and hematologic findings in thrombosis and thrombocytopenia after vaccination with ChAdOx1 nCoV-19 (AstraZeneca): https://pubmed.ncbi.nlm.nih.gov/34402666/

531. Spectrum of neuroimaging findings in post-CoVID-19 vaccination: a case series and review of the literature: https://pubmed.ncbi.nlm.nih.gov/34842783/

532. Cerebral venous sinus thrombosis, pulmonary embolism, and thrombocytopenia after COVID-19 vaccination in a Taiwanese man: a case report and review of the literature: https://pubmed.ncbi.nlm.nih.gov/34630307/

533. Fatal cerebral venous sinus thrombosis after COVID-19 vaccination: https://pubmed.ncbi.nlm.nih.gov/33983464/

534. Autoimmune roots of thrombotic events after COVID-19 vaccination: https://pubmed.ncbi.nlm.nih.gov/34508917/.

535. New portal vein thrombosis in cirrhosis: is thrombophilia exacerbated by vaccine or COVID-19: https://www.jcehepatology.com/article/S0973-6883(21)00545-4/fulltext.

536. Images of immune thrombotic thrombocytopenia induced by Oxford / AstraZeneca® COVID-19 vaccine: https://pubmed.ncbi.nlm.nih.gov/33962903/.

537. Cerebral venous sinus thrombosis after vaccination with COVID-19 mRNA of BNT162b2: https://pubmed.ncbi.nlm.nih.gov/34796065/.

538. Increased risk of urticaria/angioedema after BNT162b2 mRNA COVID-19 vaccination in health care workers taking ACE inhibitors: https://pubmed.ncbi.nlm.nih.gov/34579248/

539. A case of unusual mild clinical presentation of COVID-19 vaccine-induced immune thrombotic thrombocytopenia with splanchnic vein thrombosis: https://pubmed.ncbi.nlm.nih.gov/34843991/

540. Cerebral venous sinus thrombosis following vaccination with Pfizer-BioNTech COVID-19 (BNT162b2): https://pubmed.ncbi.nlm.nih.gov/34595867/

541. A case of idiopathic thrombocytopenic purpura after a booster dose of COVID-19 BNT162b2 vaccine (Pfizer-Biontech): https://pubmed.ncbi.nlm.nih.gov/34820240/

542. Vaccine-induced immune thrombotic immune thrombocytopenia (VITT): targeting pathologic mechanisms with Bruton’s tyrosine kinase inhibitors: https://pubmed.ncbi.nlm.nih.gov/33851389/

543. Thrombotic thrombocytopenic purpura after vaccination with Ad26.COV2-S: https://pubmed.ncbi.nlm.nih.gov/33980419/

544. Thromboembolic events in younger females exposed to Pfizer-BioNTech or Moderna COVID-19 vaccines: https://pubmed.ncbi.nlm.nih.gov/34264151/

545. Potential risk of thrombotic events after COVID-19 vaccination with Oxford-AstraZeneca in women receiving estrogen: https://pubmed.ncbi.nlm.nih.gov/34734086/

546. Thrombosis after adenovirus-vectored COVID-19 vaccination: a concern for underlying disease: https://pubmed.ncbi.nlm.nih.gov/34755555/

547. Adenovirus interactions with platelets and coagulation and vaccine-induced immune thrombotic thrombocytopenia syndrome: https://pubmed.ncbi.nlm.nih.gov/34407607/

548. Thrombotic thrombocytopenic purpura: a new threat after COVID bnt162b2 vaccine: https://pubmed.ncbi.nlm.nih.gov/34264514/.

549. Unusual site of deep vein thrombosis after vaccination against coronavirus mRNA-2019 coronavirus disease (COVID-19): https://pubmed.ncbi.nlm.nih.gov/34840204/

550. Neurological side effects of SARS-CoV-2 vaccines: https://pubmed.ncbi.nlm.nih.gov/34750810/

551. Coagulopathies after SARS-CoV-2 vaccination may derive from a combined effect of SARS-CoV-2 spike protein and adenovirus vector-activated signaling pathways: https://pubmed.ncbi.nlm.nih.gov/34639132/

552. Isolated pulmonary embolism after COVID vaccination: 2 case reports and a review of acute pulmonary embolism complications and follow-up: https://pubmed.ncbi.nlm.nih.gov/34804412/

553. Central retinal vein occlusion after vaccination with SARS-CoV-2 mRNA: case report: https://pubmed.ncbi.nlm.nih.gov/34571653/.

554. Complicated case report of long-term vaccine-induced thrombotic immune thrombocytopenia A: https://pubmed.ncbi.nlm.nih.gov/34835275/.

555. Deep venous thrombosis after vaccination with Ad26.COV2.S in adult males: https://pubmed.ncbi.nlm.nih.gov/34659839/.

556. Neurological autoimmune diseases after SARS-CoV-2 vaccination: a case series: https://pubmed.ncbi.nlm.nih.gov/34668274/.

557. Severe autoimmune hemolytic autoimmune anemia after receiving SARS-CoV-2 mRNA vaccine: https://pubmed.ncbi.nlm.nih.gov/34549821/

558. Occurrence of COVID-19 variants among recipients of ChAdOx1 nCoV-19 vaccine (recombinant): https://pubmed.ncbi.nlm.nih.gov/34528522/

559. Prevalence of thrombocytopenia, anti-platelet factor 4 antibodies, and elevated D-dimer in Thais after vaccination with ChAdOx1 nCoV-19: https://pubmed.ncbi.nlm.nih.gov/34568726/

560. Epidemiology of acute myocarditis/pericarditis in Hong Kong adolescents after co-vaccination: https://academic.oup.com/cid/advance-article-abstract/doi/10.1093/cid/ciab989/644 5179.

561. Myocarditis after 2019 coronavirus disease mRNA vaccine: a case series and determination of incidence rate: https://academic.oup.com/cid/advance-article/doi/10.1093/cid/ciab926/6420408

562. Myocarditis and pericarditis after COVID-19 vaccination: inequalities in age and vaccine types: https://www.mdpi.com/2075-4426/11/11/1106

563. Epidemiology and clinical features of myocarditis/pericarditis before the introduction of COVID-19 mRNA vaccine in Korean children: a multicenter study: https://pubmed.ncbi.nlm.nih.gov/34402230/

564. Shedding light on post-vaccination myocarditis and pericarditis in COVID-19 and non-COVID-19 vaccine recipients: https://pubmed.ncbi.nlm.nih.gov/34696294/

565. Myocarditis Following mRNA COVID-19 Vaccine: https://journals.lww.com/pec-online/Abstract/2021/11000/Myocarditis_Following_ mRNA_COVID_19_Vaccine.9.aspx.

566. Myocarditis following BNT162b2 mRNA Covid-19 mRNA vaccine in Israel: https://pubmed.ncbi.nlm.nih.gov/34614328/.

567. Myocarditis, pericarditis, and cardiomyopathy following COVID-19 vaccination: https://www.heartlungcirc.org/article/S1443-9506(21)01156-2/fulltext

568. Myocarditis and other cardiovascular complications of COVID-19 mRNA-based COVID-19 vaccines: https://pubmed.ncbi.nlm.nih.gov/34277198/

569. Possible Association Between COVID-19 Vaccine and Myocarditis: Clinical and CMR Findings: https://pubmed.ncbi.nlm.nih.gov/34246586/

570. Hypersensitivity Myocarditis and COVID-19 Vaccines: https://pubmed.ncbi.nlm.nih.gov/34856634/.

571. Severe myocarditis associated with COVID-19 vaccine: zebra or unicorn?: https://www.internationaljournalofcardiology.com/article/S0167-5273(21)01477-7/fulltext.

572. Acute myocardial infarction and myocarditis after COVID-19 vaccination: https://www.ncbi.nlm.nih.gov/labs/pmc/articles/PMC8522388/

573. Myocarditis after Covid-19 vaccination in a large healthcare organization: https://www.nejm.org/doi/10.1056/NEJMoa2110737

574. Association of myocarditis with COVID-19 messenger RNA BNT162b2 vaccine in a case series of children: https://jamanetwork.com/journals/jamacardiology/fullarticle/2783052

575. Clinical suspicion of myocarditis temporally related to COVID-19 vaccination in adolescents and young adults: https://www.ahajournals.org/doi/abs/10.1161/CIRCULATIONAHA.121.056583?url_ver=Z39.88-2003&rfr_id=ori:rid:crossref.org&rfr_dat=cr_pub%20%200pubmed

576. STEMI mimicry: focal myocarditis in an adolescent patient after COVID-19 mRNA vaccination:. https://pubmed.ncbi.nlm.nih.gov/34756746/

577. Myocarditis and pericarditis in association with COVID-19 mRNA vaccination: cases from a regional pharmacovigilance center: https://www.ncbi.nlm.nih.gov/labs/pmc/articles/PMC8587334/

578. Myocarditis after COVID-19 mRNA vaccines: https://pubmed.ncbi.nlm.nih.gov/34546329/.

579. Patients with acute myocarditis after COVID-19 mRNA vaccination:. https://jamanetwork.com/journals/jamacardiology/fullarticle/2781602.

580. Myocarditis after COVID-19 vaccination: a case series: https://www.sciencedirect.com/science/article/pii/S0264410X21011725?via%3Dihub.

581. Myocarditis associated with COVID-19 vaccination in adolescents: https://publications.aap.org/pediatrics/article/148/5/e2021053427/181357

582. Myocarditis findings on cardiac magnetic resonance imaging after vaccination with COVID-19 mRNA in adolescents:. https://pubmed.ncbi.nlm.nih.gov/34704459/

583. Myocarditis after COVID-19 vaccination: magnetic resonance imaging study: https://academic.oup.com/ehjcimaging/advance-article/doi/10.1093/ehjci/jeab230/6 421640.

584. Acute myocarditis after administration of the second dose of BNT162b2 COVID-19 vaccine: https://www.ncbi.nlm.nih.gov/labs/pmc/articles/PMC8599115/

585. Myocarditis after COVID-19 vaccination: https://www.sciencedirect.com/science/article/pii/S2352906721001603

586. Case report: probable myocarditis after Covid-19 mRNA vaccine in a patient with arrhythmogenic left ventricular cardiomyopathy: https://pubmed.ncbi.nlm.nih.gov/34712717/.

587. Acute myocarditis after administration of BNT162b2 vaccine against COVID-19: https://www.revespcardiol.org/en-linkresolver-acute-myocarditis-after-administration-bnt162b2-S188558572100133X.

588. Myocarditis associated with COVID-19 mRNA vaccination: https://pubs.rsna.org/doi/10.1148/radiol.2021211430

589. Acute myocarditis after COVID-19 vaccination: a case report: https://www.sciencedirect.com/science/article/pii/S0248866321007098

590. Acute myopericarditis after COVID-19 vaccination in adolescents:. https://pubmed.ncbi.nlm.nih.gov/34589238/.

591. Perimyocarditis in adolescents after Pfizer-BioNTech COVID-19 vaccination: https://academic.oup.com/jpids/article/10/10/962/6329543.

592. Acute myocarditis associated with anti-COVID-19 vaccination: https://ecevr.org/DOIx.php?id=10.7774/cevr.2021.10.2.196.

593. Myocarditis associated with COVID-19 vaccination: echocardiographic, cardiac CT, and MRI findings:. https://pubmed.ncbi.nlm.nih.gov/34428917/.

594. Acute symptomatic myocarditis in 7 adolescents after Pfizer-BioNTech COVID-19 vaccination:. https://pubmed.ncbi.nlm.nih.gov/34088762/.

595. Myocarditis and pericarditis in adolescents after first and second doses of COVID-19 mRNA vaccines:. https://academic.oup.com/ehjqcco/advance-article/doi/10.1093/ehjqcco/qcab090/64 42104.

596. COVID 19 vaccine for adolescents. Concern for myocarditis and pericarditis: https://www.mdpi.com/2036-7503/13/3/61.

597. Cardiac imaging of acute myocarditis after vaccination with COVID-19 mRNA: https://pubmed.ncbi.nlm.nih.gov/34402228/

598. Myocarditis temporally associated with COVID-19 vaccination: https://pubmed.ncbi.nlm.nih.gov/34133885/

599. Acute myocardial injury after COVID-19 vaccination: a case report and review of current evidence from the vaccine adverse event reporting system database: https://pubmed.ncbi.nlm.nih.gov/34219532/

600. Acute myocarditis associated with COVID-19 vaccination: report of a case: https://www.ncbi.nlm.nih.gov/labs/pmc/articles/PMC8639400/

601. Myocarditis following vaccination with COVID-19 messenger RNA: a Japanese case series: https://pubmed.ncbi.nlm.nih.gov/34840235/.

602. Myocarditis in the setting of a recent COVID-19 vaccination: https://pubmed.ncbi.nlm.nih.gov/34712497/.

603. Acute myocarditis after a second dose of COVID-19 mRNA vaccine: report of two cases: https://www.clinicalimaging.org/article/S0899-7071(21)00265-5/fulltext.

604. Prevalence of thrombocytopenia, antiplatelet factor 4 antibodies, and elevated D-dimer in Thais after vaccination with ChAdOx1 nCoV-19: https://pubmed.ncbi.nlm.nih.gov/34568726/

605. Epidemiology of acute myocarditis/pericarditis in Hong Kong adolescents after co-vaccination: https://academic.oup.com/cid/advance-article-abstract/doi/10.1093/cid/ciab989/6445179

606. Myocarditis after 2019 coronavirus disease mRNA vaccine: a case series and incidence rate determination: https://academic.oup.com/cid/advance-article/doi/10.1093/cid/ciab926/6420408.

607. Myocarditis and pericarditis after COVID-19 vaccination: inequalities in age and vaccine types: https://www.mdpi.com/2075-4426/11/11/1106

608. Epidemiology and clinical features of myocarditis/pericarditis before the introduction of COVID-19 mRNA vaccine in Korean children: a multicenter study: https://pubmed.ncbi.nlm.nih.gov/34402230/

609. Shedding light on post-vaccination myocarditis and pericarditis in COVID-19 and non-COVID-19 vaccine recipients: https://pubmed.ncbi.nlm.nih.gov/34696294/

610. Diffuse prothrombotic syndrome after administration of ChAdOx1 nCoV-19 vaccine: case report: https://pubmed.ncbi.nlm.nih.gov/34615534/

611. Three cases of acute venous thromboembolism in women after coronavirus 2019 vaccination: https://pubmed.ncbi.nlm.nih.gov/34352418/

612. Clinical and biological features of cerebral venous sinus thrombosis after vaccination with ChAdOx1 nCov-19; https://jnnp.bmj.com/content/early/2021/09/29/jnnp-2021-327340.

613. COV2-S vaccination may reveal hereditary thrombophilia: massive cerebral venous sinus thrombosis in a young man with normal platelet count: https://pubmed.ncbi.nlm.nih.gov/34632750/

614. Post-mortem findings in vaccine-induced thrombotic thrombocytopenia: https://haematologica.org/article/view/haematol.2021.279075

615. COVID-19 vaccine-induced thrombosis: https://pubmed.ncbi.nlm.nih.gov/34802488/.

616. Inflammation and platelet activation after COVID-19 vaccines: possible mechanisms behind vaccine-induced immune thrombocytopenia and thrombosis: https://pubmed.ncbi.nlm.nih.gov/34887867/.

617. Anaphylactoid reaction and coronary thrombosis related to COVID-19 mRNA vaccine: https://pubmed.ncbi.nlm.nih.gov/34863404/.

618. Vaccine-induced cerebral venous thrombosis and thrombocytopenia. Oxford-AstraZeneca COVID-19: a missed opportunity for rapid return on experience: https://www.sciencedirect.com/science/article/pii/S235255682100093X

619. Occurrence of splenic infarction due to arterial thrombosis after vaccination with COVID-19: https://pubmed.ncbi.nlm.nih.gov/34876440/

620. Deep venous thrombosis more than two weeks after COVID-19 vaccination: https://pubmed.ncbi.nlm.nih.gov/33928773/

621. Case report: Take a second look: Cerebral venous thrombosis related to Covid-19 vaccination and thrombotic thrombocytopenia syndrome: https://pubmed.ncbi.nlm.nih.gov/34880826/

622. Information on ChAdOx1 nCoV-19 vaccine-induced immune-mediated thrombotic thrombocytopenia: https://pubmed.ncbi.nlm.nih.gov/34587242/

623. Change in blood viscosity after COVID-19 vaccination: estimation for persons with underlying metabolic syndrome: https://pubmed.ncbi.nlm.nih.gov/34868465/

624. Management of a patient with a rare congenital limb malformation syndrome after SARS-CoV-2 vaccine-induced thrombosis and thrombocytopenia (VITT): https://pubmed.ncbi.nlm.nih.gov/34097311/

625. Bilateral thalamic stroke: a case of COVID-19 (VITT) vaccine-induced immune thrombotic thrombocytopenia or a coincidence due to underlying risk factors: https://pubmed.ncbi.nlm.nih.gov/34820232/.

626. Thrombocytopenia and splanchnic thrombosis after vaccination with Ad26.COV2.S successfully treated with transjugular intrahepatic intrahepatic portosystemic shunt and thrombectomy: https://onlinelibrary.wiley.com/doi/10.1002/ajh.26258

627. Incidence of acute ischemic stroke after coronavirus vaccination in Indonesia: case series: https://pubmed.ncbi.nlm.nih.gov/34579636/

628. Successful treatment of vaccine-induced immune immune thrombotic thrombocytopenia in a 26-year-old female patient: https://pubmed.ncbi.nlm.nih.gov/34614491/

629. Case report: vaccine-induced immune immune thrombotic thrombocytopenia in a patient with pancreatic cancer after vaccination with messenger RNA-1273: https://pubmed.ncbi.nlm.nih.gov/34790684/

630. Idiopathic idiopathic external jugular vein thrombophlebitis after coronavirus disease vaccination (COVID-19): https://pubmed.ncbi.nlm.nih.gov/33624509/.

631. Squamous cell carcinoma of the lung with hemoptysis following vaccination with tozinameran (BNT162b2, Pfizer-BioNTech): https://pubmed.ncbi.nlm.nih.gov/34612003/

632. Vaccine-induced thrombotic thrombocytopenia after Ad26.COV2.S vaccination in a man presenting as acute venous thromboembolism: https://pubmed.ncbi.nlm.nih.gov/34096082/

633. Myocarditis associated with COVID-19 vaccination in three adolescent boys: https://pubmed.ncbi.nlm.nih.gov/34851078/.

634. Cardiovascular magnetic resonance findings in young adult patients with acute myocarditis after COVID-19 mRNA vaccination: a case series: https://pubmed.ncbi.nlm.nih.gov/34496880/

635. Perimyocarditis after vaccination with COVID-19: https://pubmed.ncbi.nlm.nih.gov/34866957/

636. Epidemiology of acute myocarditis/pericarditis in Hong Kong adolescents after co-vaccination: https://pubmed.ncbi.nlm.nih.gov/34849657/.

637. Myocarditis-induced sudden death after BNT162b2 COVID-19 mRNA vaccination in Korea: case report focusing on histopathological findings: https://pubmed.ncbi.nlm.nih.gov/34664804/

638. Acute myocarditis after vaccination with COVID-19 mRNA in adults aged 18 years or older: https://pubmed.ncbi.nlm.nih.gov/34605853/

639. Recurrence of acute myocarditis temporally associated with receipt of the 2019 coronavirus mRNA disease vaccine (COVID-19) in an adolescent male: https://pubmed.ncbi.nlm.nih.gov/34166671/

640. Young male with myocarditis after mRNA-1273 coronavirus disease-2019 (COVID-19) mRNA vaccination: https://pubmed.ncbi.nlm.nih.gov/34744118/

641. Acute myocarditis after SARS-CoV-2 vaccination in a 24-year-old male: https://pubmed.ncbi.nlm.nih.gov/34334935/.

642. Ga-DOTATOC digital PET images of inflammatory cell infiltrates in myocarditis after vaccination with COVID-19: https://pubmed.ncbi.nlm.nih.gov/34746968/

643. Occurrence of acute infarct-like myocarditis after vaccination with COVID-19: just an accidental coincidence or rather a vaccination-associated autoimmune myocarditis?”: https://pubmed.ncbi.nlm.nih.gov/34333695/.

644. Self-limited myocarditis presenting with chest pain and ST-segment elevation in adolescents after vaccination with BNT162b2 mRNA vaccine: https://pubmed.ncbi.nlm.nih.gov/34180390/

645. Myocarditis Following Immunization with COVID-19 mRNA Vaccines in Members of the U.S. Military: https://pubmed.ncbi.nlm.nih.gov/34185045/

646. Myocarditis after BNT162b2 vaccination in a healthy male: https://pubmed.ncbi.nlm.nih.gov/34229940/

647. Myopericarditis in a previously healthy adolescent male after COVID-19 vaccination: Case report: https://pubmed.ncbi.nlm.nih.gov/34133825/

648. Acute myocarditis after SARS-CoV-2 mRNA-1273 mRNA vaccination: https://pubmed.ncbi.nlm.nih.gov/34308326/.

649. Chest pain with abnormal electrocardiogram redevelopment after injection of COVID-19 vaccine manufactured by Moderna: https://pubmed.ncbi.nlm.nih.gov/34866106/

650. Biopsy-proven lymphocytic myocarditis after first vaccination with COVID-19 mRNA in a 40-year-old man: case report: https://pubmed.ncbi.nlm.nih.gov/34487236/

651. Multimodality imaging and histopathology in a young man presenting with fulminant lymphocytic myocarditis and cardiogenic shock after vaccination with mRNA-1273: https://pubmed.ncbi.nlm.nih.gov/34848416/

652. Report of a case of myopericarditis after vaccination with BNT162b2 COVID-19 mRNA in a young Korean male: https://pubmed.ncbi.nlm.nih.gov/34636504/

653. Acute myocarditis after Comirnaty vaccination in a healthy male with previous SARS-CoV-2 infection: https://pubmed.ncbi.nlm.nih.gov/34367386/

654. Acute myocarditis in a young adult two days after vaccination with Pfizer: https://pubmed.ncbi.nlm.nih.gov/34709227/

655. Case report: acute fulminant myocarditis and cardiogenic shock after messenger RNA coronavirus vaccination in 2019 requiring extracorporeal cardiopulmonary resuscitation: https://pubmed.ncbi.nlm.nih.gov/34778411/

656. Acute myocarditis after 2019 coronavirus disease vaccination: https://pubmed.ncbi.nlm.nih.gov/34734821/

657. A series of patients with myocarditis after vaccination against SARS-CoV-2 with mRNA-1279 and BNT162b2: https://pubmed.ncbi.nlm.nih.gov/34246585/

658. Myopericarditis after Pfizer messenger ribonucleic acid coronavirus coronavirus disease vaccine in adolescents: https://pubmed.ncbi.nlm.nih.gov/34228985/

659. Post-vaccination multisystem inflammatory syndrome in adults without evidence of prior SARS-CoV-2 infection: https://pubmed.ncbi.nlm.nih.gov/34852213/

660. Acute myocarditis defined after vaccination with 2019 mRNA of coronavirus disease: https://pubmed.ncbi.nlm.nih.gov/34866122/

661. Biventricular systolic dysfunction in acute myocarditis after SARS-CoV-2 mRNA-1273 vaccination: https://pubmed.ncbi.nlm.nih.gov/34601566/

662. Myocarditis following COVID-19 vaccination: MRI study: https://pubmed.ncbi.nlm.nih.gov/34739045/.

663. Acute myocarditis after COVID-19 vaccination: case report: https://docs.google.com/document/d/1Hc4bh_qNbZ7UVm5BLxkRdMPnnI9zcCsl/e

664. Association of myocarditis with COVID-19 messenger RNA BNT162b2 vaccine COVID-19 in a case series of children: https://pubmed.ncbi.nlm.nih.gov/34374740/

665. Clinical suspicion of myocarditis temporally related to COVID-19 vaccination in adolescents and young adults: https://pubmed.ncbi.nlm.nih.gov/34865500/

666. Myocarditis following vaccination with Covid-19 in a large healthcare organization: https://pubmed.ncbi.nlm.nih.gov/34614329/

667. AstraZeneca COVID-19 vaccine and Guillain-Barré syndrome in Tasmania: a causal link: https://pubmed.ncbi.nlm.nih.gov/34560365/

668. COVID-19, Guillain-Barré and vaccineA dangerous mix: https://pubmed.ncbi.nlm.nih.gov/34108736/.

669. Guillain-Barré syndrome after the first dose of Pfizer-BioNTech COVID-19 vaccine: case report and review of reported cases: https://pubmed.ncbi.nlm.nih.gov/34796417/.

670. Guillain-Barre syndrome after BNT162b2 COVID-19 vaccine: https://link.springer.com/article/10.1007%2Fs10072-021-05523-5.

671. COVID-19 adenovirus vaccines and Guillain-Barré syndrome with facial palsy: https://onlinelibrary.wiley.com/doi/10.1002/ana.26258.

672. Association of receipt association of Ad26.COV2.S COVID-19 vaccine with presumed Guillain-Barre syndrome, February-July 2021: https://jamanetwork.com/journals/jama/fullarticle/2785009

673. A case of Guillain-Barré syndrome after Pfizer COVID-19 vaccine: https://pubmed.ncbi.nlm.nih.gov/34567447/

674. Guillain-Barré syndrome associated with COVID-19 vaccination: https://pubmed.ncbi.nlm.nih.gov/34648420/.

675. Rate of recurrent Guillain-Barré syndrome after COVID-19 BNT162b2 mRNA vaccine: https://jamanetwork.com/journals/jamaneurology/fullarticle/2783708

676. Guillain-Barre syndrome after COVID-19 vaccination in an adolescent: https://www.pedneur.com/article/S0887-8994(21)00221-6/fulltext.

677. Guillain-Barre syndrome after ChAdOx1-S / nCoV-19 vaccination: https://pubmed.ncbi.nlm.nih.gov/34114256/.

678. Guillain-Barre syndrome after COVID-19 mRNA-1273 vaccine: case report: https://pubmed.ncbi.nlm.nih.gov/34767184/.

679. Guillain-Barre syndrome following SARS-CoV-2 vaccination in 19 patients: https://pubmed.ncbi.nlm.nih.gov/34644738/.

680. Guillain-Barre syndrome presenting with facial diplegia following vaccination with COVID-19 in two patients: https://pubmed.ncbi.nlm.nih.gov/34649856/

681. A rare case of Guillain-Barré syndrome after COVID-19 vaccination: https://pubmed.ncbi.nlm.nih.gov/34671572/

682. Neurological complications of COVID-19: Guillain-Barre syndrome after Pfizer COVID-19 vaccine: https://pubmed.ncbi.nlm.nih.gov/33758714/

683. COVID-19 vaccine causing Guillain-Barre syndrome, an uncommon potential side effect: https://pubmed.ncbi.nlm.nih.gov/34484780/

684. Guillain-Barre syndrome after the first dose of COVID-19 vaccination: case report; https://pubmed.ncbi.nlm.nih.gov/34779385/.

685. Miller Fisher syndrome after Pfizer COVID-19 vaccine: https://pubmed.ncbi.nlm.nih.gov/34817727/.

686. Miller Fisher syndrome after 2019 BNT162b2 mRNA coronavirus vaccination: https://pubmed.ncbi.nlm.nih.gov/34789193/.

687. Bilateral facial weakness with a variant of paresthesia of Guillain-Barre syndrome after Vaxzevria COVID-19 vaccine: https://pubmed.ncbi.nlm.nih.gov/34261746/

688. Guillain-Barre syndrome after the first injection of ChAdOx1 nCoV-19 vaccine: first report: https://pubmed.ncbi.nlm.nih.gov/34217513/.

689. A case of sensory ataxic Guillain-Barre syndrome with immunoglobulin G anti-GM1 antibodies after first dose of COVID-19 BNT162b2 mRNA vaccine (Pfizer): https://pubmed.ncbi.nlm.nih.gov/34871447/

690. Reporting of acute inflammatory neuropathies with COVID-19 vaccines: subgroup disproportionality analysis in VigiBase: https://pubmed.ncbi.nlm.nih.gov/34579259/

691. A variant of Guillain-Barré syndrome after SARS-CoV-2 vaccination: AMSAN: https://pubmed.ncbi.nlm.nih.gov/34370408/.

692. A rare variant of Guillain-Barré syndrome after vaccination with Ad26.COV2.S: https://pubmed.ncbi.nlm.nih.gov/34703690/.

693. Guillain-Barré syndrome after SARS-CoV-2 vaccination in a patient with previous vaccine-associated Guillain-Barré syndrome: https://pubmed.ncbi.nlm.nih.gov/34810163/

694. Guillain-Barré syndrome in an Australian state using mRNA and adenovirus-vector SARS-CoV-2 vaccines: https://onlinelibrary.wiley.com/doi/10.1002/ana.26218.

695. Acute transverse myelitis after SARS-CoV-2 vaccination: case report and review of the literature: https://pubmed.ncbi.nlm.nih.gov/34482455/.

696. Variant Guillain-Barré syndrome occurring after SARS-CoV-2 vaccination: https://pubmed.ncbi.nlm.nih.gov/34114269/.

697. Guillian-Barre syndrome with axonal variant temporally associated with Modern SARS-CoV-2 mRNA-based vaccine: https://pubmed.ncbi.nlm.nih.gov/34722067/

698. Guillain-Barre syndrome after the first dose of SARS-CoV-2 vaccine: a temporary occurrence, not a causal association: https://pubmed.ncbi.nlm.nih.gov/33968610/

699. SARS-CoV-2 vaccines can be complicated not only by Guillain-Barré syndrome but also by distal small fiber neuropathy: https://pubmed.ncbi.nlm.nih.gov/34525410/

700. Clinical variant of Guillain-Barré syndrome with prominent facial diplegia after AstraZeneca 2019 coronavirus disease vaccine: https://pubmed.ncbi.nlm.nih.gov/34808658/

701. Adverse event reporting and risk of Bell’s palsy after COVID-19 vaccination: https://www.thelancet.com/journals/laninf/article/PIIS1473-3099(21)00646-0/fulltext.

702. Bilateral facial nerve palsy and COVID-19 vaccination: causality or coincidence: https://pubmed.ncbi.nlm.nih.gov/34522557/

703. Left Bell’s palsy after the first dose of mRNA-1273 SARS-CoV-2 vaccine: case report: https://pubmed.ncbi.nlm.nih.gov/34763263/.

704. Bell’s palsy after inactivated vaccination with COVID-19 in a patient with a history of recurrent Bell’s palsy: case report: https://pubmed.ncbi.nlm.nih.gov/34621891/

705. Neurological complications after the first dose of COVID-19 vaccines and SARS-CoV-2 infection: https://pubmed.ncbi.nlm.nih.gov/34697502/

706. Type I interferons as a potential mechanism linking COVID-19 mRNA vaccines with Bell’s palsy: https://pubmed.ncbi.nlm.nih.gov/33858693/

707. Acute transverse myelitis following inactivated COVID-19 vaccine: https://pubmed.ncbi.nlm.nih.gov/34370410/

708. Acute transverse myelitis after COVID-19 vaccination: https://pubmed.ncbi.nlm.nih.gov/34579245/.

709. A case of longitudinally extensive transverse myelitis following Covid-19 vaccination: https://pubmed.ncbi.nlm.nih.gov/34182207/

710. Post COVID-19 transverse myelitis; a case report with review of the literature: https://pubmed.ncbi.nlm.nih.gov/34457267/.

711. Beware of neuromyelitis optica spectrum disorder after vaccination with inactivated virus for COVID-19: https://pubmed.ncbi.nlm.nih.gov/34189662/

712. Neuromyelitis optica in a healthy woman after vaccination against severe acute respiratory syndrome coronavirus 2 mRNA-1273: https://pubmed.ncbi.nlm.nih.gov/34660149/

713. Acute bilateral bilateral optic neuritis/chiasm with longitudinal extensive transverse myelitis in long-standing stable multiple sclerosis after vector-based vaccination against SARS-CoV-2: https://pubmed.ncbi.nlm.nih.gov/34131771/

714. A case series of acute pericarditis after vaccination with COVID-19 in the context of recent reports from Europe and the United States: https://pubmed.ncbi.nlm.nih.gov/34635376/

715. Acute pericarditis and cardiac tamponade after vaccination with Covid-19: https://pubmed.ncbi.nlm.nih.gov/34749492/

716. Myocarditis and pericarditis in adolescents after the first and second doses of COVID-19 mRNA vaccines: https://pubmed.ncbi.nlm.nih.gov/34849667/

717. Perimyocarditis in adolescents after Pfizer-BioNTech COVID-19 vaccine: https://pubmed.ncbi.nlm.nih.gov/34319393/

718. Acute myopericarditis after COVID-19 vaccine in adolescents: https://pubmed.ncbi.nlm.nih.gov/34589238/

719. Pericarditis after administration of the BNT162b2 mRNA vaccine COVID-19: https://pubmed.ncbi.nlm.nih.gov/34149145/

720. Case report: symptomatic pericarditis post COVID-19 vaccination: https://pubmed.ncbi.nlm.nih.gov/34693198/.

721. An outbreak of Still’s disease after COVID-19 vaccination in a 34-year-old patient: https://pubmed.ncbi.nlm.nih.gov/34797392/

722. Hemophagocytic lymphohistiocytosis following COVID-19 vaccination (ChAdOx1 nCoV-19): https://pubmed.ncbi.nlm.nih.gov/34862234/

723. Myocarditis after SARS-CoV-2 mRNA vaccination, a case series: https://pubmed.ncbi.nlm.nih.gov/34396358/.

724. Miller-Fisher syndrome and Guillain-Barré syndrome overlap syndrome in a patient after Oxford-AstraZeneca SARS-CoV-2 vaccination: https://pubmed.ncbi.nlm.nih.gov/34848426/.

725. Immune-mediated disease outbreaks or new-onset disease in 27 subjects after mRNA/DNA vaccination against SARS-CoV-2: https://pubmed.ncbi.nlm.nih.gov/33946748/

726. Post-mortem investigation of deaths after vaccination with COVID-19 vaccines: https://pubmed.ncbi.nlm.nih.gov/34591186/

727. Acute kidney injury with macroscopic hematuria and IgA nephropathy after COVID-19 vaccination: https://pubmed.ncbi.nlm.nih.gov/34352309/

728. Relapse of immune thrombocytopenia after covid-19 vaccination in young male patient: https://pubmed.ncbi.nlm.nih.gov/34804803/.

729. Immune thrombocytopenic purpura associated with COVID-19 mRNA vaccine Pfizer-BioNTech BNT16B2b2: https://pubmed.ncbi.nlm.nih.gov/34077572/

730. Retinal hemorrhage after SARS-CoV-2 vaccination: https://pubmed.ncbi.nlm.nih.gov/34884407/.

731. Case report: anti-neutrophil cytoplasmic antibody-associated vasculitis with acute renal failure and pulmonary hemorrhage can occur after COVID-19 vaccination: https://pubmed.ncbi.nlm.nih.gov/34859017/

732. Intracerebral hemorrhage due to vasculitis following COVID-19 vaccination: case report: https://pubmed.ncbi.nlm.nih.gov/34783899/

733. Peduncular, symptomatic cavernous bleeding after immune thrombocytopenia-induced SARS-CoV-2 vaccination: https://pubmed.ncbi.nlm.nih.gov/34549178/.

734. Brain death in a vaccinated patient with COVID-19 infection: https://pubmed.ncbi.nlm.nih.gov/34656887/

735. Generalized purpura annularis telangiectodes after SARS-CoV-2 mRNA vaccination: https://pubmed.ncbi.nlm.nih.gov/34236717/.

736. Lobar hemorrhage with ventricular rupture shortly after the first dose of a SARS-CoV-2 mRNA-based SARS-CoV-2 vaccine: https://pubmed.ncbi.nlm.nih.gov/34729467/.

737. A case of outbreak of macroscopic hematuria and IgA nephropathy after SARS-CoV-2 vaccination: https://pubmed.ncbi.nlm.nih.gov/33932458/

738. Acral hemorrhage after administration of the second dose of SARS-CoV-2 vaccine. A post-vaccination reaction: https://pubmed.ncbi.nlm.nih.gov/34092400/742.

739. Severe immune thrombocytopenic purpura after SARS-CoV-2 vaccine: https://pubmed.ncbi.nlm.nih.gov/34754937/

740. Gross hematuria after severe acute respiratory syndrome coronavirus 2 vaccination in 2 patients with IgA nephropathy: https://pubmed.ncbi.nlm.nih.gov/33771584/

741. Autoimmune encephalitis after ChAdOx1-S SARS-CoV-2 vaccination: https://pubmed.ncbi.nlm.nih.gov/34846583/

742. COVID-19 vaccine and death: causality algorithm according to the WHO eligibility diagnosis: https://pubmed.ncbi.nlm.nih.gov/34073536/

743. Bell’s palsy after vaccination with mRNA (BNT162b2) and inactivated (CoronaVac) SARS-CoV-2 vaccines: a case series and a nested case-control study: https://pubmed.ncbi.nlm.nih.gov/34411532/

744. Epidemiology of myocarditis and pericarditis following mRNA vaccines in Ontario, Canada: by vaccine product, schedule, and interval: https://www.medrxiv.org/content/10.1101/2021.12.02.21267156v1

745. Anaphylaxis following Covid-19 vaccine in a patient with cholinergic urticaria: https://pubmed.ncbi.nlm.nih.gov/33851711/

746. Anaphylaxis induced by CoronaVac COVID-19 vaccine: clinical features and results of revaccination: https://pubmed.ncbi.nlm.nih.gov/34675550/.

747. Anaphylaxis after Modern COVID-19 vaccine: https://pubmed.ncbi.nlm.nih.gov/34734159/.

748. Association of self-reported history of high-risk allergy with allergy symptoms after COVID-19 vaccination: https://pubmed.ncbi.nlm.nih.gov/34698847/

749. Sex differences in the incidence of anaphylaxis to LNP-mRNA vaccines COVID-19: https://pubmed.ncbi.nlm.nih.gov/34020815/

750. Allergic reactions, including anaphylaxis, after receiving the first dose of Pfizer-BioNTech COVID-19 vaccine – United States, December 14 to 23, 2020: https://pubmed.ncbi.nlm.nih.gov/33641264/

751. Allergic reactions, including anaphylaxis, after receiving the first dose of Modern COVID-19 vaccine – United States, December 21, 2020 to January 10, 2021: https://pubmed.ncbi.nlm.nih.gov/33641268/

752. Prolonged anaphylaxis to Pfizer 2019 coronavirus disease vaccine: a case report and mechanism of action: https://pubmed.ncbi.nlm.nih.gov/33834172/

753. Anaphylaxis reactions to Pfizer BNT162b2 vaccine: report of 3 cases of anaphylaxis following vaccination with Pfizer BNT162b2: https://pubmed.ncbi.nlm.nih.gov/34579211/

754. Biphasic anaphylaxis after first dose of 2019 messenger RNA coronavirus disease vaccine with positive polysorbate 80 skin test result: https://pubmed.ncbi.nlm.nih.gov/34343674/

755. Acute myocardial infarction and myocarditis after COVID-19 vaccination: https://pubmed.ncbi.nlm.nih.gov/34586408/

756. Takotsubo syndrome after COVID-19 vaccination: https://pubmed.ncbi.nlm.nih.gov/34539938/.

757. Takotsubo cardiomyopathy after coronavirus 2019 vaccination in patient on maintenance hemodialysis: https://pubmed.ncbi.nlm.nih.gov/34731486/.

758. Premature myocardial infarction or side effect of COVID-19 vaccine: https://pubmed.ncbi.nlm.nih.gov/33824804/

759. Myocardial infarction, stroke, and pulmonary embolism after BNT162b2 mRNA COVID-19 vaccine in persons aged 75 years or older: https://pubmed.ncbi.nlm.nih.gov/34807248/

760. Kounis syndrome type 1 induced by inactivated SARS-COV-2 vaccine: https://pubmed.ncbi.nlm.nih.gov/34148772/

761. Acute myocardial infarction within 24 hours after COVID-19 vaccination: is Kounis syndrome the culprit: https://pubmed.ncbi.nlm.nih.gov/34702550/

762. Deaths associated with the recently launched SARS-CoV-2 vaccination (Comirnaty®): https://pubmed.ncbi.nlm.nih.gov/33895650/

763. Deaths associated with recently launched SARS-CoV-2 vaccination: https://pubmed.ncbi.nlm.nih.gov/34425384/

764. A case of acute encephalopathy and non-ST-segment elevation myocardial infarction after vaccination with mRNA-1273: possible adverse effect: https://pubmed.ncbi.nlm.nih.gov/34703815/

765. COVID-19 vaccine-induced urticarial vasculitis: https://pubmed.ncbi.nlm.nih.gov/34369046/.

766. ANCA-associated vasculitis after Pfizer-BioNTech COVID-19 vaccine: https://pubmed.ncbi.nlm.nih.gov/34280507/.

767. New-onset leukocytoclastic vasculitis after COVID-19 vaccine: https://pubmed.ncbi.nlm.nih.gov/34241833/

768. Cutaneous small vessel vasculitis after COVID-19 vaccine: https://pubmed.ncbi.nlm.nih.gov/34529877/.

769. Outbreak of leukocytoclastic vasculitis after COVID-19 vaccine: https://pubmed.ncbi.nlm.nih.gov/33928638/

770. Leukocytoclastic vasculitis after exposure to COVID-19 vaccine: https://pubmed.ncbi.nlm.nih.gov/34836739/

771. Vasculitis and bursitis in [ 18 F] FDG-PET/CT after COVID-19 mRNA vaccine: post hoc ergo propter hoc?; https://pubmed.ncbi.nlm.nih.gov/34495381/.

772. Cutaneous lymphocytic vasculitis after administration of COVID-19 mRNA vaccine: https://pubmed.ncbi.nlm.nih.gov/34327795

773. Cutaneous leukocytoclastic vasculitis induced by Sinovac COVID-19 vaccine: https://pubmed.ncbi.nlm.nih.gov/34660867/.

774. Case report: ANCA-associated vasculitis presenting with rhabdomyolysis and crescentic Pauci-Inmune glomerulonephritis after vaccination with Pfizer-BioNTech COVID-19 mRNA: https://pubmed.ncbi.nlm.nih.gov/34659268/

775. Reactivation of IgA vasculitis after vaccination with COVID-19: https://pubmed.ncbi.nlm.nih.gov/34848431/

776. Varicella-zoster virus-related small-vessel vasculitis after Pfizer-BioNTech COVID-19 vaccination: https://pubmed.ncbi.nlm.nih.gov/34310759/.

777. Imaging in vascular medicine: leukocytoclastic vasculitis after COVID-19 vaccine booster: https://pubmed.ncbi.nlm.nih.gov/34720009/

778. A rare case of Henoch-Schönlein purpura after a case report of COVID-19 vaccine: https://pubmed.ncbi.nlm.nih.gov/34518812/

779. Cutaneous vasculitis following COVID-19 vaccination: https://pubmed.ncbi.nlm.nih.gov/34611627/.

780. Possible case of COVID-19 mRNA vaccine-induced small-vessel vasculitis: https://pubmed.ncbi.nlm.nih.gov/34705320/.

781. IgA vasculitis following COVID-19 vaccination in an adult: https://pubmed.ncbi.nlm.nih.gov/34779011/

782. Propylthiouracil-induced anti-neutrophil cytoplasmic antibody-associated vasculitis following vaccination with COVID-19: https://pubmed.ncbi.nlm.nih.gov/34451967/

783. Coronavirus disease vaccine 2019 (COVID-19) in systemic lupus erythematosus and neutrophil anti-cytoplasmic antibody-associated vasculitis: https://pubmed.ncbi.nlm.nih.gov/33928459/

784. Reactivation of IgA vasculitis after COVID-19 vaccination: https://pubmed.ncbi.nlm.nih.gov/34250509/

785. Clinical and histopathologic spectrum of delayed adverse skin reactions after COVID-19 vaccination: https://pubmed.ncbi.nlm.nih.gov/34292611/.

786. First description of immune complex vasculitis after COVID-19 vaccination with BNT162b2: case report: https://pubmed.ncbi.nlm.nih.gov/34530771/.

787. Nephrotic syndrome and vasculitis after SARS-CoV-2 vaccine: true association or circumstantial: https://pubmed.ncbi.nlm.nih.gov/34245294/.

788. Occurrence of de novo cutaneous vasculitis after vaccination against coronavirus disease (COVID-19): https://pubmed.ncbi.nlm.nih.gov/34599716/.

789. Asymmetric cutaneous vasculitis after COVID-19 vaccination with unusual preponderance of eosinophils: https://pubmed.ncbi.nlm.nih.gov/34115904/.

790. Henoch-Schönlein purpura occurring after vaccination with COVID-19: https://pubmed.ncbi.nlm.nih.gov/34247902/.

791. Henoch-Schönlein purpura following the first dose of COVID-19 viral vector vaccine: case report: https://pubmed.ncbi.nlm.nih.gov/34696186/.

792. Granulomatous vasculitis after AstraZeneca anti-SARS-CoV-2 vaccine: https://pubmed.ncbi.nlm.nih.gov/34237323/.

793. Acute retinal necrosis due to varicella zoster virus reactivation after vaccination with BNT162b2 COVID-19 mRNA: https://pubmed.ncbi.nlm.nih.gov/34851795/.

794. A case of generalized Sweet’s syndrome with vasculitis triggered by recent vaccination with COVID-19: https://pubmed.ncbi.nlm.nih.gov/34849386/

795. Small-vessel vasculitis following Oxford-AstraZeneca vaccination against SARS-CoV-2: https://pubmed.ncbi.nlm.nih.gov/34310763/

796. Relapse of microscopic polyangiitis after COVID-19 vaccination: case report: https://pubmed.ncbi.nlm.nih.gov/34251683/.

797. Cutaneous vasculitis after severe acute respiratory syndrome coronavirus 2 vaccine: https://pubmed.ncbi.nlm.nih.gov/34557622/.

798. Recurrent herpes zoster after COVID-19 vaccination in patients with chronic urticaria on cyclosporine treatment – A report of 3 cases: https://pubmed.ncbi.nlm.nih.gov/34510694/

799. Leukocytoclastic vasculitis after coronavirus disease vaccination 2019: https://pubmed.ncbi.nlm.nih.gov/34713472/803

800. Outbreaks of mixed cryoglobulinemia vasculitis after vaccination against SARS-CoV-2: https://pubmed.ncbi.nlm.nih.gov/34819272/

801. Cutaneous small-vessel vasculitis after vaccination with a single dose of Janssen Ad26.COV2.S: https://pubmed.ncbi.nlm.nih.gov/34337124/

802. Case of immunoglobulin A vasculitis after vaccination against coronavirus disease 2019: https://pubmed.ncbi.nlm.nih.gov/34535924/

803. Rapid progression of angioimmunoblastic T-cell lymphoma after BNT162b2 mRNA booster vaccination: case report: https://www.frontiersin.org/articles/10.3389/fmed.2021.798095/

804. COVID-19 mRNA vaccination-induced lymphadenopathy mimics lymphoma progression on FDG PET / CT: https://pubmed.ncbi.nlm.nih.gov/33591026/

805. Lymphadenopathy in COVID-19 vaccine recipients: diagnostic dilemma in oncology patients: https://pubmed.ncbi.nlm.nih.gov/33625300/

806. Hypermetabolic lymphadenopathy after administration of BNT162b2 mRNA vaccine Covid-19: incidence assessed by [ 18 F] FDG PET-CT and relevance for study interpretation: https://pubmed.ncbi.nlm.nih.gov/33774684/

807. Lymphadenopathy after COVID-19 vaccination: review of imaging findings: https://pubmed.ncbi.nlm.nih.gov/33985872/

808. Evolution of bilateral hypermetabolic axillary hypermetabolic lymphadenopathy on FDG PET/CT after 2-dose COVID-19 vaccination: https://pubmed.ncbi.nlm.nih.gov/34735411/

809. Lymphadenopathy associated with COVID-19 vaccination on FDG PET/CT: distinguishing features in adenovirus-vectored vaccine: https://pubmed.ncbi.nlm.nih.gov/34115709/.

810. COVID-19 vaccination-induced lymphadenopathy in a specialized breast imaging clinic in Israel: analysis of 163 cases: https://pubmed.ncbi.nlm.nih.gov/34257025/.

811. COVID-19 vaccine-related axillary lymphadenopathy in breast cancer patients: case series with literature review: https://pubmed.ncbi.nlm.nih.gov/34836672/.

812. Coronavirus disease vaccine 2019 mimics lymph node metastases in patients undergoing skin cancer follow-up: a single-center study: https://pubmed.ncbi.nlm.nih.gov/34280870/

813. COVID-19 post-vaccination lymphadenopathy: report of fine-needle aspiration biopsy cytologic findings: https://pubmed.ncbi.nlm.nih.gov/34432391/

814. Regional lymphadenopathy after COVID-19 vaccination: review of the literature and considerations for patient management in breast cancer care: https://pubmed.ncbi.nlm.nih.gov/34731748/

815. Subclinical axillary lymphadenopathy associated with COVID-19 vaccination on screening mammography: https://pubmed.ncbi.nlm.nih.gov/34906409/

816. Adverse events of COVID injection that may occur in children.Acute-onset supraclavicular lymphadenopathy coincident with intramuscular mRNA vaccination against COVID-19 may be related to the injection technique of the vaccine, Spain, January and February 2021: https://pubmed.ncbi.nlm.nih.gov/33706861/

817. Supraclavicular lymphadenopathy after COVID-19 vaccination in Korea: serial follow-up by ultrasonography: https://pubmed.ncbi.nlm.nih.gov/34116295/

818. Oxford-AstraZeneca COVID-19 vaccination induced lymphadenopathy on [18F] choline PET / CT, not just an FDG finding: https://pubmed.ncbi.nlm.nih.gov/33661328/

819. Biphasic anaphylaxis after exposure to the first dose of Pfizer-BioNTech COVID-19 mRNA vaccine COVID-19: https://pubmed.ncbi.nlm.nih.gov/34050949/

820. Axillary adenopathy associated with COVID-19 vaccination: imaging findings and follow-up recommendations in 23 women: https://pubmed.ncbi.nlm.nih.gov/33624520/

821. A case of cervical lymphadenopathy following COVID-19 vaccination: https://pubmed.ncbi.nlm.nih.gov/34141500/

822. Unique imaging findings of neurologic phantosmia after Pfizer-BioNtech COVID-19 vaccination: a case report: https://pubmed.ncbi.nlm.nih.gov/34096896/

823. Thrombotic adverse events reported for Moderna, Pfizer, and Oxford-AstraZeneca COVID-19 vaccines: comparison of occurrence and clinical outcomes in the EudraVigilance database: https://pubmed.ncbi.nlm.nih.gov/34835256/

824. Unilateral lymphadenopathy after COVID-19 vaccination: a practical management plan for radiologists of all specialties: https://pubmed.ncbi.nlm.nih.gov/33713605/

825. Unilateral axillary adenopathy in the setting of COVID-19 vaccination: follow-up: https://pubmed.ncbi.nlm.nih.gov/34298342/

826. A systematic review of cases of CNS demyelination following COVID-19 vaccination: https://pubmed.ncbi.nlm.nih.gov/34839149/

827. Supraclavicular lymphadenopathy after COVID-19 vaccination: an increasing presentation in the two-week wait neck lump clinic: https://pubmed.ncbi.nlm.nih.gov/33685772/

828. COVID-19 vaccine-related axillary and cervical lymphadenopathy in patients with current or previous breast cancer and other malignancies: cross-sectional imaging findings on MRI, CT and PET-CT: https://pubmed.ncbi.nlm.nih.gov/34719892/

829. Adenopathy after COVID-19 vaccination: https://pubmed.ncbi.nlm.nih.gov/33625299/.

830. Incidence of axillary adenopathy on breast imaging after vaccination with COVID-19: https://pubmed.ncbi.nlm.nih.gov/34292295/.

831. COVID-19 vaccination and lower cervical lymphadenopathy in two-week neck lump clinic: a follow-up audit: https://pubmed.ncbi.nlm.nih.gov/33947605/.

832. Cervical lymphadenopathy after coronavirus disease vaccination 2019: clinical features and implications for head and neck cancer services: https://pubmed.ncbi.nlm.nih.gov/34526175/

833. Lymphadenopathy associated with the COVID-19 vaccine: https://pubmed.ncbi.nlm.nih.gov/33786231/

834. Evolution of lymphadenopathy on PET/MRI after COVID-19 vaccination: https://pubmed.ncbi.nlm.nih.gov/33625301/.

835. Autoimmune hepatitis triggered by SARS-CoV-2 vaccination: https://pubmed.ncbi.nlm.nih.gov/34332438/.

836. New-onset nephrotic syndrome after Janssen COVID-19 vaccination: case report and literature review: https://pubmed.ncbi.nlm.nih.gov/34342187/.

837. Massive cervical lymphadenopathy following vaccination with COVID-19: https://pubmed.ncbi.nlm.nih.gov/34601889/

838. ANCA glomerulonephritis following Modern COVID-19 vaccination: https://pubmed.ncbi.nlm.nih.gov/34081948/

839. Extensive longitudinal transverse myelitis following AstraZeneca COVID-19 vaccination: https://pubmed.ncbi.nlm.nih.gov/34507942/.

840. Systemic capillary extravasation syndrome after vaccination with ChAdOx1 nCOV-19 (Oxford-AstraZeneca): https://pubmed.ncbi.nlm.nih.gov/34362727/

841. Unilateral axillary lymphadenopathy related to COVID-19 vaccine: pattern on screening breast MRI allowing benign evaluation: https://pubmed.ncbi.nlm.nih.gov/34325221/

842. Axillary lymphadenopathy in patients with recent Covid-19 vaccination: a new diagnostic dilemma: https://pubmed.ncbi.nlm.nih.gov/34825530/.

843. Minimal change disease and acute kidney injury after Pfizer-BioNTech COVID-19 vaccine: https://pubmed.ncbi.nlm.nih.gov/34000278/

844. COVID-19 vaccine-induced unilateral axillary adenopathy: follow-up evaluation in the USA: https://pubmed.ncbi.nlm.nih.gov/34655312/.

845. Gastroparesis after Pfizer-BioNTech COVID-19 vaccination: https://pubmed.ncbi.nlm.nih.gov/34187985/.

846. Acute-onset supraclavicular lymphadenopathy coincident with intramuscular mRNA vaccination against COVID-19 may be related to the injection technique of the vaccine, Spain, January and February 2021: https://pubmed.ncbi.nlm.nih.gov/33706861/

847. Supraclavicular lymphadenopathy after COVID-19 vaccination in Korea: serial follow-up by ultrasonography: https://pubmed.ncbi.nlm.nih.gov/34116295/

848. Oxford-AstraZeneca COVID-19 vaccination induced lymphadenopathy on [18F] choline PET / CT, not just an FDG finding: https://pubmed.ncbi.nlm.nih.gov/33661328/

849. Biphasic anaphylaxis after exposure to the first dose of Pfizer-BioNTech COVID-19 mRNA vaccine COVID-19: https://pubmed.ncbi.nlm.nih.gov/34050949/

850. Axillary adenopathy associated with COVID-19 vaccination: imaging findings and follow-up recommendations in 23 women: https://pubmed.ncbi.nlm.nih.gov/33624520/

851. A case of cervical lymphadenopathy following COVID-19 vaccination: https://pubmed.ncbi.nlm.nih.gov/34141500/

852. Unique imaging findings of neurologic phantosmia after Pfizer-BioNtech COVID-19 vaccination: a case report: https://pubmed.ncbi.nlm.nih.gov/34096896/

853. Thrombotic adverse events reported for Moderna, Pfizer, and Oxford-AstraZeneca COVID-19 vaccines: comparison of occurrence and clinical outcomes in the EudraVigilance database: https://pubmed.ncbi.nlm.nih.gov/34835256/

854. Unilateral lymphadenopathy after COVID-19 vaccination: a practical management plan for radiologists of all specialties: https://pubmed.ncbi.nlm.nih.gov/33713605/

855. Unilateral axillary adenopathy in the setting of COVID-19 vaccination: follow-up: https://pubmed.ncbi.nlm.nih.gov/34298342/

856. A systematic review of cases of CNS demyelination following COVID-19 vaccination: https://pubmed.ncbi.nlm.nih.gov/34839149/

857. Supraclavicular lymphadenopathy after COVID-19 vaccination: an increasing presentation in the two-week wait neck lump clinic: https://pubmed.ncbi.nlm.nih.gov/33685772/

858. COVID-19 vaccine-related axillary and cervical lymphadenopathy in patients with current or previous breast cancer and other malignancies: cross-sectional imaging findings on MRI, CT and PET-CT: https://pubmed.ncbi.nlm.nih.gov/34719892/

859. Adenopathy after COVID-19 vaccination: https://pubmed.ncbi.nlm.nih.gov/33625299/.

860. Incidence of axillary adenopathy on breast imaging after vaccination with COVID-19: https://pubmed.ncbi.nlm.nih.gov/34292295/.

861. COVID-19 vaccination and lower cervical lymphadenopathy in two-week neck lump clinic: a follow-up audit: https://pubmed.ncbi.nlm.nih.gov/33947605/.

862. Cervical lymphadenopathy after coronavirus disease vaccination 2019: clinical features and implications for head and neck cancer services: https://pubmed.ncbi.nlm.nih.gov/34526175/

863. Lymphadenopathy associated with the COVID-19 vaccine: https://pubmed.ncbi.nlm.nih.gov/33786231/

864. Evolution of lymphadenopathy on PET/MRI after COVID-19 vaccination: https://pubmed.ncbi.nlm.nih.gov/33625301/.

865. Autoimmune hepatitis triggered by SARS-CoV-2 vaccination: https://pubmed.ncbi.nlm.nih.gov/34332438/.

866. New-onset nephrotic syndrome after Janssen COVID-19 vaccination: case report and literature review: https://pubmed.ncbi.nlm.nih.gov/34342187/.

867. Massive cervical lymphadenopathy following vaccination with COVID-19: https://pubmed.ncbi.nlm.nih.gov/34601889/

868. ANCA glomerulonephritis following Modern COVID-19 vaccination: https://pubmed.ncbi.nlm.nih.gov/34081948/

869. Extensive longitudinal transverse myelitis following AstraZeneca COVID-19 vaccination: https://pubmed.ncbi.nlm.nih.gov/34507942/.

870. Systemic capillary extravasation syndrome after vaccination with ChAdOx1 nCOV-19 (Oxford-AstraZeneca): https://pubmed.ncbi.nlm.nih.gov/34362727/

871. Unilateral axillary lymphadenopathy related to COVID-19 vaccine: pattern on screening breast MRI allowing benign evaluation: https://pubmed.ncbi.nlm.nih.gov/34325221/

872. Axillary lymphadenopathy in patients with recent Covid-19 vaccination: a new diagnostic dilemma: https://pubmed.ncbi.nlm.nih.gov/34825530/.

873. Minimal change disease and acute kidney injury after Pfizer-BioNTech COVID-19 vaccine: https://pubmed.ncbi.nlm.nih.gov/34000278/

874. COVID-19 vaccine-induced unilateral axillary adenopathy: follow-up evaluation in the USA: https://pubmed.ncbi.nlm.nih.gov/34655312/.

875. Gastroparesis after Pfizer-BioNTech COVID-19 vaccination: https://pubmed.ncbi.nlm.nih.gov/34187985/.

876. Abbate, A., Gavin, J., Madanchi, N., Kim, C., Shah, P. R., Klein, K., . . . Danielides, S. (2021). Fulminant myocarditis and systemic hyperinflammation temporally associated with BNT162b2 mRNA COVID-19 vaccination in two patients. Int J Cardiol, 340, 119-121. doi:10.1016/j.ijcard.2021.08.018. https://www.ncbi.nlm.nih.gov/pubmed/34416319

877. Abu Mouch, S., Roguin, A., Hellou, E., Ishai, A., Shoshan, U., Mahamid, L., . . . Berar Yanay, N. (2021). Myocarditis following COVID-19 mRNA vaccination. Vaccine, 39(29), 3790-3793. doi:10.1016/j.vaccine.2021.05.087. https://www.ncbi.nlm.nih.gov/pubmed/34092429

878. Albert, E., Aurigemma, G., Saucedo, J., & Gerson, D. S. (2021). Myocarditis following COVID-19 vaccination. Radiol Case Rep, 16(8), 2142-2145. doi:10.1016/j.radcr.2021.05.033. https://www.ncbi.nlm.nih.gov/pubmed/34025885

879. Aye, Y. N., Mai, A. S., Zhang, A., Lim, O. Z. H., Lin, N., Ng, C. H., . . . Chew, N. W. S. (2021). Acute Myocardial Infarction and Myocarditis following COVID-19 Vaccination. QJM. doi:10.1093/qjmed/hcab252. https://www.ncbi.nlm.nih.gov/pubmed/34586408

880. Azir, M., Inman, B., Webb, J., & Tannenbaum, L. (2021). STEMI Mimic: Focal Myocarditis in an Adolescent Patient After mRNA COVID-19 Vaccine. J Emerg Med, 61(6), e129-e132. doi:10.1016/j.jemermed.2021.09.017. https://www.ncbi.nlm.nih.gov/pubmed/34756746

881. Barda, N., Dagan, N., Ben-Shlomo, Y., Kepten, E., Waxman, J., Ohana, R., . . . Balicer, R. D. (2021). Safety of the BNT162b2 mRNA Covid-19 Vaccine in a Nationwide Setting. N Engl J Med, 385(12), 1078-1090. doi:10.1056/NEJMoa2110475. https://www.ncbi.nlm.nih.gov/pubmed/34432976

882. Bhandari, M., Pradhan, A., Vishwakarma, P., & Sethi, R. (2021). Coronavirus and cardiovascular manifestations- getting to the heart of the matter. World J Cardiol, 13(10), 556-565. doi:10.4330/wjc.v13.i10.556. https://www.ncbi.nlm.nih.gov/pubmed/34754400

883. Bozkurt, B., Kamat, I., & Hotez, P. J. (2021). Myocarditis With COVID-19 mRNA Vaccines. Circulation, 144(6), 471-484. doi:10.1161/CIRCULATIONAHA.121.056135. https://www.ncbi.nlm.nih.gov/pubmed/34281357

884. Buchhorn, R., Meyer, C., Schulze-Forster, K., Junker, J., & Heidecke, H. (2021). Autoantibody Release in Children after Corona Virus mRNA Vaccination: A Risk Factor of Multisystem Inflammatory Syndrome? Vaccines (Basel), 9(11). doi:10.3390/vaccines9111353. https://www.ncbi.nlm.nih.gov/pubmed/34835284

885. Calcaterra, G., Bassareo, P. P., Barilla, F., Romeo, F., & Mehta, J. L. (2022). Concerning the unexpected prothrombotic state following some coronavirus disease 2019 vaccines. J Cardiovasc Med (Hagerstown), 23(2), 71-74. doi:10.2459/JCM.0000000000001232. https://www.ncbi.nlm.nih.gov/pubmed/34366403

886. Calcaterra, G., Mehta, J. L., de Gregorio, C., Butera, G., Neroni, P., Fanos, V., & Bassareo, P. P. (2021). COVID 19 Vaccine for Adolescents. Concern about Myocarditis and Pericarditis. Pediatr Rep, 13(3), 530-533. doi:10.3390/pediatric13030061. https://www.ncbi.nlm.nih.gov/pubmed/34564344

887. Chai, Q., Nygaard, U., Schmidt, R. C., Zaremba, T., Moller, A. M., & Thorvig, C. M. (2022). Multisystem inflammatory syndrome in a male adolescent after his second Pfizer-BioNTech COVID-19 vaccine. Acta Paediatr, 111(1), 125-127. doi:10.1111/apa.16141. https://www.ncbi.nlm.nih.gov/pubmed/34617315

888. Chamling, B., Vehof, V., Drakos, S., Weil, M., Stalling, P., Vahlhaus, C., . . . Yilmaz, A. (2021). Occurrence of acute infarct-like myocarditis following COVID-19 vaccination: just an accidental co-incidence or rather vaccination-associated autoimmune myocarditis? Clin Res Cardiol, 110(11), 1850-1854. doi:10.1007/s00392-021-01916-w. https://www.ncbi.nlm.nih.gov/pubmed/34333695

889. Chang, J. C., & Hawley, H. B. (2021). Vaccine-Associated Thrombocytopenia and Thrombosis: Venous Endotheliopathy Leading to Venous Combined Micro-Macrothrombosis. Medicina (Kaunas), 57(11). doi:10.3390/medicina57111163. https://www.ncbi.nlm.nih.gov/pubmed/34833382

890. Chelala, L., Jeudy, J., Hossain, R., Rosenthal, G., Pietris, N., & White, C. (2021). Cardiac MRI Findings of Myocarditis After COVID-19 mRNA Vaccination in Adolescents. AJR Am J Roentgenol. doi:10.2214/AJR.21.26853. https://www.ncbi.nlm.nih.gov/pubmed/34704459

891. Choi, S., Lee, S., Seo, J. W., Kim, M. J., Jeon, Y. H., Park, J. H., . . . Yeo, N. S. (2021). Myocarditis-induced Sudden Death after BNT162b2 mRNA COVID-19 Vaccination in Korea: Case Report Focusing on Histopathological Findings. J Korean Med Sci, 36(40), e286. doi:10.3346/jkms.2021.36.e286. https://www.ncbi.nlm.nih.gov/pubmed/34664804

892. Chouchana, L., Blet, A., Al-Khalaf, M., Kafil, T. S., Nair, G., Robblee, J., . . . Liu, P. P. (2021). Features of Inflammatory Heart Reactions Following mRNA COVID-19 Vaccination at a Global Level. Clin Pharmacol Ther. doi:10.1002/cpt.2499. https://www.ncbi.nlm.nih.gov/pubmed/34860360

893. Chua, G. T., Kwan, M. Y. W., Chui, C. S. L., Smith, R. D., Cheung, E. C., Tian, T., . . . Ip, P. (2021). Epidemiology of Acute Myocarditis/Pericarditis in Hong Kong Adolescents Following Comirnaty Vaccination. Clin Infect Dis. doi:10.1093/cid/ciab989. https://www.ncbi.nlm.nih.gov/pubmed/34849657

894. Clarke, R., & Ioannou, A. (2021). Should T2 mapping be used in cases of recurrent myocarditis to differentiate between the acute inflammation and chronic scar? J Pediatr. doi:10.1016/j.jpeds.2021.12.026. https://www.ncbi.nlm.nih.gov/pubmed/34933012

895. Colaneri, M., De Filippo, M., Licari, A., Marseglia, A., Maiocchi, L., Ricciardi, A., . . . Bruno, R. (2021). COVID vaccination and asthma exacerbation: might there be a link? Int J Infect Dis, 112, 243-246. doi:10.1016/j.ijid.2021.09.026. https://www.ncbi.nlm.nih.gov/pubmed/34547487

896. Das, B. B., Kohli, U., Ramachandran, P., Nguyen, H. H., Greil, G., Hussain, T., . . . Khan, D. (2021). Myopericarditis after messenger RNA Coronavirus Disease 2019 Vaccination in Adolescents 12 to 18 Years of Age. J Pediatr, 238, 26-32 e21. doi:10.1016/j.jpeds.2021.07.044. https://www.ncbi.nlm.nih.gov/pubmed/34339728

897. Das, B. B., Moskowitz, W. B., Taylor, M. B., & Palmer, A. (2021). Myocarditis and Pericarditis Following mRNA COVID-19 Vaccination: What Do We Know So Far? Children (Basel), 8(7). doi:10.3390/children8070607. https://www.ncbi.nlm.nih.gov/pubmed/34356586

898. Deb, A., Abdelmalek, J., Iwuji, K., & Nugent, K. (2021). Acute Myocardial Injury Following COVID-19 Vaccination: A Case Report and Review of Current Evidence from Vaccine Adverse Events Reporting System Database. J Prim Care Community Health, 12, 21501327211029230. doi:10.1177/21501327211029230. https://www.ncbi.nlm.nih.gov/pubmed/34219532

899. Dickey, J. B., Albert, E., Badr, M., Laraja, K. M., Sena, L. M., Gerson, D. S., . . . Aurigemma, G. P. (2021). A Series of Patients With Myocarditis Following SARS-CoV-2 Vaccination With mRNA-1279 and BNT162b2. JACC Cardiovasc Imaging, 14(9), 1862-1863. doi:10.1016/j.jcmg.2021.06.003. https://www.ncbi.nlm.nih.gov/pubmed/34246585

900. Dimopoulou, D., Spyridis, N., Vartzelis, G., Tsolia, M. N., & Maritsi, D. N. (2021). Safety and tolerability of the COVID-19 mRNA-vaccine in adolescents with juvenile idiopathic arthritis on treatment with TNF-inhibitors. Arthritis Rheumatol. doi:10.1002/art.41977. https://www.ncbi.nlm.nih.gov/pubmed/34492161

901. Dimopoulou, D., Vartzelis, G., Dasoula, F., Tsolia, M., & Maritsi, D. (2021). Immunogenicity of the COVID-19 mRNA vaccine in adolescents with juvenile idiopathic arthritis on treatment with TNF inhibitors. Ann Rheum Dis. doi:10.1136/annrheumdis-2021-221607. https://www.ncbi.nlm.nih.gov/pubmed/34844930

902. Ehrlich, P., Klingel, K., Ohlmann-Knafo, S., Huttinger, S., Sood, N., Pickuth, D., & Kindermann, M. (2021). Biopsy-proven lymphocytic myocarditis following first mRNA COVID-19 vaccination in a 40-year-old male: case report. Clin Res Cardiol, 110(11), 1855-1859. doi:10.1007/s00392-021-01936-6. https://www.ncbi.nlm.nih.gov/pubmed/34487236

903. El Sahly, H. M., Baden, L. R., Essink, B., Doblecki-Lewis, S., Martin, J. M., Anderson, E. J., . . . Group, C. S. (2021). Efficacy of the mRNA-1273 SARS-CoV-2 Vaccine at Completion of Blinded Phase. N Engl J Med, 385(19), 1774-1785. doi:10.1056/NEJMoa2113017. https://www.ncbi.nlm.nih.gov/pubmed/34551225

904. Facetti, S., Giraldi, M., Vecchi, A. L., Rogiani, S., & Nassiacos, D. (2021). [Acute myocarditis in a young adult two days after Pfizer vaccination]. G Ital Cardiol (Rome), 22(11), 891-893. doi:10.1714/3689.36746. https://www.ncbi.nlm.nih.gov/pubmed/34709227

905. Fazlollahi, A., Zahmatyar, M., Noori, M., Nejadghaderi, S. A., Sullman, M. J. M., Shekarriz-Foumani, R., . . . Safiri, S. (2021). Cardiac complications following mRNA COVID-19 vaccines: A systematic review of case reports and case series. Rev Med Virol, e2318. doi:10.1002/rmv.2318. https://www.ncbi.nlm.nih.gov/pubmed/34921468

906. Fazolo, T., Lima, K., Fontoura, J. C., de Souza, P. O., Hilario, G., Zorzetto, R., . . . Bonorino, C. (2021). Pediatric COVID-19 patients in South Brazil show abundant viral mRNA and strong specific anti-viral responses. Nat Commun, 12(1), 6844. doi:10.1038/s41467-021-27120-y. https://www.ncbi.nlm.nih.gov/pubmed/34824230

907. Fikenzer, S., & Laufs, U. (2021). Correction to: Response to Letter to the editors referring to Fikenzer, S., Uhe, T., Lavall, D., Rudolph, U., Falz, R., Busse, M., Hepp, P., & Laufs, U. (2020). Effects of surgical and FFP2/N95 face masks on cardiopulmonary exercise capacity. Clinical research in cardiology: official journal of the German Cardiac Society, 1-9. Advance online publication. https://doi.org/10.1007/s00392-020-01704-y. Clin Res Cardiol, 110(8), 1352. doi:10.1007/s00392-021-01896-x. https://www.ncbi.nlm.nih.gov/pubmed/34170372

908. Foltran, D., Delmas, C., Flumian, C., De Paoli, P., Salvo, F., Gautier, S., . . . Montastruc, F. (2021). Myocarditis and Pericarditis in Adolescents after First and Second doses of mRNA COVID-19 Vaccines. Eur Heart J Qual Care Clin Outcomes. doi:10.1093/ehjqcco/qcab090. https://www.ncbi.nlm.nih.gov/pubmed/34849667

909. Forgacs, D., Jang, H., Abreu, R. B., Hanley, H. B., Gattiker, J. L., Jefferson, A. M., & Ross, T. M. (2021). SARS-CoV-2 mRNA Vaccines Elicit Different Responses in Immunologically Naive and Pre-Immune Humans. Front Immunol, 12, 728021. doi:10.3389/fimmu.2021.728021. https://www.ncbi.nlm.nih.gov/pubmed/34646267

910. Furer, V., Eviatar, T., Zisman, D., Peleg, H., Paran, D., Levartovsky, D., . . . Elkayam, O. (2021). Immunogenicity and safety of the BNT162b2 mRNA COVID-19 vaccine in adult patients with autoimmune inflammatory rheumatic diseases and in the general population: a multicentre study. Ann Rheum Dis, 80(10), 1330-1338. doi:10.1136/annrheumdis-2021-220647. https://www.ncbi.nlm.nih.gov/pubmed/34127481

911. Galindo, R., Chow, H., & Rongkavilit, C. (2021). COVID-19 in Children: Clinical Manifestations and Pharmacologic Interventions Including Vaccine Trials. Pediatr Clin North Am, 68(5), 961-976. doi:10.1016/j.pcl.2021.05.004. https://www.ncbi.nlm.nih.gov/pubmed/34538306

912. Gargano, J. W., Wallace, M., Hadler, S. C., Langley, G., Su, J. R., Oster, M. E., . . . Oliver, S. E. (2021). Use of mRNA COVID-19 Vaccine After Reports of Myocarditis Among Vaccine Recipients: Update from the Advisory Committee on Immunization Practices – United States, June 2021. MMWR Morb Mortal Wkly Rep, 70(27), 977-982. doi:10.15585/mmwr.mm7027e2. https://www.ncbi.nlm.nih.gov/pubmed/34237049

913. Gatti, M., Raschi, E., Moretti, U., Ardizzoni, A., Poluzzi, E., & Diemberger, I. (2021). Influenza Vaccination and Myo-Pericarditis in Patients Receiving Immune Checkpoint Inhibitors: Investigating the Likelihood of Interaction through the Vaccine Adverse Event Reporting System and VigiBase. Vaccines (Basel), 9(1). doi:10.3390/vaccines9010019. https://www.ncbi.nlm.nih.gov/pubmed/33406694

914. Gautam, N., Saluja, P., Fudim, M., Jambhekar, K., Pandey, T., & Al’Aref, S. (2021). A Late Presentation of COVID-19 Vaccine-Induced Myocarditis. Cureus, 13(9), e17890. doi:10.7759/cureus.17890. https://www.ncbi.nlm.nih.gov/pubmed/34660088

915. Gellad, W. F. (2021). Myocarditis after vaccination against covid-19. BMJ, 375, n3090. doi:10.1136/bmj.n3090. https://www.ncbi.nlm.nih.gov/pubmed/34916217

916. Greenhawt, M., Abrams, E. M., Shaker, M., Chu, D. K., Khan, D., Akin, C., . . . Golden, D. B. K. (2021). The Risk of Allergic Reaction to SARS-CoV-2 Vaccines and Recommended Evaluation and Management: A Systematic Review, Meta-Analysis, GRADE Assessment, and International Consensus Approach. J Allergy Clin Immunol Pract, 9(10), 3546-3567. doi:10.1016/j.jaip.2021.06.006. https://www.ncbi.nlm.nih.gov/pubmed/34153517

917. Haaf, P., Kuster, G. M., Mueller, C., Berger, C. T., Monney, P., Burger, P., . . . Tanner, F. C. (2021). The very low risk of myocarditis and pericarditis after mRNA COVID-19 vaccination should not discourage vaccination. Swiss Med Wkly, 151, w30087. doi:10.4414/smw.2021.w30087. https://www.ncbi.nlm.nih.gov/pubmed/34668687

918. Hasnie, A. A., Hasnie, U. A., Patel, N., Aziz, M. U., Xie, M., Lloyd, S. G., & Prabhu, S. D. (2021). Perimyocarditis following first dose of the mRNA-1273 SARS-CoV-2 (Moderna) vaccine in a healthy young male: a case report. BMC Cardiovasc Disord, 21(1), 375. doi:10.1186/s12872-021-02183-3. https://www.ncbi.nlm.nih.gov/pubmed/34348657

919. Hause, A. M., Gee, J., Baggs, J., Abara, W. E., Marquez, P., Thompson, D., . . . Shay, D. K. (2021). COVID-19 Vaccine Safety in Adolescents Aged 12-17 Years – United States, December 14, 2020-July 16, 2021. MMWR Morb Mortal Wkly Rep, 70(31), 1053-1058. doi:10.15585/mmwr.mm7031e1. https://www.ncbi.nlm.nih.gov/pubmed/34351881

920. Helms, J. M., Ansteatt, K. T., Roberts, J. C., Kamatam, S., Foong, K. S., Labayog, J. S., & Tarantino, M. D. (2021). Severe, Refractory Immune Thrombocytopenia Occurring After SARS-CoV-2 Vaccine. J Blood Med, 12, 221-224. doi:10.2147/JBM.S307047. https://www.ncbi.nlm.nih.gov/pubmed/33854395

921. Hippisley-Cox, J., Patone, M., Mei, X. W., Saatci, D., Dixon, S., Khunti, K., . . . Coupland, C. A. C. (2021). Risk of thrombocytopenia and thromboembolism after covid-19 vaccination and SARS-CoV-2 positive testing: self-controlled case series study. BMJ, 374, n1931. doi:10.1136/bmj.n1931. https://www.ncbi.nlm.nih.gov/pubmed/34446426

922. Ho, J. S., Sia, C. H., Ngiam, J. N., Loh, P. H., Chew, N. W., Kong, W. K., & Poh, K. K. (2021). A review of COVID-19 vaccination and the reported cardiac manifestations. Singapore Med J. doi:10.11622/smedj.2021210. https://www.ncbi.nlm.nih.gov/pubmed/34808708

923. Iguchi, T., Umeda, H., Kojima, M., Kanno, Y., Tanaka, Y., Kinoshita, N., & Sato, D. (2021). Cumulative Adverse Event Reporting of Anaphylaxis After mRNA COVID-19 Vaccine (Pfizer-BioNTech) Injections in Japan: The First-Month Report. Drug Saf, 44(11), 1209-1214. doi:10.1007/s40264-021-01104-9. https://www.ncbi.nlm.nih.gov/pubmed/34347278

924. In brief: Myocarditis with the Pfizer/BioNTech and Moderna COVID-19 vaccines. (2021). Med Lett Drugs Ther, 63(1629), e9. Retrieved from https://www.ncbi.nlm.nih.gov/pubmed/34544112https://www.ncbi.nlm.nih.gov/pubmed/3454412

925. Ioannou, A. (2021a). Myocarditis should be considered in those with a troponin rise and unobstructed coronary arteries following Pfizer-BioNTech COVID-19 vaccination. QJM. doi:10.1093/qjmed/hcab231. https://www.ncbi.nlm.nih.gov/pubmed/34463755

926. Ioannou, A. (2021b). T2 mapping should be utilised in cases of suspected myocarditis to confirm an acute inflammatory process. QJM. doi:10.1093/qjmed/hcab326. https://www.ncbi.nlm.nih.gov/pubmed/34931681

927. Isaak, A., Feisst, A., & Luetkens, J. A. (2021). Myocarditis Following COVID-19 Vaccination. Radiology, 301(1), E378-E379. doi:10.1148/radiol.2021211766. https://www.ncbi.nlm.nih.gov/pubmed/34342500

928. Istampoulouoglou, I., Dimitriou, G., Spani, S., Christ, A., Zimmermanns, B., Koechlin, S., . . . Leuppi-Taegtmeyer, A. B. (2021). Myocarditis and pericarditis in association with COVID-19 mRNA-vaccination: cases from a regional pharmacovigilance centre. Glob Cardiol Sci Pract, 2021(3), e202118. doi:10.21542/gcsp.2021.18. https://www.ncbi.nlm.nih.gov/pubmed/34805376

929. Jaafar, R., Boschi, C., Aherfi, S., Bancod, A., Le Bideau, M., Edouard, S., . . . La Scola, B. (2021). High Individual Heterogeneity of Neutralizing Activities against the Original Strain and Nine Different Variants of SARS-CoV-2. Viruses, 13(11). doi:10.3390/v13112177. https://www.ncbi.nlm.nih.gov/pubmed/34834983

930. Jain, S. S., Steele, J. M., Fonseca, B., Huang, S., Shah, S., Maskatia, S. A., . . . Grosse-Wortmann, L. (2021). COVID-19 Vaccination-Associated Myocarditis in Adolescents. Pediatrics, 148(5). doi:10.1542/peds.2021-053427. https://www.ncbi.nlm.nih.gov/pubmed/34389692

931. Jhaveri, R., Adler-Shohet, F. C., Blyth, C. C., Chiotos, K., Gerber, J. S., Green, M., . . . Zaoutis, T. (2021). Weighing the Risks of Perimyocarditis With the Benefits of SARS-CoV-2 mRNA Vaccination in Adolescents. J Pediatric Infect Dis Soc, 10(10), 937-939. doi:10.1093/jpids/piab061. https://www.ncbi.nlm.nih.gov/pubmed/34270752

932. Kaneta, K., Yokoi, K., Jojima, K., Kotooka, N., & Node, K. (2021). Young Male With Myocarditis Following mRNA-1273 Vaccination Against Coronavirus Disease-2019 (COVID-19). Circ J. doi:10.1253/circj.CJ-21-0818. https://www.ncbi.nlm.nih.gov/pubmed/34744118

933. Kaul, R., Sreenivasan, J., Goel, A., Malik, A., Bandyopadhyay, D., Jin, C., . . . Panza, J. A. (2021). Myocarditis following COVID-19 vaccination. Int J Cardiol Heart Vasc, 36, 100872. doi:10.1016/j.ijcha.2021.100872. https://www.ncbi.nlm.nih.gov/pubmed/34568540

934. Khogali, F., & Abdelrahman, R. (2021). Unusual Presentation of Acute Perimyocarditis Following SARS-COV-2 mRNA-1237 Moderna Vaccination. Cureus, 13(7), e16590. doi:10.7759/cureus.16590. https://www.ncbi.nlm.nih.gov/pubmed/34447639

935. Kim, H. W., Jenista, E. R., Wendell, D. C., Azevedo, C. F., Campbell, M. J., Darty, S. N., . . . Kim, R. J. (2021). Patients With Acute Myocarditis Following mRNA COVID-19 Vaccination. JAMA Cardiol, 6(10), 1196-1201. doi:10.1001/jamacardio.2021.2828. https://www.ncbi.nlm.nih.gov/pubmed/34185046

936. Kim, I. C., Kim, H., Lee, H. J., Kim, J. Y., & Kim, J. Y. (2021). Cardiac Imaging of Acute Myocarditis Following COVID-19 mRNA Vaccination. J Korean Med Sci, 36(32), e229. doi:10.3346/jkms.2021.36.e229. https://www.ncbi.nlm.nih.gov/pubmed/34402228

937. King, W. W., Petersen, M. R., Matar, R. M., Budweg, J. B., Cuervo Pardo, L., & Petersen, J. W. (2021). Myocarditis following mRNA vaccination against SARS-CoV-2, a case series. Am Heart J Plus, 8, 100042. doi:10.1016/j.ahjo.2021.100042. https://www.ncbi.nlm.nih.gov/pubmed/34396358

938. Klein, N. P., Lewis, N., Goddard, K., Fireman, B., Zerbo, O., Hanson, K. E., . . . Weintraub, E. S. (2021). Surveillance for Adverse Events After COVID-19 mRNA Vaccination. JAMA, 326(14), 1390-1399. doi:10.1001/jama.2021.15072. https://www.ncbi.nlm.nih.gov/pubmed/34477808

939. Klimek, L., Bergmann, K. C., Brehler, R., Pfutzner, W., Zuberbier, T., Hartmann, K., . . . Worm, M. (2021). Practical handling of allergic reactions to COVID-19 vaccines: A position paper from German and Austrian Allergy Societies AeDA, DGAKI, GPA and OGAI. Allergo J Int, 1-17. doi:10.1007/s40629-021-00165-7. https://www.ncbi.nlm.nih.gov/pubmed/33898162

940. Klimek, L., Novak, N., Hamelmann, E., Werfel, T., Wagenmann, M., Taube, C., . . . Worm, M. (2021). Severe allergic reactions after COVID-19 vaccination with the Pfizer/BioNTech vaccine in Great Britain and USA: Position statement of the German Allergy Societies: Medical Association of German Allergologists (AeDA), German Society for Allergology and Clinical Immunology (DGAKI) and Society for Pediatric Allergology and Environmental Medicine (GPA). Allergo J Int, 30(2), 51-55. doi:10.1007/s40629-020-00160-4. https://www.ncbi.nlm.nih.gov/pubmed/33643776

941. Kohli, U., Desai, L., Chowdhury, D., Harahsheh, A. S., Yonts, A. B., Ansong, A., . . . Ang, J. Y. (2021). mRNA Coronavirus-19 Vaccine-Associated Myopericarditis in Adolescents: A Survey Study. J Pediatr. doi:10.1016/j.jpeds.2021.12.025. https://www.ncbi.nlm.nih.gov/pubmed/34952008

942. Kostoff, R. N., Calina, D., Kanduc, D., Briggs, M. B., Vlachoyiannopoulos, P., Svistunov, A. A., & Tsatsakis, A. (2021a). Erratum to “Why are we vaccinating children against COVID-19?” [Toxicol. Rep. 8C (2021) 1665-1684 / 1193]. Toxicol Rep, 8, 1981. doi:10.1016/j.toxrep.2021.10.003. https://www.ncbi.nlm.nih.gov/pubmed/34642628

943. Kostoff, R. N., Calina, D., Kanduc, D., Briggs, M. B., Vlachoyiannopoulos, P., Svistunov, A. A., & Tsatsakis, A. (2021b). Why are we vaccinating children against COVID-19? Toxicol Rep, 8, 1665-1684. doi:10.1016/j.toxrep.2021.08.010. https://www.ncbi.nlm.nih.gov/pubmed/34540594

944. Kremsner, P. G., Mann, P., Kroidl, A., Leroux-Roels, I., Schindler, C., Gabor, J. J., . . . Group, C.-N.-S. (2021). Safety and immunogenicity of an mRNA-lipid nanoparticle vaccine candidate against SARS-CoV-2 : A phase 1 randomized clinical trial. Wien Klin Wochenschr, 133(17-18), 931-941. doi:10.1007/s00508-021-01922-y. https://www.ncbi.nlm.nih.gov/pubmed/34378087

945. Kustin, T., Harel, N., Finkel, U., Perchik, S., Harari, S., Tahor, M., . . . Stern, A. (2021). Evidence for increased breakthrough rates of SARS-CoV-2 variants of concern in BNT162b2-mRNA-vaccinated individuals. Nat Med, 27(8), 1379-1384. doi:10.1038/s41591-021-01413-7. https://www.ncbi.nlm.nih.gov/pubmed/34127854

946. Kwan, M. Y. W., Chua, G. T., Chow, C. B., Tsao, S. S. L., To, K. K. W., Yuen, K. Y., . . . Ip, P. (2021). mRNA COVID vaccine and myocarditis in adolescents. Hong Kong Med J, 27(5), 326-327. doi:10.12809/hkmj215120. https://www.ncbi.nlm.nih.gov/pubmed/34393110

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948. Lee, E. J., Cines, D. B., Gernsheimer, T., Kessler, C., Michel, M., Tarantino, M. D., . . . Bussel, J. B. (2021). Thrombocytopenia following Pfizer and Moderna SARS-CoV-2 vaccination. Am J Hematol, 96(5), 534-537. doi:10.1002/ajh.26132. https://www.ncbi.nlm.nih.gov/pubmed/33606296

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950. Li, J., Hui, A., Zhang, X., Yang, Y., Tang, R., Ye, H., . . . Zhu, F. (2021). Safety and immunogenicity of the SARS-CoV-2 BNT162b1 mRNA vaccine in younger and older Chinese adults: a randomized, placebo-controlled, double-blind phase 1 study. Nat Med, 27(6), 1062-1070. doi:10.1038/s41591-021-01330-9. https://www.ncbi.nlm.nih.gov/pubmed/33888900

951. Li, M., Yuan, J., Lv, G., Brown, J., Jiang, X., & Lu, Z. K. (2021). Myocarditis and Pericarditis following COVID-19 Vaccination: Inequalities in Age and Vaccine Types. J Pers Med, 11(11). doi:10.3390/jpm11111106. https://www.ncbi.nlm.nih.gov/pubmed/34834458

952. Lim, Y., Kim, M. C., Kim, K. H., Jeong, I. S., Cho, Y. S., Choi, Y. D., & Lee, J. E. (2021). Case Report: Acute Fulminant Myocarditis and Cardiogenic Shock After Messenger RNA Coronavirus Disease 2019 Vaccination Requiring Extracorporeal Cardiopulmonary Resuscitation. Front Cardiovasc Med, 8, 758996. doi:10.3389/fcvm.2021.758996. https://www.ncbi.nlm.nih.gov/pubmed/34778411

953. Long, S. S. (2021). Important Insights into Myopericarditis after the Pfizer mRNA COVID-19 Vaccination in Adolescents. J Pediatr, 238, 5. doi:10.1016/j.jpeds.2021.07.057. https://www.ncbi.nlm.nih.gov/pubmed/34332972

954. Luk, A., Clarke, B., Dahdah, N., Ducharme, A., Krahn, A., McCrindle, B., . . . McDonald, M. (2021). Myocarditis and Pericarditis After COVID-19 mRNA Vaccination: Practical Considerations for Care Providers. Can J Cardiol, 37(10), 1629-1634. doi:10.1016/j.cjca.2021.08.001. https://www.ncbi.nlm.nih.gov/pubmed/34375696

955. Madelon, N., Lauper, K., Breville, G., Sabater Royo, I., Goldstein, R., Andrey, D. O., . . . Eberhardt, C. S. (2021). Robust T cell responses in anti-CD20 treated patients following COVID-19 vaccination: a prospective cohort study. Clin Infect Dis. doi:10.1093/cid/ciab954. https://www.ncbi.nlm.nih.gov/pubmed/34791081

956. Mangat, C., & Milosavljevic, N. (2021). BNT162b2 Vaccination during Pregnancy Protects Both the Mother and Infant: Anti-SARS-CoV-2 S Antibodies Persistently Positive in an Infant at 6 Months of Age. Case Rep Pediatr, 2021, 6901131. doi:10.1155/2021/6901131. https://www.ncbi.nlm.nih.gov/pubmed/34676123

957. Mark, C., Gupta, S., Punnett, A., Upton, J., Orkin, J., Atkinson, A., . . . Alexander, S. (2021). Safety of administration of BNT162b2 mRNA (Pfizer-BioNTech) COVID-19 vaccine in youths and young adults with a history of acute lymphoblastic leukemia and allergy to PEG-asparaginase. Pediatr Blood Cancer, 68(11), e29295. doi:10.1002/pbc.29295. https://www.ncbi.nlm.nih.gov/pubmed/34398511

958. Martins-Filho, P. R., Quintans-Junior, L. J., de Souza Araujo, A. A., Sposato, K. B., Souza Tavares, C. S., Gurgel, R. Q., . . . Santos, V. S. (2021). Socio-economic inequalities and COVID-19 incidence and mortality in Brazilian children: a nationwide register-based study. Public Health, 190, 4-6. doi:10.1016/j.puhe.2020.11.005. https://www.ncbi.nlm.nih.gov/pubmed/33316478

959. McLean, K., & Johnson, T. J. (2021). Myopericarditis in a previously healthy adolescent male following COVID-19 vaccination: A case report. Acad Emerg Med, 28(8), 918-921. doi:10.1111/acem.14322. https://www.ncbi.nlm.nih.gov/pubmed/34133825

960. Mevorach, D., Anis, E., Cedar, N., Bromberg, M., Haas, E. J., Nadir, E., . . . Alroy-Preis, S. (2021). Myocarditis after BNT162b2 mRNA Vaccine against Covid-19 in Israel. N Engl J Med, 385(23), 2140-2149. doi:10.1056/NEJMoa2109730. https://www.ncbi.nlm.nih.gov/pubmed/34614328

961. Minocha, P. K., Better, D., Singh, R. K., & Hoque, T. (2021). Recurrence of Acute Myocarditis Temporally Associated with Receipt of the mRNA Coronavirus Disease 2019 (COVID-19) Vaccine in a Male Adolescent. J Pediatr, 238, 321-323. doi:10.1016/j.jpeds.2021.06.035. https://www.ncbi.nlm.nih.gov/pubmed/34166671

962. Mizrahi, B., Lotan, R., Kalkstein, N., Peretz, A., Perez, G., Ben-Tov, A., . . . Patalon, T. (2021). Correlation of SARS-CoV-2-breakthrough infections to time-from-vaccine. Nat Commun, 12(1), 6379. doi:10.1038/s41467-021-26672-3. https://www.ncbi.nlm.nih.gov/pubmed/34737312

963. Moffitt, K., Cheung, E., Yeung, T., Stamoulis, C., & Malley, R. (2021). Analysis of Staphylococcus aureus Transcriptome in Pediatric Soft Tissue Abscesses and Comparison to Murine Infections. Infect Immun, 89(4). doi:10.1128/IAI.00715-20. https://www.ncbi.nlm.nih.gov/pubmed/33526560

964. Mohamed, L., Madsen, A. M. R., Schaltz-Buchholzer, F., Ostenfeld, A., Netea, M. G., Benn, C. S., & Kofoed, P. E. (2021). Reactivation of BCG vaccination scars after vaccination with mRNA-Covid-vaccines: two case reports. BMC Infect Dis, 21(1), 1264. doi:10.1186/s12879-021-06949-0. https://www.ncbi.nlm.nih.gov/pubmed/34930152

965. Montgomery, J., Ryan, M., Engler, R., Hoffman, D., McClenathan, B., Collins, L., . . . Cooper, L. T., Jr. (2021). Myocarditis Following Immunization With mRNA COVID-19 Vaccines in Members of the US Military. JAMA Cardiol, 6(10), 1202-1206. doi:10.1001/jamacardio.2021.2833. https://www.ncbi.nlm.nih.gov/pubmed/34185045

966. Murakami, Y., Shinohara, M., Oka, Y., Wada, R., Noike, R., Ohara, H., . . . Ikeda, T. (2021). Myocarditis Following a COVID-19 Messenger RNA Vaccination: A Japanese Case Series. Intern Med. doi:10.2169/internalmedicine.8731-21. https://www.ncbi.nlm.nih.gov/pubmed/34840235

967. Nagasaka, T., Koitabashi, N., Ishibashi, Y., Aihara, K., Takama, N., Ohyama, Y., . . . Kaneko, Y. (2021). Acute Myocarditis Associated with COVID-19 Vaccination: A Case Report. J Cardiol Cases. doi:10.1016/j.jccase.2021.11.006. https://www.ncbi.nlm.nih.gov/pubmed/34876937

968. Ntouros, P. A., Vlachogiannis, N. I., Pappa, M., Nezos, A., Mavragani, C. P., Tektonidou, M. G., . . . Sfikakis, P. P. (2021). Effective DNA damage response after acute but not chronic immune challenge: SARS-CoV-2 vaccine versus Systemic Lupus Erythematosus. Clin Immunol, 229, 108765. doi:10.1016/j.clim.2021.108765. https://www.ncbi.nlm.nih.gov/pubmed/34089859

969. Nygaard, U., Holm, M., Bohnstedt, C., Chai, Q., Schmidt, L. S., Hartling, U. B., . . . Stensballe, L. G. (2022). Population-based Incidence of Myopericarditis After COVID-19 Vaccination in Danish Adolescents. Pediatr Infect Dis J, 41(1), e25-e28. doi:10.1097/INF.0000000000003389. https://www.ncbi.nlm.nih.gov/pubmed/34889875

970. Oberhardt, V., Luxenburger, H., Kemming, J., Schulien, I., Ciminski, K., Giese, S., . . . Hofmann, M. (2021). Rapid and stable mobilization of CD8(+) T cells by SARS-CoV-2 mRNA vaccine. Nature, 597(7875), 268-273. doi:10.1038/s41586-021-03841-4. https://www.ncbi.nlm.nih.gov/pubmed/34320609

971. Park, H., Yun, K. W., Kim, K. R., Song, S. H., Ahn, B., Kim, D. R., . . . Kim, Y. J. (2021). Epidemiology and Clinical Features of Myocarditis/Pericarditis before the Introduction of mRNA COVID-19 Vaccine in Korean Children: a Multicenter Study. J Korean Med Sci, 36(32), e232. doi:10.3346/jkms.2021.36.e232. https://www.ncbi.nlm.nih.gov/pubmed/34402230

972. Park, J., Brekke, D. R., & Bratincsak, A. (2021). Self-limited myocarditis presenting with chest pain and ST segment elevation in adolescents after vaccination with the BNT162b2 mRNA vaccine. Cardiol Young, 1-4. doi:10.1017/S1047951121002547. https://www.ncbi.nlm.nih.gov/pubmed/34180390

973. Patel, Y. R., Louis, D. W., Atalay, M., Agarwal, S., & Shah, N. R. (2021). Cardiovascular magnetic resonance findings in young adult patients with acute myocarditis following mRNA COVID-19 vaccination: a case series. J Cardiovasc Magn Reson, 23(1), 101. doi:10.1186/s12968-021-00795-4. https://www.ncbi.nlm.nih.gov/pubmed/34496880

974. Patone, M., Mei, X. W., Handunnetthi, L., Dixon, S., Zaccardi, F., Shankar-Hari, M., . . . Hippisley-Cox, J. (2021). Risks of myocarditis, pericarditis, and cardiac arrhythmias associated with COVID-19 vaccination or SARS-CoV-2 infection. Nat Med. doi:10.1038/s41591-021-01630-0. https://www.ncbi.nlm.nih.gov/pubmed/34907393

975. Patrignani, A., Schicchi, N., Calcagnoli, F., Falchetti, E., Ciampani, N., Argalia, G., & Mariani, A. (2021). Acute myocarditis following Comirnaty vaccination in a healthy man with previous SARS-CoV-2 infection. Radiol Case Rep, 16(11), 3321-3325. doi:10.1016/j.radcr.2021.07.082. https://www.ncbi.nlm.nih.gov/pubmed/34367386

976. Perez, Y., Levy, E. R., Joshi, A. Y., Virk, A., Rodriguez-Porcel, M., Johnson, M., . . . Swift, M. D. (2021). Myocarditis Following COVID-19 mRNA Vaccine: A Case Series and Incidence Rate Determination. Clin Infect Dis. doi:10.1093/cid/ciab926. https://www.ncbi.nlm.nih.gov/pubmed/34734240

977. Perrotta, A., Biondi-Zoccai, G., Saade, W., Miraldi, F., Morelli, A., Marullo, A. G., . . . Peruzzi, M. (2021). A snapshot global survey on side effects of COVID-19 vaccines among healthcare professionals and armed forces with a focus on headache. Panminerva Med, 63(3), 324-331. doi:10.23736/S0031-0808.21.04435-9. https://www.ncbi.nlm.nih.gov/pubmed/34738774

978. Pinana, J. L., Lopez-Corral, L., Martino, R., Montoro, J., Vazquez, L., Perez, A., . . . Cell Therapy, G. (2022). SARS-CoV-2-reactive antibody detection after SARS-CoV-2 vaccination in hematopoietic stem cell transplant recipients: Prospective survey from the Spanish Hematopoietic Stem Cell Transplantation and Cell Therapy Group. Am J Hematol, 97(1), 30-42. doi:10.1002/ajh.26385. https://www.ncbi.nlm.nih.gov/pubmed/34695229

979. Revon-Riviere, G., Ninove, L., Min, V., Rome, A., Coze, C., Verschuur, A., . . . Andre, N. (2021). The BNT162b2 mRNA COVID-19 vaccine in adolescents and young adults with cancer: A monocentric experience. Eur J Cancer, 154, 30-34. doi:10.1016/j.ejca.2021.06.002. https://www.ncbi.nlm.nih.gov/pubmed/34233234

980. Sanchez Tijmes, F., Thavendiranathan, P., Udell, J. A., Seidman, M. A., & Hanneman, K. (2021). Cardiac MRI Assessment of Nonischemic Myocardial Inflammation: State of the Art Review and Update on Myocarditis Associated with COVID-19 Vaccination. Radiol Cardiothorac Imaging, 3(6), e210252. doi:10.1148/ryct.210252. https://www.ncbi.nlm.nih.gov/pubmed/34934954

981. Schauer, J., Buddhe, S., Colyer, J., Sagiv, E., Law, Y., Mallenahalli Chikkabyrappa, S., & Portman, M. A. (2021). Myopericarditis After the Pfizer Messenger Ribonucleic Acid Coronavirus Disease Vaccine in Adolescents. J Pediatr, 238, 317-320. doi:10.1016/j.jpeds.2021.06.083. https://www.ncbi.nlm.nih.gov/pubmed/34228985

982. Schneider, J., Sottmann, L., Greinacher, A., Hagen, M., Kasper, H. U., Kuhnen, C., . . . Schmeling, A. (2021). Postmortem investigation of fatalities following vaccination with COVID-19 vaccines. Int J Legal Med, 135(6), 2335-2345. doi:10.1007/s00414-021-02706-9. https://www.ncbi.nlm.nih.gov/pubmed/34591186

983. Schramm, R., Costard-Jackle, A., Rivinius, R., Fischer, B., Muller, B., Boeken, U., . . . Gummert, J. (2021). Poor humoral and T-cell response to two-dose SARS-CoV-2 messenger RNA vaccine BNT162b2 in cardiothoracic transplant recipients. Clin Res Cardiol, 110(8), 1142-1149. doi:10.1007/s00392-021-01880-5. https://www.ncbi.nlm.nih.gov/pubmed/34241676

984. Sessa, F., Salerno, M., Esposito, M., Di Nunno, N., Zamboni, P., & Pomara, C. (2021). Autopsy Findings and Causality Relationship between Death and COVID-19 Vaccination: A Systematic Review. J Clin Med, 10(24). doi:10.3390/jcm10245876. https://www.ncbi.nlm.nih.gov/pubmed/34945172

985. Sharif, N., Alzahrani, K. J., Ahmed, S. N., & Dey, S. K. (2021). Efficacy, Immunogenicity and Safety of COVID-19 Vaccines: A Systematic Review and Meta-Analysis. Front Immunol, 12, 714170. doi:10.3389/fimmu.2021.714170. https://www.ncbi.nlm.nih.gov/pubmed/34707602

986. Shay, D. K., Gee, J., Su, J. R., Myers, T. R., Marquez, P., Liu, R., . . . Shimabukuro, T. T. (2021). Safety Monitoring of the Janssen (Johnson & Johnson) COVID-19 Vaccine – United States, March-April 2021. MMWR Morb Mortal Wkly Rep, 70(18), 680-684. doi:10.15585/mmwr.mm7018e2. https://www.ncbi.nlm.nih.gov/pubmed/33956784

987. Shazley, O., & Alshazley, M. (2021). A COVID-Positive 52-Year-Old Man Presented With Venous Thromboembolism and Disseminated Intravascular Coagulation Following Johnson & Johnson Vaccination: A Case-Study. Cureus, 13(7), e16383. doi:10.7759/cureus.16383. https://www.ncbi.nlm.nih.gov/pubmed/34408937

988. Shiyovich, A., Witberg, G., Aviv, Y., Eisen, A., Orvin, K., Wiessman, M., . . . Hamdan, A. (2021). Myocarditis following COVID-19 vaccination: magnetic resonance imaging study. Eur Heart J Cardiovasc Imaging. doi:10.1093/ehjci/jeab230. https://www.ncbi.nlm.nih.gov/pubmed/34739045

989. Simone, A., Herald, J., Chen, A., Gulati, N., Shen, A. Y., Lewin, B., & Lee, M. S. (2021). Acute Myocarditis Following COVID-19 mRNA Vaccination in Adults Aged 18 Years or Older. JAMA Intern Med, 181(12), 1668-1670. doi:10.1001/jamainternmed.2021.5511. https://www.ncbi.nlm.nih.gov/pubmed/34605853

990. Singer, M. E., Taub, I. B., & Kaelber, D. C. (2021). Risk of Myocarditis from COVID-19 Infection in People Under Age 20: A Population-Based Analysis. medRxiv. doi:10.1101/2021.07.23.21260998. https://www.ncbi.nlm.nih.gov/pubmed/34341797

991. Smith, C., Odd, D., Harwood, R., Ward, J., Linney, M., Clark, M., . . . Fraser, L. K. (2021). Deaths in children and young people in England after SARS-CoV-2 infection during the first pandemic year. Nat Med. doi:10.1038/s41591-021-01578-1. https://www.ncbi.nlm.nih.gov/pubmed/34764489

992. Snapiri, O., Rosenberg Danziger, C., Shirman, N., Weissbach, A., Lowenthal, A., Ayalon, I., . . . Bilavsky, E. (2021). Transient Cardiac Injury in Adolescents Receiving the BNT162b2 mRNA COVID-19 Vaccine. Pediatr Infect Dis J, 40(10), e360-e363. doi:10.1097/INF.0000000000003235. https://www.ncbi.nlm.nih.gov/pubmed/34077949

993. Spinner, J. A., Julien, C. L., Olayinka, L., Dreyer, W. J., Bocchini, C. E., Munoz, F. M., & Devaraj, S. (2021). SARS-CoV-2 anti-spike antibodies after vaccination in pediatric heart transplantation: A first report. J Heart Lung Transplant. doi:10.1016/j.healun.2021.11.001. https://www.ncbi.nlm.nih.gov/pubmed/34911654

994. Starekova, J., Bluemke, D. A., Bradham, W. S., Grist, T. M., Schiebler, M. L., & Reeder, S. B. (2021). Myocarditis Associated with mRNA COVID-19 Vaccination. Radiology, 301(2), E409-E411. doi:10.1148/radiol.2021211430. https://www.ncbi.nlm.nih.gov/pubmed/34282971

995. Sulemankhil, I., Abdelrahman, M., & Negi, S. I. (2021). Temporal association between the COVID-19 Ad26.COV2.S vaccine and acute myocarditis: A case report and literature review. Cardiovasc Revasc Med. doi:10.1016/j.carrev.2021.08.012. https://www.ncbi.nlm.nih.gov/pubmed/34420869

996. Tailor, P. D., Feighery, A. M., El-Sabawi, B., & Prasad, A. (2021). Case report: acute myocarditis following the second dose of mRNA-1273 SARS-CoV-2 vaccine. Eur Heart J Case Rep, 5(8), ytab319. doi:10.1093/ehjcr/ytab319. https://www.ncbi.nlm.nih.gov/pubmed/34514306

997. Takeda, M., Ishio, N., Shoji, T., Mori, N., Matsumoto, M., & Shikama, N. (2021). Eosinophilic Myocarditis Following Coronavirus Disease 2019 (COVID-19) Vaccination. Circ J. doi:10.1253/circj.CJ-21-0935. https://www.ncbi.nlm.nih.gov/pubmed/34955479

998. Team, C. C.-R., Food, & Drug, A. (2021). Allergic Reactions Including Anaphylaxis After Receipt of the First Dose of Pfizer-BioNTech COVID-19 Vaccine – United States, December 14-23, 2020. MMWR Morb Mortal Wkly Rep, 70(2), 46-51. doi:10.15585/mmwr.mm7002e1. https://www.ncbi.nlm.nih.gov/pubmed/33444297

999. Thompson, M. G., Burgess, J. L., Naleway, A. L., Tyner, H., Yoon, S. K., Meece, J., . . . Gaglani, M. (2021). Prevention and Attenuation of Covid-19 with the BNT162b2 and mRNA-1273 Vaccines. N Engl J Med, 385(4), 320-329. doi:10.1056/NEJMoa2107058. https://www.ncbi.nlm.nih.gov/pubmed/34192428

1000. Tinoco, M., Leite, S., Faria, B., Cardoso, S., Von Hafe, P., Dias, G., . . . Lourenco, A. (2021). Perimyocarditis Following COVID-19 Vaccination. Clin Med Insights Cardiol, 15, 11795468211056634. doi:10.1177/11795468211056634. https://www.ncbi.nlm.nih.gov/pubmed/34866957

1001. Truong, D. T., Dionne, A., Muniz, J. C., McHugh, K. E., Portman, M. A., Lambert, L. M., . . . Newburger, J. W. (2021). Clinically Suspected Myocarditis Temporally Related to COVID-19 Vaccination in Adolescents and Young Adults. Circulation. doi:10.1161/CIRCULATIONAHA.121.056583. https://www.ncbi.nlm.nih.gov/pubmed/34865500

1002. Tutor, A., Unis, G., Ruiz, B., Bolaji, O. A., & Bob-Manuel, T. (2021). Spectrum of Suspected Cardiomyopathy Due to COVID-19: A Case Series. Curr Probl Cardiol, 46(10), 100926. doi:10.1016/j.cpcardiol.2021.100926. https://www.ncbi.nlm.nih.gov/pubmed/34311983

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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.

Third part of a timeline of ivermectin-related events in theCOVID-19 pandemic

See Part 1 and Part 2

Mika Turkia M.Sc.
mika.turkia@alumni.helsinki.fi
September 30, 2021

Abstract

This review presents a third part extending two previous parts of a timeline describing ivermectin-related events in the COVID-19 pandemic, with this third part covering a period from July 2021 to September 2021.

Among the most notable developments during the period were allegations that a clinical trial about prophylaxis and late treatment of COVID-19 with ivermectin by Elgazzar et al. carried out in Egypt in mid-2020was fraudulent, with some of the introduction plagiarized and the patient data claimed to appear fabricated.

The government of Egypt initiated an investigation on the issue, the results of which were not available bythe end of the period.

Ivermectin skeptics noted that the retraction of the Elgazzar et al. trial, along with suspicions about failed randomization in another trial by Niaee et al., seemed to invalidate the various meta-analyses which had included these trials. Ivermectin proponents argued that the retraction did not affect the conclusions of their meta-analyses. Later, the validity of an Argentinian prophylaxis trial by Carvallo et al. was questioned; as an observational trial it had not been included in the meta-analyses.

Among new trial results were the results of ’Together’ trial led by a Canadian university but carried out in Brazil. The primary endpoint was extended emergency room observation or hospitalization, and the secondary endpoint was mortality. Fluvoxamine produced a statistically significant result for the first endpoint but not for the second. In 677 treated patients vs 678 controls ivermectin indicated some risk reduction but the differences were not statistically significant. One of the authors concluded that ivermectin had ’noeffect whatsoever’ on their endpoints. On the other hand, a intervention program in La Pampa province of Argentina with 3,269 treated and 18,149 untreated indicated mortality rates of 1.5% vs 2.1% (p=0.029),and in subjects over 40 years 2.7% vs 4.1% (p=0.005). A Cochrane meta-analysis concluded that all aspects regarding ivermectin’s efficacy for either treatment or prophylaxis were currently unknown.

After a 24-fold increase in ivermectin prescriptions from US pharmacies compared to the pre-pandemic baseline, US Food and Drug Administration (FDA), American Medical Association, American Pharmacists Association and American Society of Health-System Pharmacists campaigned against ivermectin, calling for‘an immediate end’ to prescribing, dispensing and using it. However, this campaigning also resulted in an increased public awareness of ivermectin.

A prominent social media figure with over ten million followers revealed that he had been prescribed ivermectin for COVID-19. The fact was subsequently propagated internationally by the news media which represented ivermectin as a dangerous ‘horse dewormer’. Several international news outlets published a false story about emergency rooms in Oklahoma being full of people having overdosed ivermectin, blocking out other patients including gunshot victims.

A Japanese doctor who had treated 500 patients with ivermectin reported having received death threats after telling about his methods on a television program. A group of British scientists which had published a meta-analysis about ivermectin reported having received death threats after questioning the efficacy of ivermectin. An ivermectin discussion forum was flooded with pornographic images and incoherent babbling.

A hospital was harassed for not administering ivermectin.

An Indian physician claimed that due to the World Health Organization’s opposition to ivermectin, India’s second wave had been countered by an almost nationwide covert use of early treatment protocols including ivermectin. Another physician reported that in one city in Amazonas, Brazil, a mass distribution of ivermectin had resulted in the city having no hospitalized COVID-19 patients during the surge of the gamma variant in the first half of 2021.

Frontline COVID-19 Critical Care Alliance (FLCCC) faced criticism for its ivermectin advocacy and communication style. With regard to treatment protocols, the addition of dual anti-androgen therapy to FLCCC’sMATH+ hospital treatment protocol was said to have restored the protocol’s efficacy against the delta variant in intensive care unit patients. FLCCC also published a scoping review of the pathophysiology ofCOVID-19, emphasizing the role of platelet activation with the release of serotonin and the activation and degranulation of mast cells contributing to the hyper-inflammatory state.

In an overview, the period from April 2020 to March 2021 could be characterized as a period of argumentation and attempted rationality, the period from April 2021 to June 2021 as a period of emotion and campaigning,and the period from July 2021 to September 2021 as a period of chaos.

Current best practices for meta-analyses were found to be unsound. A new approach based on individual patient data analysis was proposed.

Introduction

The period covering the first part of the timeline from April 2020 to March 2021 [1] could be characterized as a period of research, argumentation and rationality. During the period, smaller-scale research and experimentation of ivermectin for COVID-19 was pursued and eventually, alliances and groups of clinicians and researchers were formed to promote combination treatment protocols that included ivermectin. However, at the end of the period, first the European Medicine Agency (EMA) and second the World Health Organization(WHO) advised against the use of ivermectin except in clinical trials.

The second period from April 2021 to June 2021 [2] could be characterized as a period of emotion and campaigning. During the period, a failure of the approach based on argumentation led to a disillusionment of clinicians and researchers in favor of ivermectin treatments and stopped communication between the proponents and administrative agencies. Instead, ivermectin proponents turned directly to the public and the clinicians. The analysis related to the second part of the timeline focused on possible structural corruption and the role of the WHO.

The third period from July 2021 to September 2021 covered in this paper might best be characterized as a period of chaos, initiated by accusations of plagiarism and data fabrication in one of the early ivermectin trials [3]. As the trial was included in published meta-analyses of ivermectin’s efficacy [4,5,6], the allegations undermined the believability of these meta-analyses, although the authors of the meta-analyses at first stated that the exclusion did not essentially change the results of the analyses. Later, one of the groups diverged from this view.

The history, indications and safety of ivermectin have been described in the previous parts. Some events preceding July 2021 not included in the previous parts of the timeline have been included.

March 2020

On March 25, Waltner-Toews et al. wrote that COVID-19 requires a new approach to science [7]. They referred to ‘post-normal science’ (PNS) developed in the 1990s by Silvio Funtowicz and Jerome R. Ravetz which represented a novel approach for the use of science on issues where ‘facts are uncertain, values in dispute, stakes high and decisions urgent’ [8]. As an example, PNS recommended that models to predict and control the future should be replaced by models to map our ignorance about the future; it also stressed the importance of trust, participation and transparency, all of which had been lacking during the COVID-19pandemic. Waltner-Toews et al. wrote that ‘everywhere, we are seeing a total breakdown of the epistemic consensus required to make normal science “work”. This is happening not only in the fields you might expect– behavioral psychology, sociology, and ethics – but also in virology, genetics, and epidemiology. In other words, when “applied scientists” and “professional consultants” are no longer in their comfort zones but find themselves in a post-normal context, fitness for purpose changes meaning. And even in established fields, disagreements can’t be hidden (or consensus enforced) from broad audiences: are the present draconian measures justified or not? More data (even “reliable data”) and better predictive models cannot resolve the“distribution of sacrifice” which involves, among other things, the arbitration of dilemmas that appear at every scale. Hiding behind some general notion of science or the “lack of data” – as if data had the power to resolve these dilemmas – is feckless, feeble and confused’.

November 2020

On November 29, an article by Cherkes et al. in the clinical practice guidelines and recommendations section of an Ukrainian journal Proceedings of the Shevchenko Scientific Society – Medical Sciences gave a detailed description of FLCCC’s MATH+ hospital treatment protocol [9].

April 2021

On April 14, an article by Seet et al. described an open-label randomized trial (n=3,037) describing a 42-day prophylaxis regimen with four different medications, one of which was povidone iodine throat spray(n=735), compared to 500 mg per day of oral vitamin C (n=619), indicated 44.7% lower risk of severe disease (5.7% vs 10.3%, RR 0.55, p=0.05) and 31.1% lower risk of infection (46.0% vs 70.0%, RR 0.69,p=0.01) [10,11]. A single 12 mg dose of ivermectin (n=617) did not produce a statistically significant difference. Hydroxychloroquine produced a slightly smaller risk reduction than povidone iodine.

May 2021

On May 11, two Norwegian doctors presented data on ivermectin trials to the Norwegian government [12].

On May 26, an investigational monoclonal antibody for mild to moderate COVID-19, sotrovimab, was issued an emergency use authorization by the US Food and Drug Administration (FDA). Sotrovimab was to be administered as a single intravenous infusion of 500 mg over 30 minutes within 10 days of symptom onset [13].

The wholesale price of a single dose was USD 2,100 [14].

On May 28, Bloomberg Law discussed YouTube’s censorship practices [15]. YouTube chief executive officer Susan Wojcicki commented that ‘the complex nature of misinformation online presents a number of challenges for platforms such as YouTube and I welcome your suggestions as to what we can do better’.

June 2021

On June 1, a commentary by Chosidow et al. asked whether ivermectin would be a potential treatment forCOVID-19 [16].

On June 4, an article by Payne et al. about evidence-based approach to early outpatient treatment considered zinc gluconate, melatonin and vitamin D feasible options but repeated the usual objections to ivermectin[17].

On June 7, an article by Sajidah et al. discussed the host nuclear transport machinery in detail [18].

On June 10, Kumar et al. discussed the role of vitamins and minerals as immunity boosters in COVID-19, pointing out for example the protective roles of calcium, magnesium, copper, iodine, selenium, manganese,cobalt and sulfur, and the possibly harmful effect of iron [19].

On June 14, an article by Duru et al. described an in silico study suggesting that ivermectin bound well toSARS-CoV-2 spike glycoprotein [20].

On June 17, an article by Yanagida et al. concluded that ivermectin had low proarrhythmic risk [21].

On June 18, an article by Mart´ınez investigated the antioxidant properties of several pharmaceuticals, positing the idea that oxide reduction balance might help explain the toxicity or efficacy of these drugs, and noting that ivermectin and molnupiravir, two powerful COVID-19 drugs, were not good electron acceptors,and the fact that they were not as effective oxidants as other studied molecules might be an advantage [22].

On June 18, a commentary by Taibbi discussed politicization and censorship of ivermectin in the US [23,24].

On June 18, a Norwegian newspaper Aftenposten interviewed two Norwegian proponents of FLCCC protocols, one of whom was FLCCC founding member Eivind Hustad Vinjevoll [25] and the other Anders Bugge.

The Norwegian Medicines Agency remained unconvinced, stating that it was not their task to assess unapproved treatments: they only followed the recommendations of US National Institutes of Health and the World Health Organization.

On June 21, referring to lack of evidence and low quality of trials, eleven Norwegian senior physicians disagreed with Vinjevoll’s and Bugge’s views [26].

On June 22, Huang et al. summarized recent advances in the exploration of ivermectin’s anticancer properties [27].

On June 27, Salvador et al. published a protocol of a prospective observational study aiming to evaluate the effectiveness and safety of a single-dose ivermectin for treatment of uncomplicated strongyloidiasis in immunosuppressed patients [28].

On June 28, Bugge replied to the Norwegian senior physicians [29].

On June 28, an article by Roman et al. presented a meta-analysis of ten randomized controlled trials(RCTs) including 1,173 patients with mild or moderate disease [30]. The authors wrote that in comparison to standard of care or placebo, ivermectin did not reduce all-cause mortality, length of stay or viral clearance.

They concluded that ivermectin was not a viable option to treat COVID-19 patients. The article was based on a previous preprint [31,32]. The CovidAnalysis group noted that in addition to numerous uncorrected errors,the preprint and the PDF of the article stated that the authors had no conflicts of interest, yet Pasupuleti’saffiliation listed in the abstract on the journal’s website was a company delivering brand and portfolio commercial strategy for biotech and pharma, working with 24 of the top 25 pharmaceutical companies as well as hundreds of biotechs globally [33,34]. The company also stated that they were working withthe European Federation of Pharmaceutical Industries (EFPIA) to support their activities, and that the company’s regulatory consultancy practice in the US was preparing a number of emergency use authorizations to the FDA [35].

On June 28, an article by Patterson et al. presented a model for predicting COVID-19 severity and chronicity [36]. A score measuring severity of COVID-19 was defined as (IL-6 + sCD40L / 1000 + VEGF / 10 + 10 * IL-10) / (IL-2 + IL-8). A score measuring chronicity (long haul symptoms) was defined as (IFN-γ+ IL-2) / CCL4-MIP-1β. CCL4 (chemokine ligands 4), also called MIP-1β(macrophage inflammatory protein-1β),was related to the C-C chemokine receptor type 5 (CCR5) pathway. About VEGF, see also [37,38,39,40].

On June 30, Thailand’s FDA and Chiang Mai University’s faculty of pharmacy warned against using ivermectin for COVID-19 [41].

On June 30, an article by Nippes et al. reviewed research on the presence of chloroquine, hydroxychloroquine, azithromycin, ivermectin, dexamethasone, remdesivir, favipiravir and some HIV antivirals in the environment, and presented treatment technologies for each drug [42].

On June 30, Syed interviewed FLCCC’s Marik about treatments and the origin of SARS-CoV-2 [43].

July 2021

On July 1, HART group consisting of UK doctors compared adverse events reported to the WHO of ivermectin (20 deaths and 5,484 adverse events since 1992), remdesivir (534 deaths and 6,707 adverse events since 2020) and COVID-19 vaccines (6,667 deaths and 1,198,200 adverse events since 2020) [44]. They also suggested that some of the ongoing studies were designed to fail and actually aimed at stalling the adoption of ivermectin.

On July 1, Vice magazine wrote about ivermectin advocates, saying that ‘proponents of a dubious COVID19 cure have signaled they’re ready for a long fight against what they see as censorship in medicine and media’ [45].

On July 2, an article by Vallejos et al. described a low dose RCT with 501 relatively low-risk outpatients in Argentina which did not produce statistically significant results (NCT04529525) [46,47].

On July 2, an article by Adegboro et al. reviewed the antiviral effects of ivermectin [48].

On July 2, a Twitter post reported that a video featuring Nobel prize winner Satoshi ¯Omura discussing Japanese ivermectin emergency use authorization bill had been removed by YouTube for violating their terms of service [49].

On July 2, a blog post by Crawford investigated the details and the background of the meta-analysis by Roman et al., noting that the meta-analysis came at a politically contentious moment, the language and behavior appeared political, the work was error-laden, took research out of its true context, used numbers that didn’t seem to come from the actual studies, chose papers testing ivermectin under the least favorable circumstances, gave unexplained and inappropriate weights to the small amount of data that stood as outliers to the bigger picture, and extracted an unfavorable conclusion from a massive average mortality reduction that did not quite reach statistical significance while consistently complaining about the low quality of evidence represented by the studies [50]. Crawford asked whether these were ‘just mistakes’, adding that ‘a medical journal published all this – just in time to push back the Lawrie case. Think on all that for a moment’.

On July 3, an open letter signed by 43 researchers and clinicians requested retraction of the meta-analysis by Roman et al. [51,52].

On July 6, an article by Hill et al. (submitted on January 20) presented a meta-analysis including eleven RCTs of moderate/severe infection [5]. The analysis indicated 56% reduction in mortality (3% vs 9%, RR0.44, 95% CI 0.25-0.77, p=0.004), favorable clinical recovery and reduced hospitalization. In contrast to the preprint stating that ivermectin should be validated in larger studies before the results are sufficient for review by regulatory authorities [53], the published version said that a network of large clinical trials was in progress to validate the results seen to date.

On July 6, a TrialSite news report suggested that the WHO might have been attempting to limit the use of ivermectin to neglected tropical diseases only [54,55,56]. The report also discussed the apparent lack of objectivity of Wikipedia, noting that it had, among other omissions, mentioned the rejection of FLCCC’s review by Frontiers of Pharmacology but failed to mention that it had later been published in the American Journal of Therapeutics, failed to mention the meta-analysis by the BIRD group, and failed to mention USNIH’s transitioning to a neutral stance on ivermectin. The report asked why any positive aspects would be omitted unless there was an explicit goal to completely discredit this possible therapeutic option and researchers looking into the matter.

On July 6, Yahoo News UK published a news story featuring ivermectin in a positive light [57].

On July 6, WHO announced that it had updated its patient care guidelines to include interleukin-6 receptor blockers tocilizumab (by Roche) and sarilumab (by Regeneron Pharmaceuticals and Sanofi) [58]. The strong recommendation was based on findings from a prospective and a living network meta-analysis including data(also prepublication data) from over 10,000 patients enrolled in 27 clinical trials. The meta-analyses were said to show that in severely or critically ill patients these drugs reduced the odds of death by 13% and the odds of mechanical ventilation by 28% compared to standard of care, with high certainty of evidence [59]. WHO said tocilizumab and sarilumab were the first drugs found to be effective against COVID-19 since corticosteroids were recommended in September 2020 [58]. WHO director-general Tedros Adhanom Ghebreyesus said, however, that the drugs would remain inaccessible to most, and called on manufacturers to reduce prices and make supplies available to low-and middle-income countries. Ghebreyesus also encouraged companies to agree to transparent, non-exclusive voluntary licensing agreements using WHO’s Covid-19 Technology Access Pool (C-TAP) platform and the Medicines Patent Pool, or to waive exclusivity rights. Rochwerg et al. noted that compared with other treatments IL-6 receptor blockers were expensive but the the recommendation did not take account of cost effectiveness [59]. They also acknowledged that access to these drugs was challenging in many parts of the world and that the recommendation could exacerbate health inequity. However, the strong recommendation aimed at providing a stimulus to improve global access to these treatments.

On July 6, an article by WHO Rapid Evidence Appraisal for COVID-19 Therapies (REACT) WorkingGroup presented a meta-analysis on the efficacy of tocilizumab and sarilumab [60]. Absolute mortality risk was 22% for IL-6 antagonists compared with an assumed mortality risk of 25% for standard of care or placebo, with especially sarilumab showing very low efficacy. Regarding conflicts of interests, one of the authors reported being involved with two patents owned by Genentech/Roche, one on treating COVID-19with an IL-6 antagonist, and another for tocilizumab and remdesivir combination therapy for COVID-19pneumonia. Two other authors reported being co-inventors of a filed patent covering the use of low-dose tocilizumab for treatment of viral infections. Nine other authors also reported associations with Roche.

Seven authors reported associations with Sanofi. Three reported being employees of and owning stock in Regeneron, and two reported other associations with it. Also associations with, for example, Merck Sharp and Dohme, Gilead Sciences, ViiV Healthcare, Janssen, Cilag, Thera technologies, Lilly, Biohope, Gebro, Bristo lMyers Squibb, Abbvie, Pfizer, Novartis, PharmaMar, GlaxoSmithKline, Boehringer Ingelheim, Celgene,Alexion, Inatherys, AB Science, Argenx, Oncoarendi, Biogen, Ose Pharmaceutical, Shionogi, Genetech, EliLilly, Swedish Orphan Biovitrum AB, Sanofi Genzyme, Aspen Pharmacare, Crist´alia and AM Pharma were reported.

On July 6, a press release by M´edecins Sans Fronti`eres (MSF) noted that the Swiss pharmaceutical company Roche continued to have de facto market exclusivity and tocilizumab was likely to remain unaffordable and inaccessible for most of the world [61]. MSF wrote that Roche had kept the price of tocilizumab very high in most countries (USD 410 in Australia, USD 646 in India and USD 3,625 in the US per dose of 600mg for COVID-19, while the manufacturing cost was estimated to be around USD 60).

On July 6, an article by Malin et al. presented a key summary of German national treatment guidance for COVID-19 inpatients [62]. The guideline recommended corticosteroids, prophylactic anti-coagulation, and optionally tocilizumab. Convalescent plasma, azithromycin, ivermectin and vitamin D3were recommended against. With regard to ivermectin, it was said that achievable tissue concentrations seemed to be far below the half maximal inhibitory concentration in vitro, that in February 2021 only one peer-reviewed RCT with 72 patients was available for consideration, and that the numerous preprints did not report clinically relevant endpoints or presented with significant methodological issues and a high risk of bias.

On July 6, a commentator asked why WHO targeted IL-6 instead of going upstream to block NF-kB [63] which in turn inhibits IL-6 (ivermectin is an NF-kB antagonist [64]) [65,66].

On July 6, the US president Biden proposed the creation of the Advanced Research Projects Agency for Health (ARPA-H), a new organization under the NIH, aimed at facilitating and accelerating more innovation and breakthroughs in fundamental biomedical and health research [67].

On July 6, an article by Margolin et al. described a small controlled trial (n=113) that suggested benefits from supplementation with zinc, zinc ionophores quina plant bark extract and quercetin, vitamins C, D3and E, and L-lysine [68].

On July 7, an article by Cadegiani et al. about an open-label observational prospective outpatient study indicated 98.0% lower risk of hospitalization (0% vs 19.7%, RR 0.02, p<0.001) and 94.2% lower risk of ventilation (0% vs 6.6%, RR 0.06, p=0.005) [69,70,71]. The authors said treatments showed overwhelming improvements; therefore, it had become ethically questionable to conduct further studies employing full placebo arms in early COVID-19.

On July 7, a preprint by Hazan et al. described a retrospective late treatment study with 24 outpatients and a synthetic control arm calculated from the US Centers for Disease Control and Prevention (CDC)database [72]. The study used a combination therapy protocol with ivermectin, doxycycline, zinc, vitaminD and vitamin C, resulting in 100% survival and cure in unselected ambulatory ‘moderate to severely’ illCOVID-19 outpatients, with some initially presenting with SpO2values as low as 73% and 77%. Despite a symptom to treatment delay of over nine days, mean SpO2values rose from 86.5 to 93.1 in the first 24 hours.

On July 8, an article by Muthusamy et al. described an in silico study identifying 32 anti-parasitic compounds effectively inhibiting the receptor binding domain of the SARS-CoV-2 spike protein [73]. The most effective compounds, in a descending order, were selamectin, ivermectin, artefenomel, moxidectin, posaconazole, imidocarb, piperaquine, cepharantine, betulinic acid and atovaquone.

On July 9, Cameron et al. proposed a two-axis model to describe variability in decision-making among critical care physicians [74]. The authors emphasized the necessity for a better understanding of the root causes of physician-attributable differences in patient management in order to foster a better collaborative and educational environment to help critical care systems adapt to emerging ideas. The first axis of the model measured interventionism (early, aggressive treatment) versus minimalism (’wait and see’) preferences. The second axis measured individualism versus collectivism.

On July 12, a preprint by Neil et al. described a Bayesian meta-analysis of ivermectin’s effectiveness in COVID-19 [75].

On July 13, a news report in the Atlantic by Mazer discussed FDA’s recent approval of Alzheimer’s disease medicine aducanumab [76]. It said aducanumab was approved despite scant evidence of benefit, and against the nearly unanimous advice of the agency’s expert advisers, with ten members against approval and one being uncertain [77]. Aducanumab was priced at USD 56,000 a patient per year. The estimated cost of treating all patients with it was larger than NASA’s yearly budget. The article said that ‘the actions of drug regulators, like those of industrial polluters, are often freighted with unacknowledged externalities .. . the FDA specifically does not really worry about those larger societal issues and doesn’t really worry about cost. . . instead, the agency is judged by how many drugs it can approve’.

On July 14, an opinion by Flam said that high hopes for ivermectin owe more to politics than to science[78].

On July 14, Mathachan et al. reviewed current uses of ivermectin in dermatology, tropical medicine andCOVID-19 [79].

On July 15, an article by Ravikirti et al. describing a clinical trial in India on patients with mild to moderate disease (n=112) using 12 mg of ivermectin on two consecutive days did not produce statistically significant results [80].

On July 15, referring to a 2020 preprint by Elgazzar et al. [3], a news article by Davey in the Guardian said that a huge study supporting ivermectin as COVID-19 treatment had been withdrawn over ethical concerns [81]. The article described ivermectin being promoted by right wing figures, then interviewed a person described as a medical student, Jack Lawrence, who had analyzed the preprint and the associated dataset for an assignment as a part of his master’s degree. He had found that the introduction section appeared plagiarized, raw data apparently contradicted the study protocol on several occasions, there were errors in data formatting, and the dataset didn’t match the numbers in the preprint. He also described that ivermectin hype was ‘dominated by a mix of right-wing figures, anti-vaxxers and outright conspiracists’.

A data analyst Nick Brown had helped Lawrence to analyze the data. He said that the main error was that at least 79 of the patient records were obvious clones of other records. An epidemiologist, Gideon Meyerowitz-Katz, commented that the data appeared totally faked, and since the study had been included in most meta-analyses, if removed, the conclusions of these meta-analyses would have their conclusions entirely reversed. Yet another researcher said the data appeared fabricated. Lawrence concluded that ‘something is clearly broken in a system that can allow a study as full of problems as the Elgazzar paper to run unchallenged for seven months . . . thousands of highly educated scientists, doctors, pharmacists, and at least four major medicines regulators missed a fraud so apparent that it might as well have come with a flashing neon sign’.

On July 15, a post by Lawrence on an online disinformation website discussed retraction of the preprint by Elgazzar et al. [82]. Jack Lawrence introduced himself on his blog as a journalist and a disinformation researcher [83].

On July 15, a blog post by Brown analyzed details of the study by Elgazzar et al [84].

On July 15, a blog post by Meyerowitz-Katz pictured ivermectin for COVID-19 research as ‘potentially the most consequential medical fraud ever committed’ [85].

On July 15, the Covid Analysis group removed Elgazzar et al. from their meta-analysis. Since the study was a preprint, the analysis of 37 peer-reviewed studies (n=11,352) in the July 15 version 99 of 60 studies [86] remained unchanged, indicating 88% efficacy in prophylaxis (95 % CI 70%-95%), 74% efficacy in early treatment (95% CI 58%-84%) and 42% efficacy in late treatment (95% CI 19%-58%). Since Elgazzar etal. only concerned prophylaxis and late treatment, also the early treatment results remained unchanged, indicating 64% reduction in mortality (95% CI 15%-85%). In comparison to the previous, July 9 version 98 of 62 studies [87] (Elgazzar study included prophylaxis (n=200) and late treatment (n=400) parts), the new version indicated the same or slightly improved prophylaxis efficacy but slightly widened confidence intervals, with all studies indicating 85% (95% CI 75%-91%) vs 85% (95% CI 75%-92%) efficacy, and RCTs indicating83% (95% CI 39%-95%) vs 84% (95% CI 25%-96%) efficacy. For late treatment, the new version indicated lower efficacy, with all studies indicating 46% (95% CI 30%-59%) vs 43% (95% CI 26%-56%) efficacy, and RCTs indicating 40% (95% CI 11%-60%) vs 29% (95% CI 3%-48%) efficacy.

On July 16, FLCCC and BIRD gave a joint statement saying that there was no scientific basis to state that the removal of one study from meta-analyses would ‘reverse results’, yet the Guardian article had reported it as a fact [88]. They also said that according to the most recent analyses by BIRD, excluding the Elgazzar data from the meta-analyses by Bryant and Hill did not change the conclusions of these reviews, with the findings still clearly favoring ivermectin for both prevention and treatment. They added that even the prestigious Institute Pasteur in France had confirmed that the evidence was sound [89].

On July 16, Hill tweeted that ‘after removal of Elgazzar trial from ivermectin meta-analysis, borderline significant effects still seen for hospitalization and survival, but small number of endpoints. More evidence still needed from large ongoing randomized trials – must be continued’ [90].

On July 16, a news article said that a study that had ‘lit up the right-wing sphere of COVID deniers had been retracted over questionable methods’, adding that it was ‘just totally faked’ [91].

On July 16, a South African news article reviewed the retraction [92]. It also featured video interviews of patients, doctors and officials which concentrated on the black market of ivermectin in South Africa and the possible dangers of counterfeit medications.

On July 16, an opinion by Razak, the rector of International Islamic University of Malaysia, aimed at ‘setting the pace for a more courageous narrative’ about ivermectin’s possibilities in COVID-19 [93].

On July 17, the United Arab Emirates announced the treatment results for intravenously administered monoclonal antibody sotrovimab, produced by GlaxoSmithKline, in treating mild to moderate COVID-19cases among high-risk outpatients [94]. 6,175 patients were administered sotrovimab in Abu Dhabi between30 June and 13 July. Within 14 days, 97 percent of recipients achieved full recovery. There were zero deaths. 1 percent were admitted to ICU.

On July 17, a news report by Weisser described that early in the pandemic in Indonesia, an enterprising philanthropist Haryoseno made ivermectin available to the masses for free or at low cost, which resulted in Indonesia having an extremely low COVID-19 mortality rate. On June 12, 2021, however, in line withthe WHO recommendation, the ministry of health decided to disallow ivermectin and threatened Haryoseno with a fine and a ten-year jail sentence. Subsequently, the supply of ivermectin dried up and mortality increased five-fold [95]. About Australia, the report noted that clinician Mark Hobart had been reported to the Australian Health Practitioner Regulation Agency (AHPRA) which had decided that there had been no infringement. Subsequently, federal health minister had written that off-label ivermectin prescribing was not regulated or controlled by the Therapeutic Goods Administration (TGA) but was at the discretion ofthe prescribing physician. The physicians had formed Covid Medical Network [96], the members of which predominantly followed a ‘triple-therapy protocol’ developed by Thomas Borody, consisting of ivermectin, zinc and doxycycline [97]. The report also said that although the research on ivermectin for COVID-19 had originated from Australia, the researchers had been starved of resources and the discovery ignored.

On July 20, BBC wrote about Indonesia, saying that local media reports had incorrectly stated that theIndonesian authorities had granted ivermectin emergency approval [98]. The reports had been based on a July 15 statement issued by the Food and Drugs Authority of Indonesia (BPOM) in which ivermectin had been listed together with other drugs, two of which had had emergency approval. Shortly afterwards the head of BPOM had told local media that no emergency approval had been given to ivermectin. It had been listed because it was undergoing clinical trials at eight hospitals, the results of which were not expected until October.

On July 20, Med Page Today wrote about retraction of the preprint by Elgazzar et al. [99].

On July 20, a Swedish medical newspaper published an opinion by three Swedish doctors suggesting that Sweden should follow the example of the Czech Republic, Slovakia and other countries which had adopted ivermectin [100].

On July 22, Los Angeles Times wrote that ‘ivermectin, another bogus treatment, becomes a darling ofconspiracy-mongers’ [101]. In addition to reviewing the main points behind the retraction of the Elgazzaret al. preprint the columnist delved into an analysis of ivermectin politics, saying it was rather different from hydroxychloroquine controversy, as ‘the political underpinning of the ivermectin craze involves a conspiracy-infused attack on the pharmaceutical and medical establishment. In this it resembles the antivaccine movement .. . like anti-vaxxers, ivermectin advocates claim that information about the drug is being “suppressed,” generally by agents of Big Pharma; the core idea is that because drug companies can’t make very much money out of a drug available in generic form, they prefer to foist vaccines, on which they canmake billions of dollars in profits, on the innocent public . . . let’s be clear: information about the drug isn’t being “suppressed” for political reasons. It’s being treated as what it is: dangerous misinformation’.

On July 23, an interview of science writer Matt Ridley in the Wall Street Journal said that science had lost the public’s trust and that the politicization of science had led to a loss of confidence in science as an institution, and whereas the distrust may have been justified it left a vacuum that was often filled by lessrigorous approaches to knowledge [102]. Ridley pointed to a distinction between ‘science as a philosophy’ and‘science as an institution’, with the former wanting to remain open-minded, and the latter wanting to present a unified and authoritative voice, fostering a naive belief in the supremacy of scientists in understanding the world, luring politicians to affiliate themselves with this alleged power. Regardless, scientists often deliberately published things that fit with their political prejudices, ignored things that didn’t, or presented models based on rather extreme assumptions. Pessimistic predictions often being more popular in the media introduced a bias. A third conceptualization of or a type of identification with the concept of science,‘science as a profession’, had become off-puttingly arrogant and political, permeated by motivated reasoning and confirmation bias, with increasing numbers of scientists falling prey to groupthink [103]. According to Ridley, the tendency of scientific establishment ‘to turn into a church, enforcing obedience to the latest dogma and expelling heretics and blasphemers’ had previously been kept in check by the fragmented natureof the scientific enterprise but social media was eliminating the space for heterodoxy, leaving those believingin science as a philosophy increasingly estranged from science as an institution.

On July 23, an article by Mansour et al. described a preclinical tolerance study on the safety of inhaled lyophilized ivermectin formulation indicating 127-fold increase in drug aqueous solubility but also safety issues [104].

On July 24, World Ivermectin Day was organized by the BIRD group, the FLCCC, TrialSite News and 15 other affiliates [105]. Panel discussions included Shabnam Palesa Mohamed in conversation with PinkyN.J. Ngcakani (South Africa) and Wahome Ngare (Kenya); Erin Stair in conversation with Hector Carvallo(Argentina), Lucy Kerr (Brazil) and Flavio Cadegiani (Brazil); Shabnam Palesa Mohamed in conversation with Pierre Kory (US), Ira Bernstein (Canada) and Sabine Hazan (United States); Vincent Rey Vicente(US) in conversation with Iggy Agbayani, Homer Lim and Allan Landrito (Philippines), and PriyamadhabaBahera, Binod Kumar Patro, Biswa Mohan Padhy and Rashmi Ranjan Mohanty (India); Daniel O’Connorin conversation with Juan Bertoglio (Chile) and Matjaˇz Zwitter (Slovenia); Daniel O’Connor in conversationwith Juan Chamie (US), Pierre Kory (US) and Nathi Mdladla (South Africa).

On July 25, a preprint by Ontai et al. described a nationwide implementation of multi-drug COVID-19inpatient and outpatient treatment protocol CATRACHO in Honduras since May 3, 2020 [106,107]. The inpatient protocol consisted of dexamethasone, colchicine, tocilizumab, ivermectin, zinc, azithromycin andheparin. There were two outpatient protocols, one consisting of mouthwash, azithromycin, ivermectin andzinc, and the other consisting of prednisone, colchicine and rivaroxaban. The results indicated a case fatalityrate (CFR) decrease from May 3,2020 baseline of 9.3% to 3.0%, or from June 10, 2020 baseline of 5.0% to3.0%. Mexico used as a control country failed to show a similar decline.

On July 27, upon receiving a Special Benevolence Award from Tan Sri Lee Kim Yew of Malaysia on World Ivermectin Day, Kory of the FLCCC gave a lecture outlining the history of ivermectin in COVID-19 [108,109].

He mentioned that the MATH+ protocol had been adopted as the standard protocol in Ukraine, and thatthe hospital mortality rate there was the lowest of the countries in the area.

On July 27, press releases by Cochrane Deutschland and the University of W¨urzburg stated that there was no evidence of ivermectin’s efficacy [110,111].

On July 27, the university hospital of St. Anny in Brno in the Czech Republic published a report about their ivermectin treatment, saying it had been well tolerated and likely had a positive effect on COVID19 [112]. Ivermectin had been available at hospitals and for outpatient treatment since late 2020. Head of internal cardioangiology clinic Michal Rezek described the results of their analysis of 150 patients with a mean age of 63 years (32-93 years, median 65 years) treated between December 2020 and January 2021 with two doses of 0.2 mg/kg of ivermectin. 117 patients had required oxygenation and corticosteroids, 42 had required high-flow oxygen, and 17 had received also remdesivir. 18 patients had needed mechanical ventilation, six of which had died. Hospital mortality had been 10%, with the average age of the deceased being 75 years. There had been no control group. The hospital intended to continue ivermectin treatment and was preparing a RCT in collaboration with Masaryk University and Czech Clinical Research InfrastructureNetwork (CZECRIN) [113]. Lack of COVID-19 patients was mentioned as a possible obstacle to the trial. Rezek said a combination antiviral therapy with ivermectin and remdesivir was likely more effective than single-agent therapies.

On July 28, a Cochrane review by Popp et al. concluded that its authors were uncertain about the efficacy and safety of ivermectin for treatment or prophylaxis of COVID-19 [114]. With regard to late treatment(inpatients), the authors were uncertain whether ivermectin compared to placebo or standard of care reduced or increased mortality (RR 0.60, 95% CI 0.14-2.51, 2 studies, n=185, very low certainty), mechanical ventilation (RR 0.55, 95% CI 0.11-2.59, 2 studies, 185 participants, very low certainty), need for supplemental oxygen (0 participants required supplemental oxygen, one study, 45 participants, very low certainty), adverse events within 28 days (RR 1.21, 95% CI 0.50-2.97, one study, 152 participants, very low certainty), or viral clearance at day seven (RR 1.82, 95% CI 0.51-6.48, 2 studies, 159 participants, very low certainty). With regard to outpatients, the authors were uncertain about mortality up to 28 days (RR 0.33, 95% CI 0.018.05, 2 studies, 422 participants, very low certainty), mechanical ventilation (RR 2.97, 95% CI 0.12-72.47,one study, 398 participants, very low certainty) and symptoms resolution up to 14 days (RR 1.04, 95% CI0.89-1.21, one study, 398 participants, low certainty). With regard to prophylaxis there was only one eligible study, with mortality up to 28 days being the only outcome eligible for primary analysis; the authors were uncertain whether ivermectin reduced or increased mortality compared to no treatment (zero participants died, one study, 304 participants, very low certainty). The Covid Analysis group criticized the meta-analysis for being ’a very biased meta analysis designed to exclude almost all studies’ [115].

On July 28, an opinion in the Wall Street Journal questioned FDA’s negative stance on ivermectin [116]. The next day the authors wrote that they had not been aware of the retraction of the Elgazzar et al. study, yet stated that ‘the broader point stands: there’s strong evidence of ivermectin’s efficacy in COVID-19’ [117].

On July 28, GlaxoSmithKline (GSK) and Vir Biotechnology announced a joint procurement agreement with European Commission to supply up to 220,000 doses of sotrovimab [118], a contract worth USD 462 million at the wholesale price of USD 2,100 per dose. The agreement enabled participating European Union member states to quickly purchase sotrovimab, following local emergency authorization or authorization at the EUlevel, to treat high-risk patients with COVID-19 who might benefit from early treatment with sotrovimab.

On July 29, an article in Times of India explained a much higher rate of infections in the state of Kerala bylower COVID-19 seropositivity [119].

On July 30, a Czech Republic newspaper published a timeline of ivermectin-related events in the CzechRepublic [120].

On July 30, an article by Rella et al. suggested that in the current conditions the vaccines-only pandemic response may create vaccine-resistant strains [121,122].

On July 31, Kiekens interviewed George Fareed about outpatient treatment protocols for newly infected andfor long haul COVID-19 syndrome (LHCS) patients, implemented jointly with Brian Tyson on thousands of patients in the US [123]. For neurological LHCS symptoms in some instances, Fareed suggested a two to three-day high-dose ivermectin treatment as suggested by Alessandro Santin [124].

August 2021

On August 2, a news article from Israel reported on a clinical trial by Biber et al. (NCT04429711) [125], saying that ivermectin could help reduce the length of infection for less than a USD 1 per day, and that only 13%of ivermectin-treated patients were infectious after six days, compared with 50% of patients in the placebo group [126]. Schwartz, the leader of the trial, said that three journals had rejected the paper: ‘No one even wanted to hear about it. You have to ask how come when the world is suffering’.

On August 2, an open letter by Covid Medical Network stressed the importance of early treatment and noted that the federal health minister had acknowledged and even encouraged off-label prescribing of some treatments including ivermectin [127].

On August 2, an article by Reardon in Nature said that shocking revelations of widespread flaws in the data of a preprint study by Elgazzar et al. dampened ivermectin’s promise and highlighted the challenges of investigating drug efficacy during a pandemic [128]. Gideon Meyerowitz-Katz, an Australian epidemiologist,said he had lost all faith in the results of ivermectin trials published to date.

On August 2, an article by Sengthong et al. said that repeated ivermectin treatment induced ivermectin resistance in Strongyloides ratti infected rats [129].

On August 3, an article by Santin et al. reviewed the current status of ivermectin research, mentioning that the indicated biological mechanism of ivermectin, competitive binding with SARS-CoV-2 spike protein, was ikely non-epitope specific, possibly yielding full efficacy against emerging viral mutant strains [130].

On August 3, BBC wrote about the mystery of rising infections in India’s Kerala [131]. The southern Indian state of Kerala, with barely 3% of India’s population, accounted for more than half of the country’s new COVID-19 infections. Kerala was testing more than double the people per million compared to the rest of the country. Antibody tests survey revealed that only 43% people above the age of six in Kerala had been exposed to the infection, compared to 68% nationwide. Kerala had fully vaccinated more than 20% of its eligible population and 52% had received a single jab (70% of people over 45 years) which was much higher than the national average. BBC wrote that the state appeared to be testing widely, reporting cases honestly and vaccinating quickly, ensuring that future waves of infection would be less severe. Yet Kerala was said to be at an early stage in runaway exponential growth of cases. More forceful enforcement of rolling lockdowns was suggested as a solution.

On August 3, George Fareed discussed early treatments on Fox News television [132].

On August 5, an article by Behera et al. described a prospective cohort study (n=3,532) in India, indicatingthat two doses of oral ivermectin (0.3 mg/kg/dose given 72 hours apart) as chemoprophylaxis among healthcare workers reduced the risk of COVID-19 infection by 83% in the following month (6% vs 15%, adjustedrelative risk 0.17; 95% CI, 0.12-0.23) [133].

On August 5, a preprint by Rana et al. described an in silico study showing strong binding affinity ofivermectin and doxycycline for SARS-CoV-2 main protease 3CLpro, and increased binding affinity for thecombination of both [134,135].

On August 5, a Finnish technology magazine wrote about ivermectin, saying that according to FLCCC,there was already an effective medication for COVID-19 but it was rarely used [136]. A head of unit at theFinnish Medicines Agency (FIMEA) commented that doctors were allowed to prescribe it off-label, providedthat the patient was informed about it not being officially approved for COVID-19. The official commentedthat ‘in an international comparison the Finnish medical community is quite conservative about adoptingnew treatments without a sufficiently strong evidence base’. Also, a process to officially adopt ivermectin forCOVID-19 could only be initiated by a producer of ivermectin or the European Medicine Agency (EMA).

On August 6, an article by Kow et al. reviewed sample size calculations in ivermectin trials, indicating thatexisting trials had been very underpowered [137].

On August 6, US National Institutes of Health (NIH) Collaboratory published a video interview of EdwardJ. Mills, the head researcher of Together adaptive platform trial [138]. Mills discussed interim results of their outpatient trial which included fluvoxamine and ivermectin (0.4 mg/kg for three days). For ivermectin,the risk reduction for extended emergency room observation or hospitalization was 9% (86/677 vs 95/678,RR 0.91, 95% CI 0.69-1.19) and for mortality 18% (RR 0.82, 95% CI 0.44-1.52); these were not statistically significant. Mills commented that ivermectin had had ’no effect whatsoever’ on their primary and secondary endpoints. For fluvoxamine, the risk reduction for extended emergency room observation or hospitalization was 31% (74/742 vs 107/738, RR 0.69, 95% CI 0.52-0.91) and for mortality 29% (17/742 vs 24/738, RR0.71, 95% CI 0.39-1.29); the first endpoint was statistically significant while the second was not. The trial was done at ten locations in Minas Gerais, Brazil. It was unclear whether over-the-counter ivermectin usehad been an exclusion criteria. At the time the gamma variant was prevalent and assumed to cause higher viral loads and a more severe disease than most other variants. The Covid Analysis group criticized various aspects of the trial [139].

On August 6, a report on SARS-CoV-2 variants by Public Health England indicated that concerning deathswithin 28 days of positive specimen date between February 1 and August 2 there had been 71 deaths in people under 50 years and 670 in people over 50 years [140]. In the first group, 18% had been vaccinatedtwice and 68% were unvaccinated. In the second group, 58% had been vaccinated twice and 31% were unvaccinated.

On August 6, a podcast by Nature discussed ivermectin [141].

On August 9, a commentary by US medical doctor using a pseudonym Justus R. Hope described a ‘blackouton any conversation about how ivermectin beat COVID-19 in India’ [142,143]. It claimed that the US newsmedia were trying to confuse the public with false information by saying the deaths in India were ten times greater than official reports. Using August 5 numbers as examples the author said that in ivermectin-using states of India such as Uttar Pradesh with a population 240 million of which 4.9% were fully vaccinated there were 26 daily cases and three deaths, in Delhi with a population of 31 million of which 15% were fully vaccinated there were 61 daily cases and two deaths, in Uttarakhand with a population of 11.4 million of which 15% were fully vaccinated there were 24 daily cases with zero deaths. In states not using ivermectin such as Tamil Nadu with a population of 78.8 million of which 6.9% were fully vaccinated there were 1,997daily cases with 33 deaths. In the US with a population of 331 million of which 50.5% were fully vaccinated there were 127,108 daily cases with 574 deaths. He compared FDA’s and WHO’s ban on ivermectin to Pope’sban on all books and letters that argued the Sun was the center of the universe instead of Earth, adding that the US government was ‘all-in with vaccines with the enthusiasm of a 17th century Catholic church’.

On August 10, a news story by Yahoo! Japan reported that a Japanese clinician Kazuhiro Nagao, appearingon the Fuji TV television program, had suggested that ivermectin should be distributed to all Japanese nationals in advance to be taken after COVID-19 infection, and that COVID-19 should be in the same administrative category as seasonal influenza in order to avoid delays and make early treatment possible [144].

On August 10, a news report from La Pampa province of Argentina described minister of health MarioRub´en Kohan releasing the latest results of the implementation of a monitored intervention program on the use of 0.6 mg/kg of ivermectin for five days in 3,269 treated patients versus 18,149 untreated patients[145,146]. The risk of death was 27.4% lower (RR 0.73) and the risk of death or ICU admission was 38.0%lower (RR 0.62). For people over 40 years of age the risk of death was 33.4% lower (RR 0.67). For people over 40 years of age and with comorbidities the risk of death was 44.0% lower (RR 0.56).

On August 11, Los Angeles Times wrote about ivermectin having ‘no effect whatsoever’ in the Togethertrial [147]. The head researcher Mills said that ‘in our specific trial we do not see the treatment benefit that a lot of the advocates believe should have been seen’. He complained that many researchers had faced unprecedented abuse from advocates of specific treatments.

On August 11, an article by Cobos-Campos et al. reviewed ivermectin for COVID-19 [148].

On August 12, vaccine expert Geert Vanden Bossche, who on May 24, 2021 had proposed mass chemoprophylaxis with ivermectin [149], demanded stopping of COVID-19 mass vaccination [150]. A rationale for the demand was the increased infectiousness of new variants already noted with respect to the alpha and delta variants, both more infective than the original variant, and the delta variant being significantly more infective than the alpha variant. Bossche expected this trajectory to continue, possibly resulting in an uncontrollable situation. In Bossche’s view, the increased infectivity had resulted from a natural selection of increasingly vaccine immunity escaping variants in the vaccinated part of the population. In other words, mass vacci11nation had created an evolutionary pressure for development of these variants which were then transferred to the non-vaccinated population. In addition, vaccine-induced antibodies possibly competed with natural antibody based, variant-nonspecific immunity, possibly rendering the population more vulnerable to some vaccine immunity escaping variants. The issue was also taken up by other researchers [151].

On August 12, a preprint by Elavarasi et al. described a retrospective study about hospitalized patients in India which did not show a statistically significant result [152].

On August 12, an article by Pedroso et al. described that self-prescribed use of early ivermectin treatment by 45 healthcare workers in Brazil was associated with a lower rate of seroconversion in a dose-dependentresponse [153].

On August 13, an article by Zhou et al. suggested that ivermectin might be a new potential anticancer drug therapy for human colorectal cancer and other cancers [154].

On August 13, on NIH Collaboratory, Smith discussed the history of proposed therapies for COVID-19 andthe adaptive platform trial ACTIV-2 [155].

On August 14, a Japanese clinician Kazuhiro Nagao wrote in a blog post that he had been harassed and had received death threats after appearing on TV and telling about treating 500 COVID-19 patients with ivermectin with no deaths [156,157].

On August 14, Kiekens interviewed an Italian physician Andrea Stramezzi about his early treatment protocol and his telehealth treatment method [158]. He was using hydroxychloroquine as a part of the outpatient protocol due to its easy availability. According to Stramezzi, it was useful in the first few days. Initially in the pandemic it had been provisionally recommended [159], then banned [160]. Stramezzi had initiated a legal proceeding about the ban, initially winning the case but subsequently losing an appeal. Regardless,the judge had decreed that physicians were free to prescribe medications off-label at their discretion. In addition, the protocol had included anti-inflammatories such as aspirin, and bromhexine. Also vitamins C and D were used, although Stramezzi did not consider high levels of vitamin D sufficient to prevent COVID19. Additionally, vitamin K was administered separately from vitamin D due to their antagonism. A later addition, ivermectin, useful also in later stages to reduce replication of the virus, needed to be imported from the neighboring countries. Stramezzi said that about 10% of Italians had a genetic vulnerability toSARS-CoV-2 induced hyperinflammation. For this group, prevention with corticosteroids and enoxaparin was necessary. He said that there were approximately 1,500 physicians in Italy working with the similar protocols, exchanging information with each other. The public’s awareness of early treatments in Italy was still low because health authorities did not recommend it or talk about it, instead just recommendingparacetamol and waiting for severe pneumonia to emerge before contacting healthcare facilities. Stramezzisaid they had met Sileri, a physician/researcher and deputy minister of health (M5s) [161,162], for an hour.

Sileri had said he was aware of the therapeutical options, had treated a hundred patients himself, and hadco-authored an article about the genetic defect [163]. Also, the parliament of Italy had voted in favor ofearly treatments [164]. Regardless, after several months nothing had happened with regard to adoption of these treatments. Stramezzi was developing a free mobile phone app for doctors who had too many patients or who were unsure of how to treat COVID-19: the app would give suggestions for a suitable treatment protocol.

On August 16, a letter to the editor by Chahla et al. in the American Journal of Therapeutics described a randomized controlled trial (n=234) in Argentina with ivermectin and iota-carrageenan as pre-exposureprophylaxis for health care workers (NCT04701710) [165,166,167]. The treated group (n=117) received 6mg ivermectin every seven days, and six nasal sprays of iota-carrageenan per day for 4 weeks. The risk ofCOVID-19 infection was 84.0% lower (3.4% vs 21.4%, RR 0.16, p=0.001), and the risk of moderate or severe disease was 95.2% lower (0.0% vs 8.5%, RR 0.05, p=0.002). The authors hypothesized that the combination treatment formed a double viral barrier: first, carrageenan behaved as a mucolytic agent in a barrier of sulfated polysaccharides with negative charge in the nasal cavity; second, ivermectin decreased viral load by systemic cellular action.

On August 16, an article by Winter examined the ongoing discussion about ivermectin [168].

On August 17, an article by Gonz´alez-Paz et al. described an in-silico elastic network model analysis of ivermectin components (avermectin-B1a and avermectin-B1b) providing a biophysical and computational perspective of proposed multi-target activity of ivermectin for COVID-19 [169,170].

On August 17, Associated Press reported that ’dozens of people in Oregon have contacted the state’s poisoncenter after self-medicating against COVID-19 with a drug used to treat parasites, with five becoming hospitalized and two of them winding up in intensive care units’ [171].

On August 18, Los Angeles Times wrote that fluvoxamine may actually work against COVID-19 [172].

On August 19, an article by Gonz´alez-Paz et al. described an in silico analysis of the components of ivermectin (avermectin-B1a and avermectin-B1b), suggesting different and complementary inhibitory activity of each component, with an affinity of avermectin-B1b for viral structures, and of avermectin-B1a for host structures [173,174].

On August 20, an article by Amaya-Aponte reviewed ivermectin in COVID-19 [175].

On August 20, the investigational monoclonal antibody sotrovimab was granted a provisional approval forthe treatment of COVID-19 in Australia [176].

On August 20, a letter by Popp et al. in the BMJ said that the different assessments between Popp et al’sCochrane meta-analysis and the one by Bryant et al. were partly due to baseline data of included studies:Bryant et al. pooled heterogeneous patient populations, interventions, comparators and outcomes whereasPopp et al. did not; thus, according to Popp et al., Bryant et al. compared apples and oranges, ‘serving a large bowl of a colorful fruit salad’ [177]. The authors accused Bryant et al. of ‘creating pseudotrustworthiness for substances that cannot be considered effective and safe treatment options nor game changers, at this stage’.

On August 21, an article by Karvanen et al. described a new algorithm for causal effect identification: do search based on do-calculus [178]. The algorithm might allow for improving clinical trial result analysis [179,180,181].

On August 21, due to overlap and confusion with the I-MATH+ prophylaxis and early outpatient treatment protocol, the FLCCC discontinued its I-MASS mass prophylaxis and home treatment protocol introduced a few months earlier [182].

On August 21, the US Food and Drug Administration (FDA) tweeted about ivermectin, stating that ‘You are not a horse. You are not a cow. Seriously, y’all. Stop it.’ [183]. The tweet linked to FDA’s March 2021advisory against ivermectin [184].

On August 21, a Slovenian newspaper reviewed ivermectin, mentioning two previous articles published in the same newspaper written by a Slovenian ivermectin proponent Matjaˇz Zwitter [185,186].

On August 21, a blog post by Meyerowitz-Katz discussed a study by Cadegiani et al. [69], claiming that thedata in a spreadsheet uploaded by the authors didn’t look real: ’data for this study may not be fake, but it is at least incredibly suspicious’ [187,188].

On August 21, a preprint by Izcovich et al. presented a systematic review about bias as a source of inconsistency in ivermectin trials [189]. Based on a review of 29 RCTs with 5,592 cases the authors concluded that previous reports about ivermectin’s benefits were based on potentially biased results, and further research was needed.

On August 22, an Indian geriatrician, preventive cardiologist and anti-aging specialist Lenny Da Costa described ivermectin use in India [190,191]. According to Costa, beginning from March 2020, India distributed an outpatient home treatment kit containing hydroxychloroquine, azithromycin, doxycycline, ivermectin and vitamin C. In March 2021, ignoring evidence from India, WHO stated that ivermectin should not be used.

The statement was given by an Indian epidemiologist, WHO chief scientist Soumya Swaminathan. A group of Indian physicians filed a legal case against her. To protect Swaminathan, Indian central government removedivermectin from official recommendations. However, state governments were responsible for guidelines for medical care in the states, not the central government; most states continued the use of ivermectin. Costasaid that no-one had stopped using ivermectin but they did not advertise the fact. According to Costa,during the deadly second wave in April-May 2021, India’s most populous state, Uttar Pradesh, reduced the number of daily cases from 60,000 to 15,000 in a month by distributing ivermectin for everyone for free. Clinicians did not wait for RT-PCR test results; instead, medication was started immediately on the presentation of symptoms. Prescriptions were given for free by telemedicine (WhatsApp). Ivermectin prevented people from infecting others, especially family members. Also, numerous physicians had been using ivermectin since March 2020 for prophylaxis, with none of them getting infected. On June 29, 2021, the government of Uttar Pradesh announced a home treatment kit for children, containing paracetamol, multivitamins and ivermectin. Costa claimed that India’s success in controlling the second wave was primarily due to an early administration of ivermectin, doxycycline, zinc and other medications used for early treatment.

On August 23, a medical doctor writing under a pseudonym Justus R. Hope continued on India’s ‘ivermectin blackout’ [192,193]. On August 15, Kerala, a state reportedly not using ivermectin, with a population of approximately 3% of India’s population, had accounted for 56% of India’s new cases and 25% of India’s new deaths. Delhi, a state with nearly the same population size as Kerala but using ivermectin, accounted for 0.2% of new cases and 0% of deaths. Uttar Pradesh, with a population almost eight times larger than

Kerala, accounted for 0.09% of new cases and 0.2% of deaths. Hope wrote that Kerala ranked in the top five most vaccinated of India’s 29 states, adding that Kerala’s failure in comparison to most other states of India could be explained by the facts that Kerala had not used ivermectin for early treatment whereas most other states had, and that ivermectin lowered the viral load and inhibited transmission whereas vaccination did not, giving a false sense of security. Those with prior infection, negative test result, or at least one vaccine dose (56% of adults) had been exempted from lockdown [194]. Hope called Kerala’s comparatively highvaccination rate its most problematic feature leading to rampant viral transmission. Kerala had adopted ivermectin in April but restricted its use to severe cases with additional risk factors. On August 5, Kerala had removed ivermectin from state guidelines completely. In contrast, Uttar Pradesh had been the first stateto introduce large-scale prophylactic and therapeutic use of ivermectin. The state had treated all contacts of an infected patient prophylactically with ivermectin. The lesson, Hope said, was that ivermectin could make up for the low use of vaccination but vaccination could not make up for the low use of ivermectin.

On August 23, ABC News report written by a medical toxicology fellow and an emergency medicine physician in New York stated that health officials had said that a potentially dangerous, unproven deworming drugs hould not be used to treat COVID-19 [195]. The report blamed social media for informing people about the medication ‘not authorized by independent regulators at the FDA’ (see e.g. [196]). Not a single trial to prove ivermectin’s usefulness existed and an interviewee advised that people ‘don’t have to go with something that doesn’t have a scientific basis’.

On August 23, CBS News reported that officials had warned against using anti-parasite drug for COVID19 [197].

On August 24, Mother Jones magazine interviewed Boulware, an ivermectin researcher, involved in a University of Minnesota trial (NCT04510194) [198,199]. Boulware had received hostile messages calling him ’are embodied Josef Mengele’ from people believing that ivermectin was a miracle cure and placebo-controlled trials were therefore unethical. Another researcher at Washington University in St. Louis commented on the polarization, saying that if she tweeted something about vaccines as positive, she was being attacked by people pro early treatment, and if she tweeted about potential treatments, she provoked the ire of vaccine advocates who ‘kind of seem to suppress any information about early treatment, maybe because they feel like it’s going to make people think they don’t need to be vaccinated’. The article also described Steve Kirsch’s frustration with the government’s unwillingness to recommend treatments on the basis of small trials with encouraging results. Researchers also worried that the recent reports of ivermectin self-dosing could scare people off of enrolling in any kind of treatment trials in the future.

On August 25, an article by Mohan et al. described a trial (RIVET-COV, n=157) investigating the effect of single-dose oral ivermectin (12 or 24 mg) in mild and moderate COVID-19 which indicated no statistically significant effects on viral load or RT-PCR negativity [200].

On August 25, on the social media platform Reddit, subreddit r/ivermectin which had been a public, uncensored discussion forum initiated a year before for discussions related to ivermectin research and treatments,was flooded with tens of horse-themed pornographic cartoon images, in reference to ivermectin as ‘horse paste’, as well as hundreds of sexual, offensive or irrelevant comments. The moderator said the attack had been coordinated by a group of moderators of other, large subreddits, yet refused to remove the irrelevant content, referring to his disbelief in censorship [201].

On August 25, in a FLCCC weekly update, endocrinologist and researcher Fl´avio Cadegiani described his experience in the state of Amazonas in Brazil during a gamma variant outbreak in 2021 (the gamma variantwas considered to cause a more severe disease than the delta variant) [202]. The research group had visitedvarious cities with hospitals overwhelmed with COVID-19 patients. However, in the city of Coari located afew hundred kilometers west from Manaus there had been no hospitalized COVID-19 patients at all. At first Cadegiani had been unable to get an explanation to the situation but later, in private, a health official had revealed that the city had been providing ivermectin for its whole population for two months already. As to the question why the explanation had not been given immediately the official replied that she had been afraid of being accused of giving unapproved treatments. Cadegiani said the experience had been shocking.

He added that secondary endpoints in single-agent trials were important indicators of possible efficacy as a component in a multi-agent treatment protocol.

On August 25, in the FLCCC weekly update, Kory and Marik discussed the addition of dual anti-androgentherapy (dutasteride 2 mg on day one followed by 1 mg daily for ten days [203], and spironolactone 100 mg twice daily for ten days [204]) to their delta variant early treatment protocol which at the time included twelve components [202]. They stated the addition provided ‘massive improvements’.

On August 26, Krolewiecki et al. published additional details about their trial on the antiviral effect of high-dose ivermectin in COVID-19 [205].

On August 26, Centers for Disease Control and Prevention (CDC) reported that ivermectin prescriptionsfrom US pharmacies had increased 24-fold from the pre-pandemic baseline [206]. Ivermectin-related calls to poison control centers had increased five-fold, respectively. The report gave two examples of adverse effects:one patient becoming disoriented after taking tablets of unknown strength (5 tablets per day for five days),and another patient presenting with confusion, drowsiness, visual hallucinations, tachypnea and tremors after drinking an injectable form of veterinary ivermectin.

On August 26, Newsweek interviewed Joe Varon of the FLCCC saying that since a year ago he had treated thousands of COVID-19 patients in the US with off-label ivermectin in combination with other pharmaceuticals in the FLCCC treatment protocols [207]. During the pandemic Varon had been widely featured in the US media but the reporters had chosen to not mention ivermectin.

On August 26, a news story in Vice magazine complained that Facebook did not properly censor ivermectin content and Facebook’s ivermectin groups were ‘unhinged and out of control’ [208,209].

On August 28, Newsweek reported about a far-right political commentator’s use of ivermectin for his COVID19 infection [210].

On August 28, Newsweek reported that a Republican representative from Texas had appeared to speak in support of unproven treatments for COVID-19, including ivermectin, a drug often used as a dewormer for cows and horses [211]. The representative was also said to have praised president Trump and have raised concerns about vaccines.

On August 29, Anthony Fauci warned against using ivermectin for COVID-19 [212].

On August 29, Cohen wrote in Forbes that ivermectin had become embedded in a ‘cultural war’, commenting that ‘of all drugs right-wingers would have gravitated to, ivermectin and hydroxychloroquine are most unusual candidates, in that they’re largely used in humans in developing nations for conditions rarely seen in the US’ [213]. Ivermectin for COVID-19 was pictured as unproven misinformation harming public health, and the politicization of the issue had been to the detriment of efforts to contain the pandemic, taking attention away from clinically confirmed instruments such as vaccines. The author worried that there were a surprising number of people in the medical profession who believed in ivermectin, such as the physician advisor to Florida’s governor. Cohen said that ‘these contrarians are not waiting for the completion of confirmatory studies to disseminate their advice to the gullible minions to take ivermectin off-label, even if doing so may endanger lives’.

On August 30, Newsweek reported that an US hospital had refused to administer FLCCC member FredWagshul’s prescription for a patient, after which a judge had ordered the hospital to administer it [214]. The next day, a regional US newspaper interviewed Wagshul who attributed the lack of adoption of ivermectinto ‘propaganda, money and big pharma’ [215].

On August 30, a report by German news agency said that ivermectin trials have been of a low quality and that Cochrane Deutschland and the University of W¨urzburg considered ivermectin inefficacious [216].

On August 30, a video interview of Fernando Valerio describes Honduras’ treatment protocols in detail [217].

On August 31, a preprint by Omrani et al. presented a systematic review and meta-analysis of effectiveness of ivermectin/doxycycline combination, concluding that based on low-quality evidence, the combination was accompanied with a shorter time of clinical recovery but did not significantly reduce all-cause mortality, viral clearance, and hospital stay [218].

On August 31, Pfeiffer described patients’ experiences in US hospitals [219].

On August 31, Kory of the FLCCC accused the US National Institutes of Health (NIH) of being the main agent in the ‘war against ivermectin’ due to not having given a recommendation for ivermectin [220]. Healso stated the FDA was only ‘running interference for [NIH] by telling jokes and lies’.

On August 31, a Swedish newspaper G¨oteborgs-Posten wrote about veterinary ivermectin use in the US [221].

On August 31, a preprint describing a randomized controlled trial of community-level surgical mask promotion in rural Bangladesh with 111,525 individuals in the intervention arm and 155,268 individuals in the control arm indicated 14% relative reduction in COVID-19-like symptoms, with absolute reductions of 7.5%vs 8.6%. Divided by age groups, differences were not statistically significant in people under 50. In people between 50-60 years there was a reduction of 23%, and in people over 60 a reduction of 35%, respectively.

The impact of the intervention faded after five months [222].

September 2021

On September 1, ABC News wrote that due to lack of evidence and increase in reports related to ivermectin toxicity, the American Medical Association, American Pharmacists Association and American Society of Health-System Pharmacists had called for an ‘immediate end’ to prescribing, dispensing or using the deworming drug ivermectin to treat or prevent COVID-19 [223].

On September 1, Washington Post wrote that people using ivermectin for prophylaxis had been shocked about having ended up being hospitalized for COVID-19 [224]. The story mentioned the rise in prescriptions and FDA’s tweet and warned about overdoses. Numerous interviewees advised against ivermectin, with the most critical comparing it to ‘snake oil’. Overall, a part of the population preferring ivermectin and vitamin cocktails over vaccines was seen to indicate ‘a broader problem: a public health crisis made worse by many people’s distrust of medical authorities while they rely on often faulty information from some ofthe country’s most influential people, which is amplified through social media’. Ivermectin was said to have gained particular traction in conservative circles. Wagshul of the FLCCC was quoted saying that ivermectin was more effective than vaccines against variants given waning immunity. A researcher working on an ongoingclinical trial on ivermectin in the US ([225,226]) commented that ‘there’s either people that believe it totally is a cure-all and works or that it is highly dangerous . . . and the reality is, neither extreme is true’.

On September 1, a letter by Keehner et al. in the New England Journal of Medicine reported about a dramatic decline in vaccine effectiveness from June to July in a highly vaccinated health system workforce in California, likely due to the emergence of the delta variant, waning of immunity over time, and the end of masking requirements in California [227].

On September 1, KFOR News published a news story in which a rural Oklahoma doctor, Jason McElyea,claimed that local emergency rooms were so backed up with patients having overdosed ivermectin that gunshot victims had hard time getting to the facilities [228]. In addition, ivermectin overdose patients were completely clogging ambulance services: McElyea was quoted saying that ‘all of their ambulances are stuck at the hospital waiting for a bed to open so they can take the patient in and they don’t have any, that’s it. . . if there’s no ambulance to take the call, there’s no ambulance to come to the call’.

On September 1, 2021 the subreddit r/ivermectin was ‘quarantined’ by the Reddit platform but that did notstop the flood of offensive posts. Alternative forums were created but they seemed to fail to capture largeaudiences (e.g. [229]). Another subreddit, r/IVMScience appeared to have stalled after August 23, 2021,with the moderator’s account deleted.

On September 1, podcaster Joe Rogan, with 11.1 million followers on YouTube, 13.2 million followers on Instagram and a USD 100 million contract to publish his podcast exclusively on Spotify, revealed on Instagram that he had got COVID-19 and had been treated with monoclonal antibodies, ivermectin, azithromycin, prednisone, nicotinamide adenine dinucleotide drip and a vitamin drip for three days in a row [230]. Rogan’s statement was widely taken up by news media [231,232,233]. On July 1, 2021, in the context of an unrelated controversy, a journalist at the New York Times had called Rogan ‘too big to cancel . . . one of the most consumed media products on the planet – with the power to shape tastes, politics, medical decisions’ [234].

On September 1, a letter to the editor by Bryant et al. commented on the recent report in the Guardian [81]discussing the effect of the removal of the Elgazzar et al. trial on the meta-analysis by Bryant at al. [4].

The authors stated that ‘while quantitative measures of effect do of course change on removal of any study,the overall findings of a significant mortality advantage in ivermectin treatment, and in prophylaxis, remain robust to removal of the disputed data. The claim that conclusions are “entirely reversed” cannot be sustained on the evidence’ [235].

On September 1, Due˜nas-Gonz´alez et al. discussed repurposing of ivermectin as a novel anticancer [236].

On September 2, Newsweek published a version of McElyea’s story, saying people taking the horse de-wormer medication were filling up the area’s emergency rooms [237]. The report mentioned FDA’s ‘stern warnings’against ivermectin, the unavailability of ambulances, and gunshot victims’ difficulties.

On September 2, Rolling Stone wrote about how Joe Rogan ‘became a cheerleader for ivermectin . . . no one has been more successful at promoting ivermectin than Rogan’ [238].

On September 2, a major Finnish newspaper Helsingin Sanomat republished a news article written by Finnish News Agency (STT) about an US podcast host Joe Rogan treating his COVID-19 infection with a ‘dewormer intended for horses’ warned against by ‘medical officials’ [239]. The article described that after his diagnosis Rogan begun taking ‘all kinds of potions’ including ivermectin, which, according to Washington Post and the Guardian, was used as a dewormer for horses. However, ‘some representatives of conservative media’had ‘advertised the controversial dewormer’. In addition to mentioning the negative stance of the European

Medicine Agency (EMA), the article also cited FDA’s tweet saying: ‘You are not a horse. You are not a cow.

Seriously, y’all. Stop it’. According to the article, calls about ivermectin exposure to poison control centers in the US jumped to five times over normal levels in July 2021. Rogan was also described having spread ‘lies’about COVID-19 and being against vaccines. The leading infectious diseases expert Anthony Fauci was said to have criticized Rogan’s earlier statements. Up to the 1990s, STT, founded in 1887, was often consideredt he ‘official’ national news source. Helsingin Sanomat, the most widely distributed newspaper in Finland,essentially holds a monopoly in the metropolitan area. The article was also republished by the most widely distributed yellow press media Ilta-Sanomat belonging to the same concern as Helsingin Sanomat [240]. In addition, the story was posted in some regional newspapers [241], essentially reaching the whole population of the country.

On September 2, a competing Finnish yellow press newspaper wrote about Rogan’s use of dewormer, saying that it had no proven efficacy and it could be dangerous, even deadly [242]. Rogan was said to regularly ‘flirt with misinformation’. The article also described FDA warnings and retraction of the Elgazzar et al. trial.

On September 2, citing insufficient evidence of efficacy, leading health experts in Sri Lanka urged people to stop using ivermectin for COVID-19; however, a local trial was ongoing [243].

On September 2, Marik and Kory published a reanalysis of the data of their earlier meta-analysis [6],saying that the summary point estimates were largely unaffected when the study by Elgazzar et al. was removed [244].

On September 2, a letter to the editor by Neil et al. said that their Bayesian analysis provided sufficientconfidence that ivermectin was an effective treatment for COVID-19, also after the exclusion of Elgazzar et al. study [245].

On September 2, a Cochrane review concluded that the authors were uncertain whether the investigational monoclonal antibody sotrovimab had an effect on mortality (RR 0.33, 95% CI 0.01-8.18) and invasive mechanical ventilation requirement or death (RR 0.14, 95% CI 0.01-2.76). Treatment with sotrovimab was said to possibly reduce the need for oxygenation (RR 0.11, 95 % CI 0.02-0.45), hospital admission or death by day 30 (RR 0.14, 95% CI 0.04-0.48) [246].

On September 2, an article by Alves et al. in the BMJ about poorly designed studies contributing to misinformation in Brazil said that ’much like a poorly written sequel to a blockbuster, the ivermectin narrative appears to be a subsidiary of the rationale that gave the world the HCQ pseudo-solution to COVID-19: cheap, readily available answer to the biggest sanitary crisis of our time’ [247]. The authors argued that public communication of science (i.e. news reporting) should be evidence based: any interaction between scientists and press should aim at summarizing and contextualizing the most important findings of an article for the general public, preserving context and limitations of the research, promoting transparency,integrity and scientific literacy. Also, research findings should be published without delay and include full datasets. Otherwise, the authors said, public communication may be only fueling polarization and an eventual implementation of harmful, inefficient or wasteful public health policies.

On September 2, an article by Chaudhry et al. presented a systematic review about the role of ivermectin in hospitalized patients [248].

On September 2, a report in BuzzFeed news questioned the validity of two prophylaxis trials by Carvallo etal. in Argentina [249]. The report claimed that the reported numbers, genders and ages of trial participants had slight inconsistencies. Carvallo was said to have declined to share the raw data even to his coauthors, the timeline and ethical approvals of the trials were unclear, as well as who had performed the statistical analyses.

It was also unclear which hospitals had been involved and in which ways. Carvallo denied accusations of fraud.

On September 3, an article by Okogbenin et al. described a retrospective study in Nigeria, with 300 patients treated with ivermectin, zinc, vitamin C and azithromycin, reporting zero mortality [250].

On September 3, a rapid response by Bryant et al. to Popp et al. [177] stated that their Bryant et al. metaanalysis was a non-commissioned research paper that strictly followed PRISMA systematic review guidelines,and that Popp et al. itself contained several misleading items, including using death instead of infection for the prophylaxis outcome, specifying outcome measures not found in the included trials but ignoring the outcome measures found in the trials, subsequently stating that they found ‘no data’ [251]. The authors concluded that in a pandemic context, the benefits of ivermectin almost certainly outweighed any risks.

On September 3, a blog post by Meyerowitz-Katz discussed the study by Carvallo et al. [252], pointing outissues that indicated possible fraud, yet noted that the study was not a randomized controlled trial and thus

not included in most meta-analyses or given the same credence, and it did not change recommendations forofficial medical organizations. However, Meyerowitz-Katz added, ’it perhaps had an even bigger impact onpeople actually taking ivermectin than previously fraudulent research. This paper showed a 100% benefit,it was enormously popular on social media, and it was given a huge amount of credence by promoters ofivermectin for nearly a year. It is not a stretch to say that this one study has perhaps caused hundreds ofthousands or even millions of people to take ivermectin as a prophylactic drug to prevent COVID-19’ [253].

On September 3, South African Health Products Regulatory Authority (SAHPRA) repeated its warnings against the use of ivermectin, saying its stance was aligned to that of US FDA [254].

On September 3, Yahoo News published a version of McElyea’s story, mentioning that he was an emergency room physician affiliated with multiple hospitals in Sallisaw, Oklahoma, and that the situation was so dire that even people with gunshot wounds have to wait their turn to get treatment [255]. McElyea added that people were suffering real ramifications from taking a dosage meant for a full-sized horse, including ‘scary’instances of vision loss, nausea, and vomiting.

On September 3, Rolling Stone magazine published a version of McElyea’s story [256].

On September 4, the Guardian published a version of McElyea’s story [257].

On September 4, BBC published a version of McElyea’s story [258].

On September 4, the administration of Northeastern Health Systems (NHS) Sequoyah posted a statement saying that although McElyea was not an employee of NHS Sequoyah, he was affiliated with a medical staffing group that provided coverage for the emergency room at Sallisaw but he had not worked there in over two months [259,260]. The administration clarified that NHS Sequoyah had not treated any patients due to complications related to taking ivermectin, including not treating any patients for ivermectin overdose. They added that all patients who had visited the emergency room had received medical attention as appropriate,and the hospital had not needed to turn away any patients seeking emergency care.

On September 4, KXMX interviewed a hospital administrator of NHS Sequoyah who stated that the hospital being overloaded by ivermectin patients was ‘simply not the case in Sallisaw .. . we have not seen or had anypatients in our ER or hospital with ivermectin overdose . . . we have not had any patients with complaints or issues related to ivermectin . . . we are not overrun with patients with ivermectin related issues’ [261].

The administrator added that McElyea had treated patients in the Sallisaw emergency room but not in the past several months, and added that she wanted the public to know that McElyea did not speak for NHSSequoyah.

On September 4, NPR wrote that poison control centers are fielding a surge of ivermectin overdose calls [262,263].

On September 4, Reuters published a fact-check article saying that ‘outrage has spread online that Afghan refugees entering the United States will receive the drug ivermectin although it does not have U.S. approval as a COVID-19 treatment. However, the posts miss the vital context that refugees are given ivermectin for infections unrelated to the novel coronavirus . . . ivermectin is administered as a presumptive treatment forintestinal parasite’ [264]. The ‘outrage’ was said to have been caused by ivermectin being administered to refugees but being largely unavailable for US citizens willing to use it for COVID-19.

On September 4, an article by Associated Press published in Indian Express said that efforts to stamp out use of parasite drug ivermectin for COVID-19 in US were growing [265]. It said that ivermectin was being‘promoted by Republican lawmakers, conservative talk show hosts and some doctors, amplified via social media to millions of Americans who remain resistant to getting vaccinated’, with the American Medical Association, two US pharmacist groups, FDA, CDC and WHO advising against it.

On September 5, the Guardian added an amendment to the end of their article, quoting parts of the statementby NHS Sequoyah, saying that the hospital had not treated any patients related to taking ivermectin,including overdose [266].

On September 5, a ‘fact check’ by Shore News Network called the McElyea story ‘completely false’, mentioning that the publishers had not issued retractions, saying that ‘the left continues to push a media narrativethat conservatives and Republicans are creating an ivermectin health crisis’ [267].

On September 6, a preprint by Buonfrate et al. described randomized controlled trial in Italy with results indicating statistically insignificant dose dependent viral load reduction (NCT04438850) [268]. The authors said that ivermectin remained safe with dosing regimes of 0.6 mg/kg and 1.2 mg/kg for five days. The study was terminated early due to lack of eligible patients.

On September 6, a blog post by an US doctor working on new models for mental health care called theMcElyea story ‘too good to check’, saying that ’the media has tried to spread the word that the scientific consensus [about ivermectin for COVID-19] remains skeptical. In the process, they may have gone a littleoverboard and portrayed it as the world’s deadliest toxin that will definitely kill you and it will all somehow be Donald Trump’s fault’ [269,270].

On September 6, a report by News On 6 said ‘a false report has Oklahoma trending nationally . . . the doctor at the center of the story told News 9 he was misquoted, and the story was wrong’. McElyea clarifiedthat ‘as the story ran, it sounded like all of Oklahoma hospitals were filled with people who have overdosed on ivermectin and that’s not the case, . . . the cases we are seeing, people who are overdosing on ivermectin,they are taking full strength cattle doses and coming in and that is something that could be avoided’.

The report mentioned another hospital in the area, Integris Grove, having stated that they had seen ‘a handful of ivermectin patients in their emergency rooms . . . while our hospitals are not filled with people who have taken ivermectin, such patients are adding to the congestion already caused by COVID-19 and other emergencies’. The report concluded with a mention that the Oklahoma Center for Poison and Drug Information had received 12 ivermectin-related calls last month [271].

On September 6, Soave analyzed the media reporting, saying that the media fell for a viral hoax about ivermectin overdoses straining rural hospitals [272]. He commented that McElyea clearly stated that ivermectin overdoses were a problem and claimed that some hospitals were dealing with strain in general but he neveractually connected these two issues. Instead, the KFOR’s journalist had added that framing; she had notresponded to a request for comment. If other media outlets had called the doctor or the hospitals they would have easily uncovered the error. Soave added that while the mainstream media had vigorously condemned COVID-19 misinformation in social media, readers could also encounter it in mainstream media such as Rolling Stone, New York Times or Associated Press (AP) which had recently reported that 70 percent of calls to Mississippi’s poison hotline were from people who had taken ivermectin while the actual figure was 2 percent [273] (AP was a member of the Trusted News Initiative (TNI) [274]).

On September 6, another judge reversed the earlier decision concerning administration of ivermectin prescribed by Wagshul to a patient in a US hospital, saying there ‘was no doubt that the medical and scientific communities do not support the use of ivermectin as a treatment for COVID-19’ [275]. The judge addedt hat ‘COVID-19 has ravaged the world. However, the rule of law must be followed once the court system is involved. The law in its purest form shall have neither hatred nor sympathy to anyone or anything. It shall stand unwavering in its truth, justice, and fairness to call’ [276]. A spokesperson for the hospital described the ruling as ‘positive in regards to the respect for science and the expertise of medical professionals’, adding that they implore the community ‘to do what we know works: wear a mask, become fully vaccinated and use social distancing whenever possible’. She added that the hospital appreciated scientific rigor and did not believe they should be ordered to administer medications ’against medical advice’.

On September 6, a German magazine for pharmacists reported about American Pharmacists Association’s recent demand to stop off-label ivermectin prescribing [277]. The article mentioned the ongoing PRINCIPLEtrial by University of Oxford.

On September 7, Fox News reported that McElyea was an employee of an agency that staffs emergencydepartments [278]. The report also mentioned that while NHS Sequoyah had stated they had not treatedany ivermectin patients, Integris Grove Hospital, had seen a handful’. Integris added that ‘there is a lotof media attention surrounding remarks reportedly made by Dr. McElyea. While we do not speak on hisbehalf, he has publicly said his comments were misconstrued and taken out of context’.

On September 7, a CNN reporter Daniel Dale tweeted about McElyea case, saying local media had misrepresented the interview of McElyea, national and international media had failed to do due diligence, and readers and critics had jumped to conclusions. He concluded that ‘lots of people involved here – certainly the local outlet/the big aggregating outlets/the prominent tweeters on the left, but also some critics on the right – could’ve done a better job pursuing facts/waiting for facts before coming to conclusions’ [279]. CNN published a ‘fact-check’ report with similar content [280].

On September 7, an Austrian newspaper wrote that the misconception that horse dewormer ivermectin wouldhelp against COVID-19 is widespread internationally and also in Austria [281]. The article mentioned thatno poisonings had been reported in Austria, and that Czech Republic had adopted ivermectin in hospitals.

A toxicologist commented that ivermectin was still dangerous and there was insufficient data on the safety of chronic consumption.

On September 7, the title of a January 2021 article in a German women’s magazine, originally asking whether ivermectin might be useful, was updated to ‘People are not horses’ [282].

On September 7, a Swedish newspaper Svenska Dagbladet wrote that instead of being vaccinated Americans are taking ivermectin as the latest alternative treatment for COVID-19, the only problem being that it was intended for treating parasites in horses and cows [283].

On September 7, Joe Rogan complained that CNN had reported that he had been taking ‘horse dewormer’;Rogan stated that ‘I literally got it from a doctor’ [284].

On September 7, wealthy Chinese exile Guo Wengui was said to be using his online misinformation network to promote the use of unproven treatments for COVID-19 [285].

On September 8, an article by Cruciani et al. presented a systematic review and meta-analysis of ivermectin for prophylaxis and treatment of COVID-19 [286]. Based on an analysis of eleven RCTs, the authors concluded that there was limited evidence for the benefit of ivermectin.

On September 8, a letter published in the Guardian by Hill, the main author of one of the meta-analyses about ivermectin [5], said that after his team had questioned the clinical benefits of ivermectin the team and his family had received daily death threats. As social media platforms had not reacted he had stopped using social media but abuse by email had continued. Hill described the situation as shocking, affecting many scientists, and said that scientists must be protected from anti-vaxxer abuse, possibly by police action [287].

On September 8, Wired magazine wrote about Together trial results, quoting the head researcher saying that ivermectin proponents had ignored their fluvoxamine findings, only being interested in ivermectin,‘feeling strongly’ about it but not about other possible options [288]. The article also mentioned US NIH’s ongoing ACTIV-6 ivermectin trial, into which people could sign up at home. A co-chair of the trial’s steering committee said that there was no data on ivermectin’s benefit but since people were using it, the point of their trial was to get a definitive answer.

On September 8, the Guardian worried about some Australian clinics’ off-label prescribing of ‘unapproved’ivermectin [289]. The president of the Royal Australian College of General Practitioners (RACGP) said that while RACGP did not consider its role to be looking over the shoulders of every GP, the advice from the health experts to not use ivermectin was ‘100% clear’. However, she added, ‘the status of other drugs, suchas sotrovimab, is very different. That is an example of a new drug for the treatment of Covid-19 that haspassed through the rigorous testing safety procedures of the Therapeutic Goods Administration’.

On September 9, Geert Vanden Bossche summarized the negative effects of mass vaccination as follows: itwill, first, eventually drive dominant propagation of super variants that are highly infectious and increasinglyresist vaccine-induced neutralizing antibodies; second, erode innate immune defense in the non-vaccinated(due to high infectious pressure exerted by enhanced circulation of more infectious variants); and third,erode naturally acquired immunity (due to increasing viral resistance to neutralizing spike protein specificantibodies). Of these, the second and third consequences together prevent herd immunity from being established.

Yet the solution, according to Bossche, would be induction of herd immunity by starting from scratch against the more infectious variants. This could be achieved by providing multidrug early treatment for the infected which would result in enhanced rates of recovery from disease and rise in the number of people who develop life-long protective immunity. Also, mass antiviral treatment with any drug that would effectively reduce viral infectious pressure would be required to prevent innate antibodies in previously asymptotically infected individuals from being suppressed by short-lived, spike protein specific antibodies and thus enable the healthy, unvaccinated part of the population to deal with all SARS-CoV-2 variants; these massantiviral campaigns might need to include pets and live-stock and be combined with lockdown rules foras long as titers of these short-lived antibodies were measurable (6-8 weeks).

Boscche said that a larger unvaccinated population would circulate also less infectious variants, attenuating circulation of more infectious variants. However, the above methods would still be unlikely to sufficiently reduce transmission among healthy individuals; therefore ultimately an immune intervention able to prevent infection in all susceptible age groups would be required, and as long as such an intervention, likely based on natural killer cell based vaccines, would not be available, repeated antiviral chemoprophylaxis might be necessary. However, as along term strategy the chemoprophylaxis would not be feasible, as overuse could promote viral resistance to the compound.

About his personal intentions Bossche wrote that ‘one can always do more, write morearticles, bring more scientific evidence to the table, do more interviews and podcasts, reply to more questionsand destroy more of the nonsense divulgated by scientifically incompetent experts or illiterate fact-checkers.

However, I’ve decided to not continue along this path as I knew from the very start that this big alliance of stakeholders would not listen and as the primary purpose of my endeavors has always been to share, as broadly as possible, my scientific insights on why this [mass vaccination] experiment is an incredible blunder, so that none the involved experts, key opinion leaders, public health authorities or peers from industry could ever pretend that this was unknown and simply unpredictable’ [290].

He said that he had a history of going against ‘groupthink’, for example speaking against the results of Gavi The Vaccine Alliance’s phase III Ebola vaccine trials conducted by the World Health Organization (WHO) and published in a peer-reviewed journal. Bossche said the results falsely concluded that the vaccine had 100% efficacy, whereas according to Bossche’s analysis ‘the truth looked extremely different’ [291]. He added that to him it seemed that ‘many of our experts and scientists, even including a substantial number of renowned professors, are so stuck within their small silos that they have simply lost touch with reality’.

On September 9, Hill responded to a tweet by the BIRD group which had said that according to Hill, the conclusions of the meta-analysis by Hill et al. remain clearly in favor of ivermectin even after exclusion ofElgazzar et al. trial [292,293]. Hill stated: ‘Misleading information from the BIRD group. In our analysis there is no significant survival benefit for ivermectin in randomized trials after exclusion of apparently fraudulent and biased studies’ [292]. Later on the same days he responded with ‘more misleading information from the BIRD group misquoting our research’ to another tweet by the BIRD group which had said that‘Hill’s work also shows that ivermectin not only reduces the risk of death, it clears the virus from the bloodstream faster than controls, thus ivermectin reduces the time that an infected person can transmit the virus’ [294].

On September 9, Joe Rogan discussed the ‘horse dewormer’ narrative, referring to regulatory capture in theUS [295].

On September 10, a news report in the BMJ discussed US court rulings and ivermectin prescriptions [296].

On September 10, the BIRD group announced that their meta-analysis by Bryant et al. [4] had reached a position in the top ten of 18.9 million articles tracked by Altmetric [297,298].

On September 10, Hill tweeted that the ‘survival benefit of ivermectin disappears when only trials at low risk of bias are analyzed. The reported survival effects are entirely driven by studies at high risk of bias or medical fraud’ [299]. An accompanying graph indicated slightly over 50% benefit (p=0.01) with Elgazzar et al. study included, slightly under 40% benefit (p=0.05) without it but including studies with a high risk for bias, and approximately 4% benefit (p=0.90) with only low risk studies included.

On September 10, a blog article discussing failed communication attempts between ivermectin skeptics and proponents commented that ‘what you are witnessing is just the most absurd example of a decades-long war on re-purposed (aka “non-profitable”) medicines’ [300,301,302].

On September 10, Hindustan Times wrote about a clinical trial (RIVET-COV) with 157 patients with mild to moderate disease carried out by All India Institute of Medical Sciences (AIIMS) which indicated that ivermectin did not reduce the viral load or duration of symptoms [303]. Mohan said that ‘all the ivermectin being prescribed or being taken by people left, right, and centre will definitely not show any effect’; therefore ivermectin should not be used outside clinical trials, although he added that their trial did not investigate possible effect on mortality.

On September 11, TrialSite News wrote about US NIH’s refusal to release information on who had been involved in its decision to recommend neither for nor against ivermectin [304]. However, US CDC had released the names of the members of the working group [305]. According to TrialSite News, three of the nine members, Adimora, Bedimo and Glidden, had disclosed a financial relationship with Merck & Co/MSD.

Another member, Naggie, had later received USD 155 million funding for US NIH’s ACTIV-6 trial which included ivermectin, fluvoxamine and fluticasone (NCT04885530) [306].

On September 11, TrialSite News wrote that Australia’s Therapeutic Good Administration (TGA) had formally placed a national prohibition on off-label prescribing of ivermectin to all general practitioners,citing interruption of vaccination as a factor in the decision [307].

On September 12, a three-day International Covid Summit started in Rome [308,309], with presentationsin the Roman Senate held also in Italian and Spanish and translated into sign language. Lecturers included Roberta Ferrero, Francesca Donato, Albert Bagnai, Luigi Icardi, Ivan Vilibor Sincic, Joseph Tritto, Robert Malone, Mauro Rango, Christof Plothe, David Anderson, Ira Bernstein, Fabio Burigana, Steven Hatfill,Roberto Accinelli, Tess Lawrie, Oswaldo Castaneda, Rosanna Chifari, Antonietta Gatti, Andrea Stramezzi, Peter Mccullough, George Fareed, Pierre Kory, Roberta Lacerda, Carlos Maggi, Bruce Patterson, DilipPawar, Victor Villa, Mattia Perroni and Francesco Matozza. In addition, the summit featured groups of researchers and clinicians from Italy, Croatia, Czech Republic, Poland, Romania, Bulgaria, Tanzania, South Africa, Nigeria, Mali, Spain, UK, France, Brazil, Bolivia, Argentina, Paraguay, Peru, Canada and US. Several treatment protocols including McCullough et al’s sequenced multidrug protocol [310] and FLCCC’s MATH+protocol were discussed.

On September 13, a Dominican Republic newspaper described details of an early 2020 ivermectin trial by Morgenstern et al. [311,312].

On September 13, a story in Rolling Stone ridiculed ‘anti-vaxxers’ for using povidone iodine mouthwash to prevent COVID-19 [313]. An interviewed gynecologist/obstetrician commented that ‘we use it before surgery to clean the vagina’ and that ‘it could result in iodine poisoning if taken orally’. Another physician who appeared unable to give statements without including profanities in his sentences commented that ‘drinking iodine’ had caused a patient a transient kidney failure and that povidone iodine definitely could not reducethe effects of COVID-19 or prevent its transmission. An ’Australian family physician’ stated that ‘there have been no human studies on the use of Betadine to treat COVID-19, just hypotheses and lab studies’.

On September 13, the Guardian wrote about ‘ivermectin frenzy’ being ‘a cottage industry of advocacy groups, anti-vaccine activists and telehealth companies’ despite stances of FDA, NIH and some US medical and pharmaceutical associations [314]. It noted that FLCCC had signed open letters in favor of ivermectin which had also been signed by ‘anti-vaxx’ organizations. Telehealth sites were said to have connections to a conservative doctor group America’s Frontline Doctors in favor of hydroxychloroquine treatments and whose opinions had been quoted by ‘Donald Trump, his son Donald Trump Jr and numerous QAnon conspiracists’.

On September 13, Mother Jones magazine wrote that people associated with Q-Anon had harassed a hospital where a Q-Anon member had been hospitalized with hundreds of calls and emails, in order to get ivermectin administered to her [315].

On September 14, in a Cochrane Collaboration author interview, Stephanie Weibel and Maria Popp described their ivermectin meta-analysis [316]. The authors said that because of a lack of good-quality evidence, it was unknown whether ivermectin reduces or increases mortality, caused adverse effects, improved or worsened patients’ condition, or increased or decreased viral load, led to more or fewer negative COVID-19 tests 7days after treatment. Likewise, they could not say whether ivermectin prevented COVID-19 infection or reduced the number of deaths after high-risk exposure to the SARS-CoV-2 virus.

On September 14, Menichella wrote about Peter McCullough’s influence in Italy and about a protocol developed in Italy by a group led by Giuseppe Remuzzi [317]. The Remuzzi protocol was mainly based on relatively selective COX-2 inhibitors [318]. In a retrospective observational matched-cohort study with 90outpatients and 90 controls with mild disease the proportions of patients who required hospitalization were2% vs 14% (p=0.01); cumulative days of hospitalization were 44 vs 481 days, and costs of hospitalization were EUR 28,000 vs EUR 296,000, respectively. Menichella wrote that the standard of care resulted in approximately 2% mortality; with a ’serious home treatment protocol’ mortality could be lowered to 0.05%.

On September 15, an article by Talwar et al. described a case of a successful management of ivermectinpoisoning [319]. A 6-year-old girl weighing 20.5 kg had accidentally consumed 600 mg of ivermectin (29.3mg/kg). Mechanical ventilation, ceftriaxone, clindamycin, intravenous midazolam, phenytoin and supportivemeasures were utilized. The girl was discharged after nine days of hospitalization.

On September 15, a news report in Willamette Week discussed US biologist Bret Weinstein’s role in the ivermectin controversy, including his influence on Joe Rogan [320].

On September 15, a letter to the editor by Boretti discussed quercetin, suggesting that quercetin might help to lower inflammation, as well as reduce the toxic effects of COVID-19 vaccines and the chances of being infected [321]. Quercetin had been included in the FLCCC protocols since early 2020.

On September 15, Fenton et al. discussed unreliability of current vaccine studies [322].

On September 16, Cheng et al. presented a meta-analysis about efficacy and safety of various medications for treating severe and non-severe COVID-19 patients [323].

On September 16, Malhotra discussed Indian Bar Association’s legal notice to WHO [324].

On September 16, an Australian medical newspaper wrote that a secretive organization called the COVID19 Antiviral Advisory Group had said it had been instructing 200 doctors to prescribe ivermectin and was planning on going public against TGA’s ivermectin ban [325].

On September 17, an article by Singh et al. suggested a positive correlation between European populations’zinc sufficiency status and COVID-19 mortality. The authors noted that the observed association was contrary to what would be expected if zinc sufficiency was protective in COVID-19, suggesting that controlled trials or retrospective analyses of the adverse event patients’ data should be undertaken to correctly guidethe practice of zinc supplementation in COVID-19 [326].

On September 17, an article by Gurung et al. described an in silico study which indicated that ivermectin demonstrated moderate binding to human serum albumin [327].

On September 17, a preprint by Karale et al. presented an updated systematic review and meta-analysis of mortality, need for ICU admission, use of mechanical ventilation, adverse effects and other clinical outcomes

[328]. 52 studies (n=17,561) were included in a qualitative analysis and 44 of those (n=14,019) were included in the meta-analysis. A mortality meta-analysis indicated lower odds of death (OR 0.54, 95% CI 0.34-0.86,p=0.009, 29 studies). As adjuvant therapy, the odds of viral clearance were higher (OR 3.52, 95%CI 1.816.86, p=0.0002, 22 studies), the duration to achieve viral clearance was shorter (p=0.02, 8 studies), andthe need for hospitalization was reduced (OR 0.34, p=0.008, 6 studies). The authors concluded that themortality benefit of ivermectin in COVID-19 is uncertain but as an adjuvant therapy ivermectin may improve viral clearance and reduce the need for hospitalization.

On September 17, a news report by Piper in Vox magazine questioned the validity of studies by Carvallo etal. [329,330], saying that experts on scientific fraud didn’t believe Carvallo conducted his study as described:the data appeared fabricated, key data was missing, study registration and published results didn’t match with each other, Carvallo could not explain these issues, and the hospital in which the study was said to have been conducted stated that it had not been conducted there, to which Carvallo replied that it had been but without the hospital administration knowing [331]. In another context, Lawrie of the BIRD group had been asked what evidence would persuade her that ivermectin didn’t work, to which she had replied thatthere could be nothing that would persuade her. Mills involved in the Together trial commented that themost culpable parties weren’t those who had believed in the apparently fraudulent studies but those whohad conducted, published, and boosted them.

On September 17, Business Insider wrote about FLCCC’s Kory and Marik, calling them ’fringe doctors whipping up false hope that could have deadly consequences’ [332]. According to Business Insider, Kory was’a once respected doctor whose hospital rejected his unsupported treatment ideas’ while Marik was ’a doctor who ostracized himself from mainstream medicine after his high-profile sepsis treatment was a dud’, adding that ’Marik’s failed sepsis protocol later became the backbone of the FLCCC’s first iterations of COVID-19treatment’ (the MATH+ inpatient protocol) [333]. Recently they had been ’sucked (willingly or not) into the embrace of the anti-vaccine far right .. . ivermectin is now a darling drug of QAnon’. A former FLCCCmember, Eric Osgood, had left the group in summer 2021. The editor in chief of Science Communication said that FLCCC’s communication style was objectionable but added that the existence of ’rogue opinions’was a necessary condition for scientific breakthroughs. However not everyone had the skills to assess claimsnor understood how science worked, which had led to ’a conflict between our commitment to freedom of speech and a clash with the nature of scientific truth and people’s right to say anything they want . . . the hype machine they’ve created is out of control’.

On September 17, Seheult on MedCram reviewed ivermectin, with comments from cell biologist Rhonda Patrick [334]. Seheult stressed the importance of taking all treatment options into account; Patrick said ivermectin had seemed to consistently reduce viral load but the hype around ivermectin was pushing researchers away from the subject.

On September 20, an Indian news agency reported that 31 of 75 districts of the state of Uttar Pradesh inIndia were COVID-19 free [335]. In total, the state reported 17 new cases in the last 24 hours out of 182,742samples tested.

On September 20, the Guardian worried about horses being deprived of a deworming agent [336].

On September 21, Brazil’s president Bolsonaro stated that Brazil had supported clinicians’ early treatment measures since the beginning of the pandemic, adding that he could not understand why some countries opposed early treatment measures [337].

On September 21, Ars Technica discussed the validity of Covid Analysis group’s ivmmeta.com meta-analysis[338].

On September 22, a letter to the editor by Lawrence et al. in Nature Medicine concluded that metaanalyses based on summary data alone were inherently unreliable [339]. The authors stated that most,if not all, of the flaws in recent ivermectin meta-analyses would have been immediately detected if metaanalyses were performed on an individual patient data (IPD) basis. They recommended that meta-analysts who study interventions for COVID-19 should request and personally review IPD in all cases, even if IPDsynthesis techniques were not used. They also recommended that all clinical trials published on COVID-19should immediately follow best-practice guidelines and upload anonymized IPD. They authors said that their proposal was a change to a nearly universally accepted practice over many decades and substantially more rigorous than current standards; regardless, the proposed change was imperative.

On September 22, in a FLCCC weekly update, Marik announced an upcoming publication of an article on the pathophysiology of COVID-19 [340].

On September 22, a video by John Campbell described the contents of ivermectin kits used in state of Goain India [341]. The kits in Goa contained pulse oximeter, a thermometer, paracetamol, vitamin C and D,multivitamin tablets containing zinc, ivermectin (10 x 12 mg), doxycycline (10 x 100 mg), and personal protective equipment. The cost of one kit was USD 2.65. The kits used in Uttar Pradesh contained ivermectin, doxycycline, vitamins B, C and D, zinc, paracetamol, thermometer and a pulse oximeter. Outpatients weremonitored by phone twice a day. Campbell said that the intervention had actually been organized under a WHO monitoring program. A WHO report described that since May 5, 2021, 141,610 government teams were moving across 97,941 villages in 75 districts over five days in Uttar Pradesh, a state with a population of 230 million [342]. WHO field officers monitored over 2,000 government teams and visited at least 10,000 households. WHO also said it was to support the Uttar Pradesh government on the compilation of the final reports; these reports had not yet been published.

On September 23, a preprint by Mayer et al. described an intervention program of high-dose ivermectin in COVID-19 carried out by the Ministry of Health of the Province of La Pampa, Argentina [343]. Within five days of symptoms onset, 0.6 mg/kg/day of ivermectin for five days was administered. Active pharmacosurveillance was performed for 21 days, with hepatic laboratory assessments performed in a subset of patients. From 21,232 subjects with COVID-19, 3,266 were offered and agreed to participate in the ivermectin program. 17,966 did not participate and were considered as controls. A total of 567 participantsreported 819 adverse events; 3.13% discontinued ivermectin due to adverse events. Mortality was lower in the ivermectin group in the full group analysis (1.5% vs 2.1%, OR 0.720, p=0.029), as well as in subjects over 40year-old (2.7% vs 4.1%, OR 0,655, p=0.005). ICU admission was significantly lower in the ivermectin groupcompared to controls among participants over 40 year-old (1.2% vs 2.0%, OR 0.608, p=0.024). According to Covid Analysis group [344], in a full group analysis the unadjusted risk of death was 27.6% lower (RR 0.72,p=0.03) and unadjusted risk of ICU admission was 26.0% lower (RR 0.74, p=0.13).

On September 23, several groups of clinicians in favor of early treatments announced a new organization,World Council for Health, an umbrella organization with over 45 affiliated organizations [345]. The council released a home treatment guide with a combination protocol consisting of vitamins C and D, zinc, quercetin, melatonin, ivermectin, mouthwash, ibuprofen, N-acetylcysteine, antihistamines, aspirin, and others [346].

The protocol was one of the first ones to tentatively include iodine (Lugol’s solution).

On September 23, the Indian Council of Medical Research (ICMR) dropped ivermectin and hydroxychloroquine from clinical guidelines for the management of adult COVID-19 patients [347,348,349,350].

On September 23, a fact-checking website discussed social media posts claiming that ’ivermectin apparently sterilizes the majority (85%) of men that take it’ and a news report claiming that ’ivermectin causes sterilization in 85 percent of men, study finds’ [351,352].

On September 24, the Guardian wrote about misinformation spreading globally [353].

On September 24, the Guardian wrote about fraudulent ivermectin studies [354].

On September 24, Mashable interviewed ex-FLCCC member Osgood who said that he had initially joined the FLCCC because they were ’forward thinking doctors who were able to get ahead of the profession’ on a few hospital treatments (e.g. the use of anticoagulants) but he had left the organization because of his view that FLCCC insisted on promoting ivermectin over vaccines [355]. He referred to povidone iodine prophylaxis of COVID-19 as misinformation.

On September 26, an article by Marik et al. presented a scoping review of the pathophysiology of COVID-19[356]. The article described severe COVID-19 as one of the most complex of medical conditions known to medical science, noting that an overarching and comprehensive understanding of its pathogenesis, a requirement for the formulation of effective prophylactic and treatment strategies, was still lacking. Threebasic pathologic processes were identified: a pulmonary macrophage activation syndrome with uncontrolled inflammation, a complement-mediated endothelialitis together with a procoagulant state with a thromboticmicroangiopathy, and platelet activation with the release of serotonin and the activation and degranulation of mast cells contributing to the hyper-inflammatory state (quercetin had been a part of FLCCC protocols sinceMarch 2020; in one study, it was found more effective than cromolyn in blocking mast cell cytokine release[357]). The article also mentioned the C-C chemokine receptor type 5 (CCR5) pathway which interacts with chemokine ligand 5 (CCL5 or RANTES).

On September 26, in a discussion with Robert Malone, Geert Vanden Bossche stated that the proper way would have been to vaccinate vulnerable groups only, and mentioned ivermectin chemoprophylaxis as a possible solution [358].

On September 26, the New York Times interviewed the acting head of the New Mexico (US) state health department who claimed that ivermectin ’had contributed to’ deaths of two hospitalized patients who had previously self-medicated with ivermectin ’instead of proven treatments like monoclonal antibodies’ [359].

On September 27, in a discussion with Anmol Ambani and Peter A. McCullough, Marik presented the contents of the new article in a video lecture [360].

On September 27, 5,200 doctors had signed a Global Covid Summit related ’Rome declaration’ [361].

On September 27, an article by Deng et al. presented a systematic review and meta-analysis about the efficacy and safety of ivermectin [362]. Based on an analysis of three observational studies and 14 RCTs representingvery low to moderate quality of evidence, the authors concluded that ivermectin was not efficacious atmanaging COVID-19.

On September 28, an article by Barkati et al. concluded that corticosteroid therapy was an important risk factor for Strongyloides hyperinfection but there were challenges associated with the performance, availability and quality of Strongyloides tests. The authors concluded that presumptive use of ivermectin was reasonablein selected situations [363].

On September 28, an article by Zhang et al. presented a Bayesian network meta-analysis of 222 randomized controlled trials with 102,950 patients, suggesting that imatinib, intravenous immunoglobulin andtocilizumab led to lower risk of death; baricitinib plus remdesivir, colchicine, dexamethasone, recombinanthuman granulocyte colony stimulating factor and tocilizumab indicated lower occurrence of mechanical ventilation; tofacitinib, sarilumab, remdesivir, tocilizumab and baricitinib plus remdesivir increased the hospital discharge rate; convalescent plasma, ivermectin, ivermectin plus doxycycline, hydroxychloroquine, nitazoxanide and proxalutamide resulted in better viral clearance [364]. On a treatment class level, the analysis found that the use of antineoplastic agents was associated with fewer mortality cases, immunostimulants could reduce the risk of mechanical ventilation and immunosuppressants led to higher discharge rates.

On September 28, the New York Times wrote that Facebooks groups promoting ivermectin continued to flourish [365].

On September 28, a rapid review by Cardwell et al. about pharmacological interventions to prevent COVID19 mentioned ivermectin prophylaxis trials [366].

On September 29, a preprint by Budhiraja et at. described secondary infections in hospitalized patients inNorth India, mentioning that 43.5% of the patients had been administered ivermectin [367].

On September 29, referring to FLCCC, BIRD and America’s Frontline Doctors (AFLDS), Scientific Americanwrote about fringe doctors’ groups promoting ivermectin for COVID despite a lack of evidence [368].

On September 29, Chemistry World wrote that ivermectin debacle had exposed flaws in meta-analysis methodology [369]. The report stated that ’the people who’ve done these meta-analyses haven’t stuffed up. . . they haven’t deviated from accepted standards or made big mistakes . . . instead, there is a fundamentalflaw in the approach’.

On September 29, the Hill, the largest independent political news site in the US, wrote that ivermectin disinformation had led to new kinds of chaos [370].

On September 30, a preprint by Schaffer et al. describing changes in dispensing of medicines proposed for re-purposing in the first year of the COVID-19 pandemic in Australia noted that there had a small but sustained increase in ivermectin dispensing between March 2020 and November 2020 [371].

On September 30, an introduction to Popp et al.’s Cochrane review by Jordan said that at this stage there were very few completed well conducted studies about either prevention or treatment but 31 trials were underway [372].

Discussion

On a closer look it appeared that the quality of some early ivermectin trials had been lower than assumed.

As individual patient data had not been generally available, most parties including various groups publishing meta-analyses had implicitly trusted the summary data and ignored slight inconsistencies. The current best practice guidelines did not require analysis of individual patient data. The proposal that meta-analyses should be performed on individual patient data appeared justified. An additional, likely necessary change to methodology would be adoption of the do-search method, assumedly the most general tool currently available for causal effect identification, and as such an improvement over Bayesian methods [179,373].

In 2014, Every-Palmer et al. noted that little ‘high quality’ (according to evidence-based medicine standards)empirical evidence existed that EBM should benefit the population, i.e. evidence about EBM’s superiority in improving patient outcomes [374]. In 2018, Anjum claimed that EBM relied on a flawed positivist methodology [375]. Recently, Martini claimed that the concept of evidence was insufficiently defined [376].

A fundamental error appeared to be the insistence on trialing single agents instead of combination protocols.

All of the currently utilized early treatment protocols were combination protocols and it was unlikely that the same results could have been obtained with a single agent. Thus, combination protocol trials would have been more likely to produce statistically significant effects. The insistence on large trials, instead of eliminating biases, possibly introduced them. For example, a lack of funding for repurposing may have introduced a severe funding-related bias.

It appeared that prolonged stress and continuing unpredictability of the situation had overwhelmed many,occasionally leading to actions whose consequences were perhaps badly thought out. The situation seemedto amplify preexisting tendencies and weaknesses within groups, leading to group-specific biases, formationof subcultures, or variants of ’groupthink’ [103]. Groups suspecting the pharmaceutical industry, authoritiesand ’the mainstream’ seemed to amplify these tendencies in-group, whereas groups suspecting anything’fringe’ but favoring mechanistic thinking and overreliance on specific methods or paradigms seemed toamplify these tendencies. Groups with a tendency to act out in panic or anger exhibited that behavior,while groups with a tendency to retreat into fearful inaction and silence did that. The central role of trustwas highlighted, yet trust seemed practically nonexistent.

Also strengths were exhibited, most prominently the capability of forming groups and alliances. However,these groups tended to become tribal in their nature, and the result resembled tribal warfare, a practice that the humanity should already have transcended. It seemed as if everyone was trying to take care of others in their own ways but these ways were incompatible with each other; someone once defined conflicts as ’failed attempts to love’.

It also seemed that journalists and the public had an idealized image of science and were trying to find solace in it as in a religion, with some scientists maybe trying to maintain these illusions. One commentator noted that ’society was not ready to watch science in real time’ [377]. Another added that ’science was not prepared to display itself to the public in real time’, while a third said that ’society was not ready to watch science in any other way either’.

In the news media, emotionally manipulative tactics seemed common. A prime example of arrogance and lack of due diligence was the case of Rolling Stone ridiculing povidone iodine use [313], claiming that there had been no human trials about it on COVID-19, despite the fact that there had been several, with promising results [10,378,379,380,381] (for observational studies, see e.g. [382,383]; for an updating list, see [384]).

Ways of reasoning appeared incompatible for example in the case of the Guardian’s critique of the BIRD group affiliating with organizations labeled as anti-vaccine for the purposes of promoting early treatment.

In the view of the BIRD group founder, vaccinations were unrelated to early treatments and, subsequently,the vaccination stances of the affiliates irrelevant. While technically correct, this view predictably appeared confusing.

In a similar manner it could be noted that, for example, the possible usefulness and validity of FLCCC’s protocols was unrelated to FLCCC members’ extra-medical opinions, and that ivermectin was only one component of the synergistic protocols consisting of more than ten components. Also, some news reports[332] severely misrepresented the sepsis protocol [333]. With regard to the social media communications of the FLCCC, it may have made a mistake in leaving these communications largely to a couple of ex-journalists whose communication style appeared unsuitable already in the first half of 2020.

With regard to conflicts of interest, the members of US National Institutes of Health’s (NIH) ivermectinworking group had disclosed several relationships to pharmaceutical companies working on COVID-19 treatments [385]. As mentioned, three of the nine members of the working group [305] had disclosed relationshipswith Merck & Co/MSD which, during the pandemic, had issued a statement against the use of ivermectinin COVID-19 [386], was working on a competing product molnupiravir [387,388,389], and had receivedsignificant US government funding for development of investigational pharmaceuticals for COVID-19 [390].

Adimora had received research support from Gilead Sciences and was a consultant and a member of an advisory board of Merck & Co/MSD; Bedimo was a member of advisory boards of Gilead Sciences, Merck &Co/MSD and ViiV Healthcare (a subsidiary of GlaxoSmithKline); Glidden was a consultant to Gilead Sciences and a member of an advisory board of Merck & Co/MSD [385]. A fourth member, Pavia, was a consultant to GlaxoSmithKline. A fifth member, Naggie, the head of US NIH’s ACTIV-6 trial (NCT04885530) [306]had received research support from AbbVie and Gilead Sciences, had a connection to Bristol Myers SquibbCompany, and was a stockholder and an advisory board member of Vir Biotechnology, the producer ofsotrovimab together with GlaxoSmithKline [391]. In summary, more than half of the members of the working group were associated with producers of molnupiravir, sotrovimab, remdesivir (Gilead Sciences),lopinavir/ritonavir (AbbVie), and investigational monoclonal antibodies (Bristol Myers Squibb Company).

However, NIH had specifically intended to involve the industry in its decision-making processes through the ACTIV public-private partnership [392]. Whereas this organizational structure likely appeared beneficialfrom the point of view of a swift development of investigational pharmaceuticals, with regard to repurposingit appeared to have included conflicts of interest by design.

For the pharmaceutical industry, incentives for unethical behavior may currently overpower those for ethical behavior. The current setting appeared designed for gambling [393], hardly the best method for optimizing public health, and it was difficult to see why societies considered it appropriate.

The event descriptions did not delve into details of the experiences of Honduras and the Dominican Republic; readers are encouraged to acquaintance themselves with the original sources [217,106,107,311,312].

These countries used relatively little clinical trial evidence to implement their protocols. Similarly, no RCT evidence on FLCCC protocols exists, yet they have been successfully used. These parties seemed to embrace uncertainty instead of requiring an unattainable level of certainty; high-income countries were probably less accustomed to radical uncertainty than developing countries.

Cameron described critical care archetypes on a two-axis model, with the first axis comparing interventionism(early, aggressive treatment) versus minimalism (’wait and see’) preferences, and the second axis measuring individualism versus collectivism [74]. In this model, the FLCCC appeared high on interventionism and individualism. The ’mainstream’, for example the World Health Organization and national authorities, appeared high on minimalism and collectivism.

During the whole pandemic (and before it), little to no attention was paid to the optimization of innate immunity. If the immune system is dysfunctional or in a suboptimal state, attempts at medicating symptoms including symptoms of SARS-CoV-2 infection are unlikely to be very effective, and the same likely applies to vaccines. While the role of zinc was acknowledged to some degree, the roles of, for example, copper, selenium and iodine were still mostly ignored. Conventionally, a long-term zinc supplementation without simultaneous copper supplementation is considered a risk for development of copper deficiency which would compromise immune function and host defence [394]; FLCCC recently lowered the dose of zinc supplementation. Astudy on European populations found a positive correlation between zinc sufficiency status and COVID-19mortality and incidence, contrary to what would be expected if zinc sufficiency was protective in COVID-19[326]; however, the result might also indicate lack of zinc ionophores.

Suggested solutions

In addition to the methodological issues there were other types of challenges to overcome. Considering that the nature of communication between parties involved in the ivermectin controversy was predominantly ofa rather violent nature, a method for improving communications would be needed. A suitable method forthe purpose may be the rather well known but rarely applied ’non-violent communication’ (NVC) method developed by Marshall Rosenberg [395,396]. The method presupposes a willingness to a certain degree ofvulnerability in order to express one’s real needs and feelings, and a willingness to actually listen to others without judging.

The method consists of two parts: expressing oneself, and empathically acknowledging others. NVC defines empathy as ’a process of connecting with another by guessing their feelings and needs’ [397]. Friesem describes the expressing part as a sequence of four steps: making observations (not evaluations) without blaming or criticizing, connecting feelings (bodily sensations instead of thoughts) to these observations, expressing the needs/values (not preferences) that caused the feelings, and making requests (concrete actions instead of vague wishes) without demanding [398]. The listening part consists of the same steps but the expressions use the pronoun ’you’ instead of ’I’. The four components are thus expressed as ’when I/you see/hear. . . ’(observation), ’I/you feel. . . ’ (feeling), ’. . . because I/you need/value. . . ’ (need), and ’would you be willing to/would you like. . . ’ (request).

The content must be as free from interpretations as possible, instead expressed in a neutral ’observation anguage’. Feelings, which are functions of the states of satisfaction of various needs, must be identified, named, connected with, and expressed without interpretation. Needs must be distinguished from strategies(strategies include objects and parameters while needs do not). Requests are aimed at assessing how likelyone is to get cooperation for particular strategies for meeting one’s needs; requests should be concrete and specific. Pandemic-specific examples are left as an exercise for the reader. With regard to therapeutics research, it might be worth a try to organize a conference whose participants would be required to find at least one detail they could agree on and then build on that foundation.

Considering that the communications at times appeared hopelessly dysfunctional, more potent methods are likely also needed. To a large extent, the damage associated with the pandemic was not caused by the virus itself but by a preexisting societal conditioning to fixed beliefs and subconscious biases which eventually led to disorganized and dissociative behavior. This ’inflexible disorganization’ subsequently created a massive amount of additional anxiety, burnout and depression.

Psychedelic therapy, currently maybe the second most trendy research subject after COVID-19 itself, wouldlend itself well for resolving these issues [399,400,401,402,403,404]. Psychedelics are likely the most effectivefacilitator of inspection of subconscious biases and fixed beliefs, and as such a valuable tool especially forscientists. Smaller doses may be preferable; this practice is called psycholytic therapy. It differs from the so-called ’microdosing’ in that doses are typically approximately a half or a third of a regular dose, and the effects of the substance are clearly perceived but different from those of high-dose psychedelic therapy.

Subconscious biases could be said to be a type of dissociative phenomena, in which a trigger related to a previous experience of overwhelming trauma triggers a slight dissociation, or a ’defence mechanism’. The mechanism of action of psychedelics in this case, in short, is to enable a person to relive the traumatic experience in order to neutralize the trigger. This must be done in an environment which provides thenecessary support so that the experience would not be experienced as overwhelming once again, as that would constitute a retraumatizing experience. Although various psychedelics produce slightly different effects, all of them would be useful for this kind of work. This includes also substances not always considered psychedelics,namely MDMA which is often called an ’empathogen’, and ketamine, often called a ’dissociative’.

Thus, an available pharmacological method would be off-label ketamine [405,406,407]. A trial by Federet al. compared treatment of post-traumatic stress disorder with either midazolam or ketamine (n=30)(NCT02397889) [408,409,410]. The mean score on the clinician-administered PTSD Scale for DSM-5(CAPS-5) was reduced from 40.1 to 33.2 in the midazolam group, and from 41.9 to 22.5 in the ketaminegroup. A similar reduction was observed for depressive symptoms.

A recent example of conflict resolution through altered states of consciousness, with promising results, was an attempt to alleviate the Israeli-Palestinian conflict by organizing ayahuasca group ceremonies [411].

The essence of psychedelic therapy, however, are not the molecules but the ’states of consciousness’, or states of mind, or emotional states, reached with the help of the molecules; change, progress or ’healing’ happens in or through these states. The same states may also be reached by other methods, although psychedelics provide a shortcut in situations in which there is a lack of time, skill or resources; the cost-effectiveness of psychedelic therapy is typically superior to other methods.

Non-pharmaceutical methods capable of inducing altered states include holotropic breathwork developed by Stanislav and Christina Grof [412]. Holotropic breathwork consists of continuous forceful circular breathing,combined with some bodywork and other techniques for guidance. The breathing technique leads to changes in oxygenation and typically to altered states of consciousness with the potential of resolving embodied traumatic experiences or opening new perspectives to overcome fixed beliefs. Grof developed the method as an alternative to LSD therapy sessions and has described the states and results as similar. A gentler approach from Buddhist traditions, also applicable to trauma therapy, is the Ch¨od method based on visualization[413,414].

The Wim Hof method is applicable for innate immune system enhancement [415]. In 2014, Kox et al.proved that sympathetic nervous system and immune system can be voluntarily influenced, and that itis possible to attenuate the innate immune response in humans [416,417]. Healthy volunteers practicing specific breathwork (hyperventilation), meditation and cold exposure techniques exhibited profound increases in the release of epinephrine, which in turn led to increased production of anti-inflammatory mediators and subsequent dampening of the proinflammatory cytokine response elicited by intravenous administration ofbacterial endotoxin. The Wim Hof method has numerous advantages: it is free, available to everyone,unlikely to produce adverse effects, and unconnected to health care systems and clinicians.

Conclusions

Similarly to SARS-CoV-2 virus emerging as a possibly inexhaustible source of ever more infectious variants,the issue of COVID-19 treatments emerged as a possibly inexhaustible source of increasingly complex epistemological challenges. Current best practices of clinical trial result meta-analysis were found to be unsound;methodological changes were proposed. More broadly, the whole approach based on sole reliance on single agent clinical trials that no-one really wanted to fund appeared fundamentally unsound. The pandemic also revealed various severe problems with mindsets and subconscious biases; methods to overcome these issues were also proposed. The impression of the ivermectin controversy as a whole was that what is ideally understood by science will remain out of reach if scientists are riddled with subconscious biases, methodologies are fundamentally unsound, commercial interests dominate, and the behavior more closely resembles tribal warfare than a silent meditation retreat.

Authors’ contributions

The author was responsible for all aspects of the manuscript.

Funding

This research did not receive any specific grant from funding agencies in the public, commercial, or not-for-profit sectors.

Availability of data and materials

Not applicable.

Ethics approval and consent to participate

Not applicable.

Consent for publication

Not applicable.

Competing interests

The author declares that he has no competing interests.

Author details

Independent researcher, Helsinki, Finland. ORCID iD: 0000-0002-8575-9838

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Friday September 17, 2021
University of Guelph
50 Stone Rd. E.
Guelph, ON, N1E 2G1

Dear Dr. Charlotte A.B. Yates, President and Vice-Chancellor,

I will forewarn you that this is a lengthy letter. However, it only represents a fraction of the information that I would like to be able to share with you. I have found it necessary to write this so you can fully understand my perspective. With my life and that of my family, many friends and treasured colleagues being destroyed under your watch, I figure the least you can do is read and consider this very carefully. It is incredible to note that many, if not most, of my on-campus detractors have judged me without reading any of my scientific arguments or talking to me about them.

The COVID-19 Vaccine Mandate at the University of Guelph

You issued a mandate that everyone within the University of Guelph community must receive a COVID-19 vaccine. I have spent most of my lifetime learning to be a very deep and critical thinker and to follow the weight of scientific evidence. I am a well-recognized expert in vaccinology. As per my extensive funding, research, publication, and teaching records, I am a vaccine lover and an innovator in this field. I promote highly effective vaccines that have undergone extensive, rigorous, and proper safety testing as the most efficient type of medicines that exist. Vaccines that meet these criteria have prevented a vast amount of mortality and morbidities around the world. However, I could not be in stronger disagreement with you forcing the current COVID-19 vaccines upon everyone who is part of our campus community. I respect the challenges that a university president faces when trying to manage a large and dynamic academic institution. However, your roots are as a scholar. As a publicly funded institution of advanced learning, it is incumbent on us to demonstrate an ability to view the world around us in a constructively critical fashion such that we can improve the lives of others. We should be able to do this free of political or financial pressures and without bias or prejudice or fear of censorship and harassment. As a viral immunologist that has been working on the front lines of the scientific and medical community throughout the duration of the declared COVID-19 pandemic, I feel compel ed to speak on behalf of the many who will not, due to extreme fear of retribution. We now live in a time when it is common practice for people to demand and expect to receive confidential medical information from others. I will not be coerced into disclosing my private medical information. However, for the sake of highlighting some of the absurdities of COVID-19 vaccine mandates I choose, of my own free will, to freely disclose some of my medical information here…

Those with Naturally Acquired Immunity Don’t Need to be Vaccinated and are at Greater Risk of Harm if Vaccinated

I participated in a clinical trial that has been running for approximately 1.5 years. The purpose is to develop a very sensitive and comprehensive test of immunity against SARS-CoV-2; in large part to inform the development of better COVID-19 vaccines (https://insight.jci.org/articles/view/146316 ). My personal results prove that I have naturally acquired immunity against SARS-CoV-2. With this test, spots indicate a positive result for antibodies against a particular part of the virus. Darker spots correlate with more antibodies. Antibody responses correlate with the induction of memory B cells. Antibodies will wane over time, but B cells can survive for many years and rapidly produce massive quantities of antibodies upon re-exposure to a pathogen. On the following page are my results, along with a map of which part of the virus each spot represents…

The dark spot at position D26 is the positive control and indicates that the assay worked. My results demonstrate that I have broad immunity against multiple components of SARS-CoV-2, including the spike protein. Importantly, spot B26 shows that I have antibodies against the membrane protein. This protein is not highly conserved across coronaviruses. As such, it provides evidence that I was infected with SARS-CoV-2. Note that I was sick only once since the pandemic was declared. It was a moderately severe respiratory infection that took four weeks to recover from. The SARS-CoV-2 PCR test was negative, despite being run at an unreasonably high number of cycles. This suggests that I was one of the many for whom SARS-CoV-2 has proven to be of low pathogenicity or not even a pathogen (i.e. no associated disease).

There is a plethora of scientific literature demonstrating that naturally acquired immunity against SARS-CoV-2 is likely superior to that conferred by vaccination only. Indeed, it is much broader, which means that emerging variants of SARS-CoV-2 will have more difficulty evading it as compared to the very narrow immunity conferred by the vaccines. Importantly, the duration of immunity (i.e. how long a person is protected) has proven to be far longer than that generated by the current vaccines. The duration of immunity for the mRNA-based COVID-19 vaccines appears to be a horrifically short 4.5 months. I actually wrote a lay article back in February 2021 to explain why a vaccine of this nature would fail to be able to achieve global herd immunity on its own (https://theconversation.com/5-factors-that-could-dictate-the-success-or-failure-of-the-covid-19-vaccine-rollout- 152856). This is why places like Canada, the USA, and Israel have found it necessary to roll out third doses. And now there is talk (and a commitment in Israel) to roll out fourth doses (yes, that’s four doses within one year). The World Health Organization recognized the value of natural immunity quite some time ago. Unfortunately, in Canada and at the University of Guelph, we have failed to recognize that the immune system works as it was designed to. Its ability to respond is not limited solely to vaccines.

Here are some references to support this: https://www.who.int/publications/i/item/WHO-2019-nCoV-Sci_Brief-Natural_immunity-2021.1; https://academic.oup.com/jid/advance-article/doi/10.1093/infdis/jiab295/6293992; https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7803150/.

As someone who develops vaccines, I can tell you that it is difficult to make a vaccine that will perform as poorly as the current COVID-19 vaccines. Indeed, most vaccines given in childhood never require a booster shot later in life. The take-home message here is that people like me, who have naturally acquired immunity, do not need to be vaccinated. Nor is it needed to protect those around the person who already has immunity. Worse, research from three independent groups has now demonstrated that those with naturally acquired immunity experience more severe side-effects from COVID-19 vaccines than those who were immunologically naïve prior to vaccination (https://www.thelancet.com/journals/eclinm/article/PI S2589- 5370(21)00194-2/fulltext; https://www.medrxiv.org/content/10.1101/2021.04.15.21252192v1; https://www.medrxiv.org/content/10.1101/2021.02.26.21252096v1). In other words, for those with natural immunity, vaccination is not only unnecessary, but it would put them at enhanced risk of harm. Knowing this, nobody should ever mandate COVID-19 vaccination. Instead, it would be in the best interest of helping everyone make the most informed health decisions for themselves to make voluntary testing for immunity available.

Testing for Natural y Acquired Immunity was a Viable Option but was Ignored

You and the provost met with me and two other colleagues back in March 2021 and we presented the opportunity for the University of Guelph to show leadership and offer testing for immunity to our campus community in support of a safe return to in-person teaching and learning. You embraced this idea with enthusiasm and promised to move forward with it. This did not materialize so one of my colleagues contacted you. Once again, you agreed it was an excellent idea and that you would move forward with it. Nothing happened. So, my two colleagues and I met with one of our vice-presidents in May 2021. They also thought that making an antibody test available was an excellent idea and promised to work on getting it implemented on campus. Nothing materialized. They were contacted again by one of my colleagues. There was no response. There is no excuse for forcing vaccines on people, especially after having been given the opportunity to implement testing for immunity and refusing to do so.

The University of Guelph won’t pay for me to receive a booster vaccine against rabies unless I can demonstrate that my antibodies are below what has been deemed to be a protective titer. This is because it would not be appropriate to give me a vaccine that is not without risk if I don’t need it. Also, the university does not want to pay the $850 cost of the vaccination regimen unless I absolutely need it. In short, you will not allow me to receive that booster vaccine without first evaluating me on an annual basis for evidence of immunity (or lack thereof). So why was this principle rejected for the SARS-CoV-2 vaccines, for which there is vastly less reliable safety data available, and none for the long-term? Canada should have been acquiring data about immunity starting a long time ago. It is a particularly poor precedent for a university to reject the concept of acquiring data that could inform safer and more effective COVID-19 policies. Immunity testing would even benefit vaccinated individuals. It is well known that responses to vaccines in outbred populations follows a normal curve and includes individuals that are non-responders (i.e. they are left without immunity and are, therefore, unprotected following vaccination) and low-responders (insufficient protection). In fact, this concept has been the focus of an internationally recognized research program on our campus that has brought many accolades and awards to our institution.

You have banned me from campus for at least the next year. I can show proof of immunity against SARS-CoV-2 but you will not allow me to enter buildings. But someone else can show a receipt saying that someone saw two needles go into their arm and you will allow them to enter. You actually have no idea if that person has immunity. There have even been reported cases of people accidental y or even intentionally (e.g. a case in Germany) being administered saline instead of the vaccine. Does it make sense to ban someone who is immune from campus but al ow people who are presumed, but not confirmed, to be immune? This is a scenario that you have created. As a fellow academic, I am requesting that you provide me with a strong scientific rationale why you are al owing thousands with an unconfirmed immunity status onto our campus, but you are banning people like me who are known to have immunity. Further, please explain how you feel it is ethical to force COVID-19 vaccines on people who are uncomfortable with being coerced when you do not know their immunity status. Despite attempts to halt the spread of SARS-CoV-2 via masking and physical distancing, the reality is that the virus has not complied with these attempts to barricade it. Indeed, it has infected many people across Canada, many of whom may not have even realized it because it is not a dangerous pathogen for them. From the perspective of a medical risk-benefit analysis, this is a no-brainer. A medical procedure that adds no value but carries known and still-to-be-defined risks should never be mandated!

The University Back-Tracked on Advice from its Own Legal Counsel

I, along with two colleagues, attended a meeting with one of our vice-presidents in May 2021. In that meeting the legal advice that was provided to the University of Guelph was disclosed. We were told this included making COVID-19 vaccines voluntary, that nobody on campus should be made to feel coerced into being vaccinated, and that nobody should feel pressured to disclose their vaccination status. On this basis, I was to serve as one of the on- campus faculty contacts for anyone who experienced any of these issues. Did Canada’s laws change during the summer in a way that rendered this legal advice no longer valid? Now I am having to spend an inordinate amount of time trying to help the many people whose lives have imploded due to the university’s vaccine mandate.

I am a Scientist Who is Knowledgeable and Values Integrity Despite What So-Cal ed ‘Fact Checkers’ Have Claimed

There are many on our campus who repeatedly put my name out to the public with claims that I disseminate misinformation. Not one of these individuals has ever given me the courtesy of a conversation prior to publicly attacking me. None of them will engage me in public discussions of the science to allow people to judge the legitimacy, or lack thereof, of what I am saying. Censorship on our campus has become as prevalent as it is off- campus. My detractors, rather than showing a deep understanding of the science underlying COVID-19 vaccines, continually refer to the so-cal ed ‘fact checks’ that have been posted about me. Let me tell you some things about the so-called ‘fact checkers’. Firstly, they give scientists and physicians of integrity unreasonably short periods of time to respond to their requests for answers. For example, as I write this letter, I have 13,902 unread messages in my inbox and my voice mail is at maximum capacity. I have yet to see a ‘fact check’ request prior to its expiry, which remarkably, is often within mere hours of an e-mail being sent. This is an unreasonable expectation from a busy professional. Also, many ‘fact checkers’ lack sufficient expertise. In some cases, ‘fact checker’ sites have had to rely on postdoctoral trainees in other countries to write responses.

Most of the harassment against me began after ‘fact checkers’ cherry-picked one short radio interview that I gave to a lay audience. Some have accused me of only giving half the story in that interview. They were most kind; I was only able to reveal 0.5% of the story. It is unfair to critique a tiny portion of one’s arguments that were presented off-the-cuff to a lay audience with no opportunity for me to respond in real-time. For your information, I have rebutted every single one of the ‘fact checks’ that I am aware of in various public interviews. Let me give you one example that some of our colleagues on our campus have repeatedly misused while harassing me in social media…

One of the many issues that I have raised with the vaccines is that should a reasonable concentration of the free spike protein get into systemic circulation, it could potentially harm the endothelial cells lining our blood vessels. I cited this study: https://www.ahajournals.org/doi/10.1161/CIRCRESAHA.121.318902. The authors were contacted, and they claimed I had misinterpreted the study. They said that spike-specific antibodies would mop up any spike proteins in the blood, thereby protecting the blood vessels. They argued that this demonstrated that vaccinating people against the spike protein is a good thing.

However, the authors are not immunologists and they failed to recognize the limitations of their own study in drawing these kinds of conclusions. Specifically, they did not recognize that in a naïve individual receiving a mRNA-based COVID-19 vaccine, there are no antibodies; either pre-existing in the host, or in the vaccine formulation. In fact, it will take many days for the antibody response to be induced and for titers to begin reaching substantial concentrations. This leaves a large window of time in which any free spike proteins could exert their biological functions/harm in the body before there are any antibodies to neutralize them. Worse, most of the spike proteins should be expressed by our own cells. In that case, the antibodies will target and kill them in a form of autoimmunity. The authors of the paper forgot that their model was in the context of natural infection, where vaccination would precede exposure to SARS-CoV-2. In that case, I agree that there would be pre-existing antibodies that could neutralize spike proteins of viral origin entering the circulation. This was perceived to be one of the ‘strongest’ arguments used by others to try to discredit me. The reality is that it is completely incorrect and represents an embarrassing misinterpretation by the authors of the original paper and the many ‘fact-checkers’ that believed them without question.

Criminal Harassment

You have allowed colleagues to harass me endlessly for many consecutive months. They have lied about me, cal ed me many names, and have even accused me of being responsible for deaths. I submitted a harassment claim and your administrators ruled that it did not meet the bar of civil harassment. In stark contrast, I have been contacted by members of off-campus policing agencies who have told me that it exceeds the minimum bar of criminal harassment. I am sorry, but a faculty member can only take so much bullying and see such a lack of adherence to scientific and bioethical principles before it becomes necessary to speak up. Under your watch, you have allowed my life to be ruined by turning a blind eye to on-campus bullying, ignoring our campus principles of promoting mental well-being and a workplace in which I can feel safe. In addition to this you have banned me from the campus because I have robust, broadly protective, and long-lasting immunity against SARS-CoV-2 but lack a piece of paper suggesting that it was obtained via two injections.

Did you see this front page of one of Canada’s major newspapers?

…remarkably, the on-campus COVID-19 policies you are promoting fuel this kind of pure hatred from people, most of whom have not confirmed their own immunity status, against someone like me who is immune to SARS-CoV-2!!! Does that make any sense? My workplace has become a poisoned environment where the bullying, harassment, and hatred against me have been incessant. Are you ever going to put an end to the childish and irrational behaviours being demonstrated by our colleagues? I have received thousands of emails from around the world that indicate the university should be embarrassed and ashamed to allow such childish behaviour from faculty members to go unchecked in front of the public.

I have invested a decade of my life into the University of Guelph. I have conducted myself professionally and worked to an exceptional y high standard. I have consistently received excellent ratings for my research, teaching, and service. I have received rave reviews from students for my teaching. I have received prestigious research and teaching awards. I have brought funding to our campus from agencies that had never partnered with the University of Guelph in our institution’s history. I have brought in

$1 million-worth of equipment to improve our infrastructure, etc., etc. I am a man of integrity and a devoted public servant. I want to make Canada a better place for my family and for my fellow Canadians. We are a public institution. My salary is covered by taxpayers. This declared pandemic involves science that is in my ‘wheelhouse’. Since the beginning, I have made myself available to answer questions coming from the public in a fashion that is unbiased and based solidly on the ever-exploding scientific literature. My approach has not changed. Has some of it contradicted the very narrow public health narrative carried by mainstream media? Yes. Does that make it wrong? No. I will stand by my track record. When Health Canada authorized the use of AstraZeneca’s vaccine I, along with two colleagues, wrote an open letter requesting that this vaccine not be used, in part on the grounds that it was being investigated for a link to potentially fatal blood clots in many European countries. I was accused at that time by so-called ‘fact checkers’ of providing misinformation. Less than two months later, Canada suspended the AstraZeneca vaccination program because it was deemed to be too unsafe as a result of causing blood clots that cost the unnecessary loss of lives of Canadians. More recently, I was heavily criticized for raising concerns in a short radio interview about a potential link between the Pfizer BioNTech COVID-19 vaccine and heart inflammation in young people, especially males. This is now a well recognized problem that has been officially listed as a potential side-effect of the mRNA COVID-19 vaccines. It was also the subject of a recent Public Health Ontario Enhanced Epidemiological Summary Report highlighting the increased risk of myocarditis and pericarditis to young males following COVID-19 mRNA vaccination. As such, I have a proven track record of accurately identifying concerns about the COVID-19 vaccines.

A Lack of Safety Data in Pregnant Females as Another Example of Why Vaccines Should Not be Mandated

I would like to give another disconcerting safety-related example of why a COVID-19 vaccine mandate could be dangerous. We have pregnant individuals or those who would like to become pregnant on campus. There was a highly publicized study in the prestigious New England Journal of Medicine that formed the foundation of declaring COVID-19 vaccines safe in pregnant females (https://www.nejm.org/doi/ful /10.1056/nejmoa2104983). The authors of this study declared that there was no risk of increased miscarriage to vaccinated females. This study resulted in many policies being instituted to promote vaccination of this demographic, for which the bar for safety should be set extremely high.

Did you know that this apparent confirmation of safety had to be rescinded recently because the authors performed an obvious mathematical error? I witnessed several of my colleagues from Canada and other countries bravely push for a review of this paper under withering negative pressures. Once the editor finally agreed to do so, the authors had no choice but to admit that made a mathematical error. Most of the world does not realize this. This admission of using an inappropriate mathematical formula can be found here: https://www.nejm.org/doi/ful /10.1056/NEJMx210016. This means that the major rationale for declaring COVID-19 vaccines safe in pregnant females is gone! How can someone force a COVID-19 vaccine on a pregnant female when there are insufficient safety data available to justify it?

Advocating for the Vulnerable and Those Fearful of Retribution

My concern is not primarily for myself. I am using my case to highlight how wrong your vaccine mandate is. I am more concerned for the more vulnerable on our campus. I hold tenure, and if ever there was a time when this was important, it is now. However, I have had to bear witness to numerous horrible situations for students and staff members. Students have been physically escorted off our campus, sometimes being removed from their residence, sometimes with their parents also being escorted off. Staff members have been escorted off campus and immediately sent home on indefinite leaves without pay, leaving them unable to adequately care for their families.

In many of these situations it seemed like the interactions intentionally occurred in very public settings with it being made clear to all onlookers that the person or people were not vaccinated. Parents have been denied attending meetings with their children who are entering the first year of a program. They recognize that adult learners would normally not have their parents accompany them, but we are living in unusual times with excessive and unfair (arguably illegal?) pressures being applied and these parents are entitled to advocate and defend the best interests of their sons and daughters.

Many students have deferred a year in the desperate hope that our campus community will not be so draconian next year. Others fought hard to earn their way into very competitive programs and are not being guaranteed re-entry next year. Many faculty members refused to offer on-line learning options for those who did not wish to be vaccinated.

On the flip-side, there are also faculty members, like many students and staff, who are completely demoralized. This includes some who were happily vaccinated but are upset by the draconian measures of your COVID-19 policies and/or will be unwilling to receive future booster shots. I can tell you many stories of students and staff members who couldn’t resist the pressure to get vaccinated because they were losing vast amounts of sleep and experiencing incredible anxiety and were on the verge of mental and/or physical breakdowns. In some of these cases, they were crying uncontrollably before, during, and after their vaccination, which they only agreed to under great duress. This does not represent informed consent!

I have had several members of our campus community contact me with concerns that they may have suffered vaccine-induced injuries ranging from blood clots to chest pain to vision problems to unexpected and unusual vaginal bleeding. Can I prove these were due to the vaccine? No. But can anyone prove they were not? No. And it is notable that these are common events reported in adverse event reporting systems around the world. In all cases, the attending physicians refused to report these events, even though it is supposed to be a current legal requirement to do so. These people obediently got vaccinated and were then abandoned when they became cases that did not help sell the current public health messaging.

A World Where Everyone is Vaccinated Looks Nothing Like Normal

The two-week lockdown that was supposed to lead into learning to live with SARS-CoV-2 has turned into the most mismanaged crisis in the history of our current generations. I ask you to look around with a very critical eye. You just reported that 99% of the campus community is vaccinated. Congratulations, you have far exceeded the stated standard for what is apparently the new goal of ‘herd vaccination’. I cannot use the typical term ‘herd immunity’ here because immunity is not being recognized as legitimate; only inferred immunity based on receiving two needles counts. We were told that achieving herd immunity by vaccination alone was the solution to this declared pandemic. This has been achieved on our campus in spades. I sat in on our town hall meetings with our local medical officer of health who confidently told us that the risk of breakthrough infections in the vaccinated was almost zero. Why, then are people so petrified of the unvaccinated. Look at vaccines for travellers going to exotic locations.

These are vaccines of some quality. Travellers take these vaccines, and not only do they not avoid the prospective pathogen, but they happily travel to the location where it is endemic (i.e. they enthusiastically enter the danger zone because they are protected). So, what does our campus look like with almost every person vaccinated? Everyone must remain masked and physically distanced. There is no gathering or loitering allowed in stairwells or any open spaces in buildings or outside. People are still being told which doors to enter and exit, when they can do so, where to stand in line, when to move. Incredibly, time restrictions are even being implemented in some eating areas because some students were deemed to be “snacking too long” with their masks off and, therefore, putting others at risk of death. In short, the on-campus COVID-19 policies are even more draconian than they were last year, but everyone is vaccinated. It doesn’t seem like the vaccines are working very well when a fully vaccinated campus cannot ease up on restrictions.

But, of course, we already know how poorly these vaccines are performing. Based on fundamental immunological principles, parenteral administration of these vaccines provides robust enough systemic antibody responses to allow these antibodies to spill over into the lower respiratory tract, which is a common point at which pathogens can enter systemic circulation due to the proximity of blood vessels to facilitate gas exchange. However, they do not provide adequate protection to the upper respiratory tract, like natural infection does, or like an intranasal or aerosolized vaccine likely would. As such, people whose immunity has been conferred by a vaccine only are often protected from the most severe forms of COVID-19 due to protection in the lower lungs, but they are also susceptible to proliferation of the virus in the upper airways, which causes them to shed equivalent quantities of SARS-CoV-2 as those who completely lack immunity. Dampened disease with equal shedding equals a phenotype that approaches that of a classic super-spreader; something that we erroneously labelled healthy children as until the overwhelming scientific evidence, which matches our historical understanding, clarified that this was not the case.

I have been in meetings where faculty have demanded to know who the unvaccinated students will be in their classes so they can make them sit at the back of the classroom! I can’t believe that some of my colleagues are thinking of resorting to the type of segregation policies that heroes like Viola Desmond, Rosa Parks, Martin Luther King Jr., Carrie M. Best, and Lulu Anderson fought so hard against so many years ago.

The Exemption Fiasco

With respect to exemptions for COVID-19 vaccines, the University of Guelph provided a number based on creed or religion but then, remarkably, rescinded these. These previously exempt individuals were required to resubmit applications using a more onerous form; many that had been honoured previously were rejected upon re- submission. Many have been rejected since. Based on the reports I have received from many people these rejections of exemption requests were typically not accompanied by explanations. Nor have many been told, despite asking, who it is that sits on the committee making decisions about these exemptions.

I would never be allowed to assign marks to students anonymously, nor without being able to justify them. Yet there seems to be a lack of transparency with exemptions and many of these decisions are destroying people’s lives; the outcomes are not trivial. Could you please disclose the names of the people serving on the University of Guelph’s committee that reviews exemptions? Also, could this committee please provide to applicants, retroactively, comments to justify their decisions? I have even heard it said in recent meetings that a lot of people are happy to hear that exemptions, including some medical exemptions are being denied. Why are our faculty celebrating refusals of medical exemptions for students?

A Lack of Consultation with the Experts on Vaccines

You have stated on numerous occasions that your COVID-19 policies have only been implemented after extensive consultation with local and regional experts. Interestingly, however, you have refused, for some unknown reason, to consult with any of the senior non-administrative immunologists on your campus. I would like to remind you that vaccinology is a sub-discipline of immunology. Notably, all three of us have offered repeatedly to serve on COVID-19 advisory committees, both on-campus and for our local public health unit, which also lacks advanced training in immunology and virology. The three of us have stayed on top of the cutting-edge scientific findings relevant to COVID-19 and meeting regularly with many national and international collaborative groups of scientists and physicians to debate and discuss what we are learning. I think it is notable that the senior non-administrative immunologists unanimously agree that COVID-19 vaccines should not be mandated for our campus based on extensive, legitimate scientific and safety reasons.

Mandating COVID-19 Vaccines is Criminal

I am no legal expert but have consulted with many lawyers who have told me that these vaccine mandates break many existing laws. Here is one example copied from the Criminal Code of Canada: Extortion • 346 (1) Every one commits extortion who, without reasonable justification or excuse and with intent to obtain anything, by threats, accusations, menaces or violence induces or attempts to induce any person, whether or not he is the person threatened, accused or menaced or to whom violence is shown, to do anything or cause anything to be done. In your case, you are demanding that members of our academic community submit to receiving a COVID-19 vaccine against their will (a medical procedure that may very well be unnecessary and carry enhanced risk of harm) or face banishment from the campus. Again, I am not an expert in this area, but I am confident there will be lawyers willing to test this in court. Those responsible for issuing vaccine mandates will need to decide how confident they are that they will not lose these legal battles.

Integrity of Teaching

In this new world where followers of scientific data are vilified, I also worry about my ability to teach with integrity. Unbelievably, the Minister of Health of Canada, Patty Hajdu, told Canadians that vitamin D being a critical and necessary component of the immune system in its ability to clear intracellular pathogens like SARS-CoV-2 is fake news! Do you now that I have taught all my students about the importance of vitamin D (often in the historical context of how it was discovered as being critical for positive outcomes in patients with tuberculosis that were quarantined in sanatoriums).

I also teach the concept of herd immunity, with vaccination being a valuable tool to achieve this. I do not teach the concept of ‘herd vaccination’ while promoting ignorance of natural immunity. There are other basic immunological principles that I teach that have either not been recognized during the pandemic as legitimate scientific principles or they have been altogether contradicted by public health and/or government officials. Will I still be allowed to teach immunology according to the decades of scientific information that I have built my course upon? Or will I be disciplined for teaching immunological facts? There are many attempts to regulate what I can and cannot say these days, so these are serious questions.

Instilling Fear of a Minority Group Breeds Hatred

We live in an era where issues of equity, diversity, and inclusion are supposed to be at the forefront of all discussions at academic institutions. However, you are openly discriminating against and excluding a subset of our community that happens to be highly enriched with people engendered with critical thinking; a quality that we are supposed to be nurturing and promoting. With COVID-19 mandates, an environment has been created on our university campus that promotes hatred, bullying, segregation, and fear of a minority group whose only wrongdoing has been to maintain critical thinking and decision-making that is based on facts and common sense. I have yet to meet an anti-vaxxer on our campus. Everyone I know of is simply against the mismanagement of exceptionally poor- quality COVID-19 vaccines. History tells us that instilling fear of a minority group never ends well. This scenario must be rectified immediately if our campus is ever to return to a safe and secure working and learning environment for all.

Committing to Abolishing the COVID-19 Vaccine Mandate

President Yates, the favour of a reply is requested. Not the kind that defers to public health officials, or a committee, or anyone else. Instead, a reply with the scientific rigour expected from a scholarly colleague rebutting each of my comments and addressing each question. Surely, you know the science underpinning COVID-19 vaccines inside and out by now. I strongly suspect that nobody would made a decision that disrupts an entire community and destroys the lives of some of its members without a fully developed rationale that can point to the weight of the peer-reviewed scientific literature to back it up. If it would be easier, I would be happy to have an open and respectful, but public and blunt moderated conversation about your vaccine mandate in front of our campus community; much like in the spirit of old-fashioned, healthy scientific debates. You can have your scientific and medical advisors attend and I will invite an equal number.

I am not saying this to be challenging. I honestly think it would be a great way to educate our campus community and expose them to the full spectrum of the science. And, if I am as wrong as my ‘fact checkers’ say, I would love for them to demonstrate this for my own sake as much as anyone else’s. So far, despite hundreds of invitations, not one person has done this in a scenario where I can respond in real-time. You need to understand; all I want is my life back and to be able to recognize my country again. I want to see the lives of the students, staff, and other faculty members that I have seen destroyed be restored again. I want to be able to return to my workplace and not be fearful of being hated or exposed to social, mental, and physical bullying. Instead, I want to be able to turn my talents and full attention back to being an academic public servant who can design better ways to treat diseases and help train Canada’s next generation of scientific and medical leaders. I simply cannot know all that I have shared in this letter and have suffered as much as I have and be silent about it.

My great uncles and family members before them served heroically in the World Wars to ensure Canada would remain a great and free democracy. I think they would be horrified by what they see in Canada today. Indeed, many of my friends who immigrated from Communist countries or countries run by dictatorships are sharing fears about the direction our country is heading; it is reminding them of what they fled from. Further, mandating COVID-19 sets a scary precedent.

Did you know that multiplex tests for both SARS-CoV-2 and influenza viruses are on the horizon, along with dual- purpose vaccines that will use the same mRNA-based technology to simultaneously target SARS-CoV-2 and influenza viruses (https://www.ctvnews.ca/health/coronavirus/moderna-developing-single-dose-covid-19-flu-combo- vaccine-1.5578445). Rhetorically, will the University of Guelph consider masking, distancing, and/or mandating vaccines for influenza in the future? Please rescind your COVID-19 vaccine mandate immediately. It is doing more harm than good. Unbelievably, among many other problems, it is even discriminating against those who can prove they are immune to SARS-CoV-2!

Mandating COVID-19 Vaccines Creates Absurd Situations

In closing, and to highlight the absurdity of mandating COVID-19 vaccines… President Yates, I have proven to you that I am immune to SARS-CoV-2, but you have banned me from the campus and ruined my life because I don’t have a piece of paper saying that someone saw two needles go into my shoulder. You have a piece of paper that says that someone saw two needles go into your shoulder, but you have not proven that you are immune to SARS-CoV-2. However, you are allowed on campus and your life can proceed uninterrupted. How is that fair?

Respectfully and in the mutual interest of the health and well-being of all members of our community,

Dr. Byram W. Bridle, PhD
Associate Professor of Viral Immunology
Department of Pathobiology
University of Guelph

This is — without a doubt — the best articulation as to the ethical problem posed by mandatory vaccines or vaccine passports.

Dr. Julie Ponesse explains the dilemma in a persuasive manner.

Watch the whole 4 minute video, split across 3 segments in this thread

Introduction

This article aims at giving an overview of the ivermectin controversy, including current practices of research, publishing and governmental policy formation, by presenting a timeline of relevant events, compiled from peer-reviewed academic journals indexed in PubMed, preprint servers such as medRxiv, chemRxiv, SSRN, Research Square and ResearchGate, international clinical trials registers, international newspapers and medical news service providers as well as websites. As there have been a lot of sparsely documented events internationally, the search has not been systematic, the timeline is unavoidably incomplete, and there may naturally be some personal bias with regard to what has been selected. Also, the main focus of the article is on the last quarter of the 2020s and the first quarter of 2021. Despite these limitations the timeline may serve as a template for more detailed inquiries.

Due to the large number of studies and limited space, each study is mentioned only briefly, without a possibility to analyze methodologies or results in depth. Statistically significant endpoints are reported, with nonsignificant endpoints mostly left out. For consistency, results are in most cases formatted as they appear in a meta-analysis by the Covid Analysis research group, possibly reformulated in comparison to the original sources (e.g. odds ratios converted to relative risk or methodological errors corrected) [1];[2];[3].

Ivermectin was invented in Japan in 1975 by Kitasato University professor emeritus Satoshi ¯ Omura, for which he won the 2015 Nobel Prize in physiology or medicine [4]. The drug has proven effective in eradicating parasitic infections and it is therefore best known as an antiparasitic agent, with several billion doses having been administered since 1981. The patent for the product was owned by Merck & Co/MSD. In most countries the patent expired in 1996. Currently, ivermectin preparations are available internationally from many sources, with the production cost of a single dose estimated to be less than 0.1 US dollars [5].

For prophylaxis of onchocerciasis (river blindness) and strongyloidiasis ivermectin is administered as a single oral yearly dose of 0.15-0.20 mg/kg [6];[7]. For lymphatic filariasis, a once-yearly dose of 0.3-0.4 mg/kg or bi-yearly dose of 0.15–0.2 mg/kg is administered [6]. For classic scabies, two doses of 0.2 mg/kg approximately one week apart are recommended, and for crusted scabies three to seven doses of 0.2 mg/kg depending on the infection severity [8];[9]. With regard to malaria, repurposing ivermectin as a complement to current malaria vector control tools is currently being investigated, with a proposed dosing regime of 0.4 mg/kg repeated three times during the malaria season, and another proposed dosing regime of 0.3 mg/kg on three consecutive days in combination with two other pharmaceuticals also repeated three times during the season [10].

With regard to its in vitro antiviral action, ivermectin has shown robust antiviral action towards a range of RNA and DNA viruses, including HIV-1, dengue, Zika and West Nile Virus, Venezuelan equine encephalitis virus, Chikungunya, pseudorabies virus, adenovirus, and SARS-CoV-2 (COVID-19) [11]. For dengue virus, a combined phase II/III patient randomized controlled trial (RCT) has been completed[12].

Another recent line of research has been an investigation into ivermectin’s efficacy in cancer. A study found out that ivermectin at a very low dose drastically reversed the resistance of the tumor cells to the chemotherapeutic drugs both in vitro and in vivo [13]. Ivermectin could thus be used in combination with chemotherapeutic agents to treat drug-resistant cancers.

With regard to the mechanism of action of ivermectin as an antiparasitic medication, Chung et al. describe that ivermectin interacts with vertebrate and invertebrate γ-aminobutyric acid (GABA) receptor and invertebrate glutamate-gated chloride channels, increasing chloride ion influx with subsequent paralysis and death in the target organism [14]. Ivermectin is effective in killing nematodes and arthropods with a single dose of 0.1-0.3 mg/kg but has has a very wide margin of safety in mammals because in mammals GABA-mediated nerves occur only in the central nervous system and ivermectin does not readily cross the blood-brain barrier [14].

With regard to safety of overdosing, in chickens and most dogs subcutaneous doses of approximately 5 mg/kg have been shown to cause mild symptoms and doses of approximately 15 mg/kg severe symptoms up to coma and death. In two described cases on humans, a 16-month-old child ingesting 6.7 to 8.72 mg/kg ivermectin resulted in frequent vomiting, somnolence, mild tachycardia, and hypotension, and a 61-year old woman became comatose three hours after ingesting 15.4 mg/kg agricultural ivermectin, requiring supportive intensive care but was discharged uneventfully on day 9 [14].

A double-blind, placebo-controlled dose escalation study with 68 healthy volunteers found no indication of central nervous system or general toxicity, or a difference in adverse effects between ivermectin and placebo groups for doses up to 2 mg/kg (ten times the highest FDA-approved dose of 0.2 mg/kg), in either single doses of 90 mg (1.0-1.5 mg/kg) or 120 mg (1.4-2.0 mg/kg), or in a repeated dosing regime with 30 mg (0.35-0.54 mg/kg) or 60 mg (0.71-1.1 mg/kg) on days 1, 4 and 7 (a total of three doses) [15]. Mean plasma concentrations were 2.6 times higher when administered with food.

The FDA-approved dosing for treatment of parasitic diseases is 0.2 mg/kg. The doses used in COVID-19 related clinical trials described in this article varied between 0.2-0.6 mg/kg. With regard to safety of ivermectin in general, a current World Health Organization (WHO) document on the treatment of onchocerciasis states that “ivermectin is safe and can be used on a wide scale” [16]. With regard to safety for children, a recent systematic review and and an individual patient data meta-analysis of ivermectin use in children weighing less than 15 kg concluded that existing limited data between January 1980 and October 2019 suggest that oral ivermectin in children weighing less than 15 kilograms is safe [17]. Overall a total of 1.4% (15/1,088) of children experienced 18 adverse events all of which were mild and self-limiting. No serious adverse events were reported.

With regard to safety of ivermectin during pregnancy, a document from 2004 published by the WHO titled “Mass treatment with ivermectin: an underutilized public health strategy” describes safety during pregnancy, noting that “a number of follow-up studies have found that inadvertent filariasis mass campaign use of ivermectin during pregnancy has not been associated with adverse pregnancy outcomes or negative effects on pregnant women or their offspring”, referring to a study by Gyapong et al. who concluded “there is no evidence of a higher risk of congenital malformation or abortions in those who are inadvertently exposed” [18];[19].

April 2020

On April 3, a Monash University of Australia in vitro ivermectin study by Caly et al. reported that ivermectin is an inhibitor of SARS-CoV-2 virus in vitro, that a single treatment effected approximately 5000-fold reduction in virus at 48 h in cell culture, and that ivermectin is FDA-approved for parasitic infections and included on the WHO model list of essential medicines, thus being widely available [20];[21];[22];[23].

On April 6, a French biotechnology company MedinCell which had been studying ivermectin for malaria announced an initiative to develop an injectable form of ivermectin for prophylaxis of COVID-19 [24];[25];[26].

On April 10, mentioning increased interest in ivermectin after the Australian in vitro study, US FDA issued a warning against using veterinary ivermectin as treatment for COVID-19 in humans, citing safety concerns [27]. It noted additional testing is needed to determine whether ivermectin might be safe or effective in COVID-19 in humans.

On April 13, two Florida, US pulmonologists Rajter and Cepelowicz-Rajter were said to be pioneering early treatments with ivermectin, reporting a nearly 100% response rate with early administration, adding that they were initiating clinical studies [28].

On April 13, a preprint by Patel et al. described an observational registry-based study from 169 hospitals claiming that a single dose of 0.15 mg/kg of ivermectin produced a significant mortality reduction (7.7% vs. 18.6%) in 1,970 patients requiring mechanical ventilation [29];[30].

On April 14, two medical doctors, Gustavo Elera Arévalo and Fernando Polanco Hinostroza in La Merced (Chanchamayo) in Peru, begun treating a COVID-19 outbreak in a prison with ivermectin, later also treating the local police [31].

... and hundreds more events to April 3 2021. Go to the source to read the full chronology.

Discussion

A central question in the communications was whether more studies were needed. In October 2020, when the FLCCC Alliance recommendation on ivermectin was published, the decision to recommend it was assumedly largely based on the perceived consistent positivity of the effects: “seeing a ‘signal’ in the data”. This method could also be called reliance on “clinical experience” or even “intuition”. Comparing five Covid Analysis group’s meta-analyses from November 26 (n=21), December 29 (n=28),January 26 (n=35), February 27 (n=42), and March 31 (n=49) [438], calculated improvements in clinical indicators, with probabilities of an equal or greater percentage of positive results from an ineffective treatment, were as follows: improvements in prophylaxis (pre-exposure/post-exposure or total) we-re 98%/87% (p=0.063/0.25), 91%/90% (p=0.0078/0.25), 90% (p=0.00098), 89% (p=0.00049), and 89%(p=0.00024), respectively. In early treatment, the improvements were 91% (p=0.13), 87% (p=0.016), 84%(p=0.00098), 83% (p=0.00012), and 80% (p=0.0000076). In late treatment, the improvements were 60%(p=0.00024), 48% (p=0.00012), 39% (p=0.000031), 51% (p=0.0000038), and 50% (p=0.00000095). All together, the improvements were 75% (p=0.00000048), 78% (p=0.0000000037), 74% (p=0.000000000029),75% (p=0.00000000000023), and 72% (p=0.000000000000002). It appears that in 2021 the variation in estimated efficacy due to addition of more studies to the meta-analysis was too small to be clinically meaningful. Therefore, more studies provided little additional clinically relevant information, and the argument against the treatment was solely based on the assumed unreliability of all the existing data.The panel which prepared the WHO guideline of March 30, 2021 included in its meta-analysis only five studies that directly compared ivermectin with standard of care and reported mortality [428]. The result indicated 64% reduction in mortality (RR 0.36, 95% CI 0.17-0.75, no p value given, n=915,very low certainty evidence). The meta-analysis of six studies by Hill et al. indicated 75% reduction in mortality (RR 0.25, CI 0.12-0.52, p=0.0002, n=1,255) [275]. The March 31, 2021 meta-analysis of eight randomized controlled trials by the Covid Analysis group indicated 70% reduction in mortality (RR 0.31,95% CI 0.16-0.61, n=1,729, p<0.00032) [437]. The meta-analysis of thirteen trials by Bryant et al. devised using Cochrane standards indicated 68% reduction in mortality (RR 0.32, 95% CI 0.14-0.72, n=1,892,low to moderate-certainty evidence) [387]. The FLCCC group’s meta-analysis of four observational and six randomized controlled trials indicated an overall 69% reduction in mortality (RR 0.31, n=3,508,p<0.0001) [168];[214].

In addition to presenting the new meta-analysis, the guideline presented data from the WHO living guideline [439]. The living guideline analysis indicated 70 deaths per 1,000 patients (7%) for standard of care, and 14 (1.4%) for ivermectin, respectively, i.e. an absolute difference of 56 patients (5.6%) with a 95% confidence interval of 64 to 44 fewer deaths, and a relative mortality reduction of 80%. The odds ratio for mortality was 0.19 (OR 0.19, 95% CI 0.09-0.36) based on 1,419 patients in seven studies. The certainty of evidence was estimated to be very low due to serious risk of bias and very serious imprecision.

This imprecision was explained as follows: “for mortality there were only 31 deaths across all 915 patients randomised - an extremely small number of events on which to base conclusions” (referring to five studies instead of seven), suggesting unsuitability of the chosen methodology for evaluation of medicines that might significantly reduce mortality, as conclusions could then not be made.

As a reference for the above data the guideline cited Siemieniuk et al. [440] which did not contain theabove results but instead presented a third set of mortality results, indicating a mortality of 130 per1000 patients (13%) for stardard of care. For a combination of doxycycline and ivermectin, the estimated reduction in deaths was 130 (95% CI 130-123). For ivermectin alone, the reduction was 103 (95% CI117-78). For proxalutamide, the values were 130 (95% CI 130-118), for colchicine 78 (95% CI 110-9), and significantly less for other included options.

These two additional sets of results indicated larger reductions in mortality (approximately 80%) than the meta-analysis. With regard to the earlier meta-analysis by Hill et al. [275], Siemieniuk et al. stated that “several of these trials could not be included in the analysis . . . ten trials that reported no outcomesof interest”, citing the Hill et al. meta-analysis among the trials reporting no outcomes of interest. Thenew meta-analysis was presented in Rochwerg et al. [441]. This article mentioned neither the meta-analysis by Hill et al. nor the mortality results of Siemieniuk et al. Rochwerg et al. also noted that “we currently lack persuasive evidence of a mechanism of action for ivermectin in covid-19; any observed clinical benefit would be unexplained”, possibly suggesting that not even an effective intervention could be utilized unless the mechanism of action was “explainable”.

Based on their meta-analyses the other groups (FLCCC, CovidAnalysis, BIRD) recommended treatment, the WHO panel did not, referring to “the strong likelihood that chance may be playing a role in the observed findings” [441]. None of the authors of the WHO-funded meta-analysis by Hill et al. were included in the panel. The low cost and wide availability of ivermectin did not, in the panel’s view, mandate the use of a drug with uncertain benefits and possible harms. Resource considerations, accessibility,feasibility and impact on health equity “did not alter the recommendation”. The panel worried about drug shortages in helminth control and elimination programmes [441];[428]. The panel listed the risk of severe adverse events leading to drug discontinuation as a reason for non-adoption, apparently suggesting that a pharmaceutical should not be adopted at all if a small subset of patients might stop using it. For some reason the panel “inferred that almost all well-informed patients would want to receive ivermectin only in the context of a randomized trial, given that the evidence left a very high degree of uncertainty . . . the panel anticipated little variation in values and preferences between patients when it came to this intervention”, giving an impression of dictating patients’ preferences without asking them or giving them a choice.

The panel “raised concerns about diverting attention and resources away from care likely to provide a benefit such as corticosteroids in patients with severe COVID-19 and other supportive care interventions”. Considering that in the majority of countries, no prophylaxis or early treatment method was officiallyavailable, that corticosteroids were to be avoided in prophylaxis and early treatment, and that the useof corticosteroids in late treatment practically necessitated use of ivermectin to prevent strongyloidiasis-related hyperinflammation, this rationale appeared particularly illogical. The panel did note, however,that “ivermectin may still be considered in strongyloidiasis endemic areas, at the discretion of clinicians overseeing treatment, albeit not for treatment of COVID-19 itself”.

Considering the attitudes towards ivermectin in the industrialized countries in general, one of the main obstacles for reception of the idea of repurposed medicines may have been the Surgisphere scandal and the widespread controversy regarding hydroxychloroquine in early 2020, leading to a generalized distrust of research among the politicians, governmental administrative personnel and the public, especially in the more developed countries which appeared to put more importance on the research. This distrust, in turn, possibly opened new avenues for various kinds of societal manipulation.

The distrust appeared to have also lead to, for example, social media and video streaming platforms actively but inconsistently and indiscriminately censoring many subjects and groups, including ivermectin research groups and their results, regardless of their level of academic merit. These practices often appeared similar to censorship practices in authoritarian countries. Mainstream media appeared to maintain an inverted understanding on the process of science in which scientific knowledge was apparently assumed to flow down from the NIH and WHO to the researchers, not the other way around. Financial newspapers (Wall Street Journal, Financial Times) may have possessed a more realistic view on medical research and ivermectin than generalist press conventionally considered high quality (e.g. The New York Times, Associated Press, The Guardian), with some practically accusing researchers of not adhering to the guidelines given by the NIH, for example. The open encyclopedia Wikipedia took pains to only mention negative studies about ivermectin, listing it among the COVID-19 misinformation, even citing a commentator saying that “the narrative of ivermectin as a ‘miracle cure’ for COVID-19 is a ‘metastasized’ version of a similar conspiracy theory around the drug hydroxychloroquine, in which unspecified powers are thought to be suppressing news of the drug’s effectiveness for their own malign purposes” [442];[443];[444].

As noted by Wall Street Journal quite early on in the ivermectin saga, the majority of the medical establishment appeared to require almost absolute certainty, resulting in “too much caution killing patients”, both health-wise and financially [183]. This approach seemed to only take into account quite theoretical health risks, disregarding not only the very probable societal harms of not taking any action but also the possible health benefits of taking an action under uncertainty. Thus, the process appeared largely a failure of a relatively simple risk-benefit analysis.

The more medically oriented arguments against the adoption of ivermectin were usually based on the hypothesis that the required (as indicated by the Caly et al. in vitro study [22]) plasma and lung tissue concentrations for an antiviral effect would likely not be achievable. Another argument was based on the host-directedness and the assumed toxicity of larger doses.

An additional disagreement concerned the use of placebo in clinical trials. This disagreement may havebeen at least partly related to a long-standing divide of the research community into active-control and placebo orthodox proponents [445]. Vagueness of the Helsinki Declaration of 2013 may easily lead into opposite interpretations of what should be done [446]. For example, the sentence to allow the use of placebo “where no proven intervention exists” left open who should decide what is a “proven intervention”, easily leading to a circular reasoning according to which a proven intervention cannot exist without a placebo-controlled randomized trial, thus the use of placebo must be allowed to prove the efficacy of the intervention. Similar vagueness plagues the whole section about placebo controls. The parties involved in the ivermectin trial controversies appeared unable to find any common ground with regard to this issue.During the period there appeared to be somewhat scarce interest in treatments research, with the wealthy societies’ focus on vaccinations and lockdowns, despite vaccinations being largely unavailable and lockdowns harmful for the economy. These countries appeared to pursue expensive, narrow-spectrum vaccination and new pharmaceuticals based strategies, ignoring cheaper options, whereas developing countries put more emphasis on affordable, broad-spectrum antivirals. One factor may have been the developing nations’ clinicians’ familiarity with ivermectin and its easy availability, whereas it has been a rarely prescribed medicine in most industrialized countries. In addition, prejudices and a bias against ideas originating outside of familiar organizations or one’s own country may have played a part in the industrialized countries ignoring ivermectin research carried out in the developing countries [447]. Cost-effectiveness of government funding for development of new medications and vaccines is an important issue. The US government invested USD 356 million in 60,000-100,000 doses of MK-7110, indicating aunit price between USD 5,933.00 and USD 3,560.00, with the initial results of efficacy indicating the same or slightly smaller efficacy as that of ivermectin. A 2015 article about mass treatment of onchocerciasisin Africa stated that Merck & Co/MSD had offered ivermectin at USD 1.51 per treatment, indicating a2300 to 3900-fold difference between the prices of ivermectin and MK-7110 [448];[222]. In this example,allocation of US government funding appeared inefficient with respect to investment in an experimental product with the unit costs in thousands of dollars, versus the option to use an existing medication with similar efficacy proven at least on a similar level of evidence and the unit costs in single digits.

There was a widespread disagreement on the fundamentals: which methods were appropriate as a basis for decision making, what counted as evidence, and what was ethical. In a broader view, the appropriateness and usefulness of the evidence based medicine paradigm as it was understood and applied during the period appeared questionable. US and European governmental bodies appeared to reject or ignore most of the ivermectin-related data, referring to insufficient evidence. In the US, the paradigm appeared inconsistently applied; more specifically, not applied to US Food and Drug Administration Emergency Use Authorization of remdesivir, whereas strictly applied to other medications including ivermectin. In addition, a strict requirement to compare a significantly more effective treatment to placebo may be considered unethical with regard to high mortality of patients in control groups. These indicate a clear need for a new methodology better than the current understanding and application of evidence-based medicine.

With regard to conflicts of interest, the US Food and Drug Administration (FDA) issued an EmergencyUse Authorization (EUA) for the use of remdesivir in patients with severe disease on May 1, even before the initial results of an ongoing trial were published and despite remdesivir being an investigational drug not approved for any indication. The 1,063-patient randomized controlled trial of remdesivir publishedon May 22 only indicated that remdesivir shortened the time to recovery (11 days vs 15 days, p<0.001)[449]. There wasn’t an obvious difference in mortality rates (8% vs. 11.6%, p=0.059) and the endpoints were changed mid-study which was deemed a questionable practice [450]. The final results were published on October 8. On August 28 the EUA was extended to “no longer require a severe disease”.

The adoption of corticosteroids as a consequence of the WHO-initiated 2,000-patient RECOVERY trial results was relatively swift. Also the emergency use authorization of remdesivir in the US was swift,based on initial and conflicting evidence. Twenty randomized clinical trial results on ivermectin’s efficacy for COVID-19 were available in February 2021. These trials were predominantly carried out outside the US and the EU, and did not lead to emergency use authorizations in the US or the EU. US FDA document “Emergency Use Authorization of Medical Products and Related Authorities – Gui-dance for Industry and Other Stakeholders” section “1. Criteria for Issuance” subsection “d. No Alternatives” states that “For FDA to issue an EUA, there must be no adequate, approved, and available alternative to the candidate product for diagnosing, preventing, or treating the disease or condition. A potential alternative product may be considered ‘unavailable’ if there are insufficient supplies of the approved alternative to fully meet the emergency need. A potential alternative product may be considered ‘inadequate’ if, for example, there are contraindicating data for special circumstances or populations (e.g., children, immunocompromised individuals, or individuals with a drug allergy), if a dosage form of an approved product is inappropriate for use in a special population (e.g., a tablet for individuals who cannot swallow pills), or if the agent is or may be resistant to approved and available alternative products” [451].

It may thus be derived that licensing of repurposed medicines such as ivermectin for outpatient treatment and prophylaxis of COVID-19 would have prevented emergency use authorizations of new pharmaceuticals in development. In the case of prophylaxis, such licensing might even have affected vaccines. Thus,there appeared to exist substantial financial conflicts of interest against licensing of repurposed medicines.

Considering the total net utility of a society it is unlikely that unilateral support to only the investments of the pharmaceutical industry could ever offset the harms to other industries and the population. The society thus has a strong incentive to abolish the financial incentive structures of the pharmaceutical industry and the government that led to the current situation, in order to prevent a similar outcome in the future.

Considering the estimated efficacy of ivermectin around 90% in prophylaxis and the option of an early outpatient treatment with an estimated efficacy around 75%, an early introduction of ivermectin might have prevented a large part of COVID-19 infections post first wave in many European Union countries and in the United States.

Administrative issues, inconsistent requirements of evidence related to the evidence-based medicine paradigm, and possibly conflicts of interest with patentable, commercial products in development prevented introduction of early outpatient ivermectin treatments in the last quarter of 2020 and the first quarter of 2021. This lack of response is likely to have caused unnecessary deaths and difficult-to-repair financial and health consequences in the affected societies.

The culture of medical litigation prevalent in the United States may have created patterns of behavior that have also spread to countries with less actual litigation, yet leading to mental paradigms favoring extreme caution and non-action, in turn leading to stagnation. One of the features of a paradigm is an inability of the involved people to transcend it or even see that it is just one possible paradigm out of many options, some of which may be more optimal in a given situation.

Conclusion

The period appeared conflicted, with researchers, clinicians, governmental agencies and commercial entities holding deeply conflicting views on fundamental issues, including which methods were considered appropriate as a basis for decision making, what could be considered as sufficient evidence, and what was ethical. In a broader historical perspective, the timeline of events depicts rather dysfunctional societies unable to properly communicate and organize themselves, leading to misallocation of resources and decisions that may have conflicted with elementary ethical considerations, with this behavior rationalized by claiming adherence to mental paradigms that may have poorly matched the situation. In summary, the pandemic response especially in the United States and the European union appeared severely lacking.Further research on the details of these processes is warranted.

28th June 2021

“The lamps are going out all over Europe, we shall not see them lit again in our life-time.” Edward Grey

Several years ago, I wrote a book called Doctoring Data. It was my attempt to help people navigate their way through medical headlines and medical data.

One of the main reasons I was stimulated to write it, is because I had become deeply concerned that science, especially medical science, had been almost fully taken over by commercial interests. With the end result that much of the data we were getting bombarded with was enormously biased, and thus corrupted. I wanted to show how some of this bias gets built in.

I was not alone in my concerns. As far back as 2005, John Ioannidis wrote the very highly cited paper ‘Why most Published Research Findings are False’. It has been downloaded and read by many, many, thousands of researchers over the years, so they can’t say they don’t know:

‘Moreover for many current scientific fields, claimed research findings may often be simply accurate measures of the prevailing bias.’1

Marcia Angell, who edited the New England Journal of Medicine for twenty years, wrote the following. It is a quote I have used many times, in many different talks:

‘It is simply no longer possible to believe much of the clinical research that is published, or to rely on the judgement of trusted physicians or authoritative medical guidelines. I take no pleasure in this conclusion, which I reached slowly and reluctantly over my two decades as an editor of the New England Journal of Medicine.’

Peter Gotzsche, who set up the Nordic Cochrane Collaboration, and who was booted out of said Cochrane collaboration for questioning the HPV vaccine (used to prevent cervical cancer) wrote the book. ‘Deadly Medicine and Organised Crime. [How big pharma has corrupted healthcare]’.

The book cover states… ‘The main reason we take so many drugs is that drug companies don’t sell drugs, they sell lies about drugs… virtually everything we know about drugs is what the companies have chosen to tell us and our doctors… if you don’t believe the system is out of control, please e-mail me and explain why drugs are the third leading cause of death.’

Richard Smith edited the British Medical Journal (BMJ) for many years. He now writes a blog, amongst other things. A few years ago, he commented:

‘Twenty years ago this week, the statistician Doug Altman published an editorial in the BMJ arguing that much medical research was of poor quality and misleading. In his editorial entitled ‘The scandal of Poor Medical Research.’ Altman wrote that much research was seriously flawed through the use of inappropriate designs, unrepresentative sample, small sample, incorrect methods of analysis and faulty interpretation… Twenty years later, I feel that things are not better, but worse…

In 2002 I spent eight marvellous weeks in a 15th palazzo in Venice writing a book on medical journals, the major outlets for medical research, and the dismal conclusion that things were badly wrong with journals and the research they published. My confidence that ‘things can only get better’ has largely drained away.’

Essentially, medical research has inexorably turned into an industry. A very lucrative industry. Many medical journals now charge authors thousands of dollars to publish their research. This ensures that it is very difficult for any researcher, not supported by a university, or a pharmaceutical company, to afford to publish anything, unless they are independently wealthy.

The journals then have the cheek to claim copyright, and charge money to anyone who actually wants to read, or download the full paper. Fifty dollars for a few on-line pages! They then bill for reprints, they charge for advertising. Those who had the temerity to write the article get nothing – and nor do the peer reviewers.

It is all very profitable. Last time I looked the Return on Investment (profit) was thirty-five per-cent for the big publishing houses. It was Robert Maxwell who first saw this opportunity for money making.

Driven by financial imperative, the research itself has also, inevitably, become biased. He who pays the paper calls the tune. Pharmaceutical companies, food manufacturers and suchlike. They can certainly afford the publication fees.

In addition to all the financial and peer-review pressure, if you dare swim against the approved mainstream views you will, very often, be ruthlessly attacked. As many people know, I am a critic of the cholesterol hypothesis, along with my band of brothers…we few, we happy few. In the 1970s, Kilmer McCully, who plays double bass in our band, was looking into a cause of cardiovascular disease that went against the mainstream view. This is what happened to him:

‘Thomas N. James, a cardiologist and president of the University of Texas Medical Branch who was also the president of the American Heart Association in 1979 and ’80, is even harsher [regarding the treatment of McCully]. ”It was worse than that – you couldn’t get ideas funded that went in other directions than cholesterol,” he says. ”You were intentionally discouraged from pursuing alternative questions. I’ve never dealt with a subject in my life that elicited such an immediate hostile response.”

It took two years for McCully to find a new research job. His children were reaching college age; he and his wife refinanced their house and borrowed from her parents. McCully says that his job search developed a pattern: he would hear of an opening, go for interviews and then the process would grind to a stop. Finally, he heard rumors of what he calls ”poison phone calls” from Harvard. ”It smelled to high heaven,” he says.’

McCully says that when he was interviewed on Canadian television after he left Harvard, he received a call from the public-affairs director of Mass. General. ”He told me to shut up,” McCully recalls. ”He said he didn’t want the names of Harvard and Mass. General associated with my theories.’ 2

More recently, I was sent a link to an article outlining the attacks made on another researcher who published a paper which found that being overweight meant having a (slightly) lower risk of death than being of ‘normal weight. This, would never do:

‘A naïve researcher published a scientific article in a respectable journal. She thought her article was straightforward and defensible. It used only publicly available data, and her findings were consistent with much of the literature on the topic. Her coauthors included two distinguished statisticians.

To her surprise her publication was met with unusual attacks from some unexpected sources within the research community. These attacks were by and large not pursued through normal channels of scientific discussion. Her research became the target of an aggressive campaign that included insults, errors, misinformation, social media posts, behind-the-scenes gossip and maneuvers, and complaints to her employer.

The goal appeared to be to undermine and discredit her work. The controversy was something deliberately manufactured, and the attacks primarily consisted of repeated assertions of preconceived opinions. She learned first-hand the antagonism that could be provoked by inconvenient scientific findings. Guidelines and recommendations should be based on objective and unbiased data. Development of public health policy and clinical recommendations is complex and needs to be evidence-based rather than belief-based. This can be challenging when a hot-button topic is involved.’ 3

Those who lead the attacks on her were my very favourite researchers, Walter Willet and Frank Hu. Two eminent researchers from Harvard who I nickname Tweedledum and Tweedledummer. Harvard itself has become an institution, which, along with Oxford University, comes up a lot in tales of bullying and intimidation. Willet and Hu are internationally known for promoting vegetarian and vegan diets. Willet is a key figure in the EAT-Lancet initiative.

Where is science in all this? I feel the need to state, at this point, that I don’t mind attacks on ideas. I like robust debate. Science can only progress through a process of new hypotheses being proposed, being attacked, being refined and strengthened – or obliterated. But what we see now is not science. It is the obliteration of science itself:

‘Anyone who has been a scientist for more than 20 years will realize that there has been a progressive decline in the honesty of communications between scientists, between scientists and their institutions and the outside world.

Yet, real science must be an area where truth is the rule; or else the activity simply stops being scient and becomes something else: Zombie science. Zombie science is a science that is dead, but is artificially keep moving by a continual infusion of funding. From a distance Zombie science looks like the real thing, the surface features of a science are in place – white coats, laboratories, computer programming, PhDs, papers, conferences, prizes etc. But the Zombie is not interested in the pursuit of truth – its citations are externally-controlled and directed at non-scientific goals, and inside the Zombie everything is rotten…

Scientists are usually too careful and clever to risk telling outright lies, but instead they push the envelope of exaggeration, selectivity and distortion as far as possible. And tolerance for this kind of untruthfulness has greatly increased over recent years. So, it is now routine for scientists deliberately to ‘hype’ the significance of their status and performance and ‘spin’ the importance of their research.’ Bruce Charlton: Professor of Theoretical Medicine.

I was already pretty depressed with the direction that medical science was taking. Then COVID19 came along, the distortion and hype became so outrageous that I almost gave up trying to establish what was true, and was just made up nonsense.

For example, I stated, right at the start of the COVID19 pandemic, that vitamin D could be important in protecting against the virus. For having the audacity to say this, I was attacked by the fact checkers. Indeed, anyone promoting vitamin D to reduce the risk of COVID19 infection, was ruthlessly hounded.

Guess what. Here from 17th June:

‘Hospitalized COVID-19 patients are far more likely to die or to end up in severe or critical condition if they are vitamin D-deficient, Israeli researchers have found.

In a study conducted in a Galilee hospital, 26 percent of vitamin D-deficient coronavirus patients died, while among other patients the figure was at 3%.

“This is a very, very significant discrepancy, which represents a big clue that starting the disease with very low vitamin D leads to increased mortality and more severity,” Dr. Amir Bashkin, endocrinologist and part of the research team, told The Times of Israel.’ 4

I also recommended vitamin C for those already in hospital. Again, I was attacked, as has everyone who has dared to mention COVID19 and vitamin C in the same sentence. Yet, we know that vitamin C is essential for the health and wellbeing of blood vessels, and the endothelial cells that line them. In severe infection the body burns through vitamin C, and people can become ‘scrobutic’ (the name given to severe lack of vitamin C).

Vitamin C is also known to have powerful anti-viral activity. It has been known for years. Here, from an article in 1996:

‘Over the years, it has become well recognized that ascorbate can bolster the natural defense mechanisms of the host and provide protection not only against infectious disease, but also against cancer and other chronic degenerative diseases. The functions involved in ascorbate’s enhancement of host resistance to disease include its biosynthetic (hy-droxylating), antioxidant, and immunostimulatory activities. In addition, ascorbate exerts a direct antiviral action that may confer specific protection against viral disease. The vitamin has been found to inactivate a wide spectrum of viruses as well as suppress viral replication abd expression in infected cell.’ 5

I like quoting research on vitamins from way before COVID19 appeared, where people were simply looking at Vitamin C without the entire medico-industrial complex looking over their shoulder, ready to stamp out anything they don’t like. Despite a mass of evidence that Vitamin C has benefits against viral infection, it is a complete no-go area and no-one even dares to research it now. Facebook removes any content relating to Vitamin C and COVID19.

As of today, any criticism of the mainstream narrative is simply being removed. Those who dare to raise their heads above the parapet, have them chopped off:

‘Dr Francis Christian, practising surgeon and clinical professor of general surgery at the University of Saskatchewan, has been immediately suspended from all teaching and will be permanently removed from his role as of September.

Dr Christian has been a surgeon for more than 20 years and began working in Saskatoon in 2007. He was appointed Director of the Surgical Humanities Program and Director of Quality and Patient Safety in 2018 and co-founded the Surgical Humanities Program. Dr. Christian is also the Editor of the Journal of The Surgical Humanities.

On June 17th Dr Christian released a statement to over 200 of his colleagues, expressing concern over the lack of informed consent involved in Canada’s “Covid19 vaccination” program, especially regarding children.

To be clear, Dr Christian’s position is hardly an extreme one.

He believes the virus is real, he believes in vaccination as a general principle, he believes the elderly and vulnerable may benefit from the Covid “vaccine”… he simply doesn’t agree it should be used on children, and feels parents are not being given enough information for properly informed consent.’ 6

When I wrote Doctoring Data, a few years ago, I included the following thoughts about the increasing censorship and punishment that was already very clearly out in the open:

…where does it end? Well, we know where it ends.

First, they came for the communists, and I didn’t speak out because I wasn’t a communist

Then they came for the socialists, and I didn’t speak out because I wasn’t a socialist

Then they came from the trade unionists, and I didn’t speak out because I wasn’t a trade unionist

Then they came for me, and there was no-one left to speak for me

Do you think this is a massive over-reaction? Do I really believe that we are heading for some form of totalitarian stated, where dissent against the medical ‘experts’ will be punishable by imprisonment? Well, yes, I do. We are already in a situation where doctors who fail to follow the dreaded ‘guidelines’ can be sued, or dragged in front the General Medical Council, and struck of. Thus losing their job and income…

Where next?

The lamps are not just going out all over Europe. They are going out, all over the world.

1: https://journals.plos.org/plosmedicine/article?id=10.1371/journal.pmed.0020124

2: https://www.nytimes.com/1997/08/10/magazine/the-fall-and-rise-of-kilmer-mccully.html

3: https://www.sciencedirect.com/science/article/pii/S0033062021000670

4: https://www.timesofisrael.com/1-in-4-hospitalized-covid-patients-who-lack-vitamin-d-die-israeli-study

5: https://www.researchgate.net/publication/14383321_Antiviral_and_Immunomodulatory_Activities_of_Ascorbic_Acid 6: https://off-guardian.org/2021/06/25/canadian-surgeon-fired-for-voicing-safety-concerns-over-covid-jabs-for-children/

Abstract

Background:

After COVID-19 emerged on U.S shores, providers began reviewing the emerging basic science, translational, and clinical data to identify potentially effective treatment options. In addition, a multitude of both novel and repurposed therapeutic agents were used empirically and studied within clinical trials.

Areas of Uncertainty:

The majority of trialed agents have failed to provide reproducible, definitive proof of efficacy in reducing the mortality of COVID-19 with the exception of corticosteroids in moderate to severe disease. Recently, evidence has emerged that the oral antiparasitic agent ivermectin exhibits numerous antiviral and anti-inflammatory mechanisms with trial results reporting significant outcome benefits. Given some have not passed peer review, several expert groups including Unitaid/World Health Organization have undertaken a systematic global effort to contact all active trial investigators to rapidly gather the data needed to grade and perform meta-analyses.

Data Sources:

Data were sourced from published peer-reviewed studies, manuscripts posted to preprint servers, expert meta-analyses, and numerous epidemiological analyses of regions with ivermectin distribution campaigns.

Therapeutic Advances:

A large majority of randomized and observational controlled trials of ivermectin are reporting repeated, large magnitude improvements in clinical outcomes. Numerous prophylaxis trials demonstrate that regular ivermectin use leads to large reductions in transmission. Multiple, large “natural experiments” occurred in regions that initiated “ivermectin distribution” campaigns followed by tight, reproducible, temporally associated decreases in case counts and case fatality rates compared with nearby regions without such campaigns.

Conclusions:

Meta-analyses based on 18 randomized controlled treatment trials of ivermectin in COVID-19 have found large, statistically significant reductions in mortality, time to clinical recovery, and time to viral clearance. Furthermore, results from numerous controlled prophylaxis trials report significantly reduced risks of contracting COVID-19 with the regular use of ivermectin. Finally, the many examples of ivermectin distribution campaigns leading to rapid population-wide decreases in morbidity and mortality indicate that an oral agent effective in all phases of COVID-19 has been identified.

...

One of the major North American archaeological discoveries of the 20th century was made in 1967 by a bulldozer crew preparing a site for a movie theater in the small fishing village of Port au Choix (PAC), on Newfoundland’s Northern Peninsula. It was a vast, 4,000-year-old cemetery created by a complex maritime culture known among researchers as the Maritime Archaic. The graves contained beautifully preserved skeletons covered in a brilliant red powder called red ocher (powdered specular hematite). Buried with the skeletons were many finely crafted artifacts. A few similar ones had previously turned up in earlier field surveys on the island, but no archaeologist had suspected that such a large and magnificent ceremonial site existed in the North American subarctic.

Had the discovery been made only a few years earlier, it is likely that no trained archaeologist would have taken over from the bulldozer crew. But fortunately, Memorial University in St. Johns had just added archaeologist James (“Jim”) Tuck (1940–2019) to its faculty. The American-born scholar set out to explore the cemetery, eventually excavating more than 150 graves spread over three clusters (which he referred to as loci).

Jim and I had both been field-trained by American archaeologist William Ritchie. We had never worked together, but stayed in close contact. As Bill’s protégés, the two of us were among the first generation of professionally-trained archaeologists to take the field in north-eastern North America outside New York State. Many of us shared a common objective, which was to track down a culture (or was it a series of cultures?) dating from between 4,000 and 5,000 years ago, which had left behind stone artifacts similar to those from PAC, and deposited them in ocher-filled graves extending from Maine to Ontario; and now, it had been discovered, Newfoundland.

Plummet, Nevin site.

We suspected that the communities represented by these cemeteries were linked, because of their similarly beautiful stone adzes, spear tips flaked from unusual rock types, elegant lance-tip-like objects made of ground slate, and tear-drop-shaped stone weights (called “plummets”). All of these artifacts, like the cemeteries themselves, differed from anything produced by more recent prehistoric peoples.

Prior to the discovery of PAC, the most studied of these early cultures was known from the dozens of cemeteries found along and near the Maine coast near Portland, extending as far east as Grand Lake, in New Brunswick. Locally known as the “Red Paint People” because of their ocher-filled graves, they became a focus of intense interest as scientific archaeology emerged in the 1880s.

Tuck’s discovery at PAC sparked animated discussions and interpretive disagreements among us, with debate focusing on the Maritime Archaic and its relationship to the Red Paint People. The similarities were undeniable. Aside from sharing high-quality lithic technology, both had developed sophisticated bone and antler technologies, including long daggers, toggling and barbed harpoons of the type used by Inuit hunters, bone needles (probably indicative of tailored clothing, which is a rarity among hunting and gathering Indigenous North Americans south of the Arctic), and nearly identical shaman’s paraphernalia. Moreover, both populations evidently contained accomplished hunters of large marine animals, and seemed to take spiritual inspiration from the sea, manifested in the Maritime Archaic by effigies of marine birds and killer whales, and among the Red Paint People by small figurines of imaginary marine creatures with features not found in any living species.

I should underscore how unusual these cultures were in comparison to both preceding and succeeding prehistoric peoples in these regions. Archaeologists working in northern temperate and subarctic North America were quite unprepared for the discovery of such well-organized and complex cultures in cool, moist environmental zones that otherwise were characterized by apparently simpler hunting and gathering cultures.

Ocher-stained moose leg bone daggers with fine incised decoration from the Red Paint People Nevin site.

Prior to the appearance of these cultures, human occupation in the area had been sparse and had featured less sophisticated technology. The few burial sites that we know of might have contained several artifacts of impressive quality, but they were usually isolated, as if created by transitory occupants who soon moved on. In Maine and at PAC, however, true cemeteries, as we know them, would seem to indicate thriving groups of maritime hunters with complex tools and trading routes stretching westward to the Great Lakes. Their discretely marked territories, technological complexity, mortuary ritual elaboration, and widespread trade connections set them apart from both earlier and later populations.

Another characteristic they shared was their sudden cultural collapse and disappearance sometime between 3,800 and 3,400 years ago. In the north, the Maritime Archaic gave way to Pre-Dorset Palaeoeskimos (as they are known in the literature) that had recently arrived from Siberia. And in the south, the Red Paint People, along with their neighbors in temperate north-eastern North America, gave way to a wave of immigrants from the southern Appalachians.

Unresolved, however, was the important question of how these two groups related to one other. In this regard, Jim and I held diametrically opposed views.

Mine was that, though sharing many close similarities, the two groups had different origins. I saw the Red Paint People as locals, descended from northward moving immigrants with cultural ties down the Atlantic coast to the Carolinas. Though both cultures were expert maritime hunters, I noted, their prey differed. Maritime Archaic hunters pursued walrus and caribou, while the Red Paint People were the world’s earliest swordfish hunters, and also fished for cod and hunted moose and deer. Moreover, there remains a large gap of over 350 miles between the southernmost Maritime Archaic sites and the northernmost Red Paint cemetery. Similarities between the two groups, I thought, probably arose either through the social interaction one might expect from two widely-ranging maritime cultures (and were especially evident in the flaked quartzite projectile points from northern Labrador found in several Red Paint cemeteries that must have traveled through the hands of Maritime Archaic traders). Or perhaps they shared common descent from some earlier culture.

Jim had demonstrated that the Maritime Archaic descended from basically the same ancestral stock as the Red Paint People. But I felt he glossed over the details of this common-ancestry hypothesis so as to posit that both were manifestations of a Maritime Archaic that originated in Labrador and eventually spread to Maine. We remained at friendly loggerheads for decades, unable to resolve the issue with the archaeological tools at hand. Then an entirely new avenue of research opened up: human paleogenetics.

* * *

In the early 1990s, visionary Italian geneticist Luca Cavalli-Sforza (1922–2018) and colleagues began the Human Genome Diversity Project (HGDP) at Stanford University’s Morrison Institute. The aim was to record the genetic profiles mainly of relatively small Indigenous populations, which geneticists thought were best suited for reconstructing human population movement and change over time in any given region (due to their relatively low rates of genetic exchange with neighbors through a process known as admixture). The HGDP’s strategy worked well and progress was rapid. In 1994, only three years after its formation, Cavalli-Sforza and two co-authors published The History and Geography of Human Genes, which synthesized research from a wide array of fields so as to explain how the world came to be populated.

The peopling of the world by early humans. Numbers represent kilo years ago (e.g., 5 kya = 5,000 years ago).

The book, published by Princeton University Press, received global accolades. But it also attracted strong criticism from lay readers on both sides of the political spectrum. One Indigenous leader called it “unethical, invasive, and may even be criminal. It violates the group rights [of] Indigenous peoples around the world.” Meanwhile, Cavalli-Sforza was receiving hate mail from right-wing extremists who bristled at their genetic connection to parts of humanity they imagined to be “inferior.”

Yet despite these criticisms, Cavalli-Sforza’s work inspired other geneticists to develop human genetic studies by extending their inquiries further back in time. Much of the pioneering work of recovering ancient DNA from archaeological bone, for instance, was done at Svante Pääbo’s lab at the Max Planck Institute for Evolutionary Anthropology at Leipzig, Germany. The group’s major breakthrough came in 2010, with published studies of three ancient genomes, including Neanderthals, a new species of archaic human called Denisovans (recognized solely by DNA retrieved from a finger bone), and, shifting to North America, a 4,000-year-old male from Greenland. As Harvard geneticist David Reich wrote in Who We Are and How We Got Here: Ancient DNA and the Science of the Human Past, the early and mid-2010s were marked by additional new discoveries.

It wasn’t long before a multinational team of paleogeneticists led by Ana Duggan of McMaster University, located in the Canadian city of Hamilton, tackled the issue of Maritime Archaic origins and disappearance. Duggan’s group relied on mitochondrial DNA (mDNA) from skeletal remains found in Labrador and Newfoundland dating roughly from between 7,500 BC and the early historic period. Team members summarized their results as follows:

By examining the mitochondrial genome diversity and isotopic ratios of 74 ancient remains in conjunction with the archaeological record, we have provided definitive evidence for the genetic discontinuity between the maternal lineages of these populations. This northeastern margin of North America appears to have been populated multiple times by distinct groups that did not share a recent common ancestry, but rather one much deeper in time at the entry point into the continent. (Emphasis added.)

Eyed bone needles, Nevin site.

In regard to the Red Paint People, Reich’s lab at Harvard Medical School analyzed material from the Nevin site in Blue Hill, Maine—the only known Red Paint cemetery that is likely ever to produce well-preserved human remains. Reich’s analysis was not confined to mDNA (which, unlike nuclear DNA, is transmitted through the maternal line, and so cannot address paternal ancestry), and focused instead on autosomal DNA (aDNA) found in cell nuclei, thereby adding information on the paternal line. (This addition can be critically important because, as Reich’s lab had demonstrated, a population can be founded by males and females with very different origins.) The Reich team has yet to publish comprehensive results of its Nevin site analysis. But from what I have heard, their work will confirm the existence of genetic discontinuities between the Red Paint People and later populations in the region, much as with Duggan’s work in regard to the Maritime Archaic.

But this is where events took a strange turn: It was when Duggan’s group announced that they’d gained the capacity to analyze aDNA, and made known their plans to apply this technology to the male genome of their Labrador/Newfoundland skeletal sample, that a sense of apprehension seemed to spread through some quarters of the paleogenetic community.

During the summer of 2020, amid the COVID-19 pandemic and Black Lives Matter protests, Duggan’s project went noticeably quiet. I inquired among team members with whom I regularly communicated, but received oblique and evasive responses about the pace of research and publication. Suspecting that this might be related to sensitivities surrounding Indigenous populations (a topic that has consumed Canadian academia in recent years), I contacted Duggan directly, expressing concern that her valuable work might not be published.

My interest related to my own longstanding focus on the Red Paint People and their relationship to the Maritime Archaic, as described above. In the early 1990s, with Jim Tuck’s approval and guidance, I’d undertaken extensive isotopic research on the PAC skeletal sample to explore dietary differences between PAC and several prehistoric Maine populations. And it was on the basis of this established engagement with the subject that I made my inquiries of Duggan. “Science, after all, is about openness and transparency in communication,” I wrote. “Has your group had requests from Indigenous people that this work not be carried forward?”

In (partial) response, Duggan replied that she and her team remained “invested” in the project, but were proceeding in line with “standards and ethics of research suitable for the 21st century”—standards that specifically “include the continued support of present-day Indigenous communities as well as full institutional ethics approval.” These standards, which she described as “common to ancient DNA genomics research with Indigenous populations across North America,” require that “discussions and agreements” with Indigenous communities take place before “yet another ancient genome” could be published.

As described below, however, the Port au Choix sample is far from just “yet another” lineage. And I asked whether the Indigenous permissions that Duggan’s group apparently had obtained for their earlier research on mDNA had been revoked. As of this writing, I have received no response. Duggan told me that my own concerns were “meaningless when compared to the distress caused to Indigenous communities by the historical treatment of their ancestral remains.” But she failed to provide detail on this potential “distress.” Until this discussion, a half century had passed with no complaint, to my knowledge, from any Indigenous group, in regard to this specific area of study.

Duggan’s response struck me as odd given the circumstances of the Port au Choix discovery. Had that discovery occurred only a few years earlier, the bones and amazing artifacts likely would have been thrown away or taken home by members of the construction crew. Tuck’s excavations saved all these scientifically precious specimens, and had resulted in the publication of important research, to the incalculable benefit of anyone interested in North American Indigenous history.

We now know that Tuck’s three loci were but a small portion of a much larger cemetery unparalleled in the Northwest Atlantic region, if not beyond. Unfortunately, no further excavations have been conducted. More graves reportedly have been dug up by construction equipment. But the fate of these items is unpublished and unknown to me or to any Canadian archaeologist I have consulted. In the current political climate, the very fact of their existence is now apparently seen as awkward, even taboo—an ironic reversion to an unenlightened period when few cared about the history of Indigenous peoples.

When the Maritime Archaic tradition vanished, it was replaced, as noted earlier, by unrelated Paleoeskimos, an Arctic people who had then recently derived from Siberia. Following their own disappearance, more recently arrived inhabitants migrated from Labrador, these probably being ancestors of the historic Beothuk, who still lived in the region when Europeans arrived. The last surviving Beothuk, a woman named Shanawdithit, died of tuberculosis in 1829. And since that time, there has been no descendant Beothuk community with whom Duggan, or anyone else, could engage in the “discussions and agreements” she’d described to me.

And even if there were, moreover, Duggan’s own research has demonstrated that the Beothuk were not descended from the Maritime Archaic people of Port au Choix. The only community Duggan might be referring to is the (genealogically unrelated) Newfoundland Mi’kmaq community, whose ancestors arrived on Newfoundland from Nova Scotia in the 18th century, several hundred years after the arrival of Europeans.

Modified bird wing bones, probably shaman’s equipment. Top pair from Port au Choix cemetery. Bottom pair from Red Paint village site, North Haven Island, Maine (~17 cm long).

In a 2017 article published in Science, Ann Gibbons wrote about the power of DNA analysis to “bust” the myths associated with Europeans’ origins: “Despite their tales of origin, most people are the mixed descendants of many migrations… As techniques for probing ethnic origins spread, nearly every week brings a new paper testing and then falsifying lore about one ancient culture after another.” Gibbons properly describes this as a positive development. But if this principle is true for the so-called old world, why is it untrue in regard to Indigenous peoples? The only way one might consider Duggan’s research to be offensive or controversial is to such extent as one might wish to preserve the idea of Indigenous peoples as staking out an unbroken genetic (and therefore moral) claim to this or that part of North America. Certainly, I can think of no other basis on which Duggan might be required to secure the permission of modern First Nations (as they are known in Canada) to conduct scientific research on populations that haven’t existed for thousands of years.

As it turned out, I had been naïve about the extent to which this kind of politics was now interfering with paleogenetic research. The ideologically correct approach had been articulated at a 2019 Brown University conference titled “State of the Field: The Ancient DNA Revolution in Archaeology.” There, Robert Preucel of Brown’s Haffenreffer Museum presented a roster of speakers who laid out what they regarded as state-of-the-art ethical standards in the field. They advised audience members to pursue a “commonly agreed set of best practices” with “descendant communities”—especially when paleogenomic conclusions challenge, or conflict with, community knowledge about the past. Folklore and myths must be taken into account, and we must discourage the idea of science “controlling the narrative.”

Moreover—and here is where I began to understand why Duggan’s lab had suddenly gone dark on this issue—“Even if we can’t seek consent from the study subjects themselves for inclusion in our ancient DNA studies, descendant-affiliated or geographically proximate communities should be consulted and engaged prior to the start of research because they may wish to speak for the ancestors” (my emphasis).

This anti-paleogenetic movement, as I would describe it, has roots dating back to the American Indian Movement (AIM) of the 1960s. AIM emerged among urban-dwelling Indigenous neighborhoods, not on Indian reservations (though AIM does deserve credit for calling out the poor living conditions in those communities). This was an important cause. But over time, AIM became more radicalized thanks to the influence of activists who sought to block scientific research in the name of cultural sensitivity. Eventually, this movement led to the passage of the Native American Graves Protection and Repatriation Act (NAGPRA) of 1990, a US law requiring federally funded entities to return “cultural items” (as broadly defined) to the ancestors or cultural affiliates of the communities from which those items originated.

When NAGPRA was passed, it was presented as a balanced means to accommodate both scientific inquiry and the rights of Indigenous communities seeking to protect the remains of their ancestors. But the application of the law became more expansive over time—as the demands of Indigenous communities typically are seen as more morally compelling (especially to academics) than those of the researchers who populate this field of scientific inquiry. This is especially true now that the scientific work of researchers has been lumped in with the (apparently ongoing) ideological and historical sins broadly described under the rubric of “settler colonialism.”

At the aforementioned Brown session, for instance, genetic analysis was denigrated because it serves to deny “the humanity of the individuals we study [and to not] regard them as human relatives who deserve respect.” This disrespect is said to extend even beyond skeletal individuals, to DNA found in “coprolites, dental calculus, cultural materials, or soil.” It is preferable, we are told, to put away our scientific instruments, and instead consider the oral histories of local community members. As a result, established academics in this field are not only backing away from future projects, but even apologizing for their invaluable discoveries of the past. Geneticist Christiana Scheib of the University of Tartu in Estonia, for example, reports that she feels “disappointed that I hadn’t known better to do it a different way in the first place.”

Moreover, it proved but a short jump from the denunciation of Western science to the insistence that traditional folklore and origin stories be protected from scientific scrutiny. In some academic quarters, it is now seen as insulting to bring up the fact that humans arrived in the Americas from Asia via Beringia during the Last Glacial Maximum about 16,000 years ago, as this fact conflicts with spiritual notions that, in many cases, roughly correspond to Christian creationist myths.

I should say that I don’t know any archaeologist or physical anthropologist active in 1990 who opposed the passage of NAGPRA outright. Indeed, everyone I knew welcomed it, as did I. And even those of us who are critical of the way NAGPRA has been applied generally have long experience with Indigenous individuals and communities, many of whom are sincerely interested in our research and have a clear and unsentimental understanding of their own genealogy, even if the media naturally focus on those leaders who give voice to contrary opinions. We also pay attention to traditional knowledge. (Linguist Norbert Francis has properly emphasized the importance of studying pre-literate traditional narrative genres, even as he recognizes that a sense of objectivity must be retained in regard to new findings in evolutionary science and population genetics.) Our real concern, subsequently borne out, was that stakeholders would use the law to expand their own authority—including non-Indigenous consultants and activists who inserted themselves as advisors to tribal leadership.

Much of this comes down to faddish ideological trends (including the “oikophobia,” or Western self-hatred, identified by Roger Scruton) that are by now well-known to Quillette readers. In the context of the anti-vaccination movement, for example, scientist and physician Dr. David Hotez recently commented that there is a “proliferation of attacks against science… in favor of alternative views, often linked to the targeting or harassment of individual scientists.”

But there is also a more concrete political dimension to these campaigns. Indigenous groups typically have membership requirements that depend upon (or at least relate indirectly to) “blood quantum,” i.e., the degree to which a person is descended from “full-blooded” ancestors. As anthropologist Ryan W. Schmidt has explained, these rules could threaten the integrity of Indigenous groups because, for example, “over 60 percent of all American Indians are married to non-Indians [and] by the year 2080, less than 8 percent of American Indians [are expected to] have one-half or more Indian ‘blood.’” By demonstrating the degree to which today’s Indigenous communities may themselves be entirely separate from ancient precursors, paleogenetics can be seen as a further threat to the ideal of Indigenous communities as homogenous, genetically distinct populations rooted timelessly in specific geographic areas.

Indeed, paleogenetic research has demonstrated that many Indigenous groups are fairly recently arrived in what is now considered their “traditional” territories. The earliest known human discovered in Greenland’s southern region, for instance, was a male member of the Paleoeskimo Saqqaq people. In 2010, archaeologists recovered a hair ball yielding genetic material that showed his genetic ancestry lay not in Nunavut, a mere 200 miles across the Davis Strait, but rather with the Nganasan, Koryak, and Chukchi peoples, 3,000 miles away in Siberia. Thus it is possible, even likely, that the Saqqaq people arrived in the New World at a much later date than the first humans to cross from Siberia into Alaska. This finding underscores a basic point emphasized by Gibbon: Humans move around a lot.

And this penchant for moving around didn’t end when humans arrived in North America. In the north-eastern part of North America, south of the St. Lawrence River and Gulf, for example, the arrival of mainly Basques and French settlers in the late 16th century set off a scramble among Indigenous groups—not generally to escape oppressive “settler colonization,” but rather to gain access to the new arrivals for purposes of trade and the formation of military alliances against existing enemies. This competition set off a series of long and bloody wars, which in turn led to the extermination of whole Indigenous cultures—true genocides, whose human toll was exacerbated by the epidemics brought from Europe.

These wars, in turn, eventually forced swathes of Algonquian-speaking peoples to move westward, pursued by Iroquois enemies in many cases, into what the French called the Pays d’en Haut, a vast area west of Montreal that extends to the Great Lakes, Ohio, and Illinois. Here, whole new cultural identities formed from the refugees (much in the same way that the demographic map of Europe was massively redrawn during the late stages of the Roman empire, with Goths, Gauls, Vandals, and dozens of other groups criss-crossing the continent in a bid to survive). The result is that most federally-recognized tribes in the American east and Midwest are late-colonial-to-recent in origin, and are largely populated by the descendants of widely scattered and, in some cases, vanished communities. The development of a homogenizing Plains Indian Culture resulted from a roughly analogous process. In many cases, paleogenetics is revealing that even those “true” homelands were not as ancient as once believed.

In the American Southwest, by late prehistoric times, every population apart from the Rio Grande Pueblos was turned upside down demographically in cataclysms that featured either huge die-offs or mass migrations. Roughly 75 years before the Spaniards arrived, the Classic Period (AD 1300–1450) Hohokam of central and southern Arizona had vanished, perhaps admixed with immigrants from northern Mexico and southward-migrating Puebloans who’d abandoned their villages in the Four Corners area. Farther west, in California, equally transformative events were brought about after 1700 by the Spanish, who created a highly coercive colonial system that extensively reorganized Indigenous communities around Catholic missions.

Throughout North America, certainly, the arrival of Europeans brought tremendous forces for change, often accompanied by unconscionable cruelty. But this occurrence didn’t represent the disruption of a stable, pacifistic land mass whose peoples had self-organized in their current state since the beginning of time—but rather a new challenge to a continent that, much like Europe itself, perpetually featured migrations, conquests, and tragedies wrought by competition among different groups. Ultimately, these are the stories that many people (including many non-Indigenous people) don’t want told—much less verified through ongoing paleogenetic research—as they disrupt our mythologized image of the Indigenous Americas as a sort of secular Eden.

And of course, it is their right to militate against science. But it is disheartening to see, as Francis does, that scientists themselves are falling in with these campaigns through “a widespread self-censorship among other scholars associated with work in Native American communities in anthropology and related social sciences.”

* * *

Even those who do not follow paleogenetic controversies closely may know Kennewick Man, the name assigned to the 9,000-year-old remains of a prehistoric Paleoamerican man found in Washington state 25 years ago. In that case, the remains were found to be related to tribes still present in the area where Kennewick Man was found (although this finding remains contested by some). But in many other cases, such local linkages have been harder to find. DNA from two 11,000-year-old skeletons discovered the following year in Spirit Cave, Nevada, for instance, were found to be more closely related to living Indigenous South Americans than to living Native North Americans. A much younger skeleton (about 700 years old) from Lovelock Cave, Nevada, was found to be a close genetic match with the Spirit Cave remains, and so also contained evidence of ancestry from a Mexican-related population. Nevertheless, in 2018, all three skeletons were handed over to the local Paiute-Shoshone for reburial because they had been found on their (currently understood) aboriginal homelands. “Repatriating” human remains to groups in this way has simply become the path of least resistance.

Also instructive is the case of 4,000-year-old human skeletons from the Nevin site in Blue Hill, Maine, which are held at Harvard’s Peabody Museum. These are the only well-preserved Red Paint People skeletal remains ever found, and thus are critical to resolving such issues as the relationship between them and the Maritime Archaic of Newfoundland-Labrador. They were analyzed at Reich’s Harvard lab five years ago, but the results remain unpublished (though verbal reports indicate that they bear no close relationship to the Penobscot or any of the other federally-recognized Indian tribes in Maine).

The wonderful collection of artifacts found with the Nevin skeletons were housed at a museum named for a different Peabody, the R. S. Peabody Museum at Phillips Academy in Andover, Massachusetts. Absent the publication of the Nevin DNA analyses, the director of that museum decided to honor a request from the Penobscots for their repatriation—even though he was apparently fully aware of the surrounding paleogenetic facts. And so the remarkable Nevin collection was never adequately catalogued or photographed, much less fully analyzed and reported. Requests from researchers to tribal officials about their whereabouts reportedly have, to my knowledge, gone unanswered.

Of course, some might say that there is only theoretical value in knowing about early human life in North America—so why not simply accede to the requests of Indigenous peoples? By way of answer, consider that Reich’s lab at Harvard has published a staggering amount of paleogenetic data, much of it relating directly to human wellbeing. Svante Pääbo’s lab is similarly productive, as illustrated by a 2020 paper published in Nature, entitled ‘The major genetic risk factor for severe COVID-19 is inherited from Neanderthals.’ It identifies a gene cluster on chromosome 3 that is a “major genetic risk factor for severe symptoms in patients,” and shows that the risk is conferred by “a genomic segment of around 50 kilobases in size that is inherited from Neanderthals and is carried by around 50% of people in south Asia and around 16% of people in Europe.”

Such discoveries have been made regarding all manner of diseases. And we will never know how many new discoveries we may have missed now that human remains are being taken from—or freely given away by—scientists in the name of politics. It is past time for science to reassert itself for the benefit of all humanity.

Bruce Bourque is senior archaeologist, emeritus, at the Maine State Museum, and senior lecturer in Anthropology, emeritus, at Bates College.

Featured Image: Inuit-like toggling harpoon tips: (left) Port au Choix cemetery, 9 cm long; (center) Red Paint village site, North Haven Island, Maine; (right) Nevin site.