The assertion is at the heart of a 3,000-word email sent to FDA employees Friday, November 28, by Vinay Prasad. He took the opportunity to suggest that it will be necessary to strengthen regulations on all vaccines, and not just those against COVID.
But the only source used in his email to support this assertion is the VAERS platform (Vaccine Adverse Event Reporting System), a system that allows anyone to publish what they believe to be a side effect of a vaccine. Those who manage VAERS, however, are careful to emphasize that a testimony on VAERS cannot be considered as proof of anything: it is a first alert, which other experts will then have to verify.
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And this is what has happened in recent years. For example, a meta-analysis – or synthesis of studies – published in 2023 in JAMA Pediatrics had reviewed 17 studies covering 10 million children aged 5 to 11 who had received the anti-COVID vaccine from Pfizer or Moderna: vaccinated children were systematically less at risk of having been hospitalized as a result of the virus. At the same time, a study published in 2024 in Nature Communications found no risk of serious side effects in young children after COVID vaccination.
As for the email of November 28, the experts denounced at the end of the week – notably in the medical journal STATthe first to get their hands on this shipment—it does not contain any data allowing us to know more about the causes of these alleged deaths, which would have taken place between 2021 and 2024. Prasad suggests that it could be myocarditis—heart problems—but without saying more. As recalled by New York Timesregardless of the medical problem, such an announcement normally comes with preliminary indications about the ages of the children, or pre-existing illnesses, or how cause and effect was determined: have autopsies been done to determine the cause of death, asks in STAT Kathyrn Edwards, a longtime vaccine researcher at Vanderbilt University. What is the time gap between vaccination and death?
It is also strange, several critics note, that no vaccine is identified in this email, when there are several in circulation.
The email also says nothing about an intention to publish data, which is the basis for establishing the validity of any claim in science — since from this publication, other researchers can examine the data and in turn conduct new studies.
Ultimately, the approach behind this email is “irresponsible,” denounces pediatrician Paul Offit of the Children’s Hospital of Philadelphia. Prasad “should have submitted this to an excellent scientific journal, where [les données] can be reviewed by subject experts who can say “yes, this is solid evidence”… That’s how it works. »
Vinay Prasad, who was a professor in the department of epidemiology at the University of California and a specialist in cancer drugs before being hired at the FDA in May 2025, is more specifically director of the Center for Biological Evaluation and Research: it is a department of the FDA in charge of evaluating and revising regulations surrounding vaccines, gene therapies or blood reserves. During COVID, Prasad became known for his opposition to COVID-19 measures—from masks to vaccines—and for the parallels he drew between the U.S. response to the pandemic and the early days of Adolf Hitler’s rule. He also wrote about the risks of heart problems in children from the COVID vaccine, but never clarified that these were minor heart problems, nor that the risks of such problems were much higher because of the virus.
Last August, the FDA announced that it was restricting access to anti-COVID vaccines for those over 65. Is the agency preparing a total ban on these vaccines or a severe restriction on their distribution? One thing is certain, it is not just these vaccines that are in the spotlight: Prasad suggested in the same message that he wants to “reform” the management of the annual flu vaccine as well as the childhood vaccination schedule.
In May 2025, barely appointed to his new position, he co-signed with the FDA commissioner – also appointed by Trump – an opinion text in the New England Journal of Medicinewhere both announced that the FDA would limit access to COVID vaccines to the elderly — which is now done — and that it would ask pharmaceutical companies to conduct new studies in children and young adults.
This email comes days before a two-day meeting of the CDC’s vaccine advisory committee (Advisory Committee on Immunization Practicesor ACIP), meeting which is scheduled to begin Thursday, December 4. This is the committee whose 17 experts were dismissed by Health Minister Robert F. Kennedy Jr. last June, replacing them with non-experts, some of whom flatly denied the usefulness of vaccines. On the agenda for this meeting is a discussion on the childhood vaccination schedule, and the legitimacy of vaccinating babies against hepatitis B.
