12 Former FDA Heads Call Out FDA’s Leaked Memo Claiming COVID-19 Vaccines Killed Children In Bid To Change Policy

In a leaked memo sent to staff on Black Friday, November 28, the director of the Center for Biologics Evaluation and Research (CBER) – a branch of the Food and Drug Administration (FDA) – called for significant changes to vaccine policy on the basis that “at least 10 children” had allegedly been found to have died due to receiving a COVID-19 vaccine. A claim former FDA commissioners have criticized as unsubstantiated. 

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The memo, republished in full by BioCentury, was addressed to “Team CBER” and was sent by Vinayak (Vinay) Prasad, a hematologist-oncologist who was appointed as head of the CBER in May 2025 – barring a two-week period in late July/early August when he briefly stepped down after being accused of being a “leftist saboteur”. 

That’s a whole other messy situation; but now, Prasad is back, and apparently pulling no punches when it comes to progressing his agenda at the CBER. However, 12 former FDA heads who have held the post for the past 35 years have published a response to the memo in the New England Journal of Medicine, expressing their deep concern that the claims of child deaths related to the COVID-19 vaccine had already been determined by the FDA to not be vaccine-related, that changing its vaccine policy could undermine public saftey, and that the memo told “staff members who disagree with the new framework to ‘submit your resignation letters.’”

What the memo says

“I am writing to report that OBPV [Office of Biostatistics and Pharmacovigilance] career staff have found that at least 10 children have died after and because of receiving COVID-19 vaccination,” the memo reads. “These deaths are related to vaccination (likely/probable/possible attribution made by staff).”

Prasad went on to say that this “profound revelation” was likely an underestimate, and that children were “coerced” into receiving a “harmful” vaccine. There’s also a stark warning to whistleblowers discussing concerns or criticisms of agency decisions outside the agency: “this behavior is both unethical, illegal, and, as this case illustrates, factually incorrect.” 

The memo concludes with a roadmap that encompasses changes in vaccine regulation affecting not only the COVID-19 vaccines, but pneumonia and seasonal flu vaccines too. 

Prasad also suggests that there should be further research into the safety of administering multiple vaccines at once. Senior figures in the Trump administration, including the President himself, have previously called into question the safety of the MMR combined vaccine, based on precisely zero scientific evidence.

Prasad’s calls for “pre-market randomized trials” also echo edicts made by Health and Human Services (HHS) Secretary Robert F. Kennedy, Jr. earlier this year that all new vaccines must undergo placebo-controlled trials – something that is often neither scientifically desirable nor ethical. And in reality, all vaccines that get to market are thoroughly tested beforehand. 

Data collection doesn’t just stop once they’re approved, either – for all its flaws, the Vaccine Adverse Events Reporting System (VAERS) does exist for a good reason, as it’s vital to keep tabs on any emerging safety concerns once any drug or product has come to market. 

Studies are also performed in populations that are vaccinated, such as a massive study that showed no evidence of safety concerns with aluminum compounds in vaccines – one that Kennedy so strongly disagreed with that he petitioned the journal to retract it. It did not.

Moreover, there’s centuries-worth of evidence to show that vaccines are among the most transformative medical inventions humankind has ever created.

COVID-19 vaccines are now known to have saved millions of lives during the pandemic; pneumonia (pneumococcal) vaccines have markedly reduced the number of cases of this potentially deadly disease since they were introduced in the US; and seasonal flu shots save lives and keep vulnerable people from getting very sick every year. 

Former FDA commissioners respond

Even with the overwhelming evidence of the good that vaccines can do, though, if there were reason to believe that 10 children had died as a direct result of receiving a vaccine, that would be something to take seriously. But there isn’t reason to believe that, as an unprecedented response to the memo from 12 former FDA commissioners points out. 

“Previously, all the cases reported to the Centers for Disease Control and Prevention (CDC) and to the FDA had been carefully reviewed by FDA staff, who drew different conclusions,” they wrote. 

In other words, this is not new data, and these deaths had previously been assessed and deemed not to be linked to COVID shots. 

“The memo offered no explanation of the process and analyses that were used to reach the new retrospective judgment, nor did it indicate why that assessment should justify wholesale rewriting of vaccine regulation,” they wrote.

The proposed changes to vaccine regulation are not minor, either. In fact, the ex-commissioners refer to them as “a major shift in the FDA’s understanding of its job.” Requiring long, burdensome trials for every new product – even when it’s an update to an existing product, which has been well characterized and tested prior – only means that the most vulnerable will have to wait longer for the protection that updated and improved vaccines can offer them. 

The paper also picks up on language in the memo suggesting that we don’t have good data about the benefits of COVID-19 vaccines in children. This, the authors assert, is incorrect. In fact, we have “substantial evidence” that COVID vaccines reduce hospitalizations and severe illnesses. 

Science also suggests we ignore the risks of leaving kids unvaccinated at our peril. Just this year, a study found that kids are at greater risk of long COVID after their second COVID infection. 

We’re at a time when medical misinformation is being confidently proclaimed from the very heart of the US government, when state authorities and scientists themselves are having to step up to fill in the gaps and provide reliable advice to citizens. Science and research has been fiscally deprioritized at every turn. 

This latest chapter, according to the group of former commissioners, “is the latest in a series of troubling changes at the FDA, including substantial departures of FDA staff, that could diminish both the FDA’s strength and Americans’ health and safety”.