A top Food and Drug Administration (FDA) official called for introspection, humility and transformation at the agency in an email obtained by the Daily Caller News Foundation (DCNF) following a report by career staff that the deaths of ten children may be attributed to the COVID-19 vaccine.
“At least 10 children have died after and because of receiving COVID-19 vaccination,” FDA Chief Medical Officer and Center for Biologics Evaluation and Research Director Vinay Prasad said in an email sent to staff Friday afternoon.
“For the first time, the US FDA will acknowledge that COVID-19 vaccines have killed American children,” Prasad said. “Healthy young children who faced tremendously low risk of death were coerced, at the behest of the Biden administration, via school and work mandates, to receive a vaccine that could result in death. In many cases, such mandates were harmful. It is difficult to read cases where kids aged 7 to 16 may be dead as a result of covid vaccines.”
The finding — and the fact it would not have been uncovered without President Donald Trump’s appointee, FDA Commissioner Marty Makary, at the helm — provokes important questions about the direction and culture of the agency, wrote Prasad, Makary’s handpicked deputy.
“Why did it take until 2025 to perform this analysis, and take necessary further actions? Deaths were reported between 2021 and 2024, and ignored for years,” he wrote.
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The report on suspected COVID vaccine deaths in children has not been released. An HHS spokesperson did not immediately respond to a DCNF request for comment.
The report amounts to a wake-up call, Prasad said. He called for a transformation of his own center’s mission, a crusade likely to face severe counterwinds from the pharmaceutical industry and some of the agency’s longtime vaccine reviewers. He also issued an ultimatum to these staffers.
“Never again will the US FDA commissioner have to himself find deaths in children for staff to identify it,” he wrote. “Some staff may not agree with these core principles and operating principles. Please submit your resignation letters to your supervisor.”
Earlier this year Prasad assigned career staff at the FDA Office of Biostatistics and Pharmacovigilance (OBPV) to assess reports to the Vaccine Adverse Event Reporting System (VAERS), a surveillance program tracing vaccine side effects, according to the email. Prior to joining the FDA, Makary and Prasad tracked reports of vaccine-induced myocarditis — inflammation of the heart muscle — which occurs most frequently in young, healthy boys and men.
FDA officials assessed whether the COVID vaccine caused the deaths reported in VAERS against a subjective scale ranging from certain to unlikely, Prasad wrote. The ten detected deaths had “likely, probable or possible” attribution. Only highly motivated physicians complete the tedious process to submit VAERS reports, thus the figure is likely an underestimate, Prasad said. The COVID-19 vaccine manufacturers were due to conduct more safety studies, but FDA has not enforced its own requirements.
The FDA cannot answer the question of whether the COVID-19 vaccine killed more healthy kids than it saved because it lacks reliable data on the absolute risk reduction in severe disease and death in healthy children, Prasad said.
“The truth is we do not know if we saved lives on balance,” he wrote. “It is horrifying to consider that the US vaccine regulation, including our actions, may have harmed more children than we saved. This requires humility and introspection.”
“I suspect the answer is cultural and systemic,” he continued. “I have no doubt that many vaccines have saved millions of lives globally, and many have benefits that far exceed risks, but vaccines are like any other medical product. The right drug given to the right patient at the right time is great, but the same drug can be inappropriately given, causing harm. The same is true for vaccines.”
Prasad said the FDA should not lower its standards with the goal of further incentivizing the growth of the $30 billion vaccine market, pointing to the enormous profits of the COVID-19 vaccines and the fact that vaccines do not face generic competition.
Other forthcoming changes at CBER include changes to vaccine approvals in pregnant women, requiring more clinical trials rather than relying on laboratory studies testing antibody levels, revamping the annual flu vaccine rollout and studying the impact of administering multiple vaccines at the same time.
Prasad’s email amounts to a scathing critique of his predecessor, former CBER Director Peter Marks, who in 2021 pushed the agency to approve annual COVID boosters even for the young and healthy and to issue a full approval of the COVID vaccines, paving the way for higher-ups in the Biden White House to issue vaccine mandates, according to a
2024 congressional investigation. Marks’ push prompted the resignations of the agency’s two top vaccine reviewers, Marion Gruber and Philip Krause, who later told congressional investigators that they felt pressure to cut corners.
“Some have felt the CBER director should override reviewers to approve gene therapies that do not work because of patient demand. When these products later result in post market deaths, it is difficult to take corrective action. I favor approving products with benefits that exceed risks,” Prasad wrote.
Prasad’s changes tackle the post-pandemic plummet in public confidence in the FDA. Just
37% of Americans trust the FDA to act independently without outside influence, according to an August 2025 Kaiser Family Foundation poll. Just
27% of Americans rated the work of the FDA as “excellent” or “good” in an October 2025 Gallup poll.
Still, the mission has been rocky for Prasad, who faces opposition both from career staff who bristle at his criticism of the status quo and biotech investors wary of stricter standards.
His tenure was disrupted and prematurely ended when the White House fired him following a smear campaign by the Wall Street Journal editorial board and right-wing influencer Laura Loomer. That smear
campaign coincided with the FDA temporarily halting shipments of Elevidys, a Duchenne muscular dystrophy (DMD) gene therapy made by Sarepta Therapeutics. Prasad resumed his position after Makary and Health and Human Services Secretary Robert F. Kennedy Jr. lobbied the White House
to reinstate him, according to press reports.
The FDA did not pull Elevidys from the market but added a black boxed warning to the drug limiting the therapy to ambulatory patients four years of age and older on Nov. 14.
Prasad has been routinely undermined by leaks.
In the summer of 2025, Tracy Beth Hoeg, a senior advisor for clinical sciences to Makary and Prasad, began investigating the VAERS reports. She soon concluded the deaths attributable to COVID vaccination were real, according to Prasad’s email. Hoeg organized a meeting to discuss her research with the FDA’s OBPV and Office of Vaccines Research and Review; however, details were soon leaked to the press.
“Some staff present who leaked portrayed the incident as Dr. Hoeg attempting to create a false fear regarding vaccines,” Prasad wrote.
Prasad lambasted the leaks in the email.
“I have no doubt that individuals who are providing media outlets with slides, emails and personal anecdotes believe they are doing the right thing,” he said. “Unfortunately, this behavior is both unethical, illegal, and, as this case illustrates, factually incorrect.”
Editor’s note: The headline of this report was updated for accuracy.
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