A leaked internal memo from the Food and Drug Administration has intensified debate over federal vaccine policy after the agency's top biologics regulator claimed that COVID-19 shots were responsible for "at least 10" child deaths without providing data or documentation to support the assertion. The memorandum, written by Dr. Vinay Prasad, Director of the FDA's Center for Biologics Evaluation and Research, is dated May 16, 2025, but surfaced publicly only this week after being obtained by The New York Times. The disclosure arrives as the Biden administration faces declining vaccination rates and growing political scrutiny over federal oversight.
In the document, Prasad wrote that an internal review "found that at least 10 children have died after and because of receiving COVID-19 vaccination." The memo contains no supporting material-no case summaries, age information, medical histories, comorbidities, or timelines indicating how a causal relationship was established instead of a temporal association. The statement also does not reference autopsy results, surveillance reports or adjudicated safety reviews, leaving unclear how the determination was made.
Prasad attributed the alleged deaths to myocarditis, a rare inflammatory condition that has been associated with a small number of vaccine recipients. Medical authorities, including federal agencies and independent researchers, have previously emphasized that myocarditis occurs at significantly higher rates after COVID-19 infection than after vaccination, and that vaccine-linked cases typically present with milder symptoms and favorable recovery outcomes.
None of the claims referenced in the leaked memo have appeared in peer-reviewed journals, and the FDA has not released internal data validating Prasad's statements. Dr. Paul Offit of the Children's Hospital of Philadelphia criticized the document as "science by press release," warning that unverified assertions risk eroding public confidence during an already turbulent period for vaccine messaging.
The memo also sheds light on a shift in federal decision-making earlier this year. On the same day the document was written, May 16, Prasad authorized a narrowed approval of Novavax's COVID vaccine, NUVAXOVID, limiting its use to adults 65 and older and to individuals between 12 and 64 with high-risk medical conditions. In that decisional memo, he argued that declining national mortality rates and limited evidence from observational studies had changed the balance of risks and benefits for the general population. He wrote that the agency faced "overreliance on potentially confounded observational data" and expressed concern about "healthy vaccinee bias" in existing datasets.
Prasad also identified myocarditis as a "known risk" associated with Novavax and cited imbalances in neurological, cardiac and thrombotic adverse events in post-marketing surveillance. The FDA nevertheless approved the vaccine for older and high-risk patients and required Novavax to launch a randomized placebo-controlled study of adults ages 50 to 64 to reassess booster safety and efficacy.
Major medical organizations have pushed back against the implications of Prasad's leaked memo. Federal data continue to cite myocarditis rates of roughly eight cases per million doses among people under 65, with the highest incidence in males ages 16 to 25. The American Academy of Pediatrics maintains recommendations for vaccination of children ages six months to two years, while the Infectious Diseases Society of America advises vaccination for everyone six months and older. Dr. Céline Gounder, a contributor to CBS News, urged caution, saying, "There is a lot of noise out there. Families should stick the course and talk to their doctors about keeping children up to date on their vaccinations."
The release of the memo has amplified political scrutiny surrounding vaccine oversight under Health and Human Services Secretary Robert F. Kennedy Jr., who has expressed skepticism about federal vaccination programs. Lawmakers and public-health experts are now calling on the FDA to release any data supporting Prasad's assertion regarding child deaths, arguing that unsupported claims risk fueling misinformation during a period of declining trust in public health guidance.
