WASHINGTON, D.C. — An internal memo from the U.S. Food and Drug Administration concluded that at least 10 children likely died “because of” COVID-19 vaccination, according to reporting from the New York Times. Reuters confirmed Friday that the memo, authored by Dr. Vinay Prasad, cited myocarditis — an inflammatory heart condition — as a possible link, though the analysis omitted ages, medical histories, and information about which vaccines were involved.
The findings have not undergone peer review, and the FDA has not publicly released supporting data. Prasad, who previously criticized federal pandemic-response measures, described the unpublished conclusion as “a profound revelation” and said the agency would pursue new oversight requirements, including randomized studies for major subgroups receiving vaccines.
The memo surfaces days before the CDC’s vaccine advisory committee meets to review national immunization policy. It also follows sweeping changes by Health Secretary Robert F. Kennedy Jr., who recently restricted COVID-19 vaccine access to people 65 and older or those with serious medical conditions. Kennedy, a longtime vaccine skeptic prior to joining the Trump administration, has worked to overhaul federal vaccination policy.
Federal health agencies have not commented on the memo, and no peer-reviewed research has established a causal connection between COVID vaccines and multiple pediatric deaths. Both the FDA and CDC previously maintained that vaccine-associated myocarditis cases were rare and typically mild.
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