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FDA Memo Links 10 Child Deaths to COVID Vaccines

An internal FDA review linked 10 child deaths to COVID-19 vaccines, citing myocarditis; findings have not been peer-reviewed and precede a CDC vaccine committee meeting.

  • On Friday, Vinay Prasad, MD, MPH, Director of FDA Center for Biologics Evaluation and Research, circulated an internal memo concluding `no fewer than 10` child deaths were linked to COVID-19 vaccination.
  • After analyzing 96 reported deaths, the FDA team recommended a randomized studies requirement following Prasad's conclusion that at least 10 deaths in VAERS were vaccine related, aligning with Robert F. Kennedy Jr., Health Secretary’s policy.
  • Independent experts pushed back, saying VAERS is unverified and can be misused, Paul Offit, MD, called the memo `dangerous` and `irresponsible`, and vaccine experts urged peer review with autopsy and cause-of-death assessment.
  • The timing places the memo before the ACIP meeting to review the childhood vaccine schedule on Dec. 4–5, and Prasad said the FDA will implement approval process changes.
  • With millions of children already vaccinated, studies covering more than 10 million children show COVID vaccines are safe, but critics warn tougher rules could disrupt routine childhood schedules and vaccine availability.
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FDA Memo Claims COVID Vaccine Tied to 10 Child Deaths

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STAT broke the news in Boston, United States on Wednesday, November 12, 2025.
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