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An internal FDA review linked 10 child deaths to COVID-19 vaccines, citing myocarditis; findings have not been peer-reviewed and precede a CDC vaccine committee meeting.

  • The FDA's top vaccine regulator has proposed tightening standards for how vaccines win federal approval after an internal safety review found at least 10 child deaths were vaccine related.
  • Under the proposed framework, manufacturers would need larger trials that prove real-world protection, not only antibody responses, and must show reductions in diseases like pneumonia, not just immune markers.
  • Some current and former FDA staffers warned the overhaul could dramatically lengthen timelines and discourage new vaccine projects by requiring larger, longer trials for each eligible population.
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Bias Distribution

  • 36% of the sources lean Left
36% Left

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