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Is FDA about to restrict vaccination even further?

FDA review linked 10 child deaths to COVID vaccines, prompting proposals for stricter testing and approval rules including subgroup studies and flu-shot policy revisions.

  • On Friday, Dr. Vinay Prasad, FDA's CBER director, sent a memo alleging 10 of 96 child deaths reported to VAERS were related to COVID vaccines, prompting FDA review.
  • Prasad's memo proposes requiring vaccine makers to study new shots in all subgroups including pregnant people and re-examining annual flu shot approval plus limits on combination vaccines, which experts say would raise costs and slow childhood vaccine access.
  • The findings have not been peer-reviewed, and the memo cited 96 VAERS death reports without ages or vaccine details; the FDA's summer restrictions limited vaccines to those over 65 or high-risk, while mRNA-based COVID vaccines gained stronger warnings and the CDC changed wording last month.
  • The Advisory Committee on Immunization Practices is meeting later this week as experts warn adopting proposals would raise costs, delay childhood vaccinations, and complicate care.
  • The developments signal a vaccine-sceptic shift under HHS Secretary Robert F. Kennedy Jr., with Prasad urging dissenters to resign and public-health experts citing extensive testing and resolved myocarditis cases.
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Pharmaphorum broke the news in on Monday, December 1, 2025.
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