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yesterday

FDA Officials Plan to Cite 25 Child Deaths Tied to Covid Shots at CDC Advisory Meeting

The planned claim relies on unverified VAERS reports that experts say cannot establish a causal link.

A child receives a dose of the Covid-19 vaccine in Schwenksville, Pennsylvania, on September 11, 2025.
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Overview

  • CDC’s Advisory Committee on Immunization Practices is scheduled to meet Sept. 18–19 to consider Covid vaccine guidance that could affect eligibility, insurance coverage, and pharmacy administration.
  • HHS said FDA and CDC staff routinely review VAERS and other safety systems and will share analyses through the ACIP process, while sources say the presentation and methods are not yet final.
  • Reports of the planned presentation sent Moderna shares down about 7% and Pfizer more than 3%, with Novavax and BioNTech also declining.
  • FDA Commissioner Marty Makary said the agency is investigating reports of pediatric deaths after vaccination and plans to release findings in the coming weeks, with Tracy Beth Høeg expected to brief the panel, according to reports.
  • The push comes after HHS Secretary Robert F. Kennedy Jr. removed routine Covid shot recommendations for healthy children and pregnant people and replaced ACIP members, as medical groups point to studies supporting vaccine safety in children.