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A dozen former FDA leaders lambaste claims by the agency’s current vaccine chief

Former FDA leaders say an internal memo's unproven claims and policy shifts could hinder vaccine innovation and harm millions at high risk, citing evidence vaccines reduce severe illness.

  • On Wednesday, a dozen prior leaders of the U.S. Food and Drug Administration published a letter in the New England Journal of Medicine denouncing new FDA vaccine safety claims as a major shift in the agency's role.
  • Last week, an internal FDA memo outlined plans to revamp how life-saving vaccines for flu, COVID-19 and other respiratory diseases are handled, which former officials said would disadvantage millions of Americans at high risk.
  • Dr. Vinay Prasad's unreleased internal memo, authenticated by a source, claimed without evidence that COVID-19 vaccines caused 10 children's deaths, urged FDA staff who disagreed to resign, and proposed revisions to yearly flu-shot updates and policy on simultaneous vaccine administration.
  • Former FDA leaders warned last week the proposals would reject long-standing science, slow innovation and disadvantage millions, while a Department of Health and Human Services spokesperson said Wednesday night the criticisms confirm progress.
  • Health Secretary Robert F. Kennedy Jr. has been remaking vaccine policy, ousting a CDC advisory committee and firing Susan Monarez, former CDC chief, as the CDC's vaccine advisory committee meets Thursday and Friday.
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abc News broke the news in United States on Wednesday, December 3, 2025.
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