FILE - The Food and Drug Administration seal is seen at the Hubert Humphrey Building Auditorium in Washington, April 22, 2025. (AP Photo/Jose Luis Magana, File)
FILE - Health and Human Services Secretary Robert F. Kennedy Jr. speaks during a news conference at the Hubert Humphrey Building Auditorium in Washington, April 22, 2025. (AP Photo/Jose Luis Magana, file)
FILE - The Food and Drug Administration seal is seen at the Hubert Humphrey Building Auditorium in Washington, April 22, 2025. (AP Photo/Jose Luis Magana, File)
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FILE - Health and Human Services Secretary Robert F. Kennedy Jr. speaks during a news conference at the Hubert Humphrey Building Auditorium in Washington, April 22, 2025. (AP Photo/Jose Luis Magana, file)
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FILE - In this undated photo provided by the U.S. Food and Drug Administration, Vinay Prasad smiles for a portrait. (U.S. FDA via AP)
WASHINGTON (AP) — A dozen prior leaders of the U.S. Food and Drug Administration — appointed by Republicans and Democrats alike — issued a scathing denunciation of new FDA assertions casting doubt on vaccine safety.
The former officials say the agency's plans to revamp how life-saving vaccines for flu, COVID-19 and other respiratory diseases are handled — outlined in an internal FDA memo last week — would “disadvantage the people the FDA exists to protect, including millions of Americans at high risk from serious infections.”
“The proposed new directives are not small adjustments or coherent policy updates. They represent a major shift in the FDA’s understanding of its job,” the officials, former FDA commissioners and acting commissioners, wrote Wednesday in the New England Journal of Medicine.
The internal memo by FDA vaccine chief Dr. Vinay Prasad hasn't been publicly released but a source familiar with the document confirmed its authenticity. The document claimed — without providing evidence — that COVID-19 vaccines caused 10 children’s deaths. It went on to outline planned agency changes in handling those and certain other vaccines, and said that FDA staff who disagreed should resign.
Among Prasad's plans were revising how yearly flu shot updates are handled and focusing more on “the benefits and harms of giving multiple vaccines at the same time." A common message of vaccine skeptics is that too many shots may overwhelm kids' immune systems or that ingredients may build up to cause harm — although scientists say repeated research into those claims has turned up no concerns.
The FDA's planned vaccine changes come at a time when Health Secretary Robert F. Kennedy Jr. — who helped lead the anti-vaccine movement for years — is seeking to broadly remake federal policies on vaccines.
Kennedy already ousted a committee that advised the Centers for Disease Control and Prevention on vaccine recommendation and replaced it with handpicked members. And in August, he fired Susan Monarez 29 days into her tenure as CDC chief over vaccine policy disagreements. The CDC's vaccine advisory committee will meet Thursday and Friday to discuss hepatitis B vaccinations in newborns and other vaccine topics.
Wednesday, the former FDA leaders wrote that Prasad's claim about child deaths related to COVID-19 vaccines had been reported to a surveillance system that doesn't contain medical records or other information sufficient to prove a link — and that government scientists had carefully combed through those reports in previous years, reaching different conclusions. They also noted that “substantial evidence” shows COVID-19 vaccines reduce children's risk of severe disease and hospitalization.
But the bigger picture, the former FDA leaders argued, is that the new proposals would reject long-standing science about how to evaluate vaccines being updated to better match virus strains, slow innovation to replace older vaccines with newer, potentially better ones, and make the process less transparent to the public.
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Associated Press writer Ali Swenson contributed to this report. Ungar reported from Louisville, Kentucky.
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The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute’s Department of Science Education and the Robert Wood Johnson Foundation. The AP is solely responsible for all content.
