Washington– Dozens of former FDA leaders — appointed by Republicans and Democrats alike — issued scathing condemnation of new FDA assertions that cast doubt on the safety of vaccines.
The former officials say the agency’s plans to revamp how it handles life-saving vaccines against influenza, COVID-19 and other respiratory illnesses — outlined in an internal FDA memo last week — would “disadvantage the people the FDA is there to protect, including millions of Americans who are at high risk of serious infection.”
“The proposed new guidance is not small tweaks or coherent policy updates. They represent a major shift in FDA’s understanding of its function,” former FDA officials and acting commissioners wrote Wednesday in the New England Journal of Medicine.
The internal memo from FDA vaccines chief Dr. Vinay Prasad has not been made public, but a source familiar with the document confirmed its authenticity. The document claimed – without providing evidence – that Covid-19 vaccines caused the death of 10 children. She went on to outline the agency’s planned changes in handling of those and some other vaccines, and said that FDA employees who disagreed should resign.
Among Prasad’s plans is to review how annual flu vaccine updates are handled and focus more on “the benefits and harms of giving multiple vaccines at the same time.” One common message from vaccine skeptics is that too many doses may overwhelm children’s immune systems or that ingredients may build up to cause harm — although scientists say repeated research into these claims has not raised any concerns.
The FDA’s planned vaccine changes come as Health Secretary Robert F. Kennedy Jr. — who has helped lead the anti-vaccine movement for years — seeks to broadly rewrite federal policies on vaccines.
Kennedy actually ousted the committee that advised the Centers for Disease Control and Prevention on vaccine recommendations and replaced it with carefully selected members. In August, he fired Susan Monarrez after 29 days as head of the Centers for Disease Control and Prevention 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.
On Wednesday, former FDA leaders wrote that Prasad’s claim about child deaths linked to COVID-19 vaccines had been reported to a monitoring system that did not have enough medical records or other information to prove a link — and that government scientists had carefully combed through those reports in previous years, arriving at different conclusions. They also noted that “substantial evidence” shows that COVID-19 vaccines reduce children’s risk of serious illness and hospitalization.
But the bigger picture, former FDA leaders said, is that the new proposals would dismiss long-standing science on how to evaluate vaccines that are updated to better match virus strains, slow innovation to replace older vaccines with newer and perhaps 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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