A dozen former FDA leaders criticize claims of current FDA vaccine chief

Appointed by a dozen former leaders of the US Food and Drug Administration republican And democrat Issued a scathing condemnation of the same – new fda Claims raising doubts on the safety of the vaccine.

Former officials say the agency’s plan to reform how life-saving vaccines for flu, COVID-19 and other respiratory diseases are managed — outlined in an internal FDA memo last week — “will harm the people the FDA exists to protect, including millions of people.” Americans At high risk from serious infection.”

“The proposed new directives are not small adjustments or consistent policy updates. They represent a major change in the FDA’s understanding of its job,” officials, former FDA commissioners and acting commissioners wrote in the New England Journal of Medicine on Wednesday.

The internal memo by FDA vaccine chief Dr. Vinay Prasad has not been released publicly, but a source familiar with the document has confirmed its authenticity. The document claimed – without providing evidence – that COVID-19 vaccines caused the deaths of 10 children. It outlined planned agency changes in the handling of those and some other vaccines, and said FDA employees who disagreed should resign.

Prasad’s plans included revising how annual flu shot updates are managed and focusing more on “the pros and cons of giving multiple vaccines at the same time.” A common message from vaccine skeptics is that too many shots could overwhelm children’s immune systems or that the ingredients could clump together and cause harm — though scientists say repeated research on those claims has shown no concern.

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 had already put out a committee advising Centers for Disease Control and Prevention On Tika’s recommendation and in his place, elected members were appointed. And in August, he fired Susan Monarez 29 days into her tenure as CDC head over vaccine policy disagreements. CDC’s Vaccine Advisory Committee will meet Thursday and Friday to discuss hepatitis B vaccination in newborns and other vaccine topics.

On Wednesday, former FDA leaders wrote that Prasad’s claims about child deaths related to COVID-19 vaccines were reported to a surveillance system that did not include enough medical records or other information to prove a link — and that government scientists had carefully studied those reports in previous years, and came to different conclusions. They also noted that “substantial evidence” shows that COVID-19 vaccines reduce the risk of severe disease and hospitalization in children.

But the bigger picture, former FDA leaders argued, is that the new proposals would throw out long-standing science on how to evaluate vaccines being updated to better match virus strains, slow innovation to replace older vaccines with newer, potentially better vaccines, and make the process less transparent to the public.

,

Associated Press writer Ali Swenson contributed to this report. Unger reported from Louisville, Kentucky.

,

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. AP is solely responsible for all content.