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

By LAURAN NEERGAARD and LAURA UNGAR 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 Related Articles Newly distributed photos show disturbing look into Epstein Island Pentagon knew boat attack left survivors but still launched a follow-on strike AP sources say White House tours resume in time for Christmas but they re different than before Republican states will help Homeland Measure obtain driver s license records US adds more penalties to those linked to Tren de Aragua gang The former bureaucrats say the agency s plans to revamp how life-saving vaccines for flu COVID- 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 menace from serious infections The proposed new directives are not small adjustments or coherent protocol updates They represent a major shift in the FDA s understanding of its job the agents 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 issued but a source familiar with the document verified its authenticity The document claimed without providing evidence that COVID- vaccines caused children s deaths It went on to outline planned agency changes in handling those and certain other vaccines and disclosed that FDA staff who disagreed should resign 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 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 numerous shots may overwhelm kids immune systems or that ingredients may build up to cause harm although scientists say repeated research into those states has turned up no concerns On Wednesday the former FDA leaders wrote that Prasad s claim about child deaths related to COVID- vaccines had been broadcasted to a surveillance system that doesn t contain healthcare records or other information sufficient to prove a link and that administration scientists had attentively combed through those reports in previous years reaching different conclusions They also noted that substantial evidence shows COVID- vaccines reduce children s menace of severe disorder 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 constituents An administration spokesman didn t forthwith comment Various doctors and population medical experts also have expressed alarm about the memo Vaccines save lives period Dr Ronald Nahass president of the Infectious Diseases Society of America commented in a report It is a sad day when FDA creates confusion and mistrust without supplying evidence spreading propaganda that makes lifesaving vaccines harder to access and that creates additional confusion and mistrust for the citizens The FDA s planned vaccine changes come at a time when Physical condition Secretary Robert F Kennedy Jr who helped lead the anti-vaccine movement for years is seeking to broadly remake federal policies on vaccines FILE Fitness and Human Services Secretary Robert F Kennedy Jr speaks during a news conference at the Hubert Humphrey Building Auditorium in Washington April AP Photo Jose Luis Magana file Kennedy already ousted a committee that advised the Centers for Condition Control and Prevention on vaccine recommendation and replaced it with handpicked members And in August he fired Susan Monarez days into her tenure as CDC chief over vaccine framework disagreements The CDC s vaccine advisory committee will meet Thursday and Friday to discuss h epatitis B vaccinations in newborns and other vaccine topics Ungar shared from Louisville Kentucky Associated Press writer Ali Swenson contributed to this review The Associated Press Wellness and Science Department receives aid from the Howard Hughes Anatomical Institute s Department of Science Development and the Robert Wood Johnson Foundation The AP is solely responsible for all content