A dozen former FDA leaders lambaste claims by current FDA vaccine chief

A dozen prior leaders of the FDA — appointed by Republicans and Democrats alike — issued a scathing denunciation of new FDA assertions casting doubt on vaccine safety.

A dozen prior leaders of the 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.