Former FDA Chiefs Condemn Internal Memo Casting Doubt on Vaccine Safety

By Blessing Nweke

A dozen former leaders of the Food and Drug Administration — appointed across Republican and Democratic administrations — issued a sharp rebuke Wednesday of new internal FDA assertions raising doubts about vaccine safety, warning the agency is veering away from science-based decision-making.

In an article published in the New England Journal of Medicine, the former commissioners and acting commissioners criticized an internal memo drafted last week by FDA vaccine chief Dr. Vinay Prasad. The memo, which has not been publicly released, was confirmed as authentic by a source familiar with the document. It claimed — without evidence — that COVID-19 vaccines caused the deaths of 10 children and urged sweeping changes to how flu, COVID-19 and other respiratory vaccines are evaluated. It also reportedly suggested that FDA staff who disagreed with the planned changes should resign.

“The proposed new directives are not small adjustments or coherent policy updates,” the former officials wrote. “They represent a major shift in the FDA’s understanding of its job and would disadvantage the people the FDA exists to protect, including millions of Americans at high risk from serious infections.”

Prasad’s memo outlined plans to alter the longstanding process for updating annual flu shots and to increase scrutiny of administering multiple vaccines simultaneously. Such concerns are frequently echoed by vaccine skeptics, though extensive research has found no evidence that routine childhood or combined vaccinations overwhelm the immune system or cause harm.

The controversy comes as Health Secretary Robert F. Kennedy Jr., a longtime figure in the anti-vaccine movement, seeks to overhaul federal vaccine policy. Kennedy has already disbanded a CDC vaccine advisory committee and replaced its members, and in August fired CDC Director Susan Monarez after just 29 days over vaccine-related disagreements.

The former FDA leaders said the memo misinterprets data from surveillance systems that lack the medical documentation needed to prove vaccine-linked deaths. They warned that adopting Prasad’s proposals would undermine established science, stall development of improved vaccines and reduce transparency in a system that relies on public trust.