A powerful coalition of twelve former leaders of the U.S. Food and Drug Administration (FDA) has launched a fierce public rebuke of sweeping claims made by the agency's current vaccine chief, which cast doubt on the safety of life-saving immunisations.
Scathing Critique in Prestigious Journal
In a remarkable move, the group of former commissioners and acting commissioners – appointed under both Republican and Democratic presidents – published a denunciation in the New England Journal of Medicine on Wednesday, 3rd December 2025. Their target is an internal FDA memo authored by Dr. Vinay Prasad, the head of the FDA's vaccine division.
The former officials argue that the plans outlined in the memo to revamp how vaccines for flu, COVID-19, and other respiratory diseases are handled would "disadvantage the people the FDA exists to protect, including millions of Americans at high risk from serious infections." They stress these are not minor tweaks but represent "a major shift in the FDA’s understanding of its job."
Controversial Claims and Proposed Changes
Although the memo has not been officially released, a source confirmed its authenticity to the Associated Press. The document allegedly claimed, without providing evidence, that COVID-19 vaccines caused 10 children’s deaths. It then detailed planned agency changes and suggested staff who disagreed should resign.
Dr. Prasad's proposals include revising the process for annual flu shot updates and increasing focus on "the benefits and harms of giving multiple vaccines at the same time." This latter point echoes a common talking point among vaccine sceptics, despite scientists stating repeated research has found no evidence that multiple shots overwhelm children's immune systems.
The former FDA leaders directly countered the claim about child deaths, noting it was based on a surveillance system that lacks the medical records needed to prove causation. They pointed out that government scientists had previously analysed these reports and reached different conclusions. They also emphasised that "substantial evidence" shows COVID-19 vaccines reduce children's risk of severe disease and hospitalisation.
Broader Political Context and Consequences
This internal conflict emerges amidst a broader push by Health Secretary Robert F. Kennedy Jr. to remake federal vaccine policy. Kennedy, a long-time figure in the anti-vaccine movement, has already replaced a key CDC advisory committee with handpicked members and fired CDC chief Susan Monarez after just 29 days over vaccine policy disagreements.
The former FDA leaders warn the new proposals would have far-reaching negative effects. They argue the plans would reject long-standing science on evaluating updated vaccines, slow innovation for newer, better vaccines, and make the regulatory process less transparent to the public.
The controversy unfolds as the CDC's vaccine advisory committee meets to discuss hepatitis B vaccinations for newborns and other topics, highlighting the ongoing high-stakes debate over immunisation policy in the United States.
