Former FDA Leaders Express Concerns Over Vaccine Safety Claims

Fri Dec 05 2025 08:51:33 GMT+0200 (Eastern European Standard Time)

A group of twelve former FDA leaders has criticized new assertions doubting vaccine safety by the agency, expressing concern for the health of vulnerable populations.

Twelve former leaders of the U.S. FDA condemned recent FDA claims regarding vaccine safety, particularly concerning COVID-19 vaccines. In a memo, the agency suggested that vaccines caused deaths among children without scientific evidence, raising alarms about potential changes to how vaccines are handled. The former officials argue such changes may disadvantage the public and undermine established scientific understanding of vaccines.

WASHINGTON (AP) — A dozen prior leaders of the U.S. Food and Drug Administration (FDA), appointed under both Republican and Democratic administrations, have issued a scathing denunciation of recent FDA statements expressing doubts about vaccine safety.

These former officials argue that the agency’s proposed changes in managing vaccines for flu, COVID-19, and other respiratory diseases could risk public health, particularly harming millions of Americans at high risk for severe infections.

In a letter published Wednesday in the New England Journal of Medicine, the ex-FDA commissioners stated that the recent directives represent not just minor adjustments but a considerable shift in the agency's mission and responsibilities.

The memo from Dr. Vinay Prasad, the FDA vaccine chief, reportedly claimed—without providing verifiable evidence—that COVID-19 vaccines might have resulted in the deaths of 10 children, suggesting that FDA personnel who contradict this viewpoint should resign.

Prasad’s recommendations include significant revisions to the annual flu vaccine process and an increased focus on weighing the benefits and risks of administering multiple vaccines simultaneously. Critics point out that such views echo long-standing vaccine skepticism, despite extensive scientific research dismissing these safety claims.

As tensions mount over vaccine strategies, Health Secretary Robert F. Kennedy Jr., a prominent figure in the anti-vaccine movement, is seeking to reform federal vaccination policies further, having already made significant personnel changes within the CDC.

The group of former FDA leaders emphasized the lack of imminent public health threats that warrant such drastic policy changes and noted that considerable evidence exists that COVID-19 vaccines significantly lower risks of severe disease and hospitalization among children.

They warned that the proposed changes would not only challenge established scientific understandings but could also decelerate innovation in vaccine development and obscure the transparency necessary for public trust.

The wider implications of these proposals signal a profound transformation in the FDA's approach to vaccination, sparking widespread concern among public health advocates.