Former FDA Leaders Condemn Agency's Shift on Vaccine Safety

Thu Dec 04 2025 05:07:58 GMT+0200 (Eastern European Standard Time)

Dozens of ex-FDA heads from both parties criticize new policies that they believe undermine vaccine safety and innovation.

Twelve former leaders of the U.S. FDA have issued a strong rebuke against the agency's recent internal memo that casts doubt on the safety of COVID-19 vaccines and proposes significant shifts in vaccine regulation. The memo's claims regarding child deaths allegedly linked to vaccines have been met with skepticism, with former officials arguing it misrepresents long-standing scientific evidence on vaccine safety. They warn that the proposed changes could hinder vaccine development and transparency, ultimately endangering public health and safety.

WASHINGTON (AP) — A dozen prior leaders of the U.S. Food and Drug Administration (FDA), appointed by both Republicans and Democrats, have publicly condemned the agency’s recent claims that cast doubt on vaccine safety.

The group asserts that the FDA's plans to overhaul how it oversees life-saving vaccines, including those for flu and COVID-19, would adversely affect the very people the agency aims to protect, particularly at-risk Americans.

In a piece published Wednesday in the New England Journal of Medicine, the former officials, who include both past commissioners and acting commissioners, criticized the FDA's proposals as a major shift in its understanding of its responsibilities. They argue these changes could have detrimental implications for vaccine safety and efficacy.

Although Dr. Vinay Prasad, the FDA's vaccine chief, has not released the memo to the public, a verified source has confirmed its authenticity. It suggests, without substantiation, that COVID-19 vaccines may have caused the deaths of 10 children and calls for a reconsideration of how vaccines are updated and evaluated in terms of benefits and risks, particularly for simultaneous vaccinations.

These assertions align with long-standing skepticism from some parents and advocates about the safety of multiple shots, despite scientific evidence reassuring the opposite.

The timing of the FDA's proposals is particularly sensitive as Health Secretary Robert F. Kennedy Jr., previously a prominent voice against vaccination policies, seeks extensive changes in federal vaccine regulations. Under his direction, the CDC has already seen significant personnel changes, including the dismissal of its previous advisory committee.

The former FDA officials contend that the recent suicide claims listed on a surveillance database do not sufficiently establish a causative relationship and that exhaustive inquiries have previously dismissed such claims. They reaffirm that substantial evidence supports the safety and effectiveness of COVID-19 vaccines in preventing severe illness and hospitalization in children.

Ultimately, the former leaders caution that the revisions would overturn decades of scientific understanding regarding vaccine evaluation and slow down the innovation needed to adapt to emerging viral strains.

As tensions rise over vaccine policy amidst a backdrop of public skepticism, the former FDA officials urge the agency to recommit to transparent, science-driven approaches that prioritize public health.