Former FDA Leaders Warn Against New Vaccine Safety Standards

Tue Dec 09 2025 07:37:16 GMT+0200 (Eastern European Standard Time)

A group of 12 past FDA leaders from both parties criticizes new proposals questioning vaccine safety, voicing concerns about potential harm to at-risk populations.

Twelve former leaders of the U.S. Food and Drug Administration have spoken out against a new internal memo from the agency that disparages the safety of vaccines for diseases such as COVID-19 and influenza. They argue that these proposed changes could endanger public health, notably among vulnerable populations. The document asserted, without evidence, that COVID-19 vaccines were linked to children's deaths, prompting outrage from these former officials, who emphasized the importance of maintaining scientific integrity and public trust in vaccine safety and efficacy.

WASHINGTON (AP) — A dozen former leaders of the U.S. Food and Drug Administration (FDA), representing both political parties, have issued a harsh critique of the agency's recent statements that raise doubts about vaccine safety.

The former officials asserted that the FDA's planned overhaul of its vaccine management policies threatens to disadvantage the very populations it was designed to protect, particularly those at high risk for severe 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 former FDA commissioners and acting commissioners expressed in a joint letter published in the New England Journal of Medicine.

This internal memo, authored by FDA vaccine chief Dr. Vinay Prasad, has not yet been made public but has been confirmed as legitimate by a source familiar with its content. It alleges—without providing solid evidence—that COVID-19 vaccines were responsible for ten child fatalities.

The memo proposed significant modifications related to the administration of annual flu shots and emphasized the scrutiny of administering multiple vaccines simultaneously, an idea that resonates with skepticism about vaccine safety among some groups. Despite these claims, scientific investigations consistently indicate that such fears are unfounded.

The FDA’s proposed changes surface amidst an ongoing shift in federal health policy initiated by Health Secretary Robert F. Kennedy Jr., known for his previous leadership in the anti-vaccine movement. Kennedy has already dismissed an advisory committee for the CDC and has begun staffing these roles with individuals who align more closely with his views.

The FDA leaders contend that Priasad's claims about child fatalities related to COVID-19 vaccines came from a surveillance dataset that lacks sufficient medical records to establish any causal connection and highlight that past evaluations by government scientists reached different conclusions regarding vaccine safety.

Ultimately, the former FDA officials argue that these new policies threaten to undermine established science regarding vaccine updates, hinder the acceleration of newer vaccine innovations, and diminish transparency for the public regarding vaccine-related health discussions.

— Associated Press writer Ali Swenson contributed to this report. This coverage was supported by the Howard Hughes Medical Institute's Department of Science Education and the Robert Wood Johnson Foundation. The AP is solely responsible for all content.