Former FDA Leaders Condemn Agency's Vaccine Safety Reassessment

Fri Dec 05 2025 13:40:24 GMT+0200 (Eastern European Standard Time)

A group of former FDA leaders from both political parties has criticized the agency's recent internal memo questioning vaccine safety. They warn that proposed changes could harm public health.

A dozen former leaders of the U.S. Food and Drug Administration have expressed grave concerns over an internal memo from the agency that suggests significant changes in vaccine safety assessments. The memo, purportedly from FDA vaccine chief Dr. Vinay Prasad, claimed without evidence that COVID-19 vaccines were linked to deaths of children. The former officials argue these proposed changes could undermine public trust in vaccine safety and endanger vulnerable populations during a critical time for public health.

WASHINGTON (AP) — A dozen prior leaders of the U.S. Food and Drug Administration — appointed by Republicans and Democrats alike — issued a scathing denunciation of new FDA assertions casting doubt on vaccine safety.

The former officials say the agency’s plans to revamp how life-saving vaccines for flu, COVID-19, and other respiratory diseases are handled, as outlined in an internal FDA memo last week, would “disadvantage the people the FDA exists to protect, including millions of Americans at high risk from serious 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 officials, former FDA commissioners and acting commissioners, wrote Wednesday in the New England Journal of Medicine.

The internal memo by FDA vaccine chief Dr. Vinay Prasad hasn’t been publicly released, but a source familiar with the document confirmed its authenticity. The document claimed — without providing evidence — that COVID-19 vaccines caused 10 children’s deaths. It outlined planned agency changes in handling those and certain other vaccines, asserting that FDA staff who disagreed should resign.

Among Prasad’s plans are changes in how yearly flu shot updates are managed and a heightened focus on “the benefits and harms of giving multiple vaccines at the same time.” Although it’s a common concern among vaccine skeptics, scientists say extensive research has found no harmful impact from administration of multiple vaccines.

The FDA’s proposed vaccine changes surface at a time when Health Secretary Robert F. Kennedy Jr. — known for leading the anti-vaccine movement — is seeking significant changes in federal vaccine policies.

Kennedy has already replaced a committee advisory to the CDC on vaccine recommendations with nominees he personally selected. Additionally, he dismissed Susan Monarez, CDC chief, just 29 days into her role, due to disagreements on vaccine policies. The CDC’s advisory committee is set to convene this week to discuss hepatitis B vaccination protocols among other topics.

The former FDA leaders asserted that Prasad’s allegation regarding child mortality linked to COVID-19 vaccines was reported to a monitoring system devoid of sufficient medical records for establishing a causal link, which had been scrutinized by scientists in earlier analyses, yielding different findings. Moreover, evidence supports that COVID-19 vaccines notably reduce the risks of severe illness among children.

However, the broader implication expressed by the former FDA leaders is that these new proposals turn away from established scientific approaches regarding vaccine updates, stifle innovation that could lead to enhanced vaccines, and diminish transparency to the public regarding vaccine safety processes.