Former FDA Leaders Criticize New Vaccine Safety Claims

Thu Dec 04 2025 06:50:17 GMT+0200 (Eastern European Standard Time)

A coalition of twelve past FDA leaders rebukes the agency's recent challenges to vaccine safety, warning that proposed changes could harm public health.

In a notable stance against recent assertions by the FDA regarding vaccine safety, twelve former leaders of the agency across the political spectrum criticized proposed changes that could jeopardize public health, especially for high-risk individuals. Their concerns center on claims made in an internal memo regarding COVID-19 vaccine-related child deaths and the implications of slowing vaccine innovation and transparency.

WASHINGTON (AP) — A coalition of a dozen former leaders of the U.S. Food and Drug Administration (FDA), spanning both Republican and Democratic appointments, has issued a strong denunciation of the agency's recent assertions that raise doubts about vaccine safety.

The ex-officials expressed alarms over the FDA's plans for overhauling the management of essential vaccines for flu, COVID-19, and other respiratory illnesses, as outlined in an internal memo released last week. They argued that these directives would disadvantage the people the FDA exists to protect, including millions of Americans at high risk from serious infections.

In their response published in the *New England Journal of Medicine*, the former commissioners described the proposed changes as a significant shift in the FDA’s approach toward its responsibilities. They outlined concerns regarding an internal memo attributed to FDA vaccine chief Dr. Vinay Prasad, which reportedly claimed—without substantial evidence—that COVID-19 vaccines were linked to the deaths of ten children. Moreover, the memo suggested that FDA staff members who disagreed with this information should resign.

Among Prasad's proposals were revisions to how annual flu shot updates are managed and a deeper examination of the benefits and harms of administering multiple vaccines concurrently. Critics of vaccination often argue that administering too many vaccines can overwhelm children's immune systems, although extensive research has consistently debunked these claims.

The FDA's shift in vaccine policy comes amidst broader changes in federal vaccine policies under Health Secretary Robert F. Kennedy Jr., noted for his leadership in the anti-vaccine movement. Kennedy has removed a committee that advised the CDC on vaccine recommendations and made significant staffing changes, including the recent dismissal of Susan Monarez, who served for only 29 days as CDC chief.

The CDC's vaccine advisory committee is scheduled to meet to discuss hepatitis B vaccinations among other topics. Meanwhile, the former FDA leaders pointed out that claims regarding COVID-19 vaccine-related child deaths were made based on a surveillance system lacking adequate medical data to substantiate such links. They stressed that substantial evidence exists demonstrating that COVID-19 vaccines significantly lower the risks of serious illness and hospitalization in children.

They emphasized that the broader implications of the FDA's proposed changes could undermine decades of scientific understanding regarding vaccine evaluation, hinder the process of updating vaccines to match emerging virus strains, and decrease transparency, posing a threat to public health.