A dozen former FDA leaders lambaste claims by the agency’s current vaccine chief

Former FDA Leaders Slam New Vaccine Safety Directives as Dangerous Shift

Twelve former leaders of the U.S. Food and Drug Administration issued a forceful rebuke Wednesday against new internal FDA directives that cast doubt on vaccine safety, calling the changes a “major shift” that could endanger public health.

The bipartisan group of former FDA commissioners and acting commissioners, appointed by both Republican and Democratic administrations, published their criticism in The New England Journal of Medicine. They argued that planned changes to how the agency handles vaccines for flu, COVID-19, and other respiratory diseases would “disadvantage the people the FDA exists to protect, including millions of Americans at high risk from serious infections.”

At the center of the controversy is an internal memo authored by FDA vaccine chief Dr. Vinay Prasad that has not been publicly released. According to the former officials, the memo makes unsubstantiated claims that COVID-19 vaccines caused 10 children’s deaths without providing evidence to support this assertion. The document reportedly outlines significant changes to vaccine approval processes and suggests that FDA staff who disagree with the new approach should resign.

“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 leaders wrote.

Among the changes reportedly planned by Prasad are revisions to how annual flu shot updates are handled and increased scrutiny on “the benefits and harms of giving multiple vaccines at the same time.” The former officials noted that these concerns echo common vaccine-skeptic talking points that have been repeatedly investigated by scientists with no evidence of harm found.

The former FDA leaders took particular issue with Prasad’s claim about child deaths related to COVID-19 vaccines. They explained that such reports came from a surveillance system that lacks medical records or other information sufficient to prove causation. Government scientists had previously examined these reports and reached different conclusions. They emphasized that “substantial evidence” shows COVID-19 vaccines actually reduce children’s risk of severe disease and hospitalization.

Beyond specific claims about vaccine safety, the former officials expressed broader concerns that the new approach would reject established scientific methods for evaluating updated vaccines, slow innovation for potentially better vaccines, and reduce transparency with the public.

The Department of Health and Human Services defended the changes Wednesday night, stating, “The fact these criticisms are coming from former FDA officials who opposed raising the bar for vaccine science confirms we are on the right track.”

The controversy has alarmed many medical professionals and public health experts. Dr. Ronald Nahass, president of the Infectious Diseases Society of America, said in a statement, “Vaccines save lives, period. It is a sad day when FDA creates confusion and mistrust without supplying evidence, spreading propaganda that makes lifesaving vaccines harder to access and that creates additional confusion and mistrust for the public.”

These developments come amid a broader reshaping of federal vaccine policy under Health Secretary Robert F. Kennedy Jr., who has long been associated with the anti-vaccine movement. Kennedy has already dismantled and reconstituted the committee that advised the Centers for Disease Control and Prevention on vaccine recommendations with handpicked members. In August, he fired Susan Monarez just 29 days into her tenure as CDC chief over vaccine policy disagreements.

The timing is particularly significant as the CDC’s vaccine advisory committee meets Thursday and Friday to discuss hepatitis B vaccinations for newborns and other vaccine topics.

The current controversy highlights growing tensions between established scientific consensus on vaccine safety and effectiveness and a new administrative approach that appears more skeptical of traditional vaccine policies. Public health experts worry these changes could undermine decades of progress in preventing infectious diseases through vaccination programs.

The broader implications of this policy shift remain to be seen, but many in the medical community fear it could lead to reduced vaccination rates and increased vulnerability to preventable diseases across the population.