Twelve former FDA leaders criticize current FDA vaccine chief's claims

WASHINGTON Twelve past leaders of the U.S. Food and Drug Administration, appointed by both Republican and Democratic administrations, have strongly criticized recent claims made by the current FDA vaccine chief that question vaccine safety.

In a piece published Wednesday in the New England Journal of Medicine, these former commissioners and acting commissioners warned that the agencys proposed changes to managing vaccines for flu, COVID-19, and other respiratory illnesses could disadvantage the very people the FDA is meant to protect, including millions of Americans at high risk of serious infections.

The controversial internal memo, drafted by FDA vaccine chief Dr. Vinay Prasad, has not been publicly released. Sources familiar with it confirmed its authenticity. The memo alleged, without evidence, that COVID-19 vaccines were linked to the deaths of ten children, and outlined significant alterations in how certain vaccines would be handled. It also suggested that FDA staff who disagreed with the changes should resign.

Among the proposals are revisions to the annual flu vaccine updates and increased attention to the benefits and risks of administering multiple vaccines simultaneously. While vaccine skeptics often argue that multiple shots can overwhelm childrens immune systems or cause harm over time, repeated scientific studies have found no evidence supporting these concerns.

The FDAs proposed changes arrive amid broader efforts by Health Secretary Robert F. Kennedy Jr. to reshape federal vaccine policies. Kennedy has already disbanded the CDCs vaccine advisory committee, replacing it with selected members, and previously removed Susan Monarez from her role as CDC chief due to policy disagreements.

Meanwhile, the CDCs vaccine advisory committee is scheduled to meet this week to discuss hepatitis B vaccination in newborns and other related topics.

The former FDA leaders emphasized that the reports cited by Prasad regarding child deaths came from a surveillance system that lacks sufficient medical data to establish a causal link. They also noted that government scientists reviewing these reports in prior years reached different conclusions. Evidence continues to show that COVID-19 vaccines effectively reduce the risk of severe illness and hospitalization in children.

More broadly, the former officials argue that the proposed changes would undermine established science, slow the development of improved vaccines, and reduce transparency in the vaccine approval process, potentially delaying innovation and public access to safer, updated vaccines.

Author: Sophia Brooks