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.

Analysis: FDA Vaccine Policy Shift Faces Strong Opposition

The recent controversy surrounding the FDA's internal memo on vaccine safety has sparked significant concern among former agency leaders, who have criticized the proposed changes as potentially harmful. These twelve past FDA commissioners, representing both Republican and Democratic administrations, have voiced strong opposition to the claims made by Dr. Vinay Prasad, the FDA’s current vaccine chief. The criticism is particularly focused on the memo's suggestion that COVID-19 vaccines are linked to child deaths, a claim that lacks sufficient medical evidence.

The proposed revisions to vaccine management, which include adjustments to annual flu vaccine updates and changes in the administration of multiple vaccines simultaneously, have raised alarms. Vaccine skeptics have long argued that simultaneous vaccination can have adverse effects, particularly on children’s immune systems. However, multiple scientific studies have consistently found no evidence to support these concerns. The former FDA leaders argue that such revisions, if implemented, could undermine public trust in vaccines and slow the progress of vaccine development, potentially putting vulnerable populations at risk.

Furthermore, the former officials emphasized that the surveillance system referenced in the memo is insufficient for drawing definitive conclusions about the alleged link between child deaths and the COVID-19 vaccine. Previous government reviews of the data have not found a causal connection. Despite these claims, evidence continues to support the effectiveness of COVID-19 vaccines in reducing severe illness and hospitalization among children. The proposed changes, therefore, could not only jeopardize public health but also reduce the transparency and efficiency of the vaccine approval process.

In the broader context, these developments come amid efforts by Health Secretary Robert F. Kennedy Jr. to reshape federal vaccine policies, further fueling debates on the future of public health strategies. As the CDC's vaccine advisory committee convenes this week, it is clear that these ongoing policy shifts will have far-reaching implications for vaccine science and public trust.

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• A dozen former FDA leaders lambast claims by current FDA vaccine chief