December 3, 2025 / 9:49 PM EST / CBS/AP
A dozen former leaders of the U.S. Food and Drug Administration — appointed by presidents of both parties — sharply criticized new FDA assertions that raise doubts about vaccine safety.
The ex-officials said an internal FDA memo from the agency’s current vaccine chief outlines plans to change how vaccines for influenza, COVID-19 and other respiratory illnesses are evaluated and managed, and that those plans would “disadvantage the people the FDA exists to protect, including millions of Americans at high risk from serious infections.”
In a letter published Wednesday in The New England Journal of Medicine, the former commissioners and acting commissioners wrote that the proposals are not minor tweaks but a significant redefinition of the FDA’s responsibilities.
The memo by Dr. Vinay Prasad has not been publicly released. Multiple sources told CBS News the memo reported a review that “found that at least 10 children have died after and because of receiving COVID-19 vaccination.” According to those sources, Prasad suggested the deaths were linked to myocarditis, inflammation of the heart muscle. The sources said Prasad did not provide the data behind the review — such as the children’s ages, underlying conditions, or the methods used to determine causation — and the findings were not published in a peer-reviewed journal.
The memo reportedly outlines agency changes including revising how annual influenza vaccine updates are handled and placing greater emphasis on evaluating the benefits and harms of administering multiple vaccines at the same time. Those points echo arguments often made by vaccine skeptics, who claim repeated shots could overwhelm immune systems or cause harmful accumulation of ingredients, claims that scientists say repeated studies have not supported.
In their NEJM piece, the former FDA leaders noted that the child deaths cited in the memo were reported to a surveillance system that does not contain medical records or other information sufficient to prove causation, and that government scientists had previously reviewed such reports and reached different conclusions. They stressed that substantial evidence shows COVID-19 vaccines reduce the risk of severe disease and hospitalization in children and adolescents.
“The memo asserts, incorrectly, that ‘we do not have reliable data’ on the benefits of Covid vaccination in children,” the former officials wrote. They added that while reasonable debate over recommendations for lower-risk children is appropriate, the evidence supports that vaccination can reduce severe outcomes for many young people.
Beyond the dispute over reported deaths, the former leaders argued the proposed changes would discard long-standing scientific approaches for evaluating vaccines updated to match circulating virus strains, slow the replacement of older vaccines with potentially superior ones, and reduce public transparency in the process.
A Department of Health and Human Services spokesperson said Wednesday night that criticism from former FDA officials “who opposed raising the bar for vaccine science confirms we are on the right track.”
Many physicians and public health experts voiced alarm at the memo. “Vaccines save lives, period,” said Dr. Ronald Nahass, president of the Infectious Diseases Society of America. He called it “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.”
The FDA’s internal deliberations come as Health Secretary Robert F. Kennedy Jr., who long opposed mainstream vaccine policy, seeks broad changes to federal vaccine governance. Kennedy has already removed members from the Centers for Disease Control and Prevention’s advisory committee on immunization practices and replaced it with handpicked members. In August, he fired CDC chief Susan Monarez 29 days into her tenure over disagreements about vaccine policy. The CDC’s vaccine advisory committee is scheduled to meet this week to discuss hepatitis B vaccination for newborns and other topics.
Dr. Céline Gounder contributed to this report.