December 3, 2025 / 9:49 PM EST / CBS/AP
Twelve former commissioners and acting commissioners of the U.S. Food and Drug Administration — appointed by presidents of both parties — sharply challenged recent internal assertions by the agency’s current vaccine chief that cast doubt on vaccine safety and oversight.
In a letter published Wednesday in The New England Journal of Medicine, the ex-officials said an internal FDA memo authored by Dr. Vinay Prasad proposes substantial changes to how vaccines for influenza, COVID-19 and other respiratory illnesses are evaluated and managed. They argued the changes are not minor adjustments but a “significant redefinition” of the FDA’s responsibilities that would disadvantage the people the agency exists to protect, including millions at high risk for serious infections.
The memo itself has not been released publicly. 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,” and that the deaths were linked to myocarditis, inflammation of the heart muscle. According to those sources, Prasad did not provide underlying data — such as ages, medical histories, or causal-determination methods — and the findings were not published in a peer-reviewed journal.
Reported proposed changes include revising how annual influenza vaccine updates are handled and placing greater emphasis on assessing the benefits and harms of administering multiple vaccines at the same visit. Those themes mirror arguments sometimes made by vaccine skeptics — for example, concerns that repeated shots could overwhelm the immune system or cause harmful accumulation of ingredients — positions most scientists say are not supported by the preponderance of evidence.
In their NEJM piece, the former FDA leaders noted that the child deaths cited in the memo were reported to a surveillance system that lacks medical records and other information necessary to prove causation. They said government scientists had previously reviewed similar reports and reached different conclusions, and they emphasized substantial evidence that 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 debate about recommendations for lower-risk children is reasonable, the evidence supports vaccination’s role in preventing severe outcomes for many young people.
Beyond the dispute over reported deaths, the former leaders warned the proposals would abandon long-standing scientific approaches for evaluating vaccines updated to match circulating strains, slow adoption of potentially superior vaccines, and reduce transparency in decision-making.
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 criticized the memo. “Vaccines save lives, period,” said Dr. Ronald Nahass, president of the Infectious Diseases Society of America, calling it “a sad day when FDA creates confusion and mistrust without supplying evidence, spreading propaganda that makes lifesaving vaccines harder to access.”
The FDA debate is unfolding amid broader changes pushed by Health Secretary Robert F. Kennedy Jr., who has long opposed mainstream vaccine policy. Kennedy has removed and replaced members of the Centers for Disease Control and Prevention’s advisory committee on immunization practices with handpicked appointees, and in August he dismissed CDC chief Susan Monarez 29 days into her tenure over policy disagreements. The CDC’s vaccine advisory committee is scheduled to meet this week to discuss topics including hepatitis B vaccination for newborns.
Dr. Céline Gounder contributed to this report.