Ex-FDA Leaders Rebuke Vaccine Chief’s Memo Claiming Child Deaths, Warn of Harm to Public Health

Twelve former commissioners and acting commissioners of the U.S. Food and Drug Administration — appointed by both Republican and Democratic administrations — have publicly challenged an internal FDA memo from the agency's vaccine chief, Dr. Vinay Prasad. The former officials said the memo's conclusions and proposed policy changes would harm the people the FDA is meant to protect, particularly those at high risk from respiratory infections.

What the memo reportedly says

The memo, which has not been released publicly, is reported to state that a review "found that at least 10 children have died after and because of receiving COVID-19 vaccination." According to sources familiar with the document, Dr. Prasad suggested myocarditis — inflammation of the heart muscle — as a possible factor. The memo reportedly did not include the underlying data, ages of the children, information on preexisting conditions, or detailed methods linking vaccination to those deaths, and its findings were not published in a peer-reviewed journal.

Former FDA leaders respond

In a commentary published in a medical journal, the former FDA leaders said the child-death reports appear to come from a passive surveillance system that lacks medical records and sufficient information to establish causation. They noted that government scientists have previously reviewed similar reports and reached different conclusions.

"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 officials wrote, warning that the changes could overturn established methods for evaluating vaccines, slow innovation, and reduce regulatory transparency.

Proposed policy shifts and critics' concerns

The memo reportedly recommends reworking how annual influenza vaccine updates are handled and placing more emphasis on the "benefits and harms of giving multiple vaccines at the same time." Those specific concerns echo talking points used by vaccine skeptics; mainstream scientific reviews have repeatedly found no evidence that routine childhood vaccines overwhelm immune systems or cause harm when given according to recommended schedules.

Public health leaders and many clinicians expressed alarm. Dr. Ronald Nahass, president of the Infectious Diseases Society of America, said: "Vaccines save lives, period. It is a sad day when FDA creates confusion and mistrust without supplying evidence," arguing that unsupported claims could make lifesaving vaccines harder to access.

Government response and broader context

A spokesperson for the Department of Health and Human Services defended the agency's direction, saying that criticism from former officials who opposed raising the bar for vaccine science "confirms we are on the right track." The dispute comes as senior health officials undertake broader changes to federal vaccine policy, including reconstituting advisory bodies and leadership changes at the Centers for Disease Control and Prevention.

The CDC's vaccine advisory committee is scheduled to meet to discuss several vaccine topics, including hepatitis B vaccination for newborns, as the debate continues over both data transparency and how best to evaluate vaccine safety and effectiveness for children and vulnerable populations.

What to watch next: whether the FDA releases the memo and underlying data, how advisory panels respond during upcoming meetings, and whether independent, peer-reviewed analyses support or refute the memo's claims.