FDA Vaccine Chief’s Memo Blames Covid Shots for 10 Child Deaths Without Data

The Food and Drug Administration’s top vaccine regulator told staff in a memo that an internal review found at least 10 children died “after and because of” receiving a Covid vaccine, but gave no data to support the claim, NBC News and CBS News reported.

The memo, sent Friday, was written by Dr. Vinay Prasad, director of the agency’s Center for Biologics Evaluation and Research, NBC News reported. It says agency staff determined that at least 10 of 96 child deaths reported to the Vaccine Adverse Event Reporting System, or VAERS, between 2021 and 2024 were related to vaccination, and that the true number may be higher, according to NBC News and NPR. The New York Times first reported it, CBS News said. The memo did not include the children’s ages or medical histories, timelines, documentation or the vaccine manufacturer, NBC News reported, and the findings were not published in a peer-reviewed journal, according to both outlets. Dr. Prasad suggested the deaths were tied to myocarditis, an inflammation of the heart muscle, without evidence, both outlets said.

Experts rejected the approach. VAERS is an unverified system to which anyone can submit reports, and its website warns that entries can be inaccurate, incomplete or biased, NBC News reported. Dr. Paul Offit of Children’s Hospital of Philadelphia called the memo “science by press release,” “irresponsible” and “dangerous.” Dr. Peter Marks, the FDA’s former vaccine chief, who was ousted by Health Secretary Robert F. Kennedy Jr. earlier this year, said the agency is misusing the database, which it normally uses to find early “signals,” and called the claims part of the “anti-vaccine playbook.”

On the underlying science, CBS News reported that myocarditis has been linked to Covid vaccines, but studies have largely found the risk is significantly higher after a coronavirus infection, and the outlook after vaccine-related cases is better. Pfizer and Moderna vaccines carry warnings about myocarditis, expanded in April to males 16 to 25, CBS News said, and the FDA then put the rate at around 8 cases per million doses for children and adults under 65. NBC News noted that most cases among young men are mild and resolve within days.

NPR reported that Dr. Prasad’s email also said the agency would change its annual flu vaccine framework and update vaccine labels, and NPR said FDA Commissioner Marty Makary told Fox News on Saturday that 10 children had died from the Covid shot, without offering specifics.

Most public health experts argue the current vetting process has long ensured that benefits of vaccines outweigh their risks, NPR reported. The FDA directed media questions to the Department of Health and Human Services, NBC News reported.

The administration has taken other steps on Covid shots. CBS News reported that officials overrode career staff to narrow approvals of Novavax and Moderna vaccines, and that the CDC’s advisory panel, all of whose members Mr. Kennedy chose, voted in September to change its recommendations for the shot.