Blaming 10 Children's Deaths on COVID Shot, FDA Plans Changes

The Food and Drug Administration plans a more skeptical approach to vaccine approval, prompted by an internal memo that claims without providing evidence that at least 10 children died "after and because of receiving" a COVID shot. The memo, written by Dr. Vinay Prasad, head of the FDA's vaccine division, and obtained by NBC News, cites an internal review of deaths reported to the Vaccine Adverse Event Reporting System between 2021 and 2024. Prasad asserts the real number could be higher and accuses the agency of ignoring safety concerns about the vaccine for years. Outside experts have pushed back.

Commissioner Marty Makary said Saturday on Fox News that the FDA will no longer "rubber-stamp new products that don't work," per NPR, which he said makes a "mockery of science." He said the FDA will make information available on the deaths it is tying to the coronavirus vaccine, per the Washington Post. Prasad told his team in a memo the day before that the agency will change vaccine labels to make them "honest" and initiate other changes to its review process, including its framework for flu shots. Prasad's memo gives no details about the children, documentation, or which manufacturers' vaccines are involved.

Experts counter that VAERS is an open system that accepts unverified reporting from anyone. They said the system is intended to flag potential safety issues, not establish causality, and that Prasad is misusing the data. Paul Offit, director of the Vaccine Education Center at Children's Hospital of Philadelphia, pointed out that vaccine makers have to provide evidence when a new shot is added to the childhood schedule. Calling Prasad's memo irresponsible, Offit said, "This is sort of science by press release." He said the vague language makes it tough to tell what the changes mean for vaccines overall. Extensive independent research continues to support the safety and effectiveness of COVID vaccines for children, per NBC, though a small increased risk of myocarditis has been identified, mostly in teen boys, with most cases resolving quickly.

• Politico reports that Makary and Health Secretary Robert F. Kennedy Jr. are clashing over issues including vaccine policy.