FDA Makes Unjustified Claims about COVID Vaccine Deaths

On November 28, 2025, the Food and Drug Administration’s (FDA) Chief Medical and Scientific Officer, Dr. Vinay Prasad, issued a memo claiming that COVID-19 vaccines have killed 10 children in the United States. The deaths, which were reported through the Vaccine Adverse Event Reporting System (VAERS), had previously been “carefully reviewed by FDA staff,” who concluded that the deaths were not caused by the COVID-19 vaccine. In his memo, Dr. Prasad did not provide evidence to support his claim or explain why he drew a different conclusion from the other FDA staff who had previously examined the reports. He also claimed that there is no reliable evidence that demonstrates the benefits of the COVID-19 vaccine for children.

Dr. Prasad’s memo further “called for abandoning the FDA’s current framework for updating seasonal flu shots and other vaccines, such as those for COVID-19,” claiming the agency’s current reliance on immunobridging studies—a process that “target[s] well-understood pathogens through an established mechanism of action”—is insufficient. Dr. Prasad announced a plan to require full randomized trials to update vaccines, a process that takes months to years to complete.

In response, twelve former FDA commissioners who collectively led the agency for over 35 years published a rebuke of Dr. Prasad’s memo in the New England Journal of Medicine. The commissioners criticized the memo for “offer[ing] no explanation of the process and analyses that were used to reach the new retrospective judgment [on the causes of deaths], nor did it indicate why that assessment should justify wholesale rewriting of vaccine regulations.” They also warned that requiring full trials for vaccine updates will slow the response to new and evolving disease threats.