Unpacking the FDA’s Black Friday Vaccine Memo

The head of the Food and Drug Administration’s vaccine division claimed in a leaked email that “at least 10 children” died from COVID-19 vaccination, using that to justify significant vaccine regulatory changes. Experts, however, say too little information was provided to verify the claim.

Studies and safety assessments in the U.S. and other countries have repeatedly shown that the COVID-19 vaccines are remarkably safe, including for children, and do not increase mortality risk. While serious side effects can occur, they are rare.

Dr. Vinay Prasad, the official who penned the memo, used the alleged deaths to announce a variety of ways in which the agency would be more stringent in approving future vaccines, which some experts say are unnecessary and impractical and could reduce access to shots.

In a perspective published Dec. 3 in the New England Journal of Medicine, a dozen former FDA commissioners assailed the memo, saying Prasad’s proposals would “impede the ability to update vaccines” and “suppress innovation and competition,” ultimately “disadvantag[ing]” the American people. They added that deaths reported to the CDC and FDA previously “had been carefully reviewed by FDA staff, who drew different conclusions.”