Former FDA Commissioners Criticize Proposed Vaccine Regulation Changes

Twelve former U.S. Food and Drug Administration (FDA) commissioners have publicly criticized proposed changes to vaccine regulation introduced by the agency's current chief medical and scientific officer, Dr. Vinay Prasad. In a letter published in the New England Journal of Medicine, the former commissioners expressed deep concern over Prasad's recent internal memo, which suggested that COVID-19 vaccines may have contributed to the deaths of at least 10 children due to heart inflammation. Prasad's memo also proposed stricter standards for vaccine approval, advocating for randomized trials rather than studies that measure immune response, including for routine immunizations like flu shots. The former commissioners argued that these proposed changes represent a significant departure from established, scientifically rigorous FDA practices and could delay the arrival of vaccines better matched for evolving viruses, make it prohibitively expensive for new vaccines to come to market, and slow the expanded approval of vaccines for more people. They emphasized that existing evidence shows COVID-19 vaccines reduce children's risks of severe illness. An HHS spokesperson defended the proposed changes, stating that opposition from past FDA leaders indicates the new direction is necessary. Prasad did not respond to media inquiries about the memo.