Former FDA Leaders Criticize Agency's New Vaccine Safety Stance
Twelve former FDA commissioners have expressed strong concern over proposed changes to vaccine regulation introduced by the current FDA Chief Medical and Scientific Officer, Vinay Prasad.
A group of twelve former U.S. Food and Drug Administration (FDA) commissioners has publicly criticized recent assertions and proposed policy changes by the agency's current vaccine chief, Dr. Vinay Prasad. In an internal memo, Prasad claimed that COVID-19 vaccines may have caused the deaths of at least 10 children due to heart inflammation, though he provided little detail about the analysis. He also proposed stricter standards for vaccine approval, advocating for randomized trials rather than immune response measures, including for routine immunizations like flu shots.
The former commissioners, in a piece published in the New England Journal of Medicine, criticized the proposed changes as a significant departure from established, scientifically rigorous FDA practices. They argued that the changes rest on selective evidence and lack transparency. Prasad, appointed by Health Secretary Robert F. Kennedy Jr.—an outspoken vaccine skeptic—has previously pushed for placebo-based vaccine trials, which many scientists argue are ethically problematic.
An HHS spokesperson defended the move, saying opposition from past FDA leaders shows the new direction is necessary. Prasad did not respond to media inquiries about the memo.