FDA, commissioner and Vaccine Policy
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Myocarditis is a known — but small — side effect of the mRNA Covid vaccines from Pfizer and Moderna, information that federal agencies have discussed openly since 2021.
A dozen prior leaders of the U.S. Food and Drug Administration have issued a scathing denunciation of an FDA memo to staff that made sweeping claims casting doubt on vaccine safety.
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 major vaccine regulatory changes.
U.S. Food and Drug Administration officials said COVID-19 vaccines killed at least 10 children, providing no evidence for the statement. Citing these deaths, the agency said it plans to make existing vaccine regulations more strict.
FDA chief medical officer Vinay Prasad told reporters that the agency would be changing its vaccine approval process.
Food and Drug Administration officials say they will ratchet up requirements for vaccine studies, citing concerns about COVID shots for kids. But public health experts question the agency's analysis.
The top vaccine chief at the Food and Drug Administration sent out a memo saying the FDA will seek a stricter review and approval protocol for vaccine trials.
In a closed meeting, Vinay Prasad pushes back on criticism of his vaccine policy changes, morale issues at the FDA, and his role in recent drug-approval turbulence.
Twelve former U.S. FDA commissioners said on Wednesday they were deeply concerned about proposed changes to vaccine regulation by the agency's chief scientific officer and the details of his assertion that the COVID-19 vaccine killed 10 children.