On Friday, FDA’s chief medical officer, Vinay Prasad, issued a controversial memo claiming COVID-19 vaccines have caused the deaths of 10 children in the U.S., prompting significant changes in vaccine regulation, including seasonal flu shots. Former FDA commissioners responded sharply in the New England Journal of Medicine, expressing deep concern that Prasad’s memo poses a threat to the agency’s integrity and public health. Prasad’s proposed changes would replace current immunobridging studies with costly randomized trials for vaccine updates, potentially extending approval timelines.
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