FDA's vaccine chief, Dr. Vinay Prasad, intervened to restrict approvals for Novavax and Moderna COVID vaccines. While FDA reviewers supported approval for everyone 12 and older, Prasad expressed concern about the benefits of the vaccines versus their risks, particularly amid declining COVID-related deaths and hospitalizations. He limited the vaccines' use to high-risk groups, explaining the rare harms from vaccination might outweigh benefits. This decision reflects ongoing tensions within the FDA regarding vaccine management and concerns about the current public health threat posed by COVID-19.
Prasad explained that the COVID vaccine benefits must be reconsidered in light of falling rates of death and hospitalization and the possibility for vaccine side effects.
Even rare vaccination related harms both known and unknown now have higher chance of outweighing potential benefits.
Internal correspondence show Prasad disagreed with staffers who planned to approve the shots for everyone 12 and older.
COVID-19 remains a public health threat, resulting in 32,000 to 51,000 U.S. deaths and more than 250,000 hospitalizations since last fall.
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