The FDA's chaotic flip-flop on Moderna's flu vaccine — refusing review one week, then reversing course the next — exposes an agency in disarray under political pressure. Vinay Prasad personally overruled career scientists to block the application, only to cave after industry backlash, undermining confidence in regulatory processes. This circus reveals an FDA beset by inconsistency and outside influence rather than sound science.
Moderna finally caved to FDA's legitimate scientific demands after trying to blame regulators for its own shoddy trial design. The company pooled age groups to hide missing efficacy data for seniors over 65 and used weak comparators instead of the high-dose vaccines that population actually needs. FDA held the line on rigorous evidence standards, forcing Moderna to provide real data rather than statistical sleight of hand.
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