FDA Tightens Vaccine Approval Rules, Impacting Moderna
Update: 2025-12-01
Description
Modernas stock plummeted in premarket trading following the FDAs announcement of stricter vaccine approval rules. The FDA plans to impose additional testing requirements and demand more extensive data from manufacturers, particularly for flu shots and those marketed to pregnant women. This shift in approach, influenced by Secretary Kennedy Junior, has led to limited access to COVID shots and a controversial suggestion of a link between vaccines and autism. Analysts warn that these changes could hinder Modernas flu vaccine and COVID business.
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