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FDA approves Moderna's mRNA flu vaccine after initial pushback
CBS News • • business
Key Points:
- The FDA has approved Moderna's mFLUSIVA, the first seasonal flu vaccine using mRNA technology, for adults aged 50 and older.
- The approval marks a significant milestone for mRNA technology, despite prior criticism and vaccine project cancellations by Health and Human Services Secretary Robert F. Kennedy Jr.
- The initial FDA refusal to consider the vaccine application was reversed after Moderna submitted a revised application and regulatory approach, addressing concerns about clinical trial comparisons.
- Moderna's clinical trial showed mFLUSIVA was more effective than a standard flu shot in adults 50 and older, but the FDA required additional studies for use in adults 65 and older.
- Moderna plans to make mFLUSIVA available for the 2026-27 flu season.
