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FDA to Review Moderna's mRNA Flu Vaccine Approval by 2026

2/20/2026

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Summary

Story summary

The U.S. Food and Drug Administration (FDA) will review Moderna, Inc.'s mRNA flu vaccine application after it was initially rejected due to trial design flaws.
Moderna, Inc. seeks full approval for adults aged 50 to 64.
Moderna, Inc. seeks accelerated approval for adults aged 65 and older.
The FDA aims to decide by August 2026, potentially enabling availability for the 2026-2027 flu season.

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Story summary

The U.S. Food and Drug Administration (FDA) will review Moderna, Inc.'s mRNA flu vaccine application after it was initially rejected due to trial design flaws.
Moderna, Inc. seeks full approval for adults aged 50 to 64.
Moderna, Inc. seeks accelerated approval for adults aged 65 and older.
The FDA aims to decide by August 2026, potentially enabling availability for the 2026-2027 flu season.