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FDA Approves mRNA Flu Vaccine

The FDA based its approval for adults aged 50 to 64 years on phase 3 trial results, while use in adults aged 65 years and older received accelerated approval.

  • By

  • Kathryn Wighton

  • August 6, 2026

  • 2 min

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  • 1

    The FDA approved Moderna's mFLUSIVA, the first mRNA-based influenza vaccine, for adults aged 50 years and older.

  • 2

    mFLUSIVA is expected to be available in the US for the 2026 to 2027 respiratory virus season.

  • 3

    FDA approval followed a unanimous recommendation from the Vaccines and Related Biological Products Advisory Committee.

  • 4

    The approval for adults aged 65 years and older was granted based on a trial involving 2,992 participants in the US.

  • 5

    Reported adverse events included injection-site reactions and systemic symptoms such as fatigue, headache, and muscle pain.

Original Source(s)

FDA Approves mRNA Flu Vaccine

  • by Kathryn Wighton

  • August 6, 2026

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