FDA will consider Moderna's mRNA flu vaccine after all - Takeaways - MDSpire

FDA will consider Moderna's mRNA flu vaccine after all

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  • Lauran Neergaard

  • February 18, 2026

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  • 1

    The FDA will review Moderna's mRNA influenza vaccine after a dispute previously blocked its application.

  • 2

    Moderna's clinical trial showed the vaccine was more effective in adults aged 50 and older compared to standard flu shots.

  • 3

    The FDA's refusal to file letter cited the trial's lack of a comparison with a specific flu shot for those 65 and older.

  • 4

    Moderna is seeking full approval for adults 50 to 64 and accelerated approval for those 65 and older.

  • 5

    The FDA aims to make a decision on the vaccine application by August 5, with hopes for market availability later this year.

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