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Key FDA committee unanimously recommends its first vaccine since 2023

The FDA Vaccines and Related Biological Products Advisory Committee voted 9-0 on June 18 to recommend mFlusiva for adults aged 50 and older. The panel concluded the benefits of the mRNA-based vaccine outweigh its risks. This marks the first vaccine the committee has recommended since 2023.

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What changed

The update adds the specific vote date of June 18 and the vaccine's mRNA technology.

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  1. FDA Panel Unanimously Recommends Moderna mRNA Flu Vaccine mFlusiva

    The FDA Vaccines and Related Biological Products Advisory Committee voted 9-0 on June 18 to recommend mFlusiva for adults aged 50 and older. The panel concluded the benefits of the mRNA-based vaccine outweigh its risks. This marks the first vaccine the committee has recommended since 2023.

    What's confirmed:

    • The FDA Vaccines and Related Biological Products Advisory Committee voted 9-0 to recommend Moderna's mFlusiva for adults aged 50 and older.
    • The panel's unanimous vote occurred on June 18.
    • mFlusiva uses messenger RNA technology.
    • The committee determined the vaccine's benefits outweigh its risks.
    • This is the first vaccine the committee has recommended since 2023.

    Still unconfirmed:

    • Phase 3 data showed the vaccine to be about 27% more effective than a standard flu vaccine.
    • Moderna is seeking standard approval for younger groups and accelerated approval for older adults.
    • The company will be required to run an additional clinical trial after the vaccine reaches the market for older adults.
    • Legal fights and ACIP turmoil could threaten the fall 2026 rollout.
    confidence 100%

  2. FDA Committee Unanimously Recommends Moderna mRNA Flu Vaccine

    The FDA's Vaccines and Related Biological Products Advisory Committee voted 9-0 to recommend Moderna's mFlusiva. The vaccine is intended for adults aged 50 and over. This is the first vaccine the committee has recommended since 2023.

    What's confirmed:

    • The FDA advisory committee unanimously recommended the approval of Moderna's mRNA-based seasonal influenza vaccine.
    • The committee voted 9-0 to recommend mFlusiva for adults aged 50 and over.
    • This is the first vaccine recommendation from the committee since 2023.
    confidence 100%

  3. FDA Committee Unanimously Recommends Moderna mRNA Flu Vaccine

    The FDA's Vaccines and Related Biological Products Advisory Committee voted 9-0 to recommend Moderna's mFlusiva for adults aged 50 and over. This is the first mRNA-based influenza vaccine to receive such an endorsement. The move marks the committee's first vaccine recommendation since 2023.

    What's confirmed:

    • The FDA advisory panel voted 9-0 to recommend Moderna's mRNA influenza vaccine, mFlusiva, for adults 50 and over.
    • This is the first vaccine the committee has recommended since 2023.
    • The vaccine, known as mRNA-1010, uses messenger-RNA technology.
    • The committee's vote was in favor of the benefit-risk profile of the vaccine.

    Still unconfirmed:

    • Phase 3 showed 26.6% RVE vs. standard dose and 47.9% vs. healthcare outcomes.
    • The PDUFA date is August 5, 2026.
    • Robert F. Kennedy Jr. pulled back almost $500 million in mRNA vaccine development contracts last year.
    confidence 95%