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New First-of-Its-Kind Flu Vaccine Approved by FDA Expert Panel

Federal health advisers unanimously recommended the approval of Moderna's mFlusiva vaccine for adults 50 and older. The shot uses mRNA technology and is the first of its kind for influenza. Phase 3 data indicated it is about 27% more effective than standard flu vaccines.

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What changed

The panel's support was confirmed as unanimous and phase 3 efficacy data was revealed.

Live updates

  1. FDA Panel Unanimously Backs Moderna mRNA Flu Vaccine

    Federal health advisers unanimously recommended the approval of Moderna's mFlusiva vaccine for adults 50 and older. The shot uses mRNA technology and is the first of its kind for influenza. Phase 3 data indicated it is about 27% more effective than standard flu vaccines.

    What's confirmed:

    • The FDA's Vaccines and Related Biological Products Advisory Committee unanimously backed Moderna's mFlusiva vaccine.
    • mFlusiva is intended for adults aged 50 and older.
    • The vaccine utilizes mRNA technology.
    • Phase 3 data showed the vaccine to be about 27% more effective than a standard flu vaccine.
    confidence 100%

  2. FDA Panel Unanimously Recommends Moderna mRNA Flu Vaccine

    Federal health advisers voted on June 18 to recommend Moderna's mFlusiva vaccine for adults aged 50 and older. The vaccine uses mRNA technology similar to those used during the COVID-19 pandemic. The panel concluded that the benefits of the shot outweigh its risks.

    What's confirmed:

    • An FDA advisory committee unanimously recommended the approval of Moderna's mRNA influenza vaccine, also known as mFlusiva or mRNA-1010.
    • The vaccine is intended for adults aged 50 and older.
    • The panel voted on June 18.
    • The vaccine utilizes mRNA technology.
    • The advisory panel concluded the vaccine's benefits outweigh its risks.

    Still unconfirmed:

    • Moderna is seeking standard approval for younger groups and accelerated approval for the older group.
    • The company must run an additional clinical trial after the vaccine reaches the market for the older group.
    • The FDA declined to review the shot earlier this year.
    confidence 95%

  3. FDA Advisory Panel Unanimously Endorses Moderna mRNA Flu Vaccine

    An FDA advisory committee unanimously recommended the approval of Moderna's mRNA-1010 seasonal influenza vaccine. The shot is intended for adults aged 50 and older. This marks the first vaccine recommended by the committee since 2023.

    What's confirmed:

    • FDA advisors voted unanimously to recommend Moderna's mRNA influenza vaccine.
    • The vaccine, known as mRNA-1010 or mFlusvia, is intended for adults 50 and older.
    • This is the first vaccine the committee has recommended since 2023.
    • The vaccine uses mRNA technology.

    Still unconfirmed:

    • The vaccine promises fewer hospitalizations and more stable learning environments in schools.
    • The mRNA-based influenza vaccine expands the B cell response breadth in humans.
    confidence 95%