FDA panel recommends Moderna’s mRNA flu shot for older adults
Federal health advisers recommended approval of Moderna's mFLUSIVA vaccine for adults 50 and older. The shot uses mRNA technology and showed a 27% greater reduction in flu illness than standard vaccines. Final decisions from the FDA and CDC are pending.
What changed
New data shows the vaccine outperformed standard shots by about 27% in a peer-reviewed trial.
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FDA Panel Backs Moderna mRNA Flu Vaccine for Older Adults
confidence 90%Federal health advisers recommended approval of Moderna's mFLUSIVA vaccine for adults 50 and older. The shot uses mRNA technology and showed a 27% greater reduction in flu illness than standard vaccines. Final decisions from the FDA and CDC are pending.
What's confirmed:
- A federal advisory panel unanimously recommended Moderna's mFLUSIVA mRNA flu vaccine for adults aged 50 and older.
- The vaccine uses mRNA technology.
- The panel concluded the vaccine's benefits outweigh its risks.
Still unconfirmed:
- The mRNA shot reduced flu illness by about 27% more than a standard-dose vaccine.
- An FDA decision is due in August.
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FDA Panel Recommends Moderna mRNA Flu Vaccine for Older Adults
confidence 95%A federal advisory panel unanimously recommended Moderna's mFLUSIVA mRNA flu vaccine for adults aged 50 and older. The panel concluded the vaccine's benefits outweigh its risks. Final approval from the FDA and CDC is required before the shot becomes available.
What's confirmed:
- The FDA advisory panel unanimously recommended Moderna's mRNA flu vaccine candidate.
- The vaccine, known as mFLUSIVA, is recommended for adults aged 50 years and older.
- Phase 3 trials showed a 26.6% RVE compared to the standard dose.
- The FDA and CDC must provide final sign-off before the vaccine is available.
- The PDUFA date is August 5, 2026.
Still unconfirmed:
- The vaccine showed 47.9% effectiveness versus healthcare outcomes.
- The vaccine is about 27% more effective than the standard flu shot.