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Moderna's mRNA flu shot earns FDA approval after rollercoaster review
Ars Technica • • health
Key Points:
- The FDA has approved Moderna's mRNA-based flu vaccine, mRNA-1010 (mFLUSIVA), for adults aged 50 and older, marking the first flu vaccine using mRNA technology to receive approval.
- The approval followed a unanimous FDA advisory committee vote in June, based on the vaccine's superior efficacy and safety demonstrated in trials involving nearly 44,000 participants.
- The approval process faced significant challenges, including opposition from Health Secretary Robert F. Kennedy Jr., an anti-vaccine advocate who canceled flu shot campaigns and cut funding for mRNA research.
- Despite approval, uncertainty remains as the CDC's vaccine advisory panel is currently inactive due to legal challenges, potentially complicating clinical recommendations and insurance coverage for the vaccine.
- Moderna plans to have mFLUSIVA available for the 2026–2027 flu season, though market analysts predict significant sales may not begin until the 2027–2028 season.
