FDA advisors unanimously vote to approve Moderna's mRNA after agency drama
Summary
FDA advisors voted unanimously to approve Moderna’s new seasonal mRNA flu vaccine called mRNA-1010 or mFlusiva. The vaccine was found to be more effective than standard flu shots and safe for older adults, and its approval follows earlier controversy within the FDA about reviewing the vaccine.Key Facts
- The FDA advisory committee voted 9–0 to support Moderna’s mRNA flu vaccine.
- The vaccine is called mRNA-1010 and branded as mFlusiva.
- A large Phase 3 trial with over 40,000 adults aged 50+ showed it was 27% more effective than traditional flu shots.
- A smaller Phase 3 trial with nearly 3,000 people aged 65+ showed stronger immune responses than the current high-dose flu vaccine.
- The vaccine uses mRNA technology, the same used in Moderna’s COVID-19 vaccines, which allows faster development and better response to flu strains.
- Earlier, a Trump-appointed FDA official blocked the vaccine from review, claiming the trial was inadequate, but this decision was reversed amid objections from FDA scientists.
- The blocked official, Vinay Prasad, left FDA after other controversial decisions.
- Moderna’s CEO expressed satisfaction with the committee’s approval and looks forward to working with the FDA.
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