Moderna’s mRNA Flu Vaccine Approved by FDA

The agency requires more data to prove efficacy for over 65s, but has licensed the first mRNA-based flu shot in the United States for those aged 50–64.

Moderna’s mRNA Flu Vaccine Approved by FDA

TL;DR

  • FDA approves Moderna's mFlusiva, the first mRNA vaccine for seasonal flu.
  • Approved for adults aged 50-64 (traditional approval) and over-65s (accelerated approval).
  • Moderna needs to provide more data on efficacy for the over-65 age group.
  • A late-stage trial showed the shot was 26.5% more effective than a standard-dose flu vaccine.