FDA Approves Moderna Flu Shot

The FDA approved Moderna’s mFlusiva, the first U.S. seasonal influenza vaccine made with mRNA technology, for adults 50 and older. Moderna received traditional approval for adults ages 50 to 64 and accelerated approval for adults 65 and older, with a requirement to run an additional clinical trial in the older group. In a late-stage study, mFlusiva was about 27% more effective than a standard flu shot. The authorization follows an earlier FDA refusal-to-file decision and a unanimous June advisory committee vote backing approval.