FDA approves Moderna’s mRNA flu shot for adults 50+, after initial review reversal
The FDA has approved Moderna's mRNA seasonal flu vaccine, mFlusiva (mRNA-1010), for adults 50 and older after initially declining to review the application; Phase 3 data show the vaccine is superior to standard vaccines in preventing influenza-like illness in adults 50+, with more mild adverse events, and approvals cover ages 50-64 (and accelerated approval for those 65 and older).