FDA approves Moderna's mFlusiva, its first standalone flu shot

The FDA approved Moderna's mFlusiva (mRNA-1010) on August 5 for seasonal influenza in adults 50 and older, with the 65-plus indication cleared under accelerated approval pending a postmarketing study. In Moderna's Phase 3 trial of more than 40,000 adults 50 and older, the shot was about 27% more effective than a standard flu vaccine over the 2024-25 season, and Moderna expects it available for adults 50-plus this fall as a fourth product in its respiratory franchise.