U.S. FDA approves Moderna's first mRNA flu shot for adults aged 50 and older

Published Aug 6, 06:45 AM UTC

The U.S. Food and Drug Administration has approved Moderna's mRNA-based flu vaccine, mFlusiva, for adults aged 50 and older, marking the first approval of an mRNA vaccine for seasonal flu. The shot received traditional approval for ages 50-64 and accelerated approval for those 65 and older, with Moderna agreeing to conduct additional studies to confirm benefits in the older group. Approval was based on a late-stage trial of over 40,000 adults showing 26.6% greater efficacy than a standard-dose flu vaccine. Moderna also submitted data indicating stronger antibody responses than Sanofi's high-dose vaccine in seniors. The vaccine uses mRNA technology to prompt immune response, potentially allowing faster updates for circulating strains. Analysts do not expect meaningful revenue until late 2027 due to missed contracting cycles. The approval comes amid heightened FDA scrutiny and leadership changes, including the resignation of former Commissioner Marty Makary and vaccine chief Vinay Prasad.