FDA Approves First mRNA Flu Shot for Adults 50+, Showing 27% Better Efficacy
Updated
Updated · Your Local Epidemiologist · Aug 18
FDA Approves First mRNA Flu Shot for Adults 50+, Showing 27% Better Efficacy
3 articles · Updated · Your Local Epidemiologist · Aug 18
Summary
mFlusiva won FDA approval for adults 50 and older after a large trial showed 2.0% of recipients got flu symptoms versus 2.8% with a standard shot.
The mRNA vaccine offers a potentially faster-updated flu platform at a time when conventional flu shots can be only 15% to 60% effective because the virus mutates quickly.
Side effects were more common than with standard flu vaccines, including injection-site pain in 66% versus 30%, fatigue in 45% versus 20%, and headaches in 38% versus 18%; no serious safety issues were reported.
For adults 65 and older, approval rests on accelerated evidence such as antibody responses rather than a head-to-head trial against high-dose flu shots, and FDA has required Moderna to run that study.
Availability this fall is clearest for Medicare beneficiaries 65 and older, while broader uptake may be limited by ACIP's legal dispute and by declining U.S. vaccination rates.