Moderna's mRNA Flu Vaccine, mFLUSIVA, Approved by FDA for Adults 50 and Older

The FDA has approved Moderna's mRNA-based influenza vaccine, mFLUSIVA (mRNA-1010), for adults aged 50 years and older. This marks Moderna's fourth FDA-approved product and the first mRNA-based flu vaccine. The approval for adults 50 through 64 was based on a Phase 3 trial showing 26.6% relative vaccine efficacy, while for those 65 and older, efficacy reached 27.4% under accelerated approval, requiring a confirmatory postmarketing trial.