Moderna's mFLUSIVA receives FDA approval as first mRNA flu vaccine

The U.S. Food and Drug Administration has approved Moderna’s mFLUSIVA, the first mRNA-based seasonal influenza vaccine. Designed for adults aged 50 and older, the vaccine aims to address the varying effectiveness of traditional flu shots, which typically range between 40 and 60 percent.

In a phase 3 clinical trial involving over 40,000 adults across 11 countries, mFLUSIVA demonstrated approximately 27 percent greater relative efficacy in preventing RT-PCR confirmed flu-like illness in adults aged 50 to 64 compared to standard-dose vaccines.

The FDA granted full approval for adults aged 50 to 64, while providing accelerated approval for those aged 65 and older. The accelerated status for the older demographic requires additional post-approval evidence to confirm clinical effectiveness in preventing severe outcomes such as hospitalization and death.