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FDA approves Moderna's mRNA seasonal flu vaccine
Moderna says the shot was 27% more effective than standard flu vaccines in a company study of more than 40,000 adults.
In August, the Food and Drug Administration approved Moderna's mFlusiva, the nation's first mRNA-based flu vaccine for adults 50 and older. Standard approval was granted for ages 50–64 and accelerated approval for those 65+.
Unlike traditional shots using inactivated virus, mRNA vaccines encode viral proteins to generate immune responses. Because manufacturing is faster, strain selection occurs in May rather than February, offering flexibility to match circulating strains.
Moderna's study of over 40,000 participants found the vaccine about 27% more effective than standard shots during the 2024-25 season. Experts emphasize the need for real-world effectiveness data in the 65-and-older population to confirm clinical benefits.
Moderna reports mFlusiva is available at more than 13,000 locations, though Walgreens and CVS will offer limited quantities this season. Pharmacy supply orders placed earlier in the year may constrain initial rollout.
The authorization followed a rocky regulatory path after the FDA initially rejected the application in February before reversing course. Independent vaccine advisers voted unanimously in June that the vaccine's benefits outweigh its risks.