Key facts
- The FDA has approved Moderna's mRNA flu vaccine, mFlusiva, for adults aged 50 and older.
- This is the first flu vaccine to utilize mRNA technology.
- The vaccine received full approval for individuals aged 50-64 and accelerated approval for those 65 and older.
- A study indicated mFlusiva reduced flu cases by about 27% compared to a routine vaccine in the 50-64 age group.
- Moderna anticipates the vaccine will be available at select retailers soon.
The Food and Drug Administration has approved Moderna's mFlusiva, the first flu vaccine to use mRNA technology, for adults aged 50 and older. This decision reverses an earlier refusal to review the application. The vaccine received full approval for individuals aged 50 to 64, based on a study showing a 27% reduction in flu cases compared to a routine vaccine. For those aged 65 and older, it received accelerated approval, pending a postmarketing study. Moderna expects the vaccine to be available soon at select retailers, offering a new option for influenza prevention, particularly for vulnerable older adults. However, uncertainty remains regarding clinical use recommendations and insurance coverage due to ongoing litigation affecting the CDC's advisory panel.