FDA Approves First mRNA Flu Vaccine for Adults 50 and Up
On August 5, Moderna received FDA approval for mFlusiva, marking the first mRNA flu vaccine aimed at adults over 50. This decision comes after a late-stage study involving nearly 41,000 participants from 11 countries, which was published in the New England Journal of Medicine in May and indicated a 27% decrease in flu cases compared to conventional vaccines. Experts commend this innovative method for its adaptability to new strains. While side effects were more frequent than those from traditional vaccines, they were primarily mild. Serious reactions included low blood pressure and heart inflammation. The vaccine is set to be available for the 2026 flu season, though access may be restricted due to a federal judge's ruling against CDC guidance.
Key facts
- FDA approved mFlusiva on August 5 for adults 50+
- mFlusiva is the first mRNA flu vaccine
- Developed by Moderna
- Clinical trial involved nearly 41,000 participants in 11 countries
- mRNA vaccine reduced flu cases by 27% compared to traditional vaccines
- Side effects more common but mostly mild to moderate
- Serious adverse events included low blood pressure and heart inflammation
- Availability may be limited due to CDC advisory committee litigation
Entities
Institutions
- Food and Drug Administration (FDA)
- Moderna
- Centers for Disease Control and Prevention (CDC)
- American Public Health Association
- New York Times
- Washington University School of Medicine
- Science News
- New England Journal of Medicine
- Nature Immunology
- Boston Children's Hospital
- NBC News
- FDA
Locations
- United States
- New York City