FDA to Revisit Moderna’s New mRNA Flu Vaccine for Adults 50+
TL;DR
The FDA will review Moderna’s newly developed mRNA seasonal flu vaccine after a prior rejection over trial design, with no safety or efficacy concerns cited. Moderna says it has met with the FDA and proposed a revised regulatory pathway, seeking full approval for adults 50–64 and accelerated approval for 65+, potentially making the vaccine available for those 50+ in the 2026–2027 flu season if approved.
- FDA reverses course and will review Moderna’s mRNA flu shot, company says CNN
- F.D.A. Reverses Decision and Agrees to Review Moderna’s Flu Vaccine The New York Times
- FDA reverses course, will review Moderna flu shot after controversial refusal The Boston Globe
- U.S. rejection of new mRNA flu vaccine 'sends chills,' epidemiologist says PBS
- FDA will now review flu vaccine it had rejected Axios
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