Moderna receives FDA approval for mFLUSIVA flu vaccine
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- The single biggest development was Moderna receiving U.S. FDA approval for its mRNA-based seasonal influenza vaccine.
- This regulatory milestone marks the fifth globally approved product for the business and its first mRNA flu vaccine in America.
- Management stated they expect to supply the vaccine for eligible populations during the upcoming 2026–2027 respiratory virus season.
Moderna (NASDAQ:MRNA) received U.S. FDA approval for mFLUSIVA, an mRNA-based seasonal influenza vaccine for adults over 50.
This milestone marks the fifth globally approved product for the business and its first U.S. mRNA flu vaccine.
Approval for the 50 to 64 age demographic was supported by a Phase 3 trial involving 40,805 participants.
The agency granted accelerated approval for adults over 65 based on a separate trial with 2,992 participants.
Management expects supply for the 2026–2027 season.
The clinical program demonstrated an acceptable safety profile with no new safety concerns identified by researchers.
The biotechnology company stated it has additional regulatory reviews underway in the EU, Canada, and Australia.
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