Technology & Science
FDA Reverses Feb-10 Refusal, Accepts Moderna mRNA-1010 Flu Vaccine for Review
Eight days after issuing a refusal-to-file letter, the FDA on 18 Feb 2026 agreed to review Moderna’s amended BLA for its mRNA-1010 seasonal flu shot, setting an Aug 5 decision deadline and split approval pathways for adults 50-64 (full) and 65+ (accelerated).
Focusing Facts
- Original Refusal-to-File letter signed by vaccine chief Dr. Vinay Prasad on 10 Feb 2026 cited lack of a high-dose comparator for adults 65+; Moderna’s amended filing was accepted on 18 Feb 2026 after a Type A meeting.
- The accepted filing carries a Prescription Drug User Fee Act (PDUFA) target date of 5 Aug 2026, aiming for U.S. market launch in the 2026-27 flu season for roughly 115 million Americans aged 50 and over.
- HHS Secretary Robert F. Kennedy Jr. had canceled 22 government mRNA respiratory-virus contracts worth $500 million on 5 Aug 2025, underscoring official skepticism toward the platform.
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