mFlusiva

Overview

Moderna's standalone mRNA seasonal influenza vaccine (mRNA-1010), the fourth product in its respiratory franchise alongside Spikevax, mRESVIA, and mCOMBRIAX.

FDA-approved August 5, 2026 for adults 50 and older, with the 65+ indication cleared under accelerated approval contingent on a postmarketing study. In Moderna's Phase 3 trial of over 40,000 adults 50+, mFlusiva was about 27% more effective than a standard flu shot over the 2024-25 season. Moderna expects the vaccine available in the US for the 2026-2027 flu season; filings are under review in the EU, Canada and Australia.

Key Specs

FDA Approval

Aug 5, 2026 (adults 50+; accelerated approval for 65+)

Trial Efficacy

~27% more effective than standard flu shot (Phase 3, 40,000+ adults 50+)