Health Canada authorizes Moderna’s mRNA flu vaccine and flu‑COVID combination for adults 50+
Moderna announced that Health Canada approved its seasonal mRNA influenza vaccine, mFLUSIVA, and its combined influenza‑COVID‑19 vaccine, mCOFLU, for adults aged 50 and older. Canada is the first country to clear both products. The flu vaccine showed a relative efficacy of 26.6% in adults 50‑plus and 27.4% in adults 65‑plus, while the combo shot was cleared based on immunogenicity data that demonstrated higher antibody responses versus co‑administered licensed vaccines.
Why it matters
The approvals give Moderna its first regulatory clearance for both products in a major market, opening a path to future sales in Canada (the company said it will engage with health authorities). No launch date, price or supply contract was disclosed, so revenue impact will depend on subsequent negotiations.
Key facts
- 1Health Canada authorized mFLUSIVA and mCOFLU on November 5, 2026. stocktitan.net
- 2Canada is the first country to approve both Moderna’s seasonal mRNA flu vaccine and the flu‑COVID combination. stocktitan.net
- 3mFLUSIVA’s Phase 3 efficacy trial enrolled about 40,800 adults and showed relative vaccine efficacy of 26.6% in adults 50 + and 27.4% in adults 65 + versus a standard‑dose flu shot. finance.yahoo.com
- 4mCOFLU was cleared on a Phase 3 immunogenicity study of roughly 8,000 adults (two cohorts of about 4,000) that demonstrated higher antibody responses against three flu strains and SARS‑CoV‑2 compared with co‑administered licensed vaccines. quantisnow.com
- 5Moderna said the vaccines will not be available for the 2026‑2027 flu season. brandonsun.com
- 6Moderna’s market value was reported as $96.4 billion in the Quantisnow analysis. quantisnow.com
Summary written by AlphAI AI Desk from 11 of 11 sources. Not investment advice. Figures are as stated by the linked sources.