{"url":"https://newsforagent.com/news/2026-11-05/moderna-health-canada-mrna-vaccine-approvals","markdown_url":"https://newsforagent.com/news/2026-11-05/moderna-health-canada-mrna-vaccine-approvals.md","title":"Moderna Wins Health Canada Approval for Two mRNA Vaccines","headline":"Health Canada Authorizes Moderna's mRNA Flu and Combination Flu-COVID Vaccines for Adults 50 and Older","description":"Health Canada authorized Moderna's mFLUSIVA and mCOFLU vaccines for adults 50 and older, making Canada the first country to clear both mRNA products.","section":"Regulation & Approvals","published_at":"2026-11-05T22:41:15+00:00","modified_at":"2026-11-05T22:41:15+00:00","author":"News Desk","key_takeaways":["Health Canada authorized mFLUSIVA and mCOFLU for adults 50 years of age and older.","Canada is the first country to authorize both Moderna's mRNA influenza vaccine and its combination influenza and COVID-19 vaccine.","mFLUSIVA showed 26.6% relative vaccine efficacy against influenza-like illness in a Phase 3 trial of approximately 40,800 adults."],"companies":[{"name":"Moderna","is_primary":true,"profile_url":"https://akta.pro/company-profiles/00004gr/moderna","website":"http://www.modernatx.com"},{"name":"Health Canada","is_primary":false,"profile_url":"https://akta.pro/company-profiles/00yoj4z/health-canada","website":"https://www.canada.ca"}],"source":{"publisher":"Stock Titan","title":"Moderna gets Health Canada authorization for 2 vaccines","url":"https://www.stocktitan.net/news/MRNA/health-canada-authorizes-moderna-s-m-rna-influenza-and-combination-xod30q9s2py7.html"},"other_sources":[],"tags":["Regulation & Approvals","Moderna","Health Canada"],"body_markdown":"Moderna said on November 5, 2026 that [Health Canada](https://akta.pro/company-profiles/00yoj4z/health-canada) authorized mFLUSIVA, its mRNA influenza vaccine, and mCOFLU, its combination influenza and COVID-19 vaccine, for adults 50 years of age and older. Canada is the first country to authorize both products, according to [Stock Titan](https://www.stocktitan.net/news/MRNA/health-canada-authorizes-moderna-s-m-rna-influenza-and-combination-xod30q9s2py7.html).\n\n## What Health Canada Cleared\n\n[Moderna](https://akta.pro/company-profiles/00004gr/moderna) is a Cambridge, Massachusetts-based biotechnology company that develops mRNA vaccines and therapeutics. mFLUSIVA is Canada's first mRNA-based seasonal influenza vaccine, and mCOFLU is the country's first combination influenza and COVID-19 vaccine, the company said.\n\nThe authorizations follow the U.S. Food and Drug Administration's approval of mFLUSIVA in August 2026 and the European Commission's authorization of the combination vaccine, marketed as mCOMBRIAX, in April 2026. Both vaccines remain under regulatory review in additional markets.\n\n\"Health Canada's authorizations of mFLUSIVA and mCOFLU today mark another important step in bringing the benefits of mRNA technology to seasonal respiratory vaccination,\" said Stéphane Bancel, Moderna's chief executive. \"It's not every day that a company gets two product approvals on the same day.\"\n\nHealth Canada's decision on mFLUSIVA rests on the Phase 3 mRNA-1010-P304 study, a randomized, active-controlled trial of approximately 40,800 adults 50 and older across 11 countries. The vaccine showed relative efficacy of 26.6% (95% CI: 16.7-35.4) in adults 50 and older and 27.4% (95% CI: 12.1-40.0) in adults 65 and older compared with a standard-dose inactivated influenza vaccine against RT-PCR-confirmed influenza-like illness. The mCOFLU authorization is supported by a Phase 3 trial in two cohorts of approximately 4,000 adults each that met all primary endpoints demonstrating non-inferiority of immune responses.\n\n## Moderna's Regulatory Record\n\nAccording to akta.pro [company records](https://akta.pro/company-data), an FDA advisory committee voted 9-0 in June 2026 to recommend approval of mFLUSIVA for adults 50 and older, with an FDA decision expected by August 5, 2026. The same records show Moderna appointed Ester Banque as chief commercial officer effective June 15, 2026, recruiting her from Zoetis to lead global commercial operations and execute planned product launches.\n\n## Earlier Steps Toward Approval\n\nIn June 2026, Moderna announced an organizational restructuring into three commercial business units and expanded President Stephen Hoge's responsibilities across research, manufacturing and commercial activities to support multiple product launches in 2027-2028, according to akta.pro company records. The FDA's approval of mFLUSIVA in August 2026 and the European Commission's authorization of the combination vaccine in April 2026 preceded the Canadian decision.\n\n## Next Steps for Moderna\n\nModerna said it will engage with Canadian health authorities and immunization partners as it advances plans for the future availability of mFLUSIVA and mCOFLU in Canada.\n","publisher":{"name":"News for Agent","url":"https://newsforagent.com"}}