Key insights
- Health Canada has authorized Moderna's mFLUSIVA (seasonal influenza vaccine) and mCOFLU (combination influenza and COVID-19 vaccine) for adults 50 and older. Canada is the first country to authorize both. The approvals are based on Phase 3 trials demonstrating vaccine efficacy and superior immune responses. Moderna will engage with Canadian health authorities on future availability.
CAMBRIDGE, Mass. - Moderna Inc. (NASDAQ:MRNA) announced today that Health Canada has authorized two mRNA vaccines for adults 50 years and older: mFLUSIVA, a seasonal influenza vaccine, and mCOFLU, a combination influenza and COVID-19 vaccine.
Canada becomes the first country to authorize both vaccines, according to a company press release statement. mFLUSIVA represents Canada’s first mRNA-based seasonal influenza vaccine, while mCOFLU is the country’s first combination influenza and COVID-19 vaccine.
The U.S. Food and Drug Administration approved mFLUSIVA in August 2026, and the European Commission authorized Moderna’s combination vaccine, marketed as mCOMBRIAX, in April 2026. Both vaccines remain under regulatory review in additional markets.
Health Canada’s authorization of mFLUSIVA is based on a Phase 3 trial involving approximately 40,800 adults 50 years and older across 11 countries. The study demonstrated relative vaccine efficacy of 26.6% in adults 50 years and older and 27.4% in adults 65 years and older compared with a standard-dose inactivated influenza vaccine. A separate Phase 3 study showed superior antibody responses compared with a high-dose inactivated influenza vaccine in adults 65 years and older.
The mCOFLU authorization is supported by a Phase 3 trial with approximately 8,000 adults. The study met all primary endpoints demonstrating non-inferiority of immune responses. mCOFLU elicited statistically higher immune responses against three influenza strains and SARS-CoV-2 in both age cohorts compared with co-administered licensed comparator vaccines.
Common adverse reactions for both vaccines included injection-site pain, fatigue, headache, muscle pain, joint pain, chills and underarm swelling or tenderness. Most reactions were mild to moderate and resolved within one to two days.
Moderna stated it will engage with Canadian health authorities regarding future availability of both vaccines in Canada.
This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.
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