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Health Canada has authorized Moderna's mFLUSIVA influenza vaccine and mCOFLU combination influenza and COVID-19 vaccine for adults aged 50 and older. Moderna says Canada is the first country to authorize both products.
Health Canada has authorized Moderna's mRNA vaccine for influenza and its combination influenza and COVID-19 vaccine for adults 50 years of age and older, according to Global News and a Moderna press release.
The two vaccines are mFLUSIVA, an mRNA seasonal influenza vaccine, and mCOFLU, a combination influenza and COVID-19 mRNA vaccine. Moderna describes mFLUSIVA as Canada's first mRNA-based seasonal influenza vaccine and mCOFLU as the country's first combination influenza and COVID-19 vaccine.
Moderna says Canada is the first country to authorize both products. The U.S. Food and Drug Administration approved mFLUSIVA in August 2026, and the European Commission authorized Moderna's combination influenza and COVID-19 vaccine, marketed as mCOMBRIAX, in April 2026.
Health Canada's authorization of mFLUSIVA is supported by a Phase 3 trial involving approximately 40,800 adults 50 years of age and older across 11 countries. The study showed relative vaccine efficacy of 26.6% in adults 50 and older and 27.4% in adults 65 and older, compared with a standard-dose inactivated influenza vaccine.
The authorization of mCOFLU is supported by a Phase 3 trial involving two cohorts of approximately 4,000 adults each. The study met all primary endpoints, demonstrating non-inferiority and statistically significantly higher immune responses against three influenza strains and SARS-CoV-2 compared with co-administered licensed comparator vaccines. No serious adverse events were assessed as related to mCOFLU in the pivotal study.
The most commonly reported 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.
It is unclear when the shots will be available for Canadians over 50 to get. Moderna 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." A Moderna spokesperson told Global News that the new flu shot and combination vaccine will not be part of the 2026-2027 immunization season.
Sources
This article was drafted with AI assistance and checked against the sources above. Company claims are reported as claims. Cover image is AI-generated.
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