Health Canada has authorized Moderna's mFLUSIVA flu vaccine and mCOFLU combination COVID-19 and flu vaccine for adults aged 50 and older.
Health Canada has approved two Moderna mRNA vaccines for adults 50 years of age and older: mFLUSIVA, a seasonal influenza vaccine, and mCOFLU, a combination influenza and COVID-19 vaccine.
Health Canada says both vaccines can now be used for adults 50 years of age and older. Moderna said Canada is the first country to approve 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.
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." It is unclear when the shots will be available for Canadians over 50 to get.
According to a company press release cited by StreetInsider, Health Canada's authorization of mFLUSIVA is supported by a Phase 3 trial of approximately 40,800 adults 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. A separate Phase 3 study demonstrated superior antibody responses versus a high-dose inactivated influenza vaccine in adults 65 and older.
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.
Moderna CEO Stéphane Bancel said in a statement: "Health Canada's authorizations of mFLUSIVA and mCOFLU today mark another important step in bringing the benefits of mRNA technology to seasonal respiratory vaccination. It's not every day that a company gets two product approvals on the same day."
The approvals add mRNA-based options to Canada's respiratory vaccine supply for older adults. The National Advisory Committee on Immunization recommends that everyone six months of age and older get the non-mRNA flu shot available this year, and recommends a higher-dose version for adults aged 65 and older. The committee also strongly advises COVID-19 vaccination for anyone 65 years of age and older and residents of long-term care, retirement homes or assisted living.
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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