Health Canada has authorized two Moderna vaccines for adults 50 years of age and older: mFLUSIVA, an mRNA seasonal influenza vaccine, and mCOFLU, a combined influenza and COVID-19 mRNA vaccine. Moderna said Canada is the first country to authorize both products.
#Details of the Canadian authorizations
mFLUSIVA, also known as mRNA-1010, is authorized for the active immunization of adults 50 years of age and older against influenza disease caused by influenza virus subtypes A and B represented in the vaccine.
mCOFLU, also known as mRNA-1083, is authorized for the active immunization of adults 50 years of age and older against influenza disease caused by influenza virus types A and B represented in the vaccine, as well as SARS-CoV-2.
Moderna described mFLUSIVA as Canada’s first mRNA-based seasonal influenza vaccine and mCOFLU as the country’s first combination influenza and COVID-19 vaccine.
#Clinical evidence for mFLUSIVA
Health Canada’s authorization of mFLUSIVA was supported by the Phase 3 mRNA-1010-P304 study, a randomized, active-controlled trial involving approximately 40,800 adults 50 years of age and older across 11 countries.
Moderna said the study met all pre-specified statistical success criteria. Relative vaccine efficacy was 26.6% (95% CI: 16.7-35.4) in adults 50 years of age and older and 27.4% (95% CI: 12.1-40.0) in adults 65 years of age and older, compared with a standard-dose inactivated influenza vaccine against RT-PCR-confirmed, protocol-defined influenza-like illness caused by influenza A or B.
A separate Phase 3 mRNA-1010-P303 Part C study reported superior antibody responses compared with a high-dose inactivated influenza vaccine in adults 65 years of age and older.
For mFLUSIVA, the commonly reported adverse reactions included injection-site pain, fatigue, headache, muscle pain, joint pain, chills and axillary swelling or tenderness. Moderna said most solicited reactions were mild to moderate and resolved within one to two days.
#Clinical findings for mCOFLU
The authorization of mCOFLU was supported by a Phase 3 randomized, observer-blind, active-controlled study involving two cohorts of approximately 4,000 adults each.
Adults 65 years of age and older received either mCOFLU or co-administered Fluzone HD, a high-dose influenza vaccine, and Spikevax. Participants aged 50 to 64 received either mCOFLU or co-administered Fluarix, a standard-dose influenza vaccine, and Spikevax.
The study met all primary endpoints for non-inferiority of immune responses. Following a single dose, Moderna reported statistically significantly higher immune responses against three influenza strains—A/H1N1, A/H3N2 and B/Victoria—and SARS-CoV-2 in both age cohorts compared with the co-administered licensed comparator vaccines.
An exception was B/Yamagata. For that strain, which is no longer recommended for inclusion in seasonal influenza vaccines, a statistically significantly higher immune response was not observed in adults 65 years of age and older.
Moderna reported that mCOFLU had an acceptable safety and tolerability profile. Commonly reported adverse reactions included injection-site pain, fatigue, muscle pain, headache, joint pain, chills and axillary swelling or tenderness. Most were mild to moderate and short in duration, and no serious adverse events were assessed as related to mCOFLU in the pivotal study.
#Regulatory status and Canadian availability
The U.S. Food and Drug Administration approved mFLUSIVA in August 2026. In April 2026, the European Commission authorized Moderna’s combination influenza and COVID-19 mRNA vaccine, marketed as mCOMBRIAX. Both vaccines remain under regulatory review in additional markets.
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. The company’s forward-looking statements regarding availability and regulatory applications involve risks and uncertainties, and are not promises or guarantees. No availability date was provided.
#Key Takeaways
- Health Canada authorized Moderna’s mFLUSIVA and mCOFLU for adults 50 years of age and older.
- Canada is the first country to authorize both Moderna’s seasonal mRNA influenza vaccine and its combination influenza and COVID-19 vaccine.
- The mFLUSIVA Phase 3 study involved approximately 40,800 adults across 11 countries and reported relative vaccine efficacy of 26.6% in adults 50 years of age and older.
- The mCOFLU study met its primary endpoints for non-inferiority of immune responses, with a stated exception for B/Yamagata in adults 65 years of age and older.
- Moderna said it is working with Canadian health authorities and immunization partners on future availability, while both vaccines remain under regulatory review in additional markets.
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