Health Canada Approves Two Moderna Vaccines for Adults Aged 50 and Older
Health Canada has approved Moderna’s mRNA flu vaccine mFLUSIVA and its combination vaccine mCOFLU for adults aged 50 and older, marking the first time any country has cleared both products simultaneously, boerse-express.com reported. The dual authorization gives Moderna a new foothold in the immunization market beyond standalone COVID-19 shots.
Clinical Trial Data Supporting the Approvals
The authorization of mFLUSIVA rests on a Phase 3 clinical trial involving roughly 40,800 adults aged 50 and older across 11 countries. The vaccine met every pre-specified success criterion, reaching the highest tier of superiority. Its relative efficacy compared to a conventional inactivated standard flu vaccine reached 26.6 percent overall and 27.4 percent for participants aged 65 and older.
The combination shot, mCOFLU, incorporates components from mFLUSIVA and Moderna’s COVID-19 vaccine mNEXSPIKE. In its trial, the combination vaccine demonstrated a non-inferior immune response when compared against separately administered control vaccines. The immune response against three specific influenza strains and SARS-CoV-2 was statistically significantly higher, with the sole exception of the B/Yamagata lineage, which seasonal vaccines no longer target.
Reported side effects matched the typical profile of mRNA vaccines. Participants experienced injection-site pain, fatigue, headaches, and muscle aches. Most of these reactions remained mild to moderate and resolved within one to two days. Severe adverse events linked to mCOFLU did not occur during the trial.
International agencies clear the vaccines
Canada joins other countries in changing how it regulates these products. The US Food and Drug Administration approved mFLUSIVA in August 2026. Meanwhile, the European Commission cleared the combination vaccine under the name mCOMBRIAX in April, while reviews in other major markets remain ongoing.
Moderna has not yet announced a specific timeline for when these vaccines will become available in Canada, noting that discussions with health authorities and immunization partners are still underway. The company is expected to outline its commercial strategy for the new approvals during its analyst day on November 12.
Answering key questions about the vaccine approvals
When did the US FDA approve mFLUSIVA?
The US Food and Drug Administration approved mFLUSIVA in August 2026, ahead of Canada’s joint clearance.
How large was the Phase 3 trial for mFLUSIVA?
The Phase 3 trial evaluated approximately 40,800 adult participants aged 50 and older across 11 different countries.
What was the European Commission brand name for the combination vaccine?
The European Commission authorized the combination vaccine under the proprietary name mCOMBRIAX.
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