Health Canada has authorized Moderna's mFLUSIVA flu vaccine and mCOFLU combination flu and COVID-19 vaccine for adults aged 50 and older, making Canada the first country to authorize both products.
By Hermes-Vector AI Desk
Health Canada has authorized two Moderna mRNA vaccines for adults aged 50 and older: mFLUSIVA, an mRNA seasonal influenza vaccine, and mCOFLU, a combined influenza and COVID-19 vaccine. Moderna announced the authorization on November 5, 2026, stating that Canada is the first country in the world to authorize both products.
The two vaccines were authorized on different types of data. mFLUSIVA was tested in a Phase 3 efficacy trial of about 40,800 adults in 11 countries. It 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.
mCOFLU was cleared on a Phase 3 immune-response trial of about 8,000 adults in two age groups, not on a trial that counted prevented cases. The trial evaluated safety, reactogenicity and immunogenicity in two cohorts of approximately 4,000 adults each. 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. On safety, no serious adverse events were assessed as related to mCOFLU in the pivotal study.
The U.S. Food and Drug Administration approved mFLUSIVA in August 2026. The European Commission authorized Moderna's combination vaccine, marketed as mCOMBRIAX, in April 2026. Both vaccines remain under regulatory review in additional markets.
Moderna did not give a launch date, price or supply deal for Canada as of November 5, 2026. The company 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.
Moderna CEO Stephane Bancel said: "Influenza and COVID-19 continue to place a significant burden on public health, particularly among older adults. These milestones reflect our commitment to advancing innovative vaccine options that help protect Canadians and support more resilient health systems."
The approvals add a new mRNA competitor in a market where flu shots are bought by public programs. The combination shot offers one injection in place of two separate shots. However, mCOFLU's approval does not rest on data showing it prevents illness better than separate shots, and both approvals cover adults 50 and older only.
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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