Health Canada authorizes Moderna's mRNA flu and flu-COVID vaccines for adults 50 and older

What Health Canada authorized

Health Canada authorized mFLUSIVA, or mRNA-1010, and mCOFLU, or mRNA-1083, for adults 50 and older, Moderna said. The company said mFLUSIVA is Canada's first mRNA-based seasonal influenza vaccine and mCOFLU is the country's first combination influenza and COVID-19 vaccine. Canada is the first country to authorize both, according to Moderna.

Why the shots will not arrive this season

Moderna told The Canadian Press the shots will not reach Canadian pharmacies in time for the current respiratory virus season. Existing influenza and COVID-19 vaccines remain available for Canadians seeking immunization this fall and winter. The National Advisory Committee on Immunization recommends this year's non-mRNA flu shot for everyone six months and older and a higher-dose vaccine for adults over 65. It also strongly recommends COVID-19 vaccination for people 65 and older and residents of long-term care, retirement homes or assisted living.

What the trials showed

Health Canada's authorization of mFLUSIVA is supported by the Phase 3 mRNA-1010-P304 study (NCT06602024), a randomized, active-controlled trial of about 40,800 adults 50 and older in 11 countries. Moderna said the vaccine met all pre-specified success criteria. Relative vaccine efficacy was 26.6% (95% CI: 16.7-35.4) in adults 50 and older and 27.4% (95% CI: 12.1-40.0) in adults 65 and older, compared with a standard-dose inactivated influenza vaccine, against RT-PCR-confirmed influenza-like illness caused by influenza A or B. The figure is relative to that comparator, not an absolute efficacy rate. The authorization is also supported by the Phase 3 mRNA-1010-P303 Part C study (NCT05827978), which showed superior antibody responses compared with a high-dose inactivated influenza vaccine in adults 65 and older.

mCOFLU's authorization is supported by a Phase 3 trial (NCT06097273), a randomized, observer-blind, active-controlled study in two cohorts of about 4,000 adults each. Adults 65 and older received mCOFLU or co-administered Fluzone HD and Spikevax; adults 50 to 64 received mCOFLU or co-administered Fluarix and Spikevax. The study met all primary endpoints for non-inferiority of immune responses. After one dose, mCOFLU elicited statistically significantly higher immune responses against A/H1N1, A/H3N2, B/Victoria and SARS-CoV-2 in both cohorts than the co-administered comparators. The exception was B/Yamagata, no longer recommended for seasonal vaccines, where a significantly higher response was not seen in adults 65 and older.

How the Canadian decision compares

The U.S. Food and Drug Administration approved mFLUSIVA in August 2026. The European Commission authorized the combination vaccine in April 2026, where Moderna sells it as mCOMBRIAX. Both remain under regulatory review in additional markets, the company said.

Availability

Moderna 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 said. No timeline was announced.