Canada clears Moderna flu and COVID-19 vaccines for adults aged 50 and older

Key Facts

Canada has authorized Moderna’s mRNA vaccines to prevent influenza: one seasonal vaccine and another combining influenza and COVID-19, making it the first country to clear both types. In its statement, the company said mFLUSIVA is Canada’s first mRNA-based seasonal flu vaccine and mCOFLU is the country’s first vaccine combining flu and COVID-19 vaccines. The authorization covers adults aged 50 and older. mFLUSIVA is authorized to prevent influenza caused by the A and B strains included in the vaccine, while mCOFLU targets prevention of influenza and SARS-CoV-2. Moderna said both vaccines remain under regulatory review in other markets.

Authorization of mFLUSIVA was based on a randomized, controlled Phase 3 trial involving about 40,800 adults aged 50 and older in 11 countries. The trial recorded relative efficacy of 26.6% among participants in this age group compared with a standard-dose inactivated flu vaccine. Relative efficacy was 27.4% among those aged 65 and older, according to company data. A U.S. Food and Drug Administration document gives the study size more precisely, at 40,805 participants, and confirms that it included adults from 11 countries. The document also records the same overall relative efficacy of 26.6% compared with the standard vaccine.

The U.S. Food and Drug Administration had previously authorized mFLUSIVA on 5 August 2026 to prevent influenza in people aged 50 and older. The U.S. assessment followed two pathways: traditional approval for adults aged 50 to 64, and accelerated approval for those aged 65 and older. Moderna said the Canadian authorization followed U.S. approval in August. These steps show that the seasonal vaccine advanced through regulatory review in the United States before receiving Canadian authorization. In Europe, the European Commission authorized the company’s combination flu and COVID-19 vaccine in April 2026, marketed as mCOMBRIAX.

Regulatory filings for the mRNA flu vaccine mRNA-1010 were under review in Canada, Europe and Australia, according to an earlier company disclosure, which at the time expected potential approvals to begin in 2026. In the same disclosure, Moderna said the filing for its mRNA-1083 flu and COVID-19 vaccine was under review in Canada and Europe. It added that it was awaiting guidance from the U.S. Food and Drug Administration on resubmitting the combination vaccine filing in the United States. The Canadian authorization of both vaccines marks a new regulatory development in the process the company described in its disclosure. Other markets remain under regulatory review, according to its current statement.

Moderna shares closed at $258.38 in the 4 November 2026 session, after closing at $228.44 on 3 November, according to EL7 data. Both figures are for sessions before the company’s announcement published on 5 November, so they do not reflect trading after news of the Canadian authorization. No post-announcement reading is available in the EL7 data cited here. The 4 November close remains the latest share price among the figures provided for this story. The share performance is presented in a timeframe separate from the authorization announcement.

Moderna said it would work with Canadian health authorities and immunization partners to develop plans for the future availability of mFLUSIVA and mCOFLU. The announcement did not set a date for the vaccines’ availability. That leaves the timing of actual availability tied to plans the company will develop with health authorities and immunization partners. The statement also said both vaccines remain under regulatory review in other markets, without specifying dates for decisions. The company said its goal is to advance plans for the future availability of both vaccines in Canada.