Health Canada authorizes Moderna’s mRNA flu and combination flu-COVID vaccines
Posted on November 6, 2026
Moderna has received Health Canada authorization for two mRNA-based respiratory vaccines, including its seasonal influenza vaccine mFLUSIVA and combination influenza and COVID-19 vaccine mCOFLU.
Both vaccines are authorized for adults aged 50 and older.
The decision makes Canada the first country to authorize both Moderna’s standalone mRNA seasonal influenza vaccine and its combined influenza and COVID-19 vaccine.
mFLUSIVA, also known as mRNA-1010, is authorized to prevent influenza caused by vaccine-matched influenza A and B strains.
mCOFLU, also known as mRNA-1083, is authorized to prevent both influenza and COVID-19.
The authorization of mFLUSIVA was supported by the Phase III mRNA-1010-P304 study, which enrolled approximately 40,800 adults aged 50 and older across 11 countries.
The vaccine met all prespecified statistical success criteria.
Compared with a standard-dose inactivated influenza vaccine, mFLUSIVA demonstrated relative vaccine efficacy of 26.6% in adults aged 50 and older.
Among adults aged 65 and older, relative vaccine efficacy was 27.4%.
The results were based on RT-PCR-confirmed, protocol-defined influenza-like illness caused by influenza A or B.
Additional support came from the Phase III mRNA-1010-P303 Part C study.
In that trial, mFLUSIVA produced superior antibody responses compared with a high-dose inactivated influenza vaccine in adults aged 65 and older.
The most commonly reported adverse reactions across the studies included injection-site pain, fatigue, headache, muscle pain, joint pain, chills and underarm swelling or tenderness.
Most reactions were mild to moderate and resolved within one to two days.
Health Canada’s authorization of mCOFLU was supported by a pivotal Phase III study involving two cohorts of approximately 4,000 adults each.
Adults aged 65 and older received either mCOFLU or co-administered high-dose influenza vaccine and Spikevax.
Adults aged 50 to 64 received mCOFLU or a standard-dose influenza vaccine administered alongside Spikevax.
The trial met all primary endpoints for non-inferiority of immune responses.
Following a single dose, mCOFLU generated statistically significantly higher immune responses against influenza A/H1N1, A/H3N2 and B/Victoria, as well as SARS-CoV-2, compared with the co-administered licensed comparator vaccines in both age groups.
A statistically significant improvement against B/Yamagata was not observed in adults aged 65 and older.
Moderna noted that B/Yamagata is no longer recommended for inclusion in seasonal influenza vaccines.
The safety and tolerability profile of mCOFLU was considered acceptable.
The most common adverse reactions included injection-site pain, fatigue, muscle pain, headache, joint pain, chills and underarm swelling or tenderness.
No serious adverse events were considered related to mCOFLU in the pivotal study.
mFLUSIVA had previously received U.S. Food and Drug Administration approval in August 2026, while Moderna’s combination vaccine was authorized by the European Commission under the name mCOMBRIAX in April 2026.
Both products remain under regulatory review in additional markets.
Moderna said it will work with Canadian health authorities and immunization partners as it prepares for future availability of both vaccines in Canada.
Related Topics and Keywords
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