Health Canada has authorized two new mRNA vaccines developed by Moderna to help protect adults against seasonal influenza and COVID-19. The approvals, announced on November 5, 2026, cover an updated influenza vaccine called mFLUSIVA and a combination influenza and COVID-19 vaccine called mCOFLU.
Both vaccines are authorized for adults aged 50 and older. The announcement represents an important development in Canada’s seasonal respiratory disease prevention efforts, as the country becomes the first in the world to authorize both of Moderna’s new mRNA vaccine options.
According to Moderna’s announcement, the authorizations introduce new vaccine options that use messenger RNA (mRNA) technology to help the immune system recognize and respond to influenza viruses and SARS-CoV-2, the virus responsible for COVID-19.
Moderna’s Two New Vaccines Explained
The first vaccine, mFLUSIVA, is designed to protect against seasonal influenza caused by influenza A and B virus strains represented in the vaccine. It is Canada’s first authorized mRNA-based seasonal influenza vaccine.
The second vaccine, mCOFLU, combines influenza and COVID-19 protection in a single shot. It is designed to help protect adults against influenza A, influenza B and SARS-CoV-2.
The combination approach could offer a more convenient option for eligible adults who need protection against both seasonal respiratory illnesses.
Moderna said the two authorizations represent an important milestone for its mRNA technology platform and its efforts to develop vaccines targeting multiple infectious diseases.
Clinical Trial Results Supported the Approvals
The authorization of mFLUSIVA was supported by a large Phase 3 clinical trial involving approximately 40,800 adults aged 50 and older across 11 countries.
According to Moderna, the study demonstrated relative vaccine efficacy of 26.6% among adults aged 50 and older and 27.4% among adults aged 65 and older compared with a standard-dose inactivated influenza vaccine. These results were measured against laboratory-confirmed influenza-like illness caused by influenza A or B.
The approval of mCOFLU was supported by another Phase 3 clinical trial involving approximately 8,000 adults across two age groups.
The study met its primary immune-response objectives, demonstrating non-inferior immune responses compared with separately administered licensed influenza and COVID-19 vaccines. The combination vaccine also produced statistically higher immune responses against several influenza strains and SARS-CoV-2 in the studied groups.
These findings provided clinical evidence supporting Health Canada’s authorization decisions.
What Are the Possible Side Effects?
Like other vaccines, Moderna’s new mRNA products can cause temporary side effects.
According to the clinical trial information released by the company, commonly reported reactions included:
- Pain at the injection site
- Fatigue and tiredness
- Headaches
- Muscle pain
- Joint pain
- Chills
- Underarm swelling or tenderness
Most reported reactions were mild to moderate and generally resolved within one to two days.
Individuals considering vaccination should discuss potential benefits, risks and suitability with a qualified healthcare professional.
When Will the New Vaccines Be Available in Canada?
Although Health Canada has authorized both vaccines, their immediate availability remains uncertain.
Moderna said it plans to engage with Canadian health authorities and immunization partners regarding future availability. A report from The Canadian Press published on November 5 indicated that the vaccines would not reach pharmacies in time for the current respiratory virus season.
Meanwhile, Canada’s National Advisory Committee on Immunization continues to recommend available seasonal influenza vaccination for eligible individuals aged six months and older. It also provides additional recommendations for older adults and people at higher risk of severe respiratory illness.
The authorization of Moderna’s products does not mean that existing influenza and COVID-19 vaccination recommendations have automatically changed.
Canada Becomes the First Country to Approve Both Vaccines
Moderna’s latest regulatory milestone follows earlier approvals in other international markets.
The U.S. Food and Drug Administration approved mFLUSIVA in August 2026. Meanwhile, the European Commission authorized Moderna’s combination influenza and COVID-19 vaccine, marketed in Europe as mCOMBRIAX, in April 2026.
Canada’s authorization of both mFLUSIVA and mCOFLU makes it the first country to approve the two products together.
The company continues to pursue regulatory reviews in additional markets.
What This Means for the Future of Vaccination
The latest approvals highlight the growing role of mRNA technology in vaccine development. Researchers and pharmaceutical companies are exploring how this technology can support vaccines targeting multiple infectious diseases.
A combination influenza and COVID-19 vaccine could potentially simplify seasonal vaccination for eligible adults by providing protection against two respiratory diseases in one injection.
However, the real-world impact will depend on vaccine availability, continued clinical evaluation, public health recommendations and individual vaccination decisions.
Final Thoughts
Health Canada’s authorization of Moderna’s mFLUSIVA and mCOFLU marks an important development in Canada’s respiratory disease prevention landscape. Both vaccines are approved for adults aged 50 and older, offering new mRNA-based options for seasonal influenza and combined influenza and COVID-19 protection.
Although the products will not be available in Canadian pharmacies in time for the current respiratory virus season, the approvals represent progress in vaccine development.
As Moderna works with Canadian health authorities on future availability, healthcare professionals and eligible adults will be watching for additional information about distribution, vaccination guidance and access to these new products.