Canada has become the first country in the world to authorize both Moderna’s seasonal mRNA influenza vaccine and its combined influenza and COVID-19 vaccine, marking a significant breakthrough in the company’s push to expand mRNA technology into respiratory disease prevention.

 

Moderna, Inc. announced that Health Canada has approved mFLUSIVA (mRNA-1010), its seasonal influenza vaccine, and mCOFLU (mRNA-1083), a combination vaccine targeting influenza and COVID-19. Both vaccines are authorized for adults aged 50 and older.

 

The twin approvals represent a major regulatory win for Moderna, giving the company a first-mover advantage in Canada's emerging market for mRNA-based seasonal respiratory vaccines.

 

"Health Canada's authorizations of mFLUSIVA and mCOFLU today mark another important step in bringing the benefits of mRNA technology to seasonal respiratory vaccination. It's not every day that a company gets two product approvals on the same day," said Stéphane Bancel, Chief Executive Officer of Moderna.

 

"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 make mFLUSIVA Canada's first mRNA-based seasonal influenza vaccine and mCOFLU the country's first combination influenza and COVID-19 vaccine.

 

The Canadian authorizations follow the US Food and Drug Administration's approval of mFLUSIVA in August 2026 and the European Commission's authorization of Moderna's combination influenza and COVID-19 vaccine, marketed as mCOMBRIAX, in April 2026. Both products are also undergoing regulatory review in other markets.

 

Health Canada's approval of mFLUSIVA is backed by the pivotal Phase 3 mRNA-1010-P304 trial, which involved approximately 40,800 adults aged 50 and older across 11 countries.

 

The randomized, active-controlled study met all pre-specified statistical success criteria, including the highest level of pre-specified superiority.

 

The vaccine demonstrated relative vaccine efficacy of 26.6% in adults aged 50 and older and 27.4% in those aged 65 and older compared with a standard-dose inactivated influenza vaccine. The results were measured against RT-PCR-confirmed, protocol-defined influenza-like illness caused by influenza A or B.

 

The approval was further supported by the Phase 3 mRNA-1010-P303 Part C study, which demonstrated superior antibody responses compared with a high-dose inactivated influenza vaccine among adults aged 65 and older.

 

The most commonly reported adverse reactions across the two studies included injection-site pain, fatigue, headache, muscle pain, joint pain, chills and swelling or tenderness in the underarm area. Most reactions were mild to moderate and resolved within one to two days.