Health Canada Authorizes Moderna's mRNA Influenza and Combination Influenza and COVID-19 Vaccines

CAMBRIDGE, MA / ACCESS Newswire / November 5, 2026 / Moderna, Inc. (NASDAQ:MRNA) today announced that Health Canada has authorized mFLUSIVA^® (Influenza mRNA vaccine; mRNA-1010) and mCOFLU^® (Combined Influenza and COVID-19 mRNA vaccine; mRNA-1083) for adults 50 years of age and older. Canada is the first country in the world to authorize both Moderna's seasonal mRNA influenza vaccine and combination influenza and COVID-19 vaccine.

"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."

mFLUSIVA is Canada's first mRNA-based seasonal influenza vaccine, while mCOFLU is the country's first combination influenza and COVID-19 vaccine. Health Canada's authorizations follow the U.S. Food and Drug Administration's approval of mFLUSIVA in August 2026 and the European Commission's authorization of the Company's combination influenza and COVID-19 mRNA vaccine, marketed as mCOMBRIAX®, in April 2026. Both vaccines remain under regulatory review in additional markets.

mFLUSIVA is authorized for active immunization of adults 50 years of age and older for the prevention of influenza disease caused by influenza virus subtypes A and B represented in the vaccine.ⁱ mCOFLU is authorized for active immunization of adults 50 years of age and older for the prevention of influenza disease caused by influenza virus types A and B represented in the vaccine and SARS-CoV-2.ⁱⁱ

Health Canada's authorization of mFLUSIVA is supported by the pivotal Phase 3 mRNA-1010-P304 study (NCT06602024), a randomized, active-controlled trial involving approximately 40,800 adults 50 years of age and older across 11 countries. mFLUSIVA met all pre-specified statistical success criteria, including the highest level of pre-specified superiority, demonstrating relative vaccine efficacy of 26.6% (95% CI: 16.7-35.4) in adults 50 years of age and older and 27.4% (95% CI: 12.1-40.0) in adults 65 years of age and older compared with a standard-dose inactivated influenza vaccine against RT-PCR-confirmed, protocol-defined influenza-like illness caused by influenza A or B.ⁱⁱⁱ

The authorization is also supported by the Phase 3 mRNA-1010-P303 Part C study (NCT05827978), which demonstrated superior antibody responses compared with a high-dose inactivated influenza vaccine in adults 65 years of age and older.^iv

Across both studies, the most commonly reported adverse reactions included injection-site pain, fatigue, headache, muscle pain, joint pain, chills and axillary (underarm) swelling or tenderness. Most solicited reactions were mild to moderate and resolved within one to two days.^v

mCOFLU builds on the clinical development of mFLUSIVA and mNEXSPIKE^®.

Health Canada's authorization of mCOFLU is supported by a pivotal Phase 3 trial (NCT06097273), a randomized, observer-blind, active-controlled study evaluating safety, reactogenicity and immunogenicity in two cohorts of approximately 4,000 adults each. Adults 65 years of age and older received mCOFLU or co-administered Fluzone HD^®, a high-dose influenza vaccine, and Spikevax^®, Moderna's licensed COVID-19 vaccine. Adults 50 to 64 years of age received mCOFLU or co-administered Fluarix^®, a standard-dose influenza vaccine, and Spikevax.^vi

The study met all primary endpoints demonstrating non-inferiority of immune responses. Following a single dose, mCOFLU elicited statistically significantly higher immune responses against three influenza strains (A/H1N1, A/H3N2 and B/Victoria) and SARS-CoV-2 in both age cohorts compared with co-administered licensed comparator vaccines. The exception was B/Yamagata, a strain no longer recommended for inclusion in seasonal influenza vaccines, for which a statistically significantly higher immune response was not observed in adults 65 years of age and older.^vii

mCOFLU demonstrated an acceptable safety and tolerability profile. The most commonly reported adverse reactions included injection-site pain, fatigue, muscle pain, headache, joint pain, chills and axillary (underarm) swelling or tenderness. Most were mild to moderate and short in duration. No serious adverse events were assessed as related to mCOFLU in the pivotal study.^viii

Moderna will engage with Canadian health authorities and immunization partners as it advances plans for the future availability of mFLUSIVA and mCOFLU in Canada.

About Moderna

Moderna is a pioneer and leader in the field of mRNA medicine. Through the advancement of its technology platform, Moderna is reimagining how medicines are made to transform how we treat and prevent diseases. Since its founding, Moderna's mRNA platform has enabled the development of vaccines and therapeutics across infectious diseases, cancer, rare diseases and more.

With a global team and a unique culture, driven by the company's values and mindsets, Moderna's mission is to deliver the greatest possible impact to people through mRNA medicines. For more information about Moderna, please visit modernatx.com and connect with us on X, Facebook, Instagram, YouTube and LinkedIn.

mFLUSIVA^®, mCOFLU^®, Spikevax^®, mCOMBRIAX^® and mNEXSPIKE^® are registered trademarks of Moderna.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including regarding: Moderna's engagement with Canadian health authorities and immunization partners; the future availability of mFLUSIVA and mCOFLU in Canada; the potential of Moderna's mRNA platform to advance respiratory disease prevention; and the review of additional regulatory applications of Moderna's influenza and combination influenza and COVID-19 vaccines in other markets. The forward-looking statements in this press release are neither promises nor guarantees, and you should not place undue reliance on these forward-looking statements because they involve known and unknown risks, uncertainties, and other factors, many of which are beyond Moderna's control and which could cause actual results to differ materially from those expressed or implied by these forward-looking statements. These risks, uncertainties, and other factors include those other risks and uncertainties described under the heading "Risk Factors" in Moderna's Annual Report on Form 10-K for the fiscal year ended December 31, 2025, filed with the U.S. Securities and Exchange Commission (SEC), and in subsequent filings made by Moderna with the SEC, which are available on the SEC's website at www.sec.gov. Except as required by law, Moderna disclaims any intention or responsibility for updating or revising any forward-looking statements contained in this press release in the event of new information, future developments or otherwise. These forward-looking statements are based on Moderna's current expectations and speak only as of the date hereof.

Moderna Contacts

Media Global

Chris Ridley
Vice President, Global Head of Communications
+1 617-800-3651
Chris.Ridley@modernatx.com

Media Canada

Sacha Kennedy
Director, Communications and Media
sacha.kennedy@modernatx.com

Investors

Lavina Talukdar
Senior Vice President & Head of Investor Relations
+1 617-209-5834
Lavina.Talukdar@modernatx.com

ⁱ Moderna Biopharma Canada Corp. mFLUSIVA® (Influenza mRNA vaccine) Product Monograph, November 4, 2026, Control No. 304643, Section 1 (Indications).

ⁱⁱ Moderna Biopharma Canada Corp. mCOFLU® (Combined Influenza and COVID-19 mRNA vaccine) Product Monograph, November 4, 2026, Control No. 303836, Section 1 (Indications).

ⁱⁱⁱ Moderna Biopharma Canada Corp. mFLUSIVA® Product Monograph, November 4, 2026, Sections 14 and 14.1 (Study mRNA-1010-P304; NCT06602024). See also Leroux-Roels I, Huang G, Ferguson M, et al. "Efficacy and Safety of an mRNA Seasonal Influenza Vaccine in Adults." New England Journal of Medicine. 2026;394(18):1803-1813.

^iv Moderna Biopharma Canada Corp. mFLUSIVA® Product Monograph, November 4, 2026, Section 14 (Clinical Trials), including Study mRNA-1010-P303 Part C immunogenicity and safety data.

^v Moderna Biopharma Canada Corp. mFLUSIVA® Product Monograph, November 4, 2026, Section 8 (Adverse Reactions).

^vi Moderna Biopharma Canada Corp. mCOFLU® Product Monograph, November 4, 2026, Control No. 303836, Section 14 (Clinical Trials).

^vii Moderna Biopharma Canada Corp. mCOFLU® Product Monograph, November 4, 2026, Control No. 303836, Section 14 (Clinical Trials).

^viii Moderna Biopharma Canada Corp. mCOFLU® Product Monograph, November 4, 2026, Control No. 303836, Section 8 (Adverse Reactions), including Study mRNA-1083-P301 (NCT06097273).

SOURCE: Moderna, Inc.