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The trial met all primary non-inferiority endpoints, with a single dose of mCOMBRIAX eliciting statistically higher immune responses against three influenza strains, A/H1N1, A/H3N2, and B/Victoria, as well as against SARS-CoV-2 in both age groups. Most reported side effects were mild to moderate, including injection site pain, fatigue, muscle pain, and headache.
In Europe, the path proved more straightforward. The EMA's Committee for Medicinal Products for Human Use adopted a positive opinion on February 26, 2026, finding the vaccine triggered adequate antibody production against both viruses. The European Commission's ratification followed less than two months later.
EU Approves Moderna's mCOMBRIAX, World's First Combined Flu-COVID Vaccine
April 22, 2026
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The European Commission has granted marketing authorisation for Moderna's mCOMBRIAX, the world's first vaccine combining flu and COVID-19 protection in a single shot. Approved for adults 50 and over across all 27 EU member states plus Iceland, Liechtenstein, and Norway, the vaccine could be available for the 2026-2027 flu season. The approval contrasts sharply with the vaccine's troubled regulatory path in the United States, where the FDA requested additional data.
A Historic First for Combination Vaccines
The European Commission on Tuesday granted marketing authorisation for Moderna's mCOMBRIAX, making it the world's first approved vaccine to combine protection against both influenza and COVID-19 in a single shot. The approval covers adults aged 50 and older across all 27 EU member states, along with Iceland, Liechtenstein, and Norway, representing a significant milestone in mRNA vaccine technology.Clinical Trial Results
The authorisation is based on results from a Phase 3 clinical trial involving approximately 8,000 adults split across two age groups: those aged 65 and over, and those aged 50 to 64. The randomised, observer-blind study compared a single dose of mRNA-1083 against co-administered licensed vaccines, including Moderna's Spikevax COVID-19 jab and authorised flu vaccines Fluzone HD and Fluarix.The trial met all primary non-inferiority endpoints, with a single dose of mCOMBRIAX eliciting statistically higher immune responses against three influenza strains, A/H1N1, A/H3N2, and B/Victoria, as well as against SARS-CoV-2 in both age groups. Most reported side effects were mild to moderate, including injection site pain, fatigue, muscle pain, and headache.
Diverging Regulatory Paths
The European approval stands in stark contrast to the vaccine's troubled regulatory journey in the United States. Moderna first filed for U.S. clearance in 2024 but withdrew its application in May 2025 after the FDA requested additional data on the flu component. The FDA has set higher approval standards for combination vaccines, leaving U.S. prospects uncertain.In Europe, the path proved more straightforward. The EMA's Committee for Medicinal Products for Human Use adopted a positive opinion on February 26, 2026, finding the vaccine triggered adequate antibody production against both viruses. The European Commission's ratification followed less than two months later.
What Comes Next
mCOMBRIAX becomes Moderna's fourth authorised product. The company has said the vaccine could be available in select EU markets for the 2026-2027 flu season, with broader rollout expected in 2027 as existing EU vaccine contracts expire. Availability will depend on individual countries' regulatory and access procedures, as national authorities ultimately decide which vaccines to include in their immunisation campaigns.Published April 22, 2026 at 5:37am
