Combination mRNA COVID-Influenza Shot Recommended by European Medicines Agency

The European Medicine Agency (EDA) has recommended marketing authorization for Moderna’s mCombriax mRNA (messenger ribonucleic acid) shot. The product, also known as mRNA-1083, is a genetically engineered biologic targeting both influenza and COVID-19. It builds on work Moderna has done on its next-generation mRNA COVID shot known as mNexSpike and mRNA-1010.^{1 2 3}

The recommendation was made by the EMA’s Committee for Medicinal Products for Human Use (CHMP) on Feb. 26, 2026 in response to a license application by Moderna Biotech Spain SL of Madrid.³ Stéphane Bancel, CEO of Moderna, said:

The CHMP’s positive opinion represents an important milestone for respiratory virus vaccination and for Moderna, with the introduction of the world’s first flu plus COVID combination vaccine. If approved, this would be Moderna’s fourth marketed product in Europe. Combination vaccines have the potential to simplify vaccination and support improved health outcomes.³

The recommendation was based on the results of a Phase 3 randomized, observer-blind clinical trial consisting of two cohort groups of 4,000 healthy people each consisting of adults 50 years of age and older. One cohort which included adults 65 years of age and older compared those given mCombriax to those administered Sanofi Pasteur’s licensed Fluzone high-dose influenza vaccine and Moderna’s licensed Spikevax mRNA influenza shot. The other cohort which included adults 50-64 years old compared those given mRNA-1083 to those administered GlaxoSmithKline’s (GSK) licensed Fluarix standard-dose influenza vaccine and Spikevax.^{3 4}

Safety and Tolerability Profile for mCombriax Deemed “Acceptable”

The results of the trial showed that those who received mCombriax had “non-inferior” (comparable) immune responses to those who received Moderna’s Spikevax shot or Fluzone and Fluarix. According to a Moderna press release, mCombriax demonstrated an “acceptable safety and tolerability profile.” Most of the “solicited adverse reactions” were of a Grade 1 or Grade 2 level of clinical severity and “consistent with the licensed vaccines used in the trial.”^{1 2 3 4}

Based on the U.S. Department of Health and Human Service’s Common Terminology Criteria for Adverse Events (CTCAE), a Grade 1 level of severity for an adverse event (AE) is characterized as “Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated.” Grade 2 level of for an AE is described as Moderate; minimal, local or noninvasive intervention indicated; limiting age appropriate instrumental ADL” (activities of daily living).⁵

The CHMP’s recommendation will now be reviewed by the European Commission (EC) and a final decision on licensing mCombriax in Europe is expected soon.⁶

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