Moderna's Combination Covid-Flu Vaccine Receives Positive CHMP Opinion in Europe

The European Medicines Agency's Committee for Medicinal Products for Human Use has adopted a positive opinion recommending marketing authorization in the European Union for mCOMBRIAX (mRNA-1083), Moderna's combination vaccine indicated for active immunization for the prevention of influenza and COVID-19 caused by SARS-CoV-2 in individuals 50 years of age and older. This represents the world's first flu plus COVID combination vaccine to receive a positive CHMP opinion and would be Moderna's fourth marketed product in Europe if approved.

The CHMP opinion is supported by results from a pivotal Phase 3 clinical trial (ClinicalTrials.gov Identifier: NCT06097273), a randomized, observer-blind, active-controlled study evaluating the safety, reactogenicity and immunogenicity of mRNA-1083 in two independent age cohorts of approximately 4,000 adults each. One cohort included adults 65 years of age and older and compared mRNA-1083 to co-administered Fluzone HD (licensed in the European Union as Efluelda), a high-dose influenza vaccine, and Spikevax, Moderna's licensed COVID-19 vaccine. The second cohort included adults 50 to 64 years of age and compared mRNA-1083 to co-administered Fluarix, a standard-dose influenza vaccine, and Spikevax.

All primary endpoints demonstrating the non-inferiority of immune responses were met. Following a single dose, mRNA-1083 elicited statistically significantly higher immune responses against three influenza virus strains (A/H1N1, A/H3N2 and B/Victoria) and against SARS-CoV-2 in both age cohorts. The B/Yamagata strain, which is no longer recommended for inclusion in seasonal influenza vaccines, was the only strain for which a statistically significantly higher immune response was not observed for adults 65 years of age and older compared to the co-administered licensed comparator vaccines.

mRNA-1083 demonstrated an acceptable safety and tolerability profile. The majority of solicited adverse reactions were grade 1 or 2 in severity and consistent with the licensed vaccines used in the trial.

Following the CHMP's positive opinion, the European Commission will consider the recommendation and is expected to adopt a final decision on marketing authorization. Once the European Commission approves a product, the marketing authorization is valid in all EU Member States as well as in the European Economic Area countries of Iceland, Liechtenstein and Norway. Upon European Commission approval, Moderna will work with national regulatory and health authorities to support local access and implementation.

mCOMBRIAX builds on the advances of mNEXSPIKE, Moderna's COVID-19 vaccine, and mRNA-1010, Moderna's investigational seasonal influenza vaccine, which has been accepted for review in the United States, the European Union, Canada and Australia.

The combination vaccine has faced a rocky path to approval, as Moderna pulled its application for the vaccine's approval in May 2025 after filing for the FDA's blessing the previous year. This is because the FDA requested to see data backing the efficacy of the jab's flu component before approving the combination, marking a tightening of vaccine regulatory policy in the US. At the time, Moderna noted it would resubmit its Biologics License Application for mCombriax later in 2025, though it has not yet publicly announced this resubmission to date.

Most recently, the US Food and Drug Administration refused to review Moderna's seasonal flu vaccine, mRNA-1010, due to the agency's concerns around trial design. The regulator later pivoted on this decision following an appeal from Moderna, with the caveat that the vaccine will be reviewed differentially across the 50-64 and 65+ age categories.

As Moderna contends with a rapidly evolving vaccine landscape and waning sales of its Covid-19 vaccine portfolio, the company has seen a gradual reduction in revenue, with the company posting a net loss of $826m in Q4 2025.