The positive decision covers all 27 Member States, as well as Iceland, Liechtenstein, and Norway. This is the final authorization, which directly follows a positive opinion issued by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA).
The approved product, marketed under the name mCOMBRIAX (known during trials as mRNA-1083), is an innovative vaccine that integrates proven mRNA technology targeting the SARS-CoV-2 virus with protection against seasonal flu. The product has been officially authorized for use in adults aged 50 and older, which is intended to help minimize bureaucracy and vaccine fatigue in high-risk groups.
The EU policymakers’ approval is based on hard data from a multicenter Phase III clinical trial involving approximately 8,000 adult patients, divided into two independent cohorts. The results left no doubts regarding the formulation’s efficacy. In the group of individuals aged 65 and older, mCOMBRIAX demonstrated efficacy equal to or greater than the simultaneous administration of two separate vaccines: a high-dose flu vaccine (Fluzone HD / Efluelda) and Spikevax. Similar – so-called “non-inferior” – results were achieved in the younger cohort (50–64 years), where the benchmark was a standard flu vaccine (Fluarix).
Commenting on the significance of this step, Stéphane Bancel, CEO of Moderna, highlighted both the convenience and the strategic goal of the new vaccine:
“We welcome the European Commission’s approval of mCOMBRIAX, the world’s first flu plus COVID-19 combination vaccine. By combining protection against two significant respiratory viruses in a single dose, our vaccine aims to simplify immunization for adults, particularly those at high risk. mCOMBRIAX offers an important new option for Europeans, while also aiming to strengthen the resilience of healthcare systems across Europe.”
For Moderna, this marks the fourth product authorized for the European market. The next step will be rolling out the vaccine to individual Member States – the ultimate availability of mCOMBRIAX in national clinics will depend on local procedures and the decisions of health authorities.