Europe First to Authorize Moderna’s mRNA Flu-COVID Combination Vaccine as US Lags Behind

Moderna’s mRNA-based combination vaccine against both flu and COVID-19 has received marketing authorization from the European Commission, making it the world’s first authorized combination shot for the two respiratory viruses.

The vaccine, known as mRNA-1083 or mCOMBRIAX, was authorized following a positive review in February from the European Medicines Agency’s Committee for Medicinal Products for Human Use, which paved the way for the approval.

Moderna CEO Stéphane Bancel welcomed the decision, stating that combining protection against two significant respiratory viruses in a single dose aims to simplify immunization for adults, particularly those at high risk.

Bancel added that mCOMBRIAX offers an important new option for Europeans while aiming to strengthen the resilience of healthcare systems across Europe.

The authorization allows the vaccine to be available in all 27 European Union member states, as well as Iceland, Liechtenstein, and Norway.

According to Moderna, mCOMBRIAX combines its authorized COVID-19 vaccine with an investigational influenza vaccine called mRNA-1010, which is still under review in Europe.

The authorization was based on findings from a Phase III clinical trial involving approximately 4,000 adults, divided into two groups: participants aged 50 to 64 and those aged 65 and older.

In both age groups, mCOMBRIAX elicited statistically significant higher immune responses against common flu strains (A/H1N1, A/H3N2, and B/Victoria) and against SARS-CoV-2 compared to comparator vaccines.

No major safety concerns or adverse events were observed during the Phase III trial.