Moderna’s combo flu-COVID vaccine receives European authorization

The world’s first combination seasonal influenza and COVID-19 vaccine, Moderna’s mCombriax, has received marketing authorization from the European Commission, following a positive review from the European Medicines Agency’s Committee for Medicinal Products for Human Use.

“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,” said Moderna CEO Stephane Bancel, MBA, in a press release. “mCOMBRIAX offers an important new option for Europeans, while also aiming to strengthen the resilience of healthcare systems across Europe."

Shot performed well in older adults 

According to the company, mCombriax was based on the clinical development of mNexspike, Moderna's COVID-19 vaccine, and mRNA-1010, Moderna’s investigational seasonal influenza vaccine, which has been accepted for review in the European Union (EU), United States, Canada, and Australia.

The vaccine performed well in a phase 3 trial, where a single dose elicited statistically significant higher immune responses against three influenza virus strains (A/H1N1, A/H3N2, and B/Victoria) and against SARS-CoV-2 in adults 50 to 64 years and 65 years and older. 

The marketing authorization is valid in all 27 EU member states, as well as Iceland, Liechtenstein, and Norway. No major safety concerns or adverse events were seen in the phase 3 trial. 

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