The European Medicines Agency (EMA) today said it’s recommending marketing authorization for mCombriax, Moderna’s combined mRNA vaccine for protecting older adults against COVID-19 and flu.
The recommendation was made by the EMA’s Committee for Medicinal Products for Human Use, which looked at data from a phase 3 trial involving 8,000 participants aged 50 and older. The results of that trial showed participants who received mCombriax (mRNA-1083) had non-inferior immune responses to those who received Moderna’s licensed COVID-19 vaccine (Spikevax) or authorized high- or standard-dose flu vaccines (Fluzone and Fluarix).
If the European Commission accepts the recommendation, the vaccine will be available throughout the European Union. The EMA said the vaccine will provide people with the option of having a single shot to protect against both illnesses.
Potential to simplify vaccination
“mCombriax will be one more option for national authorities to consider for vaccination campaigns against COVID-19 and influenza,” the EMA said in a news release. “National authorities decide which vaccines to roll out and make recommendations about who should receive them, taking into account the situation in their countries.”
Moderna CEO Stephane Bancel, MBA, MEng, said in a statement that the recommendation “represents an important milestone for respiratory virus vaccination and for Moderna.”
“Combination vaccines have the potential to simplify vaccination and support improved health outcomes,” Bancel said. “We appreciate the EMA's rigorous scientific review.”
Moderna submitted a Biologic License Application to the US Food and Drug Administration (FDA) for mCmobriax in 2024 but pulled the application in May 2025 after the FDA asked for more data.