Global pharma powerhouse Moderna has secured a major regulatory milestone after the European Commission granted marketing authorization for mCOMBRIAX (mRNA-1083) — a single-dose vaccine against both influenza and COVID-19 in adults above 50.
The approval, following a positive recommendation from the European Medicines Agency’s CHMP, makes the vaccine valid across all 27 EU member states, as well as Iceland, Liechtenstein, and Norway. It marks Moderna’s fourth authorized product, reinforcing its growing focus on respiratory vaccines.
“We welcome the European Commission's approval of mCOMBRIAX, the world's first flu plus COVID-19 combination vaccine,” said Stéphane Bancel, Chief Executive Officer of Moderna.
“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.”
The company says mCOMBRIAX builds on its broader mRNA vaccine pipeline, including its COVID-19 vaccine mNEXSPIKE and the investigational flu shot mRNA-1010, which is currently under regulatory review in multiple regions.
EU authorization was based on a large Phase 3 trial involving around 8,000 adults across two age groups. The study compared mRNA-1083 to currently licensed flu and COVID-19 vaccines administered together, including Fluzone HD (Efluelda in the EU), Fluarix, and Spikevax.
The results met all primary endpoints, showing non-inferior immune responses and, in many cases, stronger protection.
After a single dose, the vaccine produced statistically significantly higher immune responses against three influenza strains — A/H1N1, A/H3N2, and B/Victoria — as well as SARS-CoV-2 in both age groups. The only exception was the B/Yamagata strain in older adults, where no significant increase was observed compared with the control vaccines.
Safety data showed a tolerability profile consistent with existing vaccines, with most side effects reported as mild to moderate.
