Moderna said on April 22 that the European Commission (EC) has granted marketing authorization for mCOMIRNATY (mRNA-1083).
mCOMIRNATY is Moderna’s mRNA combination vaccine designed to prevent COVID-19 caused by SARS-CoV-2 and influenza in adults aged 50 and older.
The approval follows a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) under the European Medicines Agency (EMA) and is valid across all 27 European Union member states as well as Iceland, Liechtenstein and Norway.
mCOMIRNATY is Moderna’s fourth approved product, strengthening its respiratory portfolio and demonstrating its continued commitment to the European Union.
Moderna Chief Executive Officer Stéphane Bancel said, “We welcome the European Commission’s approval of mCOMIRNATY, the world’s first combined influenza and COVID-19 vaccine,” adding, “Our goal is to simplify vaccination, particularly for high-risk adults, by providing protection against two major respiratory viruses in a single shot.”
mCOMIRNATY was developed based on clinical development results from Moderna’s COVID-19 vaccine mNEXSPIKE and its seasonal influenza vaccine candidate mRNA-1010, which is currently under review in the European Union, the United States, Canada and Australia.
mCOMIRNATY demonstrated non-inferior immune responses across all primary endpoints. Following a single dose, mRNA-1083 induced statistically significantly higher immune responses against three influenza virus strains (A/H1N1, A/H3N2, B/Victoria) and SARS-CoV-2 in both age cohorts.
Only for the B/Yamagata strain, which is not currently recommended for inclusion in seasonal vaccines, no statistically significant increase in immune response was observed compared with the comparator vaccine in adults aged 65 and older.
mRNA-1083 showed an acceptable safety and tolerability profile. Most adverse reactions were Grade 1 or Grade 2 and were similar to those observed with existing approved vaccines used in the clinical trials.
mCOMIRNATY will be supplied across the European Union following national regulatory and access procedures, and Moderna plans to work closely with national authorities to support local access and rollout.