Moderna’s Combined COVID-19 and Flu Vaccine Receives Positive EMA Recommendation

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending marketing authorization for mCOMBRIAX (mRNA-1083), a first-in-class combination vaccine protecting against both influenza and COVID-19. The vaccine is intended for adults aged 50 years and older.

Understanding the Threat of Co-infection

The CHMP’s recommendation comes as research indicates that co-infection with influenza virus and SARS-CoV-2 can result in more severe illness than infection with either virus alone. Medscape reports on this increased risk, highlighting the importance of preventative measures like vaccination.

mCOMBRIAX: How it Works

mCOMBRIAX is an mRNA-based vaccine developed by Moderna (NASDAQ:MRNA). In pivotal Phase 3 trials, a single dose of the vaccine elicited statistically significant higher immune responses against three influenza virus strains – A/H1N1, A/H3N2, and B/Victoria – and against SARS-CoV-2 in both age cohorts studied. Stock Titan details the trial results.

Trial Details and Population

The Phase 3 trial involved approximately 4,000 adults in two age cohorts: 65 years and older, and 50 to 64 years. Even as immune responses were higher across the board, the vaccine did not demonstrate a statistically higher response for the B/Yamagata influenza strain in adults aged 65 and older. Stock Titan

Safety and Tolerability

The safety profile of mCOMBRIAX was deemed acceptable, with most adverse reactions being Grade 1 or 2 in severity. Stock Titan

What’s Next?

While the CHMP has issued a positive opinion, final marketing authorization requires a decision from the European Commission and subsequent national regulatory and access processes. If approved, mCOMBRIAX will be Moderna’s fourth marketed product in Europe. Stock Titan

Monitoring Respiratory Viruses in Europe

The European Respiratory Virus Surveillance Summary (ERVISS) provides ongoing monitoring of influenza, RSV, and SARS-CoV-2 across Europe. ECDC and ERVISS offer interactive dashboards with weekly epidemiological updates.