Overview
- The EMA’s human medicines committee adopted a positive opinion on 26 February recommending marketing authorization for Moderna’s mCombriax for adults aged 50 and older.
- mCombriax is the first single-shot vaccine targeting both illnesses, with mRNA encoding influenza A (H1N1, H3N2) and B/Victoria haemagglutinin proteins plus SARS-CoV-2 spike domains.
- In a main study of about 8,000 participants, immune responses were statistically non-inferior to receiving Spikevax alongside Fluzone HD or Fluarix.
- The most common reactions, typically short-lived, include injection-site pain, fatigue, muscle and joint pain, headache, chills, swollen lymph nodes, nausea or vomiting, and fever.
- The formulation follows 2023/2024 EMA and WHO strain recommendations, with updates expected seasonally, and will be supplied in pre-filled syringes by applicant Moderna Biotech Spain S.L.