Shots:
- The CHMP has recommended approval of mCOMBRIAX (mRNA-1083), a combination vaccine for prevention of influenza and COVID-19 in patients ≥50 yrs. If granted, the approval would be valid in all 30 EEA states
- Opinion was based on a P-III trial evaluating mRNA-1083 in ~8,000 adults across two cohorts: ≥65yrs (n~4,000) vs co-administered Fluzone High‑Dose / Efluelda + Spikevax and 50–64yrs (n~4,000) vs Fluarix + Spikevax, where all 1EPs were met, demonstrating non-inferiority of immune response with acceptable safety and tolerability
- mCOMBRIAX builds on advances from mNEXSPIKE, Moderna’s COVID-19 vaccine, and mRNA-1010, its investigational seasonal influenza vaccine currently under regulatory review in the US, EU, Canada, and Australia
Ref: Moderna | Image: Moderna| Press Release
Related News:- Moderna Reports the EC Approval of mNEXSPIKE to Protect Against COVID-19
PharmaShots! Your go-to media platform for customized news ranging for multiple indications. For more information connect with us at connect@pharmashots.com
