GSK’s RSV vaccine ‘Arexvy’ receives positive European Medicines Agency’s CHMP opinion for adults aged 50-59
Decision on EU marketing authorisation for this population expected by September 2024
Decision on EU marketing authorisation for this population expected by September 2024
GSK and Flagship to jointly fund up to $150 million upfront
The agreement has an initial term until March 31, 2029 and no further details on the financial terms of the deal are being disclosed
Aim of the collaboration is to develop mRNA platform technology, scale up and troubleshoot challenges in mRNA process optimization
Doses will be ready to ship to applicable EU member states immediately upon authorization by the European Commission
Higher efficacy was observed in mRNA-1283 compared to Spikevax in adults 18 years of age and older
Over 13 million US adults aged 50-59 years have a medical condition that increases their risk of severe RSV outcomes
The Gavi Board today approved the Vaccine Alliance's strategy for the five-year period running from 2026 to 2030
mRESVIA is Moderna's second approved product and the only RSV vaccine available in single-dose pre-filled syringes
U.S. FDA has informed Moderna that due to administrative constraints, the agency will not complete its review of mRNA-1345 by the PDUFA date of May 12, 2024
Subscribe To Our Newsletter & Stay Updated