- Moderna (NASDAQ:MRNA) announced on Thursday that an expert panel of the EU drug regulator, the European Medicines Agency (EMA), recommended marketing authorization for its updated COVID-19 vaccine targeted at the JN.1 strain of the Omicron variant.
- The so-called positive opinion of the EMA’s Committee for Medicinal Products for Human Use (CHMP) will form the basis for the marketing authorization expected from the European Commission shortly.
- The decision will allow the Cambridge, Massachusetts-based biotech to market its updated messenger-RNA-based COVID vaccine for the autumn/winter respiratory season in 2024-2025.
- In August, the U.S. FDA approved mRNA vaccines developed by Moderna (MRNA) and Pfizer (PFE)/BioNTech (BNTX) targeting the COVID-19 KP.2 variant, a subvariant of JN.1. Moderna’s (MRNA) JN.1-targeting COVID shots are approved in Japan, Taiwan, and the U.K.