Moderna, Inc. (MRNA) announced on Friday that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending the marketing authorization for mRESVIA (mRNA-1345) in the European Union. This vaccine aims to protect adults aged 60 and older from lower respiratory tract diseases caused by Respiratory Syncytial Virus (RSV).
Following the CHMP's endorsement, the European Commission will make a decision on the authorization of mRESVIA, an mRNA-based vaccine against RSV.
RSV is a highly contagious seasonal respiratory virus and is a leading cause of lower respiratory tract infections and pneumonia. The positive opinion from the CHMP for mRESVIA is grounded in favorable data from the Phase 3 clinical trial ConquerRSV, a global study involving around 37,000 adults aged 60 and older across 22 countries.
In May 2024, the U.S. Food and Drug Administration (FDA) approved mRESVIA (mRNA-1345) to safeguard adults aged 60 and over from lower respiratory tract diseases caused by RSV.
