Moderna, Inc. (MRNA) announced Friday that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending the granting of marketing authorization in the European Union for mRESVIA (mRNA-1345) to protect adults aged 60 years and older from lower respiratory tract disease caused by RSV infection.
Following the CHMP's positive opinion, the European Commission will adopt a decision on the authorization of mRESVIA, an mRNA respiratory syncytial virus (RSV) vaccine.
RSV is a highly contagious seasonal respiratory virus and a leading cause of lower respiratory tract infections and pneumonia. The CHMP positive opinion for mRESVIA is based on positive data from the Phase 3 clinical trial ConquerRSV, a global study conducted in approximately 37,000 adults ages 60 years or older in 22 countries.
In May 2024, the U.S. Food and Drug Administration (FDA) approved mRESVIA (mRNA-1345) to protect adults aged 60 years and older from lower respiratory tract disease caused by RSV infection.
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