Moderna announces positive CHMP opinion for marketing authorization of mRESVIA

Moderna announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use has adopted a positive opinion recommending the granting of marketing authorization in the European Union for mRESVIA, an mRNA respiratory syncytial virus vaccine, 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. 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. The primary analysis with 3.7 months of median follow-up found a vaccine efficacy against RSV lower respiratory tract disease of 83.7%, with these results published in The New England Journal of Medicine. In a supplementary analysis with 8.6 months of median follow-up, mRNA-1345 maintained durable efficacy, with sustained VE of 63.3% against RSV-LRTD, including two or more symptoms. VE was 74.6% against RSV-LRTD with greater than or equal to2 symptoms, including shortness of breath, and VE was 63.0% against RSV LRTD including three or more symptoms. The stringent statistical criterion of the study, a lower bound on the 95% CI of greater than20%, continued to be met for both endpoints. The most commonly reported solicited adverse reactions were injection site pain, fatigue, headache, myalgia, and arthralgia.