Moderna provides update on regulatory submissions for mRNA-1345

Moderna provided an update on regulatory submissions for mRNA-1345, a vaccine for the prevention of RSV-associated lower respiratory tract disease, or RSV-LRTD, and acute respiratory disease, or ARD, in adults aged 60 years or older. The Company has submitted marketing authorization applications for mRNA-1345 with the European Medicines Agency, or EMA, Swissmedic in Switzerland, and the Therapeutic Goods Administration, or TGA, in Australia and has initiated the rolling submission process for a Biologics License Application, or BLA, to the FDA for the licensure of the mRNA-based RSV vaccine. The regulatory applications are based on positive data from a prespecified interim analysis of the pivotal ConquerRSV study, a randomized, double-blind, placebo-controlled study of approximately 37,000 adults 60 years or older in 22 countries. The primary efficacy endpoints were based on two definitions of RSV-LRTD, defined as either two or more symptoms or three or more symptoms of disease. The trial met both its primary efficacy endpoints, with a vaccine efficacy, or VE, of 83.7% against RSV-LRTD as defined by two or more symptoms, and a VE of 82.4% against RSV-LRTD defined by three or more symptoms. The vaccine was well tolerated with a favorable safety profile. Most solicited adverse reactions were mild or moderate, and the most commonly reported solicited adverse reactions in the mRNA-1345 group were injection site pain, fatigue, headache, myalgia, and arthralgia.