Moderna announces New England Journal of Medicine publication of pivotal phase III clinical safety and efficacy data For MRNA 1345, the investigational respiratory syncytial virus (RSV) vaccine.
Moderna, Inc. announced the publication of positive Phase III clinical study results evaluating mRNA-1345, its vaccine candidate for respiratory syncytial virus (RSV), in The New England Journal of Medicine.
The peer-reviewed article summarizes safety and efficacy data from ConquerRSV, the Company's Phase II-III trial evaluating mRNA 1345. An accompanying New England Journal of Medicineop-ed discusses these results as an important achievement in the realization of effective RSV vaccines as well as a milestone in the advancement of mRNA vaccines and medicines. Moderna is the only company to have developed an mRNA-based RSV vaccine. Top-line results from this study were previously announced in January 2023.
RSV is a highly contagious virus that causes severe disease across the age spectrum, including older adults. Each year in the U.S., RSV leads to approximately 60,000-160,000 hospitalizations and 6,000-10,000 deaths among older adults. Applications for mRNA-1345 have been submitted to regulators around the world. Moderna is actively preparing for an expected 2024 marketing launch of mRNA-1345 and believes its U.S. COVID-19 market share to date demonstrates the Company's ability to compete in the commercial market. If approved, mRNA-1345 would have a potential best-in-class profile and be the only ready-to-use RSV vaccine available in single-dose prefilled syringes.
See- "Efficacy and Safety of an mRNA-Based RSV PreF Vaccine in Older Adults"- Eleanor Wilson, M.D., Jaya Goswami, M.D., Abdullah H. Baqui, M.B., B.S., M.P.H., Dr.P.H., Pablo A. Doreski, M.D., et al., for the Conquer RSV Study Group. December 14, 2023 N Engl J Med 2023; 389:2233-2244. DOI: 10.1056/NEJMoa2307079.
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