Daiichi Sankyo submits sNDA for Omicron XBB.1.5-adapted COVID vaccine in Japan

DS-5670 is an mRNA vaccine against COVID-19 designed to produce antibodies against the receptor binding domain (RBD) of the spike protein of the novel coronavirus, utilizing a novel nucleic acid drug delivery system discovered by Daiichi Sankyo. In Japan, DS-5670, an original-strain-containing monovalent mRNA vaccine, was approved for marketing in August 2023 and is authorized to be used as a booster dose with an indication of “Prevention of disease caused by SARS-CoV-2 infection.” The research and development of DS-5670 is being conducted through the “Vaccine development project” promoted by the Japan Agency for Medical Research and Development (AMED) and the “Urgent improvement project for vaccine manufacturing systems” supported by the Japanese Ministry of Health, Labour and Welfare (MHLW).