As part of Daiichi Sankyo’s efforts to combat the spread of the virus that causes COVID-19, the Daiichi Sankyo group is actively engaged in various measures and initiatives such as, but not limited to, contributing to vaccination and drug research and development, ensuring a continuous supply of the Daiichi Sankyo group products, and providing disaster relief supports.
R&D and Product Manufacturing, Supply and Delivery Activities for COVID-19 Vaccines
Daiichi Sankyo is promoting the R&D of vaccines and therapeutic agents targeting COVID-19 by leveraging the best use of our past and present research properties, technologies, and accumulated R&D knowledge and experience as an innovative pharmaceutical company, and also in collaboration with external institutions.
1. Daiichi-Sankyo R&D of genetic (mRNA) vaccines (DS-5670)
In view of the vaccination situation in Japan, and with supports from the Japan Agency for Medical Research and Development (AMED) and the Ministry of Health, Labour and Welfare‘s “Urgent improvement project for vaccine manufacturing systems” (1st round of public subscription), a clinical trial to examine the booster effect of additional administration of mRNA vaccine was started in January 2022 and in August 2023, DAICHIRONA® for Intramuscular Injection (Monovalent: Original Strain), mRNA COVID-19 Vaccine, was Approved for Manufacturing and Marketing as Booster Vaccination in Japan.
In addition to the above-mentioned development, we had submitted a supplemental New Drug Application (sNDA) to Japan’s Ministry of Health, Labour and Welfare (MHLW) for an omicron XBB.1.5-adapted mRNA vaccine (DS-5670) against the novel coronavirus infectious disease (COVID-19) for booster vaccination for individuals aged 12 years or older in September 2023.
In November 2023, DAICHIRONA® FOR INTRAMUSCULAR INJECTION (DS-5670) for booster vaccination has been approved in Japan as an Omicron XBB.1.5-adapted monovalent mRNA vaccine against COVID-19.
Through the development of DS-5670, we have also made progress in establishing LNP-mRNA technology and accumulated know-how in its development and manufacturing. We will establish this mRNA technology as a platform technology not only for DS-5670 but also for future vaccines against emerging and reemerging infectious diseases, and contribute to the maintenance of people's daily lives by providing preventive medicine. This technology will surely contribute to the public health of people around the world in preparation for the coming pandemic.
2. Daiichi-Sankyo Product Manufacturing, Supply and Delivery of genetic (mRNA) vaccines（DS-5670）
Based on the supply agreement with the MHLW, Daiichi Sankyo will commence the distribution of this first-ever Japan-made mRNA vaccine in the coming days and is committed to supply a total of 1.4 million doses in FY2023 for the current special temporary vaccination program against COVID-19 in Japan. DAICHIRONA® FOR INTRAMUSCULAR INJECTION can be distributed and stored under refrigeration (2–8°C), offering improved convenience to healthcare professionals.