Daiichi Sankyo (TSE: 4568) announced today on 02-August-2023, that it has received approval to manufacture and market DAICHIRONA® for intramuscular injection (DS-5670), an original monovalent mRNA vaccine against the novel coronavirus infectious disease (COVID-19), in Japan for the prevention infectious diseases caused by SARS-CoV-2 (booster vaccination)
Application for DAICHIRON® approval for its production and marketing in Japan in January 2023 and is now approved as Japan’s first mRNA vaccine against COVID-19. DAICHIRON® can be distributed and stored in a refrigerator (2°C–8°C) offering better convenience for health professionals.
In the current special temporary vaccination program against COVID-19, Omicron-modified bivalent mRNA vaccines are used for the booster series campaign that started in May 2023.
In addition, the Japanese government has demonstrated its intention to use XBB.1 vaccines for next year; booster series campaign scheduled to begin in September 2023. Since DAICHIRONA®, as currently approved, is the original monovalent mRNA vaccine for the booster series, it is not planned to be supplied for the campaign.
However, Daiichi Sankyo will immediately move forward with the development of a monovalent vaccine containing XBB.1 and aim to deliver a monovalent vaccine containing XBB.1.5 by the end of this year at the earliest.
About DAICHIRONA®(COVID-19 booster vaccine) for Intramuscular Injection:
DAICHIRONA® for intramuscular injection is an mRNA vaccine against COVID-19 designed to produce antibodies against the receptor binding domain (RBD) spike protein of the novel coronavirus, using a novel nucleic acid-based drug delivery system discovered by Daiichi Sankyo.
Research and development of DAICHIRONA®, including the monovalent XBB.1.5 vaccine referred to in this announcement, is being conducted through the “Vaccine Development Project” supported by the Japan Agency for Medical Research and Development (AMED) and the “Urgent Improvement Project for Vaccine Production Systems” supported by the Japanese Ministry of Health, Labor and Social Affairs (MHLW).
Vaccine business of Daiichi Sankyo:
Daiichi Sankyo is dedicated to improving Japan’s preventive health care environment and improving public health and hygiene, which is an essential part of national security, by ensuring a stable supply of vaccines, including HA influenza vaccine and live attenuated measles-rubella combination vaccine.
In addition, Daiichi Sankyo is developing a vaccine business in Japan in cooperation with Daiichi Sankyo Biotech Co., Ltd., Daiichi Sankyo Group’s functional vaccine manufacturing arm, and is seeking to introduce mRNA vaccine-related technologies and production and supply. a system that will ensure rapid delivery of Japanese-made vaccines in the event of outbreaks of emerging and re-emerging infectious diseases, thereby contributing to the protection of society’s sense of safety and security and people’s health.
About Daiichi Sankyo:
Daiichi Sankyo is an innovative global healthcare company contributing to the sustainable development of society that discovers, develops and delivers new standards of care to enrich the quality of life around the world. With more than 120 years of experience, Daiichi Sankyo uses its world-class science and technology to create new methods and innovative medicines for people with cancer, cardiovascular and other diseases with high unmet medical needs.
