Daiichi Sankyo Daichirona for Intramuscular Injection approved for manufacturing, marketing as booster vaccination in Japan

Tokyo: Daiichi Sankyo has announced that it has received approval for the manufacturing and marketing of DAICHIRONA for Intramuscular Injection (DS-5670), an original monovalent mRNA vaccine against the novel coronavirus infectious disease (hereafter, COVID-19), in Japan for the prevention of infectious disease caused by SARS-CoV-2 (booster vaccination).

The application for approval of DAICHIRONA for its manufacturing and marketing in Japan was submitted in January 2023, and it is now approved as the first Japan-made mRNA vaccine against COVID-19.

DAICHIRONA can be distributed and stored under refrigeration (2°C–8°C), offering improved convenience to healthcare professionals. In the current special temporary vaccination program against COVID-19, Omicron-adapted bivalent mRNA vaccines are used for the booster series campaign that began in May 2023. In addition, the Japanese government has shown an intention to use XBB.1 vaccines for the next booster series campaign that is scheduled to begin in September 2023.

Since DAICHIRONA as approved now is an original monovalent mRNA vaccine for booster series, its supply for the campaign is not planned. However, Daiichi Sankyo will immediately advance the development of an XBB.1-containing monovalent vaccine and strive to supply an XBB.1.5-containing monovalent vaccine before the end of this year at the earliest.

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