Daiichi Sankyo Daichirona for intramuscular injection for booster vaccination approved in Japan as Omicron XBB.1.5-adapted Monovalent mRNA Vaccine against COVID

Published On 2023-11-28 09:00 GMT   |   Update On 2023-11-30 12:21 GMT
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Tokyo: Daiichi Sankyo has announced that 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.

Daiichi Sankyo had submitted a supplemental New Drug Application (sNDA) to Japan’s Ministry of Health, Labour and Welfare (MHLW) for manufacturing and marketing approval of the Omicron XBB.1.5-adapted monovalent mRNA vaccine in September 2023.

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"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," the Company stated.

DAICHIRONA FOR INTRAMUSCULAR INJECTION can be distributed and stored under refrigeration (2–8°C), offering improved convenience to healthcare professionals. 

Read also: Daiichi Sankyo Vanflyta approved in EU as First FLT3 Inhibitor specifically for newly Diagnosed FLT3-ITD Positive AML

DAICHIRONA FOR INTRAMUSCULAR INJECTION 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. The research and development and establishment of production system of DAICHIRONA FOR INTRAMUSCULAR INJECTION are 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 MHLW.

Read also: AstraZeneca-Daiichi Sankyo Enhertu approved in EU for lung cancer

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