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

Published On 2023-09-10 04:30 GMT   |   Update On 2024-02-12 19:40 GMT
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Tokyo: Daiichi Sankyo has announced that it has 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.

The monovalent vaccine containing omicron XBB.1 lineage will be used in the current special temporary vaccination program against COVID-19 in Japan that begins in September 2023, and Daiichi Sankyo is advancing production preparations to start the supply of DS-5670 within this year.

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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).

Daiichi Sankyo has been developing the vaccine business in Japan in cooperation with Daiichi Sankyo Biotech Co., Ltd., a vaccine production functional subsidiary of the Daiichi Sankyo Group.

Read also: Daiichi Sankyo Enhertu approved in Japan as first HER2 directed therapy for patients with HER2 mutant metastatic lung cancer



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