DS 5670 an Omicron XBB.1.5-adapted COVID-19 vaccine is filed in Japan as a Supplemental New Drug Application
Daiichi Sankyo 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.
About DS 5670 :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.”
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