The Covid-19 vaccine supply is contingent on regulatory approval in Japan. Credit: Viacheslav Lopatin / Shutterstock.com.

Daiichi Sankyo has signed an agreement with Japan’s Ministry of Health, Labour and Welfare (MHLW) to deliver 1.4 million doses of its omicron XBB.1.5-adapted monovalent mRNA [messenger ribonucleic acid] vaccine (DS-5670) for Covid-19, contingent on regulatory approval.

Japan plans to use DS-5670 for its ongoing inoculation drive programme, launched in 2023. 

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In September 2023, Daiichi Sankyo filed a supplemental new drug application with the MHLW for the DS-5670 vaccine.

The company is preparing its manufacturing sites to deliver the vaccine doses.

DS-5670 is the first Covid-19 mRNA vaccine to be made in Japan.

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In a press statement, Daiichi Sankyo said that the company “will strive to further strengthen technologies for vaccine development and production, thereby contributing to the safety and security of society and people’s health in Japan”.

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DS-5670 is Daiichi Sankyo’s original-strain-containing monovalent mRNA Covid-19 vaccine and received approval for manufacture and marketing in Japan in August 2023.

It is also indicated for usage as a booster vaccine for the prevention of disease caused by SARS-CoV-2 infection.

The latest development comes after the company received European Commission approval for Vanflyta (quizartinib) to treat newly diagnosed fms-like tyrosine kinase 3 internal tandem duplication positive acute myeloid leukaemia.

Cell & Gene Therapy coverage on Pharmaceutical Technology is supported by Cytiva.

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