Japan’s Ministry of Health, Labour and Welfare (MHLW) has granted approval for Daiichi Sankyo’s Omicron XBB.1.5-adapted monovalent mRNA [messenger ribonucleic acid] vaccine, Daichirona, for intramuscular injection (DS-5670) as a booster for Covid-19.
Daichirona is the first mRNA vaccine to be made in the country.
The vaccine can induce antibodies against the receptor binding domain of the novel coronavirus’ spike protein, leveraging a new nucleic acid drug delivery system discovered by the company.
In September 2023, the company filed a supplemental new drug application (sNDA) with the Japanese regulator seeking manufacturing and marketing approval of the vaccine.
The company then entered an agreement with the MHLW to supply 1.4 million doses in FY 2023 and will begin to deliver these shortly as part of an inoculation drive against Covid-19 in Japan.
Research, development and establishment of the manufacturing system are being carried out via the Agency for Medical Research and Development’s vaccine development project and the MHLW’s urgent improvement project for vaccine manufacturing systems.
Daiichi Sankyo stated: “Daiichi Sankyo will strive to further strengthen the development and production technologies and supply system for mRNA vaccine, thereby contributing to the safety and security of society and people’s health.”
The latest development comes after the company received European Commission approval for its Vanflyta (quizartinib) for treating adults with newly diagnosed fms-like tyrosine kinase 3 internal tandem duplication positive acute myeloid leukaemia.
The approval was granted in the European Union based on data drawn from the double-blind, randomised, international, placebo-controlled Phase III QuANTUM-First clinical trial of the Vanflyta combination regimen.
This study saw the enrolment of 539 subjects at 193 trial centres in 26 countries across Europe, Asia, Oceania and North and South America.
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