Daiichi Sankyo to establish Japan’s first mRNA production facility
It would be the first mRNA vaccine facility in Japan; the site would help to ensure greater domestic self-sufficiency in COVID-19 shots. Planned capacity is 20 million doses per year by 2024, reported the Japanese media outlet.
The Japanese pharma group plans to use government subsidies to expand mRNA vaccine production at that facility by 2027, reads the story.
The plant in question is operated by subsidiary Daiichi Sankyo Biotech.
Last month, as it announced it had filed for marketing approval of DS-5670, its mRNA vaccine candidate against COVID-19, with the regulatory authorities in Japan, Daiichi Sankyo said it was “striving to establish mRNA-vaccine-related technologies and the production and supply system in Japan to ensure a prompt provision of vaccines in the event of outbreaks of emerging and re-emerging infectious diseases.”
Its submission to the Pharmaceuticals and Medical Devices Agency (PMDA) is based on results of clinical trials in about 5,000 healthy adult and elderly subjects who received two doses of an mRNA vaccine approved in Japan. The company started prior assessment consultations with the regulatory agency back in September last year.
Daiichi Sankyo is also developing an Omicron adapted booster.
The clinical development of DS-5670 is being conducted through a vaccine development project promoted by the Japan Agency for Medical Research and Development (AMED) and a vaccine manufacturing initiative backed by the Japanese health, labor and welfare ministry (MHLW).
Boosting vaccine production capacity
Other Japanese pharma companies are active in the COVID-19 vaccine space.
Shionogi is pursuing the discovery and development of a recombinant protein vaccine for Covid-19. It is also focusing on establishing large-scale production of its vaccine, equipping and expanding production facilities. It is teaming up with Unigen and Api Co on that project, with the goal of supplying over 60 million shots annually.
KM Biologics has an inactivated COVID-19 shot currently in development. A subsidiary of confectionery group, Meiji Holdings Co, it is reportedly setting up production capacity for up to 20 million doses a year in a facility in southwestern Japan.
Readying the country for future pandemics
The COVID-19 pandemic showed up the weakness of Japan’s vaccine R&D capabilities, according to some of the country's top vaccine experts.
After recognizing that Japan was slow to develop vaccines for COVID-19, the Japanese government annoucned an investment of US$2bn last year in a vaccine-research initiative to ensure that the country is ready to respond promptly to future epidemics.
The Strategic Center of Biomedical Advanced Vaccine Research and Development for Preparedness and Response (SCARDA), which is based within AMED, will initially invest in vaccine research for eight pathogens, including coronaviruses, monkeypox, dengue virus and Zika virus, using a range of technologies for vaccine delivery, such as mRNA technology, viral vectors and recombinant proteins.
SCARDA is expected to play a similar role to the US Biomedical Advanced Research and Development Authority and the National Institutes of Health in the development of vaccines.
