Daiichi Sankyo Announces Development Progress of mRNA COVID-19 Vaccine in Japan
October 21, 2021 at 05:00 am EDT
Daiichi Sankyo Company, Limited announced the progress of development of DS-5670, an mRNA vaccine in Japan, being evaluated against the
novel coronavirus infectious disease (COVID-19), including results from a phase 1/2 clinical trial. The trial was initiated in March 2021 to evaluate the safety and immunogenicity 1 of DS-5670 and to estimate the recommended dose. No relevant safety concerns have been observed following four weeks of follow-up after
administration of the second dose of the vaccine in 142 healthy adults, including elderly individuals. For the
immunogenicity, both neutralizing activity 2 and IgG titer 3 increased after the vaccination.
A non-clinical research project conducted in collaboration with the University of Tokyo's Institute of
Medical Science showed that DS-5670 induced a neutralizing activity against previously designated Variant
of Concerns, including the Delta variant. Daiichi Sankyo plans to initiate a phase 2 clinical trial in November 2021 and a phase 3 clinical trial within
FY2021, aiming for commercialization of DS-5670 in Japan within 2022. In addition, in order to initiate a
clinical trial of a supplemental booster for the vaccine (booster vaccine) in January 2022, Daiichi Sankyo is
continuing discussions with the Japanese Ministry of Health, Labour and Welfare (MHLW), Pharmaceuticals
and Medical Devices Agency (PMDA), and Japan Agency for Medical Research and Development (AMED).
These R&D projects are being conducted through the "Development of vaccines for the novel coronavirus
disease (COVID-19) (Second Round)" (company-initiated) promoted by AMED and "Emergent Initiative to
Build Production Capacity for COVID-19 Vaccines (First Round)" supported by MHLW.