Daiichi Sankyo Submits Application for Marketing Approval of mRNA COVID-19 Vaccine (DS-5670) in Japan

Daiichi Sankyo announced the submission of an application for marketing approval of DS-5670 to the regulatory authorities in Japan. DS-5670 is an mRNA vaccine, being developed against the novel coronavirus infectious disease (COVID-19) and is proposed to be used as a booster vaccine for the prevention of COVID-19.

The application is based on results of a phase 1/2/3 trial (original strain) in approximately 5,000 healthy adult and elderly subjects, who received the primary series (two doses) of an mRNA vaccine approved in Japan.

Daiichi Sankyo started prior assessment consultations for drugs with the Pharmaceuticals and Medical Devices Agency in September 2022 based on non-clinical, clinical, and quality data available up to now to obtain marketing approval at an earlier date.

In addition, Daiichi Sankyo plans to move forward with the development of DS-5670 for the Omicron strain in order to respond to new variants of the coronavirus, which continue to mutate, in parallel with the development for the original strain.

Daiichi Sankyo is 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 reemerging infectious diseases, thereby contributing to protect safety and security in society and people’s health.