Posted by Michael Wonder on 13 Jan 2023
Daiichi Sankyo submits application for marketing approval of mRNA COVID-19 vaccine (DS-5670) in Japan
13 January 2023 - Daiichi Sankyo today 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.
