Daiichi Sankyo Company, Limited announced that it has initiated a trial in Japan to investigate a booster dose of DS-5670, an mRNA vaccine against the novel coronavirus infectious disease (Covid-19).
The trial is being conducted as a phase 1/2/3 study to evaluate the safety and efficacy of DS-5670 in healthy Japanese adults, including an elderly population, who completed initial vaccination (1st and 2nd shots) against Covid-19 with vaccines approved in Japan after at least 6 months following last vaccination. The first part of the study will determine the recommended booster dose of DS-5670 followed by a controlled study in 4,500 adults comparing DS-5670 to other vaccines approved in Japan.
The current rapid spread of the Omicron variant of SARS-CoV-2 has imposed an urgent need to develop a booster vaccination program in countries around the world. As a Japanese pharmaceutical company with specialty in developing vaccines, Daiichi Sankyo is giving special priority to tackling this task and striving to help restore safety and security in society through control of the Covid-19 pandemic, which it hopes to achieve by pursuing the development and commercialization of DS-5670 in Japan during 2022.
DS-5670 is an mRNA vaccine against Covid-19 using a novel nucleic acid delivery technology discovered by Daiichi Sankyo. It is anticipated to be safe and efficacious by targeting the receptor binding domain (RBD) of the new coronavirus. In addition, DS-5670 in animal models induced neutralizing activities against the Omicron variant to a certain extent following the initial vaccination, and the additional dose further increased neutralizing activities, demonstrating a potential booster effect.
The clinical development of DS-5670 is being conducted through “Vaccine development project” promoted by Japan Agency for Medical Research and Development (AMED) and “Urgent improvement project for vaccine manufacturing systems” supported by Ministry of Health, Labour and Welfare (MHLW).
Daiichi Sankyo is dedicated to creating new modalities and innovative medicines by leveraging our worldclass science and technology for our purpose “to contribute to the enrichment of quality of life around the world.”
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