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Daiichi Sankyo Announces Results of Booster Vaccination Trial

Tokyo, Japan – (November 15, 2022) – Daiichi Sankyo (TSE: 4568) today announced that in a trial for evaluation of the efficacy and safety of booster vaccination with DS-5670, an mRNA vaccine against the novel coronavirus infectious disease (COVID-19) being developed by Daiichi Sankyo (hereafter, booster vaccination trial), the primary endpoint was achieved. The booster vaccination trial included approximately 5,000 Japanese healthy adult and elderly subjects who had completed the primary series (two doses) of mRNA vaccines approved in Japan at least six months before enrolment. In January 2022, the trial was initiated as a phase 1/2/3 trial in order to evaluate the efficacy and safety of booster vaccination with DS-5670 using mRNA vaccines approved in Japan as the control. GMFR of neutralizing antibody titer against SARS-CoV-2 (original strain) in blood four weeks after the booster vaccination, the primary endpoint of the booster vaccination trial, demonstrated a higher data and non-inferiority of DS-5670 to the mRNA vaccines (original strain) approved in Japan, achieving the intended purpose. No safety concerns were identified. Detailed results of the booster vaccination trial will be presented at academic conferences and in research papers. Based on the trial results, Daiichi Sankyo will proceed with preparation for a new drug application of the mRNA vaccine in January 2023. In addition, Daiichi Sankyo is planning to conduct clinical trials of bivalent vaccines of the original strain and Omicron strains against new coronaviruses, which continue to mutate. Daiichi Sankyo will strive to strengthen the mRNA vaccine development and production system to ensure a stable supply in ordinary times as well as prompt provision of vaccines in the event of outbreaks of emerging and reemerging infectious diseases

About DS-5670 DS-5670 is an mRNA vaccine against COVID-19 using a novel nucleic acid delivery technology discovered by Daiichi Sankyo, designed to produce antibodies against the receptor binding domain (RBD) of the spike protein of the novel coronavirus, and thus expected to have desirable prevention against COVID-19 and 2 safety. Furthermore, Daiichi Sankyo is aiming for mRNA vaccines that can be distributed in the refrigerated temperature range (2-8°C)

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Post time: Dec-17-2022