Daiichi Sankyo's mRNA COVID-19 booster vaccine meets primary trial goal

Japanese drugmaker Daiichi Sankyo (TYO: 4568) edged up 1.7% to 4,486 yen today, as it announced that a trial evaluating the efficacy and safety of booster vaccination with DS-5670, an mRNA vaccine against the novel coronavirus infectious disease (COVID-19), the primary endpoint was achieved.

The company explained that 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 I/II/III 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.