03 June 2022 | News
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
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Daiichi Sankyo has announced the current progress of development of DS-5670, an mRNA vaccine, being evaluated in Japan against COVID-19 in a phase 1/2/3 trial to determine the booster effect of an additional dose (booster vaccination trial) and a phase 2 trial in unvaccinated subjects.
The booster vaccination trial is being conducted as a phase 1/2/3 trial in healthy adult and elderly subjects who received two doses of an mRNA vaccine approved in Japan at least six months before receiving the additional dose of DS5670 (third vaccination) in order to evaluate the booster effect of DS-5670.
In January 2022, the dose-finding part of the trial was initiated, including approximately 500 healthy adult and elderly subjects. In this trial, an mRNA vaccine approved in Japan or DS-5670 at one of three dose levels (10μg,30μg,60μg) was administered. Data on neutralizing activities four weeks after receiving the vaccination show that the efficacy of DS-5670 is comparable to or higher than an approved mRNA vaccine.
Evaluation of safety during a period of seven days after the vaccination presented no serious adverse reactions.
As a Japanese pharmaceutical company with a specialty in developing vaccines, Daiichi Sankyo will continue consultation with the regulatory authorities to deliver the vaccine to people in Japan, aiming at commercialisation of DS-5670 during 2022.