Phase III trial for COVID-19 vaccine, S-268019, initiated

Japanese pharma major Shionogi (TYO: 4507) today announced that it has initiated a global Phase III placebo-controlled onset prevention trial in Vietnam of a prophylactic vaccine candidate (code No: S-268019) for COVID-19, caused by the novel coronavirus (SARS-CoV-2) infection.

The primary endpoint of this clinical trial is the incidence rate of COVID-19 with confirmed infection with SARS-Cov-2. In this trial, the onset prevention effect and safety of two doses of S-268019 will be assessed by comparison with placebo.

A placebo-controlled onset prevention trial is the conventional evaluation method for vaccine development. Even now, there are many countries where the supply of vaccines is inadequate. In order to contribute to effective countermeasures for global health, the company is conducting this trial. This time, Shionogi was able to initiate this clinical trial with the support of the Vietnam government, which supported this purpose and the construction of a large-scale clinical trial infrastructure in Asia.1