Results of Shionogi's Phase II/III COVID-19 vaccine trial

Japanese drug major Shionogi (TYO: 4507) has presented results from the Japanese Phase II/III clinical trial of S-268019, a recombinant protein-based vaccine for COVID-19, caused by the novel coronavirus (SARS-CoV-2), at the 96th Meeting of the Japanese Association for Infectious Diseases.

This clinical trial was designed to evaluate the safety, tolerability and immunogenicity of S-268019 in Japanese adults (including naïve subjects, vaccinated subjects, and subjects with history of infection) and elderly individuals. This is an open label trial including more than 3,000 patients. The evaluation period is 28 days after the second inoculation (Day 57), and the observation period is one year after the second inoculation.

At the time of the interim analysis (Day 57 assessment completed for all subjects), solicited treatment-related adverse events (TRAEs) after inoculation were observed in many subjects, but no serious safety concerns were found, and tolerability was confirmed.