First phase 3 clinical trials of South Korean COVID-19 vaccine: Bioscience's test plan is approved

Seoul: South Korean Bioscience's vaccine for COVID-19 has entered Phase 3 clinical trials for the first time as the vaccine developed in Korea.

The Ministry of Food and Drug Safety announced on the 10th that it thoroughly verified the safety and scientific validity of the clinical trial plan and approved the clinical trial plan of the COVID-19 vaccine 'GBP510' developed in Korea.

GBP510, which is being developed by SK Bioscience, is the 'recombinant vaccine' that injects a COVID-19 virus surface antigen protein by using recombinant DNA technology to induce immune response.

This SK Bioscience' vaccine has been developed to improve immune effects by generating antibodies a lot through the technology that increases antigen exposure.

The Phase 3 clinical test will be conducted as the 'comparative clinical trial' method that demonstrates the vaccine's efficacy by comparing it with other previously approved vaccines.

The Phase 3 clinical trials set the AstraZeneca as the vaccine for control group, and will be conducted on 3,990 adults aged 18 or older (3000 for test vaccine and 990 for control group vaccine). Clinical trials will be carried out not only in Korea but also in various countries including Southeast Asia and Eastern Europe.

The Ministry of Food and Drug Safety said, "The approval of the clinical trial is meaningful that it has taken the first step toward domestic vaccine self-sufficiency, starting with phase 3 clinical trials of Korean vaccine in the situation of COVID-19 pandemic."