Genexine said Wednesday that Indonesia's National Agency of Drug and Food Control has approved the phase 2/3 clinical trial of the Covid-19 vaccine, GX-19N, making it the first Korean company to conduct a global phase 2/3 study.

The company will conduct phase 3 clinical trials in 10,000 healthy adults in several countries, starting with Indonesia. When the company confirms the therapeutic efficacy of GX-19N against Covid-19 variants in the study, it plans to recruit up to 30,000 subjects.

Genexine plans to enter both phase 2 and 3 clinical trials and begin phase 3 study immediately after confirming the safety of 300 healthy adults initially enrolled.

The revealed study plan for the global phase 3 clinical trial shows that the company will evaluate preventive efficacy by administering GX-19N to half of the participants and placebo to the rest.

Vaccines can receive regulatory approval only if they show at least 60 preventive effects against the virus to prove the efficacy in the same way with the existing vaccines.

Indonesia’s population nears 275 million, the fourth most populous country in the world. The country’s daily cases dropped below 3,000 in May, but the figure rapidly increased and passed 30,000 due to the recent spread of the Delta variant first found in India.

GX-19N is a DNA vaccine that simultaneously targets the spike antigen of the Covid-19 virus and the nucleocapsid (NP) antigen. It induces a broad and strong T-cell immune response, and it is expected to provide strong protection against various variants, the company said.

“There were no moderate or severe systemic side effects confirmed in the clinical trials conducted in Korea, and mild adverse events, such as muscle pain, fatigue, and headache, were also very low,” a Genexine official said. “GX-19Nhas been evaluated as a quite safe vaccine with very few systemic side effects such as thrombosis and myocarditis.”