[Asia Economy Reporter Seo So-jeong] Genexine (CEO Sung Young-chul and Woo Jung-won) announced on the 7th that it has received approval from the Indonesian Food and Drug Authority (BPOM) for the Phase 2 and 3 clinical trials of its COVID-19 vaccine, ‘GX-19N.’
This is the first time a domestically developed vaccine has received approval for global Phase 2 and 3 clinical trials. The GX-19N, developed by the Genexine consortium (Genexine, GenNBio, Vinex, SL Vaxigen, POSTECH, International Vaccine Institute, KAIST), is a DNA-based vaccine.
The clinical trials will begin in Indonesia and proceed as Phase 3 trials involving 10,000 healthy adults across multiple countries, with plans to expand to 30,000 participants in the future.
To expedite the clinical process, Genexine will conduct Phase 2 and 3 trials simultaneously, confirming safety in the initial 300 healthy adults enrolled before immediately advancing to Phase 3.
In Genexine’s global Phase 3 trial, 50% of participants will receive GX-19N, while the other 50% will receive a placebo to evaluate efficacy by assessing protective ability. The vaccine must demonstrate at least 60% prevention effectiveness to gain approval for use.
Indonesia has the fourth largest population in the world, approximately 275 million people. Especially with the recent spread of the India-origin ‘Delta variant,’ daily confirmed cases, which had dropped below 3,000 in May, have surged to nearly 30,000 recently, making recruitment and progress of clinical trial participants relatively easier.
Meanwhile, Genexine is preparing global Phase 2 and 3 trials in various countries, starting with Indonesia and expanding to South America and Africa.
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