JAKARTA - The Ministry of Health (Kemenkes) stated that the GX-19N deoxyribonucleic acid (DNA) vaccine from Genexine, a biotechnology company from South Korea has excellent potential to provide more protection against various variants of COVID-19.
"Security for the GX-19N vaccine is seen as very good because it does not use viral vectors and adjuvants," said Acting Director General of Disease Prevention and Control at the Ministry of Health, Maxi Rein Rondonuwu, Friday, July 9.
Genexine's GX-19N vaccine is considered more resistant. With an estimate of protection in the longer term.
The Ministry of Health hopes that all stages of vaccine development can be followed properly. So that the vaccine can be used safely.
It is planned that the GX-19N vaccine will be clinically tested by PT Kalbe Farma Tbk.
The issuer has obtained permission from the Food and Drug Supervisory Agency (BPOM) to conduct phase 2b/3 clinical trials for the COVID-19 GX-19N vaccine in Indonesia. The clinical trial phase 2b/3 will begin in July 2021.
Head of BPOM, Penny K. Lukito said, the clinical trial that Kalbe will later carry out is an important step to obtain efficacy and safety data to support the registration process for the COVID-19 vaccine.
BPOM hopes that the implementation of clinical trials meets scientific aspects and upholds research ethics in accordance with guidelines for good vaccine clinical trials.
In Indonesia, the GX-19N vaccine clinical trial will recruit 1,000 subjects with the research center located at the Faculty of Medicine, University of Indonesia (UI), Tjipto Mangunkusumo Hospital (RSCM), as a referral hospital and several satellites spread across Jakarta, Depok, Bekasi. , Yogyakarta, Solo, and Klaten.
In the clinical trial process, Kalbe collaborated with the UI Faculty of Medicine, RSCM, the Faculty of Medicine and Health Sciences, Krida Wacana University, and Gadjah Mada University, to other parties.
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