JAKARTA - PT Kalbe Farma Tbk (Kalbe) has received approval from the Food and Drug Supervisory Agency (BPOM) to conduct phase IIB and III clinical trials for the COVID-19 vaccine from South Korea, Genexine or GX-19N in Indonesia. The implementation of clinical trials will begin in July 2021. This vaccine is claimed to be able to ward off or protect against various variants of COVID-19.
The Head of the Research Team for the GX-19N COVID-19 vaccine clinical trial, Iris Rengganis, said that his party had studied the GX-19N vaccine deoxyribonucleic acid (DNA) from Genexine. He considered that the vaccine was very good at providing protection against various new variants of COVID-19.
"We have studied the DNA of the GX-19N vaccine from Genexine, and it appears that this vaccine has excellent potential to provide protection against various variants of the COVID-19 virus and also the possibility of a longer period of protection," he said at a virtual press conference, Friday. , July 9th.
Iris said the GX-19N COVID-19 vaccine is different from other COVID-19 vaccines. First, the DNA-based GX-19N vaccine that encodes more viral proteins.
"So it has the potential to produce higher antibodies and last longer in the body, thus providing better protection against COVID-19," he said.
Second, the GX-19N vaccine also has the potential to provide protection against parts of the virus that rarely mutate. So that the GX-19N vaccine is expected to provide protection against new variants of COVID-19.
"Thirdly, the GX-19N vaccine does not contain adjuvants (additives in the vaccine) so it has the potential to be given to people who have a weak immune system," he said.
Fourth, from the safety data for stage 1 and stage 2A, the GX-19N vaccine showed safe results with mild and transient side effects.
"Finally, this vaccine will be given into the muscle using a special device that will increase the delivery of the vaccine directly into muscle cells," he explained.
On the same occasion, the Acting Director-General of Disease Prevention and Control of the Ministry of Health, Maxi Rein Rondonuwu said the DNA of the GX-19N vaccine from Genexine, South Korea, has excellent potential to provide protection against various variants of COVID-19.
"The safety for the GX-19N vaccine is also seen to be very good because it does not use viral vectors and adjuvants," he said.
The Ministry of Health, said Maxi, hopes that all stages of vaccine development can be followed properly, so that vaccines can be used safely. For your information, the plan is that the GX-19N vaccine will be clinically tested by PT Kalbe Farma Tbk.
| BERITA 09 Jul 2021 17:15
Kalbe has also obtained a permit from the Food and Drug Supervisory Agency (BPOM) to conduct clinical trials. On the interim side of the analysis for the safety and efficacy or the ability of the vaccine to trigger immunity against COVID-19 infection, it is targeted to be carried out by the end of 2021.
Meanwhile, the Head of BPOM, Penny K. Lukito said that the clinical trial that Kalbe would later carry out was an important step in obtaining efficacy and safety data to support the COVID-19 vaccine registration process.
"BPOM hopes that the implementation of clinical trials meets scientific aspects and upholds research ethics in accordance with guidelines for good clinical trials," said Penny.
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 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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