JAKARTA - PT Kalbe Farma Tbk in collaboration with Genexine Inc, a company from South Korea is developing a COVID-19 vaccine. This vaccine will enter phase IIB and III clinical trials of the COVID-19 GX-19N vaccine. The clinical trial is planned to start in July 2021 for the next six months.
President Commissioner of PT Kalbe Farma Tbk, Irawati Setiady said clinical trials were conducted to conduct an interim analysis of the safety and efficacy or ability of the vaccine to trigger immunity against COVID-19 infection. Irawati said this clinical trial was carried out after obtaining permission from the Food and Drug Supervisory Agency (BPOM).
"Thank you to BPOM and the Ethics Committee for granting permission for this clinical trial and to the Ministry of Health for supporting this vaccine to be used by the people of Indonesia," he said at a virtual press conference, Friday, July 9.
Here are the facts about the COVID-19 GX-19N vaccine:
1. Genexine commits to supply 10 million vaccines
According to Irawati, currently the need for a COVID-19 vaccine in Indonesia is still not enough. As an innovation-based health company, Kalbe hopes that what it does will contribute to the prevention of COVID-19 in Indonesia.
"If the clinical trials phase IIB and III are considered successful and get approval for emergency use from the POM, the GX-19N vaccine can complement the existing vaccines. For this reason, Genexine has committed to supply 10 million doses of vaccine and proceed with transfer technology for local production," he said.
2. Can ward off the new variant 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.
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.
Third, 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. Fourth, from the safety data for stage I and stage IIA, 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, 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.
"Security for the GX-19N vaccine is also seen as very good because it does not use viral vectors and adjuvants. The Ministry of Health hopes that all stages of vaccine development can be followed properly, so that the vaccine can be used safely," he said.
3. Can not be used for children.
The Head of the Research Team for the GX-19N COVID-19 vaccine clinical trial, Iris Rengganis, said that the clinical trial of the GX-19N COVID-19 vaccine was only carried out with samples of adults aged 18 years and over. This means that this vaccine is not intended for use in children.
"In us (Indonesia) the GX-19N vaccine is only for adults," he said.
On the same occasion, Kalbe Farma Director Sie Djohan said that clinical trials were conducted for adult patients over 18 years of age, so the results of phase IIB and III trials have not produced data to answer whether this vaccine can be used for children.
"Can this vaccine be used for children? I think what we are currently doing clinical trials are for adult patients over 18 years old, maybe up to elderly patients. So the results of the IIB and III tests have not yet produced the data we need, can they be used? for children or not," said Djohan.
According to Djohan, to find out whether the COVID-19 GX-19N vaccine can be used in children, clinical trials on children must be carried out.
"To (know) that, we have to do separate clinical trials for children," he said.
However, Djohan did not explain further whether Kalbe would conduct a separate clinical trial of the COVID-19 GX-19N vaccine for children.
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.
4. Vaccines are not free
Kalbe said that the GX-19N vaccine for COVID-19 that will be produced by his company was not provided free of charge. This means, to get the vaccine, the cooperation between Kalbe and South Korea, the public must spend.
Kalbe Farma Director Sie Djohan said Kalbe Farma's management has not been able to determine the price of the GX-19N vaccine. Because, currently the process of clinical trials IIB and III will still be carried out.
"For the price itself, at this time we cannot give a definite price because it is still in the development process," he said.
However, Djohan emphasized that his party will try to set the price of the GX-19N vaccine below the average price of the COVID-19 vaccine that is currently being used. This means that the price will not exceed the existing vaccines.
According to Djohan, for this price the process will be coordinated with the biotechnology company Genexine, South Korea. This is because the GX-19N vaccine is a collaboration between Kalbe and Genexine.
"We will try our best to cooperate with Genexine, we want to make sure the price we offer later is certainly not more expensive than the vaccines that are currently being used," he said.
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