More Immune To COVID-19, Check Out The Advantages Of Genexinde's GX-19N Vaccine And Kalbe Farma Owned By Conglomerate Boenjamin Setiawan

JAKARTA - PT Kalbe Farma Tbk has obtained a clinical trial permit for the Genexine or GX-19N vaccine for the corona virus. This vaccine is targeted to be circulated and injected into the public starting at the end of 2021.

The GX-19N vaccine is a COVID-19 vaccine developed by a consortium of pharmaceutical companies from South Korea, namely Genexine, Binex, the International Vaccine Institute (IVI), GenNBio, the Korea Advanced Institute of Science & Technology (KAIST), and Pohang University of Science & Technology. Currently, the GX-19N vaccine has gone through the process of preclinical testing and the first and second stages of clinical trials in its home country.

Meanwhile, Kalbe has just obtained a phase 2b/3 clinical trial permit from the Food and Drug Supervisory Agency (BPOM). Clinical trials will start from July to December involving a thousand volunteers.

In the clinical trial process, the company owned by conglomerate Boenjamin Setiawan will cooperate with the University of Indonesia, Cipto Mangunkusumo National General Hospital, the Faculty of Krida Wacana University, and Gadjah Mada University.

After the clinical trial is declared successful, BPOM will decide to grant emergency use authorization. With EUA approval, vaccines can be produced or widely distributed. In the first phase, Kalbe committed to bring in 10 million ready-made vaccines from Genexine Inc.

Genexine Inc CEO Young-Chul Sung said many countries were involved in the clinical trial process of the GX-19N vaccine. Besides Indonesia, these countries are Turkey, India, United Arab Emirates, Mexico, Peru, Colombia, Malawi, South Africa, Czechoslovakia, and Poland.

"We will recruit a total of 30,148 volunteers," he said.

Genexine or GX-19N vaccine is claimed to have a number of advantages over other vaccines. The Head of the Research Team for the GX-19N COVID-19 vaccine clinical trial, Iris Rengganis, revealed that he had studied the DNA of the GX-19N vaccine from Genexine Inc.

"It seems that this vaccine has very good potential to provide protection against various variants of the COVID-19 virus and also the possibility of a longer period of protection. The safety for the GX-19N vaccine is also seen as very good because it does not use viral vectors and adjuvants," said Iris. , Friday, July 9th.

Iris explained that in Indonesia the GX-19N vaccine clinical trial will recruit 1,000 subjects with the research center located in FKUI, RSCM as a referral hospital and several satellite hospitals spread across Jakarta, Depok, Bekasi, Yogyakarta, Solo, and Klaten.

He explained that the clinical trial of the COVID-19 GX-19N vaccine phase 2b/3 was in collaboration with the Faculty of Medicine, University of Indonesia-Cipto Mangunkusumo National General Hospital, and also in collaboration with other medical faculties, namely the Faculty of Medicine and Health Sciences, Krida Wacana University, Faculty of Medicine. Medicine, Public Health, and Nursing Universitas Gadjah Mada and other partners.

Iris said that the GX-19N COVID-19 vaccine is different from other COVID-19 vaccines, because the GX-19N vaccine is DNA-based, which encodes more viral proteins so that it has the potential to produce higher antibodies and last longer in the body.

This, he said, could provide better protection against COVID-19.

The GX-19N vaccine also has the potential to provide protection against parts of the virus that rarely mutate, so the GX-19N vaccine is expected to provide protection against new variants of COVID-19.

This GX-19N vaccine does not contain adjuvants or additives in the vaccine, so it has the potential to be given to people who have a weak immune system.

"From the safety data for stage 1 and stage 2a, the GX-19N vaccine shows safe results with a description of mild and temporary side effects," he said.

Another advantage is that this vaccine will be given into the muscle using a special device that will increase the delivery of the vaccine directly into muscle cells to get better results.

Iris Rengganis also said, Genexine vaccine is safe for people with immune or autoimmune systems. The reason is that this vaccine does not contain adjuvants or additives that function to increase immunogenicity.

"This GX-19 vaccine does not use adjuvants at all. Therefore, special tools are needed so that the vaccine penetrates well into the body and the antibodies formed are hoped to be used for people with impaired immunity," he said.

This vaccine is also touted to be more stable and can be stored at a temperature of 2-8 degrees Celsius because it is DNA-based.

"After being injected with Genexine, we hope that in 14 days to 18 days (GX-19N) can form immunity like vaccines in general. But this depends on a person's immunity," said Iris.

Director of PT Kalbe Farma Tbk as well as President Director of Kalbe Genexine Biologics, Sie Djohan, claimed that the price of the GX-19N vaccine would not be more expensive than other COVID-19 vaccines that have entered Indonesia. These include Sinovac, AstraZeneca, and Sinopharm.

"Because Genexine and Kalbe agreed that this project is not for profit, but to present a vaccine that can be useful for the community," said Djohan in a webinar, Friday, July 9, 2021.

Djohan said that his party has not been able to determine the price of the GX-19N vaccine because it is still in the development process. However, he promised that the price of Genexine vaccine would not be more expensive than other vaccines currently available in Indonesia.

"We with Genexine and Kalbe agreed that this project is not for profit, but a project that brings vaccines so that it can be more useful for the Indonesian people," said Djohan.

According to him, the Ministry of Health will determine the use and distribution of the vaccine. Will it be used as an additional mutual cooperation vaccine or a government program vaccine?

For the mutual cooperation program or free vaccines, the Ministry of Health will decide," he said.

However, this Genexine vaccine is targeted to produce 10 million doses by the end of 2021. The vaccine with the brand name GX-19N is starting to enter the clinical trial phase 2b/3 as of July 2021 for those aged 18 years and over.

"If clinical trials run smoothly. Hopefully this vaccine can be presented by the end of this year. That's the hope of all of us," he hoped.

According to Djohan, production will be carried out after a clinical trial process for about six months. The effectiveness of the vaccine in general can be seen from at least 150 cases of infection.

Later, he said, the results of the analysis will be the basis for consideration by the Food and Drug Supervisory Agency (BPOM) whether it is adequate to obtain emergency use authorization (EUA) while continuing to observe antibody levels for the next 6 months.

He added that clinical trials would start as soon as possible even though hospitals were currently full due to the surge in COVID-19 cases. The study will be conducted on people aged 18 years and over with the hope that there is a combination of 25 percent are elderly people (elderly).

Regarding the use for children, Djohan said there should be more clinical trials specifically for those under 18 years old.

"So the results of the phase 2b/3 clinical trial have not produced data whether it can be used for children or not. A separate clinical trial is needed," he explained.

In this spirit, Head of BPOM Penny K. Lukito emphasized, the clinical trial that Kalbe will later carry out is 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 vaccine clinical trials.