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The Government will Clinically Trial the Red and White Vaccine on Humans


Merdeka.com – The government is boosting the production of red and white vaccines. Director General of Pharmaceutical Chemical and Textile Industry (IKFT) of the Ministry of Industry, Muhammad Khayam said clinical trials on humans will be carried out in the near future.

Referring to the timeline for the production of the red and white vaccine by Universitas Airlangga and PT Biotis Pharmaceutical Indonesia, the first phase of preclinical testing has been completed.

“Now the second stage of pre-clinical trials on Macaca animals is being carried out, the implementation of clinical trials on humans will also begin in the near future,” he said in a Hearing Meeting with Commission VII, DPR RI, Wednesday (15/9/2021).

With this achievement, he hopes that in January 2022 the clinical trial process can enter phase three. Furthermore, it can enter the registration stage, scale up mass production, to commercial.

Referring to the roadmap displayed by Khayam, the manufacture of this red and white vaccine went through several stages. First, in the first quarter of 2021, upscaling the prototype, then in the second quarter of 2021 it will enter the realm of pre-clinical testing.

Next quarter III-IV 2021, entering a clinical trial that includes three phases, at this stage assistance and submission of EUA BPOM are also carried out. Then, in quarter II-IV 2022, it will enter the registration stage, followed by scale-up of mass production in the fourth quarter of 2022, and is expected to lead to the commercial sector.

In the development of this red and white vaccine using virus isolates from Indonesia. This means that the process of making vaccine seeds is taken from samples in Indonesia and refers to viruses that are contagious in Indonesia.

“So it is more suitable and effective for Indonesia,” he said.

He emphasized that there were several important points in the development of this red and white vaccine. These include speed, effectiveness, and independence for a better meaning for Indonesia and to support national independence in preventing Covid-19.

Other Universities

Apart from Airlangga University in collaboration with PT Biotis Pharmaceutical Indonesia, there are several other universities that are also developing red and white vaccines. In addition to the development carried out mainly by the Eijkman Institute, there are other universities that are also developing red and white vaccines with different platforms.

Among them, the Eijkman LBM with a recombinant protein subunit platform with a Yeast Excretion System and Inactivated Virus. Then LIPI with Recombinant Fusion Protein Whole Genome Sequencing Virus Sars-CoV-2.

Then, the University of Indonesia with DNA, mRNA, and Virus Like Particles vaccines. Furthermore, ITB with Vector adenovirus, UNAIR with Adenovirus, Adeno Associated Virus Based, and Inactivated Virus, and UGM with Recombinant Protein.

“We from the Ministry of Industry as a regulator who is responsible for vaccine production, of course, encourage investment from within the country and abroad for the development of this vaccine,” he said.

The Ministry of Industry is currently focusing on how this production can take place in a sustainable manner, including in the economic feasibility sector. One of them is by encouraging investment incentives. “This investment incentive, after the trial period will enter the commercial aspect, this cannot be separated from the economy, the government through the Ministry of Industry encourages investment incentives,” he said.

In addition to investment incentives, his party will also prepare Super Deducted Tax incentives, which are used as incentives for research results that are entirely carried out domestically.

“Therefore, the government will provide a compensation of 300 percent, this is indeed the regulation that has already been issued, meaning how this consortium can enjoy the incentives provided by the government,” he explained.

Information, this red and white vaccine development consortium consists of various institutions, including pharmaceutical companies and universities.

Headed by the Eijkman Institute, the consortium has partners including Bio Farma, BalitbangKes, LIPI, Balitvet, and Universities. Meanwhile, in the ministry and institutional sector, there is the Ministry of Trade which covers imports.

Then, BRIN which covers research, the Ministry of Health and BPOM which covers distribution, and the Ministry of Industry which covers production and manufacturing.

Reporter: Arief Rahman H.

Source: Liputan6.com [azz]

Also read:
Eijkman: Red and White Vaccine Expected to Meet 50 Percent Needs
BRIN: Red and White Vaccine Emergency Circulation Permit Targeted Mid-2022
List of 8 Covid-19 Vaccine Producers in the World, Some are from Indonesia
Head of Research Team Says Red and White Vaccine Can Neutralize Delta Variant
BPOM Gives CPOB Certificate for Red and White Vaccine to PT Biotis

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