New Facts Nusantara Terawan Putranto Vaccine, Antigen Virus Originated From America Not Indonesia

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JAKARTA - The Food and Drug Administration (BPOM) admitted, Vaksin Nusantara developed by former Minister of Health (Menkes) Terawan Agus Putranto has not been able to proceed to the advanced clinical trial stage.

There are several conditions that have not been met in the development of vaccines, namely How to Test a Good Clinical Practical, Proof of Concept, laboratory practice (Good Laboratory Practice) and How to Make Good Manufacturing Practice.

IDI member and Komnas Special Assessor of COVID-19 Vaccine Dr.dr.Anwar Santoso, SpJP(K) said, in addition to being hindered in the condition there are some technical constraints that have not been met by Vaksin Nusantara researchers.

"There are some technical things that have not been met by the researchers of Vaksin Nusantara which is related to good clinical practice and good manufacturing practice and there are some problems in good medical practise," Anwar said in an electronic message received by reporters, Wednesday, April 14.

The next problem is that vaksin Nusantara antigen is not derived from Indonesian virus but America.

"The antigen is not derived from the Indonesian virus but obtained from the Americas that we do not know exactly how the genoric sequence, straight what the next virus obtained from america," beber Anwar.

Previously, the Head of the Food and Drug Administration (BPOM) Penny K. Lukito explained why it did not give permission for the COVID-19 Nusantara vaccine to conduct phase II clinical trials.

Penny said, the team of vaccine researchers by former Minister of Health Terawan Agus Putranto repeatedly ignored the results of the request and evaluation bpom.

In fact, based on the results of phase I clinical trials by BPOM, Nusantara vaccine is considered to have not met many rules of clinical trial stages, including good manufacturing practice and good clinical practice.

"Commitment correction action or prevention action has been requested from the beginning, but ignored, ignored, ignored. Still can't, back to back. So various aspects, good clinical practice and good manufacturing practice for vaccine production have not been met," Penny said in a statement quoted on Wednesday, April 14.

Penny admitted that it has not passed the clinical trial phase I of nusantara vaccine, so it has not been able to get approval for phase II. Conceptually, nusantara vaccine is also not valid and the data is still incomplete.

Moreover, so far there have been no reports of improvement from the nusantara vaccine research team to BPOM. "We have given the findings, when they can give until now we have not received," he said.

Penny then invited the nusantara vaccine research team to make improvements related to procedures and rules in order to meet the approval of phase I clinical trials.

"We can not stop, please correct the proof of concept, the data needed for proof of validity, validity of stage 1 clinical trials. Only then do we decide if we can step up," he explained.