JAKARTA - Deputy Chairman of Commission IX of the DPR Melkiades Laka Lena admitted that he was confused by the attitude of the Food and Drug Supervisory Agency (BPOM) regarding the Nusantara vaccine. According to him, there was no good communication between the vaccine researcher, the idea of former Minister of Health Terawan Agus Putranto and the BPOM.

This was discovered when Commission IX of the DPR visited Dr. Kariadi Semarang some time ago.

"Our impression is that the researchers and BPOM are not in harmony with the communication. Because according to the researchers, they have already conveyed the requested information, according to BPOM it is not what they expected and recommended," said Melki in a discussion on the Trijaya Polemic entitled Who Likes Nusantara Vaccines virtually, Saturday, April 17.

Melki said that his party was a witness to the submission of data from researchers to BPOM. Because there had been the handover, the discussion was continued with Commission IX of the DPR by inviting all parties including BPOM, researchers, and Terawan as initiators, as well as objective experts.

The forum in the DPR is a discussion which in our opinion is scientific academic. We got clear information that from the phase 1 clinical trial, it turned out that a good safety aspect was obtained. Various kinds of information were obtained that volunteers were not able to experience any harmful effects from this dendritic vaccine, "explained the Golkar politician.

In conclusion, said Melki, there is no reason whatsoever for not being able to continue the phase 2 clinical trial. All parties involved in the meeting agreed that a week later there would be improvements to meet BPOM recommendations, and phase 2 clinical trials should have been given to the Nusantara vaccine.

"Because we discussed March 10, March 17, the meeting agreement should have been given and it was binding. Now BPOM is strange, how come it was not given to the second clinical trial (given, ed). It's not to the public, not the public. For millions of doses, OK, okay? but like this, how come volunteers are being detained again. The reason is that the pre-clinic has not yet been carried out, but the researcher answers that it has been done in America and the data is there, "he explained.

"Then there is another reason, foreigners who take part in the process, only foreigners do it while Indonesians don't do it well. That's insulting to the nation, what stupid people are our researchers?" continued Melki.

Melki reminded that in the conclusion of the meeting there were binding rules. There are consequences that must be carried out as part of the meeting that receives the recommendation.

"But we do not use this authority, actually legally it is enough for BPOM. Because all factions agree without exception, even everyone is ready to volunteer. If there is a different faction after that. The point is agreeing that the Nusantara vaccine is continued along with the Red and White vaccine pioneered by sir. Amin Subandrio et al, "said the East Nusa Tenggara legislator.

Melki also explained that the purpose of board members flocking to the Gatot Soebroto Army Hospital was to take another look at the research process suggested by BPOM itself.

"The researcher actually followed the advice from BPOM, didn't BPOM say the clinical trial at the Regional Army Hospital, then returned to its main house. There is also a note from BPOM that it has been perfected, what Colonel Jonny said yesterday at RSPAD would certainly meet the rules of following the provisions of BPOM and WHO. This record does not give any reason for us not to take part in the phase 2 clinical trial. So Commission IX officially encourages us, "said Melki.

Regarding the assumption that the Nusantara vaccine has a political odor, Melki considered that BPOM is now playing politics by gathering figures to express support for the institution.

"Now that BPOM is playing politics, we know who is driving it, information has already entered us. Then now BPOM has gathered a number of figures and states that BPOM is saving etc. This is not true, state institutions are gathering figures just to support him in defending what we are dismantling. "said Melki angrily.

Melki actually exposed that the BPOM had deceived the public by providing research data that deviated from the actual facts.

Previously, the BPOM explained that the Nusantara vaccine was not suitable for stage 2 clinical trials. In BPOM findings, 71.4 percent of clinical trial volunteers experienced unwanted events, in the form of muscle pain to itching.

In addition, there are a number of conditions that have not been met. Among them are good clinical trial methods, proof of concept, good laboratory practice and good drug manufacturing methods.

However, according to Melki, the data is actually different from the research results received by BPOM from researchers.

"BPOM explained that 71 percent is dangerous, you see, it has been explained in the DPR that there is no problem, how come it is problematic? This is what I checked again with Undip, they were nonchalant, how come BPOM could deceive the public. The data we gave A was said to be B, and the public was worried. with the Nusantara vaccine. So I can say that this could be categorized as public deception, "he said.

"The head of BPOM deceived the public by distorting the research data. This is what makes the head of BPOM not the DPR," said Melki.

Therefore, Melki asked BPOM to respect the results of the meeting at the DPR Commission IX at the joint meeting with related parties.

"Run! Don't play around making opinions anymore. This chaos is because BPOM is inconsistent," he said.


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