Archipelago Vaccine Controversy
The development of the Nusantara Vaccine, which was initiated by former Minister of Health Terawan Agus Putranto, continues. Strangely, vaccine development, which should be based on scientific principles, has actually become political with the strengthening support from members of the DPR RI. In fact, a number of DPR members, who had previously been vaccinated with the Sinovac vaccine, admitted that they had become volunteers for the Nusantara Vaccine. In fact, the vaccine developed by RSPAD…
FINDINGS
Archipelago Vaccine Controversy
Jakarta. April 16, 2021 – The development of the Nusantara Vaccine, which was initiated by former Minister of Health Terawan Agus Putranto, continues. Strangely, vaccine development, which should be based on scientific principles, has actually become political with the strengthening support from members of the DPR RI. In fact, a number of DPR members, who had previously been vaccinated with the Sinovac vaccine, admitted that they had become volunteers for the Nusantara Vaccine. In fact, the vaccine developed by RSPAD Gatot Soebroto, RSUP Dr. Kariadi Semarang and Diponegoro University have not yet completed their permits, due to various problems.
First, the Food and Drug Supervisory Agency (BPOM) found that vaccine products were made not according to the rules. For example, conditions are not sterile, there is no standardization and validation in testing methods, and data recording is inconsistent.
Apart from that, 71.4 percent of the 28 test subjects experienced undesirable events in grades 1 and 2. For example, local pain, muscle pain, headache, joint pain, weakness, cough, fever and nausea. Six research subjects experienced undesirable events at level 3, such as increased sodium levels and blood urea levels and cholesterol.
Second, these various findings mean that BPOM has not issued a permit for phase II clinical trials. In fact, BPOM asked for preclinical tests to be repeated. Miraculously, a number of members of Commission IX DPR RI and politicians who have received the Sinovac vaccine actually admitted to following the stages to undergo vaccination with the Nusantara vaccine. They admitted that they had taken blood samples to be processed by the system Dendritic cells and the plan is to put it back in after kicking. This attitude seems to be challenging the BPOM authority, which to date has not given permission for phase II clinical trials. In fact, according to the Regulation of the Head of BPOM RI No. 9 of 2014 concerning Procedures for Approval of Clinical Trials, implementing parties who violate BPOM decisions regarding clinical trials may be subject to administrative sanctions. Sanctions can also be in the form of imprisonment and/or fines in accordance with statutory regulations for clinical trials that result in danger to human safety, public health, preservation of environmental functions, social harmony, national safety, and harm to the state.
Third, the Nusantara Vaccine does not meet the need for a mass COVID-19 vaccine. This vaccine uses a mixture of dendritic cells from each vaccination target, the SARS-CoV-2 antigen spike proteins, and GMCSF (sarmogastrim). This vaccine is very individual because each person's needs will be created from a single cell product from themselves.
This complicated process makes it difficult to answer the need for mass vaccination. Not surprisingly, no large vaccine company has participated in developing a similar type of vaccine. Based on data vaccine tracker (vaccine tracker), apart from the Nusantara Vaccine, this dendritic-based vaccine for COVID-19 was only developed by one startup company in China.
Fourth, the naming of the Nusantara Vaccine which seems to take the jargon of the work of the nation's children does not match the facts. The vaccine research sponsored by PT Rama Emerald or PT Aivita Indonesia in collaboration with the Ministry of Health's Balitbangkes took imported ingredients from the United States. These materials include antigen, GMCSF, cell production medium, and other preparation tools. So, is it true that the Nusantara Vaccine is from the nation's children and for the nation? Or is it just a joke? Science will answer this with green light evidence from BPOM.*
Reference:
https://tirto.id/jual-divacsinasi-Member-dpr-ikut-lagi-vaksin-nusantara-terawan-gcpD
https://www.kompas.id/baca/ilmu-knowledge-technology/2021/03/16/klaim-dan-realasan-vaksin-nusantara/
