The State Rejected The Nusantara Vaccine
JAKARTA - Former Health Minister Terawan Agus Putranto proudly showed off his COVID-19 vaccine at a meeting at the House of Representatives (DPR). Terawan claims the vaccine, which he named the Nusantara vaccine, can be a solution for people with severe comorbidities and those with autoimmunity.
Terawan explained that the Nusantara vaccine is based on autologous dendritic cells or components of white blood cells, which are then exposed to the antigen from Sars-Cov-2. Therefore, according to Terawan, the Nusantara vaccine will have individual uses for the vaccination target.
"As the Minister of Health, I participated in the activities of the citizens who wanted to develop cell dendritic-based vaccines. Of course, they are autologous, individual, and of course very, very safe", said Terawan in the agenda of the Joint Commission IX Working Meeting at the Parliament Complex, Senayan, Jakarta, Wednesday, March 10.
The development and clinical trial of this vaccine is a collaboration between PT Rama Emerald Multi Sukses (Rama Pharma) with AIVITA Biomedical from the United States, Diponegoro University, and Dr. Kariadi Semarang.
Terawan said, since 2015, he has developed dendritic cells at the cure center cell at the Gatot Subroto Army Hospital. Due to the development of the COVID-19 pandemic in Indonesia, he also admitted that he immediately took the initiative to develop a dendritic cell-based virus.
Terawan also said that so far his party had published various international scientific journals about this research. It's just that the journal is still mostly based on dendritic cells for cancer, not for COVID-19.
The Weaknesses and strengths of The Nusantara Vaccines
A Biotechnology researcher at Universiti Putra Malaysia, Bimo Ario Tejo explained that there are advantages and disadvantages of vaccines using dendritic cells (DC).
The advantages include that it can be designed more specifically by using special antigens to activate dendritic cells. Then it can activate T cells and it is suspected that the immunity lasts longer than conventional inactivated vaccines.
Meanwhile, the drawback is that it is a long process and requires special facilities so that it is not suitable for a mass vaccination program.
"The cost is very expensive compared to conventional vaccines", said Bimo as quoted on Wednesday, March 10.
The Pros and cons of The Nusantara Vaccines
In the meeting that took place at the House of Representatives Building, the Head of the Food and Drug Supervisory Agency (BPOM) Penny Lukito revealed several things in the Nusantara Vaccine research. According to her, this vaccine research is not in accordance with medical principles.
Among other things, there are differences in the location of the study with the previous parties who volunteered as the ethics committee.
"The fulfillment of the rules of good clinical practice was also not carried out in this study. The ethics committee of the Gatot Subroto Army Hospital, but the implementation of the research is at Dr. Kariadi Hospital", said Penny in a joint working meeting with the DPR Commission IX, Wednesday, March 10.
In fact, she said, each research team must have an ethics committee in place of the research implementation that is responsible for the implementation and safety of research subjects. In contrast to Penny, DPT members actually support the vaccine Terawan's findings can be developed.
Member of Commission IX DPR RI from the PDIP Party faction, Rahmad Handoyo, actually accused Penny K. Lukito of not being independent. The accusation follows the tough licensing effort for the second clinical trial of the Nusantara vaccine.
Rahmad considers the Nusantara vaccine initiated by Terawan Agus Putranto as if it was complicated in the process. Even though the results of phase I clinical trial showed no serious side effects that occurred in the 30 volunteers.
"BPOM cannot possibly be forced, and the law says BPOM is the mandate of the people to control drugs. Only, from this discussion and findings from our friends during a work meeting in the area, Semarang, that the Head of BPOM Penny K. Lukito is not independent", said Rahmad in the agenda of the DPR Commission IX Joint Working Meeting, Wednesday, March 10.
The Nusantara Vaccine Team give up
The support for rejection of the discovery of vaccines has made the research team pessimistic about the Nusantara vaccine being used domestically. The Indonesian vaccine research team admitted that they gave up if the government was forced to stop the clinical trial process.
This attitude was expressed following a decision by the Food and Drug Supervisory Agency (BPOM) which had not yet granted the Clinical Trial Implementation Approval (PPUK) for clinical trial II. BPOM previously assessed that there were still clinical principles that were not fulfilled at the clinical trial phase I of the vaccine made by former Health Minister Terawan Agus Putranto.
According to the research team, so far it has met clinical standards for vaccine research and development. Starting from pre-clinical trials in animals to phase I clinical trials targeting humans.
Even so, the team acknowledged that pre-clinical testing on animals was not carried out in Indonesia, but was carried out by a sponsor, namely AIVITA Biomedical from the United States.