The long polemic between BPOM and the Nusantara Vaccine Team (VakNus) led by former Minister of Health Terawan Agus Putranto (retired army doctor) finally met a common ground that calmed the two parties. They concluded after signing an MoU at the Gatot Subroto Army Hospital, Jakarta to solve the issue.
Chief of Staff of the Army, Gen. Andi Perkasa, head of the Food and Drug Supervisory Agency, Penny K Lukito, and Minister of Health Budi Gunadi signed the MoU at the army hospital. It said that the VakNus team may start service-based research at the hospital.
There are several fundamental changes in the MoU signed on April 19, 2021. First, the vaccine is no longer uses the term vaccine but has changed to service-based research entitled "Service-Based Research Using Dendritic Cells to Increase Immunity to the SARS-CoV-2 Virus".
MoU signing
According to Kasad (Chief of Staff of the Army) Gen. Andi Perkasa, this research is not a continuation of previous research at Kariyadi Hospital, Semarang, nor a phase two clinical trial as stated by several members of Commission IX of the House of Representatives.
In addition to his statement, he also said that this research has nothing to do with the Indonesian vaccine. This is purely separate and new research based on dendritic cells to increase body immunity (immunotherapy). Hence, there is no need for a distribution permit from the BPOM as it is the patient's autonomy to decide whether they want to use the medicine or not.
Budi Gunadi Sadikin
"This research is not a continuation of previous research at Kariyadi Hospital, Semarang. Since it is not a vaccine but service-based research using dendritic cells to increase immunity against the SARS-CoV-2 virus, there is no distribution permit for BPOM to acquire. This research is also not commercial, but autologous. This means that it is only used for the patient himself autonomously,” said Chief of Staff of the Army General Andika Perkasa in his press conference at the army headquarters.
General Andika Perkasa
The second change is that currently BPOM is only tasked with providing research direction following scientific principles. Even so, the supervision and research are entirely at the Ministry of Health, no longer at BPOM.
"Currently, the Food and Drug Supervisory Agency (BPOM) is no longer in charge of supervising this dendritic cell service-based research. This is under the authority of the Ministry of Health. Regarding research, BPOM has the role of providing input and direction related to research under scientific principles," said the Head of BPOM, Penny K Lukito.
Penny K Lukito
Hopefully, this polemic ends. And the situation can immediately be conducive. BPOM can focus on monitoring drugs and food that are circulating and about to circulate. On the other hand, the VakNus team — if it can still be called that — could continue the dendritic cell service-based research according to the agreed contents of the MoU.
In the world of medicine and food, everything must be carried out on a scientific basis. And for that, there are already agreed provisions globally. However, the truth in the scientific world is not singular. There are enough stories to prove it. There is always another way to reach that truth.
Like the famous adage that "there are many roads to Rome", presumably what the dendritic cell team of the Gatot Subroto Army Hospital can benefit the whole society, despite the various controversies that surround it. It is the task of the team to provide a complete explanation to the public as potential volunteers and future users of the research service.