Foreign Researchers Become The Reason BPOM Rejects Nusantara Vaccine

Health Officials inject the COVID-19 vaccine to a State Civil Apparatus (ASN) at GOR Pekanbaru (Rony Muharrman/Antara)

JAKARTA - Head of the Food and Drug Administration (BPOM) Penny K. Lukito revealed the reason for his urung to give permission for the Approval of Clinical Trial Implementation (PPUK) phase II clinical trials against nusantara vaccines initiated by former health minister Terawan Agus Putranto.

Penny admitted that her party found many irregularities during the data validity process. So BPOM does not give the green light because the nusantara vaccine is considered not to pass the rules and ethics of research.

As such, in the results of studies and inspections on clinical trials phase I, the concept of vaccines claimed by the nation's children, it turns out that the research team is dominated by foreigners. In fact, the components of making dendritic cell vaccines are mostly obtained from expensive imported components.

"In the results of clinical trials of vaccine I, the discussion of the team of foreign researchers explained, who defended and discussed, who processed, at the time of our hearing. And proven the process of conducting clinical trials, the production process is all done by a team of foreign researchers," penny said in her statement, Thursday, April 8.

The foreign research team, penny continued, is a member of aivita biomedical sponsorship from the United States. He also revealed that the research team of Diponegoro University and RSUP dr. Kariadi Semarang did not contribute much in the process of clinical trials I vaccine nusantara.

"There is training of doctors at rsup Kariadi, but they just watch, do not do directly, because in question also they do not master," he explained.

In addition, said Penny, the component used in the phase I clinical trial research, is actually not eligible to enter the human body, because the components do not include pharmaceutical grade.

"That there are components that are really imported components and it is not cheap, plus there is another one at the time of deepening obtained antigens that are used not in quality quality to enter the human body," explained Penny.

Penny said, the concept of dendritic vaccination will be done in the open. Whereas it should be an activity that utilizes dendritic is done sterile and closed.

"The way it works everyone will be taken blood samples to then be presented with a vaccine kit formed from dendritic cells. Then the cells that have known the antigen will be incubated for 3-7 days," he said.

Then the result will be injected into the body again. In the body, dendritic cells are expected to trigger other immune cells to form a memory defense system against Sars Cov-2.

"That means there has to be a barrage of validation that proves that the product before it's put into the subject is completely sterile, not contaminated, and it's not fulfilled," Penny said.