Improve Coordination between BPOM and Researchers

KOMPAS/ADITYA PUTRA PERDANA

Activity of officers at the Clinical Pathology Laboratory of Dr. Kariadi Hospital, Semarang, Central Java, Wednesday (17/2/2021).

JAKARTA, KOMPAS — While there have been ups and downs in the development of the Nusantara vaccine, its scientific basis should continue to be prioritized. The research conducted should ensure that the Covid-19 vaccine is safe, of good quality and effective. Coordination between the Food and Drug Monitoring Agency (BPOM) and the Nusantara vaccine research team should also be improved.

Chairman of the Expert Team concurrently National Covid-19 Task Force Spokesman Wiku Adisasmito said in Jakarta on Thursday (15/4/2021) that the Nusantara vaccine or dendritic vaccine was the vaccine type worked out in the United States and subject to clinical trials in Indonesia. The government supports the development of all Covid-19 vaccines, including the Nusantara vaccine, as long they fulfill relevant requirements.

“In principle, all vaccines that will be given to the public must obtain authorization from the BPOM, especially with regard to the aspects of safety, efficacy and worthiness. The Nusantara vaccine development team is expected to work in better coordination with the BPOM so that the issue related to this vaccine can be settled soon,” said Wiku.

Also read: Vaccine Development Must Meet Standard

The Nusantara vaccine is being developed by a team comprising of personnel from the Health Research and Development Agency (Balitbangkes) of the Health Ministry, Gatot Soebroto Army Central Hospital (RSPAD), Dr Kariadi Central General Hospital (RSUP) Semarang and Diponegoro University. The research is sponsored by PT Rama Emerald or PT Aivita Indonesia in cooperation with the Health Ministry’s Balitbangkes.

The vaccine makes use of a mixture of dendritic cells originating in the person as a target of vaccination, the antigen of SARS-CoV-2 spike protein and the granulocyte-macrophage colony–stimulating factor/GMCSF (sarmogastrim) as a growth factor. The antigen and GMCSF are not yet produced in Indonesia so they have to be imported from the US.

All vaccines that will be given to the public must obtain authorization from the BPOM.

When for asked for confirmation on the matter, Head of Gatot Soebroto RSPAD, Budi Sulistya, declined to respond. Kompas had tried to contact the hospital chief from Wednesday (14/4). When contacted again on Thursday (15/4), Budi refused to speak.

Also read: Covid-19 Vaccine Embargo

KOMPAS/ADITYA PUTRA PERDANA

Examination tube at the Clinical Pathology Laboratory of Dr. Kariadi Hospital, Semarang, Central Java, Wednesday (17/2/2021).

Coordination required

BPOM Head Penny K Lukito said earlier that researchers of the Nusantara vaccine had not yet arranged coordination with the BPOM concerning the realization of their phase-two clinical trial. The BPOM even asked the researchers to carry out another preclinical trial because the data they submitted was not yet adequate.

The inadequate trial results covered the vaccine’s safety, the vaccine’s capability to form antibodies and the quality evidence of the vaccine product. Besides, based on an inspection of the BPOM, the vaccine’s development had not yet conformed to the principles of good manufacturing practice (GMP), good laboratory practice (GLP) and good clinical practice (GCP).

Also read: We Need Greater Vaccine Variety

The inspection found incompliance with the required norms, among others, the vaccine product was made in an unsterile condition, the trial method was not validated and standardized, and there was data that showed inconsistency. Research subjects that should not been chosen, such as those who had antibodies, were included in the research.

Unexpected complaints

The other thing in the spotlight was the discovery of unexpected complaints among the subjects in the first-phase clinical trial. Twenty out of 28 trial subjects or 71.4 percent experienced unexpected complaints at grades 1 and 2, like local pain, muscle pain, joint pain, headache, rash, itching, fever, coughing, runny nose, weakness and nausea.

Grade 3 unexpected complaints constitute one of the criteria for clinical trial discontinuation as indicated in clinical trial protocols.

Meanwhile, six research subjects underwent unexpected complaints at grade 3 such as hypernatremia (high sodium concentration in the blood), increased blood urea and cholesterol.

“Grade 3 unexpected complaints constitute one of the criteria for clinical trial discontinuation as indicated in clinical trial protocols, but based on the research team’s information during the inspection by the BPOM, the clinical trial was not halted,” said Penny.

The data received by the BPOM also stated that all main components of the dendritic vaccine making were imported from the U.S. such as the antigen, GMCSF, cell building medium and instruments for preparations.

“If technology is to be transferred and everything made in Indonesia, it will take a long time because the pharmaceutical industry cooperating with Aivita Biomedica Inc does not own manufacturing facilities for biological products and two to five years are needed for their development in Indonesia,” she added.

This article was translated by Aris Prawira.