Do not Disregard the Standardization of Vaccine Research

The Food and Drug Monitoring Agency (BPOM) confirmed that research for the Nusantara vaccine cannot continue onto its second phase as many aspects need to be corrected according to scientific principles.

KOMPAS/RUNIK SRI ASTUTI

Head of the Food and Drug Administration (BPOM) Penny K Lukito while checking the Sinovac Covid-19 vaccine storage facility at the Sidoarjo Health Office, East Java, Tuesday (23/2/2021).

BANDUNG, KOMPAS – Controversy regarding the development of the Nusantara vaccine must be resolved immediately so as not to hamper COVID-19 vaccine needs in the country. For optimal results, research standardization should not be ignored.

Food and Drug Monitoring Agency (BPOM) head Penny K. Lukito emphasized, while reviewing the development of the Merah Putih vaccine at Bio Farma, Bandung, West Java, Friday (16/4/2021), that vaccine development must adhere to the existing standards as it concerns human safety.

“In Indonesia we must adhere to international standards to produce vaccines that are of good quality and can compete [with others]. The vaccine must meet standards of safety, quality, effectiveness and efficacy,” she said.

Research standardization applies equally across all vaccine research. One of which is conducting preclinical trials before conducting human clinical trials of the first, second and third phases.

Because there are findings and corrections from the clinical trial that need to be amended.

Preclinical animal testing is importing for monitoring immune responses in order to protect clinical trial volunteers. “If this [preclinical trials] is not done and they skip right to clinical trials, there are bound to be mistakes,” said Penny.

Regarding the development of the dendritic cell-based Nusantara vaccine, Penny said the first phase of the clinical trial had been completed. “According to the BPOM’s assessment of the first phase of the clinical trial, [research] cannot go onto the second phase. Because there are findings and corrections from the clinical trial that need to be amended,” she said.

Also read: Vaccine Development Must Meet Standard

KOMPAS/ADITYA PUTRA PERDANA

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

According to the BPOM’s inspection, development of the Nusantara vaccine has not met the applicable principles of the scientific process. This includes good manufacturing practice (GMP), good laboratory practice (GLP) and good clinical practice (GCP).

Gadjah Mada University (UGM) pharmacology and clinical pharmacy professor Zullies Ikawati said the research must adhere to vaccine testing standards in order to ensure the safety of the research subjects. “There is a limited availability of the COVID-19 vaccine in the world, so it is necessary to accelerate domestic vaccine research. However, that does not mean scientific guidelines can be sidelined,” she said.

Meanwhile, a dendritic cell-based vaccine has been deemed inefficient to control the COVID-19 pandemic because it is not suitable for mass vaccination.

No longer involved

When asked about the involvement of Diponegoro University (UNDIP) in the development of the Nusantara vaccine, UNDIP acting deputy rector III Dwi Cahyo Utomo did not say much. Since the beginning, the research team from UNDIP has helped researchers under the coordination of Dr Kariadi General Hospital (RSUP), Semarang.

Parna from the hospital’s public relations confirmed that research for the Nusantara vaccine was no longer taking place there. “Not anymore. I’m sorry I cannot comment further,” Parna said.

Also read: Improve Coordination between BPOM and Researchers

UGM, which was also included on the list of research teams for the Nusantara vaccine’s clinical trials, resigned from the research project due to a lack of cooperation. The resignation letter was presented to the Health Ministry in February 2021.

KOMPAS/ADITYA PUTRA PERDANA

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

UGM Faculty of Medicine, Public Health and Nursing deputy dean Yodi Mahendradhata initially listed a number of researchers from UGM on the list for the vaccine’s research. “We just found out through the media that the research was ongoing at Dr Kariadi Hospital. We were not involved,” he said.

Clinical trials of the vaccine were also communicated informally since December 2020 until the issuance of Decree No. HK 01.07/MEN-KES/11176/2020, which lists the names and positions of all UGM researchers in the team. The researchers, however, were unaware of the decree.

Also read: We Need Greater Vaccine Variety

Yodi said there should have been a cooperation agreement prior to beginning the research to clarify the role of each institution. Moreover, his party never even saw the research protocols.

Merah Putih vaccine

Regarding the Merah Putih vaccine, Penny said, its development across various platforms will enrich the experiences and enhance Indonesian researchers’ abilities in mastering vaccine technology.

Also read: Covid-19 Vaccine Embargo

Clinical trials of the Merah Putih vaccine developed by Airlangga University using an inactivated virus platform are targeted for completion in the fourth quarter of 2021, with mass production targeted in early 2022. A vaccine developed by Eijkman Institute for Molecular Biology using a recombinant protein is targeted for mass production in the second half of 2022. “At the same time, production facilities are being prepared at Bio Farma,” she added.

Bio Farma director Honesti Basyir said his party was preparing a production facility for the Merah Putih vaccine. The production building was used to increase the vaccine production capacity. “If it is not enough, we will cooperate with the private sector,” he said.

This article was translated by Kesya Adhalia.