Vaccine Development Must Meet Standard

KOMPAS/ADITYA PUTRA PERDANA

Activity of officers at the Clinical Pathology Laboratory of Dr Kariadi Hospital, Semarang, Central Java, Wednesday (17/2/2021). In a different room, there is a Covid-19 test laboratory with a capacity of 300-400 examinations per day. There is also a research and development room for Nusantara vaccines, which has now been completed through phase I clinical trials.

JAKARTA, KOMPAS -- The development of Covid-19 vaccine in the country needs to be supported and comply with scientific principles and research standards. This is important to produce vaccines that will guarantee safety, security, quality and efficacy for the people.

Chairman of the Indonesian Doctors Association (IDI) Covid-19 Vaccination Advocacy Team, Prof. Iris Rengganis, when contacted in Jakarta, on Thursday (11/3/2021), said all research related to vaccines, both developed abroad and domestically, must meet the requirements set by the Food and Drug Monitoring Agency (BPOM). As an independent authority, the BPOM has the responsibility to ensure that vaccines that have secured usage license are safe and have guaranteed immunogenicity (antibody formation).

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"Even though there has been an acceleration of vaccine development, including domestic vaccines, the phases in the research process must be adhered to. It starts from pre-clinical trials, clinical trials in phases one, two and three, until the vaccine is in distribution. If the research requirements are not fulfilled, the research should not be able to start," he said.

If the research requirements are not fulfilled, the research should not be able to start.

Previously, head of BPOM Penny K Lukito said full support would be given to all research on the Covid-19 vaccine developed by domestic researchers. Even so, all researches must still comply with the principles in the research process, including the standards for conducting clinical trials as well as the ethical aspects of the research.

Penny also ensures the independence of BPOM in determining assistantship and review of research abroad and domestically. She made the statement in responding to a question related to the BPOM\'s support in domestic vaccine development while attending the House of Representatives (DPR) Commission IX Working Meeting, on Wednesday (10/3).

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"What has been developing is the Nusantara vaccine, but why does it seem that the BPOM does not have the will to issue the second phase of PPUK [Approval for Clinical Test]?" asked deputy chairman of House Commission IX from the Golkar Party faction Emanuel Melkiades Laka Lena.

KOMPAS/ADITYA PUTRA PERDANA

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

The Commission IX Working Meeting was also attended by the deputy health minister, head of the Eijkman Institute for Molecular Biology and researchers from Dr Kariadi General Hospital in Semarang.

According to Penny, the second phase of PPUK for Nusantara vaccines has not been issued because some required data have not been submitted by researchers. Previously, the first stage of PPUK had been administered even though no pre-clinical trials on animals had been carried out in Indonesia. Therefore, the first stage of PPUK was provided on the condition that strict monitoring was carried out with the research subject was limited only on three people.

The Nusantara vaccine is researched by a team from the Health Ministry’s Research and Development Agency (Balitbangkes), Dr Kariadi General Hospital, Diponegoro University and AIVITA Biomedical from the United States. Funding for this dendritic cell-based vaccine research was supported by Balitbangkes and AIVITA.

Also read: Indonesians Get More Vaccine Options in Inoculation Drive

Deputy Health Minister Dante Saksono Harbuwono hopes that the entire examination process can be carried out optimally and in accordance with the prevailing rules.

"We will support this vaccine 100 percent if later in the second phase it goes according to the rules. However, if later it does not work because there is no approval from BPOM, spending on financing can be stopped," he said.

KOMPAS/RIZA FATHONI

Health workers inject the first stage of the Covid-19 vaccine into the state civil service (ASN) at the Central Jakarta Mayor\'s Office, Wednesday (10/3/2021).

Increase mortality

On the other hand, recent research shows that variant B.1.1.7, which has spread in 94 countries, including Indonesia, has the potential to increase mortality by an average of 64 percent higher than the old variant of the SARS-CoV-2 virus. Prevention of the spread of variant B.1.1.7 is increasingly urgent.

The study is published in the journal British Medical Journal, 10 March 2021. University of Exeter modelling expert Robert Challen and University of Bristol epidemiologist, Leon Danon, are the lead authors of the study.

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Challen and his team concluded that in the population group being researched, the risk of death from this new variant increased from 2.5 to 4.1 deaths per 1,000 cases. Coupled with its ability to spread rapidly and the increased risk of death, the variant B.1.1.7 becomes a threat that must be taken seriously.

In South Kalimantan, epidemiological investigations and close contact tracing of local residents infected with the B.1.1.7 virus are still ongoing. The community is also asked to be vigilant and careful while remaining disciplined in implementing health protocols. (TAN/AIK/JUM/ZAK)

This article was translated by Kurniawan Siswoko.