Overcoming Hindrances to Merah Putih Vaccine Research

KOMPAS/RADITYA HELABUMI

A health worker prepares vaccines during the mass Covid-19 vaccination for media workers at Basket Hall, Bung Karno Stadium complex, Senayan, Jakarta, on Thursday (25/2/2021). On the first day of the vaccination, the event was attended by over 1,000 media workers from various press companies. The mass vaccination for media will run until Saturday (27/2/2021), targeting 5,500 media workers. The Covid-19 vaccine is expected to protect the media workers from risk of Covid-19 transmission.

The limited availability of experts and infrastructure both hamper COVID-19 vaccine development. This issue must be addressed thoroughly so that Indonesia can begin producing its own vaccine.

JAKARTA, KOMPAS — The limited number of human resources and research infrastructure have not dampened the enthusiasm of Indonesian COVID-19 vaccine researchers, as domestic vaccine development must be realized.

One of the vaccines being developed domestically is the Merah Putih (Red and White) vaccine, developed by Airlangga University (Unair), Surabaya, together with PT Biotis Pharmaceuticals Indonesia is currently entering the second phase of preclinical testing. Uniair is a member of the Merah Putih vaccine development consortium.

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The vaccine, developed using an inactivated virus platform, is targeted for mass production in early 2022.

Head of the Merah Putih vaccine research team from Uniair, Fedk Abdul Rantam, said on Wednesday (18/8/2021), in Jakarta, that the first phase of preclinical testing of the candidate vaccine using an inactivated platform yielded promising results. The results considered aspects of immunogenicity (the ability to trigger the body’s immune response), safety and toxicity.

KOMPAS/RIZA FATHONI

A researcher works at the Eijkman Institute for Molecular Biology after the inauguration of the facility on Thursday (26/4/2018). The center is equipped with the latest genetic sequence devices, which makes Indonesia an international-level laboratory. The center focuses on the research to identify infectious and genetic diseases, develop diagnostic test devices and study new medicines or vaccines for infection.

In a test, the research team used seven Delta variant isolates through whole genome sequencing. As a result, the candidate vaccine’s ability to neutralize was good. The candidate vaccine underwent the first phase of preclinical testing using transgenic mice, with the second phase of preclinical testing using primates.

“The second phase of preclinical trials is underway. The immune response – from physical to psychological condition – of the macaques [monkeys] research subjects, have shown a better trend thus far,” said Fedik, at a press conference where the Food and Drug Monitoring Agency (BPOM) awarded a good medicine manufacturing practices certificate (CPOB) to PT Biotis, yesterday. Fedik is also a professor at Uniair’s School of Veterinary Medicine.

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A CPOB is required as proof that the pharmaceutical company meets the BPOM’s requirements to produce a type of drug in the form of dosages, such as vaccines. President director of PT Biotis Pharmaceuticals Indonesia FX Sudirman hoped that mass production of the Merah Putih vaccine could begin in the first half of 2022. “Of course, we hope to be able to do so with the aid, supervision and support of the BPOM,” he said.

BPOM head Penny K. Lukito said the agency continued to support the firm throughout the development of the Merah Putih vaccine. Vaccine development by Uniair and PT Biotis went through several processes to have a good manufacturing practices (GMP) certificate issued. Simultaneously, the drug is being developed both at the upstream and downstream levels.

Of the six Merah Putih candidate vaccines being developed in the country, the vaccine from Uniair and PT Biotis has shown the most progress. Once preclinical trials are completed, human clinical trials are expected to begin immediately.

KOMPAS/AGUS SUSANTO

A medical worker administers a Covid-19 vaccine to an elderly person at a community health center (Puskesmas) in Duren Sawit, East Jakarta, on Tuesday (23/2/2021). Each day, the health center administers 20-50 doses of vaccines for elderly people. Health Ministry Covid-19 vaccination spokesperson Siti Nadia Tarmizi said the current second phase of the vaccination drive was for public service workers and elderly people. In the case of the elderly, the first and second shot of the vaccine are given with a 28-day interval. For people aged 18-59, the vaccines are given with a 14-day interval. According to Health Ministry data, an additional 16,297 people received their first vaccine shots on Monday, bringing the total to 1,244,215 people. With the limited global supply of vaccines, the government prioritizes the vaccination of high-risk people to lower the mortality rate.

Meanwhile, the Merah Putih vaccine research by the Ejikman Institute for Molecular Biology and PT Biofarma is currently transitioning from the laboratory to an industrial scale. The candidate vaccine, which will undergo the first phase of clinical testing at the end of the year, is prepared to face a new variant. “We have to conduct preclinical trials first,” said Eijkman Institute head Amin Soebandrio, who is the main researcher for the Merah Putih vaccine. (Kompas.id, 4 August, 2021).

Research infrastructure availability

Thus far, domestic development of the COVID-19 vaccine has been non-optimal because the expertise of researchers, production tools and other testing infrastructure are limited. In the future, this obstacle can be overcome by altering the allocation and focus of research as well as ensuring the availability of the appropriate infrastructure.

As a result, Indonesian researchers still do not have sufficient expertise and experience.

National Research and Innovation Agency (BRIN) head Laksana Tri Handoko said evaluations had been running since May 2021 but Indonesia still did not have a team that developed a vaccine. As a result, Indonesian researchers still do not have sufficient expertise and experience.

“The COVID-19 pandemic will serve as a lesson in research. Meanwhile, production capabilities are limited and obtaining GMPs can be hampered, both of which are needed to produce standardized products,” said Laksana in a webinar titled “Research for Merah Putih” yesterday.

Efforts to produce standardized products are also constrained by the limited infrastructure. Laksana admitted that not many pharmaceutical firms were even GMP-certified or even had standardized GMP production equipment. The process of borrowing such equipment will also prove difficult because in the production of different vaccines, each tool must be sanitized and re-certified. The vaccine test will not be effective because the process itself will take 3-4 months.

KOMPAS/DEONISIA ARLINTA

National Research and Innovation Agency (BRIN) head Laksana Tri Handoko

In relation to this, this year, the BRIN will reallocate and switch gears in terms of research and ensure the availability of such infrastructure. All research infrastructure will be made available so that researchers, academics and the industry can use it interchangeably.

“One of the efforts made was to provide mini GMP for all platforms, despite this year focusing on vaccine development using the recombinant protein method. Testing facilities still need to be developed as there is no level-3 animal biosafety equipment yet,” he said.

(This article was translated by Kesya Adhalia).