Nusantara Vs Merah Putih Vaccine, Which One Is The Champion?

Vaccine illustration. (Sam Moqadam/Unsplash)

JAKARTA - The government has expressed support for the development of domestic-made COVID-19 vaccines, from the Merah Putih Vaccine to the Nusantara Vaccine.

According to President Jokowi, research and development of drugs and vaccines are very important in the midst of the COVID-19 pandemic that still haunts the country. However, the President reminded that the vaccine development process must follow scientific principles.

Along with the President's support, the polemic between the two vaccines made by the nation's children is even more visible. After previously there was a rejection of the continuation of research for the Nusantara vaccine which was initiated by the former Minister of Health, Terawan Agus Putranto because it was considered not meeting clinical principles.

Terawan must agree if the Nusantara Vaccine permit is stopped by the Food and Drug Supervisory Agency (BPOM) and is canceled from government funding. Because on the other hand, a different attitude was accepted by the Merah Putih Vaccine Team, which was allowed to continue its development. In fact, it is certain to receive an emergency use authorization (EUA) in mid-2022.

So what influences the attitude of the Food and Drug Supervisory Agency (BPOM) to differentiate between the Nusantara Vaccines and the Merah Putih Vaccines?

Nusantara Vaccine

The Nusantara vaccine is said to use a dendritic approach, by cooperating with PT. Rama Emerald Multi Sukses (Rama Pharma) in collaboration with AIVITA Biomedical Inc from California, United States. This vaccine development was initiated at the end of 2020, when Terawan Agus Putranto was still Minister of Health.

In terms of technology, the use of dendritic cells allows this vaccine to be produced according to the conditions of each patient. Therefore, this vaccine is claimed to be safe for comorbids or the elderly. Dendritic cell technology previously commonly used in cancer therapy.

Health expert from the Indonesian Public Health Expert Association (IAKMI) dr. Hermawan Saputra revealed that the dendritic approach is still being debated even in the United States and has not yet been approved to be tested.

Merah Putih Vaccine

Meanwhile, the government has supported with the state budget for the Merah Putih Vaccine, and the trial will be completed in 2022.

The Merah Putih Vaccine does not refer to just one type of vaccine, but rather a group of vaccine candidates developed by a research consortium under the auspices of the Ministry of Research and Technology/National Research and Innovation Agency (Kemenristek/BRIN).

In this consortium, there are 7 institutions that also develop the Merah Putih vaccine, each with a different platform, one of which is LBM Eijkman.

Nusantara and Merah Putih Vaccine Development Stage

The initiator of the Nusantara Vaccine, Terawan Agus Putranto, said that the Nusantara Vaccine which is based on autologous dendritic cells or components of white blood cells has passed the preclinical stage of animal testing. In fact, he claims the vaccine is safe to use.

"I have WhatsApp the results of preclinical tests regarding vaccine safety (safety) and efficacy by third parties in the United States. Well, that has been done, so we no longer do (preclinical testing) in Indonesia," said Terawan during the Joint Commission IX Meeting. The DPR RI at the DPR Building, Senayan Complex, Jakarta, as written on Friday, March 12.

"The results are already there. We have sent them to BPOM. I have also consulted with the Head of the Coronavirus Research and Vaccine Formulation Team, Prof. Chaerul Nidom Anwar, regarding the preclinical test of dendritic cells for Nusantara Vaccines," he continued.

Meanwhile, the development of the Merah Putih vaccine for the new coronavirus is entering the preparatory stage for animal trials.

Head of the Eijkman Institute for Molecular Biology, Amin Soebandrio, said that his party was currently collecting recombinant proteins from mammalian cell expression systems and yeast cells.

The two cells will be used as a kind of recombinant protein factory. If the production of recombinant protein is constant, then continue with animal trials.

Furthermore, Amin explained that his institution had twelve months since last March to obtain vaccine seeds. The vaccine seeds will be handed over to Bio Farma as a producer.

Before it can be made in bulk, he added, Bio Farma must carry out clinical trial stages 1 to 3 and obtain a distribution permit from the Food and Drug Supervisory Agency (BPOM).

Will the Merah Putih vaccine be more effective and safe than vaccines from abroad, considering that its development is taken from a virus circulating in Indonesia? Amin said he could not compare because there was no data yet.

"If it is safe, we will make sure, yes. We are also not in a hurry to work because we ensure safety. If it works, we cannot compare it with other vaccines because there is no data yet," said Amin.

The Government's Attitude Towards Nusantara Vaccines and Merah Putih Vaccines

The Head of the Food and Drug Supervisory Agency (BPOM), Penny Lukito, stated that her institution is assisting the development process of the domestically made Merah Putih vaccine.

The development of the Merah Putih vaccine is planned to take place from March 2020 to February 2021, starting with antigen identification, making virus seeds, and vaccine prototypes.

"This vaccine prototype will be submitted to Biofarma to undergo the downstream process, from upscaling, preclinical testing, clinical trials in phases 1,2, and 3, and within 20 working days will receive permission for commercialization," said Penny.

Meanwhile, Secretary of Bio Farma, Bambang Heriyanto, said that it is estimated that Indonesia will have this Merah Putih vaccine by mid-2022.

Bambang also said that the Ministry of Research and Technology and the Ministry of Health had previously agreed to divide the budgeting tasks with the Nusantara Vaccine.

The Ministry of Research and Technology has provided a budget for vaccine seeds and infrastructure, while the budget for clinical trials is at the Ministry of Health.

"We are ready to accommodate, but indeed the Nusantara vaccine stage has entered clinical trials. While we are mostly in the upstream, in the lab," said Bambang.

Meanwhile, the Clinical Trial Team targets that Nusantara Vaccines can be mass-produced starting June 2021. However, this condition can only be achieved if the Food and Drug Supervisory Agency (BPOM) gives the green light for the Approval for Implementation of Clinical Trials (PPUK) for clinical trials II and III within a month of the next two months.

Later, the vaccine, which was initiated by former Health Minister Terawan Agus Putranto, will require 180 volunteers for clinical trials II. Meanwhile, the stage III clinical trial requires 1,600 volunteers.

So it can be concluded, the actual Merah Putih Vaccine production will begin at the end of 2021 or early 2022 by Bio Farma.

As for the Nusantara Vaccine, which was developed by dr. Terawan and partners, their development was rejected by the Food and Drug Supervisory Agency (BPOM) on the grounds that they did not meet good clinical principles.