The Red And White Vaccine Gets Green Light Amid The Threat Of An Embargo. The Nusantara Vaccine Is Still ‘Biting Finger’

JAKARTA - Indonesia has the potential to run out of supplies of the COVID-19 vaccine in April 2021. It is feared that this will affect the acceleration of the vaccination program in the country.

Minister of Health (Menkes) Budi Gunadi Sadikin said that the availability of the COVID-19 vaccine in Indonesia will be very low in April 2021.

This is because the plan to ship AstraZeneca vaccines for the period of March and April 2021 to Indonesia was postponed due to an embargo by producers in India.

This was following the increase in COVID-19 cases which caused the country to embargo shipments of AstraZeneca vaccines to WHO and GAVI. India is known as the largest producer of the COVID-19 vaccine in the world, apart from China by producing the Novavax vaccine, AstraZeneca, including Pfizer.

"Indonesia only had 7 million doses of the vaccine from Sinovac in April. I thought I could get 7.5 million doses of AstraZeneca", said Health Minister Budi Gunadi Sadikin in the monitored YouTube online broadcast of the Indonesian Politika Charta Politika, Monday, March 29.

According to the initial plan, Indonesia received 2.5 million doses of AstraZeneca vaccine on March 22 and an additional 7.5 million more doses of vaccine in April 2021. Budi estimates that Indonesia could have a total of 15 million vaccines.

However, Budi said, the schedule was actually postponed because there was an embargo that prevented the vaccine from leaving their country.

The House of Representatives Encourages Domestic Vaccines

Responding to the issue of the vaccine embargo, Deputy Chairman of the Indonesian Parliament, Coordinator for Economic and Financial Affairs (Korekku), Sufmi Dasco Ahmad, asked the government to accelerate the process of developing and producing domestic vaccines.

Dasco said this needed to be done considering that vaccines were currently a very urgent need in the fight against the COVID-19 pandemic.

Apart from being an urgent need, domestic vaccines can also be a solution if the vaccine embargo is carried out by a number of countries, as is the concern of Health Minister Budi Gunadi Sadikin.

"The government needs to immediately accelerate the clinical trial process and domestic vaccine production. Be it the Red and White vaccine or the Nusantara Vaccine. Don't let us fall victim to the vaccine embargo and the public will become victims", said Dasco in his statement, Sunday, March 28.

Dasco hopes that the process of the Red and White vaccine will soon be accelerated and the Nusantara Vaccine will immediately prepare a phase two clinical trial. Thus, Indonesia can avoid the threat of scarcity of the COVID-19 vaccine.

"Please immediately coordinate with hospitals that have met the requirements for phase two clinical trials. Vaccines are currently a fairly urgent need”, said the politician from the Gerindra Party.

Government Is Asked to Continue Nusantara Vaccines

Questioning about the planned embargo on vaccines from several vaccine-producing countries. Chairman of the PAN Party faction of the Indonesian House of Representatives (DPR RI), Saleh Partaonan Daulay, asked the government in particular, Minister of Health Budi Gunadi Sadikin to immediately think about alternative procurement of vaccines for the need for national vaccination injections.

Because he is worried that the embargo will interfere with the continuation and smoothness of the implementation of the COVID-19 vaccination in Indonesia.

"This vaccine is an urgent need. Apart from implementing health protocols, vaccination is also a solution in breaking the chain of the spread of the COVID-19 virus. Therefore, the government is obliged to provide vaccines for 70 percent of the target population", said Saleh, Monday, 29. March.

Meanwhile, he continued, if using the existing scheme, Indonesia would need 420 million doses of vaccine to meet the needs of 181.5 million citizens.

"This number is very large. It is not enough to rely on just one producer", said Saleh.

The member of Commission IX DPR urged the government to prioritize the procurement of vaccines in the country. He said that the Red and White Vaccine and the Nusantara Vaccine were not inferior to imported vaccines.

In fact, said Saleh, according to the researchers, Nusantara vaccines are better than imported vaccines. He also encouraged the Nusantara Vaccine to be continued with the research stage until it became a finished product.

"Surprisingly, the Nusantara Vaccine has not yet received permission to continue the second phase of clinical trials", he explained.

In fact, said Saleh, if the permit is granted, the Nusantara Vaccine is expected to be ready for production in the coming July.

"For domestic products, the Nusantara Vaccine is more advanced than other red and white vaccines. This is because it has entered the second stage of clinical trials. Meanwhile, other Red and White Vaccines are estimated to be able to undergo clinical trials by the end of 2022. It is not wrong if then many people hope that on the Nusantara Vaccine", said Saleh.

Saleh also hopes that the Ministry of Health, the National Agency of Drug and Food Control (BPOM), researchers, sponsors, and parties involved in the Nusantara Vaccine research can sit together to discuss the continuation of its development.

Nusantara Vaccine Discontinued, Red and White Vaccine Resumed

The spokesperson for the COVID-19 Vaccine from the Ministry of Health, Siti Nadia Tarmizi, has confirmed that research on the Nusantara vaccine has been postponed for a while.

"It was not stopped but there was a letter of request from the Kariadi Semarang General Hospital asking to postpone the research process being carried out there considering it would be eligible for Good Manufacturing Practices (CPOB)", said Nadia, Tuesday, March 23.

It is known that the Nusantara Vaccine which is also called AV-Covid-19 was developed from a collaboration between the Ministry of Health (Kemenkes), dr. Kariadi Semarang, and Diponegoro University.

The vaccine initiated by the former Minister of Health Terawan is said to have completed phase 1 clinical trials and began conducting the second stage clinical trials.

The phase one clinical trial for the Nusantara Vaccine has been completed, involving 27 volunteers.

The team is currently planning to proceed to phase 2 clinical trials involving 180 volunteers.

Furthermore, if the phase 2 clinical trial has been carried out, it is planned that the phase III clinical trial will be carried out on 1.600 people.

However, the Food and Drug Supervisory Agency (BPOM) decided not to continue the Nusantara Vaccine research on the grounds that it did not comply with medical standards.

"The ethics committee is from the Gatot Subroto Army Hospital, but the implementation of the research is at Dr. Kariadi Hospital", said Head of BPOM Penny Lukito.

That is one of the reasons why the BPOM considers that the national vaccine has not met scientific principles. In fact, said Penny, each research team must have an ethics committee in place of research that is responsible for the implementation and safety of research subjects.

The Red and White Vaccine Seeds Will Be Clinically Tested Immediately

Good news, although the Nusantara Vaccine must be temporarily 'bite the finger' because it is forced to wait for its fate, the government has given the green light for other domestic vaccines to be developed. Namely the Red and White Vaccine.

President Director of PT Bio Farma (Persero) Honesti Basyir said that his party would receive the Red and White vaccine seeds from Eijkman in March or April.

Furthermore, Bio Farma will soon conduct clinical trials in Mammals as well as clinical trials from phase I to stage III.

"If all goes well, it is possible that we will be able to produce the red and white vaccine in the third quarter of 2022", said Honesti during a hearing (RDP) with Commission VI of the House of Representatives (DPR) at the DPR Building, Jakarta, Monday, March 29.

According to Honesti, the presence of the red and white vaccine is the government's effort to achieve independence in handling the COVID-19 pandemic.

So far, he said, Indonesia still depends on foreign vaccine producers, both importing finished vaccines and importing raw materials for vaccines.

"This is to reduce dependence on imports and a strategy for self-reliance. If we rely on speed, we rely on vaccines and raw materials that we import", he said.

However, Honesti said the volunteer problem would be a challenge in clinical trials. Because he said, many people have received vaccinations so they cannot volunteer for clinical trials.

Even so, he said, Bio Farma would cooperate with neighboring countries to conduct joint clinical trials as a solution.

Previously, the Head of the Institute for Molecular Biology (LBM) Eijkman Amin Soebandrio had explained that the development of the Red and White vaccine had entered the deadline that had been targeted in March.

"At the end of March, we are already in the transition process of handing over the vaccine seeds to PT Bio Farma", he said Tuesday, March 16, 2021.

LBM Eijkman is one of six institutions that are developing the COVID-19 vaccine locally. The other five institutions are the Indonesian Institute of Sciences (LIPI), Gadjah Mada University (UGM), the University of Indonesia (UI), the Bandung Institute of Technology (ITB), and Airlangga University (Unair).

LBM Eijkman is also touted as the fastest Red and White vaccine developer compared to other institutions.