努桑塔拉疫苗仍然运行未经食品和药物监督机构许可， 叛乱的信号？

JAKARTA - The Nusantara Vaccine is getting more polemic after a number of political figures and officials flock to volunteer for phase II clinical trials at the Gatot Soebroto Central Army Hospital (RSPAD), Jakarta, Wednesday, April 15. In this stage, the vaccine volunteers will take a blood sample and process it for 7 days to then be injected back into the body.

Even though the vaccine was the idea of the former Minister of Health, Dr. Terawan Agus Putranto is still in the middle of the pros and cons because he has not received the permit from the Food and Drug Supervisory Agency (BPOM) to continue.

This phenomenon certainly attracts attention, why are the country's leaders willing to 'bleed' in order to pass a vaccine that is claimed to be the work of its own people?

Deputy chairman of the Indonesian House of Representatives for the Economy and Finance, Sufmi Dasco Ahmad, expressed his willingness to be injected with the Nusantara vaccine as an effort to support domestic vaccine production, especially the production of Indonesian.

"We know that vaccines from outside are also not easy to enter Indonesia, especially now that the vaccine-producing countries are embargoing them. Therefore, we must support the existing vaccines", said the daily chairman of the Gerindra Party, Wednesday, 15 April.

According to him, the Nusantara vaccines will increase the wealth of domestically produced vaccines so that they can help the government reduce the rate of COVID-19 in the country. "I think there is no need for debate because there is no problem between vaccines", said Dasco.

In line with Dasco, Deputy Chairman of Commission IX of the Indonesian House of Representatives (DPR RI) Melkiades Laka Lena said that his arrival as a volunteer is a form of support for the Nusantara vaccine as a domestic product. Moreover, the depletion of vaccine stocks is due to an embargo from producing countries.

"If you choose to let this country rotate its economy, it can be healthy immediately, especially now that vaccines are difficult, India is in an embargo. We have a shortage of vaccines", said Melki.

In addition, the national vaccination target has also stalled due to a lack of vaccine supply. Moreover, the quality of vaccines from abroad has low efficacy, so it is believed that the vaccine made by former Health Minister Terawan Agus Putranto can bring new hope.

"Our vaccination target is difficult to move because the vaccines are limited. The quality of vaccines as well as China itself says its Sinovac efficacy is low. That's what the product manufacturer said. The Astrazeneca, which has pros and cons abroad. So if there is a homemade production like this, we must support", said the legislator from East Nusa Tenggara (NTT).

Uniquely, even though it was different from the attitude of most of the PDIP Party faction members in the DPR, Adian Napitupulu actually came to the RSPAD. Adian admitted that he came on a personal behalf. He considered that the Nusantara vaccine could be efficacious for people with comorbid heart disease like him.

"I don't want to go into the pros and cons. I have to find medicine for people who have heart disease like me", said Adian at the Army Hospital, Jakarta, Wednesday, April 14.

The member of Commission VI also argued that the currently available vaccines such as Sinovac, AstraZeneca, and Johnson and Johnson cannot be used for people with a history of heart disease.

"How many people injected with Sinovac have died because they have heart disease? AstraZeneca has the effect of blood clotting and it is the enemy of heart disease. Johnson and Johnson has the effect of blood clotting. Then what medicine am I taking?", said the former '98 activist.

Not only board members, but former National Army (TNI) Commander Gatot Nurmantyo was also present to undergo the clinical trial of the Nusantara vaccine at the same time.

Gatot said that his willingness to be injected with the Nusantara vaccine was because he was very proud and loved the best Indonesian work.

In fact, he, whose blood samples had been taken, said he would come with his family in the next two weeks to be injected with the vaccine again.

"Blood will be drawn, later on the 8th, the blood will be injected to be given a kind of vaccine but for clinical trials", he said.

According to Gatot, although he has not yet obtained an official permit from the Food and Drug Supervisory Agency (BPOM), he still supports the development of the Nusantara Vaccine.

"Whatever I do for this nation and country. I do not know whether there is a permit or not, but I was offered so that my clinical trial is ready", said Gatot.

He believes that the Nusantara vaccines are better than existing vaccines and are useful for the nation and state.

"Hopefully this is the best, and mark my words, 2 years from now the whole world will definitely use this method, hopefully, it is true", he said.

What was even more astonishing was that the chairman of the PAN Party faction of the DPR RI, Saleh Partaonan Daulay, who had been injected with the Sinovac vaccine twice, also volunteered.

The DPR Commission IX member admitted to having a number of reasons why he was finally willing to be vaccinated using the Nusantara vaccine. First, he has had discussions with the researchers, both researchers from Indonesia and researchers from the US.

"I received a full explanation regarding this Nusantara vaccine. And I believe that this vaccination is very good and effective in order to increase immunity", explained the member of the DPR, who has been injected twice with the Sinovac vaccine.

Second, he has also spoken to people who have been vaccinated with the Nusantara vaccine. According to them, this vaccine can be said to have no side effects while its effectiveness is very good.

"After being vaccinated, they measure their level of immunity. Evidently, their immunity level rises quite high. They then recommend this vaccine to other people, including to me", said the legislator for the electoral district of North Sumatra II.

Third, Saleh saw that the Nusantara vaccine has the potential to be developed in Indonesia. Moreover, President Jokowi has asked Indonesia to prioritize domestic products.

"Well, this Nusantara vaccine must be an example of a domestic product that needs government support and attention", said the PAN Party politician.

Fourth, vaccination with the Nusantara vaccine is limited. Therefore, it does not violate any conditions. Saleh hopes that by carrying out this vaccination, it will be easier for BPOM to provide various kinds of permits needed.

"We dare to be an example. Dare to be vaccinated early. I see the researchers and doctors on duty are all sincere. There is no political content whatsoever", said the deputy chairman of the DPR's Honorary Council of the Court (MKD).

Fifth, he believes that Indonesia's sovereignty and independence can be guaranteed in the fields of health and medicine.

"I am sure, the momentum of COVID-19 can be an entry point. Right now we are still dependent on other countries. When embargoed, our vaccination program is immediately disrupted. At least, disrupting the predetermined schedule. That is the importance of independence and sovereignty", said Saleh Daulay.

Then is it true that the phenomenon of the figures flocking the Nusantara Vaccines is a signal of rebellion against the government?

"Finally, there are two vaccines, namely the oligarchy vaccine and the opposition vaccine. Because it seems that although technically it is a bit problematic because re-injecting blood taken from plasma and then reinserting it to provoke immunity, it is impossible for an individual to mass produce because of differences in blood plasma", said a political observer Rocky Gerung in an interview on a YouTube channel, Thursday, April 15.

According to him, the action of a number of political figures was a rebellion to support the vaccine for the idea of the former Minister of Health, Terawan Agus Putranto.

"There is a kind of quiet rebellion not to accept vaccines other than the Nusantara. That's a signal that shows that we need to be independent in vaccine research", said Rocky.

"But there is also a kind of political resistance because these figures show off that we are supporting the Nusantara vaccine", he continued.

Rocky agrees that the volunteerism of these figures is because China admits that the efficacy of the Sinovac vaccine is only around 40 percent. Then other vaccines also have problems due to mismatched doses and psychobiological conditions of people, causing several events.

"Indeed, we actually have to explore the nature of this COVID-19. So we have not conducted research about it", he said.

According to Rocky, the government set too high a rate of 70 percent for all Indonesian citizens to be injected with the vaccine to form herd immunity. In fact, it is not certain that the available vaccines can meet the percentage of the national vaccination requirement.

"Maybe 30 percent is enough because we ourselves don't know what our bodies are like, our immunity. So the long research might actually be 20 percent of the injections have been completed, but the government can always suggest that at least 70-80 percent of all injections must be injected", he explained.

"Now there is a problem with the number of vaccines decreasing, then how are going to handle that? At least one more month is up, meaning that one injection is useless. That will be trapped in the second round and even the third round of vaccines", added Rocky.

Rocky assessed that the political leaders' reciprocity to receive the Nusantara vaccine is a signal that they no longer trust government policies.

"So he wants to say stop taking vaccinations (imports, ed) but use the Nusantara vaccines. But he didn't tell the press. This is a vaccine wrapped in politics", he said.

Rocky acknowledged that there is a political dimension to the willingness to support the Nusantara vaccine. One of them is a kind of annoyance with the government because it always wants to monopolize information, monopolize transactions, and monopolize diplomacy.

"Now there is a politics of rebellion through vaccination. So live the opposition vaccine!", said Rocky Gerung.

The spokesperson for the COVID-19 Task Force, Prof. Wiku Adisasmito, responded to the polemic of continuing Nusantara vaccine research into phase II clinical trials, even though he has not received permission from the Food and Drug Supervisory Agency (BPOM).

Wiku appealed to Indonesian vaccine researchers to establish good coordination and communication with the BPOM to solve the vaccine problem initiated by Dr. Terawan Putranto.

"It is hoped that the Nusantara vaccine development team can coordinate well with the BPOM so that the existing issues related to this vaccine can be resolved soon", said Wiku during a virtual press conference, Thursday, April 15.

Wiku also asked the Nusantara vaccine researchers to comply with the regulations set by the BPOM. Because as is known, the Nusantara vaccine is a type of vaccine developed in America and tested in Indonesia.

According to Wiku, there is no COVID-19 vaccine that can be used by the public or the general public without the BPOM supervision. This is because the role of BPOM in monitoring security and the efficacy of the COVID-19 vaccine is the main reference in vaccinating COVID-19.

"In principle, all vaccines must obtain permission from the BPOM, especially regarding the aspects of safety, efficacy, and feasibility. As long as they meet the criteria, the government will provide support", said Wiku.

How does the BPOM respond?

According to the Food and Drug Supervisory Agency (BPOM), interim data on phase II clinical trials of the Nusantara vaccines are not sufficient as a basis for this research to continue to the next stage.

The head of BPOM, Penny Lukito, said that her team had insufficient safety and the ability of the vaccine to form antibodies and prove the quality of dendritic vaccine products.

Therefore, Penny emphasized that in order to obtain a clear research basis, preclinical testing is needed as an initial stage. "Preclinical research activities should be assisted by the Ministry of Research and Technology/National Agency for Research and Innovation in accordance with the agreement at the DPR's hearing", said Penny.

Penny explained that this Nusantara vaccine was developed using a dendritic cell-based method for the treatment of COVID-19 infection. The vaccine contains three main ingredients, namely dendritic cells obtained from each person, the SARS-CoV-2 Spike Protein antigen, and granulocyte-macrophage colony-stimulating factor (GMCSF) aka cytokines or small proteins that stimulate cells. The last two materials were produced by two US companies.

The BPOM found data on antibody measurements, aka immunoglobulin (IgG) antibodies, in preclinical studies fluctuating. The resulting antibody response is also inconsistent with the dose of the vaccine given.

In addition, the IgG antibody response was also seen to increase only in the group of animals that were given the combination of dendritic vaccine and GMCSF. This condition, said the BPOM, raises the assumption that the increase in antibodies in animal groups is not due to dendritic vaccines, but because of the administration of GMCSF.

"However, this cannot be confirmed, considering that in this preclinical study there is no comparison with GMCSF alone", said the Head of BPOM Penny Lukito.