The Sincere Willingness of Clinical Trial Volunteers

Phase three clinical trials for a COVID-19 candidate vaccine in Bandung city, West Java, offer great expectations of the speedy control of the virus. Volunteers play a major role in the prospects of finding a vaccine.

AFP/AZWAR IIPANK

This handout photo taken and released on August 11, 2020 by Presidential palace shows President Joko Widodo (C) visiting the Bio Farma Pharmacy that produce vaccines for COVID-19 coronavirus in Bandung, West Java. - Indonesia on August 11, 2020 launched human trials of a Chinese-made coronavirus vaccine with some 1,600 volunteers slated to take part in the six-month study.

Phase three clinical trials for a COVID-19 candidate vaccine in Bandung city, West Java, offer great expectations of the speedy control of the disease caused by the SARS-CoV-2 virus. Volunteers play a major role in the prospects of finding a vaccine.

The footsteps of Y, 26, looked quite light as he walked out of the Educational Hospital (RSP) of Padjadjaran University (Unpad), Bandung, on Tuesday (11/8/2020). His right hand was holding a red plastic file folder. “This folder contains records of a volunteer’s condition after being vaccinated. So, the conditions, symptoms and health developments must be noted down and reported in the next visit,” he said.

Y was imbued with a feeling of relief that afternoon. Several hours earlier, he and 18 clinical trial volunteers for the COVID-19 candidate vaccine had just opened a new page of concern for fellow humans. Witnessed by President Joko Widodo, they became pioneers when they were injected with the possible COVID-19 vaccine, produced by Sinovac, a pharmaceutical company from China.

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Various preparations had been made by Y and the other volunteers in order to follow clinical trials. Y had to be subjected to a swab test and other examinations starting Monday (10/8). The measures were meant to ascertain that he was fit to serve as a clinical trial participant.

A moment before being injected with the candidate vaccine, Y again had a COVID-19 rapid test. The result was non-reactive, so he could be vaccinated. After the injection, he was only a bit sore where he got injected.

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KOMPAS/TATANG MULYANA SINAGA

A member of the research team for the Covid-19 vaccine clinical trial runs a series of health checks to screen a volunteer on Thursday (6/8/2020) at the School of Medicine, Padjadjaran University (Unpad) in the city of Bandung, West Java. The clinical trial of the candidate vaccine produced by Sinovac, China, began on Tuesday (11/8/2020) at six locations: the Unpad Education Hospital, the Unpad Health Center and four puskesmas (community health centers) in the city.

Y was very convinced of the safety of the clinical trials. A medical team’s detailed explanation made him even more determined to join. Phase three clinical trials are also conducted in a number of countries like Brazil, India, Bangladesh and Chile. Previously, the candidate vaccine already went through phase one and phase two clinical trials in China. “This vaccine has been tested on humans and found safe. Why should we be afraid?” he said.

The vaccine has also passed multiple safety tests. Its phase one clinical trials involved 100 adults. After being declared safe and effective for immunity, it was followed by phase two trials with at least 400 participants in China.When the vaccine was guaranteed to be safe, Y was just worried about the transmission of the SARS-CoV-2 virus, which causes COVID-19. The disease gave rise to health and economic emergencies in many countries.

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Kompas recorded that until Wednesday (12/8/2020), over 20.5 million people in the world tested positive for COVID-19. Meanwhile, in Indonesia COVID-19 infected more than 130,000 people with 85,798 patients being declared recovered and 5,903 deaths.

If the phase three clinical trials are successful, the vaccine can speedily be mass produced for the public. Y hopes his participation will expedite the process of clinical trials. “As long as we can help, why not join? This aims to promptly overcome COVID-19,” he said.

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KOMPAS/TATANG MULYANA SINAGA

Vaccine packaging room at 43 PT Bio Farma Building, Bandung City, West Java, Wednesday (12/8/2020). If the clinical trials are successful, a Covid-19 vaccine will be produced in this building.

In spite of his vaccine shot, Y doesn’t feel immune to the disease. He will continue to strictly carry out health protocols. Besides tightly wearing a face mask, he also frequently washes his hands with soap and avoids crowds.

The desire to assist in the process of producing a COVID-19 vaccine has also prompted A, 41, to be a volunteer for COVID-19 vaccine clinical trials.

For him, his fears of becoming a volunteer vanished as soon as his family supported his intention. His burden was even more relieved when three of his colleagues also took part.

His determination to become a volunteer further heightened when A started undergoing medical tests. He was in very prime health. “My health condition will be monitored three times until the next few months,” said the resident of Lembang.

For the periods ahead, he hopes the clinical trials will run smooth. The target set for the number of volunteers needed, for instance, can hopefully be soon achieved. In this way, everything will proceed as planned.

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KOMPAS/TATANG MULYANA SINAGA

The clinical trial research team for the Covid-19 vaccine candidate showed an example of a vaccine produced by Sinovac, China, in a clinical trial simulation at the Faculty of Medicine, Padjadjaran University, Bandung City, West Java, Thursday (6/8/2020).

Domestic focus

Y and A were among around 1,200 residents acting as volunteers for the COVID-19 vaccine candidate until Tuesday. The offer to become volunteers announced at the end of July 2020 got a response from thousands of people within less than half a month. The need for 1,650 volunteers is believed to have been fulfilled.

“There’s still a month to go. I think we can achieve the target,” said Chairman of the COVID-19 Vaccine Clinical Trial Research Team of the Unpad Medical Faculty, Kusnandi Rusmil.

We are ready to produce 250 million doses a year.

The volunteers will get two injections with an interval of 14 days. Thereafter, they will have their blood examined to find out the vaccine’s performance. For about six months the volunteers have to remain in Bandung to facilitate monitoring. Apart from the RSP of Unpad, clinical trials are also conducted at the Unpad Health Center and four community health centers in Bandung.

Head of the Food and Drug Monitoring Agency, Penny K. Lukito, said collaboration between the pharmaceutical industry, the higher educational institute and the public was badly needed. He hoped such teamwork could allow vaccine testing to be complete in January 2021.

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“After the entire process is finished, we can issue an authorization of its emergency use and it is ready for use by the Indonesian population. Its emergency license requires a guarantee of the aspects of safety, quality and efficacy,” he said.

President Director of Bio Farma, Honesti Basyir, said the government had set the target of 190 million people to have access to a COVID-19 vaccine next year. To this end, his company will prepare 320 million doses as an individual gets two doses. “The primary focus covers Indonesian citizens. In December, we are ready to produce 250 million doses a year. After testing and registration, we will be producing on a large scale,” he explained.

The pursuit of this vaccine is in fact not yet over. Support and thankfulness should deservedly go to the volunteers, scientists and medical personnel currently striving to create the vaccine.