Development of Sinovac vaccine clinical trials in Indonesia

The Food and Drug Administration (BPOM) has issued an emergency use permit for the Coronavac vaccine produced by Sinovac Biotech Ltd., a biopharmaceutical company from China. The emergency use permit was issued on Monday, January 11, 2021.

Previously, Indonesia imported 1.2 million Sinovac vaccines. The vaccine arrived at Soekarno Hatta Airport on Sunday (6/12/2020). The first vaccination will be carried out on January 13, 2021. President Jokowi, Minister of Health Budi Gunadi Sadikin, and a number of other public officials will be the first to receive this vaccine.

How is the development of the Sinovac vaccine to date?

Clinical Trial of the Sinovac COVID-19 vaccine in Indonesia

Sinovac is collaborating with Bio Farma in conducting a phase 3 clinical trial of the COVID-19 vaccine in Bandung. This biopharmaceutical company from China began conducting research on the COVID-19 vaccine since the end of January and has passed pre-clinic (animal testing) and phase 2 clinical trials.

Phase 1 clinical trials are conducted to determine whether vaccines are safe for humans. Phase 1 trials on this vaccine candidate were carried out in China in April. Testing involved 144 adults aged 18-59 years.

Meanwhile, a phase 2 clinical trial was conducted to determine dosage and its safety in a larger number of participants. This phase 2 trial involved 600 participants in the same age range as the phase 1 clinical trial.

The results from the phase 1 and 2 clinical trials were reported safe and there were no serious side effects in the participants. The results of phase 2 clinical trials show that the vaccine triggers the formation of antibodies that can neutralize the SARS-CoV-2 virus that causes COVID-19. Antibodies began to form on the 14th day after vaccination.

The results of phase 1 and 2 clinical trials published in The Lancet Journal note that although antibodies are formed quite quickly, their numbers are lower than those naturally formed by people recovering from COVID-19.

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Sinovac vaccine testing in Indonesia involved 1,620 volunteers aged 18-59 years. Currently clinical trials are still in the stage of mentoring or monitoring thousands of these volunteers. The complete results of the phase 3 clinical trial of the Sinovac vaccine are expected to be known until May 2021.

On Monday (11/1/2021), BPOM has issued a permit for the emergency use of this vaccine. The head of BPOM, Penny K. Lukito, said the Sinovac vaccine which was clinically tested in Bandung, West Java, had met the safety standards of the World Health Organization (WHO). The efficacy of the Sinovac vaccine based on an interim analysis of 25 infected cases showed a value of 65.3%.

"According to WHO requirements, the minimum efficacy is 50 percent. This 65.3 percent efficacy rate shows hope that the Sinovac vaccine can reduce the incidence of infection by 65.3 percent, "said Penny.

Meanwhile, the side effects of vaccine injection were reported on a mild to moderate scale such as pain, irritation, and a little swelling that was not dangerous and recovered the next day. Based on the results of the efficacy evaluation, the Sinovac vaccine is able to form antibodies in the body and is able to kill and neutralize the SARS-CoV-2 virus in the body.

The results of the Sinovac clinical trial in Turkey showed an efficacy result of 91.25%. Meanwhile, Brazil revised the efficacy value of Sinovac there from 78% to 50.4%. According to team representatives Komnas HAM The drug assessor, Jarir At Thobari, said the low level of efficacy of the Sinovac vaccine tested in Indonesia was because the test subjects were the general public while in Brazil and Turkey some of the subjects were health workers. Apart from the characteristics of the population and clinical trial subjects, other factors that influence the level of efficacy are community behavior and the transmission process.

The clinical trial process in Indonesia and volunteer recruitment

The Ethics Committee of Padjadjaran University announced that it had given permission for the implementation of the phase 3 clinical trial of the COVID-19 vaccine candidate made by Sinovac in Indonesia.

Starting Monday (27/7), UNPAD has opened registration for clinical trial volunteers. Requirements for volunteering are healthy adults aged 18-59 with no history of contact with patients related to COVID-19. Volunteers must also test negative for COVID-19 through a throat swab test (RT-PCR).

In addition, because the clinical trial was conducted in the Bandung area, participants were required to be domiciled in Bandung. Participants who meet the requirements and have passed administrative procedures will Bio Farma give the first dose of vaccine.

On the 14th day, the participant's blood sample will be taken and examined. After that, participants will be injected with a second dose of the vaccine and their blood samples will be drawn again after 14 days.

Bio Farma is assisted by Padjadjaran University and the Ministry of Health who will participate in this clinical trial. Director of Bio Farma, Honesti Basyir, said that the vaccine clinical trial will run for six months.

"If it goes well, then we will produce it in the first quarter of 2021," Honesti said in a press release, Monday (21/7).

If the vaccine passes the phase 3 clinical trial, Bio Farma will produce 40 million doses per year with a plan to increase the distribution capacity to 250 million doses per year. That is with a note that the government has permitted its widespread use.

Vaccines may not pass clinical trials

The COVID-19 vaccine candidate Sinovac is by far one of the most promising to help deal with COVID-19 in Indonesia. However, this does not mean that this vaccine can be confirmed 100% of passing clinical trials. Clinical trials that are now being conducted may fail.

“Clinical trials mean these (failed) zones are still possible. We are waiting for the next 6 months, ”said Bio Farma's Head of Corporate Communication Iwan Setiawan in a Market Review event, Thursday (23/7).

The success of the phase 3 clinical trial on the Sinovac vaccine is not only judged by the results in Indonesia, but also must be equally effective in all countries that are trial areas.

"This final stage test must be carried out multicenter . The result must be the same, if you don't pass it you can't use it, ”he concluded.

The vaccine for COVID-19 only needs to be effective by 50 percent and does not need to be 100 percent because of its urgent need.

The special staff of the BUMN ministry Arya Sinulingga said that the clinical trial of the COVID-19 Sinovac vaccine would not affect the course of vaccine development carried out by the Eijkman molecular institute.

Eijkman is the institution appointed by the government to develop the COVID-19 vaccine for the nation's children. Currently, various institutions and organizations from many countries in the world are competing to produce the fastest COVID-19 vaccine.