Jakarta (ANTARA) - The COVID-19 vaccine from Sinovac will be registered with the Indonesian Food and Drug Monitoring Agency (BPOM) on conclusion of the phase III clinical trials planned to last six months.

"Currently, we are waiting for the next six months. We seek support and prayers for the vaccine development. I ensure that this vaccine is halal. God willing, if the phase III clinical trials go well, we will prepare to register it with the BPOM to be produced en masse and be administered to overcome the COVID-19 pandemic," Chief Executive of the Committee for Handling Covid-19 and National Economic Recovery (KPCPEN) Erick Thohir stated at the Faculty of Medicine, Padjadjaran University, Bandung, on Tuesday.

Thohir made the statement while accompanying President Joko Widodo to witness the administration of the vaccine to 20 volunteers during the phase III clinical trials at the Faculty of Medicine, Padjadjaran University.

The vaccine will be injected to 1,620 volunteers targeted for all clinical trials, including authorization from the BPOM, to be completed in January 2021.

"I thank the volunteers, Bio Farma, and Sinovac laboratory team as well as the University of Padjadjaran that facilitated this crucial stage to take place," Thohir noted.

President Widodo, in the company of Thohir, Health Minister Terawan Agus Putranto, West Java Governor Ridwan Kamil, and Bio Farma President Director Honesti Basyir, also observed the facilities and production capacity of the COVID-19 vaccine at Bio Farma.

"We are proud of the ability of state-owned company Bio Farma collaborating with the Sinovac Institute from China since it has entered the third phase of clinical trials. Not many countries or research institutions have reached clinical trials at this stage," Thohir affirmed.

Phase III of clinical trials is a stage that all pharmaceutical products, including drugs and vaccines, have to necessarily go through.

According to Bio Farma, BPOM has obtained positive results from the clinical trial stages of the COVID-19 vaccine, comprising the pre-clinical trials, phase 1 clinical trials, and phase 2 clinical trials conducted in China.

Bio Farma has partnered with Sinovac owing to a similar platform between the vaccine developed by Sinovac and Bio Farma's ability to produce it, specifically the inactivated vaccine.

The Faculty of Medicine University of Padjajaran and Bio Farma recruited 1,620 volunteers after undergoing two stages of selection, with 540 people in the first stage, and 1,080 volunteers in the second.

Volunteers were selected after clearing the test for immunogenicity, or immune response, and efficacy, or response against viruses, through blood tests.

The vaccine administration will be conducted in stages, with the first wave during the second week of August for 120 volunteers. The next test will be held in the third and fourth week of August, for each of the 144 volunteers, so by early September, as many as 408 volunteers are estimated to have undergone vaccine tests.

This process will be conducted continuously on 1,620 volunteers and will last until the third week of December. Most volunteers are the residents of Bandung, as they need to be subject to continuous checks and undergo routine analysis in gauging the effectiveness of the vaccine.

Thohir also expressed Bio Farma's readiness to boost production capacity by utilizing existing production facilities on its land, thereby circumventing the need for additional investments.

Bio Farma is pegged to be able to produce a maximum of 100 million vaccines by December 2020.

"Bio Farma is ready to increase its production capacity by 150 million doses to reach 250 million doses," President Director of Bio Farma Honesti Basyir stated. Related news: President observes 1,620 volunteers receiving COVID-19 vaccine
Related news: 1,020 volunteers to partake in Chinese vaccine trials in Indonesia


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Translator: Desca L, Azis Kurmala
Editor: Suharto
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