If the third stage of the clinical trial for the COVID-19 vaccine were to run smoothly, Bio Farma would begin its production in the first quarter of 2021Jakarta (ANTARA) - Indonesia's state-owned pharmaceutical holding, Bio Farma, is optimistic of starting production of the Chinese COVID-19 vaccine Sinovac in the first quarter (Q1) of 2021, if the third phase of the vaccine's clinical trial runs smoothly.
The third phase of the clinical trial, scheduled to run for six months, is expected to conclude by January 2021, Honesti Basyir, the president director of Bio Farma, noted in a statement here on Tuesday.
"If the third stage of the clinical trial for the COVID-19 vaccine were to run smoothly, Bio Farma would begin its production in the first quarter of 2021. To this end, we have readied its production facilities at Bio Farma, with a maximum capacity to produce 250 million doses," Basyir remarked.
Bio Farma chose Sinovac as a partner owing to its vaccine platform or the manufacturing method employed by Sinovac being at par with the company's competencies.
Through the use of the inactivation method, Bio Farma has experience in manufacturing vaccines, including the Pertussis vaccine.
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A total of 2,400 vaccines from Sinovac, China, had arrived in Bio Farma on July 19, 2020. The Indonesian company plans to start the third phase trials in August.
The COVID-19 vaccine from China, viewed as diplomatic goods, arrived in Indonesia owing to the support of the State-Owned Enterprises Ministry (KBUMN) and the Ministry of Foreign Affairs.
Prior to the clinical trial, the vaccine would be tested in the Bio Farma Laboratory and require to secure several other permits.
The clinical trial of the COVID-19 vaccine, will be conducted at the Clinical Test Center at the Faculty of Medicine, the University of Pandjajaran (Unpad), which will handle 1,620 subjects in the age group of 18 to 59 years that meet a specific criteria. The rest of the vaccine will be used for lab tests at several laboratories, including Bio Farma and the National Food and Drug Testing Center (PPOMN).
During the vaccine’s clinical trial, Bio Farma functions as a sponsor, collaborating with various parties, including the Health Research and Development Agency (Balitbangkes) of the Indonesian Ministry of Health, as a medical advisor.
In addition to Balitbangkes, Bio Farma is also collaborating with BPOM RI, as a regulator, and with Unpad's Faculty of Medicine, as an institution, with experience in conducting clinical trials of vaccines circulating in Indonesia.
Development of the COVID-19 vaccine, is one of the five target programs of Bio Farma in dealing with the spread of the COV2 SARS virus that causes COVID-19. The others are the production of Real Time Polymerase Chain Reaction (RT-PCR), Convalescent Plasma Therapy, BSL 3 Mobile Laboratory BSL 3, and Viral Transport Media (VTM) Manufacturing.
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Translator: Aji Cakti, Fardah
Editor: Sri Haryati
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