Jakarta, CNBC Indonesia – Bio Farma delivers exciting news regarding the phase III clinical trial process for the Sinovac vaccine. During a month of the clinical trial process, there were no significant side effects for the volunteers.
In addition, President Director of PT Bio Farma (Persero) Honesti Basyir said that the corona virus vaccine (Covid-19) made by his company with a Chinese company, Sinovac, will be available in early 2021.
“As stated by Professor Kusnandi earlier, clinical trials have been going on for more than 1 month and Alhamdulillah everything is running smoothly, meaning that there are no significant side effects found in volunteers,” he said, referring to the Chair of the Vaccine Research Team from the Faculty of Medicine, Prof. Kusnandi Rusmil.
“This clinical trial will last for 7 months, so that if everything goes well in January we will get the results,” he continued, in a press briefing with Indonesian Foreign Minister Retno Marsudi, Wednesday (30/9/2020).
He said that the Food and Drug Administration (BPOM) would conduct a visit to audit the development and production process of the corona vaccine at the Sinovac facility in Beijing, China in early November to maintain and ensure the quality of the Covid-19 vaccine starting from its raw materials.
“To maintain and ensure the quality of the Covid-19 vaccine, starting from its raw materials, BPOM will conduct a physical audit, the development and production process of the corona vaccine at the Sinovac facility in Beijing which is expected to be carried out around the end of October or early November,” he said.
“BPOM will also ensure that the facilities and production processes for the Covid-19 vaccine at Bio Farma meet the standards of Good Medicine (CPOB) / Good Manufacturing Practice (GMP), so that BPOM will also conduct an audit of the existing production facilities at Bio Farma,” he said.
He also said that while waiting for clinical trials to be completed, preparation for vaccine production will begin from November to December 2020.
“Currently our production capacity from the downstream will already be available at 250 million doses in 2021, an increase from 100 million doses in 2020. If the clinical trials run smoothly, they will be produced in January 2021,” he said.
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