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Jakarta, CNBC Indonesia – Bio Farma offers exciting news about the phase III clinical trial process for the Sinovac vaccine. During a month of clinical trial, the process had no significant side effects for the volunteers.
Additionally, PT Bio Farma (Persero) president director Honesti Basyir said that the corona virus (Covid-19) vaccine manufactured by his company with a Chinese company, Sinovac, will be available in early 2021.
“As Professor Kusnandi said previously, clinical trials have been going on for more than 1 month and Alhamdulillah is all running smoothly, which means that no significant side effects have been found in the volunteers,” he said, referring to the president of the Vaccine research team of the Faculty of Medicine, Prof. Kusnandi Rusmil.
“This clinical trial will last 7 months, so if everything goes well in January we will get the results,” he continued, at a press conference with Indonesian Foreign Minister Retno Marsudi, on Wednesday (9/30/2020).
He said that the Food and Drug Administration (BPOM) would conduct a visit to audit the corona vaccine development and production process at the Sinovac facility in Beijing, China in early November to maintain and ensure the quality of the Covid- vaccine. 19 from its raw materials.
“To maintain and guarantee the quality of the Covid-19 vaccine, from its raw materials, BPOM will carry out a physical audit, the development and production process of the corona vaccine at the Sinovac facility in Beijing, which is expected that it takes place in late October or early November, “he said.
“BPOM will also ensure that the Covid-19 vaccine production facilities and processes at Bio Farma meet Good Medicine (CPOB) / Good Manufacturing Practices (GMP) standards, so BPOM will also conduct an audit. of existing production facilities at Bio Farma, “he said.
He also said that while clinical trials are expected to be completed, preparation for vaccine production will begin from November to December 2020.
“Currently, our downstream production capacity will have 250 million doses available in 2021, an increase of 100 million doses in 2020. If clinical trials run smoothly, they will occur in January 2021,” he said.
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