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BPOM to visit Sinovac’s facility in Beijing as part of COVID-19 vaccine quality control
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Human trial: A volunteer receives an injection of a COVID-19 candidate vaccine during a phase III trial in Bandung, West Java, on Aug. 14. The trial is being conducted on more than 1,600 healthy people in five areas across the West Java capital. (Antara/Prima Mulia)
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ndonesia's Food and Drug Monitoring Agency (BPOM) is set to visit the facility of China’s pharmaceutical company Sinovac in Beijing to assure the quality of a COVID-19 candidate vaccine currently being developed by the latter, Foreign Affairs Minister Retno LP Marsudi has revealed.
“It’s part of our efforts to carefully prepare COVID-19 vaccination in Indonesia,” Retno said through a teleconference on Monday.
The country has secured priority access to the vaccine bulk produced by Sinovac, and will start to receive it in November. State-owned pharmaceutical firm Biofarma will then process the bulk, an aqueous form of the purified antigens, into smaller doses of ready-to-use vaccines in its facility in Bandung, West Java.
Both companies have closely coordinated in developing the candidate vaccine, dubbed CoronaVac. They launched last month a late-stage human trial for the candidate vaccine involving at least 1,620 Indonesian citizens.
Read also: Global coronavirus death toll passes one million
“Sinovac visited Bio Farma’s facility in Bandung last week to check out the clinical trial results,” Minister Retno further said, adding that the results turned out to be “good and there were no serious side effects”.
In its mid-stage clinical trial involving 600 participants in China, the candidate vaccine did not cause any serious side effects and the rate of fever was relatively low compared to other COVID-19 candidate vaccines, Reuters reported previously.
Sinovac has to test its vaccine abroad because China is no longer a suitable site for late-stage trials due to the low number of new infection cases. CoronaVac has also undergone a late-stage trial in Brazil expected to involve 9,000 people.
