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View all search resultsCOVID-19 vaccine emergency use pending Bandung clinical trial report
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tate-owned pharmaceutical company PT Bio Farma is still waiting for results from the phase three clinical trial of a COVID-19 vaccine produced by Sinovac Biotech for the vaccine to be authorized for public use.
Padjadjaran University’s School of Medicine is currently conducting the phase three clinical trial in Bandung, West Java.
“We are still [waiting for] efficacy data from the clinical trials to be reported, reviewed and approved by the Food and Drug Monitoring Agency (BPOM),” Bio Farma operational director Rahman Roestan said after a meeting with the BPOM on Thursday.
However, BPOM head Penny Kusumastuti Lukito said emergency use authorization (EUA) could be granted before the clinical trials are completed.
She went on to explain that her agency only needed to conduct a fit-and-proper trial for the vaccine as long as health authorities and vaccine research teams in other participating countries had obtained the data for the clinical trials.
“[The vaccine] doesn’t have to go through clinical trials in Indonesia, if the data on its clinical trials are already available. The BPOM can use that to conduct a fit and proper test, so that we can issue the EUA for Indonesia,” Penny said on Thursday.
Up to 1,620 volunteers in Bandung are participating in the clinical trial of the Sinovac COVID-19 vaccine that is set to end in the first or second week of January 2021.
