The Jakarta Post
State-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.
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The report will provide additional data on the safety, quality and efficacy of the Sinovac vaccine, in addition to the clinical trials conducted in Brazil.
The BPOM will then consider the report to issue the EUA for the Sinovac vaccine.
Penny also stated that the clinical trial would need blood samples from the volunteers to assess the immunogenicity of the vaccine receiver.
The immunogenicity level would show the vaccine’s effectiveness in creating antibodies in the volunteers’ body to neutralize the coronavirus should it enter the body.
“We need the scientific proof of the safety and efficacy [of the vaccine],” Penny said.
She said that the safety aspect of the vaccine could be evaluated three to six months after the volunteers had received the second shot of the vaccine.
Padjadjaran University clinical trial team head Kusnandi Rusmil said all volunteers in Bandung had received the first shot of the Sinovac Biotech vaccine.
“About [1,600] volunteers have already received their second shot. We will take blood samples from them one, three and six months after receiving the shot,” Kusnandi said.
He said there had been no safety problems after the volunteers had received their shots. However, about 20 percent of the volunteers said they had a cold and a headache after receiving their shots. (adi/ami/dpk)
Editor’s note: This article is part of a public campaign by the COVID-19 task force to raise people’s awareness about the pandemic.