The Jakarta Post
PT Bio Farma has announced that the state-owned pharmaceutical company plans to submit its interim results from the third and final trial phase of the Sinovac vaccine to the Indonesian Food and Drug Monitoring Agency (BPOM) in January 2021.
The interim report is to include the results of the phase three clinical trials of the vaccine conducted in China and Brazil, which started prior to the trials in Indonesia. The interim results are intended to provide a basis for the BPOM to approve the issuance of emergency use authorization (EUA) for the vaccine.
“Hopefully, we will obtain emergency [use] approval in the third or fourth week in January,” Bio Farma president director Honesti Basyir said on Thursday.
He added that the third phase trials of the Sinovac vaccine involved 1,620 volunteers at six research centers in Bandung, West Java, with 1,603 volunteers receiving their second injection of the candidate vaccine on Nov. 13. Meanwhile, 1,523 volunteers were now being monitored.
“We already took their blood samples two weeks after the injection. We have also conducted a neutrality test with the Health Research and Development Agency,” Honesti said, referring to the Health Ministry’s R&D agency.
In response to a question on any unexpected adverse reactions among volunteers, Honesti said that Bio Farm had not encountered any serious events that could halt the clinical trials.
He also added that Bio Farma was currently preparing its facilities and human resources for mass-producing the vaccine, and that the BPOM had inspected its production facility at the end of October.
“We will organize training workshops, such as for media observers, to ensure that the vaccine is produced safely at Bio Farma,” he said.
Vivi Setiawaty, who heads the ministry’s Center for Biomedical Research and Basic Health Technology, said that the center had started testing the Sinovac vaccine for neutrality in early November.
The test analyzes the candidate vaccine’s immunogenicity, or its ability to produce an immune response, and uses blood samples collected from the trial volunteers.
“So far, we still have yet to obtain the results, we have only validated the test,” she said.
Separately, BPOM head Penny K. Lukito said the agency would approve an EUA if the interim review on the Sinovac vaccine showed a minimum efficacy rate of 50 percent, the standard approved by the drug authorities of several countries at a World Health Organization (WHO) forum.
To put it simply, said Penny, the vaccine should protect at least 50 out of 100 COVID-19 patients.
“The usual requirement is 70 percent, but we have been given leeway during the pandemic,” she said. (adi/dpk)
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