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View all search resultsBio Farma aims to submit interim review on Sinovac vaccine in January
Bio Farma says it aims to submit its interim review of China's Sinovac vaccine to the BPOM in January 2021, with hopes that the candidate vaccine will gain emergency use authorization (EUA).
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T 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.
