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PT Bio Farma has announced that the state pharmaceutical company plans to send its interim results of the third and final phase of testing of the Sinovac vaccine to the Indonesian Food and Drug Monitoring Agency (BPOM) in January 2021.
The interim report will include the results of phase three clinical trials of the vaccine conducted in China and Brazil, which began prior to the trials in Indonesia. The interim results are intended to provide a basis for the BPOM to approve the issuance of the Emergency Use Authorization (EUA) for the vaccine.
“Hopefully, we will get [use] approval in the third or fourth week of January ”, said on Thursday the president director of Bio Farma, Honesti Basyir.
He added that the third phase of the Sinovac vaccine trials involved 1,620 volunteers at six research centers in Bandung, West Java, and 1,603 volunteers received their second injection of the candidate vaccine on Nov. 13. Meanwhile, 1,523 volunteers were being monitored.
“We already took blood samples from them two weeks after the injection. We have also conducted a neutrality test with the Health Research and Development Agency, ”Honesti said, referring to the Research and Development agency of the Ministry of Health.
In response to a question about any unexpected adverse reactions among the volunteers, Honesti said that Bio Farm had not found any serious events that could stop clinical trials.
He also added that Bio Farma was currently preparing its facilities and human resources for mass production of the vaccine, and that the BPOM had inspected its production plant in late October.
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“We will organize training workshops, such as for media watchers, to ensure the vaccine is produced safely at Bio Farma,” he said.
Vivi Setiawaty, who leads the ministry Center for Biomedical Research and Basic Health Technology, He said the center had started testing the Sinovac vaccine for neutrality in early November.
The test looks at the immunogenicity of the candidate vaccine, or its ability to elicit an immune response, and uses blood samples drawn from trial volunteers.
“Until now, we have yet to get the results, we have only validated the test,” he said.
Separately, BPOM Director Penny K. Lukito said the agency would approve an EUA if the mid-term review of the Sinovac vaccine showed a minimum efficacy rate of 50 percent, the standard approved by pharmaceutical authorities in several countries. at the World Health Organization (WHO). forum.
Simply put, Penny said, the vaccine should protect at least 50 out of 100 COVID-19 patients.
“The usual requirement is 70 percent, but we have been given room for maneuver during the pandemic,” he said. (adi / dpk)
Editor’s note: This article is part of a public campaign by the COVID-19 task force to raise awareness about the pandemic.
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