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Indonesia enters monitoring stage of Sinovac vaccine late-stage trial

Jakarta Post - November 13, 2020

Jakarta – Indonesia has entered the monitoring stage of a phase three clinical trial for the Chinese-developed vaccine Sinovac, state-owned pharmaceutical company PT Bio Farma director Honesti Basyir has said.

"This monitoring phase is being conducted to see the [vaccine's] efficacy, immunogenicity, as well to ensure its safety," Honesti said as quoted by tempo.co on Thursday.

He also hoped the clinical trial team would finish the monitoring phase by May 2021. The monitoring result will be delivered to the Indonesia Food and Drug Monitoring Agency (BPOM) through an interim report in early January next year to obtain Emergency Use Authorization (EUA). The report itself will consist of evidence on efficacy, immunogenicity and safety.

Honesti also said the phase three clinical trial was part of global multicenter clinical trials conducted by four nations, namely Brazil, Chile, Indonesia and Turkey, and involving over 20,000 volunteers.

He explained that the clinical trials were being conducted in different countries to see the vaccine's efficacy in various races worldwide.

"In Indonesia, the trial is being conducted in Bandung and participated in by 1,620 volunteers of multiple ethnicities across Indonesia. Some of the volunteers are of European descent," Honesti said.

He added that a representative team from Sinovac also monitored the late-stage clinical trials in the different locations, such as that in Indonesia, which took place from Nov. 2 to 6.

The team, which was led by Sinovac clinical department senior manager Yuan Sheng Hu, monitored the clinical trial at community health centers (Puskesmas). Honesti went on to say that Hu also visited Indonesia to discuss the trial progress in the country, as well as to make sure that the potential vaccine fulfilled the quality standards on effectiveness and safety.

As of now, there have been no reports of serious adverse events during the trials.

Previously, a team of Indonesian scientists who conducted the phase three clinical trial for the Sinovac vaccine said that trial would be continued despite suspension of a similar trial in Brazil.

On Oct. 29, Brazil's National Health Surveillance Agency reported a serious adverse event upon conducting phase three of the trial, resulting in the nation suspending the trial, which is a common case and happened before during the phase III trial for AstraZeneca and Johnson & Johnson's potential vaccine.

Chinese biopharmaceutical company Sinovac Biotech has since issued a clarification regarding the trial suspension.

"We have noticed some media reports. After communicating with the Brazilian partner, the Butantan Institute, we learned that the head of the Butantan Institute believes the SAE was not related to the vaccine." Sinovac stated on its official website, sinovac.com. (dpk)

Source: https://www.thejakartapost.com/news/2020/11/13/indonesia-enters-monitoring-stage-of-sinovac-vaccine-late-stage-trial.htm