Clinical Trials Of COVID-19 Vaccine In Indonesia Enter The Monitoring Period

BANDUNG - The clinical trial team for the COVID-19 vaccine candidate made by Sinovac, China, in Indonesia will continue the phase three clinical trial which has entered the monitoring period.

"This monitoring stage is to see the efficacy (efficacy), immunogenicity, and ensure the safety of the COVID-19 vaccine candidate," said Bio Farma President Director Honesti Basyir as quoted by Antara, Thursday, November 12.

He hopes that the clinical trial team will complete this monitoring phase, in May 2021. The results of monitoring will be submitted to the Food and Drug Administration or the POM with an interim report in the form of safety, immunogenicity and efficacy data for three months in early January 2021 for approval. use in an emergency or EUA Emergency Use Authorization.

Honesti explained that the phase three clinical trial for the COVID-19 vaccine is part of the Global Clinical Trial, which is carried out by four countries (multicenters) such as Brazil, Chile, Indonesia and Turkey with a total of more than 20 thousand volunteers.

According to him, the aim of conducting this multicenter clinical trial is to see the level of efficacy of this vaccine, in various races in the world.

"So Indonesia is part of the Phase 3 Global Clinical Trial for the COVID-19 vaccine candidate from Sinovac, with a total of more than 20 thousand volunteers. In Indonesia itself, it was held in Bandung with 1,620 volunteers from multi ethnic groups in Indonesia. some of the volunteers even came from European descent, "said Honesti.

Honesti added, Sinovac also carried out monitoring of phase three clinical trials, to places designated as multicenters for phase three clinical trials, for Indonesia itself, which was held on 2-6 November 2020.

The goal of the Sinovac team was to carry out a visit to Indonesia, to participate in monitoring the implementation of the Phase three clinical trial at the Puskesmas which was used as a clinical trial site, after they previously held the same activity in Turkey.

Until now, the phase three clinical trial for the COVID-19 vaccine candidate, has not found any serious Serious Adverse Event (SAE) or serious unwanted events from volunteers suspected of being related to vaccines or vaccination activities. .