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Over 1,600 Indonesians have received trial vaccine

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Jakarta Globe - October 18, 2020

Heru Andriyanto, Jakarta – All 1,620 Indonesian volunteers have received trial vaccine against coronavirus provided by China's Sinovac Biotech during the phase 3 clinical trial in the West Java capital of Bandung, an executive said on Sunday.

The clinical trial began in August, conducted by Padjadjaran University's medicine faculty and state-owned pharmaceutical company Bio Farma, which has secured a joint production agreement with Sinovac.

Bio Farma president director Honesti Basyir said in a statement that the number of volunteers has exceeded the target.

Every volunteer has received two doses of the trial vaccine and medical workers have taken blood samples from at least 643 of them for immunogenicity study, he said.

"This is a huge program that must be managed properly from the phase 3 clinical trial and production to distribution by Bio Farma across all provinces, public health centers and medical workers who will administer the vaccine to the society," Honesti said.

The phase 3 clinical trial seeks to test the vaccine's efficacy and safety that will take a couple of months to study the results and possible adverse events before it can be approved and licensed for production at scale.

The clinical trial is supervised by the Drug and Food Control Agency (BPOM) to make sure that it conforms to the globally-accepted standards in vaccine testing and produces reliable data for future reference.

Riska Andalusia, BPOM's director of drug registration, said there have been no reports of adverse events from volunteers who received the trial vaccine.

If everything goes as planned, the agency can authorize emergency use of the vaccine once the phase 3 trial is concluded, she said.

Riska added the Covid-19 vaccine candidate from Sinovac also underwent trials in Brazil, Chile, Turkey and Bangladesh.

"Results from clinical trials in all five countries will be compiled to get license and approval for future production of the vaccine," Riska said.

The government has targeted to vaccinate 170 million people or around 60 percent of the population next year. It means Indonesia must acquire at least 340 million doses of vaccine in a year.

Source: https://jakartaglobe.id/news/over-1600-indonesians-have-received-trial-vaccine

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