JAKARTA, KOMPAS.com – The phase 3 clinical trials for the Covid-19 vaccine developed by China’s Sinovac Biotech Ltd has entered the monitoring stage, which is expected to be completed in May 2021 in Indonesia.
The monitoring stage involves all volunteers as the clinical trial team needs to see the vaccine’s efficacy, immunogenicity, and at the same time to ensure the safety of the vaccine.
The team is scheduled to submit an interim report on safety, immunogenicity, and three-month efficacy data to the Indonesian Food and Drug Monitoring Agency (BPOM) in January 2021 to obtain approval for the use in an emergency or Emergency Use Authorization (EUA).
The phase 3 clinical trial activity for the Covid-19 vaccine is part of the global clinical trial, which is carried out by four countries or multicenter such as Brazil, Chile, Indonesia, and Turkey with total volunteers of more than 20,000.
Indonesia’s state-owned pharmaceutical Bio Farma president director Honesti Basyir said the aim of conducting the multicenter clinical trial was to see the level of efficacy of the vaccine in various races in the world.
“Indonesia is part of phase 3 global clinical trial for the Covid-19 vaccine candidate from Sinovac, with a total of more than 20,000 volunteers,” said Honesti in a statement on Friday, November 13.
“In Indonesia, the clinical trial was held in Bandung with 1,620 volunteers from multi-ethnic groups in the country, including some people of European descent,” he added.
He went on to say that Sinovac also carried out monitoring of phase 3 clinical trials in designated places for the vaccine testing.
The Sinovac team has visited Indonesia to participate in monitoring the implementation of phase 3 clinical trials at health centers where the tests took place similar to what they have done in Turkey.
“Alhamdulillah (thanks be to God), the Sinovac team led by Senior Manager Yuansheng of the Clinical Department visited Indonesia, discussing the implementation of phase 3 clinical trials in Indonesia, and ensuring the safety and efficacy of the vaccine as well as the quality that meets the standards,” the president director said.
He also said that the volunteers who received shots from the vaccine’s clinical trial team have not reported any serious unwanted events or serious adverse events (SAE).
Regarding the news about the discontinuation of phase 3 clinical trials in Brazil after the discovery of an SAE incident on volunteers, Brazil’s National Health Surveillance Agency (Anvisa) confirmed that the incident was not related to the injection of the Covid-19 vaccine candidate. Therefore, in Brazil the phase 3 clinical trials for the Covid-19 vaccine candidate can be resumed, he added.
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