Brazil Resumes Clinical Trials; Bio Farma Ensures Sinovac Vaccine's Safety

TEMPO.CO, Jakarta - Bio Farma ensures that CoronaVac, the Covid-19 vaccine being developed by Chinese company Sinovac Biotech, is safe. The company refers to the preliminary results of clinical trials in Bandung and Sao Paulo, Brazil.

"As of this press release, phase 3 of a clinical trial for the Covid-19 vaccine candidate had not yet seen reports of serious, unwanted, post-immunization incidents from volunteers, suspected of being related to vaccines or vaccination activities," Bio Farma wrote in its statement, Thursday 12 November.

The written statement quoted Brazil health authorities' decision to resume clinical trials of CoronaVac in the country, after stopping it on Monday following the death of a volunteer. It turned out that the death had nothing to do with the vaccine injection.

Outside China, Sinovac's phase 3 clinical trials are done by four countries: Brazil, Chile, Indonesia and Turkey. The tests involve 20,000 volunteers in those nations. 

In Indonesia, the phase 3 clinical trial is conducted in Bandung by a team from the Padjadjaran University's Faculty of Medicine. In Indonesia, the number of volunteers is 1,620 people.

As of now, Sinovac's vaccine clinical trial phase 3 in Bandung has entered the monitoring stage. All volunteers are being monitored, ensuring the efficacy, immunogenicity, and safety of the vaccine candidate. The monitoring phase is targeted to be completed in May 2021.

Read: COVID-19 Vaccine; Govt Open to Partnership with Pfizer-BioNTech

Ahmad Fikri (Kontributor)