Jakarta – The Indonesian Food and Drug Monitoring Agency (BPOM) has announced that it will extend the monitoring stage of a phase three clinical trial for the Chinese-developed vaccine Sinovac for another three months to determine the vaccine's efficacy and side effects.
West Java Governor Ridwan Kamil, who is participating in the clinical trial, said initially the 1,620 volunteers were scheduled to undergo their last blood tests in December.
"However, we had to take another blood test in March," Ridwan said after having his blood sample taken at Garuda community health center (Puskesmas) in Bandung, West Java, on Monday.
Ridwan explained that the BPOM had ordered researchers to take other blood samples from the volunteers six months after the fist injections of the Sinovac vaccine to ensure that they would still have antibodies against the coronavirus in the long run.
"This means the result of the clinical trials will also be postponed to March," he said.
Ridwan went on to say that he and other officials of the West Java administration who participated in the clinical trial were in good condition and reported no adverse events.
Ridwan even said he had undergone PCR tests several times and the results always came back negative.
"Whether it was because of the vaccine or not I could not say for sure, but that's my experience," he said.
The late stage clinical trial of the Sinovac vaccine in Indonesia started in August in cooperation with state-owned pharmaceutical company PT Bio Farma and Padjadjaran University (Unpad).
The clinical trial is part of global multicenter clinical trials conducted by four nations, namely Brazil, Chile, Indonesia and Turkey, and involving over 20,000 volunteers.
The Indonesian government has ordered around 143 million doses of vaccine from Sinovac in various forms, from the ready-to-administer doses to the vaccine bulk, with a total of 1.2 million doses of the vaccine arriving in the country last week.
The vaccine is now stored in a PT Bio Farma warehouse in Bandung, West Java, while the government is waiting for the BPOM to greenlight the vaccine's emergency use before it can begin inoculating people.
Previously, Bio Farma aimed to submit an interim report containing evidence of the efficacy, immunogenicity and safety of the vaccine to the BPOM in early January to help confirm use authorization.
President Joko "Jokowi" Widodo said recently that all steps must be taken properly in order to ensure public health, safety and vaccine effectiveness.
"Scientific considerations, clinical trial results will determine when vaccination can begin," he said.
Besides Sinovac, the government has been in talks with other vaccine producers, including Sinopharm, United Kingdom-based AstraZeneca, United States-based Moderna, Pfizer Inc. and BioNTech.
While the Sinovac vaccine's efficacy results have not been disclosed, the interim trial for the Sputnik V vaccine in Russia has shown encouraging results, demonstrating 92 percent effectiveness at protecting people from COVID-19, according to the vaccine's producer. (nal)