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YAKARTA: Indonesia presented on Tuesday (August 11) a complex human trial of a Chinese-made COVID-19 vaccine involving up to 1,620 patients.
The candidate vaccine, produced through Sinovac Biotech, is among the few in the world participating in phase 3 clinical trials or large-scale human trials, the last step before regulatory approval.
Sinovac released the main points on Monday of an intermediate or phase 2 examination in which he said the candidate vaccine gave the impression of being and induced detectable immune responses based on antibodies in the subjects.
The candidate vaccine, known as CoronaVac, is also undergoing a complex trial in Brazil, and Sinovac plans to do so in Bangladesh as well.
The Sinovac trial in Indonesia occurs when southeast Asia’s most populous country is grappling with an increase in the number of infections, with more than 127,000 cases reported on Tuesday. The trial has recruited another 1215 people and will last six months.
“The risk of COVID-19 will disappear until a vaccine is given to the entire population,” Indonesian President Joko Widodo said in a test release rite in Bandung, West Java.
This is where the state-owned pharmaceutical company Bio Farma will begin production of the prospective vaccine.
“I hope that in January we can produce and vaccinate everyone in the country,” Widodo added.
In addition to Bio Farma and Sinovac, Indonesian personal company Kalbe Farma and South Korean company Genexine are working in combination to produce a separate vaccine. It is still known how many doses these associations will produce and when.
In the mid-term Sinovac trial involving 600 participants in China, the fever rate in patients was lower than that of other COVID-19 candidates, adding one from AstraZeneca, showed the study prior to peer review.
Mid-term tests sometimes check a candidate’s protection and ability to cause an immune reaction in a small number of other people before performing a complex check.
The study noted that the production procedure for vaccines used in the Phase 2 trial was more optimized than in Phase 1, which produced more immune and led to greater immune responses.
Vaccines used in complex trials will be manufactured through the optimized process, said a Sinovac spokesman.
The effects of phase 2 included only antibody-based immunity, the researchers said, and added that the candidate is being evaluated for other vital parts of the immune system.
Sinovac is testing its vaccine because China is no longer an acceptable site for complex trials due to the low number of new infections.
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