By Stanley Widianto and Roxanne Liu
YAKARTA / BEIJING (Reuters) – Chinese company Sinovac Biotech Ltd on Tuesday presented a complex human trial involving up to 1,620 patients in Indonesia for a COVID-19 candidate vaccine that it will present with its Indonesian state counterpart Bio Farma.
Separately, Sinovac on Monday published the main points of a mid-term study, or Phase 2, in which he said the candidate vaccine gave the impression of inducing detectable antibody-based immune responses in subjects.
The candidate, known as CoronaVac, is one of the few prospective vaccines that have entered complex large-scale trials to gather evidence of effectiveness for regulatory approval.
CoronaVac is already undergoing a complex test in Brazil and Sinovac plans to do so in Bangladesh as well.
The Sinovac trial in Indonesia comes at a time when Southeast Asia’s most populous country is grappling with the peak 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 not go away until a vaccine is given to the entire population,” Indonesian President Joko Widodo said in a test release rite in Bandung, West Java. “I hope that in January we will be there to produce and vaccinate everyone in the country.”
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 medium-term trial of Sinovac 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 generally verify a candidate’s protection and ability to cause an immune reaction in a small number of other people before entering a complex verification.
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 immunogens and triggered a higher immune response.
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.
(Information through Stanley Widianto and Maikel Jefriando in Jakarta and Roxanne Liu in Beijing; Additional report through Kate Lamb in Sydney; Edited through Sayantani Ghosh, Christopher Cushing and Raju Gopalakrishnan)