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Indonesia starts phase 3 trial for COVID-19 vaccine, Sinovac reports phase 2 details

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JAKARTA: Indonesia on Tuesday (Aug 11) started a late-stage human trial of a Chinese-made COVID-19 vaccine that will involve as many as 1,620 patients.

The vaccine candidate, produced by Sinovac Biotech, is among just a few in the world to enter phase 3 clinical trials, or large-scale testing on humans – the last step before regulatory approval.

Sinovac released details on Monday from a mid-stage or phase 2 study in which it said the vaccine candidate appeared to be safe and induced detectable antibody-based immune responses in subjects.

The vaccine candidate, known as CoronaVac, is also undergoing a late-stage trial in Brazil, and Sinovac expects to also test it in Bangladesh.

Sinovac’s Indonesia trial comes as Southeast Asia’s most populous country grapples with spiking infection numbers, with over 127,000 cases recorded as of Tuesday. The trial has so far recruited 1,215 people and will last six months.

“The threat of COVID-19 will not subside until a vaccine is given to all the people,” said Indonesian President Joko Widodo at a ceremony to launch the trial in Bandung, West Java.

It is where state-owned pharmaceutical firm Bio Farma will begin production of the potential vaccine.

“Hopefully in January, we can produce and vaccinate everyone in the country,” Widodo added.

In addition to Bio Farma and Sinovac, private Indonesian firm Kalbe Farma and South Korea’s Genexine are cooperating to produce a separate vaccine. It is yet unclear how many doses these partnerships will produce and by when.

In Sinovac’s mid-stage trial involving 600 participants in China, the rate of fever in patients was relatively lower than other COVID-19 candidates including one from AstraZeneca, the study showed ahead of peer review.

Mid-stage trials usually test a candidate’s safety and ability to trigger an immune response in a relatively small number of people before it enters late-stage tests.

The study noted that the process to make the vaccines used in the phase 2 trial was more optimised than in phase 1, which produced more immunogens and triggered better immune responses.

Vaccines used in the late-stage trials will be made using the optimised process, a Sinovac spokesman said.

The Phase 2 results only included antibody-based immunity, the researchers said, adding that the candidate was being evaluated for other important components of the immune system.

Sinovac is testing its vaccine abroad because China is no longer a satisfactory site for late-stage trials due to the low number of new infection cases.–CNA

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