Chinese biotech company Sinovac has launched a phase 3 trial of its COVID-19 vaccine candidate CoronaVac, which is being developed in partnership with Indonesian state-owned enterprise Bio Farma.
The late-stage human trial will enrol up to 1,620 participants in Indonesia with six months of planned follow-up, as the country continues to report increasing cases of COVID-19.
The study will assess the effectiveness of the vaccine and its immunogenicity, as well as continuing to monitor the safety profile of the shot.
“The threat of COVID-19 will not subside until a vaccine is given to all the people,” said Indonesian President Joko Widodo at the trial launch in Bandung, West Java.
“Hopefully in January, we can produce and vaccinate everyone in the country,” he added.
The phase 3 trial initiation follows the release of positive results from a phase 2 study of CoronaVac, in which the candidate induced detectable antibody-based immune responses in participants and also appeared to be safe to use.
Researchers also found that the process to make the vaccine candidate used in the phase 2 trial was more optimised than phase 1, which led to the an increase in the production of immunogens and also induced superior immune responses.
The vaccines used in the phase 3 trial would be manufactured using this optimised process to increase efficacy against COVID-19, said Sinovac.
According to Reuters, Sinovac is testing CoronaVac in Indonesia as the rate of new coronavirus infection cases is too low in China, making it difficult to recruit for a large-scale study.
Bio Farma will increase its production capacity for the vaccine candidate to ensure that 250 million doses can be delivered per year by December.
Sinovac has already initiated phase 3 testing of CoronaVac in Brazil after receiving approval from the country’s national regulatory agency Anvisa.
The Brazilian study will recruit nearly 9,000 healthcare professionals working in COVID-19 specialised facilities in 12 clinical sites located in several states in Brazil.
Another Chinese biotech company, CanSino Biologics, also recently announced the launch of a phase 3 clinical trial of its COVID-19 vaccine candidate Ad5-nCOV in Saudi Arabia. The study will enrol approximately 5,000 subjects, and will be performed across multiple sites.