Chinese vaccine maker Sinovac has received approval for starting phase-3 clinical trial of its COVID-19 vaccine candidate, CoronaVac, in Brazil.
This study will recruit nearly 9,000 healthcare professionals working in CPVID-19 specialised facilities in 12 clinical sites located in several states in Brazil, Sinovac said on Monday.
The inclusion of participants is scheduled to start this month after ethical approval is obtained from each clinical site, the company added.
The study will be conducted in partnership with Instituto Butantan, a leading Brazilian producer of vaccines.
“We are pleased to advance to Phase III trials with Butantan, which will allow us one step further to our commitment to developing vaccines for global use and to our mission of supplying vaccines to eliminate human diseases,” Weidong Yin, Chairman, President and CEO of Sinovac, said in a statement.
The Brazilian National Regulatory Agency, Anvisa, fast-tracked the application for the phase-3 trial due to the public health emergency.
Sinovac’s Covid-19 vaccine candidate has become only one of three such vaccine candidates to advance to phase-3 trial after AstraZeneca and China National Pharmaceutical Group.
The US-based Moderna is also planning to start a phase-3 trial of its Covid-19 vaccine candidate this month.
Sinovac Life Sciences Co., Ltd. (Sinovac LS), a wholly owned subsidiary of Sinovac Biotech Ltd., in Brazil initiated the development of an inactivated vaccine against Covid-19 on January 28.
The phase-1 and phase-2 trials commenced on April 16 in Jiangsu province of China.
A group of healthy adults aged 18-59 years old were vaccinated in the trials.
According to the preliminary phase I/II results, there was no serious adverse event after vaccinating a total of 743 volunteers in the trials, demonstrating a good safety profile for the vaccine candidate.
Over 90 per cent seroconversion was observed in the phase II clinical trial 14 days after completion of a two-dose vaccination at day 0 and day 14.