Beijing: Chinese vaccine-maker Sinovac Biotech has announced “positive preliminary” results of phase I and II clinical trials for its COVID-19 vaccine candidate, CoronaVac, saying it can induce a positive immune response.
The phase I/II clinical trials was designed as randomized, double-blind and placebo-controlled studies.
In total, 743 healthy volunteers, aged from 18 to 59 years old, enrolled in the trials.
Of those, 143 volunteers are in phase I and 600 volunteers are in phase II, the Beijing-based company said in a statement.
The vaccine induced neutralising antibodies in “above 90 per cent” of people who were tested 14 days after receiving two injections, two weeks apart. There were no severe side effects reported, the company said in a statement.
The company expects to submit a phase II clinical study report and a phase III clinical study protocol to China’s National Medical Products Administration (NMPA) soon and commence application of phase III clinical trials outside of China.
Sinovac is collaborating with Instituto Butantan in Brazil to prepare and conduct a phase III clinical study.
The company expects to share the full data on clinical trials with the public through academic publications.
Weidong Yin, Chairman, President and CEO of Sinovac, said, “Our phase I/II study shows CoronaVac is safe and can induce an immune response.
“Concluding our phase I/II clinical studies with these encouraging results is another significant milestone we have achieved in the fight against COVID-19,” Weidong said.
“We have started to invest in building a manufacturing facility so that we can maximize the number of doses available to protect people from COVID-19. Like with our other vaccines, we are committed to developing CoronaVac for global use as part of our mission of supplying vaccines to eliminate human diseases,” he said.
Sinovac’s development of a vaccine against COVID-19 began in January 2020 in partnership with leading academic research institutes in China.
The company received approval from China’s NMPA on April 13 to conduct phase I/II trials on its inactivated vaccine candidate against COVID-19 in China.
There are currently more than two dozen research efforts underway to develop protective vaccines against the novel coronavirus that causes COVID-19.
In May, Moderna, a Cambridge, Mass-based biotech firm, announced early and encouraging immune-response results for its experimental COVID-19 vaccine.
