Chinese Firm Sinovac Biotech Announces Positive Early Results of COVID-19 Vaccine Trials

Sinovac Biotech Ltd. (Beijing, China) has announced positive preliminary results of Phase 1/2 clinical trial for the company’s COVID-19 vaccine candidate, named CoronaVac, which showed favorable immunogenicity and safety profiles.

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 National Medical Products Administration (NMPA) on April 13 to conduct Phase 1/2 studies on its inactivated vaccine candidate against COVID-19 in China. The Phase 1/2 clinical trials were 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 1 and 600 volunteers are in Phase 2. There have been no severe adverse events reported in either the Phase 1 or Phase 2 trials. The Phase 2clinical trial results showed that the vaccine induces neutralizing antibodies 14 days after the vaccination with a 0,14 day schedule. The neutralizing antibody seroconversion rate is above 90%, suggesting that the vaccine candidate can induce positive immune response.

The company expects to submit a Phase 2 clinical study report and a Phase 3 clinical study protocol to NMPA in the near future and commence application of Phase 3 clinical trials outside of China. Additionally, Sinovac is collaborating with Brazil’s Instituto Butantan to prepare and conduct a Phase 3 clinical study of its inactivated vaccine candidate against COVID-19.

“Our Phase 1/2 study shows CoronaVac is safe and can induce immune response. Concluding our Phase 1/2 study clinical studies with these encouraging results is another significant milestone we have achieved in the fight against COVID-19,” said Mr. Weidong Yin, Chairman, President and CEO of Sinovac. “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.”

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