Sinovac Biotech, a leading provider of biopharmaceutical products in China, announced positive preliminary results of phase I/II clinical trial for the company’s Covid-19 vaccine candidate, named CoronaVac showed favorable immunogenicity and safety profiles.
The phase I/II clinical trials were designed as randomized, double-blind and placebo-controlled studies. In total, 743 healthy volunteers aged 18 to 59 were enrolled in the trials. Of those, 143 volunteers are in phase I, and 600 volunteers are in phase II. There have been no severe adverse events reported in either phase I or phase II trials. The phase II clinical trial results show 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%, which concludes the vaccine candidate can induce a positive immune response.
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. As previously announced on 11 June 2020, Sinovac collaborated with Instituto Butantan to prepare and conduct a phase III clinical study in Brazil. The company expects to share the full data on our clinical trials with the public through academic publications.
Weidong Yin, chairman, president, and chief executive officer of Sinovac, commented, “Our phase I/I study shows that 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. We have started to invest in building a manufacturing facility to maximize the number of doses available to protect people from Covid-19. As with our other vaccines, we are committed to developing CoronaVac for global use as part of our mission to supply vaccines to eliminate human diseases.”
As announced previously, 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 study on its inactivated vaccine candidate against Covid-19 in China.