Sinovac Biotech said that the phase 1/2 clinical trial for its coronavirus vaccine candidate CoronaVac has delivered positive preliminary results by showing favorable immunogenicity and safety profiles.
According to the Chinese biopharma company, the phase 1/2 clinical trials are randomized, double-blind and placebo-controlled studies featuring 743 healthy volunteers, aged between 18 and 59 years.
Of the enrolled patients, 143 volunteers are in phase I and the remaining 600 volunteers are in phase II trial.
Sinovac Biotech said that there have been no severe adverse event noted in either the phase 1 or phase 2 clinical trials. The phase 2 clinical trial results show that the CoronaVac vaccine induces neutralizing antibodies two weeks after the vaccination with a 0,14 day schedule.
The Chinese biopharma company said that the neutralizing antibody seroconversion rate is more than 90%, which proves that the COVID-19 vaccine candidate can trigger a positive immune response.
Sinovac Biotech said that it is looking to submit a phase 2 clinical trial report and a phase 3 clinical study protocol to China’s National Medical Products Administration (NMPA) in the near future and start filing application of phase 3 COVID-19 clinical trials outside of China.
Earlier this month, Sinovac announced a collaboration with Instituto Butantan in Brazil to prepare and carry out a phase 3 coronavirus clinical study. The Chinese biopharma company anticipates sharing the full data of its COVID-19 clinical trials with the public via academic publications.
Weidong Yin – Chairman, President and CEO of Sinovac said: “Our phase I/II study shows CoronaVac is safe and can induce 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 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.”