Beijing: Chinese vaccine maker Sinovac has said that its Covid-19 vaccine candidate, CoronaVac, has been found to induce immune response in initial human trials.
No severe adverse events were reported in either the phase-1 or phase-2 trials, said the company on Saturday, while revealing preliminary results of the trials.
“Our phase I/II study shows CoronaVac is safe and can induce immune response,” Weidong Yin, Chairman, President and CEO of Sinovac, said in a statement.
“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 maximise the number of doses available to protect people from Covid-19.”
The clinical trials were designed as randomised, double-blind and placebo-controlled studies.
In total, 743 healthy volunteers, aged from 18 to 59 years old, enrolled in the trials — 143 volunteers in phase-1 and 600 volunteers in phase-2.
The phase-2 clinical trial results showed that the vaccine induces neutralising antibodies 14 days after the vaccination.
The neutralising antibody seroconversion rate was found to be above 90 per cent, indicating that the vaccine candidate can induce positive immune response.
Sinovac said it expects to submit a phase-2 clinical study report and a phase-3 clinical study protocol to China’s National Medical Products Administration (NMPA) in the near future and commence application of phase-3 clinical trials outside of China.
As previously announced on June 11, Sinovac is collaborating with Instituto Butantan in Brazil to prepare and conduct a phase-3 clinical study.
Sinovac said it hopes to share the full data on its clinical trials with the public through academic publications.
The Chinese vaccine maker started work on development of a vaccine against Covid-19 in January in partnership with leading academic research institutes in China.
