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Vol 24, No. 07, July 2020   |   Issue PDF view/purchase
EYE ON CHINA
Promising Results from Phase I/II Clinical Trial for COVID-19 Vaccine Candidate
Sinovac Biotech Ltd. announces positive preliminary results for its inactivated vaccine candidate against COVID-19Sinovac Biotech Ltd. announces positive preliminary results for its inactivated vaccine candidate against COVID-19

Provider of biopharmaceutical products in China, Sinovac Biotech Ltd. announced in June 2020 positive preliminary results of phase I/II clinical trial for its COVID-19 vaccine candidate, named CoronaVac. The results showed favourable immunogenicity and safety profiles.

The phase I/II clinical trials were designed as randomized, double-blind and placebo-controlled studies. With a total of 743 healthy volunteers, aged from 18 to 59 years old, enrolled in this phase I/II trial. Out of all the healthy volunteers, 143 volunteers went through phase I and 600 volunteers went through phase II. During the trials no severe adverse event was reported in either the phase I or phase II trials.

The phase II clinical trial results showed that the vaccine induces neutralizing antibodies 14 days after the vaccination with a two-dose schedule at day 0 and day 14. The neutralizing antibody seroconversion rate was found to be above 90 percent, which concludes the vaccine candidate can induce positive immune response.

Sinovac expects to submit a phase II clinical study report and a phase III clinical study protocol to China’s National Medical Products Administration (NMPA) in the near future and commence application of phase III clinical trials outside of China. As previously announced on 11 June 2020, Sinovac is collaborating with Instituto Butantan in Brazil to prepare and conduct a phase III clinical study. Sinovac expects to share the full data on our clinical trials with the public through academic publications.

Mr. Weidong Yin, Chairman, President and CEO of Sinovac, commented, “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.”

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 13 April 2020 to conduct phase I/II studies on its inactivated vaccine candidate against COVID-19 in China.

 

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