AsianScientist (Jun. 16, 2020) – Chinese vaccine maker Sinovac Biotech Ltd. announced on Monday that the company’s COVID-19 vaccine candidate, CoronaVac, showed favorable immunogenicity and safety profiles in recently concluded Phase I/II clinical trials.
Sinovac’s development of an inactivated vaccine candidate 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 begin clinical studies in China.
The Phase I/II clinical trials were designed as randomized, double-blind and placebo-controlled studies, and enrolled a total of 743 healthy volunteers, aged from 18 to 59 years old.
In Monday’s preliminary results, the company reported that the vaccine candidate induces neutralizing antibodies 14 days after the vaccination with a 0,14 day schedule, with a neutralizing antibody seroconversion rate above 90 percent. No severe adverse event was reported in either trial.
“Our phase I/II study shows CoronaVac is safe and can induce [an] immune response,” said Mr. Yin Weidong, chairman, president and CEO of Sinovac.
Calling it a “significant milestone in the fight against COVID-19,” Yin shared that Sinovac is building a manufacturing facility for the production of COVID-19 vaccines. Separately, Sinovac is collaborating with Instituto Butantan in Brazil for a Phase III clinical study.
Sinovac expects to submit a Phase II clinical study report and a Phase III clinical study protocol to the NMPA, and commence Phase III clinical trials outside of China.
Sinovac’s portfolio includes vaccines against enterovirus71 (EV71), hepatitis A and B, seasonal influenza, H5N1 pandemic influenza (avian flu) and H1N1 influenza (swine flu).
Besides CoronaVac, other vaccine products in development include a Sabin-strain inactivated polio vaccine, a pneumococcal polysaccharides vaccine and a quadrivalent influenza vaccine.
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Source: Sinovac Biotech Ltd.; Photo: Karolina Grabowska/Pexels.
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