A biopharmaceutical company in China has announced promising results in the first two phases of clinical trials for its candidate COVID-19 vaccine.
Based in Beijing, the company Sinovac Biotech said CoronaVac showed “positive preliminary results” in phases I and II of its trials involving a total of 743 healthy volunteers aged 18 to 59.
Designed as randomized, double-blind and placebo-controlled studies, the trials showed “no severe adverse event,” according to the company.
Phase II, which included 600 volunteers, revealed CoronaVac as capable of neutralizing antibodies, showing a positive immune response.
The candidate specifically neutralized antibodies in above 90% of volunteers, who were tested “14 days after the vaccination with a 0,14 day schedule.”
Sinovac started developing a vaccine against COVID-19 in January and received approval to conduct phase I/II studies in April.
“Our phase I/II study shows CoronaVac is safe and can induce immune response,”said Weidong Yin, chairman, president and CEO of Sinovac.
“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,” they said.
The company will submit a phase II clinical study report and a phase III clinical study protocol to China’s National Medical Products Administration (NMPA) before running phase III clinical trials outside China. Those trials will be conducted in partnership with Instituto Butantan in Brazil.
“This pandemic is having a tragic impact worldwide and this distinguished alliance with Sinovac to conduct the last phase of the clinical trials will bring hope to have a vaccine in the short term,” Dr. Dimas Covas, director of Instituto Butantan, said. “Butantan expects to support not only on the clinical development, but also commercialization and manufacturing activities of CoronaVac in Brazil.”
Based in Beijing, Sinovac Biotech has developed vaccines against enterovirus71 (EV71), hepatitis A and B, seasonal influenza, H5N1 pandemic influenza (avian flu), H1N1 influenza (swine flu), varicella vaccine and mumps.
The company’s clinical trials are reportedly among five that have been authorized for the development of a COVID-19 vaccine in China.
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