China’s Sinovac Biotech Begins Phase 3 Trials of Coronavirus Vaccine Candidate in Brazil

The Brazilian national regulatory agency, Anvisa, has granted approval to a phase 3 clinical trial to test efficacy and safety of the inactivated COVID-19 vaccine developed by Sinovac Life Sciences Co., Ltd. (Beijing, China).

Sinovac had initiated the development of an inactivated vaccine against COVID-19 named CoronaVac in January this year and was granted approval to conduct phase 1 and 2 clinical trials in China that began in April. A group of healthy adults aged 18-59 years old were vaccinated with a 0, 14 day schedule. Preliminary phase 1/2 results showed no serious adverse event after vaccinating a total of 743 volunteers in the trials, demonstrating a good safety profile for the vaccine candidate. Over 90% seroconversion was observed in the phase 2 clinical trial 14 days after completion of a two-dose vaccination at day 0 and day 14. A Phase 2 study on elderly adults is being conducted which will be followed by child and adolescent groups. The phase 2 trial is expected to be completed at the end of 2020.

The company has partnered with several companies outside of China for phase 3 efficacy studies of CoronaVac. In Brazil, Sinovac is partnering with Instituto Butantan, a leading Brazilian producer of immunobiologic products and vaccines, which will sponsor the phase 3 vaccine trial that aims to be a pivotal study to support the licensure of the product. Anvisa’s process review included manufacturing and clinical information generated by Sinovac, and a clinical development plan and trial protocol developed by Butantan. The study will recruit nearly 9,000 healthcare professionals working in COVID-19 specialized facilities in 12 clinical sites located in several states across Brazil. The inclusion of participants is scheduled to start this month after ethical approval is obtained from each clinical site.

“The phase 2 clinical trial approval is a demonstration that the Sinovac and Butantan partnership is an efficient collaboration to move forward offering hope to save lives worldwide,” said Dr. Dimas Covas, Director of Instituto Butantan.

“We are pleased to advance to Phase III trials with Butantan, which will allow us one step further to our commitment to developing vaccines for global use and to our mission of supplying vaccines to eliminate human diseases,” said Mr. Weidong Yin, Chairman, President and CEO of Sinovac.


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