On Sept. 22, 2020, Sinovac Biotech announced that it had recently commenced phase III clinical trials for its inactivated COVID-19 vaccine candidate developed by Sinovac Life Sciences in Turkey. The phase III clinical trial planned to test efficacy and safety of CoronaVac in Turkey and aimed to be a pivotal study to support the licensure of this product.

This case-driven, randomized, double-blinded and placebo-controlled phase III clinical trial uses an adaptive design, and all participants will be enrolled in a step-by-step basis. In the first stage, 1,300 healthcare workers between the ages of 18-59 years old will be randomly to receive two doses of vaccine or placebo at a two-week interval. In the second stage, approximately 12,000 members of the general population between the ages of 18-59 years old will be enrolled to receive two doses of vaccine or placebo at a two-week interval.

In recent months, the Company’s Phase I/II clinical trials of CoronaVac in adults (18 to 59 years old) and elderly volunteers (60 years old and above) were conducted in China’s Jiangsu and Hebei Provinces on April 16th and May 22nd, respectively. The vaccine candidate appeared to be well tolerated for different dosage and no serious vaccine-related adverse events were reported, demonstrating a good safety profile for the vaccine candidate. Both seroconversion rates in adults and elderly volunteers were above 90%, indicating favorable immunogenicity of CoronaVac. In addition to Turkey, the Company has partnered with several companies outside of China for phase III efficacy studies.