CoronaVac phase 3 trial : Sinovac Biotech, a Chinese biopharma company has secured approval in Brazil to begin a phase 3 clinical trial for CoronaVac, its inactivated COVID-19 vaccine candidate.
Brazil is currently the second most infected country after the US with the novel coronavirus.
The Chinese pharma company has been granted the approval by Anvisa, the Brazilian National Regulatory Agency.
Last month, Sinovac Biotech entered into a partnership with Instituto Butantan, a Brazilian producer of immunobiologic products, to advance the clinical development of CoronaVac to phase 3.
Weidong Yin – Chairman, President and CEO of Sinovac Biotech, commenting on the CoronaVac phase 3 trial, said: “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.”
The late-stage clinical trial sponsored by Instituto Butantan will evaluate the efficacy and safety of the inactivated COVID-19 vaccine in approximately 9,000 healthcare professionals working across specialized coronavirus facilities in twelve clinical sites across several Brazilian states.
Commenting on the CoronaVac phase 3 trial, Dr. Dimas Covas – Director of Instituto Butantan said: “The phase III 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.”
In April 2020, Sinovac Biotech launched phase 1 and 2 trials in Jiangsu Province, China. The Chinese biotech company released preliminary phase 1/2 results of CoronaVac, which revealed that there was no serious adverse event after vaccinating 743 volunteers in the trials, while showing a good safety profile for the vaccine candidate.