Sinovac Biotech’s partnership with Butantan, a leading Brazilian producer of immunobiologic products and vaccines, has reached a milestone as it moved one step further to our commitment to developing vaccines for global use after getting the approval for Phase 3 trial from Brazilian National Regulatory Agency, Anvisa.
On July 3, 2020, Anvisa granted approval to a phase III clinical trial sponsored by Instituto Butantan to test efficacy and safety of the inactivated COVID-19 vaccine developed by Sinovac Life Sciences Co., Ltd. ( or “Sinovac LS”, previously known as Sinovac Research and Development Co., Ltd. or “Sinovac R&D”), a wholly owned subsidiary of the company, in Brazil. This trial aims to be a pivotal study to support the licensure of this 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 agency fast-tracked the application due to the public health emergency which took approximately two weeks to conclude. The review was conducted at the highest standards as Anvisa is a full member of the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (“ICH”) and qualified as a full functional regulatory agency for the World Health Organization (“WHO”) prequalification process.
This study will recruit nearly 9,000 healthcare professionals working in COVID-19 specialized facilities in twelve clinical sites located in several states in Brazil. The inclusion of participants is scheduled to start this month after ethical approval is obtained from each clinical site.
“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,” commented Dr. Dimas Covas, Director of Instituto Butantan.
Mr. Weidong Yin, Chairman, President and CEO of Sinovac, commented, “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.”