On July 3, 2020, the Brazilian National Regulatory Agency, 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.”
Sinovac LS initiated the development of an inactivated vaccine against COVID-19 (named CoronaVac) on January 28th, 2020. Preclinical study results were published in the peer-reviewed academic journal Science. On April 13th, 2020 the National Medical Products Administration (“NMPA”) granted approval to conduct phase I and II clinical trials in China. The phase I and II trials commenced on April 16, 2020 in Jiangsu Province. China. A group of healthy adults aged 18-59 years old were vaccinated with a 0, 14 day schedule. Preliminary phase I/II results were recently reported.
There was 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 II clinical trial 14 days after completion of a two-dose vaccination at day 0 and day 14. A Phase II study on elderly adults is being conducted which will be followed by child and adolescent groups. The phase II trial is expected to be completed at the end of 2020. The Company has partnered with several companies outside of China for phase III efficacy studies.
Source: Company Press Release