Published 16:09 IST, July 7th 2020
China's Sinovac Biotech starts Phase III trials of its potential COVID-19 vaccine
In collaboration with Butantan, a leading Brazilian producer of immunobiological products and vaccines, China's Sinovac has been given trial approval by Anvisa.
China’s leading provider of biopharmaceutical products, Sinovac Biotech Ltd announced on July 6 that it was entering the phase III clinical trials sponsored by Instituto Butantan, Brazil, to test the efficacy of its experimental COVID-19 vaccine. As one of the three pharmaceutical companies to reach the late stages of trials, Sinovac said it will recruit over 9,000 healthcare professionals to speed up the process to invent the potential cure for the COVID-19, as per reports.
In collaboration with Butantan, a leading Brazilian producer of immunobiological products and vaccines, Sinovac has been given the approval to run the widescale trials by the Brazilian National Regulatory Agency, Anvisa. The human trials aim to be pivotal for the licensure of the product as Anvisa already reviewed the manufacturing and clinical information of the coronavirus vaccines. According to reports, Anvisa conducted the highest standards review of vaccines as it is a member of the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (“ICH”). Further, the company is also prequalified as a fully functional regulatory agency for the World Health Organization (WHO).
In as many as twelve clinical sites located in several states in Brazil, the company will start trials basis ethical approval in each clinical site. Director of Instituto Butantan, Dr. Dimas Covas 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.” Further, Chairman, President and CEO of Sinovac Weidong Yin added, “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.”
Vaccine named ‘CORONAVAC’
Earlier, on January 28th, 2020, the company started the manufacturing of the vaccine in early stages against COVID-19 with the name ‘CoronaVac’. The company published the progress, methodology and results of the clinical trial in the peer-reviewed academic journal Science. In April, the National Medical Products Administration (“NMPA”) granted the vaccine approval to conduct phase I and II clinical trials in Jiangsu Province, China, as per the reports. Sinovac has partnered with several companies for phase III efficacy studies outside China.
Updated 16:09 IST, July 7th 2020