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.
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China’s leing provider of biopharmaceutical products, Sivac Biotech Ltd anunced on July 6 that it was entering phase III clinical trials sponsored by Instituto Butantan, Brazil, to test efficacy of its experimental COVID-19 vaccine. As one of three pharmaceutical companies to reach late sts of trials, Sivac said it will recruit over 9,000 healthcare professionals to speed up process to invent potential cure for COVID-19, as per reports.
In collaboration with Butantan, a leing Brazilian producer of immubiological products and vaccines, Sivac has been given approval to run widescale trials by Brazilian National Regulatory ncy, Anvisa. human trials aim to be pivotal for licensure of product as Anvisa alrey reviewed manufacturing and clinical information of coronavirus vaccines. According to reports, Anvisa conducted highest standards review of vaccines as it is a member of International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (“ICH”). Furr, company is also prequalified as a fully functional regulatory ncy for World Health Organization (WHO).
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In as many as twelve clinical sites located in several states in Brazil, company will start trials basis ethical approval in each clinical site. Director of Instituto Butantan, Dr. Dimas Covas said, “ phase III clinical trial approval is a demonstration that Sivac and Butantan partnership is an efficient collaboration to move forward offering hope to save lives worldwide.” Furr, Chairman, President and CEO of Sivac Weidong Yin ded, “We are pleased to vance to Phase III trials with Butantan, which will allow us one step furr to our commitment to developing vaccines for global use and to our mission of supplying vaccines to eliminate human diseases.”
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Vaccine named ‘CORONAVAC’
Earlier, on January 28th, 2020, company started manufacturing of vaccine in early sts against COVID-19 with name ‘CoronaVac’. company published progress, methodology and results of clinical trial in peer-reviewed acemic journal Science. In April, National Medical Products ministration (“NMPA”) granted vaccine approval to conduct phase I and II clinical trials in Jiangsu Province, China, as per reports. Sivac has partnered with several companies for phase III efficacy studies outside China.
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16:09 IST, July 7th 2020