Brazil's Anvisa approves clinical trials of China's possible COVID-19 vaccine

Brazilian health regulator Anvisa on July 3 approved clinal trials of a Chinese coronavirus vaccine candidate Sivac. Anvisa on Friday issued an official statement where it said that it has approved vaccine developed by Sivac Research & Development Co., Ltd (Sivac Biotech Co., Ltd) for Phase III clinical trials. authorization request was made by Butantan Institute (SP) and tests will be developed in different locations across Brazil. 

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" vaccine (CoronaVac) adsorbed Covid-19 (inactivated) will be studied in order to evaluate its safety and efficacy in active immunization against disease caused by new coronavirus (Sars-CoV-2). approved study is a double-blind, randomized, placebo-controlled phase III clinical trial to evaluate efficacy and safety of healthcare professionals using Covid-19 adsorbed vaccine (inactivated) produced by Sivac," Anvisa said in a statement issued on its website. 

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vaccine is made from inactivated strains of new coronavirus. proposal provides for testing of 9,000 people in country, in states of Sao Paulo, Rio Grande do Sul, Minas Gerais, and Parana, in addition to Federal District. centers that will conduct research have been given responsibility for recruitment of volunteers.

Anvisa analyzed data from previous sts of product development, where n-clinical studies in animals were carried out, results of which demonstrated that vaccine presents acceptable safety. Phase I and II studies in healthy adult humans have also been carried out and studies have demonstrated favorable safety and immugenicity with two-dose vaccine schedule, said Anvisa. 

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Or trials

This is second test of vaccine against new coronavirus authorized by Anvisa in Brazil. On June 2, ncy had already authorised clinical trial of vaccine ChAdOx1 nCoV-19 (AZD1222) developed by United Kingdom's University of Oxford in association with pharmaceutical company AstraZeneca. 

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