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 Sinovac. Anvisa on Friday issued an official statement where it said that it has approved the vaccine developed by Sinovac Research & Development Co., Ltd (Sinovac Biotech Co., Ltd) for Phase III clinical trials. The authorization request was made by the Butantan Institute (SP) and the tests will be developed in different locations across Brazil. 

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

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

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

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Other trials

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

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