The Brazilian health regulatory agency Anvisa published this Friday night the authorization for the phase III of clinical trials of a possible vaccine against COVID-19. The approval is for the vaccine developed by the China-based company Sinovac Research & Development Co., Ltd (Sinovac Biotech Co., Ltd). This is the second vaccine to have phase III tests authorized in Brazil.
The request was made by the Brazilian biologic research and producer of immunobiological products Butantan Institute, located in Sao Paulo state. On June 29, Sao Paulo state Governor Joao Doria said 9,000 volunteers have already been registered to test the vaccine not only in Sao Paulo but also in three other states: Rio Grande do Sul, Minas Gerais, and Paraná, in addition to the Federal District.
The vaccine, called CoronaVac, is made from inactivated strains of the new coronavirus. The approved study is a double-blind, randomized, placebo-controlled phase III clinical trial to evaluate the efficacy and safety of healthcare professionals using CoronaVac against the disease caused by the new coronavirus (Sars-CoV-2).
For this authorization, Anvisa analyzed the data from the previous stages of the vaccine. The trials carried out with animals (monkeys rhesus macaques) and with humans (Phase I and II) demonstrated that the vaccine has acceptable safety and immunogenicity with the two-dose vaccine schedule.
This is the second test of the vaccine against the new coronavirus authorized by Anvisa in Brazil. On June 2, the agency had already authorized the clinical trial of the vaccine developed by the University of Oxford and produced by the produced by British drugmaker AstraZeneca, in partnership with Fundação Osvaldo Cruz (Fiocruz) in Brazil.