At the end of July, Chinese drugmaker Sinovac Biotech, in collaboration with the Brazilian Butantan Institute in Sao Paulo, began Phase 3 testing of the covid-19 CoronaVac vaccine, involving 130,000 volunteers. states CNN. The third phase of testing is the last and most important phase before regulatory approval. The local G1 news portal wrote today that the leadership of the Brazilian state of Sao Paulo, where the Chinese vaccine is being tested, called the suspension of the study a “domestic political war.”
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According to the Brazilian Medicines Authority, Anvisa, the incident took place in October, after which it decided to suspend the tests in order to better evaluate the data obtained and identify the possible risk. “No new volunteers can be vaccinated during the interruption of testing,” quotes statement by the Brazilian branch of the American station CNN.
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A government decree surprised the head of the Brazilian institute Butantan, who is testing the vaccine with a Chinese company. According to Divas Covase, there is no reason to suspend the tests. However, Covas himself reported that the patient on whom the vaccine was tested had died, but the vaccine did not affect it. “Anvisa was informed about the death, not about the adverse effect (vaccine),” Covas told Reuters.
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Covas also agrees with China’s Sinovac, which said it was “convinced of the safety of the vaccine.” “We communicated with our Brazilian partner, the Butantan Institute, whose leader believes the incident has nothing to do with the vaccine. Sinovac will continue to communicate with the Brazilian side in this matter. The work associated with our clinical research in Brazil will continue to be conducted in strict accordance with the requirements of the GCP Good Clinical Practice, ”the company said in a statement, according to CNN.
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However, President Jair Bolsonaro has long been a critic of vaccine testing in Brazil, disagreeing with a large number of governors, including the governor of Sao Paulo, where the vaccine is being tested, João Doria. Doria, like many other governors, pushed for quarantine measures, and the president rejected them, saying they were damaging the economy.
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Today, Bolsonaro called the suspension of Chinese vaccine studies on Facebook as “his next victory (over Doria)”. “Death, invalidity, anomalies. This is the vaccine that Doria wanted to vaccinate all the people of Sao Paulo, ” wrote Brazilian president.
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The suspension of Phase III testing is a hurdle for one of China’s leading vaccine candidates, and comes at a time when U.S. drugmaker Pfizer and German BioNtech said the vaccine they developed was 90 percent effective in preventing coronavirus in humans. However, suspension of vaccine testing is relatively common, with AstraZeneca and Johnson & Johnson having to join it recently, but both have resumed their tests.
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Brazil, with a population of about 210 million, is the third largest coronavirus SARS-CoV-2 (nearly 5.7 million) in the world after the United States and India. In the number of deaths associated with covid-19 (to 162,600), this largest Latin American country is the second in the world after the USA.
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