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Brazil’s National Health Surveillance Agency (Anvisa) said today it will maintain the disruption of Coronavac testing in the country, apparently caused by the suicide of a volunteer, until an international commission review the case.
Anvisa president António Barra Torres said in a press conference that the agency stopped testing Coronavac because it was informed of a serious adverse event not foreseen by the Butantan Institute, which leads the study in Brazil of the possible covid vaccine. -19 under development by the Chinese laboratory Sinovac.
“The decision made yesterday [segunda-feira] he was the only one to be taken. When faced with doubts for [paralisar o estudo] he asks for the necessary information and follows the procedure, ”Torres said.
“It was this information that led the technical area to decide on the temporary interruption of tests related to the Sinovac vaccine. I say this to emphasize that it is a technical decision, ”he said.
Authorities have not officially confirmed this, but Brazilian media reported that the death of a 33-year-old volunteer on October 29 who participated in the third phase of the Coronavac trial led to the suspension.
Rede Globo and other local media also showed a police report on the alleged volunteer’s case, which was not identified, which included suicide as the cause of death.
Torres reported that Anvisa was informed of the event on November 6, but the document only reached the agency on Monday, the date on which a technical team from the agency analyzed the data sent and found the information insufficient and incomplete.
As a result, Anvisa has decided to suspend the research, a decision it will keep until it receives information from an international committee of independent researchers analyzing the development of the immunizer.
“The regulation says, in the face of an unexpected serious adverse event that the Independent International Committee must act. So the information has value only if it comes through that channel, the other channels, although it has relevant information are not the independent committee, “Torres said, when asked if Anvisa will authorize the return to research before the press release on cause of the volunteer’s death.
“The activation of the independent committee is a planned event (…) We believe that with the possession of information that ends up being increasingly transmitted, that in theory [são divulgadas pelos ‘media’] to the creeping secret that protects the tester [voluntário]as soon as this information takes the right path, it will come to us and be analyzed, ”he added.
The Butantan Institute pointed out as soon as it was informed of the suspension of testing by local media that the death of one of the study volunteers “has no relation to the vaccine” and, therefore, considered they should continue.
Similarly, Chinese drug maker Sinovac said in a statement released in Beijing on Tuesday that he is convinced of the safety of his vaccine.
“The clinical trial in Brazil is being conducted rigorously and in accordance with the requirements of good clinical practice, and we are convinced of the safety of the vaccine,” Sinovac said in a statement on his website.
Faced with the suspension of the study, the Brazilian president, Jair Bolsonaro, hinted that the decision meant his victory over a political rival, the governor of the Brazilian state of Sao Paulo, João Doria, as the Butantan Institute is linked to the regional government. and the vaccine is tested independently.
“Another victory for Jair Bolsonaro (…) Death, disability, anomaly. This is the vaccine that Doria wanted to force the people of São Paulo to take”, wrote Bolsonaro on the social network Facebook.
The Brazilian president’s statement has generated criticism and raised doubts about the politicization of the Coronavac tests because Anvisa is subordinate to the central government structure.
On this point, Barra Torres defended that Anvisa’s decisions were technical, but acknowledged that other people were making political use of the argument.
Brazil is the Portuguese-speaking country most affected by the pandemic and one of the most affected in the world, if we count the second number of deaths (over 5.6 million cases and 162,628 deaths), after the United States.
The covid-19 pandemic has caused at least 1,263,890 deaths in more than 50.9 million cases of the infection worldwide, according to a report by the French agency AFP.
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