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BRASILIA – The International Independent Committee, which analyzes the studies of the CoronaVac vaccine, developed by the Chinese company Sinovac in association with the Butantan Institute, issued an opinion for the resumption of tests in Brazil. The documentation arrived at the National Health Surveillance Agency (Anvisa) on Tuesday, around 5 pm.
Yesterday, Anvisa ordered the tests to cease, which opened a dispute with the Butantan Institute, which considered the decision to be wrong. The absence of a causal link between a serious adverse event with a volunteer and the vaccine is one of the factors noted.
Anvisa pointed out, at a press conference on Tuesday, that the opinion should have been sent along with the communication, made by Butantan last Friday, of the serious adverse event. The agencies do not provide details about the episode for confidentiality reasons. However, the adverse event was the suicide death of one participant.
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The opinion brings data and dates that will now be analyzed by Anvisa. A group of technicians began evaluating the document in English. But the expectation is that the decision is not yet out on Tuesday.
Hours before receiving the document, the general director of Anvisa, Antonio Barra Torres, said that the study would remain suspended until the agency had all the information on the death of the volunteer. He said that Butantan’s information was “insufficient and incomplete” and that therefore the agency decided to suspend the studies.
– The information released yesterday (Monday) was considered, by the technical area, insufficient, incomplete, so that yesterday it would be possible, in its power, to continue allowing the development of the vaccine – Barra said.
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The director of Anvisa responsible for the vaccines area, Alessandra Bastos, reinforced that the decision was technical and followed international protocols.
– I would like this to be very clear: in the event of an unexpected serious adverse effect, the clinical study is suspended. Faced with a serious adverse effect expected, continue with the study – explained the director Alessandra Bastos.
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The director of the Butantan Institute, Dimas Covas, reacted on Tuesday, saying at a press conference that Anvisa’s decision caused outrage. According to him, the event has nothing to do with the CoronaVac tests.
– From the clinical point of view of the case, it is impossible that the event is related to the vaccine. This (impossible) definition puts an end to the discussion – stressed the president of Butantan.
The director also said that the agency’s decision caused “uncertainty” and “fear” in people.
– They caused uncertainty, fear in people, fostered an environment that was no longer favorable due to the fact that this vaccine was made in association with China – declared the director of the institute.
The International Committee document was received by the National Research Ethics Commission (Conep), linked to the Ministry of Health, which also monitors the development of the studies. Unlike Anvisa, when it was notified last Friday by Butantan, Conep did not recommend the suspension of studies. And it will hold that position after receiving the committee document.
– We will make it sound calm, but clear in the sense that the event does not justify suspension. The resumption of the study depends only on Anvisa – Jorge Venâncio, Conep coordinator, told GLOBO.
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Research such as vaccines must be supported by Anvisa and Conep, both when authorized and when they are resumed after the suspension of tests. Anvisa carries out a more focused analysis on the issue of health, efficiency and safety. Conep also acts in the security and defense of the rights of those who participate in the experiments. If one of the organs vetoes a test, it can’t be done.
Earlier, before receiving the opinion of the Independent International Committee, Jorge Venâncio had already said that the agency evaluated the preliminary data reported by the Butantan Institute in relation to the death of the volunteer and understood that the studies should not have been suspended. According to him, the death of the volunteer would not be related to the application of the vaccine.
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– We do not ask for suspension of studies, in any way. The volunteer took the second dose of the vaccine 22 days earlier, had no health problems, and even underwent a private checkup, with a batch of tests, shortly after. So, it makes no sense to suspend a study that mobilizes thousands of people for a vaccine that we desperately need – said Venâncio.
