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Responsible for the ethical evaluation of research with human beings in Brazil, the Conep (National Research Ethics Commission) was also informed about the death of a volunteer who tested CoronaVac, the vaccine against the new coronavirus developed by the Chinese laboratory Sinovac in association with the Butantan Institute. Unlike Anvisa (National Health Surveillance Agency), the entity recommended the continuity of the tests.
For scientific research to be carried out in Brazil, the authorization of both Anvisa and Conep is required, a body linked to the CNS (National Health Council), dependent on the Ministry of Health.
While Conep focuses on protecting those who participate in the investigation, Anvisa seeks to protect those who will consume the investigated product. Without approval from one entity or another, testing cannot continue.
The declaration
Like Anvisa, Conep was informed last Friday (6) about the death of a 32-year-old volunteer. Upon receiving the information, the Conep requested a hearing with representatives of the Butantan Institute, which occurred on Friday by videoconference.
“From what they told us, the cause of death was not related to the vaccine, but we asked for a set of documents,” he explained to the Twitter Jorge Venâncio, coordinator of Conep.
We still have to get everything to have the complete documentation, but it is not necessary to ask for the suspension because the possibility of not having anything to do with the vaccine is enormous ”.
Jorge Venâncio, Conep coordinator
Venâncio says that when many people participate in the tests “things of all kinds happen”. “The citizen can have a crisis of appendicitis, for example. It is a serious fact that we are informed, but it has nothing to do with the vaccine, “he says.
Among the documents already presented, there is a series of tests related to a check-up recently carried out at the initiative of the volunteer that would indicate that his health was in good condition.
In addition, 24 days passed between the date the volunteer took the second dose of the vaccine and his death, on October 29.
“Conep and Anvisa’s operations are parallel and simultaneous,” he explained. “Each search must have the approval of both.”
Suspension test
The death that caused the suspension of the CoronaVac vaccine tests was the suicide of the volunteer, according to the Twitter. The police report, obtained by the report, records the case as “consummated suicide.”
Anvisa’s decision to suspend the tests caused surprise and irritation in the health authorities of the state of São Paulo, who described the decision as “unfair.”
Discontent exists because those responsible for the research do not see suicide as an adverse effect related to the research.
Professionals linked to the study assure that the case was being handled in a technical way by Anvisa scientists, and that is why the sudden change in behavior surprises them. The assessment is that the news of the death caught the attention of people with unscientific interest, people who used the case to create a political fact.
Earlier today, the president of Anvisa (National Health Surveillance Agency), Antônio Barra Torres, said that the agency’s decision was technical and that the documents sent by the Butantan Institute on the “adverse event” were “incomplete.” “and” insufficient “.
