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This Monday, November 9, Anvisa ordered the suspension of clinical trials with the Coronavac vaccine, produced by the Chinese pharmaceutical company SinoVac, alleging the occurrence of a “serious adverse event” with one of the volunteers in phase three of the trials.
In a statement, the Brazilian health authority had announced that “the event that occurred on 10/29 was reported to the Agency, which decided to interrupt the study to evaluate the data observed so far and judge the risk / benefit of continuing with the study.” .
However, according to the Brazilian publication Veja, the opinion of the Legal Medical Institute (IML) indicates that the death was suicide and not adverse effects related to the vaccine.
As explained by the director of the Butantan Institute, Dimas Covas, the “adverse event” was reported to Anvisa on November 6, indicating that there would be no direct relationship between death and the vaccine. The institute in question is responsible for producing the vaccine in partnership with the pharmaceutical company Sinovac, since the Government of São Paulo and the pharmaceutical company worked together to coordinate the last phase of clinical trials in Brazilian territory.
In a press conference, representatives of the São Paulo government also defended that there is no relationship between the “adverse event” and the respective vaccine.
“There was no relationship between the vaccine and the serious adverse event presented”, explained the Secretary of Health of the State of São Paulo, Jean Gorinchteyn.
According to the publication, a meeting will have been held today between the institute and Anvisa to clarify the agency’s doubts. The director also said that clinical trials should resume in the coming days.
Coronavac is also being tested in China, Turkey, Bangladesh and Indonesia and has sparked a political battle in Brazil between São Paulo Governor João Doria and President Jair Bolsonaro, who banned the purchase of the vaccine in October.
The lack of link between the vaccine and the death of the volunteer did not prevent Bolsonaro from welcoming the suspension of the tests. “Another victory for Jair Bolsonaro,” the president wrote on his Facebook account in response to a follower who asked him if the government would buy the vaccine developed by the Chinese laboratory Sinovac if its effectiveness is proven.
“Death, disability, anomaly. This is the vaccine that Doria wanted to force the people of São Paulo to take, “added the Brazilian president in the same message, in which he reiterated that immunization” could never be mandatory “in Brazil, as the São Paulo governor defends.
Last month, Bolsonaro had already said that “the Brazilian people will not be a guinea pig to anyone” and that “there is no justification for a financial contribution of one billion dollars in a drug that has not even passed the testing phase” , alluding to what he had already said about the “Doria vaccine” and that, he warned, “will not be bought” by his Government.
