Sinovac workers prepare vaccine tests in Beijing.WU HONG / EFE
The National Health Surveillance Agency of Brazil (Anvisa) has authorized this Wednesday the resumption of the tests of the Coronavac vaccine, developed by the Chinese laboratory Sinovac in association with the Butantan Institute, linked to the Government of São Paulo.
The federal agency had suspended immunization tests against covid-19 on Monday night, after the institute informed it of an unrelated serious adverse event, which started a version war between the two entities and the suspicion of politicization of the agency by the Bolsonaro government.
In a press release, the agency states that it evaluated new data presented by the São Paulo Institute after the suspension of the study and that "it now understands that it has enough studies to allow the resumption of the experimental application of the vaccine."
On Tuesday, at a press conference, the federal body had declared that the information sent by Butantan was considered insufficient by the technical area to allow the studies to continue.
“The decision taken yesterday [Monday] by the General Directorate of Medicines was the only one that could be taken.
In case of doubt, stop the tests ”, stated Antônio Barra Torres, then general director of Anvisa.
Anvisa also states that the suspension of any study does not mean that the investigated product is not of quality, safe or effective.
"The suspension and resumption of clinical studies are common events in clinical research and all studies aimed at registering drugs authorized in the country are previously evaluated by Anvisa in order to preserve the safety of study volunteers," he stated.
The order to stop vaccine trials fueled suspicions about a political dispute in the fight to combat the coronavirus in Brazil.
Coronavac is a showcase for the governor of São Paulo, João Doria (PSDB), who has been dissatisfied with President Jair Bolsonaro.
On Tuesday morning, Bolsonaro celebrated the suspension of the tests as a victory.
“Death, disability, anomaly.
This is the vaccine that Doria wanted the people of São Paulo to take out of obligation ”.
The president said the vaccine could never be mandatory.
Once again, Jair Bolsonaro wins, "wrote the Brazilian president on Facebook. In October, the vaccine had already been a source of political tension when the president forced the Ministry of Health to undo an agreement to buy Coronavac, discouraging his minister ( the third in office during the pandemic), Eduardo Pazuello, who had announced the plan to acquire the doses the day before.
On Tuesday, the president of the Butantan Institute, Dimas Covas, said that he learned from the press about the ban.
"It is news that causes surprise, insecurity and, in our case, even outrageous," he said.
According to the São Paulo entity, the federal agency was informed from the beginning that the serious adverse event was not related to the application of the immunization;
according to various media reports, the volunteer committed suicide.