[ad_1]
In yet another turnaround in the vaccine war between the federal government and São Paulo, the Independent International Committee recommended that Anvisa (the National Health Surveillance Agency) authorize the resumption of tests with Coronavac.
The agency will now analyze the request, since it is sovereign in regulating the sector in Brazil, in conjunction with the National Council of Research Ethics, which had already requested the return of the tests.
The vaccine against Covid-19, developed in China and which will have joint production with the Butantan Institute if it is effective, had its final phase clinical trial suspended on Monday night (9).
The reason was the report of a serious adverse event, in the case of the death of 1 of the 13 thousand volunteers of the immunization program in Brazil. But the victim, a man from São Paulo, committed suicide according to the Civil Police.
The committee is an international body that evaluates vaccine trials around the world when there are disparities or concerns.
Butantan had sent the committee a request to analyze the case after Anvisa did not accept the explanations given in a morning meeting about the episode, which irritated the São Paulo government.
The whole case is part of the dispute between President Jair Bolsonaro and Governor João Doria (PSDB-SP), who since the beginning of the pandemic have had different guidelines on how to handle the problem.
After denying the severity of the crisis, Bolsonaro has now been working to politically undermine Doria’s efforts to have a broad foot vaccination campaign in the first quarter of 2021. The toucan bet heavily on the Sinovac vaccine, which was called Coronavac and proved to be safe. in the first clinical trials of the so-called phase 3 in China.
This morning, after Anvisa’s decision, Bolsonaro celebrated it as a personal victory over the governor. Doria and those around him decided not to react directly, and the government put in its technical team that deals with the matter to discuss the problem at a press conference.
In addition, the disclosure of the suspension decision on Monday night, just 38 minutes after an email was sent to Butantan inviting him to discuss the case the next morning, caused the impression in São Paulo of the search for political wear and tear . .
The death had been reported on the 6th, but he was detained for three days in the Anvisa system due to technical problems. “At 3 in the afternoon on Monday a letter was sent informing the problem and requesting data, giving a day of delay. At 6 in the afternoon, a second letter requested data, and we sent it,” he said. leaf the director of Butantan, Dimas Covas.
“Almost three hours later, they invited us to chat on Tuesday and, shortly after, they suspended the tests without notifying us. A phone call would have been resolved,” he said.
The director of Anvisa, Antonio Barra Torres, in turn, said at a press conference that this would not be his role.
Previously, the National Council for Research Ethics had recommended retesting. The entity was also notified of the death on the 6th, requested and received information from the government of São Paulo.
There is no timetable set in stone, but the Chinese expectation is that Phase 3 of Coronavac will conclude by the end of this month, which could pave the way for its registration in Brazil, responsibility of Anvisa. The safety study has so far approved the immunizer, its effectiveness remains to be seen.
Doria bought 46 million doses for delivery at the end of December, 40 million of them in the form of supplies to be formulated in Butantan. If all goes well, vaccination can start in January.
