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The National Sanitary Surveillance Agency (Anvisa) announced, this Wednesday (11), that CoronaVac tests, the vaccine developed by the Chinese laboratory Sinovac for Covid-19, it will resume in Brazil.
“ANVISA informs that it has just authorized the resumption of the clinical study related to the Coronavac vaccine, which is sponsored by the Butantan Institute,” the agency said in a note.
According to Anvisa, the cause of the adverse event that led to the suspension of the tests two days ago is being investigated. The police report related to the cause was sent to the agency, by the Butantan Institute, at 11:43 pm on Tuesday (10), according to the statement this Wednesday.
ANVISA understands that it has sufficient subsidies to allow resumption of vaccination and continues to monitor the investigation of the outcome of the case in order to define the possible causal relationship between the SAE [evento adverso grave] unexpected and the vaccine, “says the note.
The text also says that Anvisa “does not reveal the nature” of the adverse event that occurred “with respect to the privacy and integrity of research volunteers” (read the suspension details further down in this article).
After suspending the tests, on Monday (9), the agency had decided, on Tuesday (10), that they would not be resumed until the international security committee sent the data on the adverse event. This occurred, according to the agency, at 4:41 pm on Tuesday.
Understand the suspension of CoronaVac testing
The tests had been suspended by the agency on Monday night (9). At the time, Anvisa said, without giving details, that a “serious adverse event” had occurred.
The suspension sparked a confrontation between the agency and the Butantan Institute in São Paulo, which has a partnership with Sinovac to manufacture the vaccine and conduct phase 3 trials in Brazil. Shortly after the announcement of the pause, the institute’s director, Dimas Covas, said he was surprised by the agency’s decision, because the adverse event was a “death not related to the vaccine.”
On Tuesday (10), a police report obtained by TV Globo indicated that the death of the volunteer was a suicide.
Shortly after, at a press conference, the director of Anvisa, Antonio Barra Torres, said that “objectively there was no such information [sobre a causa da morte] among those we received yesterday [segunda-feira]He said the suspension of CoronaVac testing was “technical” and based on a lack of information.
Butantan, on the other hand, claimed to have sent copies of notifications to Anvisa twice about the death of the volunteer (see details). The institute said that information about the case was sent for the first time on Friday (6) and was forwarded on Monday night (9), hours before the suspension of the study was communicated to the press.
According to the note published by Anvisa this Wednesday (11), however, the cause of the serious adverse event had not been reported until November 9, nor had the police report related to it been sent until that date.
The agency claims that the cause under investigation was only reported on Tuesday morning (10) and was then officially sent at 4:41 pm the same day. The police report was sent out at 11:43 pm.
The other information that Anvisa says it also obtained on Tuesday (10) was data from the international safety committee on the tests. The agency director had announced that the suspension of the trial would be maintained until such information was presented. That was the last update of the case until this Wednesday (11).
Understand how Covid vaccine tests work
President’s statements
The dispute also involves President Jair Bolsonaro. On Tuesday (10), after the director of Butantan said that the adverse event was a death. -, the president wrote, in a social network, that the suspension of the CoronaVac tests was “another one that Jair Bolsonaro wins.”
“Death, disability, anomaly. This is the vaccine that Doria wanted to force all the people of São Paulo to take. The president said the vaccine could never be mandatory. One more that Jair Bolsonaro wins, ”Bolsonaro wrote.
In the text, the president refers to João Doria (PSDB), governor of São Paulo. The reference is due to the fact that the agreement that was signed between Butantan and the Sinovac laboratory was signed by the governor, since the institute is a public institution linked to the São Paulo Department of Health. The agreement provided for the purchase of 46 million doses of the vaccine and the transfer of technology to Brazil, so that Butantan could produce CoronaVac on Brazilian soil.
The agreement between Butantan and Sinovac had already been the subject of a dispute between the São Paulo state government and the federal government. At the end of October, the Ministry of Health announced that it would buy the vaccine developed by the Chinese laboratory. However, Bolsonaro rejected the negotiation.
