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A medical syringe seen with an Instituto Butantan company logo displayed on a screen in the background. Sinovac and Butantan Institute are testing the vaccine in Brazil.
Rafael Henrique | SOPA Pictures | LightRocket | Getty Images
On Wednesday, Brazilian health regulator Anvisa cleared the resumption of late-stage Brazilian clinical trials for the Chinese vaccine Sinovac Covid-19, which had been suspended due to the death of a study subject that was registered in São Paulo as a suicide.
Brazilian medical institute Butantan said in a statement that it will resume trials later on Wednesday.
Brazil’s President Jair Bolsonaro, a longtime Chinese critic who baselessly dismissed the Sinovac vaccine as lacking credibility, hailed Monday’s suspension as a personal victory.
Bolsonaro reiterated, however, on Wednesday evening that his government will purchase any vaccine approved by Anvisa and the Ministry of Health, which could eventually include the Sinovac vaccine, if approved.
The decision to suspend the trial – one of Sinovac’s three large late-stage studios – was criticized by trial organizers, who said the move took them by surprise and there was no need to stop the trial as death had no relationship. to the vaccine.
The suspension further inflamed tensions between Bolsonaro and Sao Paulo Governor Joao Doria, who pinned his political ambitions on the Chinese vaccine he plans to launch in his state as early as January, with or without federal assistance.
Anvisa, in its statement on Wednesday, said that the first information received on the case, which led to the suspension, was incomplete and did not have the cause of the “serious adverse event”. He strongly rejected suggestions that the decision might have been politically motivated.
“After evaluating the new data presented by the sponsor … Anvisa understands that she has sufficient reasons to allow vaccination to resume,” the agency said.
“It is important to clarify that a suspension does not necessarily mean that the product under consideration does not offer quality, safety or efficacy,” added Anvisa.
Sinovac, in a statement, said: “We are confident in the safety of the vaccine, we fully understand and appreciate Anvisa’s close supervision and the timely resumption of clinical trials.”
Brazil has one of the worst Covid-19 outbreaks in the world, with over 5.7 million confirmed cases and 163,000 deaths linked to the disease caused by the new coronavirus. Bolsonaro has been criticized for his constant elimination of the virus and its dangers.
On Tuesday, Bolsonaro said Brazilians “must stop being sissies” about the virus, adding, “We will all die one day.”
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