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Coronavirus pandemic

Brazilian health regulator ready to review decision to reject Sputnik V imports

On Monday, Anvisa rejected the application to supply and use Sputnik V in the country

Brazilian Health Regulatory Agency rafastockbr/Shutterctock/FOTODOM

Brazilian Health Regulatory Agency

© rafastockbr/Shutterctock/FOTODOM

RIO DE JANEIRO, April 30. /TASS/. Anvisa, Brazilian Health Regulatory Agency, is willing to reconsider its decision to reject imports of Russia’s Sputnik V coronavirus jab into the country after receiving new data from its developers, agency head Antonio Barra Torres said.

"We made the decision based on the data received. <…> The provided data can be reviewed, corrected and submitted again. The decision of the regulator reflects the state at the moment of consideration. On Monday, we could not approve [the vaccine import] to our great disappointment," the official said in a message to the nation, scientific community and foreign regulators.

"It is a temporary picture. It can change. We are not shutting the doors," he added, urging to unite and work together to defeat the "common invisible enemy."

On Monday, Anvisa rejected the application to supply and use Sputnik V in the country. The Anvisa meeting lasted more than four hours and featured conclusions of agency experts and their opinions about the Russian jab’s efficacy and safety. One of the arguments in favor of the rejection was the claim that Sputnik V’s second component contains the adenovirus that can replicate.

Earlier on Thursday, Gustavo Mendes, Anvisa’s manager of medicines and biological products, said that the regulator did not conduct its own tests and based its conclusion on the documentation received from Russia. Following the admission, Sputnik V developers reported their intention to sue Anvisa for knowingly spreading false information.

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