Brazil health regulator rejects Russia's Sputnik vaccine

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The Brazilian health regulator Anvisa on Monday rejected importing the Russian-made Sputnik V COVID-19 vaccine requested by state governors battling a deadly second wave of the virus that is battering Latin America's largest nation.

Anvisa's five-strong board voted unanimously not to approve the Russian vaccine after technical staff had highlighted"inherent risks" and"serious" defects, citing a lack of information guaranteeing its safety, quality and effectiveness.

A crucial issue was the presence in the vaccine of the adenovirus that could reproduce, a"serious" defect, according to Anvisa's medicines and biological products manager Gustavo Mendes. But, like Anvisa, the European Union has not yet approved the vaccine, saying it needs more information on the tests and manufacturing process.

 

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