Brazil’s health regulator suspends use of 12 million Sinovac vaccines

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By Nayara Figueiredo

SAO PAULO, Sept 4 (Reuters) – Brazil’s federal health regulator Anvisa suspended the use of more than 12 million doses of the COVID-19 vaccine developed by Chinese company Sinovac Biotech Ltd on Saturday that were produced in an unauthorized plant, it said in a statement.

Anvisa reported that it was alerted on Friday by the Butantan Institute of Sao Paulo, a biomedical center that has partnered with Sinovac to fill and finish vaccines locally, that 25 batches, or 12.1 million doses, sent to Brazil had been made in the plant.

“The manufacturing unit (…) was not inspected and was not approved by Anvisa in the authorization of emergency use of the aforementioned vaccine,” said the regulator. The ban was “a precautionary measure to avoid exposing the population to a possible imminent risk,” he added.

Butantan also informed Anvisa that another 17 batches, totaling 9 million doses, had been produced at the same plant and were on their way to Brazil, the regulator said.

During the 90-day ban, Anvisa will try to inspect the plant and find out more about the safety of the manufacturing process, he said.

Brazil’s vaccination campaign earlier this year largely focused on Sinovac injections. Since then, vaccines from other manufacturers have been added.

On Saturday, Brazil reported 21,804 new coronavirus cases and 692 deaths from COVID-19.

(Reporting by Gabriel Stargardter; Edited in Spanish by Ricardo Figueroa)

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