SAO PAULO, Sept. 4 (Reuters) – Brazilian federal health regulator Anvisa on Saturday suspended the use of more than 12 million doses of a COVID-19 vaccine developed by Chinese company Sinovac Biotech Ltd (SVA.O) which were produced in an unauthorized factory, he said in a statement.
Anvisa said she was alerted on Friday by the Butantan Institute in Sao Paulo, a biomedical center that has partnered with Sinovac to fill and locally complete the vaccines, that 25 batches, or 12.1 million doses, sent to Brazil had been manufactured in the factory.
“The manufacturing unit (…) was not inspected and was not approved by Anvisa in the authorization for emergency use of the mentioned vaccine,” said the regulator. The ban was “a precautionary measure to avoid exposing the population to any imminent risk,” he added.
Butantan also told 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 seek to inspect the plant and learn more about the safety of the manufacturing process, he said.
When the vaccine was rolled out in Brazil earlier this year, the vast majority of vaccines administered came from Sinovac. Since then, other pictures from other manufacturers have been posted.
Brazil reported 21,804 new coronavirus cases and 692 deaths from COVID-19 on Saturday.
Reporting by Gabriel Stargardter; Editing by Richard Chang
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