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

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 Sinovac Biotech Ltd (SVA.O) that are leaving produce in an unauthorized plant. he said in a statement.

Anvisa said he was alerted Friday by the Butantan Institute in São Paulo, a biomedical center that has partnered with Sinovac to fill and finish vaccines locally, which had been done at the plant 25 batches, or 12.1 million doses, sent to Brazil.

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

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

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

During the launch of vaccines in Brazil earlier this year, the vast majority of vaccines administered were from Sinovac. Since then, there have been more photographs from other manufacturers.

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

Reports by Gabriel Stargardter; Edited by Richard Chang

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