Brazil's federal health regulator Anvisa on Sept. 4 suspended the use of over 12 million doses of a COVID-19 vaccine developed by China's Sinovac Biotech Ltd that were produced in an unauthorized plant, it said in a statement.
Anvisa said it was alerted on Sept. 3 by Sao Paulo's Butantan Institute, a biomedical center that has partnered with Sinovac to locally fill and finish the vaccines, 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 mentioned vaccine," the regulator said. The ban was "a precautionary measure to avoid exposing the population to possible imminent risk," it added.
Butantan also told Anvisa that another 17 batches, totaling 9 million doses, had been produced in 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 find out more about the security of the manufacturing process, it said.
During Brazil's vaccine rollout earlier this year, the vast majority of administered vaccines were from Sinovac. More shots from other manufacturers have since come online.
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