The Brazilian health regulator suspended the use of over 12 million doses of Chinese-made vaccines on Sept. 4 over being produced in an unauthorized plant, according to an official statement.
Authorities said the ban was “a precautionary measure” to prevent “possible imminent risk.”
“The manufacturing unit … was not inspected and was not approved by Anvisa in the authorization of emergency use of the mentioned vaccine,” the country’s federal health regulator Anvisa said on Saturday.
A day previously, Sao Paulo’s Butantan Institute, a local biomedical center founded by the state government, sent an alert to Anvisa. The institution was to fill and finalize 25 batches of 12.1 million doses upon their arrival in Brazil, under a partnership with China’s Sinovac.
Another 17 batches, totaling 9 million doses produced in the same plant, were on their way to Brazil, Butantan told the regulator.
The regulator has now issued a 90-day ban and is investigating the plant and the manufacturing process.
Brazil launched its vaccine rollout earlier this year with the vast majority of administered vaccines from Sinovac. More shots from other manufacturers have since come online.
Health Minister Marcelo Queiroga said on Aug. 25 that people aged 70 or older or who have a weak immune system will be eligible for a third dose, starting Sept. 15—preferably with the Pfizer vaccine.
Diana dos Santos, 71, received two shots of the Sinovac vaccine but now refuses to leave home until she gets her booster.
“I can’t go out like before and I’m still afraid of all of this,” Santos told The Associated Press. “I will feel safer [with a booster].”
Chinese officials have maintained the vaccine protects against the Delta variant, particularly preventing hospitalizations and severe cases.
Brazil has reported over 580,000 deaths from the virus, but the country has seen a fall in both death rate and active cases in the past two months.
Reuters and The Associated Press contributed to this report.