Brazil Halts Use Of 12M Doses Of China's Sinovac Vaccine Made At Unauthorized Plant

KEY POINTS

Brazil's health regulators were informed that the batches were made at a plant that had not been inspected
Nine million more doses produced at the plant are headed for Brazil
Anvisa said it will evaluate the "possible impact" on those who have already been vaccinated using the affected batch

Brazil this weekend implemented a "precautionary ban" on the use of over 12 million doses of China's Sinovac vaccine, which has so far made up the bulk of the vaccines administered in the South American country.

Brazil's federal health regulator, Anvisa, was informed that 25 batches, or about 12.1 million doses of Sinovac's CoronaVac vaccine were made at an unauthorized plant, Reuters reported. Further, Butantan Institute, a biomedical center that has partnered with Sinovac to locally finish the vaccines, informed the agency that 17 more batches, or nine million more doses, on the way to Brazil were also produced in the same plant.

The plant had not been inspected or approved by Anvisa, it said in a statement Saturday. It implemented a "precautionary ban" to prohibit the distribution of the lots that were filled in the unapproved plant.

Anvisa said it will evaluate the conditions at the unapproved plant and determine the "possible impact" on those who have already been vaccinated using the affected batch.

"(I)t is essential to act by the Agency in order to mitigate a possible health risk," the agency said in the statement.

Anvisa and Butantan Institute held another meeting during which the institute informed the agency that it identified at the end of August 2021 that the lots came from another plant, the agency said in an update Sunday.

"This new site was performing the stages of formulation and vase of the vaccine," Anvisa noted. "However, this new manufacturing site has not been evaluated and approved by Anvisa."

"Precautionary measures are not punitive sentencing decisions, but sanitary measures to avoid exposure to the consumption and use of irregular or suspected products," Anvisa said.

So far, the "vast majority" of Brazil's administered vaccines have been from Sinovac, Reuters noted. Some cities have already begun providing booster shots of the COVID-19 vaccine despite many people not yet having their second dose, the Associated Press (AP) reported. This is due to the concerns over the more contagious delta variant that has so far become the dominant variant in Rio de Janeiro, as well as questions about the efficacy of the Chinese-made vaccines.

To date, Brazil has logged over 20,800,000 COVID-19 cases and more than 580,000 deaths.