Coronavac vaccine batches received in January 2021.| Photo: Paulo Guereta/AEN

A batch of 12.1 million doses of Coronavac vaccine manufactured in China was suspended by the National Health Surveillance Agency (Anvisa) for having been bottled in a laboratory that was not inspected by the Brazilian agency. According to information from the newspaper The globe, the problem was discovered by the Butantan Institute and reported to the regulatory agency on Friday night. The vaccines had already been distributed to the National Immunization Plan, but it is not known how many doses have already been applied.

According to the letter sent by Butantan to Anvisa, and to which the Rio newspaper had access, the active pharmaceutical ingredient (IFA) was produced in a factory certified by Anvisa, but the filling took place in another unit, which had not been inspected. Thus, it is impossible to guarantee that there is no contamination or dosing errors. Anvisa even sought information in international databases about this second factory, but did not find any report that had been produced by any other international health authority that attests to the structure and good practices in the place.

Butantan also warned that over 9 million doses of Coronavac produced under the same circumstances are on their way to Brazil, and asked Anvisa for exceptional authorization to use both this new batch and the vaccines already received, claiming that technicians from Butantan analyzed the documentation and found that there is no risk to the population.