Pasta also determined that people immunized with the embargoed compounds be monitored for 30 days; Butantan presented to Anvisa a document that concludes that there is no risk in banned vaccines
The Ministry of Health has blocked the distribution of the more than 12 million doses of CoronaVac vaccine bottled in China at a factory not certified by the National Health Surveillance Agency (Anvisa). The measure seeks to prevent the vaccines from being moved until there is a definition of the agency. Without detailing, the health ministry also determined that people immunized with embargoed batches are monitored for 30 days. In a meeting this Monday, 6, the Butantan Institute presented to Anvisa a document that concludes that there is no risk in the units of CoronaVac banned last week. However, the entity did not deliver reports that prove the Good Manufacturing Practices of the units involved, requested by the agency. In a statement, Butantan explained that, for internal reasons of the Chinese health authority, the content could not be made available directly to the Institute.
The team only had access to the data of the observed non-conformities and the proposed action plan to adjust the problems. With this, Butantan suggested that Anvisa carry out a remote inspection of the plants. The agency, on the other hand, claims that the method has “limitations and difficulties, such as language barriers and inadequate filming of the manufacturing areas”. The agency started, internally, the processes for an eventual face-to-face inspection of the units. In a statement, the Institute highlighted that the Chinese factory has certification that follows good international practices and that all CoronaVac batches have undergone strict quality control in Brazil.
*With information from reporter Nanny Cox