The National Health Surveillance Agency (Anvisa) determined on Saturday (4) the precautionary ban on batches of Coronavac vaccine, prohibiting the distribution and use of doses from batches in a plant not approved by the agency. The measure has a term of 90 days.
THE CNN got in touch with the Government of São Paulo and with the Butantan Institute, which distributes and produces the doses in the country, and is awaiting positioning.
According to Anvisa, the action will take place through the publication of two resolutions that will be published in an extra edition of the Official Gazette this Saturday (4).
a resolution which prohibits the distribution and use of batches bottled in unauthorized plant and another resolution that determines the prohibition of the distribution of lots not yet distributed.
“Under these terms, the vaccine packaged in a place not approved in the Authorization for Emergency Use is configured as a product not regulated by Anvisa,” he said in a statement.
Batches contain 21 million doses
According to Anvisa, the Butantan Institute informed the agency on Friday (3), after a meeting, that the Chinese laboratory Sinovac, manufacturer of Coronavac, sent to Brazil 25 batches with doses filled in a factory not inspected by Anvisa. Batches contain over 12 million doses.
Anvisa also stated that Butantan informed that another 17 batches, also bottled at the uninspected location, totaling 9 million doses, are in the process of being sent and released to Brazil.
According to Anvisa, the precautionary measure is not punitive, but is “a sanitary measure to avoid exposure to consumption and use of irregular or suspected products.”
During the processing period of the injunction, Anvisa said that will work on evaluating the conditions of good manufacturing practices at the unapproved manufacturing plant, the potential impact of this change in location on quality, safety and efficacy requirements, and the possible impact on people who were vaccinated with this batch.
“In addition, negotiations will be made with the Butantan Institute to regularize this new location in the vaccine manufacturing chain with Anvisa,” said the agency in a statement.
List of Impacted Lots
Batches already distributed (12,113,934 doses)
IB: 202107101H, 202107102H, 202107103H, 202107104H, 202108108H, 202108109H, 202108110H, 202108111H, 202108112H, 202108113H, 202108114H, 202108115H, 202108116H and L202106038.
SES/SP: J202106025, J202106029, J202106030, J202106031, J202106032, J202106033, H202106042, H202106043, H202106044, J202106039, L202106048.
Lots in the process of being sent and released to Brazil (9 million doses)
IB: 202108116H, 202108117H, 202108125H, 202108126H, 202108127H, 202108128H, 202108129H, 202108168H, 202108169H, 202108170H, 2021081701K, 202108130H, 202108131H, 202108134H, 202108132H, 202108132H,