The Department of Health of the State of Piauí (Sesapi) collected 23,840 doses of Coronavac vaccine that are part of one of the 25 batches of the immunizing agent banned this Saturday (4) by the National Health Surveillance Agency, Anvisa.
According to Anvisa, the agency was informed by the Butantan Institute that the partner Sinovac, manufacturer of the CoronaVac vaccine, sent to Brazil 25 batches in the vial-ampoule presentation (single dose and two doses), totaling 12,113,934 doses. The manufacturing unit responsible for the filling was not inspected and was not approved by Anvisa in the Authorization for Emergency Use of the mentioned vaccine.
According to Sesapi, the vaccines sent to Piauí belong to batch 202107101H, one of the banned. The Secretariat also reported that none of the doses were used in the state. Half was distributed to Teresina and the other part remained in Sesapi’s stock to be used as a 2nd dose.
“The vaccine packaged in a place not approved by the AUE is configured as a product that has not been regulated by Anvisa. Thus, the Agency’s action is essential in order to mitigate a possible health risk. Such action will take place through the publication of two Resolutions (RE), still this Saturday (4/9), in an Extra Edition of the Official Gazette (DOU)”, informed Anvisa yesterday.
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.
The Butantan Institute also informed that another 17 batches, totaling 9 million doses, also bottled in a place not inspected by the Agency, are in the process of being sent and released to Brazil.
The batches are: IB: 202108116H, 202108117H, 202108125H, 202108126H, 202108127H, 202108128H, 202108129H, 202108168H, 202108169H, 202108170H, 2021081701K, 202108130H, 202108131H, 202108131H, 202108129H, 202108131
Anvisa stressed that precautionary measures are not punitive decisions, but sanitary measures to avoid exposure to consumption and use of irregular or suspect products.
Hérlon Moraes (With information from Anvisa)