PBH received 2,720 vaccines from a suspended batch by Anvisa, but did not apply them – General

Loading of CoronaVac vaccines arrived in Minas this week (photo: F
CoronaVac vaccine shipment arrived in Minas this week (photo: Fbio Marchetto/SES-MG)

Belo Horizonte received, but did not apply any dose of batch 202107101H from CoronaVac (Instituto Butantan/Sinovac Biotech), which had its use suspended in a precautionary manner by the National Health Surveillance Agency (Anvisa) this Saturday (4/9). According to the Municipal Health Department, the state sent 2,720 immunization agents to the city. Also according to the city, none of these doses went to immunization posts. The guidance of the Secretary of State for Health (SES) that these vaccines are kept refrigerated until Anvisa gives an ultimatum about them.

“So far, there is no need to suspend vaccination in the capital”, explained the city hall in a note.

The state sent several of these vaccines to municipalities. “SES-MG is awaiting guidance from the Ministry of Health on the measures that must be taken if any dose from the batch has already been used for immunization”, informed the state administration.

other batches

In addition to 202107101H, Minas Gerais received 823.4 thousand CoronaVac vaccines that are part of the 25 batches suspended by Anvisa this Saturday. The injections arrived in the state this Saturday, and the Ministry of Health is going to pick them up at the State Cold Chain Center, in the Gameleira district, west of Belo Horizonte.

There are 628,952 vaccines from batch 202108111H and 194,448 from batch 202108112H, according to the position of the Minas Gerais State Department of Health (SES-MG).

In addition to these two lots, Minas received over 428.8 thousand doses of CoronaVac this Saturday. These, according to SES-MG, are safe for application in the population.

Where did the problem happen?

Anvisa’s suspension occurred due to the agency’s non-inspection at the factory responsible for filling these 25 batches. In total, Brazil lost 12,113,934 doses sent this week to states and municipalities.

Another 9 million vaccines, bottled in the same place, will also have their use suspended. They were in the process of being released by the authorities and, now, will no longer be distributed.

“Under these terms, the vaccine packaged in a place not approved in the Authorization for Emergency Use is configured as a product not regularized with Anvisa”, informed the agency in a note.

The agency also clarified that, during the precautionary interdiction, “work to assess the conditions of good manufacturing practices of the unapproved manufacturing plant, the potential impact of this change of location on quality, safety and efficiency requirements, and the possible impact on the people who have been vaccinated”.

What are the lots?

The batches of the 12 million banned doses that are in Brazil are as follows:

  • 202107101H
  • 202107102H
  • 202107103H
  • 202107104H
  • 202108108H
  • 202108109H
  • 202108110H
  • 202108111H
  • 202108112H
  • 202108113H
  • 202108114H
  • 202108115H
  • 202108116H
  • L202106038
  • J202106025
  • J202106029
  • J202106030
  • J202106031
  • J202106032
  • J202106033
  • H202106042
  • H202106043
  • H202106044
  • J202106039
  • L202106048

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