States applied vaccine banned by Anvisa; DF received, but did not apply

posted on 09/06/2021 05:58 / updated on 09/06/2021 06:43

Landing of Coronavac vaccines: 12 million doses imported from China await release from Anvisa - (credit: CLAUDIO CRUZ)


Landing of Coronavac vaccines: 12 million doses imported from China await release from Anvisa – (credit: CLAUDIO CRUZ)

So far, governments and city halls of Rio de Janeiro, Minas Gerais and Tocantins have confirmed that they have applied doses of Coronavac vaccine from batches banned last Saturday by the National Health Surveillance Agency (Anvisa). In the state of Rio de Janeiro, 1,206 doses were applied. Tocantins and Minas Gerais have not yet made a survey of how many people have received doses of the 25 batches imported by the Butantan Institute that have not received authorization for use. Anvisa banned the distribution of more than 12 million doses of Coronavac manufactured in a plant of pharmaceutical Sinovac, in China, which has not been inspected by the Brazilian regulatory agency.

After the ban, the agency and the Ministry of Health issued a warning to state and local governments to suspend vaccination with immunizations from specific batches. Some states made available data on how many municipalities had already received these immunizations.

The Municipal Health Department of Rio de Janeiro informed that, under the guidance of Anvisa, it preventively suspended, on Saturday afternoon (4), the use of one of these Coronavac lots and awaits the Ministry of Health’s position. “The Butantan Institute sent note reassuring users who were vaccinated with the suspended batches, emphasizing the safety and quality of the immunizing agent”, he declared in a note.

According to the secretariat, on the same day that Anvisa determined the ban, 1,206 people were vaccinated in the city with doses from batch 202108113H and that, “at this time, there is no indication to revaccinate these people, and any adverse reaction must be reported to the unit who applied the dose”.

The State Department of Health of Tocantins (SES) reported that, among the batches interdicted in a precautionary manner by Anvisa, the state received one, batch L202106038, with 500 doses, which were distributed to 29 municipalities, according to a report issued by the system SIES. The secretariat clarified, in a note, that, as directed by the Ministry of Health, municipalities that did not apply the doses should retain the vaccines. “In those who applied the doses, users will be monitored by health authorities. The secretariat is carrying out a survey on the application of doses of this specific batch. At the moment, whoever took the dose of Coronavac will not receive another immunizing agent.”

In Minas Gerais, the state health department reported that it received and distributed batch 202107101H of the vaccine from the Butantan Institute to regional health units and to the city of Belo Horizonte. With the ban on use, the agency recommended that the batch be kept in quarantine. According to a survey by the agency, “of the 1,252,200 vaccine doses from the Butantan Institute received, this Saturday (4), sent by the Ministry of Health, 823,400 doses are among the batches with a precautionary interdiction by Anvisa, with 628,952 batches from the batch 202108111H and 194,448 doses of batch 202108112H.”

Here in the DF, the Health Department received at the end of July batch L202106038, which is stored in the Cold Chain. “It was not distributed to any unit, due to the validity being greater than the batches received later. The batch was quarantined and the SES/DF will await guidance from the Ministry of Health”, informed the agency in a statement.

To mail, Anvisa stated that “it will work to assess the conditions of Good Manufacturing Practices of the unapproved manufacturing plant, the potential impact of this change in location on the quality, safety and efficacy requirements of vaccines, and the possible impact for people who were vaccinated with this batch” and that “negotiations will be made with the Butantan Institute for the regularization of this new location in the vaccine manufacturing chain with the Agency”. According to data provided by Butantan to Anvisa, another 17 batches, totaling 9 million doses filled at the factory not inspected, “are in the process of being sent and released to Brazil”.

Butantan, a partner at the Sinovac laboratory, guarantees that it has alerted the regulatory agency regarding the alteration of the Chinese plant. According to the institute, the factory replaced some machinery that, after replacement, was not inspected by Brazilian inspectors.