On the 4th, the National Health Surveillance Agency (Anvisa) adopted a precautionary measure to ban at least 12 million doses of the CoronaVac vaccine, prohibiting the distribution and use of bottled doses in a manufacturing site, which was not inspected and approved in the Emergency Use Authorization.
As soon as the batch numbers were published, readers of Em Pauta questioned the position of the Municipal Health Department of Bragança, which only offered a response on Thursday, 9.
According to the folder, 14,946 residents of Bragança Paulista received vaccines from the suspended batches. They are the elderly, drivers, people with disabilities, health workers, people with comorbidities, homeless people, education workers and the general public by age group.
The nearly 15 thousand doses were applied in the following Vaccination Units: Lavapés Health Center, Old Library – City Council, Epidemiological Surveillance Division (DIVE), State Park Health Academy, Lourenço Quilici Sports Gym and Health Units Santa Luzia, Henedina Cortez, Hipica Jaguari, Planejada II, Vila Aparecida and São Lourenço.
The Municipal Health Department also informed Em Pauta that it is monitoring these people, intends to contact them and is monitoring EAPV (Adverse Post-Vaccination Events) for 30 days after the date of vaccination.
When asked if this audience will be revaccinated, we did not get an answer.
WHAT ARE THE LOTS?
• 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:
• IB: 202108116H, 202108117H, 202108125H, 202108126H, 202108127H, 202108128H, 202108129H, 202108168H, 202108169H, 202108170H, 2021081701K, 202108130H, 202108131H, 202108171K, 2021081134H,
BUTANTAN AFFIRMS THAT THERE IS NO REASON FOR ALARMISM
Through a statement, the Butantan Institute clarifies that the measure by Anvisa should not cause alarmism. In fact, it was Butantan himself who, out of a commitment to transparency and extreme precaution, communicated the fact to the agency, after attesting to the quality of the doses received. “This guarantees that the immunization agents are safe for the population”, they say.
The request for release to the regulatory agency was due to a change in one of the stages of the vaccine formulation process, at Sinovac’s manufacturing facilities, which may occur in the production process.
“However, it is worth reiterating that the Chinese factory has certification that it follows good international practices, the GMP, and was also included in Anvisa. The same product also passed through the institute’s rigorous quality team”, he concludes.
According to the director of the Butantan Institute, Dimas Covas, “the documentation has been forwarded, Anvisa is awaiting the arrival of a document from the Chinese Anvisa, which should arrive before the end of this week. So, from the point of view of the quality of this vaccine, of its safety, there is no doubt.”
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