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BRASILIA – Studies by the National Health Surveillance Agency (Anvisa) that authorize the emergency use of vaccines against Covid-19. The process would allow the use of the immunizer in specific and previously defined cases, without the need for the product to already have the organ registry.
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The measure, which according to the report is being discussed in Anvisa, would allow to apply the vaccine to groups of people while the laboratories continue their investigations. For this, the agency is studying mechanisms that guarantee the safety of the product even though the laboratories have not completed their studies to obtain the registration.
One of the options would be to institute the measure based on a Resolution of the Collegiate Board (RDC). This possibility is still under debate, one of the options would be to institute the measure based on a Resolution of the Collegiate Council (RDC), but it is still under debate.
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The standard would define specific groups and controlled scenarios for the application of the immunizer in order to guarantee the safety of the process. The measure would be one of the tools to accelerate access to the Covid-19 vaccine.
On Wednesday, however, the Minister of Health, Eduardo Pazuello, affirmed in a mixed commission of Congress that the country will only apply the vaccines that are registered in the body. According to him, Anvisa is the “gold standard”.
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– Anvisa is our gold standard. Anvisa technicians and staff are focused and prepared to deal with the matter quickly and directly, with protocol changes, receiving documentation with continuous and immediate delivery of each process. We need to understand, once and for all, that we will only apply vaccines in Brazil registered in Anvisa, with all the protocols correctly followed. This should be clear – said Minister Eduardo Pazuello.
GLOBO asked Anvisa how this emergency use would be made, but has not yet received a response.
