Anvisa authorizes emergency use of vaccine against COVID-19
The measure will aim at a “specific public”
Published in 10/12/2020 - 16:27 By Pedro Peduzzi - Brasília
Brazil’s national sanitary regulator Anvisa approved a resolution “allowing laboratories to request the authorization for experimental, emergency use of vaccines against COVID-19.”
The decision was made today (Dec. 10) and formalizes the announcement made on December 2 by the watchdog on the application for the emergency use of vaccines.
According to Anvisa, no laboratory has yet filed a request for use, even after the sanitary body published guidelines for applications.
“Data on non-clinical and clinical studies, quality, good manufacturing practices, monitoring and control strategies, provisional results from clinical trials, among other scientific evidence will be taken into consideration. The company should also provide information demonstrating that manufacture and stability are appropriate to ensure the quality of the vaccine,” the note released by Anvisa reads.
The agency explains that the permit for emergency and temporary use is limited to “a public previously specified,” and is no substitute for the sanitary registration.
“The emergency and temporary use modality is laid out as part of the regulations and may benefit certain controlled groups as an additional measure to tackle the pandemic. The request for emergency and temporary use must be submitted by the company developing the vaccine against COVID-19,” Anvisa declared.
Translation: Fabrício Ferreira - Edition: Kleber Sampaio / Denise Griesinger
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