COVID-19: Pfizer starts vaccine registration process at Anvisa

This is the first step towards obtaining permission from the regulator

Published in 26/11/2020 - 14:01 By Jonas Valente - Brasília

Pharmaceutical company Pfizer announced it has started the registration process at Brazil’s national sanitary regulator Anvisa for its vaccine against COVID-19. This is the first step towards obtaining permission from the agency to have the treatment available in the country. The announcement was made after a Wednesday (Nov. 25) meeting with Anvisa specialists.

The request will come under the “continuous submission” modality, created by the agency for specific vaccines against COVID-19 to speed up analysis.

The vaccine, technically dubbed BNT162b2, is developed by Pfizer and German company BioNTech. This month, the companies reported the conclusion of the trials and stated the vaccine had 95 percent efficiency in the treatment against the disease caused by the novel coronavirus.

The data about the vaccine are to be relayed in stages, among which phase 3 tests, in which both infected patients and people without the new coronavirus are assessed. It started late in July and was joined by 43.6 thousand people across 150 locations in several countries, like the US, South Africa, Argentina, and Brazil.

Included in the study here were 2.9 thousand volunteers. The process was conducted by the São Paulo Clinical Investigation Center, and by Obras Assistenciais Irmã Dulce, in Salvador. Information will also be delivered on the samples from 38 thousand people who took part in analysis processes on the efficiency and safety of the vaccine.

Pfizer did not specify whether there is estimated date for turning in all the information about the study and when the requirement will be made official—a condition that must be met before the vaccine may be distributed in the country. The firm only reported that results will be published in academic journals when clinical trials are concluded.

Translation: Fabrício Ferreira -  Edition: Bruna Saniele / Nira Foster

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