ANVISA authorizes FIOCRUZ to produce the active pharmaceutical ingredient (API) for the Oxford-AstraZeneca COVID-19 vaccine

05/05/2021

On 30 April, the Brazilian National Health Surveillance Agency (ANVISA) approved the production of the active pharmaceutical ingredient (API) for the COVID-19 vaccine, as part of technology transfer agreements between AstraZeneca and the Institute of Technology in Immunobiologicals (Bio-Manguinhos), of the Oswaldo Cruz Foundation (Fiocruz).

Fiocruz will begin producing, on a commercial scale, pilot lots of COVID-19 vaccine based on ChAdOx1 chimpanzee adenovirus, which contains genes encoding the surface expression of the SARS-CoV-2 S protein. Following these tests, Fiocruz will be required to request the inclusion of the API produced in the current register, or request emergency use authorization. ANVISA previously conducted an inspection to verify that the production line was in compliance with good manufacturing practices.

This production, once authorized, will be provided to the Unified Health System (SUS). 

Source: https://www.gov.br/pt-br/noticias/saude-e-vigilancia-sanitaria/2021/05/fiocruz-e-autorizada-a-produzir-o-insumo-da-vacina-astrazeneca

  

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