Brazil to have fully domestic shots against COVID-19

Brazil’s national drug regulator Anvisa has approved the inclusion of the active pharmaceutical ingredient manufactured by the Oswaldo Cruz Foundation (Fiocruz) into the production of the COVID-19 vaccine at the foundation.

“In practice, the decision concludes Fiocruz’s process of enabling Brazil to have a totally domestic vaccine, with all production stages conducted in Brazil,” the agency reported in a note.

The vaccine against COVID-19 offered by Fiocruz will be produced with all of its stages carried out in Brazil, with a domestic active ingredient. “To make this decision, Anvisa considered comparison studies. They show that, if produced in the country, the ingredient keeps the same performance as the imported vaccine,” the statement goes on to read.

In May 2021, Anvisa had created the Certificate for Good Practices in Manufacture on the new ingredient, which guarantees that the production line meets all quality requirements. Before being granted the authorization, Fiocruz had been producing try-out batches.

The Friday (Jan. 7) decision brings the technological transfer at Fiocruz, initiated last year, to an end. The vaccine was authorized in Brazil on January 17, 2021, and was definitively registered on March 12, 2021.