São Paulo – The Brazilian National Health Surveillance Agency (ANVISA) approved the inclusion of the production of the vaccine against COVID-19 by the Oswaldo Cruz Foundation (Fiocruz) using the national Active Pharmaceutical Ingredient (API). The publication is in Resolution RE 35/2022 of the General Management of Medicines at ANVISA, released this Friday (7) in the Brazilian Official Federal Gazette. “In practice, the decision concludes Fiocruz’s process for the country to have an all-Brazilian vaccine, with all stages of production carried out in the country,” the agency informed in a statement.
Fiocruz’s vaccine against COVID-19 will be produced entirely in the country using a national API. “For this decision, Anvisa evaluated the comparability studies. These studies demonstrated when manufactured in the country, the input maintains the same performance as in the imported vaccine,” added the entity.
In May 2021, Anvisa had already made the Certification of Good Manufacturing Practices for the new input, which ensures the production line meets all the requirements for ensuring the quality of the API. Since then, Fiocruz has been carrying out the production of test batches to obtain authorization to use the national API in the COVID-19 (recombinant) vaccine.
With the decision, this Friday (7), the transfer of technology made by Fiocruz, which started last year, was concluded. The vaccine has been approved in Brazil since January 17, 2021, and received permanent registration on March 12, 2021.
Translated by Elúsio Brasileiro