The National Health Surveillance Agency (Anvisa) approved, this Friday (7), the inclusion in the manufacture of the vaccine against Covid-19 by the Oswaldo Cruz Foundation (Fiocruz) with the Active Pharmaceutical Input (IFA) manufactured by the foundation itself via the Institute of Technology in Immunobiologicals (Bio-Manguinhos/Fiocruz).
The decision concludes Fiocruz’s process for Brazil to have a 100% national vaccine, with all stages of production carried out in the country. Registration allows the foundation to bottle and manufacture the vaccine with 100% Brazilian API.
The foundation’s production of AstraZeneca vaccine doses, delivered to the Ministry of Health’s National Immunization Program (PNI), was subject to import by the IFA from China.
According to Anvisa, comparability studies were evaluated that showed that, when manufactured in the country, the input maintains the same performance as the imported vaccine.
So far, Fiocruz has more than 21 million doses produced with national API, in different stages of production and quality control. The forecast is that the first doses of the immunizing agent will be bottled in January and delivered to the Ministry of Health in February, as soon as the quality control tests that take place after the final processing of the vaccine are completed.
“With this approval today by Anvisa, we achieved a vaccine 100% produced in the country and, in this way, we guarantee the self-sufficiency of our Unified Health System [SUS] for this vaccine, which has been saving lives and contributing to overcoming this difficult historical phase in Brazil and in the world”, stated Fiocruz’s president, Nísia Trindade Lima, in a statement.
understand the process
In May 2021, Anvisa carried out the Certification of Good Manufacturing Practices for the new input, which guarantees that Fiocruz’s production line, in Rio de Janeiro, complies with all the necessary requirements to guarantee the quality of the API.
Fiocruz started national production in July 2021, after signing the technology transfer contract with partner AstraZeneca. Since then, Fiocruz has carried out the production of test batches to obtain authorization to use the national IFA in the vaccine against Covid-19.
Fiocruz’s vaccine has been authorized in Brazil since January 17, 2021 and received its definitive registration on March 12, 2021.
Reference: CNN Brasil
