Fiocruz projects to deliver first 100% Brazilian-made vaccine doses in February

RIO DE JANEIRO, BRAZIL – After being granted ANVISA’s (Brazilian Health Regulatory Agency) authorization to manufacture the Active Pharmaceutical Ingredient (API) for AstraZeneca’s vaccine, Fiocruz projects the delivery of the first doses produced with the national input to the Ministry of Health in February 2022, when the quality control tests that occur after the final processing of the vaccine are concluded.

The vaccine will now be produced entirely in Brazil, helping to reduce dependence on other countries, such as India. Fiocruz began producing the national API in June 2021, after a technology transfer from AstraZeneca, foreseen in the immunizer purchase contract, and has the equivalent of 21 million doses, in different stages of production and quality control.

In the authorization process, ANVISA assessed the equivalence of the production process to prove that the vaccines produced with the API from Bio-Manguinhos/Fiocruz have the same efficacy, safety and quality as those processed with the imported ingredient and follow the same production process steps and methodologies required.

AstraZeneca’s vaccine was granted emergency authorization by ANVISA to be used in Brazil on January 17, 2021, and final registration with the agency on March 12, 2021. The technology transfer occurred in record time, in less than a year, while procedures of this nature typically take up to a decade.