Anvisa gives approval for Fiocruz input, and Brazil will have 100% national Covid vaccine

Anvisa (Health Surveillance Agency) approved this Friday (7) the inclusion of the active pharmaceutical ingredient (IFA) produced by Fiocruz (Fundação Oswaldo Cruz) in the manufacture of the vaccine against Covid-19 by Fiocruz / AstraZeneca. The decision paves the way for Brazil to have a 100% national vaccine, with all stages of production carried out in the country.

The pharmaceutical immunizer has been authorized in the country since January 17, 2021 and received the definitive registration on March 12, 2021, but the input used for manufacturing was imported from China or India.

According to the agency, the decision was made after carrying out comparability studies. “These studies demonstrate that, when manufactured in the country, the input maintains the same performance as the imported vaccine”, explained the agency, in a note.

In May 2021, Anvisa had already granted the Certification of Good Manufacturing Practices for the new input, which guarantees that the production line meets all the requirements necessary to guarantee the quality of the API.

Also according to the agency, Fiocruz had been producing test batches to obtain authorization to use the national API in the Covid-19 vaccine.

In June, the foundation signed a technology transfer agreement that allowed the production, in Brazil, of the active pharmaceutical ingredient used in the manufacture of the AstraZeneca/Oxford vaccine against Covid.

The signing of the contract with the pharmaceutical company has been expected since 2021, but has experienced delays in recent months, even without a date.

The expectation is that the measure will facilitate the production and production of the vaccine in the country and avoid situations such as those that occurred at the beginning of vaccination, when delays in sending inputs from China led to constant revisions in the delivery schedule of doses of the immunizer.