Fiocruz submits a request of registration for COVID-19 vaccine using national API

Last Thursday (25 November) the Oswaldo Cruz Foundation, by means of its Immunobiological Technology Institute (Bio-Manguinhos/Fiocruz), submitted to the Brazilian Health Regulatory Agency (Anvisa) a request of post-registration alteration of its COVID-19 vaccine (recombinant), asking to include the Institute as the manufacturing unit of the Active Pharmaceutical Ingredient (API). Check out this 360º view of the production area for the Brazilian API for vaccines, at Fiocruz.

Five batches of Brazilian API have been produced, and four of them are currently going through analytical comparability studies abroad (Photo: Bio-Manguinhos)

Anvisa is expected to conclude the process in up to 30 days. This is a record-time technology transfer process. Technology transfers in the field of immunobiological products usually take about 10 years to conclude. With the Fiocruz COVID-19 vaccine, Bio-Manguinhos/Fiocruz will conclude the incorporation of this technology in just one year, as a response to the public health emergency posed by the pandemic.

Bio-Manguinhos/Fiocruz drew up the documentation for a new submission in about two months and attended three meetings with Anvisa via Parlatorio to specifically address the request of alteration of the place of manufacturing of the API. The request was submitted within the deadline expected by Fiocruz.

In order to achieve a favorable outcome, Anvisa will be evaluating the equivalence of the production process, proving that the vaccines produced with the Bio-Manguinhos/Fiocruz API have the same efficacy, safety and quality as those processed with imported API, in addition to the analytical methodologies demanded and the steps of the production process.

This is the last regulatory step to obtain a 100% Brazilian-made vaccine. In previous phases, Anvisa had already conceded the Technical-Operational Conditions (TOC) of the API production infrastructure and the Certificate of Good Manufacturing Practices (cGMP) for the production of this ingredient. In addition to the documents that make up the package handed out to Anvisa to request that the API production location be changed, more data may be presented during the analysis carried out by Anvisa.

100% Brazilian vaccine production

Up to this moment, five batches of Brazilian API have been produced, of which four were released internally and are currently going through analytical comparability studies abroad. Another three are currently being processed at the Institute.

The final processing (formulation, bottling, revision, labeling and packaging) of the batches made with national API and the first deliveries of Brazilian vaccines will only take place after the post-production approval by Anvisa and an agreement with the National Immunizations Program (PNI), in order to guarantee maximum validity of the doses at the moment of their distribution.