COVID-19 vaccine: Fiocruz delivers 80 million doses and begins its 100% national production

By means of the Immunobiological Technology Institute (Bio-Manguinhos/Fiocruz), Fiocruz has reached 80.4 million doses of the COVID-19 vaccine made available to the National Immunization Program (PNI, in the Portuguese acronym), delivering approximately 2.2 million doses this Friday (July 30th). Of these, 76.4 million were processed at Fiocruz and 4 million were imported ready to use from the Serum Institute, in India. Another milestone of the foundation is related to national sovereignty when it comes to vaccine production. The manufacturing of the first pre-validation batch of the COVID-19 vaccine using the Active Pharmaceutical Ingredient (API) produced at Bio-Manguinhos has begun.

Bio-Manguinhos has begun the production of national API for COVID-19 vaccine (Photo: Bio-Manguinhos)

The batches are now in the cellular expansion phase, during which cells are cultured and multiplied so they can later be infected with the virus, receive the enzymatic treatment and proceed into the next steps. Two pre-validation and three validation batches will be produced and then submitted to quality control tests at Bio-Manguinhos and to comparison tests with AstraZeneca vaccines.

The necessary documentation will be sent to Anvisa to request the change in the vaccine registration, including the new API manufacturing site, a necessary condition to deliver the product to the National Immunization Program. It is expected that these 100% national doses can begin to be delivered in the last trimester of 2021, making the country self-sufficient. Even before these vaccines were made available, the batches the Foundation has been delivering using imported API for 20 consecutive weeks have been used in approximately half the vaccinated people in Brazil.

Bio-Manguinhos still has a production capacity that exceeds the availability of imported API and continues to negotiate the delivery of new batches of ingredients for August. Production hit 1,165,000 million doses on a single day last week, and proceeds with the perspective of expanding its capacity as a third final processing line for vaccines is installed.

This Friday, Bio-Manguinhos concluded, with a satisfactory outcome, the regulatory inspection by the Brazilian Health Regulatory Agency (Anvisa) to obtain the technical-operational conditions (CTO, in the Portuguese acronym) for the new processing line. The result will be formalized after Anvisa provides a report and publishes it on the Diário Oficial da União, the federal government’s official journal. The new line will be capable of bottling up to 225 thousand doses of vaccine.