Fiocruz has a national API for the production of 21 million doses of vaccine

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After being authorized to start production of the vaccine against Covid-19 using the national Active Pharmaceutical Ingredient (IFA), the Oswaldo Cruz Foundation (Fiocruz) already has the input produced locally for the production of 21 million doses. of the AstraZeneca vaccine.

The product is in different stages of production and quality control at the Institute of Technology in Immunobiologicals (Bio-Manguinhos/Fiocruz).

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The information was confirmed this Thursday (13) by the federal agency. According to Fiocruz, the first national batch will be transferred from the storage area, at Bio-Manguinhos, to the formulation area this Friday (14th). At the new destination, it will go through the thawing process.

Then, other vaccine production processes will take place: formulation, packaging, review, labeling, packaging and quality control, as was already the case with immunizers produced from imported raw materials.

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Fiocruz received authorization from the National Health Surveillance Agency (Anvisa) to produce the vaccine with national IFA last Friday (7th). With the decision, the institution will be the first in the country in a position to produce and distribute a 100% national vaccine against Covid-19.

Originally, the announced objective was that doses of vaccines produced with national APIs would begin to be distributed in August 2021, reaching 110 million doses by December.

However, according to the federal agency, the delays were caused by problems in signing the technology transfer agreement with AstraZeneca. Expected to be signed in December 2020, the agreement was only sealed in June last year.

Fiocruz vice president, Marco Aurélio Krieger celebrated the importance of the moment faced by the foundation in facing the pandemic and its impact.

“There are three fundamental points: frontier technology already being fully mastered, autonomy and independence in planning and production. And, finally, the possibility of, in the near future, helping the global effort with large production capacity”, he evaluates.

The scientist’s speech refers to the fact that the Ministry of Health has ordered Fiocruz, so far, 120 million doses for this year. As the production capacity of Bio-Manguinhos is 180 million doses in the two lines of the laboratory, this difference of 60 million immunizing agents can be negotiated for export.

Reference: CNN Brasil

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