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Fiocruz sends Brazilian API to the USA for quality tests


27/10/2021

Bio-manguinhos/Fiocruz and Fiocruz News Agency

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Production of the Fiocruz Active Pharmaceutical Ingredient (API) for COVID-19 vaccines is ongoing and is now moving on to a new and important phase of the process. Two pre-validation batches of the product manufactured by Fiocruz have been approved in all in-house quality tests and are now on their way to an external quality control at USA laboratories. At these labs, the samples will go through a complex testing process that involves 14 tests in addition to those carried out in Brazil, the longest of which takes 56 days to complete. This set of tests compare Brazilian and foreign APIs, ensuring that the product manufactured at the Immunobiological Technology Institute (Bio-Manguinhos/Fiocruz) meets the same quality standards and safety of those acquired by means of Technological Order signed with AstraZeneca.

The production process includes 81 tests (Photo: Bio-manguinhos/Fiocruz)

Production of the Brazilian API began on 21 July. The first phases consist of the production of pre-validation and validation batches which are then submitted to strict quality control. Overall, the product will have gone through 81 tests throughout its production process. Four other batches, including three qualification ones, are currently being produced, in parallel with the beginning of this external quality control evaluation. By the end of 2021, Bio-Manguinhos/Fiocruz intends to have more than 30 million doses, including batches of produced API and of API being produced.

The request for vaccine registration alteration is expected to be submitted to the National Agency of Sanitary Surveillance (ANVISA) in November, with the change including the new place of manufacturing of the API. Only after approval by ANVISA will it be possible to transfer national vaccines to the National Immunization Program (PNI in the Portuguese acronym) of the Brazilian Ministry of Health. At this time, therefore, it is not yet possible to define the number of national doses that will be released before the year is over.

Fiocruz will also be receiving batches of imported API, guaranteeing the continuous production and supply of COVID-19 vaccines to the PNI. Overall, 118.3 million doses have been made available. In addition to these, the institution has about 16.7 million vaccines in different stages, of which 15 million are going through quality control and should be released beginning next week. With the new batch of API, with enough raw material to produce 5.6 million doses, expected to arrive next Sunday (24 October), non-stop weekly supplies are guaranteed until the third week of November.

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