RIO DE JANEIRO, BRAZIL – The National Health Regulator (ANVISA), in a decision taken this Friday, April 30, authorized the Oswaldo Cruz Foundation (Fiocruz) to produce in Brazil the active pharmaceutical ingredient (API) of the Oxford/AstraZeneca Covid-19 vaccine.
ANVISA’s decision was based on a technical inspection at Fiocruz’s Bio-Manguinhos plant. The API is the essential biological raw material for the production of immunizers. Today, Brazil only produces vaccines by importing APIs, mainly from China.
However, the agency considers that Fiocruz still needs to make commercial-scale batches of the vaccine with locally produced API. When the tests are completed, the Foundation will submit the results to ANVISA before full production can begin that will supply doses to the national health system SUS.
The local production is part of the contract signed by Fiocruz with the university and the pharmaceutical company, which included the transfer of technology to the Brazilian scientific institution. However, until this transfer is concluded and ANVISA authorizes the local production of APIs, Fiocruz will continue to depend on the importation of vaccine raw material.
Source: CNN