As The Brazilian Report revealed in October, a factory belonging to a Brasília-based pharmaceutical company will begin production of the Russian Sputnik V coronavirus vaccine. União Química announced today that it will begin manufacturing the immunizer on Friday.
União Química’s business director Rogério Rosso confirmed that the firm expects to produce 8 million vaccine doses per month in Brazil, where it has nine factories.
After the production phase, the vaccine will be bottled in the São Paulo city of Guarulhos. The company says it has submitted a clinical development dossier to health regulators Anvisa.
Meanwhile, Anvisa says it is currently analyzing a request for phase-three clinical trials on Sputnik V in Brazil, which was filed on December 29. “The agency requested supplementary information. So far, we have not received the data necessary to continue the analysis,” said the agency, by way of a statement.
União Química explained that it will provide the requested information this week. Once the agency signs off on the request, late-stage clinical trials may begin.
As there is no emergency approval request pending for Sputnik V, the vaccine may be produced in Brazil, but not used on the population. However, it may be sold to other companies. Initial forecasts are for the doses produced in Brasília to be exported to Argentina and Bolivia, which have already approved Sputnik V for use.
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