RIO DE JANEIRO, March 31. /TASS/. Brazilian pharmaceutical company Uniao Quimica completed the production of an experimental batch of Sputnik V anti-coronavirus vaccine’s active component at its factory in Brasilia, the Russian embassy in Brazil said.
"This stage of the project, launched last October, is an important step in transferring the technology, needed to ensure the production of the Russian vaccine in Brazil," the embassy said.
The entire batch will be sent to the Gamaleya National Research Center for Epidemiology and Microbiology of the Russian Healthcare Ministry for quality control.
In early January, Uniao Quimica received cell material to manufacture the vaccine and began producing a trial batch of the vaccine’s active components for research purposes. Uniao Quimica, which represents the Russian Direct Investment Fund (RDIF) in Brazil, submitted a new registration request for Sputnik V on March 26 to Brazil’s national sanitary watchdog Anvisa. In line with the current legislation, such requests are to be considered within seven days, but the deadline can be put off if some of the required documents were not submitted in time. On March 27, Anvisa suspended the review for an indefinite period, saying that it has not yet received some of the required documents.
This is not the first delay in the Russian vaccine’s review, and Uniao Quimica’s chief Fernando Marques had earlier accused Anvisa of deliberate delays for the benefit of other COVID-19 vaccine manufacturers.