RIO DE JANEIRO, BRAZIL – The Brazilian pharmaceutical company União Química concluded producing an experimental batch of Sputnik V vaccine components in its plant in Brasilia, according to information released by the Russian Embassy in Brazil.
The entire batch will be sent to the Gamaleya National Research Center of Epidemiology and Microbiology, in Russia, which developed the immunizer, for a quality control review.
In early January, União Química received cellular material to manufacture the vaccine and began producing a trial batch of the immunizer’s active components for research purposes. União Química, which represents the Russian Direct Investment Fund (RDIF) in Brazil, submitted to Anvisa a new request to register Sputnik V on March 26.
According to current legislation, such requests should be considered within seven days, but this can be extended if some required documents are not submitted in time. The day after the new request, Anvisa suspended the review indefinitely, claiming that it had not yet received part of the required documentation.
However, this is not the first time that the review for emergency use of the Russian vaccine in Brazil has been postponed. The president of União Química, Fernando Marques, had previously accused the agency of deliberate delays for other Covid-19 vaccine manufacturers’ benefit.
Source: G1