RIO DE JANEIRO, April 10. /TASS/. A delegation of Brazil’s National Health Surveillance Agency (Anvisa) will arrive to Russia next week to inspect the Sputnik V production facilities, the watchdog’s press service said on Friday.
"Two facilities will be inspected. First, between April 15 and 21, three Anvisa staffers will visit a factory producing the vaccine’s active component and the jab itself. After that, between April 19 and 23, inspectors will visit an enterprise responsible for final adjustments and packing," Anvisa said in a statement, posted on its website.
Anvisa will be among the first foreign regulatory agencies, whose delegations visit Sputnik V production. During the visit, Brazilian experts expect to receive more information about the Russian vaccine’s production cycle, which is needed for subsequent analysis of its request for emergency use and imports.
So far, the use of Sputnik V has not yet been officially approved in Brazil. Uniao Quimica, which represents the Russian Direct Investment Fund (RDIF) in Brazil, submitted a new registration request to Anvisa on March 26. 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 requested documents.
This is not the first delay in the Russian vaccine’s review, and Uniao Quimica’s chief Fernando Marques earlier accused Anvisa of deliberate delays for the benefit of other COVID-19 vaccine manufacturers. In early January, Uniao Quimica received cell material to manufacture the vaccine and began producing a trial batch of its active components for research purposes. Earlier, the company announced plans to produce up to 8 million doses of Sputnik V per month.