Brazil’s health regulator has denied a request for emergency use of Russia’s Sputnik V vaccine, saying it needs to see more data.
In a statement published late Saturday, the Brazilian National Health Surveillance Agency (ENVISA) said the request for emergency use was denied by the pharmaceutical company Uniao Cuamica as it does not yet have data from Phase LLL clinical trials.
Uniao Química in partnership with the Russian Direct Investment Fund (RDIF) on Friday filed a request for emergency use of 10 million doses of the vaccine. According to a statement by RDIF on Friday, as part of a partnership with UNIO CUMICA, RDIF said it “actively facilitated the transfer of technology to start production of Sputnik V in Brazil.” The collaboration included providing documentation and biometric to the Brazilian company and local production of Sputnik V in Brazil began earlier this month.
Anvisa explained that authorization is yet to be given to Unio Quimica for Phase III trials of Sputnik V, to run the tests, as the company had not responded to its requests for proper documentation.
Envisa stated, “The documents (requesting emergency authorization) were sent back to the company after not meeting the minimum criteria, specifically the lack of authorization to conduct Phase III clinical trials, a standard request, And due to issues related to good manufacturing practices “Envisa said. .
Sputnik V has been approved under emergency use authorization procedures in several countries in Latin America, including Argentina and Bolivia
CNN has reached out to Uniao Química and RDIF for comment.
Brazil is yet to approve any vaccine for use against Kovid-19.