Brazil’s health regulator has denied the request for emergency use of Russia’s Sputnik V vaccine, saying it needs to see more data.
In a statement issued on Saturday afternoon, the Brazilian National Health Surveillance Agency (Anvisa) said that the emergency use request from the pharmaceutical company Uniao Química was denied because it does not yet have data from phase II clinical trials.
Uniao Química, in collaboration with the Russian Direct Investment Fund (RDIF), filed a request on Friday for the emergency use of 10 million doses of the vaccine. As part of the partnership with União Química, RDIF said it “actively facilitated the transfer of technology to launch Sputnik V production in Brazil,” according to an RDIF statement on Friday. The collaboration included the supply of documents and biomaterials to the Brazilian company and local production of Sputnik V in Brazil began earlier this month.
Anvisa explained that it has not yet granted authorization for Phase III trials of Sputnik V to Uniao Química, which has to run the tests, because the company had not responded to its requests for proper documentation.
“The documents (requesting the emergency authorization) were returned to the company after not meeting the minimum criteria, mainly due to the lack of authorization to conduct phase III clinical trials, a standard application and issues related to good manufacturing practices, ”Anvisa said. .
Sputnik V has been approved under the emergency use authorization procedure in several Latin American countries, including Argentina and Bolivia.
CNN has contacted Uniao Química and RDIF to comment.
Brazil has not yet approved any vaccine against Covid-19.