Brazil’s health regulator has denied a request for the 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 (Anvisa), said the request for emergency use by the pharmaceutical company Uniao Química was denied because it does not yet have data from Phase lll clinical trials.
Uniao Química, in partnership with the Russian Direct Investment Fund (RDIF), filed a request for the emergency use of 10 million doses of the vaccine on Friday. As part of the partnership with União Química, RDIF said it “actively facilitated the transfer of technology to launch the production of Sputnik V in Brazil,” according to a statement from RDIF on Friday. The collaboration included providing documents and biomaterials to the Brazilian company and local production of Sputnik V in Brazil began earlier this month.
Anvisa explained that it is yet to grant authorization for Phase III trials of Sputnik V to Uniao Química, which is to run the trials, because the company had not responded to its requests for the appropriate documentation.
“The documents (requesting emergency authorization) were sent back to the company after not meeting the minimum criteria, especially due to the lack of authorization for conducting Phase III clinical trials, a standard request, and issues relating to good manufacturing practices,” said Anvisa.
Sputnik V has been approved under emergency use authorization procedure in a number of Latin America countries, 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 Covid-19.
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