Brazil’s health regulator has rejected a request for emergency use of Russia’s Sputnik V vaccine, saying it needs more data.
In a statement released late Saturday, Brazil’s National Health Surveillance Agency (Anvisa) said the emergency use request was rejected by pharmaceutical company Uniao Química because it has no data from Phase III clinical studies yet.
Uniao Química on Friday, in partnership with the Russian Direct Investment Fund (RDIF), filed a request for the emergency use of 10 million doses of the vaccine. As part of its partnership with União Química, RDIF said it has “actively facilitated the transfer of technology to launch production of Sputnik V in Brazil,” a statement from RDIF said on Friday. The collaboration included the provision of documents and biomaterial to the Brazilian company, and local production of Sputnik V in Brazil began earlier this month.
Anvisa explained that it is not yet required to authorize Phase III studies from Sputnik V to Uniao Química, who will be conducting the trials, because the company had not responded to its requests for proper documentation.
“The documents (requesting emergency clearance) were returned to the company after failing to meet minimum criteria, mainly due to lack of authorization to conduct phase III clinical studies, a standard request, and issues related to good manufacturing practice” , Anvisa said.
Sputnik V is approved under the emergency licensing procedure in a number of countries in Latin America, including Argentina and Bolivia
CNN has contacted Uniao Química and RDIF for comment.
Brazil has yet to approve a vaccine for use against Covid-19.