The Brazilian health regulator has rejected a request for the emergency use of the Russian Sputnik V vaccine, saying it needs to see more data.
In a statement issued late Saturday, Brazil’s National Health Surveillance Agency (Anvisa) said the request for emergency use of the pharmaceutical company Uniao Química had been rejected because it did not yet have data from phase II clinical trials.
Uniao Química, in partnership with the Russian Direct Investment Fund (RDIF), filed an application on Friday for the emergency use of 10 million doses of vaccine. As part of its partnership with União Química, RDIF said it had “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 Sputnik V’s phase III studies to Uniao Química, which is to conduct the studies, because the company has not responded to its requests for adequate documentation.
“The documents (requesting emergency authorization) were sent back to the company after they did not meet the minimum criteria, in particular due to the lack of authorization for Phase III clinical trials, a standard application and good manufacturing practice issues”, said Anvisa.
Sputnik V has been approved under the emergency authorization procedure in several Latin American countries, including Argentina and Bolivia.
CNN contacted Uniao Química and RDIF for comments.
Brazil has not yet approved any vaccine for use against Covid-19.