The Brazilian health regulator has rejected a request for emergency use of the Russian Sputnik V vaccine, saying it needs to see more information.
In a statement released late Saturday, the Brazilian National Health Agency (Anvisa) said the request for emergency use by pharmaceutical company Uniao Química was being rejected because it did not yet have information on Phase III clinical trials.
Uniao Química, in partnership with the Russian Direct Investment Fund (RDIF), submitted 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 had actively facilitated the transfer of technology to launch production of Sputnik V in Brazil, according to a statement from RDIF on Friday. The collaboration includes the provision of documents and biomaterials to the Brazilian company and the local production of Sputnik V in Brazil began earlier this month.
Anvisa explained that it still has to approve Phase III trials with Sputnik V to Uniao Química, which has to carry out the trials, because the company did not respond to its requests for the appropriate documentation.
“The documents (requesting emergency permission) were returned to the company after they did not meet the minimum criteria, especially due to the lack of authorization to conduct Phase III clinical trials, a standard request and issues regarding good manufacturing practices,” said Anvisa. .
Sputnik V has been approved under the Emergency Use Authorization Procedure in a number of Latin American countries, including Argentina and Bolivia.
CNN released Uniao Química and RDIF for comment.
Brazil has yet to approve any vaccine for use against Covid-19.