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