Russian officials have brushed off claims that Brazilian regulators rejected the use of Russia’s vaccine Sputnik V, saying they had merely requested more information.
The news comes in response to earlier reports that regulators in Brazil had blocked its use.
"Such requests from regulators are standard procedure and do not mean that a registration bid was rejected," the Russian Direct Investment Fund (RDIF) said in a statement. The RDIF has funded vaccine production and is responsible for selling it globally.
In a statement published late Saturday, the National Health Surveillance Agency of Brazil (Anvisa) said the request for emergency use by the pharmaceutical company Uniao Química was denied because they do not yet have data from Phase lll clinical trials.
Uniao Química, in partnership with the RDIF, filed a request for the emergency use of 10 million doses of the vaccine on Friday. Brazil is yet to approve any vaccine for use against Covid-19.
Anvisa explained it is yet to grant authorization for Phase III trials of Sputnik V to Uniao Química, which will run the trials, because it says the company has yet to respond to requests for the appropriate documentation.
The RDIF statement added, “the Sputnik V vaccine has already been registered in Serbia, Belarus, Argentina, Bolivia, Algeria, the State of Palestine, Venezuela and Paraguay. Registrations in two more countries are expected next week.”