BRASILIA — Brazil’s health regulator is seeking further data on Russia’s Sputnik V coronavirus vaccine before considering its approval for emergency use.
Documents supporting drugmaker Uniao Quimica’s application for emergency use of the vaccine have been returned to the company because they did not meet its minimum criteria, the watchdog said on Saturday.
In a statement on the Health Ministry’s website, regulator Anvisa said the request failed to provide adequate assurances on Phase III clinical trials and issues related to the manufacture of the vaccine.
Uniao Quimica is seeking approval for the use of 10 million doses of Sputnik V in Brazil in the first quarter of this year.
Russia’s RDIF sovereign wealth fund, which is promoting Sputnik globally, on Sunday said that Anvisa had requested additional information that would be provided shortly.
Its statement said that such requests from regulators were standard procedure and do not mean the registration bid has been rejected. It also said that legislation going through the Brazilian Senate, if approved, would allow use of vaccines approved by other countries.
Moscow has approved Sputnik for Russian domestic use, though clinical trials there have not yet been completed.