Brazilian Approval of Sputnik V Vaccine Delayed by Missing Data

RIO DE JANEIRO, BRAZIL – 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 União Química’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, January 16th.

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.

União Quimíca 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-V for Russian domestic use, though clinical trials there have not yet been completed. RDIF said that Sputnik-V had already been registered in Serbia, Belarus, Argentina, Bolivia, Algeria, Venezuela, Paraguay and by the Palestinian authorities. Registrations in two more countries are expected next week, it added.

ANVISA officials had previously said that the Sputnik-V vaccine would have to be submitted to Phase III clinical trials in Brazil before its use could be authorised.

ANVISA said on Saturday that any applicant requesting emergency use authorisation must show that the vaccine would deliver long-term safety and effectiveness.

The regulator is expected to make a decision on Sunday about authorising emergency use of vaccines developed by China’s Sinovac and Britain’s AstraZeneca.