January 17, 21 - 10:55 am - LABS

Approval of Sputnik V vaccine in Brazil delayed by missing data

Brazil’s health regulator Anvisa needs additional data on Russia’s Sputnik V coronavirus vaccine before considering its approval for emergency use, reported Reuters.

Documents supporting pharmaceutical firm União Quimicas application for emergency use of the vaccine have been returned to the company because they did not meet its minimum criteria, the regulator agency said on Saturday.

In a statement on the Health Ministry’s website, Anvisa said the request failed to provide adequate assurances on Phase III clinical trials and issues related to the manufacture of the vaccine.

União Quimica seeks approval for the use of 10 million doses of Sputnik V in Brazil in the first quarter of 2021.

The Russian Direct Investment Fund (RDIF), which is promoting Sputnik globally, on Sunday said that Anvisa had requested further information that would be sent 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 the use of vaccines approved by other countries.

Moscow has approved Sputnik for Russian domestic use, though clinical trials there have not yet been completed.

Anvisa officials had said before 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 decide this Sunday about authorising emergency use of vaccines developed by China’s Sinovac and Britain’s AstraZeneca.

RDIF said that Sputnik had already been registered in Serbia, Belarus, Argentina, Bolivia, Algeria, Venezuela, Paraguay and by the Palestinian authorities, and that registrations in two more countries are expected to next week.