EMA Official Says Criteria for Assessing Sputnik V Same as For Other Vaccines

MOSCOW (Sputnik) - The criteria being used by the European Medicines Agency (EMA) to assess Russia’s Sputnik V COVID-19 vaccine are the same that have been used to judge the safety and effectiveness of all vaccines against the disease, Fergus Sweeney, head of the EMA's clinical studies and manufacturing taskforce, said on Thursday.

At a press briefing, Sweeney noted that Sputnik V was currently undergoing the EMA’s rolling review process, which sees the manufacturer submit data and address questions and comments put forward by agency experts.

"We are in that process at the moment [with Sputnik V], it's ongoing. All vaccines are treated equally in that respect and we look forward to the outcome", Sweeney said.

On Tuesday, the Reuters news agency published an article alleging that there were data gaps in the material submitted by Sputnik V’s developers to the EMA.

A vial with Russia's Sputnik V coronavirus vaccine is placed on a table in a medical room at a vaccination center in the GUM, State Department store, in Red Square in Moscow, Russia, Thursday, July 1, 2021.

© AP Photo / Pavel Golovkin

The Russian Direct Investment Fund (RDIF) strongly denied the claims published by Reuters, alleging that the "fake news" article included "false comments by anonymous sources".

Kirill Dmitriev, the head of the RDIF, told the India Today portal on Wednesday that he expects the World Health Organisation to approve Sputnik V by September or October.