Russia was the first country to grant regulatory approval for a novel coronavirus vaccine, and did so before large-scale trials were complete, stirring concerns among scientists and doctors about the safety and efficacy of the shot.
An Emergency Use Listing (EUL) is meant to make a vaccine available globally faster, while a WHO prequalification is a global quality tag that ensures vaccines are safe and effective.
The procedures would allow Sputnik V to be included in the list of medical products that meet leading quality, safety and efficacy standards, RDIF CEO Kirill Dmitriev said in a statement.
The vaccine, developed by Moscow’s Gamaleya Research Institute and marketed by RDIF, is based on a platform of human adenoviral vectors. (Reporting by Vishwadha Chander in Bengaluru Editing by Mark Heinrich)
epa08600537 A handout photo made available by the Russian Direct Investment Fund (RDIF) shows containers with a new two-vector COVID-19 vaccine at Nikolai Gamaleya National Center of Epidemiology and Microbiology in Moscow, Russia, 06 August 2020 (issued 13 August 2020). Russia registered the new called Sputnik V vaccine against coronavirus Sars-Cov-2 and opens the stage of its massive testing. EPA-EFE/RDIF HANDOUT NO RESTRICTIONS, ALLOW TO USE IN SOCIAL NETWORK HANDOUT