Russia applies for WHO emergency use tag for its COVID-19 vaccine
(Reuters) - The Russian Direct Investment Fund (RDIF) has submitted applications to the World Health Organization for an Emergency Use Listing and prequalification of its coronavirus vaccine, Sputnik V, Russia’s sovereign wealth fund said on Tuesday.
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.