According to the spokesperson, the EMA is currently evaluating Sputnik V via a rolling review procedure. The representative added that the EU drug regulator will make its recommendations on Sputnik V based solely on scientific data on the effectiveness and safety of the Russian vaccine and nothing else.
The EMA spokesperson also said that the regulator will review data on Sputnik V as it becomes available to decide if the benefits of the vaccine outweigh its risks.
In August 2020, Russia became the first country in the world to register a vaccine against the coronavirus, dubbed Sputnik V, and developed by the Gamaleya research institute.
According to analysis of phase 3 clinical trials of Sputnik V, published by The Lancet medical journal, Sputnik V has 91.6 percent efficacy against symptomatic COVID-19.
On Thursday, EMA announced that it had started a rolling review to test the Russian vaccine for compliance with EU standards for effectiveness, safety and quality.