The European Medicines Agency (EMA) uses the same criteria for all drugs, including Russia’s Sputnik V, during the coronavirus vaccine approval process in the European Union (EU), Fergus Sweeney, head of EMA’s clinical trials and manufacturing process, said at a briefing.
“The approach to all vaccines is the same and we are looking forward to the results,” he said (quoted by TASS).
Sweeney added that Sputnik V is now at the stage of consistent examination in the EU.
Earlier, Kirill Dmitriev, CEO of the Russian Direct Investment Fund (RDIF), said that the campaign to discredit Sputnik V had begun even before its registration. In addition, Russian presidential press secretary Dmitry Peskov told reporters that promoting Russian vaccines abroad often faces a politicized approach.
On February 9, RDIF announced that EMA had accepted an application for registration of Sputnik V in the EU. This drug was registered as the first in the world – on August 11 last year. According to The Lancet, the vaccine was 91.6% effective, and 91.8% for volunteers over 65. The drug 100% protects against the severe course of the disease. At the moment it is registered in 67 countries of the world.
In March, the EMA announced that it had recommended the issuance of an interim marketing authorization for the coronavirus vaccine to Janssen, a division of US Johnson & Johnson. Prior to this, vaccines from Pfizer / BioNTech, Moderna and AstraZeneca were registered in the EU.