MOSCOW, (Reuters) – Russia has repeatedly delayed inspections by the European Medicines Agency (EMA) necessary for the certification of its Sputnik V COVID-19 vaccine in the European Union, the EU’s ambassador to Moscow was quoted as saying today.
The Sputnik V vaccine, widely used in Russia and approved for use in more than 70 countries, is undergoing a review by the World Health Organization and the EMA.
Russia has accused the West of refusing to certify its flagship vaccine for political reasons. Without EMA approval, it is harder for Russians to travel throughout the EU.
“This is a technical rather than a political process,” EU ambassador Markus Ederer told Russia’s RBC media outlet in an interview.
“When Russian officials talk about the process being delayed and politicised by the European side, I sometimes think they are largely referring to themselves because it is them who makes this about politics.”
Russia’s sovereign wealth fund, the Russian Direct Investment Fund (RDIF), markets Sputnik V overseas. It declined to comment.
The EMA said it could not immediately comment on the matter.
Five people with knowledge of European efforts to assess the drug told Reuters earlier this year that the developers of Sputnik V had repeatedly failed to provide data that regulators deem to be standard requirements of the drug approval process.
RDIF said at the time that Reuters’ reporting contained “false and inaccurate statements” based on anonymous sources who were attempting to harm Sputnik V as part of a disinformation campaign.
Russian Health Minister Mikhail Murashko said this month that all the barriers to register Sputnik V with the WHO had been cleared and that only some paperwork remained to be completed.
The TASS news agency cited the health ministry as saying today that EMA inspectors might carry out a visit to Russia in December.
