The European Medicines Agency (EMA) has started a sequential review of the registration files for the Russian vaccine Sputnik V, according to the agency’s press office.

“The EMA will evaluate the data as it becomes available to decide whether the benefits outweigh the risks. The ongoing review will continue until sufficient evidence is available for a formal application for marketing authorisation,” the press release said.

Recall that in mid-February, the head of the European Commission, Ursula von der Leyen, said that the Russian vaccine against coronavirus is not produced in Europe, so inspections of manufacturing companies are required for its approval in the EU. A few days later it became known that the EMA had appointed a rapporteur for the progressive review of Sputnik V.

Sputnik V has so far been registered by 42 countries with a total population of more than 1.1 billion people. It ranks among the world’s top 3 coronavirus vaccines in terms of the number of approvals received by government regulators. Studies have shown it to be highly effective and safe.