The European Union’s vaccine regulator, the European Medicines Agency (EMA), has begun a rolling review of Russia’s Covid-19 vaccine Sputnik V.
“The decision to start the rolling review is based on results from laboratory studies and clinical studies in adults” the EMA said in a statement on Thursday.
“These studies indicate that Sputnik V triggers the production of antibodies and immune cells that target the SARS-CoV-2 coronavirus and may help protect against Covid-19.”
“EMA will evaluate data as they become available to decide if the benefits outweigh the risks,” the statement adds.
The rolling review comes after complaints about the European Commission’s slow vaccine deployment. The delays have led to some member states unilaterally approving Sputnik V, the vaccine produced by Russia’s Gamaleya National Centre of Epidemiology and Microbiology.
The shot has been found to be 91.6% effective against symptomatic Covid-19 and 100% effective against severe and moderate disease, according to an interim analysis of the vaccine's Phase 3 trial results published in The Lancet medical journal.
The head of Russia’s sovereign wealth fund, Kirill Dmitriev, welcomed the announcement saying the decision “should be above politics.” The fund is responsible for global production and distribution of the vaccine.
“Vaccine partnerships should be above politics and cooperation with EMA is a perfect example demonstrating that pooling efforts is the only way to end the pandemic,” Dmitriev said.
He went on to say Russia could provide the European Union with enough vaccines to inoculate 50 million people, with distribution beginning in June 2021.
“Sputnik V can make an important contribution to saving millions of lives in Europe and we are looking forward to a thorough review,” he said.