European regulators have begun a rolling review of Russia's Sputnik V SARS-CoV-2 vaccine, Reuters reports.
The vaccine was approved for use in Russia in August even before it underwent Phase III testing, a decision that raised concerns at the time. But in November, Russia reported that Sputnik V, which is being developed by the Gamaleya Institute, had an efficacy rate exceeding 95 percent in an initial analysis and, in the Lancet last month, Gamaleya-led researchers reported it had a 91.6 percent efficacy rate against COVID-19.
The European Medicines Agency says it is now reviewing data from ongoing Sputnik V trials, Reuters reports, noting that the agency says a rolling approach enables a faster review.
"We desperately need to enlarge our portfolio of vaccines, so I see this as a very welcome development," Hans Kluge, the World Health Organization's regional director for Europe, tells the Associated Press.
Kirill Dmitriev, CEO of the Russian Direct Investment Fund that funded the vaccine, adds at the AP that, if approved, they would be able to provide vaccine doses for 50 million for Europe beginning in June.