March 4 (UPI) -- The European Union's chief pharmaceutical regulator said Thursday it has begun a "rolling review" of Russia's Sputnik V COVID-19 vaccine that could open the door for distribution in the 27-member bloc.
The European Medicines Agency said its human medicines committee began the review based on results from past laboratory and clinical studies.
The Sputnik V vaccine was developed by Moscow's Gamaleya National Center of Epidemiology and Microbiology and the Russian Direct Investment Fund.
"[We] will evaluate data as they become available to decide if the benefits outweigh the risks," the EMA said in a statement.
"The rolling review will continue until enough evidence is available for formal marketing authorization application."
The RDIF said the shot is already being given in 43 countries with populations totaling more than 1 billion, including Sri Lanka, which approved the vaccine on Thursday.
Russian authorities said last fall that the vaccine is 91% effective in fighting the coronavirus disease.
Many Western researchers have been skeptical about the shot, however, because it has been subjected to only limited independent review.
Sputnik V is an adenovirus-based vaccine given in two doses.
