EMA begins Sputnik V rolling review - RDIF
MOSCOW. March 4 (Interfax) - The European Medicines Agency (EMA) has begun a rolling review of the Russian Sputnik V coronavirus vaccine for the purpose of future registration, the Russian Direct Investment Fund (RDIF) said in a statement on Thursday.
"The Russian Direct Investment Fund (RDIF, Russia's sovereign wealth fund) announces the start of a rolling review procedure of Sputnik V vaccine against coronavirus by European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP)," the statement said.
"The CHMP's decision to start the rolling review is based on results from laboratory studies and clinical studies in adults. EMA will assess Sputnik V's compliance with the usual EU standards for effectiveness, safety and quality," it said.
"Following EMA approval, we would be able to provide vaccine for 50 million Europeans starting from June 2021," the statement quoted RDIF CEO Kiril Dmitriev as saying.