EU begins examination of Sputnik V vaccine
The European Medicines Agency (EMA) has begun a consistent examination of the registration dossier of the Russian Anti COVID vaccine Sputnik V, the Russian Direct Investment Fund (RDIF) said. The agency will test the vaccine against EU standards for efficacy, safety and quality.
“RDIF announces the start of a rolling review procedure for the Sputnik V Russian vaccine against coronavirus by the Committee on Medicines for Medical Use of the European Medicines Agency (EMA)”, – the fund said.
It is specified that the decision of the committee to start the sequential examination procedure was made taking into account the results of laboratory and clinical studies of the vaccine in adults.
“EMA will assess the compliance of the Sputnik V vaccine with the EU standards for efficacy, safety and quality”, – the RDIF said.
Hungary and Slovakia have already approved the use of “Sputnik V” on an individual basis, without waiting for the pan-European registration of the drug from the EMA. Sputnik V is one of the world’s top three coronavirus vaccines in terms of the number of approvals received by government regulators. It was registered by 42 countries, with a total population of over 1.1 billion people.