The European Medicines Agency (EMA) has begun an examination of the Russian Sputnik V vaccine. This is stated in a press release published on the website of the EU regulator.
The EMA announced the start of a sequential review of the vaccine registration dossier. It is clarified that the decision of the committee to start the procedure was made taking into account the results of laboratory and clinical studies of “Sputnik V” on adults. Now the EMA has to assess the compliance of the drug with the established EU standards for efficacy, safety and quality.
The European regulator expects the vaccine to be evaluated in a shorter time frame. RIA Novosti notes that the approval of the EMA will provide vaccines to 50 million residents of the association from June 2021.
Hungary and Slovakia have already approved the use of “Sputnik V” on an individual basis, without waiting for the registration of the drug in the EU.
Already 42 countries have registered the Russian drug.
On February 18, the head of the RDIF, Kirill Dmitriev, said that the countries that have signed a supply contract with Moscow must release 1.4 billion doses of the vaccine, which can be used to inoculate 700 million people. At the same time, some manufacturers – China, India, Iran and South Korea – will produce the drug for export to third countries.
