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According to Reuters, the Russian side has not provided the necessary data on the clinical trials of the vaccine by the set date – June 10.
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In the past, it was predicted that the European Medicines Agency (EMA) could decide in May or June whether or not to approve the use of Sputnik V in the EU.
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Meanwhile, the Russian Direct Investment Fund, which finances the production of Sputnik V and its distribution abroad, rejected Reuters’ interpretation.
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“While it is the prerogative of EZA to decide on the timing of the procedure, the Sputnik V team expects to receive registration of the vaccine within two months,” the foundation said in a statement. The Foundation also states that it has provided all the necessary documents.
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Sputnik V is currently approved for use in two EU countries, Hungary and Slovakia, but not at EU level. The vaccine has also not been approved by the World Health Organization (WHO), although contracts for the supply of Sputnik V have been made with dozens of countries.
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