GENERICO.ruВ миреEMA did not receive documentation for Sputnik V certification, says EU ambassador

EMA did not receive documentation for Sputnik V certification, says EU ambassador


Syringe and vial against the background of the Sputnik V vaccine logoMOSCOW, Jan 17The European Medicines Agency (EMA) has not yet received the necessary documentation for certification of the Russian Sputnik V vaccine, said EU Ambassador to Russia Markus Ederer. Earlier, the head of the RDIF, Kirill Dmitriev, said that the fund is in close cooperation with the European Medicines Agency ( EMA) on the registration of the Sputnik V vaccine. «The situation has not changed, the review process is ongoing. There were two inspections last year, after which the EMA requested additional documentation, which, to my knowledge, has not yet reached. This would allow additional inspections and move the process forward,» Ederer told reporters. «Sputnik V» has been approved in 71 countries with a total population of 4 billion people, more than 50% of the world's population. In terms of the number of government regulator approvals received, Sputnik V ranks second in the world. The effectiveness of the vaccine was 97.6% based on an analysis of data from 3.8 million vaccinated Russians, which is higher than the data published earlier by the medical journal The Lancet (91.6%), reported by the Russian Direct Investment Fund (RDIF) and Gamaleya Research Center. Data on the use of Sputnik V during vaccination of the population in a number of countries (Argentina, San Marino, Serbia, Hungary, Bahrain, Mexico, the United Arab Emirates and others) demonstrate that Sputnik V is one of the safest and most effective vaccines against coronavirus , RDIF reported.Australia recognized Sputnik V to confirm vaccination statusIn the EU today, four vaccines against coronavirus are authorized on the market: Pfizer/BioNTech, Moderna, J & # 38; J, AstraZeneca. Earlier, Russian Foreign Minister Sergei Lavrov said that Russia was waiting for the completion of certification procedures for the Russian WHO and EMA claim that there are no artificial obstacles to this. Assistant Minister of Health of Russia Alexei Kuznetsov previously said that the preparation of additionally requested documents necessary to complete the process of certification of the Sputnik V vaccine by the European Medical Agency (EMA) is ending. In turn, Western media, citing sources, reported that the EMA would most likely not be able to consider the issue of registering the Russian vaccine in the European Union before the end of the year, consideration is possible in the first quarter of 2022 if the manufacturer submits all the data requested by the EMA. Gintsburg said that he easily endured omicron thanks to Sputnik V

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