Russia has submitted all documents for the approval of its vaccine against coronavirus in the EU, work continues, said the press secretary of the President of the Russian Federation Dmitry Peskov.
In early March, the Russian Direct Investment Fund (RDIF) announced that the European Medicines Agency (EMA) had begun a consistent examination of the registration dossier of the Russian Sputnik V coronavirus vaccine. The agency will test the vaccine against EU standards for efficacy, safety and quality.
“This update should be provided by Europe, all documents have been submitted there, the corresponding work continues”, – said Peskov, answering the question of whether there is any new information on the approval of the Sputnik V vaccine in Europe.
The Sputnik V vaccine was registered by the Ministry of Health of the Russian Federation in August 2020, it was developed by the Gamaleya Research Center for Electrochemistry. The scientific journal Lancet has published the results of the third phase of clinical research “Sputnik V”, confirming its high efficiency and safety. During phase III clinical trials, Sputnik V demonstrated high rates of efficacy, immunogenicity and safety – the vaccine efficacy was 91.6%. As the director of the Gamaleya Center Alexander Gintsburg noted, the Russian vaccine provides one hundred percent protection against severe and moderate cases of coronavirus infection.
Since March 4, Sputnik V has been undergoing a gradual examination procedure at the EMA. Earlier, they expressed the hope that the assessment of “Sputnik V” will be held at an accelerated date, but there is no date for the approval of the vaccine.
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. The Russian Direct Investment Fund (RDIF) signed the first agreement on the production of a vaccine in the EU – in Italy – with the Swiss Adienne Pharma & Biotech. Production of Sputnik V in Italy is due to start in July, with 10 million doses expected to be produced by the end of the year. Sweden may receive the Russian Sputnik V vaccine in June, Swedish vaccination coordinator Richard Bergström told Aftonbladet newspaper, noting its high efficiency.