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To assess the effectiveness of the Russian vaccine against coronavirus “Sputnik V” and its registration in the EU, additional data from the developer is required. This was stated by the head of the department for vaccination and infection control of the European Medicines Agency (EMA) Marco Cavaleri, transfers Reuters.
“As for the Sputnik V vaccines and [китайской] Sinovac, discussion of these drugs with manufacturers was constructive, but we need [получить] more data before continuing to evaluate it, ”he said. According to him, due to the lack of additional data on the production, safety and efficiency of Sputnik, it is premature to talk about the timing of its registration.
Today the Sputnik V vaccine has been approved for use in more than 60 countries. In January, RDIF filed an application for drug registration with the European Medical Agency (EMA). Expertise of “Sputnik” started in March. How wrote Reuters, the regulator was supposed to make a decision on the drug back in May, but the deadline had to be postponed until the end of the year due to the fact that the developer – the Center. Gamalei – missed the test data submission deadline. RDIF denied this.
Another agency source close to EMA, reportedthat by early summer, the regulator had received almost no production data for the vaccine, and the clinical information provided was incomplete. This includes reporting of side effects. Director General of RDIF Kirill Dmitriev spokethat EMA specialists, during the Sputnik examination procedure, did not criticize either the quality of the tests carried out or the production itself.
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