What Will Europe Look Like In 2025?
As expertise in the European Drug Supervision Service “Satellite V” will be treated with ESDR standards such a procedure of gradual examination can be the most different, depends on the information package that will be provided. Will it be enough — The question is controversial. I think still the procedure will take months. Worst scenario — If any additional significant clinical trials are required, because those that have already been conducted, then consider insufficiently not relevant to the standard.
Obtaining a permit from the general European Drug Supervision Service — Of course, this is a completely different level and volume of potential supplies.
Both of these factors are important for the Russian pharmaceutical, so that our vaccine is recognized as an effective and better adenovirus vaccine in its niche or at least one of these. Therefore, registration — This is a reputational factor that, of course, is extremely important. “.
While in Europe, three vaccines are approved from Coronavirus: drugs from companies Pfizer / Biontech, Moderna and Astrazeneca. Soon the drug from Johnson can join them & Johnson. Vaccication of all citizens of the European Union power are planned by the end of summer. And there is a risk that “satellite V” will not have time to make its contribution: with the worst examination scenarios, it can delay at least four months, says the head of the laboratory of Vaccination named after Mechnikov Mikhail Kostinov: “Preclinical research is carried out on animals, then the first and first The second phase of clinical trials in humans, after the field test will be required — Third phase. As a result, you need at least four months.
But considering the situation, they can make a decision on the basis of all the data that we have in Russia and who were published abroad “.
Czech Republic faced a crisis scenario
Access to the European Union — It is not important that it can get “satellite V” after registration. The EU certificate for the Russian vaccine will be a universal quality mark, noted the CEO of Allergen’s Trade House Alla Denisova: “Usually, when someone has been requesting vaccines, you always ask a question, even Kazakhstan or Uzbekistan: there is a European, American or Japanese certificate? This document opens output to all markets. Another thing is that it should be enough power. But our also transmit production technology: in Belarus, a plant for the production of “satellite V” has already earned, at the opening stage there is a plant in Kazakhstan “.
As an ambulance registration of the “satellite V” react citizens of the EU
Approval of the “satellite V” of the European Union did not begin to wait for Hungary and Slovakia. Bratislava announced the purchase of 2 million doses of the Russian vaccine. But as it turned out later, the prime minister of Slovakia Igor Matovich agreed on the supply without the knowledge of the president and other politicians.