Czech Republic hopes that Russian vaccine will be registered in the EU

The Czech Republic hopes that the Russian Sputnik V vaccine will receive approval from the European Medicines Agency (EMA), after which it can be used in the republic without risking the health of citizens, Prime Minister Andrei Babish said in his traditional Facebook address on Sunday evening.

Czech Republic hopes that Russian vaccine will be registered in the EU

“A lot of people come to me with the idea of ​​purchasing the Russian Sputnik V vaccine, since, as you know, supplies of other vaccines to us are in limited quantities. On Friday we specially visited Hungary to get information there about the use of Sputnik V. Of course, we hope that the Russian vaccine will receive EMA approval, after which it can be used in the republic without risking the health of citizens”, – Babish said.

According to the prime minister, the available data on the Sputnik V vaccine indicate that this drug is safe and shows good results. But it is not known for sure whether it will appear on the European market, it depends on production facilities in the Russian Federation.

Babis also said that it is not yet clear whether the Czech State Institute for Drug Control (GIKL) will independently handle the registration of the Russian vaccine in the event that the manufacturers of Sputnik V do not apply for a pan-European certificate from the EMA.

At the same time, local media reported on Saturday that experts from the Czech Ministry of Health are already working to find an option in which permission to use the Russian vaccine in the Czech Republic would be without certification from both EMA and GIKL. If GIKL opposed this issue, the Ministry of Health could give permission to use Sputnik V. For this, paragraph 8 of the Law on Medicines could be implemented, which permits the use of vaccines in the Czech Republic, with the state taking responsibility for this.

Vaccination against COVID-19 in the Czech Republic has been taking place since December 27, Babis himself was the first to be vaccinated publicly. According to the prime minister, as of Sunday, 346 439 people received vaccinations, including 91 059 – the second time. At the same time, the Ministry of Health was forced to significantly adjust the vaccination schedule due to problems with the supply of Pfizer / BioNTech and Moderna vaccines.

The scientific journal Lancet last week published the results of the third phase of clinical trials of “Sputnik V”, confirming the high efficacy and safety of the vaccine. During phase III clinical trials, Sputnik V demonstrated high rates of efficacy, immunogenicity and safety – the vaccine efficacy was 91.6%. The vaccine provides complete protection against severe cases of the new coronavirus infection.

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