The speed of approval for use in the European Union of the Russian vaccine “Sputnik V” depends on how quickly the regulator receives the documents. Christa Virtumer-Hohe, Head of the Medicines Market Surveillance Department of the Austrian Agency for Health and Food Safety and Chairman of the Governing Council of the European Medicines Agency (EMA), told TASS about this.
“The provision of data and communication is very difficult. Fundamentally, a third-country manufacturer needs an applicant within the EU. Russia has it. This is a company located in Estonia, located in one of the Baltic countries. We are in contact with this firm. Communication is not very easy, ”said Virtumer-Hohe. She explained that she could not specify when the procedure will end.
Earlier on March 9, it was reported that the creators of Sputnik V demanded an apology from Virtumer-Hohe for comparing the possibility of emergency approval of a drug against coronavirus with Russian roulette.
On March 5, the representative of the European Commission, Eric Mamer, said that European countries are allowed to independently purchase Sputnik V, without waiting for approval from the EMA. A day earlier, the agency launched an examination of the Russian vaccine. Experts will assess the compliance of the drug with EU standards for efficacy, safety and quality.
On March 2, Austrian Chancellor Sebastian Kurz announced that the country had begun negotiations over the production of a Russian vaccine. “I spoke on the phone with [Russian President] Vladimir Putin. After that, we maintain constant contact with the Russian ambassador [in Vienna, Dmitry Lyubinsky], as well as manufacturing companies in Russia, ”the politician said.
Sputnik V is the first registered Russian vaccine against coronavirus, it was created on the basis of another adenovirus, in which the coronavirus gene is embedded. When it enters the cells, it forms proteins in them – they cause immunity and promote the development of antibodies. In Russia, the vaccination campaign started on December 5, 2020.
