
The creators of the Russian vaccine from the Coronavirus "Sputnik V" demanded apologies from the chairman of the European Agency for Medicines (EMA) Krista Virtumer-Hoch, who compared the approval of the vaccine with European countries before its official registration with the "Russian roulette".
On March 8, on the air of the Austrian television channel, ORF Krista Virtumer Hoch was asked whether Austria should approve the use of "satellite V" before registration in EMA. The official recommended not to do this, referring to the lack of data about the vaccine. “It looks like a Russian roulette in some ways,” said Virtumer-Hoch, which is quoted by the France 24 channel with reference to AFP.
"The satellite of V may appear on the market in the future, when we study the necessary data," she said, adding that the vaccine should meet European criteria for quality control and efficiency.
"We demand public apologies from Krista Virtumer -Hoch from EMA for her negative comments about the EU states that directly approve of" satellite V ". Her comments raise serious questions about the possible political intervention in the process of examination of the vaccine with an agency," the drug developers said on Twitter .
They also note that EMA had not previously allowed such statements about any other coronavirus vaccine, and such comments themselves are inappropriate and undermined the trust in the EMA and the verification process. "After EMA postponed the check" Sputnik V "for several months, she has no right to undermine the trust in 46 other regulatory authorities that checked all the necessary data," the developers concluded.
The press secretary of the President of the Russian Federation Dmitry Peskov also called "satellite V", one of the most popular and most trusted [vaccines], now there can be no doubt. "We consider this statement at least incorrect, the demand for this vaccine, the vaccination process in many countries shows the demand for this drug," said Peskov, whose words quoted the rain .
Last week, EMA began a consistent examination of the registration dossier of the Vaccine "Sputnik V". The agency will appreciate its compliance with EU standards by efficiency, safety and quality. The head of the RDPI Kirill Dmitriev said that EMA has been provided with all the necessary data on the vaccine, which has already been approved by more than 40 countries of the world.
The website of the European Agency reports that EMA will evaluate the data as it arrives and decides how profitable the registration of the drug is. Rolling Review will continue until there is enough evidence for an official application for registration of the drug.
The scientific consultation of the developers of the vaccine and representatives of the European regulator was held on January 19, and the application for registration of the drug in the EU was submitted on January 29 . Hungary and Slovakia approved the use of "Sputnik V" before the pan -European registration of the drug. In total, the "satellite V" was registered by 42 countries.