EU does not need Russia's Sputnik V vaccine, so EMA won't register it

Europe confirms unwillingness to register Russian Sputnik V vaccine

Ursula von der Leyen, the head of the European Commission, said that there were not enough convincing data for the European Medicines Agency (EMA) to approve Russia's Sputnik V vaccine. At the same time, Russian Foreign Minister Sergei Lavrov said that EMA experts did not express any complaints in relation to either the Russian Sputnik V vaccine or the degree of its efficacy.

Has Europe confirmed its unwillingness to register Sputnik V?

The application to register the Russian vaccine at the EMA was filed back in winter. In early March, the European agency proceeded with a gradual rolling review. Judging by what Russian FM Sergei Lavrov says, this procedure continues to this day.

"Currently, the Sputnik V vaccine is undergoing the so-called sequential examination at the European Medicines Agency. In April-May, EU officials visited Moscow medical institutions involved in clinical trials of Sputnik V. They also inspected production sites. EMA employees maintain direct working contact with representatives of the Ministry of Health and the Ministry of Industry and Trade of Russia. According to information on our end, there are no comments either in relation to the vaccine itself or the degree of its efficacy. We proceed from the fact that the issue lies within politics-free and professional dialogue between specialized organizations," the minister told the Komsomolskaya Pravda newspaper.

In turn, the head of the European Commission Ursula von der Leyen said that the manufacturer could not prove the safety of the drug.

"It has become very quiet around Sputnik V. The application to the EMA was submitted a long time ago. However, the manufacturer has not been able yet to provide sufficient reliable data to prove the safety of (the drug)," Von der Leyen said in an interview with Redaktionsnetzwerk Deutschland (RND) … "This raises questions," she said.

There is no understanding of the terms of registration

It is worth recalling that in winter and in spring, when there was a shortage of vaccines against coronavirus in EU countries, many European politicians insisted Russian vaccines be used. Of course, many within the structures of the European Union were opposed to this.

One may say that the registration process for the Russian vaccine was put into cold storage. Earlier it was said that Sputnik V could be registered in May or June. Russia's Ambassador to the EU Vladimir Chizhov noted that there was still no understanding of the approximate timing of vaccine registration in the EU.

In June, Reuters reported citing its own sources, that the EMA approval of the Sputnik V vaccine would be delayed until September, or perhaps until the end of the year. According to the news agency, the Gamaleya Institute, the developer of the vaccine, did not provide the required information on time. The Russian Direct Investment Fund, which applied for the EMA, called the Reuters report speculation.

Russia believes that the vaccine registration process should not be politicized. EU officials deny such claims and say that everything lies in the hands of professionals.

Meanwhile, registration deadlines still remain unknown. Judging by recent statements from Ursula von der Leyen, the EU is not going to speed up the process.

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Author`s name Anton Kulikov
Editor Dmitry Sudakov