"In terms of effectiveness, safety and quality": the EU regulator has started the examination of the vaccine "Sputnik V"

The Committee on Medicines for Medical Use of the European Medicines Agency (EMA) has begun the procedure for the consistent examination of the registration dossier of the Russian vaccine against coronavirus infection COVID-19 Sputnik V.

This was reported by the press service of the Russian Direct Investment Fund.

“The decision of the committee to start the sequential examination procedure was made taking into account the results of laboratory and clinical studies of the vaccine in adults.

EMA will assess the compliance of the Sputnik V vaccine with EU standards for efficacy, safety and quality, ”the press release said.

According to Kirill Dmitriev, RDIF CEO, the fund welcomes the EU regulator's decision to start a sequential examination procedure, stressing that the Russian side has provided EMA with all the necessary data on the vaccine.

Sputnik V has the potential to make a critical contribution to saving millions of lives across Europe, and we look forward to reviewing the data by the Committee on Medicines for Medical Use.

The vaccine partnership must take precedence over politics, and the collaboration with the EMA is an excellent example that confirms that only joining forces can defeat the pandemic, ”he said.

According to him, if the Sputnik V vaccine is approved, starting from June 2021, 50 million residents of the countries of the European Union can be provided.

The RDIF also noted that a number of EU countries (Hungary and Slovakia) individually approved the use of a domestic vaccine developed by specialists of the National Research Center for Epidemiology and Microbiology named after Honorary Academician N.F.

Gamalei.

All in all, at the moment, "Sputnik V" was registered by 42 states of the world, the total population of which exceeds 1.1 billion people.

Thus, the Russian development is in the top 3 of the world's COVID-19 vaccines in terms of the number of approvals received by government regulators.

The website of the European Medicines Agency also published a publication on the start of the gradual examination procedure.

It is noted that the decision was made "based on the results of laboratory and clinical trials," which demonstrated that vaccination with the Sputnik V vaccine triggers the production of antibodies and immune cells against the SARS-CoV-2 coronavirus.

“The EMA will evaluate the data (on the Russian vaccine - 

RT

) as they become available to decide whether the benefits of this drug outweigh the risks associated with it.

The gradual examination will continue until enough evidence has been collected to submit an official application for a marketing authorization, ”the regulator said in a statement.

It is indicated that the Sputnik V conformity assessment will be given in accordance with the EU standards of efficiency, safety and quality.

“Although the agency cannot predict the overall timeline, the time it takes to evaluate the final application should be shorter than usual, thanks to the work that will be done during the gradual review.

The agency will provide further information when an application for the issuance of a registration certificate is submitted, ”the EMA concluded.

Hans Kluge, WHO Regional Director for Europe, called it "good news" the announcements of the start of an examination of Sputnik V by the European Medicines Agency. 

“I have already said that the Russian Federation really has a large and successful experience in the development of vaccines,” TASS quotes him.

"We desperately need to expand our vaccine portfolio, so I think this is a very welcome development."

Recall that the development of the Gamaleya SRCEM became the world's first registered vaccine against coronavirus infection COVID-19.

Sputnik V is a two-component vector vaccine based on the human adenovirus, which contains an insert in its genome that encodes a fragment of the SARS-CoV-2 S-protein and induces an immune response in the organism.

Vaccination of each person is carried out in two stages (again - 21 days after the first injection).

On February 2, 2021, one of the most respected medical journals in the world, The Lancet, published the results of the third phase of a clinical trial of the vaccine, which confirmed its high efficacy at 91.6% and safety.

At the same time, Sputnik V fully protects against the severe course of the coronavirus disease.

In addition, at the end of February, international clinical trials of the Sputnik Light coronavirus vaccine, a single-component drug based on Sputnik-V, were launched.

At the same time, the Russian Direct Investment Fund filed an application for emergency approval of the drug in Russia and a number of other countries.