Covid: Russian Sputnik V vaccine not to be approved before late June, Clément Beaune says

Published by Laurent P. · Published on 1 April 2021 at 17h29 · Updated on 2 April 2021 at 09h53
This Tuesday January 19, 2021, as the Russian authorities sought approval for issuing their Covid vaccine, Sputnik V, mostly developed by the Russian direct investment fund, from the European Medicines Agency, French State Secretary for European Affairs Clément Beaune announced the vaccine was unlikely to be approve before late June.

Is a new Covid vaccine soon to be issued in Europe? On Tuesday January 19, 2021, the Russian direct investment fund announced they have filed for issuing their vaccines, Sputnik V, to the European Medicines Agency. They said in a release they expect “the first examination to take place in February”.

But February has passed and the vaccine has still not been approved by the EMA... This Thursday April 1, French State Secretary for European Affairs Clément Beaune said it could not be so "before late June". He explained: "There is a first examination step (of the approval file) we call peer-review that undoubtedly is said to take place until mid-June". He went on: "Then, there is a last step which is European Medicines Agency's approval for marketing issuance that takes another couple of weeks. Therefore, this is no vaccine likely to be approved before late June, it seems".

The State Secretary made the most of the occasion to lambast Russia, pointing out the country's limited manufacturing ability and the Kremlin's will to use the vaccine as a propagnada weapon: "There are geopolitical events and marketing ploys that have been used by our fellow Russians to show how much they are present in the European Union". He went on: "Let's not be naive, [they have] a division strategy with the EU that so far has not paid off, so much the better, beyond a few stabs".

But the solution of the Russian vaccine is not to be ruled out: "We are ruling no solution out, no lead, but we have no illusion in mind about Russian or Chinese vaccines", he concluded.

The application is to be followed – along the examination – by documents and results showing the vaccine effectiveness (it is still completing the third phase of clinical trials) and required for any file. “Based on the series of reviews, the EMA will decide on the authorization of the Sputnik V vaccine for the European Union”, the Russian authorities state.

As for the EMA, the organization told AFP the agency will “communicate when a continuous review process begins. […] At the end of October, we started the vaccine authorization process in Europe. It is a large-scale process, the objective of which is to obtain permission to use the vaccine in the EU”, the Russian direct investment fund, also specifying that “registration is an important step”.

This is the fourth vaccine to have sought approval in the European Union, after Pfizer/BioNTech, Moderna Therapeutics and AstraZeneca.

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