Why has the EU not yet approved the Russian vaccine Sputnik V?

The Russian vaccine Sputnik V is still awaiting the green light from the European Medicines Agency (EMA) before it can be deployed in all 27 member countries of the European Union.

Moscow and Brussels continue to clash over the question of the supposed slowness of the European regulator based in Amsterdam, here is a point of the situation:

– How does the decision-making process of the EMA work? –

According to the EMA, Sputnik V is subject to the same decision-making process as all other Covid-19 vaccines.

The first step is a “continuous review” of the data and clinical trials.

An official application for a one-year conditional marketing authorization must follow.

“They have to submit all the data, indeed go through the entire monitoring process, like any other vaccine,” European Commission President Ursula von der Leyen said on February 17 of Sputnik V .

The time between continuous review and clearance has so far been between two and four months.

For the moment, three vaccines are authorized in the European Union: those of Pfizer-BioNTech, Moderna and AstraZeneca.

A fourth, that of Johnson & Johnson, is subject to a request for authorization.

Two others, those from Novavax and CureVac, have started their ongoing review process.

– What does the EMA say? –

The European Medicines Agency insists that Sputnik has not even entered the continuous review phase yet.

The European Medicines Agency has not, to date, received any request for continued review or marketing authorization for the Sputnik V vaccine, “despite reports to the contrary,” she said. stated in a “clarification” dated February 10.

The regulator confirmed by email to AFP that the situation had not changed on February 18.

He also said that the EMA experts themselves “must first give their consent before developers can submit their request for access to the continuous review process.”

However, the EMA has stated that a request for “scientific advice” has been filed for Sputnik V, in order to prepare a possible application for marketing authorization.

She also confirmed that a meeting was held on January 19 to discuss an “additional commitment”.

– What are the Russians saying? –

Russian authorities boast of the adoption of the vaccine by around 30 countries as well as a study by the scientific journal The Lancet according to which Sputnik-V is 91.6% effective against symptomatic cases of Covid-19.

The developers and supporters of Sputnik V insist that a request for continuous review has been submitted.

The Russian sovereign wealth fund, which took part in the development of the vaccine, said Russian authorities “filed for registration” on January 19.

The fund also rejected “misguided” reports that after Sputnik’s Twitter account published an alleged registration filing, it turned out that it was sent to the wrong agency.

The fund insisted it was “working with the EMA to launch a continuous review” and said the agency had, a few days ago, “appointed rapporteurs for the Sputnik V dossier”.

– Is Sputnik treated the same as other vaccines? –

As this is the first vaccine developed by a non-Western country, rolled out in the European Union, senior officials said Sputnik production sites outside the EU should be inspected.

“They don’t produce in Europe, so of course there should be an inspection process at the production sites,” Ms von der Leyen said on February 17.

In the meantime, Brussels has been wary of Russian and Chinese vaccines, fearing that Moscow and Beijing will try to use it as a tool to extend their influence in the European Union:

Ms Von der Leyen herself wondered why Moscow is so keen to see the vaccine rolled out in the EU.

“Overall, I have to say that we still wonder why Russia is theoretically offering millions and millions of doses, without making enough progress in immunizing its own population,” she said.

burs-dk / amo / ob


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