Why the European Union has not yet approved the Russian vaccine Sputnik V

Russian vaccine Sputnik V still awaiting green light from European Medicines Agency (EMA) in order to be implemented in the 27 Member States of the European Union.

Moscow and Brussels continue to clash over the alleged slowness of the Amsterdam-based European regulator.

Here are the arguments of the European Union and Russia:

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

According to the EMA, Sputnik V goes through the same decision-making process as all other COVID-19 vaccines. The first step is a “continuous review” of data and clinical trials. This is followed by a one-year formal conditional marketing authorization request.

“They have to submit all the data, go through the whole review process, just like any other vaccineEuropean Commission President Ursula von der Leyen said on Sputnik V on February 17th.

The time between the current review and the authorization so far it’s been between two and four months.

Currently, there are three vaccines licensed in the European Union: those of Pfizer-BioNTech, Moderna and AstraZeneca.

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

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

– What does the EMA say?

The European Medicines Agency insists that Sputnik V has not yet started the continuous review phase.

The agency has so far not received any requests for a review or marketing authorization for the Sputnik V vaccine, “despite information to the contrary,” the agency said in a “clarification” dated 10. February.

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

He also said that the EMA’s own experts “must first give their consent before the promoters can submit their request for access to the current review process”.

However, the EMA said that Sputnik V had submitted a request for “scientific advice” in order to prepare a possible application for marketing authorization.

He also confirmed that a meeting had taken place on January 19 to discuss a “complementary commitment”.

– What are the Russians saying?

Russian authorities boast that the vaccine has been adopted by around 30 countries, including Argentina and Mexico, and that a study published in the scientific journal The Lancet found that Sputnik V is 91.6% effective against symptomatic cases of COVID-19.

Sputnik V promoters and supporters insist that request for continuous review has been filed.

The Russian sovereign wealth fund, which participated in the development of the vaccine, said the Russian authorities “filed a registration request»January 19.

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

– Is Sputnik V treated the same as other vaccines?

Since this is the first vaccine developed by a non-Western country and implanted in the European Union, senior officials have said Sputnik V production sites outside the EU should be inspected.

“They do not produce in Europe, so of course there should be an inspection process at the production sites“Von der Leyen said on Feb. 17.

Meanwhile, Brussels has shown suspicion of Russian and Chinese vaccines, fearing that Moscow and Beijing will try to use them as a tool to expand their influence in the European Union.

“In general, I have to say that we keep asking ourselves why Russia, in theory, is offering millions and millions of doses without making enough progress in immunizing its own population,” said Von der Leyen.

(By Danny Kemp – AFP)

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