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Sputnik V: Why hasn't the EU approved Russia's COVID vaccine yet?

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A health worker shows a box of the Russian vaccine Sputnik V at Szent Janos Hospital in Budapest, Hungary.
A health worker shows a box of the Russian vaccine Sputnik V at Szent Janos Hospital in Budapest, Hungary.   -   Copyright  Zsolt Szigetvary/MTI via AP
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The Russian coronavirus vaccine Sputnik V is still waiting for the green light from the European Medicines Agency (EMA) before it can be deployed in all 27 EU member states.

So far, the vaccine has only been rolled out in Hungary after prime minister Viktor Orbán, criticising the EU for potentially endangering lives, gave it a six-month emergency use authorisation.

It has also been deployed in non-EU European countries, including Serbia and Bosnia-Herzegovina. In all, Russian authorities say that the vaccine has been adopted by 31 countries.

While a study by the scientific journal The Lancet has shown that Sputnik V is 91.6 per cent effective against symptomatic cases of COVID-19, Moscow and Brussels continue to clash over the alleged slowness of the Amsterdam-based European regulator.

So, why is it taking so long to approve its use?

EU 'committed to ensuring data submitted in full'

According to the EMA, Sputnik V is subject to the same decision-making process as all other COVID-19 vaccines - but the issue being that the full data sets have been yet to be seen to move the lengthy process along.

The first step is a "continuous review" of data and clinical trials. A formal application for a one-year conditional marketing authorisation must follow afterward.

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

The time elapsed between the continuous review and authorisation has so far been between two and four months.

At present, three vaccines are authorised in the EU: those of Pfizer-BioNTech, Moderna and AstraZeneca. A fourth, from Johnson & Johnson, is subject to an application for authorisation. Two others, those of Novavax and CureVac, have started their continuous review process.

The EMA insists that Sputnik V has not even started the continuous review phase yet and has indicated that it so far hasn't received any applications for continuing review or marketing authorisation for the vaccine, "despite reports to the contrary", it said in a "clarification" on February 10.

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

It also said that the EMA experts themselves "must first give their agreement before developers can submit their request for access to the ongoing review process".

The EMA said, however, that a request for a "scientific opinion" had been filed for Sputnik V in order to prepare a possible marketing authorisation application.

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

Disputed claims and distrust

The Russian sovereign wealth fund, which was involved in the development of the vaccine, said that the Russian authorities "filed an application for registration" on January 19.

The fund also rejected "misdirected" reports that the vaccine's developers had sent documentation to the wrong agency, something it disputed by publishing a letter from the EMA on its Twitter account.

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

As this is the first vaccine developed by a non-Western country to be deployed in the EU, senior officials said Sputnik's production sites outside the EU should also be inspected.

"They don't produce in Europe, so of course there should be an inspection process at the production sites," said von der Leyen.

Meanwhile, Brussels has been wary of Russian and Chinese vaccines, fearing that Moscow and Beijing might try to use them as a tool to extend their influence in the EU.

Von der Leyen herself questioned why Moscow is so keen to roll out the vaccine in the EU.

"Overall, I have to say that we are still wondering why Russia, in theory, is offering millions and millions of doses, but not making enough progress in vaccinating its own population," she said.

The Russians have been quick to counter this, instead blasting what they called "political vaccine nationalists in the West" for not approving vaccines from Russia or China.

In a thread on Twitter, the vaccine's developers posted: "The world needs Russian, Chinese, Western vaccines. COVAX, run by UK and US, should be more inclusive and include Russian and Chinese vaccines. Political biases and narrow minds make us weaker. Together we are stronger!"