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EU begins approval process for 50m doses of Russian vaccine

The European Medicines Agency has said it should take ‘less time than normal’ to evaluate the Sputnik V vaccine, which has shown a 91.6% effectiveness rate

5 March 2021
A person wearing surgical gloves holds up a bottle of the Russian vaccine Sputnik V. EU begins approval process for 50m doses of Russian vaccineThe European Medicines Agency is beginning the approval process for the Russian vaccine, Sputnik V
By Hannah Thompson

The EU has begun to evaluate the Russian vaccine Sputnik V, as Russia says it will be ready to distribute 50 million doses in Europe from June, and the EU and France seek to speed up rollout.

The European Medicines Agency (EMA) has begun the process of examining the vaccine for safety. 

Usually, the time between evaluation and eventual approval usually takes between two and four months, but the EMA has said that in this case, approval should “take less time than normal”, as some preparation work has already been completed.

Approval of the new vaccine has been heralded by some as a way to speed up the vaccination campaigns across Europe - including in France - with the provision of extra doses.

In a statement, Kirill Dmitriev, CEO of Russian sovereign health fund the Russian Direct Investment Fund, which contributed to the vaccine’s development, said: “Sputnik V can make a significant contribution to saving millions of lives in Europe.

“Vaccination partners must detach themselves from politics, and the cooperation of the EMA is a perfect example of the fact that combining our efforts is the only way to end this pandemic.”

Over the past few weeks, there has been some tension between the developers of Sputnik V and the EMA, after Russia said that it had submitted its file for approval, but the EMA said it had not received it.

This now appears to have been resolved.

Similarly, the Russian vaccine was seen with initial scepticism by the West, but trust in the jab has been rising steadily since respected British journal The Lancet published results showing that Sputnik V has a 91.6% effectiveness rate against symptomatic forms of the virus.

Currently, three vaccines are approved for use in the EU - Pfizer/BioNTech, Moderna, and AstraZeneca.

The manufacturer of a fourth, Johnson & Johnson, has submitted its authorisation request; while the Novavax and CureVac jabs are currently under examination.

 

‘All EU citizens vaccinated by the end of summer’

It comes as the EU states it is aiming to vaccinate all member Europeans by the end of the summer.

Thierry Breton, European Commissioner for Internal Market, said on March 4: “It is an enormous challenge but we have reacted very quickly.”

Mr Breton is in charge of managing the industrial manufacturing of the Covid vaccines in Europe.

He said: “I have extremely high confidence that Europe has the capacity to deliver vaccines more quickly, and I think that by the end of the summer, we will be able to vaccinate all European citizens.”

He said that by the end of the year, Europe would be able to produce two billion to three billion vaccine doses per year.

He said: “Europe is the leading continent when it comes to producing vaccines; in second place are the United States with two billion. Between the EU and the US, we will be able to count on five billion vaccines per year for the entire world.”

Mr Breton was speaking in Rome, after the new Italian Prime Minister Mario Draghi asked European Commission President Ursula von der Leyen for a “more rapid” response to the pandemic, “especially when it comes to vaccines”.

Several EU members have criticised the bloc for what they say are slow delivery speeds and rollout of the vaccines across member states.

Related stories

France aims to vaccinate 30 million by summer, says PM

France Covid-19 vaccine campaign calendar

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