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EU medicines regulator scrutinizes Russia's Sputnik vaccine

March 23, 2021

The European Medicines Agency plans to inspect the Sputnik V vaccine production facility to see if it can be authorized in the EU.

A man receives a dose of Sputnik V (Gam-COVID-Vac) vaccine against the coronavirus disease
A man receives a dose of Sputnik V vaccine against the coronavirus disease on board a medical trainImage: Evgeny Kozyrev/REUTERS

The head of the EU's medicines regulator on Tuesday said the agency would visit the Sputnik V production and clinical facilities as it decides whether to authorize the vaccine for the bloc.

Developers of the vaccine say they have production deals with in firms Italy, France, Spain and Germany, as the EU seeks to jump start its sluggish vaccination program.

What the EMA said

The head of the EMA, Emer Cooke, said she hoped the Sputnik V vaccine would receive approval, and that the agency would visit Russia to find out more about production. 

"We do hope that this will be a valuable vaccine to add to the vaccines that were available to the European population."

"We are in the process of organizing inspections ," Cooke, who emphasized the importance of production capacity at the current stage of the pandemic, told a meeting of the European Parliament's parliamentary health committee.

In response to concerns that EMA approvals were taking too long, Cooke said the possibility of emergency approval for vaccines did exist. However, she said this was at the member state level, rather than the Europe-wide level.

Sputnik V raises hopes in Moscow

"I take this opportunity to stress again that we are committed to applying the same standards and scrutiny to this review as to any other scientific assessments," she said.

Cooke also said the EMA was also in discussions with Chinese state pharmaceutical group Sinopharm about the evaluation of its COVID-19 vaccine.

Sputnik review already underway

The EMA launched a review of Sputnik V earlier this month, although some EU countries have already begun using it.

If it is approved, Sputnik would be the first non-Western coronavirus jab to be certified for use across the 27-nation bloc.

While Sputnik says it has contracts in place for future production of the vaccine in the EU, it remains unclear how concrete these agreements are.

Earlier this month, the team behind Russia's coronavirus vaccine demanded an apology from the EMA after a senior official compared emergency rollouts of the jab to "Russian roulette." EU member Hungary has already has jumped ahead and granted emergency authorization to the Russian vaccine.

German call for more vaccines

Regional leaders in Germany last week urged the EU to accelerate its review of the Sputnik vaccine.

"It's important to accelerate approval procedures, especially in the case of Sputnik," said Bavarian premier Markus Söder, speaking after Germany's 16 state leaders held talks with European Commission president Ursula von der Leyen.

Söder claimed the vaccine's approval was now "only a matter of time", and that it was more important that the EU struck deals to secure production and supply. "In some cases better than vaccines which have already been approved," he said.

"If it's the case that production is difficult with Sputnik, then there could be an offer to produce it here in Germany," he added.

Richard Connor Reporting on stories from around the world, with a particular focus on Europe — especially Germany.
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