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In EU First, Italian Factory to Produce Russia’s Sputnik V Vaccine

The EU’s medicines regulator, the European Medicines Agency (EMA), announced the start of its rolling review of Sputnik V last week. Tiziana Fabi / AFP

Russia has secured an agreement to produce its Sputnik V coronavirus vaccine in Italy, marking the first such deal for producing the vaccine in Europe, Bloomberg reported Tuesday. 

Similar talks are underway in France and Germany despite the vaccine not yet being approved for use within the 27-member bloc. The EU’s medicines regulator, the European Medicines Agency (EMA), announced the start of its rolling review of the vaccine last week.

Adienne Pharma & Biotech SA has agreed to manufacture the Russian vaccine at the Swiss firm’s production facility in the Milan region, founder and president Antonio Francesco Di Naro told Bloomberg.

Production is set to start as early as June, said Kirill Dmitriev, head of the state-run Russian Direct Investment Fund that backs Sputnik V’s development and marketing, with 10 million doses per year being produced under the agreement.

“We have a partnership in Germany. We’re talking to several French companies,” Dmitriev told Italy’s Rai3 television channel Sunday.  

Russia has already signed production agreements with countries including India, Brazil, China and South Korea. It has sought to bring Sputnik V to the EU market as the bloc struggled with its vaccination rollout due to a lack of supplies, saying it was ready to provide enough Sputnik V doses for 50 million Europeans as soon as it gets the green light as the first non-Western vaccine.

Hungary last month became the first EU member to approve the vaccine for national use ahead of EMA approval while Slovakia and the Czech Republic have also signaled they would also bypass EMA approval.

The EMA landed in hot water with Russia on Tuesday after one of its officials compared emergency national authorizations of Sputnik V to “Russian roulette.”  

Sputnik V was found to be 91.6% effective against the coronavirus in Phase 3 trial results published in The Lancet last month, a figure that helped dispel international skepticism toward the vaccine linked to its swift approval and rollout.

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