MILAN (AP) – Russia has signed a deal to produce its Sputnik V coronavirus vaccine in Italy, the first contract in the European Union, the Italian Russian Chamber of Commerce announced on Tuesday.
The deal was signed with Adienne Srl, the Italian subsidiary of a Switzerland-based pharmaceutical company, and Kirill Dmitriev, CEO of the Russian Direct Investment Fund. Production of a planned 10 million doses this year will be launched in July.
“The innovative manufacturing process will help create new jobs and allow Italy to control the entire production of the compound,” the chamber said in a statement. Financial terms have not been released.
Sputnik V is not yet approved for use in the EU, but the body’s regulator, the European Medicines Agency, started an ongoing review of the vaccine last week.
The Russian authorities are working on 20 similar collaborations in Europe, and the Sputnik V vaccine has been registered in 45 countries around the world, the chamber said.
The EU has been criticized for slow vaccine roll-out and some EU countries have decided not to wait for EMA approval. Hungary became the first EU country to authorize the use of Sputnik V last month, while Slovakia last week announced a deal to acquire 2 million doses of Sputnik V and received the first shipment of 200,000 doses.
Despite skepticism about Russia’s hasty introduction of the vaccine, which was rolled out before it completed the final stages of trials, the vaccine appears to be safe and effective. According to a study published in The Lancet, Sputnik V is 91% effective and appears to prevent inoculated individuals from becoming seriously ill with COVID-19, although it is still unclear whether the vaccine can prevent the spread of the disease.
With a global shortage of COVID-19 vaccines, some experts say boosting vaccine use from China and Russia could provide a faster way to increase global supply. Others note that Russia’s push to export its vaccine around the world may be driven by political interests.
An EMA official has warned European countries against issuing a national emergency permit for Sputnik V.
Christa Wirthumer-Hoche, the chair of the EMA’s board and head of the Austrian Medicines and Medical Devices Agency, said on Austrian television that EU members approving Russian and Chinese vaccines through national emergency procedures are “ partially comparable. with Russian roulette ‘, citing the need to first research data on the quality, safety and effectiveness of the shots.
“Citizens are entitled to truly safe and effective medicines,” added Wirthumer-Hoche. “We may have Sputnik V on the market here in the future if we have researched the corresponding data.”
Wirthumer-Hoche’s comments caused outrage in Russia. Kremlin spokesman Dmitry Peskov called them “inappropriate” on Tuesday, and the developers of the vaccine demanded a public apology from the official, saying her comments “raise serious questions about possible political interference in the ongoing EMA review. “
“EMA did not allow such statements about any other vaccine. Such comments are inappropriate and undermine the credibility of the EMA and its review process. Vaccines and EMA must go beyond politics, ”Sputnik V’s official Twitter account said Tuesday.
An EMA spokesperson told The Associated Press in written comments that the agency “will assess Sputnik V’s compliance with usual EU standards and that any recommendation will be based on the strength of the scientific evidence regarding safety, quality and efficacy. of the vaccine, and nothing else. ”
The EU commission now has no plans for a collective purchase of Sputnik doses, but is instead relying on deals already made with other vaccine manufacturers. But it has made it clear that member states have the right to enter into separate agreements as long as they do not compete with the commission’s advance purchases of 2 billion vaccine doses.
Italian Health Minister Roberto Speranza has indicated that he is open to the introduction of the Russian-developed vaccine in Italy, as long as it has regulatory approval. Italy’s new Prime Minister Mario Draghi has pledged to speed up the vaccination campaign to dampen the spread of new variants that have put further pressure on the Italian health system. Only 2.85% of the Italian population has been fully vaccinated so far.
The Russian Direct Investment Fund that funded the vaccine and marketed it abroad has said production of Sputnik V will include several countries, including India, South Korea, Brazil, China, Turkey, as well as Belarus and Kazakhstan and possibly Iran.
Kazakhstan produced 90,000 doses of the vaccine last month, but there is little evidence to suggest that large quantities of the vaccine have been produced outside of Russia so far.
Litvinova contributed from Moscow. Samuel Petrequin contributed from Brussels. Geir Moulson contributed from Berlin.
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