MILAN (AP) – Russia has signed an agreement to produce its Sputnik V coronavirus vaccine in Italy, the European Union’s first contract, the Italian Chamber of Commerce in Russia announced on Tuesday.
The agreement was signed with Adienne Srl, the Italian subsidiary of a Swiss-based pharmaceutical company, and Kirill Dmitriev, CEO of the Russian Direct Investment Fund. Production of a 10 million dose planned for this year will be launched in July.
“The innovative production process will help create new jobs and allow Italy to control all compost production,” the chamber said in a statement. Financial conditions were not published.
Sputnik V has not yet been approved for use in the EU, but the body’s regulator, the European Medicines Agency, began an ongoing review of the vaccine last week.
Russian authorities are working on twenty 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 its slow deployment of vaccines 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 an agreement to acquire 2 million doses of Sputnik V and received the first shipment of 200,000 dose.
Despite skepticism about the rapid introduction of the vaccine by Russia, which was rolled out before completing the late-stage 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 people from developing serious COVID-19 disease, although it is not yet clear whether the vaccine can prevent the spread of COVID-19. disease.
With the global shortage of COVID-19 vaccines, some experts say increasing the use of vaccines manufactured by China and Russia could offer a faster way to increase global supply. Others point out that Russia’s drive to export its vaccine around the world may be driven by political interests.
An EMA official has warned European nations not to issue the national emergency permit for Sputnik V.
Christa Wirthumer-Hoche, chair of the EMA’s board of directors and head of the Austrian Agency for Medicines and Medical Devices, told Austrian television that EU members approving Russian and Chinese vaccines through national procedures are “partly comparable to Russian roulette”, citing the need to first examine data on the quality, safety and effectiveness of shots.
“Citizens have the right to obtain effective and safe medicines,” Wirthumer-Hoche added. “We may have Sputnik V on the market here in the future if we have examined the corresponding data.”
Wirthumer-Hoche’s statements provoked outrage in Russia. On Tuesday, Kremlin spokesman Dmitry Peskov called them “inappropriate” and vaccine developers apologized publicly to the official, saying his comments “raise serious questions about possible political interference in the EMA review. in progress”.
“The EMA did not allow claims about any other vaccine. These comments are inappropriate and undermine the credibility of the EMA and its review process. Vaccines and the EMA should be beyond politics, “Sputnik V’s official Twitter account said on Tuesday.
An EMA spokesman told The Associated Press in written comments that the agency “will assess Sputnik V’s compliance with EU standards and that any recommendation will be based on the strength of scientific evidence on safety , the quality and effectiveness of the vaccine, and nothing more. ”
The EU commission now has no plans for a collective purchase of Sputnik doses, but relies on offers already made with other vaccine manufacturers. But it has made it clear that member states have a right to reach separate agreements as long as they do not compete with the commission’s early purchase of 2 billion vaccines.
Italian Health Minister Roberto Speranza has indicated that he is open to introducing the vaccine developed by Russia in Italy, as long as it has regulatory approval. The new Italian Prime Minister, Mario Draghi, has pledged to speed up the vaccination campaign to dampen the spread of new variants that have once again put pressure on the Italian healthcare system. So far, only 2.85% of the Italian population has been completely vaccinated.
The Russian Direct Investment Fund that financed the vaccine and markets it abroad has said that production of Sputnik V will spread to several countries, including India, South Korea, Brazil, China, Turkey. , Belarus and Kazakhstan and possibly Iran.
Kazakhstan manufactured 90,000 doses of the vaccine last month, but there are few indications that a large number of vaccines have been produced outside of Russia so far.
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Litvinova contributed from Moscow. Samuel Petrequin contributed from Brussels. Geir Moulson contributed from Berlin.
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