MILAN (AP) – Russia has signed an agreement for the production of its Sputnik V coronavirus vaccine in Italy, the first contract in the European Union, the Italian Chamber of Commerce announced on Tuesday.
The agreement was signed with Adienne Srl, the Italian subsidiary of a Swiss pharmaceutical company, and with Kirill Dmitriev, CEO of the Russian Direct Investment Fund. Production of 10 million doses planned this year will begin in July.
“The innovative production process will help create new jobs and allow Italy to control the entire production of the complex,” the chamber said in a statement. The financial terms have not been released.
Sputnik V has not yet been approved for use in the EU, but the body’s regulatory body, the European Medicines Agency, began an ongoing review of the vaccine last week.
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 the slow release 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 purchase 2 million doses of Sputnik V and received its first shipment of 200,000 doses.
Despite skepticism about Russia’s hasty introduction of the vaccine, which was launched before the end of studies at a late stage, 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 becoming seriously ill with COVID-19, although it is not yet clear whether the vaccine can prevent the spread of the disease.
With a global shortage of COVID-19 vaccines, some experts say intensifying the use of vaccines produced by China and Russia could provide a faster way to increase global supply. Others note that Russia’s efforts to export its vaccine worldwide may be driven by political interests.
An EMA official has warned European nations against issuing Sputnik V’s national emergency permit.
Christa Wirthumer-Hoche, chairman of the EMA board and head of the Austrian Agency for Medicines and Medical Devices, told Austrian television that EU members approving Russian and Chinese vaccines through national emergency procedures are “partially comparable to Russian roulette”, citing the need to first examine data on the quality, safety and effectiveness of photographs.
“Citizens have the right to get really safe and effective medicines,” Wirthumer-Hoche added. “We may have Sputnik V on the market here in the future if we look at the data.”
Wirthumer-Hoche’s comments provoked outrage in Russia. Kremlin spokesman Dmitry Peskov called them “inappropriate” on Tuesday, and vaccine developers apologized publicly to the official, saying his comments “raise serious questions about possible political interference in the ongoing review of the EMA.”
“The EMA has not allowed such claims about any other vaccine. Such comments are inappropriate and undermine the credibility of the EMA and its review process. Vaccines and 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 standard EU standards and any recommendations will be based on the strength of scientific evidence on vaccine safety, quality and efficacy and nothing else.” ”
The EU Commission now has no plans for a collective purchase of doses of Sputnik, instead relying on offers already made with other vaccine manufacturers. But he made it clear that Member States are entitled to reach separate agreements as long as they do not compete with the Commission’s anticipated purchases of 2 billion doses of vaccine.
Italian Health Minister Roberto Speranza said he was open to introducing 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 reduce the spread of new options that have put pressure on Italy’s health care system again. So far, only 2.85% of Italy’s population has been completely vaccinated.
The Russian direct investment fund, which has funded the vaccine and sells it abroad, said Sputnik V production will span several countries, including India, South Korea, Brazil, China, Turkey, as well as Belarus and Kazakhstan, and possibly Iran.
Kazakhstan manufactured 90,000 doses of vaccine last month, but there is little indication that large quantities of vaccine have been produced outside 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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