MILAN (AP) – Russia has signed an agreement to manufacture its Sputnik V coronavirus vaccine in Italy, the first contract in the European Union, the Italian Russian Chamber of Commerce announced on Tuesday.
The agreement was signed with Adienne Srl, the Italian subsidiary of a Swiss pharmaceutical company, and Kirill Dmitriev, CEO of the Russian Direct Investment Fund. Production of a planned 10 million doses will begin in July this year.
“The innovative production process will help create new jobs and enable Italy to control the entire production of the compound,” the chamber said in a statement. Financial terms were not disclosed.
Sputnik V has not yet been approved for use in the EU, but the body’s regulator, the European Medicines Agency, began its ongoing investigation into 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 worldwide, the chamber said.
The EU has been criticized for the slow explosion of vaccines, and some EU countries have decided not to wait for the EMA’s approval. Hungary became the first EU country to use Sputnik V for use last month, while Slovakia last week announced an agreement to acquire 2 million Sputnik V doses and receive the first shipment of 200,000 doses.
Despite the skepticism about Russia’s hasty launch of the vaccine, which was rolled out before late-stage trials were completed, the vaccine appears to be safe and effective. According to a study published in the Lancet, Sputnik V is 91% effective and prevents vaccines 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 believe that the use of vaccines made by China and Russia could be a faster way to increase global supply. Others note that Russia’s push to export its vaccine around the world could be driven by political interests.
An EMA official has warned European countries against issuing Sputnik V national emergency declaration
Christa Wirthumer-Hoche, chair of the EMA’s board of directors and head of the Austrian Agency for Medicines and Medical Devices, said on Austrian television that EU members approving Russian and Chinese vaccinations via national emergency procedures are ‘partially comparable to the Russian roulette ‘. the need to first examine data on the quality, safety and effectiveness of the shots.
“Citizens have the right to get really safe and effective medicinal products,” Wirthumer-Hoche added. “We could have Sputnik V on the market here in the future if we researched the corresponding data.”
Wirthumer-Hoche’s remarks provoked anger in Russia. Kremlin spokesman Dmitry Peskov called them “inappropriate” on Tuesday. Vaccine developers apologized to the official, saying her comments “raise serious questions about possible political interference in the ongoing EMA investigation.”
“EMA did not allow such statements about any other vaccine. Such remarks are inappropriate and undermine the credibility of the EMA and its review process. Vaccinations and EMA must be above and beyond politics, “Sputnik V’s official Twitter account said on Tuesday.
An EMA spokesman said in a written statement to The Associated Press that the agency would “assess the compliance of Sputnik V with the usual EU standards and make any recommendation based on the strength of the scientific evidence on safety”. , quality and efficacy of the vaccine, and nothing else. ”
The EU Commission does not now have plans for the collective purchase of Sputnik doses, but rather relies on transactions already made with other vaccine manufacturers. But it has made it clear that member states are entitled to separate agreements, provided they do not compete with the commission’s pre-purchases of 2 billion vaccine doses.
Italian Health Minister Roberto Speranza has indicated that he is open to the introduction of the vaccine developed in Russia in Italy, as long as it is approved. The new Prime Minister of Italy, Mario Draghi, has promised to speed up the vaccination campaign to curb the proliferation of new variants which in turn has put pressure on Italy’s health system. So far, only 2.85% of Italy’s population has been fully vaccinated.
The Russian Direct Investment Fund, which bankrolls the vaccine and markets it abroad, said production of Sputnik V would cover several countries, including India, South Korea, Brazil, China, Turkey, as well as Belarus, Kazakhstan and possibly Iran. .
Kazakhstan produced 90,000 doses of the vaccine last month, but there are few indications that large quantities of the 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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