MILAN (AP) – Russia has reached an agreement for the production of the Sputnik V coronavirus vaccine in Italy, the first contract in the European Union, the Russian-Italian Chamber of Commerce announced Tuesday.
The deal was signed with Adienne Srl, an Italian subsidiary of a Swiss-based pharmaceutical company, and Kirill Dmitriev, CEO of the Russian Direct Investment Fund. The planned production of 10 million doses this year is expected to be launched in July.
“The innovative production process will help create new jobs and allow Italy to control the entire production of the compost,” the chamber said in a statement. The financial terms were not disclosed.
Sputnik V has not yet been approved for use in the EU, but the agency’s regulator, the European Medicines Agency, started a continuous 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 worldwide, the chamber said.
The EU has been criticized for its slow release of the vaccine 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 announced an agreement last week to purchase 2 million doses of Sputnik V and received the first shipment of 200,000 doses.
Despite skepticism about the hasty introduction of the vaccine by Russia, which was launched before completing the final stage tests, 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 remains unclear whether the vaccine can prevent the disease from spreading.
With the global shortage of COVID-19 vaccines, some experts say that increasing the use of vaccines made by China and Russia could offer a faster way to increase global supply. Others note that Russia’s pressure to export its vaccine around the world may be motivated by political interests.
An EMA official warned European nations against issuing a national emergency authorization for Sputnik V.
Christa Wirthumer-Hoche, chairman of the EMA board of directors and head of the Austrian Medicines and Medical Devices Agency, said on Austrian television that EU members who approve Russian and Chinese vaccines through national emergency procedures are “partially comparable. To Russian roulette “, citing the need to first examine the data on the quality, safety and effectiveness of the shots.
“Citizens have the right to obtain really safe and effective medicines,” added Wirthumer-Hoche. “We can have Sputnik V on the market here in the future if we look at the corresponding data.”
Wirthumer-Hoche’s remarks provoked outrage in Russia. Kremlin spokesman Dmitry Peskov on Tuesday called them “inadequate”, and vaccine developers demanded a public apology from the official, saying his comments “raise serious questions about possible political interference in the review EMA in progress “.
“EMA did not allow such statements about any other vaccine. These comments are inappropriate and undermine the credibility of the EMA and its review process. Vaccines and EMA must be above and beyond politics, ”said Sputnik V’s official Twitter account on Tuesday.
An EMA spokesman told the Associated Press in written comments that the agency “will assess Sputnik V’s compliance with usual EU standards and any recommendation will be based on the strength of scientific evidence on the safety, quality and efficacy of the vaccine, and Nothing else. ”
The EU commission now has no plans for a collective purchase of doses of Sputnik, relying on agreements already made with other vaccine manufacturers. But he made it clear that member states have the right to reach separate agreements, as long as they do not compete with the commission’s advance purchases of 2 billion doses of vaccines.
Italy’s 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. Italy’s new prime minister, Mario Draghi, has promised to speed up the vaccination campaign to stem the spread of new variants that have put the Italian health system under pressure again. So far, only 2.85% of Italy’s population has been fully vaccinated.
The Russian Direct Investment Fund, which financed the vaccine and marketed it abroad, said Sputnik V production would cover several countries, including India, South Korea, Brazil, China, Turkey, as well as Belarus and Kazakhstan and possibly Will.
Kazakhstan manufactured 90,000 doses of the vaccine last month, but there is little evidence 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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