Russia to make Sputnik V vaccine in Italy; a first in European Union

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 Tuesday.

The deal 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 planned 10 million doses this year is set to launch in July.

The innovative production 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 were not released.

Sputnik V has not yet been approved for use in the EU, but the body's regulator, the European Medicines Agency, started a rolling 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 nations worldwide, the chamber said.

The EU has been criticized for its slow vaccine rollout and some EU nations have decided not to wait for the EMA's approval. Hungary became the first EU country to authorize Sputnik V for use last month while Slovakia announced a deal last week to acquire 2 million Sputnik V doses 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 had completed late-stage trials, the vaccine appears to be safe and effective. According to a study published last month in the journal Lancet, Sputnik V is 91% effective and appears to prevent inoculated individuals from becoming severely ill with COVID-19, although it's still unclear if the vaccine can prevent the spread of the disease.

With a global shortage of COVID-19 vaccines, some experts say boosting the use of vaccines made by China and Russia could offer a quicker way to increase the global supply. Others note that Russia's push to export its vaccine around the world may be driven by political interests.

The EU commission does not at this stage have plans for a collective purchase of Sputnik doses, relying instead on deals already made with other manufacturers. But it has made clear that member states are entitled to reach separate agreements as long as they don't compete with the commission's advance purchase agreements for 2 billion doses.

Italy's health minister, Roberto Speranza, has indicated he is open to introducing the Russia-developed vaccine in Italy, as long as it has regulatory approval. Italy's new premier, Mario Draghi, has pledged to accelerate the vaccination campaign to dampen the spread of new variants which have again put the health system under pressure. So far, just 2.85% of Italy's population has been fully vaccinated.

The Russian Direct Investment Fund that bankrolled the vaccine and markets it abroad has said that the production of Sputnik V will span several countries, including India, South Korea, Brazil, China, Turkey, Iran, as well as Belarus and Kazakhstan. Some manufacturers abroad have produced trial batches of the Russian vaccine, but there are few indications they have so far produced any large amounts of the shot.