Russia to make Sputnik V vaccine in Italy, a first in EU

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, or EMA, 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.

France's government has had regular exchanges about Sputnik V, but the country now doesn't have a production site available that would meet the necessary requests so no contract has been signed so far to produce the vaccine in France, according to a French Industry Ministry official.

The official reiterated France's position that the government isn't choosing vaccines because of their country of origin, but based on whether they are effective and safe and approved by the EMA.

Russian President Vladimir Putin began a dialogue about the Sputnik V vaccine with French President Emmanuel Macron in autumn, and Paris sent a delegation of experts to Russia to conduct talks about the vaccine and advise how to handle discussions with the World Health Organization and the EMA, according to a French official who spoke on customary condition of anonymity.

Despite scepticism 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 in the Lancet, Sputnik V is 91 per cent 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.

An EMA official has warned European nations against issuing national emergency clearance of Sputnik V.

Christa Wirthumer-Hoche, the chair of the EMA's management board and the head of the Austrian Medicines and Medical Devices Agency, said on Austrian television that EU members approving Russian and Chinese vaccines via emergency national procedures is “partly comparable with Russian roulette,” citing the need to first examine data on the quality, safety and effectiveness of the shots.

“Citizens have a right to get really safe and effective medicinal products,” Wirthumer-Hoche added. “We can have Sputnik V on the market here in the future if we have examined the corresponding data.”

Wirthumer-Hoche's remarks elicited outrage in Russia. Kremlin spokesman Dmitry Peskov on Tuesday called them “inappropriate," and developers of the vaccine demanded a public apology from the official, saying that her comments “raise serious questions about possible political interference in the ongoing EMA review.”

“EMA did not allow such statements about any other vaccine. Such comments are inappropriate and undermine credibility of EMA and its review process. Vaccines and EMA should be above and beyond politics,” Sputnik V's official Twitter account said Tuesday.

An EMA spokesperson told The Associated Press in written comments that the agency “will assess Sputnik V's compliance with the usual EU standards and any recommendation will be based on the strength of the scientific evidence on the vaccine's safety, quality and efficacy, and nothing else.”

The EU commission does not now have plans for the collective purchase of Sputnik doses, relying instead on deals already made with other vaccine 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 purchases of 2 billion vaccine 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 that have again put Italy's health system under pressure. So far, just 2.85 per cent of Italy's population has been fully vaccinated.

The Russian Direct Investment Fund that bankrolled the vaccine and markets it abroad has said the production of Sputnik V 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 the vaccine last month but there are few indications any large amounts of the vaccine have been produced outside of Russia so far.