Italy to manufacture 10 million doses of Russia's 'Sputnik V' coronavirus vaccine in 2021

The Italy-Russia Chamber of Commerce on March 9 announced that Russia has signed a deal to produce its Sputnik V vaccine in Italy. According to AP, the deal, which is the first contract in the EU, was signed with Adienne Srl, the Italian subsidiary of a Swiss-based pharmaceutical company, and Kirill Dmitriev, CEO of the Russian Direct Investment Fund. Now, Sputnik-V will be produced in Italy’s Milan region and production of a planned 10 million doses this year is set to launch in July this year.

The Italy-Russia Chamber has not yet released the financial terms, however, they have said that the “innovative” production process will help create new jobs and allow Italy to control the entire production of the compound. While Sputnik V has not yet been approved for use in the EU, the Russian authorities, on the other hand, informed that they are working on 20 similar collaborations in Europe and the Sputnik V vaccine has been registered in 45 nations worldwide. 

Meanwhile, last week, the European Medicines Agency (EMA) announced the review procedure for the Sputnik-V vaccine for use in the bloc. However, even before the agency announced the review, a number of EU nations had already made independent decisions to approve the vaccine in their states, including Hungary and Slovakia. Italy's health minister, Roberto Speranza, has also indicated he is open to introducing the Russia-developed vaccine in Italy, as long as it has regulatory approval. 

EMA sounds scepticism 

The EMA, on the other hand, recently cautioned against the efficacy and safety of Russia’s Sputnik V coronavirus vaccine. In a statement to Austrian broadcaster ORF on March 7, the chair of the EMA warned the European Union (EU) nations about giving the emergency approval to the Russian manufactured jab questioning the data from the vaccine’s clinical trials. Suggesting that no emergency use authorisation should be given to Sputnik V unless the EMA completes the safety review, Christa Wirthumer-Hoche said that the jab’s safety was “unknown”.

EMA has repeatedly made claims about Russia’s Sputnik V being unsafe as even earlier, the medicinal agency issued a statement saying that there was uncertainty surrounding any scientific evidence that the jab was safe for public use.  “European Medicines Agency has to date not received an application for a rolling review or a marketing authorization for the vaccine developed by the Gamaleya National Centre of Epidemiology and Microbiology in Russia, the Sputnik V vaccine (Gam-COVID-Vac), despite reports stating the opposite,” the European agency said. It added that the EMA’s Human Medicines Committee (CHMP) and the COVID-19 EMA pandemic Task Force (COVID-ETF) needs to give their agreement after the rolling review process in order to authorize the vaccine. Sputnik V has been approved in Hungary, Slovakia, and the Czech Republic and Brussels might also start negotiations if at least 4 more EU nations demanded the purchase. 

(Image: AP)