Written by Martin Lynch, European News Editor for Industrial Info (Galway, Ireland)--Russia's COVID-19 vaccine, Sputnik V, will be produced for the first time in Europe at a manufacturing facility in Italy.

The deal has been confirmed by Russia's sovereign wealth fund, Russian Direct Investment Fund (RDIF) and the Italian-Russian Chamber of Commerce, just over a week after the European Medicines Agency (EMA) began a rolling review of Sputnik V to assess its efficacy. Swiss-based Adienne Pharma & Biotech SA has signed an agreement to make the vaccine at its production facility near Milan in the Lombardy region of Italy. It estimates that it will be able to begin production in July and produce 10 million doses by the end of the year. It is the first European production deal struck for the vaccine, which already has been approved by 43 countries, but not by the European Union (EU) nor the U.S. RDIF claimed that it is also in talks with manufacturers in France and Germany but no details were revealed. The Sputnik V vaccine comes at a time when political relations between the EU and Russia remain tense with a number of EU Member States expressing concern over the validity of Sputnik's clinical trials data.

Rolling reviews are already underway by the EMA on rival vaccine candidates from Johnson & Johnson, Novavax and CureVac, and decisions on those are expected first. The EMA has approved three COVID-19 vaccines to date from Pfizer/BioNTech, Moderna and AstraZeneca.

"We welcome the start of the rolling review procedure by EMA of Sputnik V," said Kirill Dmitriev, chief executive officer of the Russian Direct Investment Fund. "We have provided EMA with comprehensive data on the Russian vaccine, which is now approved for use in more than 40 countries. Sputnik V can make an important contribution to saving millions of lives in Europe, and we are looking forward to a thorough review of data by CHMP. Vaccine partnerships should be above politics and cooperation, with EMA as a perfect example demonstrating that pooling efforts is the only way to end the pandemic. Following EMA approval, we would be able to provide a vaccine for 50 million Europeans starting from June 2021."

In related news, Germany's CureVac has inked a deal with Novartis to boost capacity of its COVID-19 vaccine candidate, CVnCoV, by 50 million doses in 2021 and by up 200 million doses in 2022. Novartis has agreed to manufacture the mRNA and bulk drug product of the CVnCoV vaccine candidate at its Kundl plant in Austria.

Steffen Lang, Global Head of Novartis Technical Operations, said: "We feel it is our responsibility to do everything in our power to help and we are pleased to announce our collaboration with CureVac. At the Kundl site, Novartis is a pioneer and has decades of experience in pharmaceutical production of proteins and in more recent years of nucleic acids. We are currently expanding our site with additional capacities for the production of mRNA in order to best serve the increasing demand."

CureVac also has manufacturing deals with Bayer, Fareva, Wacker and Rentschler, among others. For additional information, see January 26, 2021, article--CureVac Taps Bayer to Ramp Up COVID-19 Vaccine Rollout.



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