In announcing the agreement between Adienne Srl, Italian subsidiary of Lugano, Switzerland-based Adienne Pharma & Biotech, and the Russian Direct Investment Fund on Mar. 9, the chamber said the company would produce 10 million doses at Caponago, Lombardy, this year, starting in July.

This is believed to be the first contract agreed for EU-based production of the viral vector-based vaccine, which was developed by Russia’s Gamaleya and requires two doses. The chamber said Russian authorities are working on 20 collaborations in Europe, including France and Germany, while news agencies quoted the fund as naming India, South Korea, Brazil, China and Turkey, in addition to Belarus, Kazakhstan and possibly Iran, as potential production partners.

The EMA accepted Sputnik V for a rolling review at the beginning of March. As the European Commission currently does not plan to collectively purchase it for all 27 EU member states, national governments are free to cut their own deals.  It has already been approved or is being assessed for approval in Hungary, Slovakia and the Czech Republic. If at least four member countries request a particular vaccine, Brussels has said it could start negotiations.

Hungary is already administering the shots, even without EMA approval of the vaccine. Slovakia this week announced a deal to acquire 2 million doses and said it has already received the first shipment of 200,000 doses.

While Russia’s rollout of the vaccine in December 2020, before completion of Phase 3 trials, initially met with criticism, a preliminary review published in medical journal The Lancet said that Sputnik V is 91% effective and that it appears to prevent inoculated individuals from becoming severely ill with Covid-19. As yet it is unclear whether it can prevent spread of the virus or deal with variants. 

Christa Wirthumer-Hoche, chair of the EMA’s management board and head of the Austrian Medicines and Medical Devices Agency, has already raised Russian hackles for advising EU member states to be cautious.  On Austrian television, she said that approving Russian and Chinese vaccines via emergency national procedure without first examining data on the quality, safety and effectiveness of the shots would be “partly comparable with Russian roulette.” Moscow has demanded a public apology.

Speaking to Reuters, the EMA executive said, however, that data packages coming from Russian manufacturers will be reviewed according to European standards and “when everything is proven, the vaccine will also be authorized in the European Union.”

J&J dangles EU vaccine supply shortfall

Meanwhile, Europe’s slowly accelerating vaccination effort may hit yet another snag. The EMA is set to approve the Johnson & Johnson singe-dose viral vector-based candidate at its Mar. 11 meeting, but at the beginning of this week the US healthcare group signaled that it may be unable to meet its EU supply commitment.

J&J had promised to deliver 55 million doses to the EU during the second quarter, but according to Reuters the group has now informed European officials that it is “under stress” to meet the goal because of shortfalls in the supply of production materials. In a Mar. 5 statement, it said it would provide another update to the EU Commission and member states at the next meeting of the European Union Vaccine Steering Committee in mid-March.

Author: Dede Williams, Freelance Journalist