Connect with us

coronavirus

Russia's Sputnik V could be made in Europe for first time after Italy deal signed

SHARE:

Published

on

We use your sign-up to provide content in ways you've consented to and to improve our understanding of you. You can unsubscribe at any time.

Russia’s Sputnik V vaccine against COVID-19 could be produced in Europe for the first time after a commercial deal to produce it in Italy was signed by the Moscow-based RDIF sovereign wealth fund and Swiss-based pharmaceutical company Adienne, write Andrew Osborn, Polina Nikolskaya and Gabrielle Tétrault-Farber.

The agreement, which will need approval from Italian regulators before production can be launched, has been confirmed by both RDIF and the Italian-Russian chamber of commerce.

It is the latest evidence that some EU members are not willing to wait for the EU’s own regulator - the European Medicines Agency (EMA) - to grant its approval to Sputnik V.

Advertisement

Scientists said the Russian vaccine was almost 92% effective, based on peer-reviewed late-stage trial results published in The Lancet medical journal last month.

Sputnik V has already been approved or is being assessed for approval in three EU member states - Hungary, Slovakia and the Czech Republic. EU officials have said Brussels could start negotiations with a vaccine maker if at least four member countries request it.

The Italian-Russian chamber of commerce said in a statement issued on Monday, a public holiday in Russia, that the move paved the way for the creation of the first Sputnik V production facility in Europe.

Advertisement

It said there were plans for Italian production to begin in June and that it hoped that 10 million doses of Sputnik V could be produced there by the end of the year.

“This agreement is the first of its kind with a European partner,” Vincenzo Trani, head of the chamber, said in the statement. “It can be called a historic event, which is proof of the good state of relations between our countries and shows that Italian companies can see beyond political differences.”

The Lugano-based Adienne Pharma & Biotech did not immediately respond to a request for comment.

Kirill Dmitriev, head of the RDIF sovereign wealth fund, which markets Sputnik V internationally, told Italy’s RAI 3 television channel on Sunday that many Italian regions were keen to produce the vaccine and that RDIF had struck an agreement with Adienne to produce Sputnik in Italy.

“...What we are offering is a true production partnership that will create jobs in Italy, and you can control the product, because it will be produced in Italy, and this product can not only save many lives in Italy, but it can be exported,” he said.

A senior European Medicines Agency (EMA) official urged European Union members last week to refrain from approving Sputnik V at the national level while the agency was still reviewing it, prompting the vaccine’s developers to demand a public apology.

coronavirus

US-EU agenda for beating the global pandemic: Vaccinating the world, saving lives now, and building back better health security

Published

on

Vaccination is the most effective response to the COVID pandemic. The United States and the EU are technological leaders in advanced vaccine platforms, given decades of investments in research and development.

It is vital that we aggressively pursue an agenda to vaccinate the world. Co-ordinated US and EU leadership will help expand supply, deliver in a more coordinated and efficient manner, and manage constraints to supply chains. This will showcase the force of a Transatlantic partnership in facilitating global vaccination while enabling more progress by multilateral and regional initiatives.

Building on the outcome of the May 2021 G20 Global Health Summit, the G7 and US-EU Summits in June, and on the upcoming G20 Summit, the US and the EU will expand cooperation for global action toward vaccinating the world, saving lives now, and building better health security.  

Advertisement

Pillar I: A Joint EU/US Vaccine Sharing Commitment: the United States and the EU will share doses globally to enhance vaccination rates, with a priority on sharing through COVAX and improving vaccination rates urgently in low and lower-middle income countries. The United States is donating over 1.1 billion doses, and the EU will donate over 500 million doses. This is in addition to the doses we have financed through COVAX.

We call for nations that are able to vaccinate their populations to double their dose-sharing commitments or to make meaningful contributions to vaccine readiness. They will place a premium on predictable and effective dose-sharing to maximize sustainability and minimize waste.

Pillar II: A Joint EU/US Commitment to Vaccine Readiness: the United States and the EU will both support and coordinate with relevant organisations for vaccine delivery, cold chain, logistics, and immunization programs to translate doses in vials into shots in arms. They will share lessons learned from dose sharing, including delivery via COVAX, and promote equitable distribution of vaccines.

Advertisement

Pillar III: A Joint EU/US partnership on bolstering global vaccine supply and therapeutics: the EU and the United States will leverage their newly launched Joint COVID-19 Manufacturing and Supply Chain Taskforce to support vaccine and therapeutic manufacturing and distribution and overcome supply chain challenges. Collaborative efforts, outlined below, will include monitoring global supply chains, assessing global demand against the supply of ingredients and production materials, and identifying and addressing in real time bottlenecks and other disruptive factors for global vaccine and therapeutics production, as well as coordinating potential solutions and initiatives to boost global production of vaccines, critical inputs, and ancillary supplies.

Pillar IV: A Joint EU/US Proposal to achieve Global Health Security. The United States and the EU will support the establishment of a Financial Intermediary Fund (FIF) by the end of 2021 and will support its sustainable capitalization.  The EU and United States will also support global pandemic surveillance, including the concept of a global pandemic radar. The EU and the United States, through HERA and the Department of Health and Human Services Biomedical Advanced Research and Development Authority, respectively, will cooperate in line with our G7 commitment to expedite the development of new vaccines and make recommendations on enhancing the world's capacity to deliver these vaccines in real time. 

We call on partners to join in establishing and financing the FIF to support to prepare countries for COVID-19 and future biological threats.

Pillar V: A Joint EU/US/Partners Roadmap for regional vaccine production. The EU and the United States will coordinate investments in regional manufacturing capacity with low and lower-middle income countries, as well as targeted efforts to enhance capacity for medical countermeasures under the Build Back and Better World infrastructure and the newly established Global Gateway partnership. The EU and the United States will align efforts to bolster local vaccine manufacturing capacity in Africa and forge ahead on discussions on expanding the production of COVID-19 vaccines and treatments and ensure their equitable access.

We call on partners to join in supporting coordinated investments to expand global and regional manufacturing, including for mRNA, viral vector, and/or protein subunit COVID-19 vaccines.

More information

Joint statement on the launch of the joint COVID-19 Manufacturing and Supply Chain Taskforce

Continue Reading

coronavirus

Coronavirus: 200th EU disinfection robot delivered to European hospital, a further 100 confirmed

Published

on

On 21 September, the Commission delivered the 200th disinfection robot – to Consorci Corporació Sanitària Parc Taulí hospital in Barcelona. The robots, donated by the Commission, help sanitize COVID-19 patient rooms and are part of the Commission's action to supply hospitals across the EU to help them cope with the effects of the coronavirus pandemic. Further to these initial 200 robots announced in November last year, the Commission secured the purchase an additional 100, bringing the total donations to 300.

A Europe fit for the Digital Age Executive Vice President for Margrethe Vestager, said: “Assisting member states overcome the challenges of the pandemic continues to be a number one priority and these donations – a very tangible form of support – are a prime example of what can be achieved. This is European solidarity in action and I am pleased to see the Commission can go the extra mile in donating an additional 100 disinfection robots to hospitals in need.”

Twenty-five disinfection robots have already been working night and day across Spain since February to help tackle the spread of the coronavirus. Nearly every EU Member State has now received at least one disinfection robot, which disinfects a standard patient room in under 15 minutes, alleviating hospital staff and offering them and their patients greater protection against potential infection. This action is made possible through the Emergency Support Instrument and the devices are supplied by Danish company UVD robots, which won an emergency procurement tender.

Advertisement

Continue Reading

coronavirus

Coronavirus: Commission signs contract for the supply of a monoclonal antibody treatment

Published

on

The Commission has signed a joint procurement framework contract with the pharmaceutical company Eli Lilly for the supply of a monoclonal antibody treatment for coronavirus patients. This marks the latest development in this first portfolio of five promising therapeutics announced by the Commission under the EU COVID-19 Therapeutics Strategy in June 2021. The medicine is currently under rolling review by the European Medicines Agency. 18 member states have signed up to the joint procurement for the purchase of up to 220,000 treatments.

Health and Food Safety Commissioner Stella Kyriakides said: “Over 73% of the EU adult population is now fully vaccinated, and this rate will still increase. But vaccines cannot be our only response to COVID-19. People still continue to be infected and fall ill. We need to continue our work to prevent illness with vaccines and at the same time ensure that we can treat it with therapeutics. With today's signature, we conclude our third procurement and deliver on our commitment under the EU Therapeutics Strategy to facilitate access to state-of-the-art medicines for COVID-19 patients.”

While vaccination remains the strongest asset both against the virus and its variants, therapeutics play a critical role in the COVID-19 response. They help to save lives, speed up recovery time, reduce the length of hospitalisation and ultimately ease the burden of health care systems.

Advertisement

The product from Eli Lilly is a combination of two monoclonal antibodies (bamlanivimab and etesevimab) for the treatment of coronavirus patients who do not require oxygen but are at high risk of severe COVID-19. Monoclonal antibodies are proteins conceived in the laboratory that mimic the immune system's ability to fight the coronavirus. They fuse to the spike protein and thus block the virus's attachment to the human cells.

Under the EU Joint Procurement Agreement, the European Commission has concluded until now nearly 200 contracts for different medical countermeasures with a cumulative value of over €12 billion. Under the joint procurement framework contract concluded with Eli Lilly, member states can purchase the combination product bamlanivimab and etesevimab if and when needed, once it has received either a conditional marketing authorisation at EU level from the European Medicines Agency or an emergency use authorisation in the member state concerned.

Background

Advertisement

Today's joint procurement contract follows the contract signed with Roche for the product REGN-COV2, a combination of Casirivimab and Imdevimab, on 31 March 2021 and the contract with Glaxo Smith Kline on 27 July 2021 for the supply of sotrovimab (VIR-7831), developed in collaboration with VIR biotechnology.

The EU Strategy on COVID-19 Therapeutics, adopted on 6 May 2021, aims to build a broad portfolio of COVID-19 therapeutics with the goal of having three new therapeutics available by October 2021 and possibly two more by the end of the year. It covers the full lifecycle of medicines from research, development, selection of promising candidates, fast regulatory approval, manufacturing and deployment to final use. It will also coordinate, scale-up and ensure that the EU acts together in ensuring access to therapeutics via joint procurements.

The Strategy forms part of a strong European Health Union, using a coordinated EU approach to better protect the health of our citizens, equip the EU and its Member States to better prevent and address future pandemics, and improve resilience of Europe's health systems. Focusing on the treatment of patients with COVID-19, the Strategy works alongside the successful EU Vaccines Strategy, through which safe and effective vaccines against COVID-19 have been authorised for use in the EU to prevent and reduce transmission of cases, as well as hospitalisation rates and deaths caused by the disease.

On 29 June 2021, the strategy delivered its first outcome, with the announcement of five candidate therapeutics that could soon be available to treat patients across the EU. The five products are in an advanced stage of development and have a high potential to be among the three new COVID-19 therapeutics to receive authorization by October 2021, the target set under the strategy, provided the final data demonstrate their safety, quality and efficacy.

Global co-operation on therapeutics is crucial and a key component of our strategy. The Commission is committed to working together with international partners on COVID-19 therapeutics and make them available globally. The Commission is also exploring how to support the enabling environment for manufacturing health products, while strengthening research capacity in partner countries around the globe.

More information

EU Therapeutics Strategy

Coronavirus response

Safe COVID-19 vaccines for Europeans

Continue Reading
Advertisement
Advertisement
Advertisement

Trending