With which companies have you concluded COVID-19 vaccine agreements?
The Commission is negotiating intensely to build a diversified portfolio of vaccines for EU citizens at fair prices. Contracts have been concluded with AstraZeneca (400 million doses), Sanofi-GSK (300 million doses), Johnson and Johnson (400 million doses ), BioNTech-Pfizer 300 million doses, CureVac (405 million doses) and Moderna (160 million doses). The Commission has concluded exploratory talks with the pharmaceutical company Novavax with a view to purchasing up to 200 million doses.
This means that the Commission has secured a portfolio of more than 2 billion doses. For the Commission it was important from the beginning to build a diversified portfolio of vaccines based on different technologies, to increase the chances that one or more of the vaccine candidates are approved by EMA. Should all vaccines candidates turn out to be safe and effective, Member States have the possibility to donate part of their doses to lower and middle income countries.
Which vaccine is now authorised?
The Commission has given on 21 December the conditional marketing authorisation for the vaccine developed by BioNTech and Pfizer, following EMA positive assessment of its safety and efficacy. It is now waiting for EMA’s opinion on the possible conditional marketing authorisation for the vaccine by Moderna, which should be provided by 6 January at the latest.
No other vaccine producer has formally applied for a marketing authorisation to EMA. In order to accelerate the process, EMA has started rolling reviews on the vaccines produced by Johnson and Johnson and AstraZeneca.
How will vaccines be monitored post authorisation under the Conditional Marketing Authorisation (CMA)?
The monitoring of the safety and effectiveness of vaccines after authorisation is a requirement under EU law and a cornerstone of the EU’s pharmacovigilance system relating to the detection, assessment, understanding and prevention of adverse effects or any other medicine-related problem. The system is exactly the same than for a normal market authorisation.
The safety and effectiveness of vaccines which have received conditional marketing authorisations are rigorously monitored, as for all medicines, through the EU’s established medicines monitoring system.
In addition, special measures are in place to quickly collect and evaluate new information. For example, manufacturers must usually send a safety report to the European Medicines Agency every six months. For COVID-19 vaccines, safety reports must be sent every month.
The European Medicines Agency will set up additional large-scale safety monitoring given the exceptionally high numbers of people expected to receive the vaccines.
Once authorised, when will vaccines be available in the EU?
In line with the EU vaccine strategy agreed with Member States, once authorised and produced, each vaccine will be available to Member States at the same time and at the same conditions.
The distribution will start progressively. This means that in the first few months, there will not be enough doses available to vaccinate all adults. The first doses will go to the priority groups identified by Member States (e.g. healthcare professionals, persons over 60 years of age). Supplies will increase over time, and all adults should be able to get vaccinated during the course of 2021.
For most contracts concluded, the majority of delivery is foreseen to be completed in 2021. Under some contracts, first deliveries are expected to already start in the first quarter of 2021.
First deliveries of the BioNTech and Pfizer vaccine are expected within days of authorisation and first vaccinations would take place in the context of the EU vaccination days of 27-29 December.
The Commission has been asking national authorities to prepare as early as possible for organising the fast and accessible deployment of vaccines, according to national vaccination plans and has issued guidance on the large-scale vaccination deployment.
The Commission is following the developments of national vaccination plans very closely and provides support notably by organising joint procurement for vaccination supplies, such as syringes and needles, and running a stress test of the national vaccination plans ahead of deployment together with the ECDC.
Will the EU have enough capacity to manufacture the COVID vaccines?
There is already substantial vaccine production capacity in the EU – and the Commission is working intensively to increase it. In addition, and in order to ensure that vaccine developers have the necessary capacity to scale up the production of COVID-19 vaccines as soon as they have been approved by the EMA, the Commission supports the necessary investment in the development of such production capacities.
How will logistics work? How will vaccines be distributed?
Logistics and transportation is a key aspect on which all Member States have to work, as emphasised in the Communication on preparedness for COVID-19 vaccination strategies and vaccine deployment of 15 October.
Delivery to national distribution hub(s) will be ensured by the manufacturers.
Further distribution to vaccination centres will be ensured by Member States, who will also be responsible for the vaccination of their population.
Who should be vaccinated first?
All Member States will have access to COVID-19 vaccines at the same time on the basis of the size of their population. The overall number of vaccine doses will however be limited during the initial stages of deployment and before production can be ramped up. The Commission has therefore provided examples of unranked priority groups to be considered by countries once COVID-19 vaccines become available.
Most countries have defined priority groups and are further refining who should get priority in these priority groups e.g. older person over 80 years of age. The ECDC published an overview of where EU/EEA countries and the UK are with the development of their vaccination plans/strategies. ECDC is also working on a modelling exercise on prioritisation to support Member States. This report should be published before Christmas.
Will citizens know which vaccine they will be getting?
When vaccines receive conditional marketing authorisation, the package leaflet with details on the specific vaccine will be translated into all languages and published in electronic form by the Commission.
All health care professionals and all patients would therefore have access to a leaflet in electronic form in their own languages.
The vaccine companies are responsible for putting in place the necessary mechanisms to ensure that each patient receives the package leaflet in print form in his/her language upon request without burdening healthcare professionals administering the vaccine.
What labelling and packaging information will citizens and health care professionals get with the COVID-19 vaccines?
In order to allow for a rapid deployment of COVID-19 vaccines at large scale, the Commission has developed, with Member States and the European Medicines Agency, labelling and packaging flexibilities for a temporary period. Flexibility in the labelling and packaging requirements is expected to reduce transport costs and storage space, improving the distribution of the doses between Member States and limit possible impact on the production of other routine vaccines. Despite these flexibilities, anyone vaccinated and health care professionals will have access to all the information on the vaccine used.
An example of such flexibilities is the fact that the outer and immediate packaging may only be printed in English. Also, the package leaflet does not have to be included inside the package of the medicinal product, but will be provided separately by the vaccine company, who will be responsible for the distribution of the printed package leaflet locally in the national language(s).
Some Member States do not require the package leaflet to be printed in their national language(s). The leaflet may be printed in English only, but the information contained in the leaflet should still be available in the national language(s), for instance via a QR code printed in the package leaflet and also available in the EMA website in all languages.
How will the Commission support Member States in the rolling-out of vaccines?
The Commission stands ready to support Member States to ensure the smooth deployment of COVID-19 vaccines. A number of EU instruments in the programming period 2021-2027 can offer financial support in this regard.
For instance, investments to support health reforms and resilient, effective and accessible health systems are eligible under the Recovery and Resilience Facility (RRF), and can be included in the national Recovery and Resilience Plans. Furthermore, the Cohesion Policy funds (European Regional Development Fund – ERDF and European Social Fund Plus – ESF+) as well as the REACT-EU programme can provide financing to Member States and their regions to strengthen their health systems, both in terms of managing and recovering from the current health crisis and as well as ensuring their resilience in the longer term.
Collectively, these programmes can support a range of investment needs, for example, in health infrastructure, training of health professionals, health promotion, disease prevention, integrated care models, digital transformation of healthcare, and equipment, including critical medical products and supplies to strengthen the resilience of health systems.
In this context, investments to prepare health systems for the roll out COVID-19 vaccines are eligible under these programme, especially given the direct link to the resilience of health systems, the availability of critical medical products and disease prevention. However, it will be up to each Member State to decide on the priorities and content of their Recovery and Resilience Plan and also their Programmes for the Cohesion Policy funds.
How will vaccination certificates work?
A common approach to pharmacovigilance, and to trusted, reliable and verifiable vaccination certificates across the EU could reinforce the success of vaccination programmes in Member States and the trust of citizens.
Registering data on vaccination is important both at individual and population levels. For an individual, it is a means to know and demonstrate their vaccination status. Proof of vaccination should be available from the moment vaccination starts. Vaccination certificates could for example be useful in the context of travel, showing that a person has been vaccinated and therefore may not need testing and quarantine upon arrival in another country.
The Commission and Member States, together with WHO, are working on vaccination certificates. This work includes a minimum dataset, including a unique identifier, for each individual vaccination which will ease the issuance of certificates and vaccination monitoring on a Europe-wide basis from the moment that the COVID-19 vaccines are authorised.
The development of the common specifications framework will take account of and contribute to the work of WHO. EU funds, such as RRF, ERDF, InvestEU can support the setting up of the Immunisation Information Systems (IIS), Electronic Health Records and secondary use of health data on immunisation.
How much does the vaccine cost? What is the price of the vaccine?
The Commission negotiated advantageous deals with vaccine manufacturers to secure access to almost 2 billion doses so far.
At this stage the specific pricing per dose is covered by confidentiality obligations. However, a significant part of the overall costs are funded by a contribution from the overall EU funding for vaccines.
Will the vaccine be free in all EU Member States?
While this is a Member State responsibility, the large majority of the Member States intend to offer vaccination free of charge.
Are the contracts with the companies publicly available?
The focus for the Commission is the protection of public health and securing the best possible agreements with companies so that vaccines are affordable, safe and efficacious.
Contracts are protected for confidentiality reasons, which is warranted by the highly competitive nature of this global market. This is in order to protect sensitive negotiations as well as business related information, such as financial information and development and production plans.
Disclosing sensitive business information would also undermine the tendering process and have potentially far-reaching consequences for the ability of the Commission to carry out its tasks as set out in the legal instruments that form the basis of the negotiations. All companies require that such sensitive business information remains confidential between the signatories of the contract. The Commission therefore has to respect the contracts it concludes with the companies.
When will the vaccine allow the control of the pandemic?
For some known communicable diseases, it is understood that herd immunity allowing to control a pandemic and eventually eradicate a disease requires around 70% of the population to have protection either from vaccination or previous infection.
Depending on the pace of vaccination and natural infections, the pandemic might be controlled by the end 2021 in Europe.
Can we still spread the disease once vaccinated?
We do not yet know. Additional evaluations will be needed to assess the effect of the vaccine in preventing asymptomatic infection, including data from clinical trials and from the vaccine’s use post-authorization.
Therefore, and for the time being, even vaccinated people will need to wear masks, avoid indoor crowds, and respect social distance, so on. Other factors, including how many people get vaccinated and how the virus is spreading in communities may also prompt revision of this guidance.
If I have already had COVID-19 and recovered, do I still need to get the vaccine?
There is not enough information currently available to say if or for how long after infection someone is protected from getting COVID-19 again; this is called natural immunity. Early evidence suggests natural immunity from COVID-19 may not last very long, but more studies are needed to better understand this.
Von der Leyen Outlines Vision for Stronger Europe
Ursula von der Leyen, President of the European Commission, outlined a vision for a stronger and more independent Europe based on trust and the values of liberal democracy in a special address on Thursday to business, government and civil society leaders taking part in the World Economic Forum’s virtual event, the Davos Agenda.
In the face of the COVID-19 crisis, she spoke of European democracies showing their strengths. “The pandemic has demonstrated that democracies are the more powerful, resilient and sustainable form of government,” she said.
Democracy means liberty of research, freedom of science and independent choices for investors, she added. Europe has delivered over 1.2 billion doses of vaccines to its citizens, with more than 80% of the European population double vaccinated.
She also pointed to Europe’s leadership in discovering the mRNA vaccine technology and exporting it to the world. “Europe is the only region in the world to export or donate vaccines to other countries throughout the crisis, with 1.6 billion vaccine doses made in Europe having been delivered to 150 countries.”
On the path to recovery, Europe’s most valuable asset is trust, said von der Leyen. “Trust in science, for our health. Trust among countries, for cooperation. Trust in functioning societies, for competitiveness. Trust will be essential to build the world of tomorrow.”
Trust will also be essential for European citizens to embrace the European Green Deal, a set of policy initiatives with the overarching aim of making the European Union climate-neutral by 2050. The EC has issued the first NextGenerationEU bond for green and sustainable investments in the EU. This represents, she said, the world’s largest green bond issuance, adding that it was heavily oversubscribed.
“These developments demonstrate a clear sign of international confidence and trust in Europe,” she said.
Although von der Leyen said Europe is well positioned, it must do more to build supply chains we can trust and avoid single points of failure. Issues range from dependence on non-renewable energy to lack of local manufacturing of microchips and semiconductors to Europe’s gas crisis.
“Europe’s global semiconductor market share is only 10%. And today, most of our supply comes from a handful of producers outside Europe. This is a dependency and uncertainty we simply cannot afford. We have no time to lose. And this is why I announce here today that we will propose our European Chips Act in early February,” she said.
She emphasized that trust is also essential in the international arena: “At this moment in time, the world needs trust in democracy as much as trust between democracies.” Referring to intense dialogue with Russia, she stressed that Europe will not go back to the old logic of competition and spheres of interest, where entire countries were treated as possessions or backyards.
“We want this dialogue. We want conflicts to be solved in the bodies that have been formed for this purpose. But if the situation deteriorates, if there are any further attacks on the territorial integrity of Ukraine, we will respond with massive economic and financial sanctions.”
“And what I want us never to forget is the following. Russia and Europe share geography, culture and history. We also want a common future,” she added.
Commission approves 2022-2027 regional aid map for Greece
The European Commission has approved under EU State aid rules Greece’s map for granting regional aid from 1 January 2022 to 31 December 2027 within the framework of the revised Regional aid Guidelines (‘RAG’).
The revised RAG, adopted by the Commission on 19 April 2021 and entering into force on 1 January 2022, enable Member States to support the least favoured European regions in catching up and to reduce disparities in terms of economic well-being, income and unemployment – cohesion objectives that are at the heart of the Union. They also provide increased possibilities for Member States to support regions facing transition or structural challenges such as depopulation, to contribute fully to the green and digital transitions.
At the same time, the revised RAG maintain strong safeguards to prevent Member States from using public money to trigger the relocation of jobs from one EU Member State to another, which is essential for fair competition in the Single Market.
Greece’s regional map defines the Greek regions eligible for regional investment aid. The map also establishes the maximum aid intensities in the eligible regions. The aid intensity is the maximum amount of State aid that can be granted per beneficiary, expressed as a percentage of eligible investment costs.
Under the revised RAG, regions covering 82.34% of the population of Greece will be eligible for regional investment aid:
Twelve regions (Βόρειο Αιγαίο / Voreio Aigaio, Νότιο Αιγαίο / Notio Aigaio, Κρήτη / Kriti, Aνατολική Μακεδονία, Θράκη / Anatoliki Makedonia, Thraki, Κεντρική Μακεδονία / Kentriki Makedonia, Δυτική Μακεδονία / Dytiki Makedonia, Ήπειρος / Ipeiros, Θεσσαλία / Thessalia, Ιόνια Νησιά / Ionia Nisia, Δυτική Ελλάδα / Dytiki Elláda, Στερεά Ελλάδα / Sterea Elláda and Πελοπόννησος / Peloponnisos) are among the most disadvantaged regions in the EU, with a GDP per capita below 75% of EU average. These regions are eligible for aid under Article 107(3)(a) TFEU (so-called ‘a’ areas), with maximum aid intensities for large enterprises between 30% and 50%, depending on the GDP per capita of the respective ‘a’ area. The region Ευρυτανία / Evrytania, which is part of Στερεά Ελλάδα / Sterea Elláda, also qualifies as a sparsely populated area having fewer than 12,5 inhabitants per km². In sparsely populated areas, Member States can use operating aid schemes to prevent or reduce depopulation.
In order to address regional disparities, Greece has designated as so-called non-predefined ‘c’ areas the regions of Δυτικός Τομέας Αθηνών / Dytikos Tomeas Athinon, Ανατολική Αττική / Anatoliki Attiki, Δυτική Αττική / Dytiki Attiki and Πειραιάς, Νήσοι / Peiraias, Nisoi. The maximum aid intensities for large enterprises in Δυτικός Τομέας Αθηνών / Dytikos Tomeas Athinon is 15%. The other ‘c’ areas mentioned above border with ‘a’ areas. For this reason, the aid intensity in these regions has been increased to 25%, so that the difference in aid intensity with the bordering ‘a’ areas is limited to 15 percentage points.
Greece has the possibility to designate further so-called non-predefined ‘c’ areas (up to a maximum of 1.16% of the national population). The specific designation of these areas can take place in the future and would result in one or more amendments to the regional aid map approved today.
In all the above areas, the maximum aid intensities can be increased by 10 percentage points for investments made by medium-sized enterprises and by 20 percentage points for investments made by small enterprises, for their initial investments with eligible costs up to €50 million.
Once a future territorial Just Transition plan in the context of the Just Transition Fund Regulation will be in place, Greece has the possibility to notify the Commission an amendment to the regional aid map approved today, in order to apply a potential increase of the maximum aid intensity in the future Just Transition areas, as specified in the revised RAG for ‘a’ areas.
20 years of the euro in your pocket
Twenty years ago, on 1 January 2002, twelve EU countries changed their national currency banknotes and coins for the euro in the largest currency changeover in history. In these two decades, the euro has contributed to the stability, competitiveness and prosperity of European economies. Most importantly, it has improved the lives of citizens and made it easier to do business across Europe and beyond. With the euro in your pocket, saving, investing, travelling and doing business became much easier.
The euro is a symbol of EU integration and identity. Today, more than 340 million people use it across 19 EU countries, with 27.6 billion euro banknotes in circulation for a value of about €1.5 trillion. The euro is currently the second most widely used currency in the world behind the US dollar.
As it celebrates this 20th anniversary, the EU continues the work to strengthen the international role of the euro and adapt it to new challenges, including the rapid digitalisation of the economy and the development of virtual currencies. As a complement to cash, a digital euro would support a well-integrated payments sector and would offer greater choice to consumers and businesses.
Ursula von der Leyen, President of the European Commission, said: “It is now twenty years that we, European people, can carry Europe in our pockets. The euro is not just one of the most powerful currencies in the world. It is, first and foremost, a symbol of European unity. Euro banknotes have bridges on one side and a door on the other – because this is what the euro stands for. The euro is also the currency of the future, and in the coming years it will become a digital currency too. The euro also reflects our values. The world we want to live in. It is the global currency for sustainable investments. We can all be proud of that.”
David Sassoli, President of the European Parliament, said: “The euro is the embodiment of an ambitious political project to promote peace and integration within the European Union. But the euro is also a condition for protecting and relaunching the European economic, social, and political model in the face of the transformations of our time. The euro is a symbol, the coming to fruition of a historic political vision, an ancient vision of a united continent with a single currency for a single market.”
Charles Michel, President of the European Council, said: “The euro has come a long way — it’s a true European achievement. I would even say the euro has become part of who we are. And how we see ourselves as Europeans. Part of our mind-set. And part of our European spirit. The euro belongs to all of us all European citizens. But it isn’t just a success within our EU borders. It has also anchored itself on the international stage. Despite the crises, the euro has proven to be resilient — a symbol of European unity and stability. And never has that been truer than during COVID-19. The euro has served as a bedrock of stability. A stable asset for the Union. The euro also fuels our recovery. Unlocking the full potential of sustainable development, quality jobs, and innovation.”
Christine Lagarde, President of the European Central Bank, said: “The euros we hold in our hands have become a beacon of stability and solidity around the world. Hundreds of millions of Europeans trust it and transact with it every day. It is the second most international currency in the world. As European Central Bank President, I commit we will continue to work hard to make sure that we maintain price stability. And I also pledge that we will renew the face of those banknotes and that we will give them the digital dimension as well.”
Paschal Donohoe, President of the Eurogroup, said: “The euro has proven its mettle in dealing with great economic challenges. In particular, our response to the COVID 19 pandemic demonstrated that by sharing the euro we can achieve more collectively than we can individually. The euro has strengthened its foundations over the last 20 years. Now, we need to build on those foundations to make the euro the global currency for transitioning to a lower carbon future.”
A long journey
The euro has come a long way from the early discussions on an Economic and Monetary Union in the late 1960s. Specific steps towards a single currency were first approached in 1988 by the Delors Committee. In 1992, the Maastricht Treaty marked a decisive moment in the move towards the euro, as political leaders signed on the criteria that Member States had to meet to adopt the single currency. Two years later, the European Monetary Institute (EMI) started its preparatory work in Frankfurt for the European Central Bank (ECB) to assume its responsibility for monetary policy in the euro area. As a result, on 1 June 1998, the ECB became operational.
In 1999, the euro was launched in 11 Member States as an accounting currency on financial markets and used for electronic payments. It was finally on 1 January 2002 when Austria, Belgium, Finland, France, Germany, Greece, Ireland, Italy, Luxembourg, the Netherlands, Portugal and Spain swapped their national notes and coins for euros. Slovenia joined the euro area in 2007, followed by Cyprus and Malta (2008), Slovakia (2009), Estonia (2011), Latvia (2014) and Lithuania (2015). Currently, Croatia is taking the preparatory steps to join the euro area, which it plans to do on 1 January 2023, provided it fulfils all the convergence criteria.
Twenty years of benefits for citizens and businesses
The euro has brought many benefits to Europe, especially to its citizens and businesses. The single currency has helped to keep prices stable and protected the euro area economies from exchange rate volatility. This has made it easier for European home buyers, businesses and governments to borrow money and has encouraged trade within Europe and beyond. The euro has also eliminated the need for currency exchange and has lowered the costs of transferring money, making travelling and moving to another country to work, study or retire simpler.
A large majority of Europeans support the single currency. According to the latest Eurobarometer, 78% of citizens across the euro area believe the euro is good for the EU.
A strengthened international role
The euro is the second most important currency in the international monetary system. Its stability and credibility has made it an international invoicing currency, a store of value and a reserve currency, accounting for around 20% of foreign exchange reserves. Sixty other countries and territories around the world, home to some 175 million people, have chosen to use the euro as their currency or to peg their own currency to it. Today, the euro is used for almost 40% of global cross-border payments and for more than half the EU’s exports.
Since the global financial crisis of 2008 and the subsequent sovereign debt crisis, the EU has continued to strengthen and deepen the Economic and Monetary Union. The EU’s unprecedented recovery plan NextGenerationEU will further improve the euro-area’s economic resilience and enhance economic convergence. The issuance of high-quality-denominated bonds under NextGenerationEU will add significant depth and liquidity to the EU’s capital markets and make them and the euro more attractive for investors. The euro is also now the leading currency for green investment: half of the world’s green bonds are denominated in euros, and this figure is rising thanks to the new green bonds issued to finance NextGenerationEU.
To further develop the international role of the euro, the Commission has launched outreach initiatives to promote euro denominated investments, facilitate the use of the euro as an invoicing and denomination currency, and foster a better understanding of the obstacles for its wider use. This outreach will take the form of dialogues, workshops and surveys with the public and private sector, financial regulatory agencies, and institutional investors in regional and global partner countries of the EU.
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