Today, the European Commission concluded exploratory talks with the pharmaceutical company Valneva with a view to purchasing its potential vaccine against COVID-19. The envisaged contract with Valneva would provide for the possibility for all EU Member States to purchase together 30 million doses, and they could further purchase up to 30 million more doses.
Today’s finalisation of exploratory talks with Valneva come in addition to an already secured broad portfolio of vaccines to be produced in Europe, including the contracts already signed with AstraZeneca, Sanofi-GSK, Janssen Pharmaceutica NV, BioNtech-Pfizer, CureVac, and Moderna and exploratory talks concluded with Novavax. This diversified vaccines portfolio will ensure Europe is well prepared for vaccination, once the vaccines have been proven to be safe and effective, as is already the case for BioNTech/Pfizer and Moderna, recently authorised in the EU. Member States are able to donate vaccines to lower and middle-income countries or to re-direct it to other European countries.
President of the European Commission, Ursula von der Leyen, said: “The continuing COVID-19 pandemic in Europe and around the globe makes it more important than ever that all Member States have access to the broadest possible portfolio of vaccines to help protect people in Europe and beyond. Today’s step toward reaching an agreement with Valneva further complements the EU’s vaccines portfolio and demonstrates the Commission’s commitment to find a lasting solution to the pandemic.”
Stella Kyriakides, Commissioner for Health and Food Safety, said: “With this eighth vaccine, we are adding to our already broad and diversified range of vaccines in our portfolio. By doing this, we can maximise our chances of making sure that all citizens can have access to safe and effective of vaccinations by the end of 2021. All Member States have now started their vaccination campaigns and will start receiving an increasing number of doses in order to cover all their needs during this year.”
Valneva is a European biotechnology company developing an inactivated virus vaccine. This is a traditional vaccine technology, used for 60-70 years, with established methods and a high level of safety. Most of the influenza vaccines and many childhood vaccines use this technology. This is currently the only inactivated vaccine candidate in clinical trials against COVID-19 in Europe.
The Commission, with the support of EU Member States, has taken a decision to support this vaccine based on a sound scientific assessment, the technology used, the company’s experience in vaccine development and its production capacity to supply all EU Member States.
Background
The European Commission presented on 17 June a European strategy to accelerate the development, manufacturing and deployment of effective and safe vaccines against COVID-19. In return for the right to buy a specified number of vaccine doses in a given timeframe, the Commission finances part of the upfront costs faced by vaccines producers in the form of Advance Purchase Agreements. Funding provided is considered as a down-payment on the vaccines that will actually be purchased by Member States.
Since the high cost and high failure rate make investing in a COVID-19 vaccine a high-risk decision for vaccine developers, these agreements will therefore allow investments to be made that otherwise might not happen.
Once vaccines have been proven to be safe and effective and have been granted market authorisation by the European Medicines Agency, they need to be quickly distributed and deployed across Europe. On 15 October, the Commission set out the key steps that Member States need to take to be fully prepared, which includes the development of national vaccination strategies. The Commission is putting in place a common reporting framework and a platform to monitor the effectiveness of national vaccine strategies and has adopted further actions  to reinforce preparedness and response measures across the EU and a strategy on staying safe from COVID-19 during winter offering further support to Member States in the deployment of vaccines.
The Commission is also committed to ensuring that everyone who needs a vaccine gets it, anywhere in the world and not only at home. No one will be safe until everyone is safe. This is why it has raised almost €16 billion since 4 May 2020 under the Coronavirus Global Response, the global action for universal access to tests, treatments and vaccines against coronavirus and for the global recovery and has confirmed its interest to participate in the COVAX Facility for equitable access to affordable COVID-19 vaccines everywhere. As part of a Team Europe effort, the Commission announced is contributing with €400 million in guarantees an additional €100 million in grant funding to support COVAX Facility and its objectives in the context of the Coronavirus Global Response. This €500 million from the EU budget combined with contributions from EU Member States and the EIB will be a key contribution for the COVAX Facility to ensure over one billion vaccine doses will be made available to people in low- and middle-income countries by the end of 2021.
Compliments of the European Commission.
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Denmark aspires to become one of the most climate-friendly countries in the world. In June, its Parliament overwhelmingly passed a new climate law that aims to reduce greenhouse gas emissions by 70 percent below 1990 levels by 2030, with net zero emissions targeted for 2050.
This is an even more ambitious goal than the EU’s target to cut emissions by 55 percent over the same time period.

70%Amount by which Denmark plans to reduce greenhouse gas emissions by 2030 relative to 1990 levels

A new IMF staff paper takes a closer look at Denmark’s green strategy and proposes a few adjustments to help the country realize its ambitious goals. In line with earlier IMF recommendations, the paper proposes a comprehensive strategy with enhanced carbon pricing, reinforced by fiscal incentives across different sectors. It also urges using revenues from carbon pricing to cut labor taxes.
The package proposed in the paper would provide powerful incentives for climate mitigation, while shielding households and firms from higher energy prices. Crucially, the paper argues, spreading measures to different sectors is a good way to avoid carbon prices that are too high, capping them at half the level currently suggested by the Danish Council for Climate Change. The economic cost from this lower carbon price would be fairly low—estimated at about 0.2 percent of GDP.
“Feebates”—fees on products with high emissions combined with rebates on products with low emissions—are recommended for sectors with high emissions. They could be especially useful to curb Denmark’s large agricultural emissions from the country’s huge number of farmed animals. Because feebates raise the costs of producers who farm unsustainably but reward them as they shift to sustainable farming, this program can deliver a fair low-carbon transition that preserves profitability and jobs.
By crafting an effective climate policy that protects the majority of people, Denmark’s strategy to make large cuts in its emissions could be more attainable.
Compliments of the IMF.
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Speech by Vice Chair Richard H. Clarida at the C. Peter McColough Series on International Economics Council on Foreign Relations, New York, New York (via webcast) |
It is my pleasure to meet virtually with you today at the Council on Foreign Relations.1 I regret that we are not doing this session in person, as we did last year, and I hope the next time I am back, we will be gathering together in New York City again. I look forward to my conversation with Steve Liesman and to your questions, but first, please allow me to offer a few remarks on the economic outlook, Federal Reserve monetary policy, and our new monetary policy framework.
Current Economic Situation and Outlook
In the second quarter of last year, the COVID-19 (coronavirus disease 2019) pandemic and the mitigation efforts put in place to contain it delivered the most severe blow to the U.S. economy since the Great Depression. Economic activity rebounded robustly in the third quarter and has continued to recover in the fourth quarter from its depressed second-quarter level, though the pace of improvement has moderated. Household spending on goods, especially durable goods, has been strong and has moved above its pre-pandemic level, supported in part by federal stimulus payments and expanded unemployment benefits. In contrast, spending on services remains well below pre-pandemic levels, particularly in sectors that typically require people to gather closely, including travel and hospitality. In the labor market, more than half of the 22 million jobs that were lost in March and April have been regained, as many people were able to return to work. Inflation, following large declines in the spring of 2020, picked up over the summer but has leveled out more recently; for those sectors that have been most adversely affected by the pandemic, price increases remain subdued.
While gross domestic product growth in the fourth quarter downshifted from the once-in-a-century 33 percent annualized rate of growth reported in the third quarter, it is clear that since the spring of 2020, the economy has turned out to be more resilient in adapting to the virus, and more responsive to monetary and fiscal policy support, than many predicted. Indeed, it is worth highlighting that in the baseline projections of the Federal Open Market Committee (FOMC) summarized in the latest Summary of Economic Projections (SEP), most of my colleagues and I revised up our outlook for the economy over the medium term, projecting a relatively rapid return to levels of employment and inflation consistent with the Federal Reserve’s statutory mandate as compared with the recovery from the Global Financial Crisis (GFC).2 In particular, the median FOMC participant projects that by the end of 2023—a little less than three years from now—the unemployment rate will have fallen below 4 percent, and PCE (personal consumption expenditures) inflation will have returned to 2 percent. Following the GFC, it took more than eight years for employment and inflation to return to similar mandate-consistent levels.
While the recent surge in new COVID cases and hospitalizations is cause for concern and a source of downside risk to the very near-term outlook, the welcome news on the development of several effective vaccines indicates to me that the prospects for the economy in 2021 and beyond have brightened and the downside risk to the outlook has diminished. The two new SEP charts that we released for the first time following the December FOMC meeting speak to these issues by providing information on how the risks and uncertainties that surround the modal or baseline projections have evolved over time. While nearly all participants continued to judge that the level of uncertainty about the economic outlook remains elevated, fewer participants saw the balance of risks as weighted to the downside than in September. Although a little more than half of participants judged risks to be broadly balanced for economic activity, a similar number continued to see risks weighted to the downside for inflation.
The Latest FOMC Decision and the New Monetary Policy Framework
At our most recent FOMC meetings, the Committee made important changes to our policy statement that upgraded our forward guidance about the future path of the federal funds rate and asset purchases, and that also provided unprecedented information about our policy reaction function. As announced in the September statement and reiterated in November and December, with inflation running persistently below 2 percent, our policy will aim to achieve inflation outcomes that keep inflation expectations well anchored at our 2 percent longer-run goal.3 We expect to maintain an accommodative stance of monetary policy until these outcomes—as well as our maximum-employment mandate—are achieved. We also expect it will be appropriate to maintain the current target range for the federal funds rate at 0 to 1/4 percent until labor market conditions have reached levels consistent with the Committee’s assessments of maximum employment, until inflation has risen to 2 percent, and until inflation is on track to moderately exceed 2 percent for some time.
In addition, in the December statement, we combined our forward guidance for the federal fund rate with enhanced, outcome-based guidance about our asset purchases. We indicated that we will continue to increase our holdings of Treasury securities by at least $80 billion per month and our holdings of agency mortgage-backed securities by at least $40 billion per month until substantial further progress has been made toward our maximum-employment and price-stability goals.
The changes to the policy statement that we made over the fall bring our policy guidance in line with the new framework outlined in the revised Statement on Longer-Run Goals and Monetary Policy Strategy that the Committee approved last August.4 In our new framework, we acknowledge that policy decisions going forward will be based on the FOMC’s estimates of “shortfalls [emphasis added] of employment from its maximum level”—not “deviations.” This language means that going forward, a low unemployment rate, in and of itself, will not be sufficient to trigger a tightening of monetary policy absent any evidence from other indicators that inflation is at risk of moving above mandate-consistent levels. With regard to our price-stability mandate, while the new statement maintains our definition that the longer-run goal for inflation is 2 percent, it elevates the importance—and the challenge—of keeping inflation expectations well anchored at 2 percent in a world in which an effective-lower-bound constraint is, in downturns, binding on the federal funds rate. To this end, the new statement conveys the Committee’s judgment that, in order to anchor expectations at the 2 percent level consistent with price stability, it “seeks to achieve inflation that averages 2 percent over time,” and—in the same sentence—that therefore “following periods when inflation has been running persistently below 2 percent, appropriate monetary policy will likely aim to achieve inflation moderately above 2 percent for some time.” As Chair Powell indicated in his Jackson Hole remarks, we think of our new framework as an evolution from “flexible inflation targeting” to “flexible average inflation targeting.”5 While this new framework represents a robust evolution in our monetary policy strategy, this strategy is in service to the dual-mandate goals of monetary policy assigned to the Federal Reserve by the Congress—maximum employment and price stability—which remain unchanged.6
Concluding Remarks
While our interest rate and balance sheet tools are providing powerful support to the economy and will continue to do so as the recovery progresses, it will take some time for economic activity and employment to return to levels that prevailed at the business cycle peak reached last February. We are committed to using our full range of tools to support the economy and to help ensure that the recovery from this difficult period will be as robust as possible.
Compliments of the U.S. Federal Reserve.
The post Speech | U.S. Economic Outlook and Monetary Policy first appeared on European American Chamber of Commerce New York [EACCNY] | Your Partner for Transatlantic Business Resources.

The European Commission today proposed to the EU Member States to purchase an additional 200 million doses of the COVID-19 vaccine produced by BioNTech and Pfizer, with the option to acquire another 100 million doses.
This would enable the EU to purchase up to 600 million doses of this vaccine, which is already being used across the EU.
The additional doses will be delivered starting in the second quarter of 2021.
The EU has acquired a broad portfolio of vaccines with different technologies. It has secured up to 2.3 billion doses from the most promising vaccine candidates for Europe and its neighbourhood.
In addition to the BioNTech-Pfizer vaccine, a second vaccine, produced by Moderna, was authorised on 6 January 2021. Other vaccines are expected to be approved soon.
This vaccine portfolio would enable the EU not only to cover the needs of its whole population, but also to supply vaccines to neighbouring countries.
Compliments of the European Commission.
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Paris, 14 November 2020 | by Pedro Sánchez, President of the Spanish Government and Angel Gurría, Secretary-General of the OECD. You may view the OECD 60th anniversary Leaders’ Commemoration Event here |
On 14 December this year, we are commemorating the 60th anniversary of the signature of the Convention establishing the Organisation for Economic Co-operation and Development (OECD). The OECD succeeded the Organisation for European Economic Co-operation (OEEC), which was created in 1948 to administer American and Canadian aid under the Marshall Plan for the reconstruction of Europe after the Second World War. Solidarity, ambition and international co- operation inspired the development of the Marshall Plan and the creation of the OECD. Today, perhaps more than at any other time in the last sixty years, the world needs, once again, to draw inspiration from those values, as it confronts the worst health, economic and social crisis since the Second World War.
The OECD’s vocation has always been to achieve greater well-being for its Members and partners around the world by advising governments on how to deliver policies that support resilient, inclusive and sustainable growth. The OECD has helped advance structural reforms and multilateral solutions to global challenges through evidence-based policy analysis as well as recommendations, standards and global policy networks in increasingly close collaboration with other multilateral fora, such as the UN, the G7 and the G20. Examples of the OECD’s influence include the “Polluter Pays” principle, developed in the 1970s, student assessments under PISA or ongoing efforts to promote tax transparency and harness the potential of human-centric Artificial Intelligence.
The COVID-19 pandemic has left no country or region untouched. As we continue to fight the virus and prepare for the recovery, our efforts at home need to be complemented with an equally decisive and ambitious response through international co-operation. This crisis must be an opportunity, a turning point, for reinforced and more effective multilateralism. We need to work together to develop effective global solutions for today’s global challenges: the COVID-19 recovery, climate change, biodiversity loss, growing inequalities, the concentration of wealth, digitalisation, or the future of work.
This has been the main message of the OECD Ministerial that Spain chaired this year. For the first time in four years, OECD Members were able to put aside their differences and agreed on a statement reflecting their collective vision for a strong, resilient, inclusive and green recovery from COVID-19. This was a powerful message: when it was needed the most, the OECD and its Members stepped up to the challenge with a single voice.
It is now time to put this vision in motion, to turn words into action. Our collective efforts should focus on three key areas.
The first priority for the recovery should be to contain and eradicate the virus. The trade-off between lives and livelihoods is a false dilemma. The imminent roll-out of effective vaccines is excellent news. But to be effective in beating the pandemic, vaccines and treatments need to be produced at scale, equitably distributed worldwide and affordable for all. Ensuring that all people can be immunised is both a humanitarian imperative and a precondition to secure health and prosperity. If disease is thriving anywhere, it remains a threat everywhere. Having strong, resilient and inclusive healthcare systems is another lesson from this crisis and one that needs to be incorporated in domestic priorities, but also as part of our development co-operation programmes. We need to support the most vulnerable countries, which do not have the financial means to respond to the pandemic and lack solid social protection systems to cushion its effects on their populations.
The second priority is to create the conditions for a broad-based recovery. We need to work together to develop common approaches to restore international mobility as soon as possible. We must also preserve the benefits of free, fair and inclusive trade as an engine of growth and prosperity, while strengthening the resilience of global value chains and levelling the playing field. The post-COVID-19 world is going to be more digital, and international co-operation is required to make sure we address the issues of skills, privacy, security and competition. Reaching a global, consensus-based solution by mid-2021 on the tax challenges arising from the growing digitalisation of the world economy, based on the OECD’s initiative, is another critical objective.
The third priority is to support a transformative recovery and develop a new narrative on economic growth. National recovery and resilience plans constitute unique opportunities not just to jump- start our economies, but also to undertake bold and transformative action to make them more equal, cohesive and environmentally sound, in line with the 2030 Agenda and the Sustainable Development Goals. The COVID-19 crisis has increased inequalities, while climate change, biodiversity loss and other environmental emergencies loom large. Analysis by the OECD shows that ambitious climate action to decarbonise our economies can be a source of growth, incomes and jobs. The COP26 in Glasgow and the UN Biodiversity Conference, both to be held in 2021, will be tests for our collective determination. Our single, most important intergenerational responsibility is to protect the planet. This new narrative also requires fostering an economic and productivity growth model based on fair wages, decent working conditions and enhanced social dialogue.
Over the last decade, the OECD has been a leading voice in promoting an approach to economic growth that combines inclusiveness and environmental sustainability. Building on solid evidence and data, we need to work together to develop this narrative further, measuring outcomes beyond GDP, and developing a consensus around a new economic framework that reconciles people, prosperity and the planet.
We are living in extraordinary times. The challenges ahead are too significant for any one country to tackle them alone. Only through collective action will we be able to address them and “build back better” towards more resilient, more inclusive and greener economies and societies. With a long- term vision, a strong ambition and an enlightened sense of mission, as we celebrate the OECD’s 60th Anniversary, let us draw inspiration from its history and its accomplishments, to deliver better policies for better lives for the generations to come.
Working with over 100 countries, the OECD is a global policy forum that promotes policies to improve the economic and social well-being of people around the world.
Compliments of the OECD.
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The Commodity Futures Trading Commission (CFTC) and the European Securities and Markets Authority (ESMA) today announced the signing of a new Memorandum of Understanding (MOU) regarding cooperation and the exchange of information with respect to certain registered derivatives clearing organizations established in the United States that are central counterparties (CCPs) recognized by ESMA under the European Market Infrastructure Regulation (EMIR).
Through the MOU, ESMA and the CFTC express their desire for enhanced cooperation as to the larger U.S. CCPs operating in the European Union with provisions that expand upon the collaboration set out in the 2016 CFTC-ESMA MOU related to recognized CCPs. The MOU reflects ESMA’s and the CFTC’s commitment to strengthening their mutual cooperative relationship, which has continued to flourish under the leadership of Chair Steven Maijoor and Chairman Heath P. Tarbert.
“We look forward to building upon our strong relationship with ESMA and embarking upon a cooperative relationship with ESMA’s new CCP Supervisory Committee,” said Suyash Paliwal, Director of the CFTC’s Office of International Affairs. “The deferential approach embodied in this MOU is a major milestone in the years-long engagement between the CFTC and its EU counterparts on the implementation of EMIR as amended.”
“I am pleased to see ESMA entering a phase of closer cooperation with the CFTC,” said Chair of ESMA’s CCP Supervisory Committee Klaus Löber. “This MOU sets out the basis for the enhanced collaboration between our institutions and is an important step towards building the risk-based and outcome-focused supervision of CCPs in accordance with the amended European Market Infrastructure Regulation.”
Compliments of the European Securities and Market Authority.
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EU-UK relations are changing following Brexit and the deal reached at the end of 2020. Find out what this means for you.
The UK left the EU on 31 January 2020. There was a transition period during which the UK remained part of the Single market and Customs Union to allow for negotiations on the future relations. Following intense negotiations, an agreement on future EU-UK relations was concluded end of December 2020. Although it will be provisionally applied, it will still need to be approved by the Parliament before it can formally enter into force. MEPs are currently scrutinising the text in the specialised parliamentary committees before voting on it during a plenary session.
A number of issues were already covered by the withdrawal agreement, which the EU and the UK agreed at the end of 2019. This agreement on the separation issues deals with the protection of the rights of EU citizens in the UK and UK citizens living in other parts of the EU, the UK’s financial commitments undertaken as a member state, as well as border issues, especially on the Isle of Ireland.
Living and working in the UK or the EU
EU citizens in the UK or UK citizens in an EU member state who were already living there before January 2021 are allowed to continue living and working where they are now provided they registered and were granted settlement permits by the national authorities of the member states or the UK.
For those UK citizens not already living in the EU, their right to live and work in any EU country apart from the Republic of Ireland (as the UK has a separate agreement with them) is not automatically granted and can be subject to restrictions. Also, they no longer have their qualifications automatically recognised in EU countries, which was previously the case.
For UK citizens wanting to visit or stay in the EU for more than 90 days for any reason need to meet the requirements for entry and stay for people from outside the EU. This also applies to UK citizens with a second home in the EU.
People from the EU wanting to move to the UK for a long-term stay or work – meaning more than six months – will need to meet the migration conditions set out by the UK government, including applying for a visa.
Travelling
UK citizens can visit the EU for up to 90 days within any 180-day period without needing a visa.
However, UK citizens can no longer make use of the EU’s fast track passport controls and customs lanes. They also need to have a return ticket and be able to prove they have enough funds for their stay. They also need to have at least six months left on their passport.
EU citizens can visit the UK for up to six months without needing a visa. EU citizens will need to present a valid passport to visit the UK.
Healthcare
EU citizens temporarily staying in the UK still benefit from emergency healthcare based on the European Health Insurance Card. For stays longer than six months, they need to pay a healthcare surcharge.
Pensioners continue to benefit from healthcare where they live. The country paying for their pension will reimburse the country of residence.
Erasmus
The UK has decided to stop participating in the popular Erasmus+ exchange programme and to create its own exchange programme. Therefore EU students will not be able to participate in exchange programme in the UK anymore. However, people from Northern Ireland can continue to take part.
Trade in goods and services
With the agreement, goods exchanged between the UK and EU countries are not subject to tariffs or quotas. However, there are new procedures for moving goods to and from the UK as border controls on the respect of the internal market rules (sanitary, security, social, environmental standard for example) or applicable UK regulation are in place. This means more red tape and additional costs. For example, all imports into the EU are subject to customs formalities while they must also meet all EU standards so they are subject to regulatory checks and controls. This does not apply to goods being moved between Northern Ireland and the EU.
Regarding services, UK companies no longer have the automatic right to offer services across the EU. If they want to continue operating in the EU, they will need to establish themselves here.
Compliments of the European Parliament
The post Brexit deal: how new EU-UK relations will affect you first appeared on European American Chamber of Commerce New York [EACCNY] | Your Partner for Transatlantic Business Resources.

The Commission has announced today the first round of direct equity investment through the new European Innovation Council (EIC) Fund. 42 highly innovative start-ups and small and medium-sized businesses (SMEs) will together receive equity financing of around €178 million to develop and scale up breakthrough innovations in health, circular economy, advanced manufacturing and other areas. Among them, the French company CorWave is the first EU company in which the EIC Fund is investing.
Mariya Gabriel, Commissioner for Innovation, Research, Culture, Education and Youth said: “Europe has many innovative, talented start-ups, but too often these companies remain small or relocate elsewhere. This new form of financing – combining grants and equity – is unique to the European Innovation Council. It will bridge the funding gap for highly innovative companies, unlock additional private investments and enable them scale up in Europe.”
The equity investments, ranging from €500.000 to €15 million per beneficiary, complement the grant financing, which has already been provided through the EIC Accelerator Pilot to enable companies to scale up faster. This is the first time the Commission has made direct equity or quasi-equity investments, namely equity investment blended with a grant, in start-up companies, with ownership stakes expected to range from 10% to 25%.
Under the EIC Accelerator a total of 293 companies have already been selected for funding worth over €563 million in grants since December 2019. Among those, 159 companies have been selected to additionally receive the new equity investments from the EIC Fund. The 42 companies announced today are the first of this group to successfully pass the evaluation and due diligence process. The other 117 companies are in the pipeline to receive investments pending the outcome of the relevant process.
CorWave: first EU company to sign investment agreement with the EIC Fund

The highly innovative French company CorWave was the very first to receive a direct equity investment. CorWave’s mission is to bring a new standard of care to patients with life-threatening heart failure. The €15 million EIC Fund investment has played a critical role by mobilising additional investors to unite behind the French SME, which led to a €35 million of investments in the fourth stage of start-up financing for CorWave.
This sizeable venture will enable CorWave to successfully bring to the market and scale up its innovative medical solution “Left Ventricular Assist Device” (LVAD), which will significantly improve the lives of those with advanced heart failure, reducing by half severe complications and the need for rehospitalisation, while at the same time improving significantly their quality of life. CorWave’s high-growth potential will also translate into high-quality jobs in the EU.
Next steps for beneficiaries
The investment agreements with the other target companies are now being finalised, and will be announced shortly. A few examples of this first round of investments:

Hiber (The Netherlands): an international satellite and communication company that provides global and affordable Internet of Things connectivity;

XSUN (France): a solar aircraft company that designs energy-independent drones to be fully autonomous so they can operate without any human intervention;

GEOWOX LIMITED (Ireland): a technological company that provides automated property valuations, leveraging high-quality open data and machine learning models;

EPI-ENDO PHARMACEUTICALS EHF (Iceland): a pharmaceutical company focused on developing a proprietary portfolio of drugs to address the huge global burden of chronic respiratory diseases.

These first investments are preceded by a thorough evaluation by external experts, a due diligence process overseen by the external practitioners and investors on the EIC Fund Investment Committee, and a final decision by the EIC Fund Board of Directors.
Background
Established in June 2020, the European Innovation Council (EIC) Fund is a breakthrough initiative of the Commission to make direct equity and quasi-equity investments (between €500.000 and €15 million) in the capital of start-ups and SMEs. It is first of its kind in terms of EU intervention in direct equity-type investments. In its current stage, it makes such investments, in combination with grants, as part of blended finance under the EIC Accelerator Pilot. The allocated maximum funding (grants and equity) can reach €17.5 million.
The EIC Fund aims to fill a critical financing gap faced by innovative companies when bringing their technologies from high technology readiness levels to the commercialization stage. The Fund will help to fill this financing gap at the start-up stage where the EU venture capital market still underperforms compared to the global venture capital market. Its main purpose is not to maximise the return on the investments, but to have a high impact by accompanying companies with breakthrough and disruptive technologies in their growth as patient capital investor.
The Fund aims to support equality and gender balance, and to highly contribute to sustainability with a particular focus on health, resilience and the green and digital transitions. Its role has become even more important today, as the coronavirus crisis had a very strong impact on many SMEs in the EU, including many innovative startups.
Compliments of the European Commission.
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Today, the European Commission has granted a conditional marketing authorisation (CMA) for the COVID‑19 vaccine developed by Moderna, the second COVID-19 vaccine authorised in the EU. This authorisation follows a positive scientific recommendation based on a thorough assessment of the safety, effectiveness and quality of the vaccine by the European Medicines Agency (EMA) and is endorsed by the Member States.
The President of the European Commission, Ursula von der Leyen, said: “We are providing more COVID-19 vaccines for Europeans. With the Moderna vaccine, the second one now authorised in the EU, we will have a further 160 million doses. And more vaccines will come. Europe has secured up to two billion doses of potential COVID-19 vaccines. We’ll have more than enough safe and effective vaccines for protecting all Europeans.”
Stella Kyriakides, Commissioner for Health and Food Safety, said: “We are all in this together and united. This is why we have negotiated the broadest vaccine portfolio in the world for all our Member States. Today we are authorising a second safe and effective vaccine from Moderna, which together with BioNTech-Pfizer, will ensure that 460 million doses will be rolled out with increasing speed in the EU, and more will come. Member States have to ensure that the pace of vaccinations follows suit. Our efforts will not stop until vaccines are available for everyone in the EU.”
Moderna submitted on 30 November 2020 an application for marketing authorisation to EMA, which had already started a rolling review of the data in November. Thanks to this rolling review, EMA has been assessing the quality, safety and efficacy of the vaccine as data has become available. EMA’s human medicines committee (CHMP) has thoroughly assessed the data and recommended by consensus that a formal conditional marketing authorisation is granted. A conditional marketing authorisation is one of EU’s regulatory mechanisms for facilitating early access to medicines that fulfil an unmet medical need, including in emergency situations such as the current pandemic.
On the basis of EMA’s positive opinion, the Commission has verified all the elements supporting the marketing authorisation and consulted Member States before granting the conditional market authorisation.
The Moderna vaccine is based on messenger RNA (mRNA). mRNA plays a fundamental role in biology, transferring instructions from DNA to the cells’ protein making machinery. In an mRNA vaccine, these instructions produce harmless fragments of the virus, which the human body uses to build an immune response to prevent or fight disease. When a person is given the vaccine, their cells will read the genetic instructions and produce a spike protein, a protein on the outer surface of the virus which it uses to enter the body’s cells and cause disease. The person’s immune system will then treat this protein as foreign and produce natural defences — antibodies and T cells — against it.
Next steps
Moderna, with whom the Commission signed a contract on 25 November, will deliver the total amount of 160 million doses between the first and the third quarters of 2021. It will add to the 300 million doses of the vaccine distributed by BioNTech/Pfizer, the first vaccine to have been authorised in the EU on 21 December 2020.
Background
A conditional marketing authorisation (CMA) is an authorisation of medicines on the basis of less complete data required for a normal marketing authorisation. Such a CMA may be considered if the benefit of a medicine’s immediate availability to patients clearly outweighs the risk linked to the fact that not all the data are yet available. However, once a CMA has been granted, companies must provide within certain deadlines further data including from ongoing or new studies to confirm that the benefits continue to outweigh the risks.
Moderna submitted on 30 November 2020 an application for a CMA for their vaccine to EMA. EMA has already been assessing data on the vaccine’s safety, effectiveness and quality and results from laboratory studies and clinical trials in the context of a rolling review. This rolling review and the assessment of the CMA application allowed EMA to quickly conclude on the safety, effectiveness and quality of the vaccine. EMA recommended granting the conditional marketing authorisation as the benefits of the vaccine outweigh its risks.
The European Commission has verified whether all necessary elements – scientific justifications, product information, educational material to healthcare professionals, labelling, obligations to marketing authorisation holders, conditions for use, etc. – were clear and sound. The Commission also consulted the Member States, as they are responsible for the vaccines marketing and the use of the product in their countries. Following the Member States’ endorsement and on the basis of its own analysis, the Commission decided to grant the conditional market authorisation.
Compliments of the European Commission.
The post European Commission authorises second safe and effective vaccine against COVID-19 first appeared on European American Chamber of Commerce New York [EACCNY] | Your Partner for Transatlantic Business Resources.

A salient feature of the coronavirus (COVID-19) pandemic has been the sharp and deep decline in mobility, which has caused a slump in tourism, trade in travel services and consumption by non-residents. Lockdowns and social distancing measures led to strong declines in otherwise stable services consumption. This box takes stock of developments in the tourism sector, discusses how the impact of these developments on consumption has varied across countries and reviews the near-term prospects for a recovery in tourism and travel.
The slump in tourism and travel, reflecting restrictions and uncertainties related to people’s movement across borders (e.g. owing to quarantine measures), led to a collapse in consumption by non-residents. The effects of this collapse can be seen by looking at the difference between domestic consumption and national consumption (see panel (a) of Chart A). The former includes consumption of non-residents, whereas the latter only includes that of residents.[1] For example, in Italy and Spain, domestic consumption by non-residents plummeted by more than 90% year on year in the second quarter of 2020, and similar declines were recorded in consumption expenditure of residents of these countries abroad, significantly exceeding the fall in national consumption.
Because of the decline in cross-border travel, consumption gaps – the excess of domestic consumption over national consumption owing to net expenditures by non-residents – almost closed in the second quarter of 2020 (see panel (b) of Chart A).[2] In other words, tourism has worked as a shock amplification channel during the COVID-19 pandemic in countries which are net exporters of travel services (i.e. countries which receive a lot of tourists, such as Spain, Greece and Portugal), as they experienced a sharp contraction of domestic private consumption, and as a shock cushioning channel in countries which are net importers of travel services (e.g. Germany).[3] More specifically, in net creditors of travel services, the collapse of non-resident consumption expenditure caused domestic consumption to fall by more than national consumption, whereas the opposite occurred in countries which were net debtors of travel services before the onset of the COVID-19 pandemic. This pattern is also reflected in the sharp deterioration of the travel trade balance of the countries which are net exporters of travel services and in the improvement of the balance of net importers (see panel (a) of Chart A). Available data for the third quarter of 2020 show a partial and incomplete return of consumption gaps to the levels seen before the pandemic.

Chart A

National and domestic private consumption expenditure (PCE) and trade in travel services
(panel (a): year-on-year changes as a percentage (left-hand scale) and as a share of GDP (right-hand scale) in the second quarter of 2020; panel (b): share of GDP)

Sources: Eurostat and ECB staff calculations.Notes: Euro area represents the euro area aggregate. In panel (a) the trade balance in travel services is shown as a share of GDP. In panel (b) PCE gaps are computed as the difference between domestic PCE and national PCE, which corresponds to the net balance of foreign residents’ expenditure domestically minus domestic residents’ expenditure abroad. In panel (b) the latest observations are for the third quarter of 2020, with the exception of Greece. For the euro area the third quarter of 2020 has been estimated based on partially available information for euro area countries, which does not include data for Greece and Luxembourg.

A partial rebound notwithstanding, the data show that the foreign tourism sector remained depressed in the third quarter of 2020. Data on tourist arrivals continued to show significantly low figures for foreign arrivals when compared with the situation before the outbreak of COVID-19 (see panel (b) of Chart B). By contrast, domestic tourism remained relatively resilient and was able to partially compensate for the loss of foreign tourism, despite remaining below the levels seen in 2019. During the summer, short-haul destinations were more in demand and several governments launched promotional initiatives.[4] However, the latest available data suggest a fragile and incomplete recovery. In the euro area, tourist arrivals were less than two-thirds of the levels seen a year earlier. Tourism in countries relying on foreign arrivals, such as Greece and Portugal (see panel (a) of Chart B), still remains far below normal levels. Likewise, turnover in restaurants, and less so in accommodation, recovered but still stood at very low levels, supported by domestic tourists and locals.

Chart B
Tourist arrivals and services turnover
(panel (a): percentage of total; panel (b): ratio relative to the same quarter in the previous year)

Source: Eurostat.Notes: Owing to data availability, the ratios for tourist arrivals refer to August and September for Greece. Ratios for food and accommodation services turnover are not available for Greece or Italy.

Following the widespread resurgence of COVID-19 cases, since October 2020 most euro area countries have been reimposing restrictions. Visitors are currently subject to testing or quarantine in most countries, and entry for visitors from non-EU countries is only allowed for countries considered safe.[5] In most euro area countries, governments reimposed curfews and closed tourist attractions and recreational facilities such as museums, theatres, bars and restaurants. The reintroduction of travel restrictions since October will likely imply that the substitution of foreign tourism with domestic tourism will continue to affect the dynamics of tourism services in the near term. The latest restrictions may also alter the geographical impact of the crisis on the sector, as winter tourism destinations will be more severely affected this time.
Forward-looking indicators point to a renewed deterioration of the tourism sector as restrictions are reintroduced (see Chart C). Owing to travel bans, restrictions and renewed lockdown measures (shown by the green line), travel decreased after the summer and confidence effects are weighing strongly on bookings. This is shown by a reversal in the recovery of flight capacity (red line) which occurred across euro area countries. According to the latest data, flight capacity currently stands at about 25% of pre-COVID-19 levels. Forward-looking indicators such as PMI new orders in the tourism and recreation sectors declined again in November, staying in contractionary territory. Confidence in the accommodation industry also remains depressed and well below its historical average, as suggested by the respective European Commission confidence indicator.

Chart C
Latest developments in tourism
(left-hand scale: standardised index; right-hand scale: percentage relative to the same period in the previous year)

Sources: Markit, HAVER, European Commission, OAG, Eurostat and Oxford COVID-19 Government Response Tracker.Notes: The PMI is for the EU. Accommodation is measured by the European confidence indicator. The data on flights are for Germany, Spain, France and Italy only. The stringency index is an average across euro area countries weighted by the share of tourist arrivals in 2019. Complements (100-value, where 100 is maximum stringency) of the stringency index are reported so that an increase in the series corresponds to easing and a decrease to higher stringency.

Compliments of the European Central Bank.
The post ECB | Developments in the tourism sector during the COVID-19 pandemic first appeared on European American Chamber of Commerce New York [EACCNY] | Your Partner for Transatlantic Business Resources.