EUROPEAN COMMISSION Brussels, 19.1.2021 COM(2021) 35 final COMMUNICATION FROM THE COMMISSION TO THE EUROPEAN PARLIAMENT, THE EUROPEAN COUNCIL AND THE COUNCIL EMPTY A united front to beat COVID-19



INTRODUCTION The turn of the year is likely to mark the beginning of the end of the COVID-19 pandemic. Thanks to pioneering science and remarkable political and industrial efforts, what is normally done in ten years was achieved in ten months and with speedy, mass vaccinations being rolled out, millions of Europeans have now been vaccinated against COVID-19. However, while infections rise and until vaccinations are done on a scale required to turn the tide of the pandemic, continued vigilance, containment measures and public health controls will be required. The EU and Member States must act now to contain the risk of a potentially harsher third wave of infections, characterised by the more transmissible new variants of the virus, which are already present across Europe. With the hope and sobriety that this brings, must come a renewed and united determination for Europe to act together to: ØSpeed up vaccination and vaccine supplies ØRamping up testing and sequencing to control infections and new variants ØEnsure the functioning of the Single Market ØShow international leadership and solidarity with its partners This Communication sets out the decisions and coordinated approach needed to deliver on these four priorities in the Leaders’ Meeting on 21 January. It builds on the experience of the last weeks, latest scientific advice and the ‘Staying safe from COVID-19 during winter’ Communication adopted in December. In a race against time, acting together now will help us protect more lives and livelihoods later and relieve the burden on already stretched health care systems and workers. This is how Europe will move together to the beginning of the end of the pandemic. 1.Speeding up vaccination The EU Vaccines Strategy has proved a success in securing for Member States the quantity and quality of vaccines needed. This was done by supporting their development, encouraging their production, and procuring their supply. Building on the negotiating strength of 27 Member States and 450 million people, the European Commission was able to secure 2.3 billion doses as part of the broadest portfolio of safe and secure COVID-19 vaccines in the world. This European approach will allow more than 1 billion people in Europe, its neighborhood and beyond to be vaccinated. The already-authorised BioNTech/Pfizer and Moderna vaccines alone will provide doses for 380 million people, or over 80% of the EU’s population. The expert scrutiny of the European Medicines Agency ensures the safety of all vaccines. The EMA is currently assessing a third vaccine – Oxford/AstraZeneca – with a decision due by the end of the month. It has started a rolling review of the Johnson & Johnson vaccine.

More vaccinations, more swiftly The vaccination of Europeans started during the European Vaccination Days from 27 to 29 December 2020. Since then over 13 million doses (12.25 million doses by BioNTech-Pfizer and 850.000 doses by Moderna) have been delivered to Member States based on a pro-rata population distribution key and over 5 million vaccinations have been administered in the EU. While each Member State vaccinates in line with its own strategy, it is important that vaccination efforts in Europe stay largely synchronised – for health-related and Single Market reasons alike. However, early data suggests significant differences between Member States in the percentage of people vaccinated, ranging from above to 2% to below 0.5%. While it is still early days, it is important to keep track of progress and in this spirit the Commission and the European Centre for Disease Prevention and Control will set up a system to monitor progress with vaccine deployment to support fast and efficient roll-out in all Member States. Vaccination is not a race between countries but is a race against time. As new variants spread, speeding up the administration of vaccines becomes all the more acute. Vaccination requires a complex set of management and logistical steps, as well as a readiness to scale these up in line with increases in supply. These include having adequate stocks, effective appointment management systems, organising locations and facilities for mass vaccination, the preparation of necessary cold storage, and the training of extra personnel. To support this, the Commission will work with companies to develop a transparent and clear delivery schedule of the different vaccines. It has secured a supply line of vital medical equipment needed for vaccination via EU Joint Procurement, from which Member States can now place orders. To ensure an ambitious vaccination effort concrete targets are essential. What gets measured gets done: ØBy March 2021, Member States should have vaccinated a minimum of 80% of health and social care professionals and people over 80 years old. ØBy summer 2021, Member States should have vaccinated a minimum of 70% of the adult population. Meeting these two targets would, in a first instance, reduce death and hospitalisation rates, relieve pressure on healthcare systems and then put Europe on track for herd immunity, helping to protect those who cannot be vaccinated and providing a bulwark against the spread of the virus. A successful deployment of vaccines will also help put Europe’s economy on a solid recovery path. Ramping up vaccine production, supplies and information To meet these objectives, we will need to ramp up the supply of vaccines. The European Commission and the EIB have continuously supported the increase of manufacturing capacities in the EU via the Advance Purchase Agreements and EIB loans. They will continue working with manufacturers to maximise production capacity in the EU. To this end, the Commission will engage in a structured dialogue with the actors in the vaccine manufacturing value chain. Support may take different forms such as investment support for manufacturing plants, encouraging, and facilitating where needed, agreements between manufacturers to repurpose facilities to produce each other’s approved vaccines and further expand capacities via manufacturing under contract. This will also help to overcome any supply chain issues. The Commission and Member States should work together with companies to ensure that new production comes on stream as quickly as possible. It will also work with the EMA to speed up the approval process for new production facilities. The ECDC will use stress-testing to identify successful logistical steps – such as how to set up vaccination centres and how to run electronic reservation systems – to make a stock of good practice and practical advice available to Member States.

To support this, EU-wide COVID-19 vaccine safety and effectiveness studies will be conducted and coordinated by the EMA and ECDC. The Commission will support the exchange of scientific information and good practice, involving the EU Scientific Advice Platform on Covid-19. Clear and continuous communication on the importance and safety of vaccines remains essential to address vaccine hesitancy and combat disinformation and misinformation. Vaccination documentation and mutual recognition As more people are vaccinated, the documentation and mutual recognition of vaccination become of utmost importance. Vaccination certificates allow for a clear record of each individual’s vaccination history, to ensure the right medical follow-up as well as the monitoring of possible adverse effects. A common EU approach to trusted, reliable and verifiable certificates would allow people to use their records in other Member States. Though it is premature to envisage the use of vaccine certificates for other purposes than health protection, an EU approach may facilitate other cross-border applications of such certificates in the future. The Commission will continue to work with Member States on vaccination certificates which can be recognised and used in health systems across the EU in full compliance with EU data protection law – and scaled up globally through the certification systems of the World Health Organisation. The eHealth Network will define the minimum dataset needed for such certificates at EU level, including a unique identifier and an appropriate trust framework ensuring privacy and security. This work should be completed by the end of January 2021 and presented in the WHO as a possible universal standard. KEY ACTIONS ·Member States should set targets to vaccinate minimum 80% of health and social care professionals and people over 80 years old by March 2021 and minimum 70% of the total adult population by summer. ·The Commission, Member States and the EMA will work with companies to maximise vaccine manufacturing capacity; ·Based on data to be provided by Member States, the ECDC will publish latest information on doses delivered and administered on a twice weekly basis; ·The Commission will work with vaccine manufacturers to publish and update delivery schedules. ·A common approach on vaccination certificates to be agreed by the end of January 2021 to allow Member States’ certificates to be rapidly useable in health systems across the EU and beyond; ·Commission to set up large-scale EU-wide COVID-19 vaccine safety and effectiveness studies. ·ECDC to develop stock of stress-tested logistical advice for use by Member States. 2.Dealing with variants The recent emergence of new variants of the virus is a real cause for concern. While currently there is no evidence that these cause more severe disease, the variants appear to be somewhere between 50–70 % more transmissible. This means that the virus can spread more easily and more quickly, increasing the burden on overstretched healthcare systems. This is one likely cause for the substantial rises in cases in most Member States over recent weeks. Figure 1. Timeline of positive COVID cases, suggesting a third wave. The emergence of recent variants has also raised concerns about potential impacts on the effectiveness of vaccines. There is presently no evidence that the variants decrease the protection offered by any of the vaccines now on the market or in phase III clinical trials. However, it is important to monitor the situation closely and to take steps now to reduce the development time that would be needed if vaccines needed to be modified. Vaccine manufacturers should be ready to provide the EMA with relevant data to accelerate the process if needed. Speeding up genome sequencing The speed at which variants are identified is critical to identify their threat and the policy response needed. Genome sequencing allows the tracking of changes in viral genomes, critical to understand the progress of the virus and to screen for variants. It can help to identify variants, which increase the risk, either by faster spreading or more severe symptoms.

The EU urgently needs to speed up sequencing. Currently only one Member State is testing above 1% of samples, while all others are either not sequencing enough or at all. This rate of sequencing is not enough to identify the progression of the variants or detect new ones. The ECDC is currently developing specific guidelines for sequencing, tailor-made for each new variant. Such work relies on data from genome sequencing being shared across the EU and with our international partners. All EU Member States should reach a capacity of sequencing at least 5% - and preferably 10% - of positive test results. The delays in results should be minimised and Member States should ensure that this data be shared in a comparable form. The ECDC has the capacity to complement and supplement national genome sequencing capacity by up to 18,000 virus samples. So far, only two Member States have used this service with two more expected to do so soon. Member States, especially those with no national capacities, should use the ECDC’s capacity as a matter of urgency. The Commission will also support Member States to increase capacity, for example by mobilising funds to purchase genome-sequencing equipment and to support the WHO Reference Laboratory Network. Existing sequencing equipment in national research facilities should be used to the full. The Commission will leverage initiatives and resources on genomic data, Artificial Intelligence and High Performing Computers to support vital genomic data processing and analysis . Ramping up testing Effective testing plays a key role in mitigating the spread of the virus, providing the key information for contact tracing as well as wider trends. It also facilitates the free movement of people and the smooth functioning of the internal market. Although RT-PCR tests remain the gold standard, the use of Rapid Antigen Tests (RATs) should be expanded. So far, nine Member States have strategies or specific guidance in place for the use of RATs and twelve EU Member States are currently using them in practice. Swift implementation of all Commission recommendations and swift agreement in the Council on the common framework for rapid antigen tests are essential to provide the testing system required. This is particularly important in the context of new variants. National testing strategies need urgent updating to take account of the new variants. This will enable follow-up and quarantining of people in areas with a significantly higher incidence of the variant and should be accompanied by specific contact tracing. Further work is also needed to support mutual recognition of the results of COVID-19 tests between Member States. The Joint Research Centre should establish a common list of RATs and their uses, as agreed by Member States with support from the EU Health Security Committee. The Commission will work with Member States on a standard set of data to be included on the test results form. The developments of other rapid nucleic acid-based tests to detect the virus should also be explored.

The Commission is directly helping Member States scale up their testing capacity via direct purchases, joint procurements and specific funding. It is purchasing over 21 million RATs for delivery to Member States by April, with €100 million from the Emergency Support Instrument (ESI). A further joint procurement for rapid antigen tests has been launched and will allow a much larger scale of procurement in the coming months. The International Federation of Red Cross is supporting Member States to increase testing capacity, with funding from the Emergency Support Instrument. More generally, since its adoption, the Coronavirus Response Investment Initiative (CRII) has enabled the mobilisation of €6.8 billion of Cohesion funds for healthcare overall. KEY ACTIONS Sequencing ·Member States to urgently increase genome sequencing to 5-10% of positive test results, if needed by using ECDC capacity; ·Member States to share genomic sequences at EU level; ·Commission to support Member States to increase capacity for sequencing in the near future. Testing ·Member States to implement Commission recommendations and swiftly agree on the Council Recommendation on the common framework for Rapid Antigen Tests; ·Member States should update testing strategies to incorporate the use of rapid antigen tests and develop guidance on the use of these tests; ·Member States to agree on a common list of Rapid Antigen Tests by end January; ·Commission and Member States to establish a standard set of data to be included on the results form of COVID-19 tests; ·Member States to update testing strategies to reflect the new variants during February 2021. 3.Preserving The Single Market And Free Movement While Stepping Up Mitigation Measures The backbone of the strong European response to the COVID pandemic has been unity and the preservation of the function of the Single Market. As the events of March 2020 underlined, uncoordinated and hasty border closures and export restrictions will not stop the virus, but instead weaken the Single Market and our economies, and the exercise of the right to free movement within the EU. All Member States have implemented significant measures to control and mitigate the impact of the pandemic on their population. Whilst these measures come at a high cost for the economy, social contact, and people’s well-being, they are effective in controlling the spread of the virus. Mitigation measures should be maintained until vaccination is sufficient to reduce the risks. However difficult this message will be for many citizens, the reality is that this is a necessary investment to save lives and speed up the return to a society with fewer restrictions. Measures such as testing, isolation, contact tracing and quarantine of individuals remain necessary tools for the time being. Communication and consistent messages remain as essential as ever, including explaining the continued need for restrictive measures, such as masks or physical distancing. A common EU approach to define incidence rates, which could trigger the relaxation of restrictions, would boost public confidence through tracking progress. Travel will continue to pose a particular challenge. All non-essential travel, especially to and from high risk areas, should be strongly discouraged until the epidemiological situation has considerably improved, particularly in the light of the outbreak of new variants. Border closures or blanket travel bans and suspension of flights, land transport and water crossings are not justified, as more targeted measures have sufficient impact and cause less disruption. The system of “Green Lanes” should keep transport flows moving, in particular to ensure the free movement of goods thus avoiding supply chain disruptions. Restrictions on travel should be proportionate and non-discriminatory, in line with the Council Recommendation of October 2020. Proportionate restrictions, including testing of travellers, should be maintained for those travelling from areas with a higher incidence of variants of concern. Applicable quarantine rules should be respected and enforced, with exceptions for travellers with an essential function or need, such as transport workers, health and social care, frontline, cross-border and seasonal workers. The Commission will assess whether new developments, such as the newly identified variants of concerns, require updates of the current framework on coordinating restrictions to free movement in response to the COVID-19 pandemic. Measures should be applied to further reduce the risk of transmission linked to the means of travel, such as hygiene and distancing measures in vehicles and terminuses. Testing shortly before travelling where people are in a confined space with others should be considered. Contact tracing remains of particular importance. The Passenger Locator Form exchange platform is designed to allow participating Member States to quickly identify and contact all passengers that, unknowingly, have been close contacts of a positive passenger. Three Member States – Italy, Spain and Slovakia – have already taken part in a successful pilot. KEY ACTIONS ·A common EU approach on defining incidence rates should be put in place; ·Member States should give particular attention to restrictions applying to people arriving from areas with a high incidence of the new variants. All non-essential travel should be discouraged until the epidemiological situation improves; ·Proportionate, non-discriminatory travel restrictions and testing of travellers should be maintained, in particular from areas with a higher incidence of variants of concern. ·Where required, quarantine of travellers should be strictly enforced, with appropriate exceptions for travellers with an essential function or need. 4.Ensuring European Leadership and International Solidarity The COVID-19 pandemic is putting an unprecedented strain on the whole world, with more than 93 million cases and 2 million deaths reported worldwide. This only underlines the need for a global response to this global crisis. Multilateralism, international cooperation, transparency and solidarity must remain embedded in our response. The EU is already leading international efforts, both through its own efforts and through bringing the key players together. Since its launch in April 2020, a global recovery package of €38.5 billion delivered under a common “Team Europe” approach has been supporting partner countries with emergency response to humanitarian needs, strengthening health systems and crucial health services, and assisting economic recovery and social support. Humanitarian assistance totalling €449 million has been mobilised in the form of medical supplies, medical staff, logistical help and funding support to humanitarian organisations. Team Europe has also mobilised €853 million in support of COVAX, the global initiative to ensure equitable and fair access to safe and effective vaccines. The EU as a whole is COVAX's biggest donor. EU Vaccine Sharing Mechanism