EU Vaccine Strategy

Six contracts have been concluded that allow the purchase of a vaccine once proven safe and effective:

AstraZeneca

On 14 August, the European Commission reached a first agreement with the pharmaceutical company AstraZeneca to purchase a potential coronavirus vaccine, as well as to donate or re-direct vaccines to other European or other lower and middle-income countries. On 27 August, the first contract that the Commission negotiated on behalf of the EU Member States with a pharmaceutical company entered into force following the formal signature between AstraZeneca and the Commission. AstraZeneca’s vaccine candidate has already entered large-scale Phase II / III clinical trials after achieving promising Phase I / II results in safety and immunogenicity. Once the vaccine is proven safe and effective against the coronavirus, the Commission has agreed to purchase 300 million vaccine doses on behalf of Member States, with an option for an additional purchase of 100 million doses. The agreement is financed with the Emergency Support Instrument, and the Commission continues discussing similar agreements with other vaccine manufacturers.

Sanofi-GSK

On 18 September, a second contract between Sanofi-GSK and the European Commission entered into force following the contract’s formal signature. Once Sanofi-GSK vaccine has proven to be safe and effective against COVID-19, the contract will allow all EU Member States to purchase up to 300 million doses of the vaccine. Moreover, Member States may donate reserved doses to lower - and middle-income countries. The contract was preceded by exploratory talks between Sanofi-GSK and the Commission.

The companies started a Phase I / II study in September, followed by a Phase III study by the end of 2020. If successful, and subject to regulatory considerations, the companies aim to have the vaccine available by the second half of 2021.

Sanofi and GSK will also endeavour to provide a significant portion of their vaccine supply through a collaboration with the COVID-19 Vaccines Global Access facility (COVAX) - the vaccine pillar of the Access to COVID-19 Tools Accelerator for lower and middle income countries - in a timely manner.

Johnson & Johnson

On 21 October, the European Commission approved a third contract with a pharmaceutical company, Janssen Pharmaceutica NV, one of the Janssen Pharmaceutical Companies of Johnson & Johnson. Once the vaccine has proven to be safe and effective against COVID-19, the contract allows Member States to purchase vaccines for 200 million people. They will also have the possibility to purchase vaccines for an additional 200 million people. The Janssen COVID-19 vaccine candidate leverages the AdVac® technology platform, which was also used to develop and manufacture Janssen’s recently approved Ebola vaccine and the Zika, RSV, and HIV vaccine candidates. The vaccine candidate is already in phase III of clinical trials. Member States may also decide to donate the vaccine to lower and middle income countries or to re-direct it to other European countries.

BioNTech-Pfizer

On 11 November, the European Commission approved a fourth contract with a pharmaceutical company, BioNTech-Pfizer, which provides for the initial purchase of 200 million doses on behalf of all EU Member States, plus an option to purchase up to a further 100 million doses, to be supplied once a vaccine has proven to be safe and effective against COVID-19. Member States can decide to donate the vaccine to lower and middle-income countries or to re-direct it to other European countries.

CureVac

On 19 November, the European Commission approved a fifth contract with the pharmaceutical company CureVac. The contract provides for the initial purchase of 225 million doses on behalf of all EU Member States, plus an option to request up to a further 180 million doses, to be supplied once a vaccine has proven to be safe and effective against COVID-19. Member States can also decide to donate the vaccine to lower and middle-income countries or to re-direct it to other European countries. CureVac, a European company based in Germany, signed a €75 million loan agreement with the European Investment Bank on 6 July for the development and large-scale production of vaccines, including CureVac's vaccine candidate against COVID-19.

Moderna

On 25 November, the European Commission approved a sixth contract with Moderna to purchase a potential vaccine against COVID-19. The contract provides for the initial purchase of 80 million doses on behalf of all EU Member States, plus an option to request up to a further 80 million doses, to be supplied once a vaccine has proven to be safe and effective against COVID-19. The envisaged contract would provide for the possibility for all EU Member States to purchase the vaccine, as well as to donate to lower and middle income countries or re-direct to European countries.

Moderna is a U.S. based company pioneering the development of a new class of vaccines based on messenger RNA (mRNA). This molecule acts as a data carrier and informs the body on how to make proteins that trigger immunity to COVID-19. This vaccination method has been developed over the last decade.

The Commission has taken a decision to support this vaccine based on a sound scientific assessment, the technology used, and its production capacity in Europe to supply the whole of the EU.

The exploratory talks are intended to result in an Advance Purchase Agreement to be financed through the Emergency Support Instrument, which has funds dedicated to the creation of a portfolio of potential vaccines produced by different companies.

EU Vaccine Strategy

On 17 June, the European Commission presented a European vaccine strategy to accelerate the development, manufacturing and deployment of vaccines against COVID-19. A safe and effective vaccine against is our best bet to overcome the pandemic. Every month gained in finding such a vaccine saves lives, livelihoods and billions of euro.

Questions and answers on the EU Vaccination strategy.

Vaccine development is a complex and lengthy process, which normally takes around 10 years. With the vaccine strategy, the Commission will support efforts and accelerate the development and availability of safe and effective vaccines in a timeframe between 12 and 18 months, if not earlier. At the same time strict and robust authorisation procedures and safety standards will be respected at all times. This requires running clinical trials in parallel with investing in production capacity to be able to produce millions, or even billions, of doses of a successful vaccine.

Currently, it is unknown which potential vaccine, if any, will successfully complete the development and authorisation process and thus meet efficacy and safety criteria to be placed on the EU market. Europe needs a broad portfolio of vaccine candidates based on different technological approaches to maximise the chances of quickly developing, manufacturing and deploying a vaccine for all Europeans.

As large-scale COVID-19 vaccination will be an important undertaking, on 15 October, the Commission published a Communication on preparedness for COVID-19 vaccination strategies and vaccine deployment. Member States should start preparing already. Key elements to be considered for national vaccination strategies include:

  • capacity of vaccination services to deliver COVID-19 vaccines, including skilled workforce and medical and protective equipment;
  • easy access to vaccines for target populations, both in affordability and physical proximity;
  • deployment of vaccines with different characteristics and storage and transport needs, in particular in terms of cold chain, cooled transport and storage capacity;
  • clear communication on benefits, risks and importance of COVID-19 vaccines to build public trust

As the availability of the vaccines improves, vaccines strategies and their objectives will need to be adjusted accordingly. For example, while strategies are likely to focus in the beginning on decreasing the rate of fatalities and the burden on essential services. Later in the vaccination deployment process this may shift to the reduction of wider societal and economic restrictions. Meanwhile, high on the list of actions is a decision on which groups should have priority access to vaccines. Consideration should be given to the following groups (unranked):

  • healthcare workers
  • persons over 60 years of age
  • persons whose state of health makes them particularly at risk
  • essential workers outside the health sector
  • workers who cannot socially distance
  • vulnerable socioeconomic groups and other groups at higher risk

Once available, proven safe and effective, and authorised at EU level, all Member States will have access to COVID-19 vaccines at the same time. The overall number of vaccine doses will be limited during the initial stages of deployment and before production can be ramped up.

The Commission will put in place a common reporting framework and a platform to monitor the effectiveness of national vaccine strategies. To share the best practices, the conclusions of the first review on national vaccination plans will be presented in November 2020.

Companies with a promising vaccine candidate, already in or close to starting clinical trials, are invited to contact the Commission at EC-VACCINES@ec.europa.eu

Learn more

Global cooperation

On 18 September, the European Commission confirmed its participation in the COVAX Facility for equitable access to affordable COVID-19 vaccines, following its  announcement of a contribution of €400 million. On 12 November, the European Union announced it will contribute an additional €100 million in grant funding to support the COVAX Facility to secure access to the future COVID-19 vaccine in low and middle-income countries. The funds will complement the €400 million in guarantees the EU already committed for COVAX, making the Union one of the leading donors.

COVAX is the vaccines pillar of the Access to COVID-19 Tools (ACT) Accelerator, a global collaboration to accelerate the development, production, and equitable access to COVID-19 tests, treatments, and vaccines. On 21 September, the European Commission joined the statement by Friends of the COVAX Facility to strongly support vaccine multilateralism and the goal of ensuring affordable, fair and equitable access to safe and effective COVID-19 vaccines for all.

Launched at the end of April 2020, the Access to COVID-19 Tools Accelerator brings together governments, scientists, businesses, civil society, and philanthropists and global health organizations (the Bill & Melinda Gates Foundation, CEPI, FIND, Gavi, The Global Fund, Unitaid, Wellcome, the WHO, the World Bank and Global Financing Facility). It intends to accelerate the development of universally accessible vaccines, therapeutics and diagnostics, and the improvement of the necessary health systems. Knowledge and data sharing are key.

The Council builds on what the Access to COVID-19 Tools Accelerator has achieved- more than 200 vaccine candidates, 1700 clinical trials, and 80 diagnostics, as well as 100 countries have been surveyed to identify capacity gaps. The Facilitation Council is composed by governments and non-governmental partners. It is co-chaired by Norway and South Africa, achieving geographical balance.

To date, a total of 184 countries participate in the COVAX Facility, being 92 of them low and middle-income economies eligible to get access to COVID-19 vaccines through Gavi COVAX Advance Market Commitment (AMC).

Treatments

Authorised medicine

On 7 October, the European Commission signed a joint procurement framework contract with the pharmaceutical company Gilead for the supply of up to 500,000 treatment courses of Veklury, the brand name for Remdesivir. Some 36 signatories of the Joint Procurement Agreement participate, including all EU countries, EEA countries, the UK, as well as six candidate countries and potential candidates (Albania, the Republic of North Macedonia, Montenegro, Serbia, Bosnia and Herzegovina and Kosovo). All participating countries can now place their orders to procure Remdesivir directly. Remdesivir is at this stage the only medicine with a conditional marketing authorization in the EU for the treatment of COVID-19 patients needing oxygen supply.

The Commission’s Emergency Support Instrument will finance the contract, worth a total of €63 million. This will ensure the treatment of approximately 30,000 patients with severe COVID-19 symptoms. This will help to cover the current needs over the next few months, while ensuring a fair distribution throughout the EU, taking the advice from the European Centre for Disease Prevention and Control into account.

On October 27, the Italian pharmaceutical regulatory agency, AIFA, gave the go ahead for a clinical trial of the use of Raloxifene in patients with mild symptoms caused by the coronavirus. The clinical study should validate the safety and efficiency of Raloxifene in blocking the replication of the virus in cells, and thus hold up the progression of the disease. In the initial phase, up to 450 participants in three separate treatment groups will be administered a 7-day treatment of Raloxifene capsules in a randomised sample.

Using donated plasma from recovered patients

Convalescent plasma could be a promising treatment for COVID-19. The treatment consists of transfusing convalescent plasma to sick patients to help them fight off the disease. Plasma transfusions are also used to purify antibodies to make a specific COVID-19 medicinal product (immunoglobin) as short-term alternative to vaccines. This product can be given as an injection to patients, vulnerable persons and healthcare workers, or as a treatment.

The efficacy of these treatments is still being investigated worldwide, including in an EU research project funded by Horizon 2020. Preliminary results are promising while the results from full clinical trials are forthcoming.

On 31 July, the European Commission invited more than 200 blood-collection services from around the EU to apply for funding for the purchase of plasmapheresis equipment - equipment that collects plasma from recovered COVID-19 patients who are willing to donate. The additional equipment will increase the capacity to collect convalescent plasma. When using plasmapheresis, donors can donate high volumes of plasma at one time once every 2 weeks. For comparison, with blood donations, this can only done once every 3-4 months. Additionally, ‘super donors' – donors whose plasma is particularly rich in antibodies - can be asked to give donations many times over a period of months.

Grants will be provided to public and NGO blood-collection services authorised to collect plasma. The invitation is valid for a month, and has a budget of €40 million funded through the Emergency Support Instrument. The allocation of grants will be done according to the needs expressed by Member States’ blood-collection services.

European Health Union

On 11 November, the European Commission took the first steps towards building the European Health Union. The Commission has put forward proposals to strengthen the EU’s health security framework, increase preparedness at the EU and national levels, improve data reporting on health care systems crisis coordination and reinforce health surveillance powered by artificial intelligence and other advanced technologies. Drawing lessons learned from the current crisis, today’s proposals will ensure stronger preparedness and response during the current and future health crises.

 The European Centre for Disease Prevention and Control, and the European Medicines Agency have been at the forefront of the EU’s work to address the coronavirus pandemic. Their mandates will be reinforced so that they can better support the Member States and the Commission.

European Health Union

Pharmaceutical Strategy for Europe

The Commission adopted a Pharmaceutical Strategy for Europe on 24 November to ensure that patients have access to innovative and affordable medicines while supporting   competitiveness, innovation and sustainability of the EU’s pharmaceutical industry. The Strategy will allow Europe to cover its pharmaceutical needs, including in times of crisis, through robust supply chains. The Strategy, as a key component of the European Health Union, will help establish a future-proof and crisis-resilient EU pharmaceutical system, including by drawing lessons from the COVID-19 pandemic.

Europe’s Pharmaceutical Strategy has four main objectives:

  • Ensuring access to affordable medicines for patients, and addressing unmet medical needs (e.g. in the areas of antimicrobial resistance, cancer, rare diseases);
  • Supporting competitiveness, innovation and sustainability of the EU’s pharmaceutical industry and the development of high quality, safe, effective and greener medicines
  • Enhancing crisis preparedness and response mechanisms;
  • Ensuring a strong EU voice in the world, by promoting a high level of quality, efficacy and safety standards.

Pharmaceutical Strategy for Europe

Emergency support

The Emergency Support Instrument provides support to help Member States in their efforts to address the COVID-19 pandemic. It provides a broad EU tool-box to respond to needs which can be best addressed in a strategic, coordinated manner at European level. As a financing arm of the Joint European Roadmap towards lifting COVID-19 containment measures, the instrument helps mitigate the immediate consequences of the pandemic and anticipate the needs related to the exit and recovery.

The Emergency Support Instrument is based on the principle of solidarity and pools efforts and resources to quickly address shared strategic needs. It is an important European top-up for the existing national and other European measures to tackle the ongoing public health crisis

EU medical and health support

Supporting the training of healthcare professionals

On 18 August, the Commission signed a contract making €2.5 million in funding available for training of a multidisciplinary pool of healthcare professionals in intensive care skills. The training, funded by the Emergency Support Instrument, will provide medical skills to healthcare professionals who do not regularly work in intensive care. This will help increase the capacity of adequate medical staff that could be deployed in case there is a need for a rapid, temporary and significant scale-up of intensive care capacities. The training programme will evenly cover the EU between August and December 2020, and will support a minimum of 1,000 hospitals by enrolling some 10,000 doctors and nurses.

On 7 May, the Commission issued a guidance to Member States to help address the shortages of health workers created by the coronavirus crisis. The guidance will help to speed up the recognition of health workers’ professional qualifications, and clarify the rules allowing doctors and nurses in training to practice their profession. The guidance recommends that Member States speed up procedures to facilitate the mutual recognition of qualifications in line with the ample flexibilities provided by the EU Professional Qualifications Directive. It further clarifies that Member States can request a derogation from the rules on minimum medical trainings requirements in cases where professionals are unable to complete their training due to disruptions caused by the pandemic.

Ensuring the availability of supplies and equipment

Public procurement of medical and protective equipment

Personal protective equipment – masks, gloves, goggles, face-shields, and coveralls – as well as medical ventilators and testing kits are vital for hospitals, healthcare professionals, patients, field workers and civil protection authorities. The voluntary Joint Procurement Agreement for medical equipment enables the joint purchase of such supplies. The Agreement is now signed by 37 countries, including all EU and European Economic Area countries, as well as Albania, Bosnia and Herzegovina, Montenegro, North Macedonia, Serbia and Kosovo*. (*This designation is without prejudice to positions on status, and is in line with UNSCR 1244/1999 and the ICJ Opinion on the Kosovo declaration of independence.)

The Commission launched seven calls for tenders for the supply of medical countermeasures on 28 February (gloves and coveralls), 17 March (goggles, face shields and masks, as well as ventilators), 19 March (laboratory equipment, including testing kits), 17 June (Intensive Care Unit medicines), 11 September (therapeutic remdesivir – veklury) and 28 September (medical equipment for COVID-19 vaccination) - with participation of up to 36 countries. These initiatives are proving successful. Framework contracts following the first four joint procurement procedures have been signed and Member States can place orders for:

  • Personal protective equipment (coveralls, gloves, googles, face-shields and masks);
  • Ventilators;
  • Laboratory equipment (kits, reagents, swabs, and laboratory consumables).
  • Therapeutic remdesivir (Veklury) - the only medicine with a conditional marketing authorization in the EU for the treatment of COVID-19 patients needing oxygen supply.

The Joint Procurement Agreement on Intensive Care Units medicines framework contracts are under preparation to be signed soon.

When conducting joint procurements, the European Commission has a coordinating role, while the Member States purchase the goods.

ITEMS

AVAILABLE SINCE

VOLUME

(OVER 12 MONTHS)

BUDGET CEILING

gloves icon

Gloves and coveralls

April (gloves)

May (coveralls)

Several million

€97 million

eye respiratory protection icon

Eye and respiratory protection

 April

20 million goggles

12 million face shields

37 million FFP2 masks

26 million FFP3 masks

301 million surgical masks

€1,4 billion

ventilator icon

Ventilators

 April

110,000 units

€1,4 billion

lab equipment

Laboratory equipment

 May

30 different lots

€192 million

medicines icon

Medicines used in intensive care units

October (contracts are being signed)

21 medicines in
45 presentations,
over 103 million vials

€543 million

veklury icon

Remdesivir (Veklury)

 October

Over 500,000 treatment courses

€3,4 billion

On 28 October, the Commission announced that it will launch a new joint procurement for medical equipment for vaccination.

Guidance on using the public procurement framework

On 1 April, the European Commission published guidance on how to use all the flexibilities offered by the EU public procurement framework in the emergency situation related to the coronavirus outbreak. The guidance provides an overview of the tendering procedures available to public buyers, applicable deadlines, and examples of how public buyers could find alternative solutions and ways of engaging with the market to supply much needed medical supplies. This guidance makes it easier for public buyers to supply vital protective equipment and medical supplies to those in need, by making it easier to conduct public procurements while still upholding high safety and quality standards.

Disinfection robots to European hospitals

The Commission has purchased 200 disinfection robots that will be delivered to hospitals across Europe. Hospitals from most Member States expressed a need and interest in receiving these robots that can disinfect standard patient rooms using ultraviolet light in as quickly as 15 minutes. The process is controlled by an operator who will be located outside of the room which is to be disinfected in order to avoid any exposure to the UV light. The budget of up to €12 million comes from the Emergency Support Instrument.

Increasing European production capacities

To address the coronavirus outbreak, manufacturers in Europe and the European Commission must collaborate to massively ramp-up overall production of personal protective equipment. The Commission and the European Standardisation Organisations agreed on 20 March that all the relevant European harmonised standards will exceptionally be made freely and fully available for all interested companies. This action will help both EU and third-country companies to manufacture these items without compromising on our health and safety standards and without undue delays.

On 24 March, the Commission adopted decisions on revised harmonised standards that will allow manufacturers to place on the market high performing devices to protect patients, health care professionals and citizens in general. The revised standards play a pivotal role because they relate to critical devices such as medical facemasks, surgical drapes, gowns and suits, washer-disinfectors or sterilization.

The harmonised standards will cover equipment such as medical facemasks, personal eye protection, medical gloves, protective clothing as well as respiratory protective devices.

On 30 March, the Commission announced that it will be making guidance available in 3 areas to assist manufacturers in increasing the output of essential medical equipment and material: the production of personal protective equipment such as masks, leave-on hand cleaners and hand disinfectants and 3D printing. Guidance on medical devices in the coronavirus context was published on 3 April. These documents can assist manufacturers and market surveillance authorities in ensuring that these products are effective and comply with necessary safety standards.

Availability of medical equipment

On 23 April the Council and the European Parliament adopted the postponement by one year of the application of the Medical Devices Regulation, to allow health institutions and economic operators in Member States to prioritise the fight against the coronavirus pandemic, whilst continuing to ensure patient health and safety until the new legislation enters into force.

Availability of medicines

On 8 April the Commission called on Member States to ensure that Europeans have access to necessary and affordable medicines during the coronavirus outbreak, whilst protecting public health and preserving the integrity of the Single Market. The Commission issued guidelines to ensure the rational supply, facilitation of transport, allocation and use of vital medicines and prevent any shortages

Matching demand with supply for medical equipment

The Commission has set up a ‘clearing house for medical equipment’, which is active since April 2020. It aimed at facilitating the identification of available supplies, including testing kits, and facilitating their matching with demand by the Member States. Find out more on the Commission Clearing House for medical equipment.

Stockpiling and distributing supplies and equipment

On 19 March, as an additional safety net, the Commission proposed creating a strategic RescEU stockpiling – a common European reserve -  of medical equipment such as ventilators, personal protective equipment, reusable masks, vaccines and therapeutics and laboratory supplies. The Commission will finance 100% of the costs of the stockpiling and will manage the distribution of the equipment to ensure it goes where it is needed most.

A first delivery of some 90,000 protective masks coming from the strategic rescEU distribution centre in Romania has safely arrived in Italy on 27 April. This delivery comes in addition to teams of doctors and nurses, and stocks of equipment that have been sent bilaterally and via the EU civil protection mechanism. RescEU is now fully up and running.

Export authorisations

Already on 15 March, the Commission took steps to secure the availability of personal protective equipment, by requiring exports of such equipment destined for outside the European Union to be subject to an export authorisation by Member States. On 19 March, the Commission approved guidance (accompanied by an annex) on how to implement these measures. As a result, almost all Member States have lifted by now national export restrictions and the protective equipment can be delivered seamlessly across the Union to where it is most needed.

The Commission has decided to exempt Norway, Iceland, Liechtenstein and Switzerland (countries part of the European Free Trade Association) from the export authorisation requirements. Similar exemptions have been granted to Andorra, the Faroe Islands, San Marino and the Vatican, as well as the associated countries and territories that have special relations with Denmark, France, the Netherlands and the United Kingdom (so-called Annex II countries).

On 24 April the Commission adjusted the export authorisation scheme for personal protective equipment to current needs. It reduces the list of products requiring export authorisation for masks, spectacles and protective garments, extends the geographical exception to include the Western Balkans, and requires Member States to swiftly grant authorisations for exports for humanitarian purposes. The measures remain temporary, for a duration of 30 days, and will be notified on 24 April to the World Trade Organisation partners.

Temporarily lifting customs duties and VAT on imports

The Commission has decided to approve requests from all Member States and the UK to temporarily waive customs duties and VAT on the import of medical devices, and protective equipment, from third countries. This will make it easier financially to get the medical equipment that doctors, nurses and patients desperately need. The Commission also published specialised guidance to ease the work of Member State customs authorities, and other relevant stakeholders, when dealing with customs procedures, e.g. minimising formalities on the import of human organs and bone marrow destined for transplant in the EU or various payment facilities for handling customs debt or proving preferential origin of goods.

In order to give Member States better and cheaper access to the tools needed to prevent, detect and treat COVID-19, on 28 October, the Commission extended the temporary suspension of customs duties and VAT, on the import of medical equipment from non-EU countries. The Commission also proposed that hospitals and medical practitioners should not have to pay VAT on vaccines and testing kits used in the fight against the coronavirus.

Supporting Member States in need and cross-border health cooperation

The European Commission’s Emergency Response Coordination Centre plays a key role in relief efforts and stands ready 24/7 to assist all countries, in Europe and beyond, that request specific support. This can take the form of co-financing of transport assistance, including personal protective equipment and other support such as the provision of expertise.

In addition, on 2 April the Commission adopted Guidelines on cross-border healthcare cooperation between national, regional and local authorities. The aim is to facilitate the transfer of patients from one Member State to another, help qualified medical personnel to offer their assistance in other Member States and relieve the burden that the current outbreak has placed on national health systems. The Guidelines provide for arrangements for patient mobility across borders, steps for the reimbursement of healthcare costs, and encourage national authorities to use existing bilateral and regional agreements. The requests for cross-border healthcare assistance will be coordinated by the Health Security Committee, chaired by the Commission, and the EU Early Warning and Response System

EU Solidarity for Health Initiative

On 2 April, the European Commission launched the EU Solidarity for Health Initiative, aimed at directly supporting the healthcare systems of EU Member States in combating the coronavirus pandemic. This initiative will provide for around €6 billion to cater for the needs of European health systems. Half of the amount will come from what is left of the EU budget, with the other half coming from additional contributions requested from Member States. The initiative will enable the Commission to purchase emergency support on behalf of Member States and distribute medical supplies, financially support and coordinate transportation of medical equipment and of patients, support the recruitment of additional healthcare workforce and support the construction of mobile field hospitals.

High-quality coronavirus testing

Testing is key to slow down the spread of the coronavirus.

On 18 November, the European Commission adopted a recommendation on the use of rapid antigen tests for the diagnosis of COVID-19. This follows the Commission’s recommendation on 28 October to ensure a common approach and more efficient testing strategies across the EU - setting out key elements to be considered for national, regional or local testing strategies such as their scope, priority groups, and other key points linked to testing capacities and resources.

The recommendation on the use of rapid antigen tests - how to select rapid antigen tests, when they are appropriate and who should perform them - aims to ensure the free movement of people and the smooth functioning of the internal market in times of limited testing capacities. It also calls for validation and mutual recognition of tests and their results.

The Commission has also signed an agreement with the International Federation of the Red Cross (IFRC) on 18 November, contributing €35.5 million financed by the Emergency Support Instrument to scale up COVID-19 testing capacity in the EU. The funding will be used to support the training of staff for the performance of tests, especially via mobile equipment.

To directly purchase rapid antigen tests and deliver them to Member States, the Commission is mobilising €100 million under the Emergency Support Instrument.

Where Member States are applying prior testing requirements and where no testing capacities are available for asymptomatic travellers, travellers should be offered the possibility to undergo a test after arrival.

On 18 September, the Commission published a set of recommendations for a common COVID-19 testing approach in Europe, as a follow-up initiative of the 15 July Communication on Short-Term EU Health Preparedness for COVID-19 Outbreaks. The recommendations set out concrete action points that will support countries in the planning and organisation of their testing efforts in different stages and settings of the pandemic. The document has been endorsed by the Health Security Committee, which agreed that the streamlining of national approaches will result in more coherent COVID-19 testing across the EU. The European Centre for Disease Prevention and Control has published COVID-19 testing strategies.

On 15 April the Commission adopted Guidelines on coronavirus test methodologies, to support Member States in their national containment strategies. Large-scale testing and antibody detection are necessary in monitoring the spread of the coronavirus. The guidelines set standards for testing kits quality, set up a network of coronavirus laboratories, and stepped up the fight against counterfeit devices. Find out more on performance of COVID-19 test methods

A European Team of coronavirus experts

On 17 March, the European Commission set up an advisory panel on the coronavirus composed of 7 expert epidemiologists and virologists from several Member States to formulate science-based EU response guidelines and coordinate risk management measures. The panel, which was created following a mandate by EU Member States, is chaired by Commission President, Ursula von der Leyen and Stella Kyriakides, Commissioner for health and food safety. The panel’s agenda and summaries of meetings are available under the ‘meetings tab’ here.

The advisory panel is complemented by an EU scientific advice platform on COVID-19, consisting of scientific advisors of EU Member States’ governments. The platform facilitates more coordinated scientific advice on the approach to Member State COVID-19 public health measures across the EU.

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Risk Assessment

The European Centre for Disease Prevention and Control (ECDC) is an EU agency that strengthens Europe's defences against infectious diseases.

The ECDC plays a key role in assessing the threat from a scientific viewpoint. It produces rapid risk assessments, provides frequent epidemiological updates and technical support by issuing guidance for how to best respond to the outbreak. This guidance includes, but is not limited to, outbreak surveillance, preparedness and response planning and laboratory support.

The latest ECDC risk assessments and Questions & Answers on COVID-19, including medical information and advice on prevention, are available under the respective links.
On 24 September, the ECDC also published new guidelines for non-pharmaceutical interventions.

 

Crisis coordination

The crisis is coordinated at several levels, through video conferences at the level of the European Council, through regular discussions with Health Ministers, to frequent meetings of the Health Security Committee.

These tools support cooperation, the rapid exchange of information, extensive monitoring and coordination of preparedness and response measures to the COVID-19 outbreak.

Notifications regarding serious cross-border health threats are made through Early Warning and Response System (EWRS) – an online platform that is available 24/7. This system allows EU Member States to send alerts about events with the potential impacts on the EU, to share information, and to coordinate their responses.

Documents

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