Safe and effective vaccination
Hundreds of millions of people worldwide are vaccinated each year to protect them – and their friends and family - from diseases that could have serious health consequences.
Vaccines work by ‘teaching’ a person's immune system (the body’s natural defences) to defend itself against a specific disease. When enough people in a population develop immunity to an infectious disease, the disease is then unlikely to spread from person to person. This is particularly important for a highly contagious disease like COVID-19.
The first vaccine was developed in the 18th century in the United Kingdom. It was a vaccine against smallpox, a deadly disease. Smallpox is now eradicated worldwide in humans thanks to vaccination. The last known naturally occurring case was recorded in 1977 in Somalia.
Vaccination is the best way for us to end the pandemic. Before any vaccine can be approved in the EU, it has to undergo rigorous testing by its developer and then a scientific evaluation to ensure its quality, safety and effectiveness. No corners are cut on safety when developing vaccines.
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. Safe and effective vaccines against COVID-19 is our best bet to overcome the pandemic.
That is why the Commission mobilised a significant part of the budget available under the Emergency Support Instrument to secure sufficient vaccine supplies for Member States through a wide portfolio of Advance Purchase Agreements with vaccine manufacturing companies.
To date, 2 safe and effective vaccines against COVID-19 have been authorised for use in the EU following positive scientific recommendations by the European Medicines Agency:
- BioNTech-Pfizer: up to 600 million doses: On 11 November 2020, the Commission approved a contract to purchase up to 300 million doses (of which the Commission decided to purchase 100 million additional doses on 15 December 2020). On 8 January 2021, the Commission proposed Member States to purchase another 200 million vaccine doses, with the option to acquire 100 million additional doses.
- Moderna: up to 160 million doses (of which the Commission decided to purchase 80 million additional doses on 15 December 2020).
The Commission has reached agreements with 4 pharmaceutical companies to allow the purchase of vaccines against COVID-19 once they pass clinical trials and are proven to be safe and effective:
- AstraZeneca: up to 400 million doses
- Sanofi-GSK: up to 300 million doses
- Johnson & Johnson: up to 400 million doses
- CureVac: up to 405 million doses
Exploratory talks for further contracts have concluded with:
The exploratory talks continue and 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. 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.
The European Commission is participating in the COVAX Facility for equitable access to affordable COVID-19 vaccines, following its announcement of a contribution of €400 million. This includes an initial contribution of €230 million covering options to buy 88 million doses and further €170 million in financial guarantees from the EU budget. The EU would transfer these doses to other eligible countries.
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 additional contribution brings the total amount to €500 million.
Treatments for COVID-19
On 8 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. All participating countries can place their orders to procure Remdesivir directly. Remdesivir is the only medicine with a conditional marketing authorisation in the EU for the treatment of COVID-19 patients needing oxygen supply.
The Commission also purchased and distributed to Member States and the UK doses of Remdesivir, for a total amount of €70 million under the Emergency Support Instrument.
Moreover, the Commission awarded a grant of €1 million, financed under the Emergency Support Instrument, to support the conduct of a clinical trial authorised by the Italian pharmaceutical regulatory agency, AIFA, for repurposing Raloxifene, an existing medicine used to prevent and treat osteoporosis, identified through the Horizon 2020 Exscalate4CoV supercomputing platform as a promising molecule to treat patients suffering from COVID-19. 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
Transfusing convalescent plasma to sick patients can help them fight off COVID-19. Plasma transfusions are also used to purify antibodies to make a specific COVID-19 medicinal product (immunoglobin) as a short-term alternative to vaccines. This product can be given as an injection to patients, vulnerable persons and healthcare workers. The efficacy of both of these approaches is being investigated worldwide, including in EU research projects funded by Horizon 2020, examples of which can be seen here and here.
On 8 January 2021, the Commission has selected 24 projects that will build new programmes, or expand existing ones, for the collection of plasma from donors recovered from COVID-19. The projects, which will take place in 14 Member States and the UK, are national or regional and will, in most cases, involve distribution of funds down to large numbers of local blood or plasma collection centres (over 150 in total). This action is financed through the Emergency Support Instrument, for a total of €36 million.
High-quality coronavirus testing
Large-scale testing for COVID-19 diagnostic is necessary to monitor the spread of the coronavirus and prevent further transmissions. The Commission’s recommendation for a common COVID-19 testing approach in Europe follows its communication on Short-Term EU Health Preparedness for COVID-19 Outbreaks.
In accordance to the Commission’s Communication on additional COVID-19 response measures adopted on 28 October 2020, EU countries should submit national strategies on testing by mid-November 2020.
High-quality coronavirus testing
The Commission adopted a Recommendation on COVID-19 testing strategies, including the use of rapid antigen tests. It sets out key elements to be considered for national, regional or local testing strategies such as their scope, priority groups, and key points linked to testing capacities and resources, and indications as to when rapid antigen testing may be appropriate.
Rapid antigen tests
On 28 October, the Commission adopted a Recommendation on COVID-19 testing strategies, including the use of rapid antigen tests. The Recommendation sets out key elements to be considered for national, regional or local testing strategies, such as their scope, priority groups, and key points linked to testing capacities and resources, and indications as to when rapid antigen testing may be appropriate.
On 18 November, the Commission adopted a Recommendation on the use of rapid antigen tests for the diagnosis of COVID-19 infection, which provides guidance for the selection of these tests, and where they should be used. Given the diversity of tests available, the recommendation provides guidance, on the basis of the WHO recommendations, on criteria to select rapid antigen tests, with should meet the minimum requirements of 80% sensitivity and 97% specificity.
On 18 December, the Commission proposed a Council recommendation on a common framework for the use, validation and mutual recognition of rapid antigen tests. It provides guidance to Member States for the use of rapid tests in specific settings and for population-wide screenings, as well as recommendations concerning the validation and mutual recognition of rapid antigen tests.
Validation of tests
The Commission has published guidelines on coronavirus test methodologies support EU countries in their national containment strategies. The Recommendation on the use of rapid antigen tests for the diagnosis of COVID-19 calls for validation and mutual recognition of tests and their results.
The Commission’s COVID-19 In Vitro Diagnostic Devices and Test Methods Database collects in a single place all publicly available information on performance of CE-marked in vitro diagnostic medical devices as well as in-house laboratory-developed devices and related test methods for COVID-19.
Purchase of rapid antigen tests
To directly purchase rapid antigen tests and deliver them to EU countries, the Commission is mobilising €100 million under the Emergency Support Instrument. On 18 December it signed a framework contract with Abbott and Roche, for the purchase of over 20 million rapid antigen tests. The contract will make tests available to all Member States, with the coordination and support of the Commission.
National contact tracing and warning apps
National contact tracing and warning apps can be voluntarily installed and used to warn users, even across borders, if they have been in the proximity of a person who is reported to have tested positive for coronavirus. In the case of an alert, the app may provide relevant information from health authorities, such as advice to get tested or to self-isolate, and who to contact.
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, the proposals aim to 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 EU countries and the Commission. The Commission has also set out the main elements of the future Health Emergency Response Authority (HERA), to be proposed by the end of 2021. Such a structure would be an important new element to support a better EU level response to cross-border health threats.
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.
The Emergency Support Instrument helps Member States in their efforts to address the coronavirus pandemic. It responds to needs that can be best addressed in a strategic, coordinated manner at European level.
The Emergency Support Instrument is based on the principle of solidarity and pools efforts and resources to quickly address shared strategic needs.
Ensuring the availability of supplies and equipment
Availability of medical equipment
The EU countries in the Council and the European Parliament have agreed to postpone the application of the Medical Devices Regulation by one year. This will allow health institutions and economic operators in EU countries to prioritise the fight against the coronavirus pandemic while ensuring patient health and safety until the new legislation enters into force.
Availability of medicines
The Commission has called on EU countries to ensure that Europeans have access to necessary and affordable medicines during the coronavirus outbreak while preserving the integrity of the Single Market. These guidelines ensure the rational supply, transport, allocation and use of vital medicines and prevent any shortages.
Identifying demands and matching supplies of medical equipment
The Commission set up a ‘clearing house for medical equipment (COVID-19)’ to identify available supplies and facilitate the matching with demand in EU countries. It served as a platform for dialogue and sharing of information with Member States’ representatives on the demand and supply of medical equipment at EU level and on means to overcome shortages and build capacity.
Public procurement of medical and protective equipment
The voluntary Joint Procurement Agreement for medical equipment enables the joint purchase of vital medical supplies and equipment. When conducting joint procurements, the European Commission has a coordinating role, while the EU countries purchase the items.
(OVER 12 MONTHS)
Gloves and coveralls
Eye and respiratory protection
20 million goggles
12 million face shields
37 million FFP2 masks
26 million FFP3 masks
301 million surgical masks
30 different lots
Medicines used in intensive care units
October (contracts are being signed)
21 medicines in
Over 500,000 treatment courses
These initiatives have proved successful. Framework contracts following the first four joint procurement procedures have been signed and EU countries can place orders for
- personal protective equipment (coveralls, gloves, googles, face-shields and masks)
- laboratory equipment (kits, reagents, swabs, and laboratory consumables)
- therapeutic remdesivir (Veklury)
- Intensive Care Units medicines (analgesics, antibiotics, muscle relaxers, anaesthetics, resuscitation, other)*
* Several Intensive Care Units medicines framework contracts are still being signed.
Joint procurement guidance
On 1 April 2020, the European Commission published guidance on using the public procurement framework. It provides
- an overview of the tendering procedures available to public buyers
- applicable deadlines
- examples of how public buyers could find alternative solutions
- ways of engaging with the market
Stockpiling and distributing supplies and equipment
RescEU stockpiling is a common European reserve of medical equipment such as:
- personal protective equipment
- reusable masks
- vaccines and therapeutics
- laboratory supplies
The Commission finances 100% of the costs of the stockpiling and will manage the distribution of the equipment to ensure it goes where it is needed most.
Increasing European production capacities
On 20 March 2020, the European Commission and the European Standardisation Organisations agreed on 20 March 2020 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 health and safety standards and without undue delays.
Revised harmonised standards will allow manufacturers to make high quality devices to protect patients, healthcare professionals and citizens in general. The revised standards relate to critical supplies such as:
- medical facemasks
- protective clothing
- surgical drapes
- disinfectant and sterilization agent
- personal eye protection
- medical gloves
- respiratory protective devices
The Commission has made guidance available in 3 areas to assist manufacturers in increasing the output of essential medical equipment and material, namely
- the production of personal protective equipment such as masks
- leave-on hand cleaners and hand disinfectants
- 3D printing
Guidance on medical devices in the coronavirus context was published on 3 April 2020. These documents can assist manufacturers and market surveillance authorities in ensuring that these products are effective and comply with necessary safety standards.
Temporarily lifting customs duties and VAT on imports
The Commission approved requests from all EU countries and the UK to temporarily waive customs duties and VAT on the import of medical devices, and protective equipment, from third countries.
This made it easier 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.
To give EU countries better and cheaper access to the tools needed to prevent, detect and treat COVID-19, 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. Following the green light by Member States, these temporary VAT relief measures will apply until 31 December 2022.
Supporting healthcare systems
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. This can take the form of co-financing of transport assistance, including personal protective equipment and other support such as the provision of expertise.
Guidelines on cross-border healthcare cooperation between national, regional and local authorities aim to
- facilitate the transfer of patients from one Member State to another
- allow qualified medical personnel to offer their assistance in other EU countries
- relieve the burden that the current outbreak has placed on national health systems
- arrange for patient mobility across borders
- provide steps for the reimbursement of healthcare costs
- encourage national authorities to use existing bilateral and regional agreements.
Disinfection robots to European hospitals
The Commission has purchased 200 disinfection robots to be delivered to hospitals across Europe. The budget of up to €12 million comes from the Emergency Support Instrument. The robots can disinfect standard patient rooms using ultraviolet light in as quickly as 15 minutes, and represent an important asset that can help hospitals reducing the risk of infection and containing the spread of coronavirus. 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.
Supporting the training of healthcare professionals
On 7 May 2020, the Commission issued a guidance to EU countries to help address the shortages of health workers created by the coronavirus crisis. This guidance
- aims to speed up the recognition of health workers’ professional qualifications
- aims to clarify the rules allowing doctors and nurses in training to practice their profession
- recommends that EU countries speed up procedures for the mutual recognition of qualifications (in line with the ample flexibilities provided by the EU Professional Qualifications Directive)
- clarifies that EU countries can request a derogation from the rules on minimum medical training requirements in cases where professionals are unable to complete their training due to disruptions caused by the pandemic.
The European Commission has made €2,5 million in funding available for training in intensive care skills for healthcare professionals who do not regularly work in intensive care. The training, funded by the Emergency Support Instrument, will increase the number of medical staff available in case there is a need for a significant increase of intensive care capacities. The training programme will take place across the EU between August and December 2020, with a minimum of 1,000 hospitals enrolling some 10,000 doctors and nurses.
A European Team of coronavirus experts
The European Commission’s advisory panel on coronavirus is made up of 7 expert epidemiologists and virologists from several EU countries. They are tasked with formulating a science-based EU response guidelines as well as coordinating risk management measures.
The panel was created following a mandate by EU countries and is chaired by Commission President, Ursula von der Leyen and the Commissioner for health and food safety, Stella Kyriakides.
The advisory panel is complemented by an EU scientific advice platform on COVID-19, consisting of scientific advisors from the governments of EU countries. The platform facilitates more coordinated scientific advice on the approach to Member State COVID-19 public health measures across the EU.
The European Centre for Disease Prevention and Control (ECDC) is an EU agency that strengthens Europe's defences against infectious diseases.
The ECDC provides:
- rapid risk assessments
- frequent epidemiological updates
- technical support