The development and distribution of safe and effective vaccines against COVID-19 represents a lasting response to the pandemic. It is at the heart of the European Commission’s coronavirus response.
What the EU proposes
The Commission and Member States have taken a common EU approach to securing supplies and facilitating the rollout of vaccines.
The Commission entered into Advance Purchase Agreements with individual vaccine producers on behalf of Member States. In return for the right to buy a specified number of vaccine doses in a given timeframe and at a given price, the Commission financed a part of the upfront costs faced by vaccine producers from the €2.7 billion Emergency Support Instrument.
This funding is considered a down-payment on the vaccines that Member States purchase. Additional support for vaccine producers is possible through loans from the European Investment Bank. This approach will decrease risks for companies while speeding up manufacturing.
EU Vaccines Strategy
A broad portfolio of vaccines based on different technological approaches maximises the chances of safe and effective vaccines being developed and deployed. With this in mind, on 17 June 2020, the European Commission presented the EU Vaccines Strategy to accelerate the development, manufacturing and deployment of vaccines against COVID-19.
The Commission has taken a decision to support various vaccines based on a sound scientific assessment, the technology used, and capacity to supply the whole of the EU.
Vaccine development is a complex and lengthy process, which normally takes around 10 years. With the vaccines strategy, the Commission supported efforts and made the development more efficient, resulting in safe and effective vaccines being distributed in the EU by the end of 2020. This achievement required running clinical trials in parallel with investments in production capacity to be able to produce millions of doses of a successful vaccine. Strict and robust authorisation procedures and safety standards are respected at all times.
Questions and answers on the EU Vaccination strategy.
Learn more about vaccination in the EU
Authorised Vaccines
To date, 4 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
On 21 December 2020, the European Commission granted a conditional marketing authorisation for the COVID‑19 vaccine developed by BioNTech and Pfizer, making it the first COVID-19 vaccine authorised in the EU.
This follows a positive scientific recommendation based on a thorough assessment of the safety, effectiveness and quality of the vaccine by the European Medicines Agency and is endorsed by the Member States.
The Advance Purchase Agreement with BioNTech-Pfizer 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. On 15 December 2020, the Commission decided to purchase these 100 million additional doses.
In addition, on 8 January 2021, the Commission proposed to Member States to purchase an additional 200 million BioNTech-Pfizer vaccine doses, with the option to acquire another 100 million doses.
Member States can decide to donate the vaccine to lower and middle-income countries or to re-direct it to other European countries.
On 10 March 2021, the European Commission reached an agreement with BioNTech-Pfizer for the supply of 4 million more doses of COVID-19 vaccines for Member States to tackle coronavirus hotspots and to facilitate free movement across borders. These doses come on top of the schedule of deliveries currently agreed between Member States and BioNTech-Pfizer.
On 20 May 2021, the European Commission signed a third contract with BioNTech-Pfizer. It reserves an additional 1.8 billion doses on behalf of all EU Member States, between end 2021 to 2023. It will allow for the purchase 900 million doses of the current vaccine and of a vaccine adapted to variants (if necessary and if approved), with the option to purchase an additional 900 million doses.
With the agreement of BioNTech-Pfizer, the redacted Advance Purchase Agreement is available. The Purchase Agreement is also available.
Moderna
On 6 January 2021, the European Commission granted a conditional marketing authorisation for the vaccine against COVID-19 developed by Moderna, making it the second vaccine authorised for use in the EU.
This follows a positive scientific recommendation based on a thorough assessment of the safety, effectiveness and quality of the vaccine by the European Medicines Agency and is endorsed by the Member States.
The Advance Purchase Agreement with Moderna 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. On 15 December 2020, the Commission decided to purchase 80 million additional doses.
On 17 February 2021, the European Commission approved a second contract with the pharmaceutical company Moderna, which provides for an additional purchase of 300 million doses (150 million in 2021 and an option to purchase an additional 150 million in 2022) on behalf of all EU Member States.
The contracts 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.
With the agreement of Moderna, the redacted Advance Purchase Agreement and the redacted Purchase Agreement are available.
AstraZeneca
On 29 January 2021, the European Commission granted a conditional marketing authorisation for the vaccine against COVID-19 developed by AstraZeneca, making it the third vaccine authorised for use 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 and is endorsed by the Member States.
With the agreement of AstraZeneca, the Commission has made the redacted Advance Purchase Agreement public.
Johnson & Johnson
On 11 March 2021, the European Commission granted a conditional marketing authorisation for the COVID‑19 vaccine developed by Janssen Pharmaceutica NV, one of the Janssen Pharmaceutical Companies of Johnson & Johnson, making it the fourth vaccine authorised for use 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 and is endorsed by the Member States. With the conditional market authorisation, Janssen will be able to deliver 200 million of their single dose COVID-19 vaccine to the EU starting in the second quarter of 2021. The contract, that was closed on 7 October 2020, allows Member States to purchase an additional 200 million doses.
With the agreement of Johnson & Johnson, the Commission has made the redacted Advance Purchase Agreement public.
Vaccines still in development
2 contracts have been concluded that allow the purchase of a vaccine once proven safe and effective:
Sanofi-GSK
On 18 September 2020, the Advance Purchase Agreement negotiated on behalf of the EU Member States- between Sanofi-GSK and the European Commission entered into force.
Once the vaccine is proven safe and effective, the contract allows all EU Member States to purchase up to 300 million doses of the vaccine.
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.
With the agreement of Sanofi-GSK, the redacted Advance Purchase Agreement is available.
CureVac
On 19 November 2020, the contract negotiated on behalf of the EU Member States- between CureVac and the Commission entered into force.
Once the vaccine is proven safe and effective, 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.
CureVac, a European company based in Germany, signed a €75 million loan agreement with the European Investment Bank on 6 July 2020 for the development and large-scale production of vaccines.
With the agreement of CureVac, the Commission has made the redacted Advance Purchase Agreement public.
Exploratory talks
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.
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
Novavax
On 17 December 2020, the Commission concluded exploratory talks with the pharmaceutical company Novavax, with a view to purchasing its potential vaccine against COVID-19.
The Novavax vaccine is a protein subunit product already in phase 3 clinical trial stage. The envisaged contract would provide for the possibility of all EU Member States to initially purchase 100 million doses, followed up by 100 million additional ones.
Valneva
On 12 January 2021, the 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 30 million doses, and they could further purchase up to 30 million more doses.
Objectives of the EU Vaccine Strategy
- ensuring the quality, safety and efficacy of vaccines
- securing timely access to vaccines for Member States and their population while leading the global solidarity effort
- ensuring equitable and affordable access for all in the EU to an affordable vaccine as early as possible
- making sure that preparations are made in EU countries regarding the roll-out of safe and effective vaccines, addressing transportation and deployment needs, and identifying priority groups which should gain access to vaccines first
The vaccine strategy should act as a reference point for Member States when formulating their national strategies.
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Securing the production of a sufficient quantity of vaccines in the EU through Advance Purchase Agreements with vaccine producers via the Emergency Support Instrument. Additional financing and other forms of support can be made available on top of such agreements. |
Adapt the EU rules to the current urgency in order to accelerate the development, authorisation and availability of vaccines while maintaining the standards for vaccine quality, safety and efficacy. |
Vaccination preparedness in EU countries
Vaccination saves lives. Large-scale vaccination against COVID-19 is the key instrument to control the virus.
On 15 October 2020, the European Commission published a Communication on preparedness for COVID-19 vaccination strategies and vaccine deployment. The key elements to be considered for national vaccination strategies include:
- the capacity of vaccination services to deliver vaccines against COVID-19, including skilled workforce and medical and protective equipment
- easy access to vaccines for target populations, both in affordability and physical proximity
- the 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 vaccines against COVID-19 to build public trust
Possible priority groups
As the availability of vaccines increases, national strategies will need to be adjusted accordingly. For example, in the beginning the focus will likely be 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.
Consideration should be given to the following priority 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
Speeding up vaccination in the EU
On 19 January 2021, the European Commission adopted a Communication calling on Member States to speed up the roll out of vaccines across the EU. By the end of March 2021, at least 80% of people over the age of 80, and 80% of health and social care professionals in every Member State should get vaccinated. By summer 2021, Member States should have vaccinated a minimum of 70% of the entire adult population.
Addressing bottlenecks
On 4 February 2021, the European Commission set up a taskforce under the authority of the Commissioner for the Internal Market, Thierry Breton, in cooperation with the Commissioner for Health and Food Safety, Stella Kyriakides. The Task Force aim is to ramp up production capacity for vaccines, acting as a one-stop-shop for manufacturers in need of support, and to identify and address bottlenecks in terms of capacity and supply chain.
On 29 March 2021, the Commission hosted the first pan-European matchmaking event with over 300 participating companies from 25 Member States to expand COVID-19 vaccine production capacities across Europe and address bottlenecks. The event aims to speed up connections between vaccine producers and service companies such as contract development and manufacturing organisations, fill and finish, equipment producers and others, with a view to improve planning for current and future vaccine production in Europe.
Vaccination progress in Europe
EU Digital COVID Certificate
On 17 March 2021, the Commission adopted a legislative proposal establishing a common framework for a EU Digital COVID Certificate covering vaccination, testing and recovery. This is an EU level approach to issuing, verifying and accepting certificates to facilitate free movement within the EU, based on a strict respect for non-discrimination and of the fundamental rights of EU citizens.
Process and governance on vaccination in the EU
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The Commission has set up and chair a steering board which is composed of representatives of all participating Member States. It will assist the Commission with guidance and expertise throughout the entire process. |
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The steering board includes a small team of Member States’ experts who support the Commission in the negotiations and form the joint negotiation team. |
Financing criteria
Criteria to decide which vaccine producers to support, include:
- soundness of scientific approach and technology used
- speed and ability of delivery of sufficient quantities of vaccines in 2020 and 2021
- cost
- risk-sharing and liability coverage required
- coverage of different technologies
- production capacity in the EU
- global solidarity: a commitment to offer future doses of vaccines to partner countries to end the global pandemic
- early engagement with EU regulators with the intention to apply for an EU marketing authorisation for the candidate vaccine(s)
Transparency and authorisation mechanism for exports of vaccines
In an effort to ensure timely access to COVID-19 vaccines for all EU citizens and to tackle the current lack of transparency of vaccine exports outside the EU, on 29 January 2021, the European Commission put a measure in place requiring that such exports are subject to an export authorisation by Member States.
The Commission has invested large amounts in the development of the production capacity of vaccine developers in the EU. This is meant to ensure quicker delivery of vaccines to European citizens, and to support planning and vaccination strategies with the ultimate goal of protecting public health.
It is therefore reasonable for the EU to monitor how these funds disbursed under the Advance Purchase Agreements have been used, especially in a context of potential shortages of essential COVID-19 vaccines.
The main purpose is to offer public transparency to European citizens. The transparency and authorisation system will require companies to notify the Member State authorities about the intention to export vaccines produced in the European Union.
Global cooperation
On 18 September 2020, the European Commission confirmed its participation in the COVAX Facility for equitable access to affordable COVID-19 vaccines. The first distribution forecast is available.
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 12 November 2020, 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. With this new contribution, the EU is further stepping up investment in support of the global recovery with a total of €500 million.
ACT brings together governments, scientists, businesses, civil society, philanthropists and global health organizations such as
- the Bill & Melinda Gates Foundation
- CEPI
- FIND
- Gavi
- The Global Fund
- Unitaid
- Wellcome
- the WHO
- the World Bank
- Global Financing Facility
In its Communication of 19 January 2021, the Commission announced that it will set up an EU vaccine sharing mechanism to structure the provision of vaccines shared by Member States with partner countries through a Team Europe approach, paying special attention to the Western Balkans, the Eastern and Southern neighbourhood, and Africa.
The first distribution forecast is available.