EU Vaccines Strategy

Securing access to vaccines

Safe and effective vaccines against COVID-19 were key to overcome the pandemic and remain our best tool to protect our citizens against the virus. The Commission and Member States took a common EU approach to securing supplies and facilitating their distribution, helping to ensure timely access and availability all across the EU.

Through Advance Purchase Agreements with individual vaccine producers, the Commission secured the right to buy a specified number of vaccine doses in a given timeframe and at a given price. In return, the Commission financed a part of the upfront costs from the €2.7 billion Emergency Support Instrument. This funding was considered a down-payment on the vaccines that Member States purchased.

Objectives of the strategy

On 17 June 2020, the European Commission presented the EU Vaccines Strategy to accelerate the development, manufacturing and deployment of vaccines against COVID-19.

With the Vaccines Strategy, the Commission supported efforts to make the process more efficient, resulting in the timeframe being reduced to less than one year for most vaccines.

The objectives of the EU Vaccines Strategy are:

• to ensure the quality, safety and efficacy of vaccines
• to secure timely access to vaccines for Member States and their population while leading the global solidarity effort
• to ensure equitable and affordable access for all in the EU to an affordable vaccine as early as possible
• to make 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.

The Vaccines Strategy acts as a reference point for Member States when formulating their national vaccination strategies.

Safe and effective vaccines started to be distributed in the EU by the end of 2020, following strict authorisation procedures and the highest safety standards.

Since then, the European Commission has secured up to 4.2 billion doses of COVID-19 vaccines. Vaccine deliveries to EU countries increased steadily, and as of August 2023 a total of 84.8% of the adult population has been vaccinated at least once against the virus. As of August 2023, Team Europe had also shared more than 530 million doses for donation to countries around the world.

Authorised Vaccines

To date, eight safe and effective vaccines against COVID-19 have been authorised by the Commission for use in the EU following positive scientific recommendations by the European Medicines Agency

Vaccines withdrawn from the review process

Adapted vaccines

In 2022, based on the recommendations of the European Medicines Agency, the Commission authorised the following adapted omicron vaccines in the EU:

• On 1 September 2022, the adapted Original/Omicron BA.1 vaccines from BioNTech-Pfizer and Moderna;
• On 12 September 2022, the adapted Original/Omicron BA.4-5 vaccine from BioNTech-Pfizer;
• On 20 October 2022, the adapted Original/Omicron BA.4-5 vaccine from BioNTech-Pfizer.

Recommended measures in view of new and adapted COVID-19 vaccines becoming available included:

• Developing national vaccination strategies clarifying which vaccines, including the new and adapted vaccines, to be administered to population groups in view of the possible emergence of new variants, based on the guidance issued by the European Medicines Agency and the European Centre for Disease Prevention and Control. Ensuring sufficient logistical capacity to administer the vaccines as soon as new and adapted vaccines are delivered.

In July 2023, the European Medicines Agency announced the phasing out of the extraordinary regulatory flexibilities for medicines put in place during the COVID-19 pandemic, valid until the end of 2023. The already-approved flexibilities would also apply until end-2023, to ensure a smooth phase-out and avoid any supply disruptions. After 2023, the regular mechanisms foreseen in the legislation in relation to labelling exemptions are to be followed.

On 31 August 2023, based on the recommendation of the European Medicines Agency and in line with previous recommendations by the EMA and ECDC, the Commission authorised the Comirnaty XBB.1.5-adapted COVID-19 vaccine, developed by BioNTech-Pfizer.

Vaccination preparedness

On 15 October 2020, the European Commission published a Communication on preparedness for COVID-19 vaccination that included key elements to be considered for national vaccination strategies.

The focus had initially been on decreasing the rate of fatalities and the burden on essential services. Consideration was given to priority groups such as the elderly, healthcare workers and persons whose state of health meant they were particularly at risk.

On 19 January 2021, the European Commission adopted a Communication calling on Member States to speed up the rollout of vaccines across the EU. By mid-July of that year, Europe had enough vaccine doses to vaccinate 70% of the EU adult population.

Reports and data on the vaccination progress in Europe are available on the website of the European Centre for Disease Prevention and Control (ECDC).

COVID-19 Vaccine tracker

Speeding up vaccine production

The Commission has invested large amounts of funding into the development of the production capacity of vaccine developers in the EU, and continues to monitor the epidemiological situation in order to adopt appropriate measures if necessary.

Ramping up industrial vaccine production in the EU

On 4 February 2021, the European Commission set up a Task Force 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 aims to ramp up production capacity for vaccines in the EU, acting as a one-stop-shop for manufacturers in need of support, and to identify and address bottlenecks in production capacity and supply chains.

The regular contacts of the Task Force with industry and Member States allow the Commission to have a good understanding of vaccine production capacities in the EU. The Task Force is also regularly updating a mapping of vaccine production capacities in the EU, including the related EU supply chain.

The Task Force organised matchmaking events with companies in March (focus on vaccines), July (focus on therapeutic medicines) and November 2021 respectively. Coupled with information shared by Member States, these events allowed companies to do the first mapping of the vaccines production capacity in EU.

The mapping included information on production capacity of the companies that had agreed to make this information public. This data has then been updated, as further information became available.

The Task Force contributed to the rapid increase in Europe’s industrial capacity to produce vaccines. The monthly production capacity in the EU was significantly ramped up, from 20 million vaccine doses at the beginning of 2021 to a capacity and actual production of around 300 million vaccine doses per month in the second half of 2021. By mid-July 2021, the EU had produced over 1 billion doses of vaccines, and in a year, around 3 billion doses.

The Task Force also contributed to the Team Europe initiative on manufacturing and access to medicines, vaccines and health technologies (MAV+) in Africa, and coordinated with international partners, notably the US, in the context of the EU-U.S. COVID-19 Manufacturing and Supply Chain Taskforce.

EU FAB network for vaccines manufacturing

The COVID-19 pandemic has highlighted the need for Europe to be better prepared for future health emergencies. The EU4Health programme well reflects this need: protecting citizens from cross-borders health threats is among its funding priorities.

On 30 June 2023 the European Health and Digital Executive Agency (HaDEA), acting on behalf of the Health Emergency Preparedness and Response Authority (HERA), signed a framework contract with four contractors setting up the EU FAB network for sufficient and agile manufacturing capacities for different vaccine types (mRNA-based, vector-based, and protein-based). These capacities will be kept operational and can be activated quickly, securing a total of 325 million doses per year in case of a public health emergency.

The EU FAB network comprises vaccine producers in the EU (Belgium, Ireland, the Netherlands, Spain). The actions of the network will close the gap between manufacturing and scaling up of vaccine production, while ensuring the capacity of the industry to produce life-saving medicines.

Transparency and authorisation mechanism for exports of vaccines

On 29 January 2021, the European Commission put  a measure in place requiring COVID-19 vaccine exports to be authorised by Member States. This was to ensure timely access to vaccines for all EU citizens and transparency of vaccine exports outside the EU. The vaccine export transparency measure was in place until December 2021. As of 1 January 2022, this mechanism was replaced by a new monitoring tool, providing the Commission with timely, company-specific export data. As a result, vaccine producers no longer have to request an authorisation for the export of vaccines outside the EU.

Global cooperation

During the COVID-19 pandemic, the European Commission and the EU as a whole provided assistance to non-EU countries in improving access to vaccines, tests and treatments and enhancing local vaccines production capacity.

Read more about crisis management and solidarity

On 18 September 2020, the European Commission confirmed its participation in the COVAX Facility for equitable access to affordable COVID-19 vaccines following its expression of interest on 31 August and its announcement of a contribution of €400 million.

COVAX is part 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. ACT brings together governments, scientists, businesses, civil society, philantropists and global health organisations such as the Bill & Melinda Gates Foundation, Coalition for Epidemic Preparedness Innovations (CEPI), FIND (global alliance for diagnostics), GAVI (the Vaccinee Aliance), the Global Fund, Unitaid, Wellcome, WHO, the World Bank and Global Financing Facility.

All together the Commission, Member States and the European Investment Bank became a leading investor in COVAX, contributing over €5 billion to make available 1.8 billion doses of vaccines for 92 low and middle-income countries.

In January 2021, the Commission set up an EU vaccine sharing mechanism. It allowed Member States to share EU-purchased doses with third countries, including through COVAX in a Team Europe approach, paying special attention to the Western Balkans, the Eastern and Southern neighbourhood, and Africa. By August 2023, EU Member States had shared more than 530 million doses for donation to countries around the world. The large majority, around 445 million doses were shared by COVAX. In addition, EU Member States have delivered 87 million doses through bilateral donations – for instance to our neighbours in the Western Balkans.

On 21 May 2021, at the G20 Global Health Summit in Rome, President Ursula von der Leyen announced a Team Europe initiative on manufacturing and access to vaccines, medicines and health technologies in Africa. The initiative will help create an enabling environment for local manufacturing in Africa and tackle barriers on both supply and demand sides. It will be backed by €1 billion from the EU budget and the European development finance institutions such as the European Investment Bank (EIB). This amount will be further enhanced by contributions from EU Member States.

The EU, in partnership with Spain, has also launched a partnership with Latin America and the Caribbean to support local manufacturing of vaccines, medicines and other health technologies, and to strengthen the resilience of health systems.  

EU Global Response to COVID-19