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.
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
On 21 December 2020, the Commission granted a conditional marketing authorisation for the COVID-19 vaccine developed by BioNTech and Pfizer, making it the first vaccine authorised in the EU. Following the approval of an Advance Purchase Agreement with BioNTech-Pfizer on 11 November 2020 and further contracts signed in March and May 2021, the Commission secured 2.4 billion doses of the vaccine, with an option to purchase an additional 900 million doses.
On 13 May 2022 and 26 May 2023, the European Commission and BioNTech-Pfizer concluded amendments to the existing vaccines supply contract, to better address Member States’ needs for COVID-19 vaccines, and ensure that Member States had access to vaccines as well as response capacities in case of epidemiological developments.
The amendments to the existing vaccines supply contract ensured that Member States had access to the latest vaccines when needed – including future variant-adapted vaccines if authorised, so that they could quickly respond to any epidemiological developments and continued to support partner countries globally should COVID-19 variants of concern appear in the future.
As of 7 September 2023, around 760 million doses of the vaccine have been distributed to EU Member States.
On 6 January 2021, the European Commission granted a conditional marketing authorisation for the vaccine developed by Moderna, making it the second vaccine authorised for use in the EU.
The Advance Purchase Agreement with Moderna provided for the initial purchase of 80 million doses on behalf of all EU Member States, and an option to request up to a further 80 million doses. A second contract approved on 17 February 2021 provided for an additional purchase of 300 million doses, bringing the total number of doses secured to 460 million.
On 2 June and 9 August 2022,the Commission reached further agreements with Moderna to ensure that the delivery of vaccines was adapted to the needs of Member States, ensuring the national authorities’ access to the vaccines, including variant-adapted vaccines if authorised, at the time they need them for their own vaccination campaigns and to support their global partners.
As of 7 September 2023, around 225 million doses of the vaccine have been distributed to EU Member States.
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. The Advance purchase agreement with AstraZeneca provided for the purchase of 300 million doses of the vaccine, with an option for a further 100 million doses.
As of 7 September 2023, around 129 million doses of the vaccine have been distributed to EU Member States.
On 11 March 2021, the European Commission granted a conditional marketing authorisation for the COVID19 vaccine developed by Janssen Pharmaceutica NV (of Johnson & Johnson), the fourth vaccine authorised for use in the EU.
With the conditional market authorisation, Janssen was able to deliver 200 million of their single dose COVID-19 vaccine to the EU starting in the second quarter of 2021. The Advance Purchase Agreement, concluded on 7 October 2020, allowed Member States to purchase an additional 200 million doses – bringing the total amount of doses secured to 400 million.
As of 7 September 2023, around 62 million doses of the vaccine have been distributed to EU Member States.
The conditional marketing authorisation (CMA) for the COVID 19 vaccine Nuvaxovid, developed by Novavax, the fifth COVID-19 vaccine authorised in the EU, was granted on 20 December 2021.
The Advance Purchase Agreement allowed EU Member States to secure 200 million doses of the vaccine, with an option for to purchase a further 100 million doses.
As of 7 September 2023, around 13 million doses of the vaccine have been distributed to EU Member States.
On 23 June 2022, the European Medicines Agency recommended granting a marketing authorisation for the vaccine against COVID-19 by Valneva.
The Advance Purchase Agreement with Valneva provided for EU Member States to purchase around 27 million doses in 2022, with the possibility of a further order of up to 33 million additional vaccines in 2023.
On 20 July 2022, the Commission approved an amendment to the original advance purchase agreement with Valneva, bringing the total amount of vaccines doses secured to 1.25 million.
As of 7 September 2023, around 151 000 doses of the vaccine have been distributed to EU Member States.
On 2 August 2022, the European Commission signed a joint procurement contract with the company HIPRA HUMAN HEALTH for the supply of their protein COVID-19 vaccine.
On 30 March 2023, the European Commission granted a marketing authorisation for the vaccine against COVID-19 developed by HIPRA following the positive assessment of the European Medicines Agency. The vaccine broadened the EU’s portfolio, enabling Member States to purchase up to 250 million doses under the joint procurement agreement.
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, allowing EU Member States to purchase up to 300 million doses of the vaccine.
On 11 November 2022, the European Commission granted a marketing authorisation for VidPrevtyn Beta, the protein-based COVID 19 vaccine developed by Sanofi and GSK, as a booster dose following a positive scientific recommendation from the European Medicines Agency – making it the eighth safe and effective vaccine authorised for use in the EU.
As of 7 September 2023, around 19 million doses of the vaccine have been distributed to EU Member States.
On 19 November 2020, a contract negotiated on behalf of the EU Member States - between CureVac and the European 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.
On 11 October 2021, CureVac informed the European Medicines Agency that it is withdrawing its COVID-19 vaccine from the rolling review process.
- 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.
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).
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.
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.
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.
Redacted Framework Contracts for Supplies
Redacted Advance Purchase Agreements
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