Securing access to vaccines
Safe and effective vaccines against COVID-19 are the best way out of the pandemic. The Commission and Member States have taken a common EU approach to securing supplies and facilitating their distribution.
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 purchase.
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 this timeframe being reduced to less than one year for most vaccines.
The objectives of the EU Vaccines Strategy are:
- to ensue 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 vaccine strategy should act 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.
To date, 4 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 COVID-19 vaccine authorised in the EU. This followed a positive scientific recommendation by the European Medicines Agency.
The Advance Purchase Agreement with BioNTech-Pfizer provided 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.
On 8 January 2021, the Commission proposedto Member States to purchase an additional 200 million BioNTech-Pfizer vaccine doses, with the option to acquire another 100 million doses.
On 10 March 2021, the European Commission reached an agreement with BioNTech-Pfizer for the supply of 4 million additional doses of COVID-19 vaccines to tackle coronavirus hotspots and to facilitate free movement across borders.
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 and 2023. It will allow for the purchase of 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.
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. This followed a positive scientific recommendation by the European Medicines Agency.
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 these 80 million additional doses.
On 17 February 2021, the European Commission approved a second contract with Moderna, which provided for an additional purchase of 300 million doses (150 million in 2021 and an option to purchase an additional 150 million in 2022). On 22 June 2021, the Commission approved an amendment to the second contract for the activation of the 150 million optional additional doses in 2022.
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 by the European Medicines Agency.
With the agreement of AstraZeneca, the Commission has made the redacted Advance Purchase Agreement public.
On 18 June 2021, the Court of First Instance of Brussels ordered AstraZeneca to deliver vaccine doses to the EU.
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 by the European Medicines Agency.
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
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. It allows EU Member States to purchase up to 300 million doses of the vaccine.
With the agreement of Sanofi-GSK, the redacted Advance Purchase Agreement is available.
On 19 November 2020, 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.
With the agreement of CureVac, the Commission has made the redacted Advance Purchase Agreement public.
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 EU Member States to initially purchase 100 million doses, followed by 100 million additional ones.
On 4 August 2021, the European Commission has approved an Advanced Purchase Agreement with Novavax. Under this contract, Member States will be able to purchase up to 100 million doses of the Novavax vaccine, with an option for 100 million additional doses over the course of 2021, 2022, and 2023, once reviewed and approved by European Medicines Agency as safe and effective. Member States will also be able to donate vaccines to lower and middle-income countries or to re-direct them to other European countries.
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
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.
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.
In the beginning, the focus was 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 means they are particularly at risk.
Speeding up vaccine production
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 mapping exercise is based on data gained through the Task Force activities, from the Commission-organised matchmaking event in March 2021 with companies that have consented having their name made public, publicly available information and on information shared by Member States. This data will be complemented and updated as further information becomes available.
The Task Force categorised the companies based on their main area of activity, thus companies can have more capacities that may not be reflected in the map. The data in the mapping exercise is aggregated in five main categories for visualisation purposes as follows:
- Supply (production/supply of raw materials, consumables, disposables, equipment)
- Production (manufacturing and formulation, CDMO/CMO)
- Fill & Finish, Packaging
- Storage & Shipment
- Other (process development of vaccines, CROs, R&D, clinical trial management services)
On 12 July 2021, the Task Force organised a second matchmaking event, this time on COVID-19 therapeutics, to foster industrial collaborations to accelerate the development and production of new or repurposed medicines to treat COVID-19.
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 is to ensure timely access to vaccines for all EU citizens and transparency of vaccine exports outside the EU.
The Commission has invested large amounts in the development of the production capacity of vaccine developers in the EU. It is therefore reasonable for the EU to monitor how these funds 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.
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.
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.
On 19 February 2021, the President of the European Commission announced an additional €500 million for the COVAX Facility. The new package consists of a €300 million EU grant and €200 million in guarantees by the European Fund for Sustainable Development plus (EFSD+) that will back a loan by the European Investment Bank.
With this new contribution, the EU is further stepping up investment in support of the global recovery with a total of €1 billion. Team Europe (EU and Member States) are a lead contributor to the COVAX Facility with close to €3 billion pledged to date.
ACT brings together governments, scientists, businesses, civil society, philanthropists and global health organizations such as
- the Bill & Melinda Gates Foundation
- The Global Fund
- 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.
On 21 May 2021, at the G20 Global Health Summit in Rome, the President 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.
And on 22 July, the President announced the firm commitment that Team Europe will deliver at least 200 million doses to low and middle income countries by the end of the year. A majority of these doses will be delivered through COVAX.