The development and distribution of an effective and safe vaccine against the coronavirus represents a lasting solution to the pandemic and a cornerstone of the European Commission’s coronavirus response.
The deployment of a vaccine will protect lives and livelihoods, and save billions of euro across Europe and the world. There is no guarantee that a vaccine will be found, but it is our best bet to overcome this pandemic and return to our normal way of life. To maximise the chances of successfully developing, manufacturing and deploying a vaccine for all Europeans, a broad portfolio of vaccine candidates based on different technological approaches is needed.
Challenges of vaccine development
Vaccine development is highly complex and usually takes around 10 years, but the Commission intends to achieve it within a timeframe of 12 - 18 months, if not earlier, without compromising on safety, quality or efficacy. The EU faces two major challenges:
- early large-scale investments in production capacities are needed to reduce the risks of vaccine producers before guarantees exist that these vaccines will pass the clinical trials
- large quantities of raw materials need to be secured so that production can start as soon as clinical trials are concluded, or even earlier
- Commission wants to find a vaccine within 12-18 months when it usually takes 10 years.
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
- The vaccine strategy should act as a reference point for Member States when formulating their national strategies.
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.|
What the EU proposes
funding will come from a significant part of the €2,7 billion Emergency Support Instrument
The Commission and Member States have agreed on a joint action at the EU level. The Commission plans a centralised EU approach to securing supplies and providing support for the development of a vaccine.
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
How it will work:
The Commission enters into Advanced 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 will finance a part of the upfront costs faced by vaccines producers from the Emergency Support Instrument.
This funding will be considered as a down-payment on the vaccines that will actually be purchased by Member States. Additional support is possible through loans from the European Investment Bank. This approach will decrease risks for companies while speeding up and increasing manufacturing.
Process and governance
The Commission will set up and chair a steering board. The steering board will be composed of representatives of all participating Member States to assist the Commission with guidance and expertise throughout the entire process.
The steering board will propose a small team of Member States experts who will support the Commission in the negotiations and form together with the Commission representatives the joint negotiation team.
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
- 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)
Agreements with vaccine manufacturers
Currently, three contracts have been concluded that allow the purchase of a vaccine once it has proven safe and effective:
- AstraZeneca: 300 million vaccine doses.
- Sanofi: 300 million vaccine doses.
- Johnson & Johnson: 200 million vaccine doses.
As of October 2020, the Commission continues discussing similar agreements with other vaccine manufacturers (CureVac, Moderna and BioNTech/Pfizer) with which it has concluded exploratory talks.
Preparations in Member States
As large-scale COVID-19 vaccination will be an important undertaking, on 15 October, the Commission published a Communication on preparedness for COVID-19 vaccination strategies and vaccine deployment. Member States should start preparing already. The key elements to be considered for national vaccination strategies include:
- capacity of vaccination services to deliver COVID-19 vaccines, including skilled workforce and medical and protective equipment;
- easy access to vaccines for target populations, both in affordability and physical proximity;
- 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 COVID-19 vaccines to build public trust
Possible priority groups
As the availability of the vaccines improves, vaccines strategies and their objectives will need to be adjusted accordingly. For example, while strategies are likely to focus in the beginning 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. Meanwhile, high on the list of actions is a decision on which groups should have priority access to vaccines. Consideration should be given to the following 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
- October to December 2020
Member States should ensure the capacity of vaccination services to deliver COVID-19 vaccines.
- October to December 2020
Member States should ensure easy access to vaccines for target populations, both in terms of affordability and physical proximity.
- October onwards
Member States should:
- prepare for deployment of vaccines with different characteristics and storage and transport needs
- ensure that Immunization Information Systems and other vaccination registries are updated and ready to process vaccination data
- ensure clear communication on the benefits, risks and importance of COVID-19 vaccines
- October to 2022
Member States and public health authorities should prepare to undertake studies, independent of industry interests, of vaccine effectiveness and safety.
Coronavirus Global Response
The proposed common EU approach to secure vaccines for Europeans complements the Global Response efforts towards universal access for a vaccine.
Supporting companies with clinical trials and with expanding production capacities will benefit the global population. Securing timely access to a vaccine for all Member States will allow economic and social activity to restart across borders and protect citizens from a new surge of the pandemic.
The Commission is ready to explore with international partners whether a significant number of high income countries would agree to pool resources to reserve vaccines from producers. They would not only do this for themselves, but also for low- and middle income countries. High income countries would thus act as an inclusive, international buyers group, accelerating the development of safe and effective vaccines and maximising access for all who need it most in the world.
The European Commission will ensure that the EU continues to play its part in resolving the coronavirus pandemic. The EU will only be safe if the rest of the world is safe.