Commission unveils EU vaccines strategy

Today, to help protect people everywhere, the European Commission is presenting a European strategy to accelerate the development, manufacturing and deployment of vaccines against COVID-19. An effective and safe vaccine against the virus is our best bet to achieve a permanent solution to the pandemic. Time is of the essence. Every month gained in finding such a vaccine saves lives, livelihoods and billions of euros. Today’s strategy proposes a joint EU approach and builds on the mandate received from EU health ministers.

European Commission President Ursula von der Leyen said: “This is a moment for science and solidarity. Nothing is certain, but I am confident that we can mobilise the resources to find a vaccine to beat this virus once and for all. We must be ready to manufacture and deploy such a vaccine across Europe and the world. This vaccine will be a breakthrough in the fight against the coronavirus, and a testament to what partners can achieve when we put our minds, research and resources together. The European Union will do all in its power to ensure that all peoples of this world have access to a vaccine, irrespective of where they live.”

Commissioner for Health and Food Safety Stella Kyriakides said: “Working together will increase our chances of securing access to a safe and effective vaccine at the scale we need and as quickly as possible. It will ensure fair and equitable access for all across the EU and globally, thus offering the best opportunity of finding a permanent exit strategy from the COVID-19 crisis. This is the EU at its best: pooling resources, joining efforts, bringing tangible results to the everyday lives of people. No one is safe until everyone is safe and we will leave no stones unturned in our efforts to protect EU and global citizens.”

Vaccine development is a complex and lengthy process. With today’s strategy, the Commission will support efforts to accelerate the development and availability of safe and effective vaccines in a timeframe between 12 and 18 months, if not earlier. Delivering on this complex undertaking requires running clinical trials in parallel with investing in production capacity to be able to produce millions, or even billions, of doses of a successful vaccine. The Commission is fully mobilised to support the efforts of vaccine developers in their endeavour.

This is not a European challenge, but a global one. The European Union will not be safe until the entire world has access to a vaccine, and as such, the EU and its Member States have both a responsibility and an interest to make a vaccine universally available.

An important step towards joint action between Member States has already been taken in the formation of an inclusive vaccine Alliance by France, Germany, Italy, and the Netherlands. The EU Vaccine Strategy will implement a joint approach going forward.

The strategy has the following objectives:

• Ensuring the quality, safety and efficacy of vaccines.
• Securing swift access to vaccines for Member States and their populations while leading the global solidarity effort.
• Ensuring equitable access to an affordable vaccine as early as possible.

The EU strategy rests on two pillars:

• Securing the production of vaccines in the EU and sufficient supplies for its Member States 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.
• Adapting the EU’s regulatory framework to the current urgency and making use of existing regulatory flexibility to accelerate the development, authorisation and availability of vaccines while maintaining the standards for vaccine quality, safety and efficacy.

Advance Purchase Agreements

In order to support companies in the swift development and production of a vaccine, the Commission will enter into agreements with individual vaccine producers on behalf of the Member States. In return for the right to buy a specified number of vaccine doses in a given timeframe, the Commission will finance part of the upfront costs faced by vaccines producers. This will take the form of Advance Purchase Agreements. Funding provided will be considered as a down-payment on the vaccines that will actually be purchased by Member States.

The related funding will come from a significant part of the €2.7 billion Emergency Support Instrument. Additional support will be available through loans from the European Investment Bank.

Financing criteria

When taking the financing decision on what vaccines to support, the following non-exhaustive criteria will be taken into account, including: soundness of scientific approach and technology used, speed of delivery at scale, cost, risk sharing, liability, coverage of different technologies, early engagement with EU regulators, global solidarity, and capacity to supply through development of production capacity within the EU.

There is always a risk that supported candidates fail during clinical trials. This Strategy is therefore similar to an insurance policy, by transferring some of the risks from industry to public authorities in return for assuring Member States of equitable and affordable access to a vaccine, should one become available.

A flexible and robust regulatory process

Regulatory processes will be flexible but remain robust. Together with the Member States and the European Medicines Agency, the Commission will make the greatest use of existing flexibilities in the EU’s regulatory framework to accelerate the authorisation and availability of successful vaccines against COVID-19. This includes an accelerated procedure for authorisation, flexibility in relation to labelling and packaging, and a proposal to provide temporary derogations from certain provisions of the GMO legislation to speed up clinical trials of COVID-19 vaccines and medicines containing genetically modified organisms.

Companies with a promising vaccine candidate, already in or close to starting clinical trials, are invited to contact the Commission at [email protected].

Global solidarity

The EU is contributing to the global effort for universal testing, treatment and vaccination by mobilising resources through international pledging and by joining forces with countries and global health organisations through the Access To Covid-19 Tools (ACT) Accelerator collaborative framework. The Global Coronavirus Response pledging campaign raised €9.8 billion by the end of May 2020. A second step is underway in partnership with Global Citizen and other governmental and non-governmental partners, culminating in a global pledging summit on 27 June.

The European Commission is committed to the principle of universal, equitable and affordable access to vaccines, especially for the most vulnerable countries. It is ready to explore with international partners if a significant number of countries would agree to pool resources for jointly reserving future vaccines from companies for themselves as well as for low and middle-income countries at the same time. The high-income countries could act as an inclusive international buyers’ group, thus accelerating the development of safe and effective vaccines and maximise access to them for all who need it across the world.