Statement by President von der Leyen at the Read-out of the College meeting/Press conference on the HERA Incubator to anticipate the threat of coronavirus variants - Hoofdinhoud

Good afternoon,

Let me start with the Read-out of the College meeting we had today. We, at the beginning, adopted a Communication on the HERA Incubator. We will, in a moment, discuss that with you.

The College also discussed an Action Plan to enhance the synergies and build links between the civil, defence and space industries.

We discussed as well our Communication on trade. With it, we are defining a new direction for an open, sustainable and assertive trade policy aligned with our strategic interests and priorities.

Then, we adopted a Joint Communication, together with the High Representative, on strengthening the EU's contribution to rules-based multilateralism. The EU believes that rules-based multilateralism is indispensable to deal with the challenges the world faces today. So we must use our influence to ensure that it is up to the task.

And then, as every week, HR/VP Borrell i also briefed the College on the latest developments in the international arena.

Finally, I am glad to announce that today the Commission has approved a second contract with Moderna to purchase 300 million additional doses of their vaccine against COVID-19. This is good news and this builds the bridge to the topic which we will be presenting to you today.

We are here today to present the next stage in our strategy to combat coronavirus. As you know, vaccination is progressing. So far, around 33 million doses have been delivered. 22 million people have received at least one dose and 7 million of them have received a second. We must and we will speed up vaccination in the weeks and months ahead.

Delivery of the three approved vaccines will be ramped up and new vaccines will become available soon, after approval by the EMA i. But the situation is evolving. We are seeing more and more COVID‑19 cases linked to new variants. And new variants of the virus are still emerging in Europe and across the world.

So far, the vaccines approved in Europe appear to be effective against the variants. But these variants are more infectious. And the more infections there are, the more potential variants there will be. And those variants might be more resistant to existing vaccines.

The increased spread of the new COVID-19 variants - first identified in the United Kingdom, South Africa and Brazil - are a potential paradigm shift in the global fight against COVID-19. Over the past weeks, EU countries have observed a substantial increase in the number and proportion of COVID-19 cases caused by these variants. Looking at the evolving situation, we just know how much time and structures are of the essence. And this is why we are today presenting the HERA Incubator. It is a new public-private cooperation pooling the knowledge and the resources of industry, of the research and science community, of the whole health sector and public authorities and regulators.

The aim is to use our combined strength to get ahead of the curve for the next phase of this virus from the early detection of the new variants, all along the whole chain, up to rapid mass production that is necessary if we have adapted second-level or second-generation vaccines. The good news is we have a lot to build on and a lot to learn from. We know what works well. And equally we know where there were delays, disruptions and bottlenecks the first time round.

And with this in mind, the HERA Incubator will focus on five main priorities. First of all, it is the sequencing: To identify variants quicker, we need to know more about the many possible facets of this virus to be able to combat it. Second, if necessary, science has to adapt the existing vaccines. So we have to focus on the research. Third point, we need well-organised clinical trials to have evidence-proofed data fast. And that is why we are launching today a European Clinical Trials Network. Fourth point, we need to enable EMA to fast-track the regulatory approval of updated vaccines and manufacturing sites. And fifth and finally, we need to further upscale mass production of new vaccines but also of existing vaccines.

On all five areas, the Commission will channel organisational and financial support through the HERA Incubator. We will focus on improving information sharing - this is of utmost importance among the stakeholders -, on planning and coordination in the detection and the response to the new variants. Stella Kyriakides i, the Health Commissioner, and Thierry Breton i, the Commissioner for Industry, will speak about it in more detail.

Finally, let me mention once again the most urgent measures. Firstly, identifying variants at an early stage. We must set about genome-sequencing more quickly and more widely in the EU. It is important for us that the HERA incubator works very closely with the ECDC and the Member States, especially in order to ramp up sequencing capacity and promote the large-scale use of new COVID-19 tests.

The second key element is that we will support industry in adapting the vaccines to new variants. That is the research work behind the vaccines which must be carried on relentlessly. To that end, we will start by making EUR 150 million available to research projects to specifically support this research process.

Thirdly, clinical studies on COVID-19 vaccines throughout the EU must be better coordinated. I am pleased to say that today we are launching an EU-wide, EU-funded network for clinical studies. It involves some 16 Member States and over 180 different participants - from hospitals to medical practices. This is the very first Europe-wide research network on COVID-19 vaccines. What is important for us is that we achieve a high standard, we have better data quality, better data collection and above all that the data is passed on quickly to the EMA and can be made available there in real time.

Fourthly, market approvals for improved vaccines must be streamlined. This is possible, because we are now familiar with the technologies behind them, for example mRNA technology. That means we only need to assess the updates, and no longer the vaccine per se. This is what generally happens with the ‘flu vaccines, which also have to be updated every year. At the same time, we have to speed up the certification of new production facilities because that is also important in the manufacturing process. The Commission will therefore be updating the regulatory frameworks in these two areas.

Fifthly, a very important factor: We must ensure that we have sufficient production capacity in Europe over the short- and long-term. The HERA incubator will work with the industry to create a network of production facilities that can to some extent be ‘on stand-by'. This means that when production needs to be ramped up, it can be done more quickly than has been the case up to now, with stable processes and trained staff.

The pandemic has shown us three things: We have to act early. We have to invest at large scale. We have to partner up. This is why we are proposing the HERA Incubator now. This is the message I will also take to next week's meeting with the Heads of State or Government, the EU Leaders. I will call on them to endorse this proposal and support its rapid implementation.

Thank you very much.