The Commission has presented a Communication for the proposed launch of a European bio-defence preparedness programme called “HERA Incubator” to address the emerging threat of coronavirus variants. Plans include important new research investments, mobilising an additional €30 million from Horizon 2020 to be complemented by a further €120 million from Horizon Europe.
The new programme will provide the means to detect and counter further coronavirus mutations, and help ensure access to effective vaccines when a new virus or variant has emerged. Horizon 2020 funding will support the rapid establishment of a new EU-wide vaccine trial network called VACCELERATE and boost capacities to track and analyse virus variants and to share data by reinforcing the European COVID-19 Data Platform and other existing research infrastructure projects and networks. Horizon Europe funding will complement this action by providing further support for open data sharing, cohorts studies and for vaccine trials.
At a virtual event for the signature of the grant agreement between representatives of the VACCELERATE consortium and the European Commission, Mariya Gabriel, Commissioner for Innovation, Research, Culture, Education and Youth, said:
"Research and innovation continue to be crucial in fighting the continuing challenges of this pandemic. The Hera Incubator and the reinforcement of European infrastructures and networks, supported by additional funding from Horizon 2020 and Horizon Europe, will help us deal with any variants and be better prepared for future outbreaks."
The “HERA Incubator will also prepare the ground for the European Health Emergency Preparedness and Response Authority (HERA). In detail, the European bio-defence preparedness programme aims to ensure:
Rapid detection of variants
Swift adaptation of vaccines
Setting up a European Clinical Trials Network
Fast-tracking regulatory approval of updated vaccines and of new or repurposed manufacturing infrastructures and
Enable upscaling of production. The contribution of research will be not only to detect, characterise and adapt to virus variants; but also inform vaccination strategies
VACCELERATE will receive a €12 million grant to support the rapid establishment of a clinical research network already spanning 21 countries, while other countries are encouraged to join. It will work in close collaboration with the European Medicines Agency (EMA) to enable clinical trials for COVID-19 vaccines and prepare Europe for other emerging infectious diseases in the future. In particular, it will help determine safety and efficacy of vaccines in priority groups (e.g. the elderly, pregnant women, and children), assess efficacy of vaccines for new SARS-CoV-2 variants, or for different combinations of different existing vaccines (“mix and match”). It will act as a single entry point for vaccine developers, including SMEs, who are looking for European infrastructure to carry out vaccine trials, and also tap into CLIN-Net and LAB-Net - a Europe-wide network of more than 1000 clinical study sites and laboratories in 41 countries.
These research investments supporting the HERA Incubator will be the first under Horizon Europe, the EU’s new research and innovation programme. It foresees to further fund the development of the European COVID-19 Data Platform for open data sharing and infrastructure services for rapid response to epidemics, especially for detection and assessment of variants, as illustrated by a recent report from the VEO project. It will also provide further support for the development of large scale, international/worldwide COVID-19 cohorts -, and the conduct of vaccine and therapeutic trials, as well as observational studies, to further inform public health policy and clinical management. The schedule for these funds to be available will be announced in the coming weeks.
Aside from new research investment that will help address the imperative to detect, characterise and adapt to virus variants, the European bio defence preparedness programme will also aim to adapt existing Advance Purchase Agreements and/or conclude new ones; to speed up regulatory approval of vaccines, data packages and new or repurposed manufacturing infrastructures; and to support the production of existing, adapted or novel COVID-19 vaccines. The platform will serve as a first pilot for the EU Health Emergency Preparedness and Response Authority (HERA), which will put in place permanent structures for risk modelling, threat assessment and surveillance, hence the name “HERA Incubator”.
The European Union reacted immediately to the COVID-19 outbreak with several research and innovation actions, as early as January 2020. In all, it pledged to invest €1 billion from Horizon 2020, the EU programme for research and innovation (2014-2020), under the Coronavirus Global Response initiative. To date over €780 million has already been mobilised from this pledge, of which at least €350 million supports coronavirus vaccine development.
The VACCELERATE project involves 26 partners in 16 Member States (AT, BE, CY, DE, DK, EL, ES, FR, IE, IT, LT, NL, PL, PT, SE, SK) and 5 associated countries (CH, IL, NO, RS, TR), led by University-Hospital Köln. The network will organise a Stakeholder Working Group (SWG) that facilitates strategic discussions and identification of pressing unanswered public health needs. The SWG will gather the European Medicines Agency (EMA) and national regulatory bodies, as well as the European Centre for Disease Prevention and Control (ECDC), and other relevant European and international actors. As of January 2021, VACCELERATE centralised information for more than 180 vaccine trial sites in 30 European countries on their capacity to perform vaccine trials (hospitals, primary care, paediatric networks, etc). The mapping will also identify the most suitable laboratories for vaccine trials, and specific vaccine-trial related training will be provided as needed. Finally, VACCELERATE will work towards standardised data management and support the timely sharing of data.
The reinforcement of existing research infrastructure and other projects is also foreseen:
ELIXIR-CONVERGE could improve open data-sharing and re-use by further developing the European COVID-19 Data Platform in a joint effort with the European Bioinformatics Institute of the European Molecular Biology Laboratory (EMBL-EBI), ELIXIR and the European Commission; the platform currently hosts more than 768 000 records, including 288 000 raw viral sequences, and has so far received close to 4 million web requests for data;
the European Virus Archive (EVAg) could facilitate and accelerate the supply of molecular diagnostics control and viral strains to the scientific community worldwide;
the Versatile Emerging Infectious Disease Observatory (VEO) could reinforce capacity for determining the frequency of new variants, combining data from various sources (including wastewater); analytical tools will be made available to researchers around the world via the European COVID-19 Data Platform;
the ORCHESTRA project – Connecting European Cohorts to Increase Common and Effective Response to SARS-CoV-2 Pandemic – could evaluate risk factors for the transmission of the various variants of the virus and for the disease development, thereby supporting the assessments of long-term safety and efficacy for vaccines;
the ATAC project – Antibody therapy against coronavirus – could extend testing of promising antibody-based treatments specific to the new variants.