The EU’S Bio-Defense Preparedness Programme: The HERA Incubator

Preparedness for the future is essential at a time when new and more transmissible strains of the coronavirus are emerging and spreading rapidly. Jana Joha looks at the EU’s HERA Incubator that will provide the EU with a biodefense preparedness program.

The European Commission has launched the ‘HERA incubator’, a European bio-defense preparedness programme that hopes to address the looming threat of coronavirus variants. This plan not only aims to monitor future variants but to also allow researchers to collaborate and fast-track the development of future vaccines. The Commission unveiled their plan on Wednesday the 17th of February, promising to work with researchers, biotech companies, manufacturers and public authorities both in the EU and around the world to detect and prevent the spread of new variants. The EU has pledged €30 million from Horizon 2020 and €120 million from Horizon Europe. 

This plan comes at a time when new and more transmittable strains of the coronavirus are emerging and spreading rapidly. European Commission President Ursula von der Leyen warned that we are seeing “more and more cases of COVID-19 linked to variants”. New variants are already present in Europe and in various parts around the world. Some of these variants appear to be more transmissible with the potential of becoming dominant strains. They even have the potential to reduce the efficacy of vaccines. The Commission recognises that this is a real threat and anticipates that there will be future strains. Therefore, it has launched the ‘HERA incubator’ in order to combat this. At a press conference President Ursula von der Leyen explained that “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 ‘HERA incubator’ now.”. 

The EU hopes to bring together researchers, biotech companies, manufacturers, regulators and public authorities to monitor variants, exchange data and cooperate on adapting vaccines. The plan will focus on detecting, analysing and adapting to new variants, speeding up regulatory approval and providing guidance on data requirements. They also plan to facilitate the certification of new or repurposed manufacturing infrastructures and support the rapid mass production of adapted or novel vaccines. Stella Kyriakides, European Commissioner for Health and Food Safety, stated that we need to “have fully future adapted vaccines to be approved as quickly as possible through streamlined and predictable procedures, procedures that also allow citizens to feel safe and to build up trust in public health matters.”. 

The growing threat of new Coronavirus variants looms over every government around the world. Now more than ever we need to stay ahead of this virus”

The funding provided by Horizon 2020, which is a programme that funds research, technological development and innovation, will support various different research projects and investments. This funding will help to establish a new EU-wide vaccine trial network called ‘VACCELERATE’ in order to improve the tracking and analysis of virus variants. This initiative will support the rapid establishment of a clinical research network that will span 21 countries. €12 million has already been allocated and the European Medicines Agency (EMA) plans to work closely with the initiative. 

Ireland is one of the 21 countries that is participating in VACCELERATE. The Irish partners are University College Dublin (UCD) and National University of Ireland, Galway (NUIG) which will be led from UCD by Infectious Diseases expert Professor Paddy Mallon, director of UCD Centre for Experimental Pathogen Host Research (CEPHR) and consultant at St. Vincent’s University Hospital Infectious Diseases department. The main aim of VACCELERATE is to help determine the safety and efficacy of vaccines in priority groups such as the elderly, pregnant women and children and to assess the efficacy of vaccines for new variants. 

The VACCELERATE initiative will also allow for better and more efficient sharing of data and collaboration. It will enable harmonised data collection and open data sharing and pooling for stronger and faster analysis by reinforcing and supporting the European COVID-19 Data Platform which launched in April 2020 with the goal to provide an open, trusted and scalable European and global environment for rapid collection and sharing of data. Professor Peter Doran who is the director of UCD Clinical Research Centre and Associate Dean of Research, Innovation and Impact at UCD School of Medicine believes that “The VACCELERATE project represents a unique mobilisation of European research strength in basic and clinical research” and that “the establishment of this programme will put European science at the leading edge of new vaccine development and testing.”. 

President Ursula von der Leyen explained that “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 ‘HERA incubator’ now”.

The HERA incubator programme will also adapt existing Advance Purchase Agreements (APA) in the hopes of speeding up regulatory approval of vaccines, data packages and new/repurposed manufacturing infrastructures as well as supporting the production of adapted or novel COVID-19 vaccines. Advance Purchase Agreements help address new variants by helping to de-risk private investments in the early stages of vaccine development. The Commission aims to use existing APAs to ensure rapid access to and delivery of next generation vaccines. This platform will also serve as a first pilot for the EU Health Emergency Preparedness and Response Authority (HERA). The programme is called the HERA incubator as HERA will focus on putting in place long term structures for risk modelling, threat assessment and surveillance. ‘The HERA incubator is really the precursor and strong nucleus for the future european health emergency preparedness and response authority’ - Kyriakides. 

The growing threat of new corona virus variants looms over every government around the world. Now more than ever we need to stay ahead of this virus. Continued collaboration and teamwork between scientists, biotech companies, governments and ordinary people will be the thing that will get us through this crisis sooner. The European Union shares these beliefs and are determined to achieve those goals. Through the launching of the HERA incubator we may perhaps finally get ahead and emerge from this global pandemic sooner than predicted while also being more prepared than ever before for future pandemics. Mariya Gabriel, Commissioner for Innovation, Research, Culture, Education and Youth strongly believes that “Through our joint efforts, we will better understand, diagnose and eventually overpower the pandemic.”