European Commission launches a European bio-defence preparedness plan against COVID-19 variants

The HERA Incubator will serve to detect new COVID-19 variants, provide incentives to develop new COVID-19 vaccines, speed up the approval process for these vaccines and ensure scaling up manufacturing capacities.

According to the Commission, the following key actions of the HERA Incubator will provide a basis, and lead to the establishment, of the currently proposed European Health Emergency Preparedness and Response Authority (HERA):

1. Detect, analyse and assess variants:

• Develop specialised tests for new COVID-19 variants, reach the target of 5% of genome sequencing of positive COVID-19 tests.
• Provide access to high quality data is crucial for the identification of new variants and corresponding measures to be taken. The HERA incubator will therefore enable timely coordination with producers and regulators on transitioning research to the clinical phase.
• High Performance Computing may be enabled to collect data on these new variants and as such help in developing their corresponding vaccines.
• Set up a European clinical trial network, called VACCELERATE, to address the challenges faced by the continuation of clinical trials during the COVID-19 pandemic. Research, regulatory as well as industry communities will be included in the development of this network to consider how clinical trials can be facilitated.

2. Speed up regulatory approval of adapted vaccines:

• The approval of adapted COVID-19 vaccines should be enabled with a smaller set of data submitted to the European Medicines Agency (EMA), facilitating certification of new or repurposed vaccine manufacturing sites through early involvement of regulatory authorities, and considering a new category of emergency authorisation of vaccines at EU level with shared liability among member states.

3. Ramp up production of COVID-19 vaccines:

• This will involve updating or concluding new advance purchase agreements, working closely with manufacturers, developing a voluntary dedicated licensing mechanism to facilitate technology transfer, supporting cooperation between undertakings, and ensuring the EU´s manufacturing capacity by building up the so-called “EU FAB” project.
• Acknowledging that research and innovation continue to be crucial in fighting the challenges of the COVID-19 pandemic, the HERA Incubator will be supported by €30 million and 120€ million from Horizon 2020 and Horizon Europe, respectively, and by an additional €75 million from the European Commission, making a total of €225 million.

The launch of the HERA incubator can be seen as a pilot phase of the creation of the new European Agency; European Health Emergency Preparedness and Response Authority (HERA) proposed by the European Commission in early February 2021. The creation of a new agency is a long process, with first a consultation process which will very probably be followed up by a proposal for a Regulation only by Q4 2021, followed by a legislative process which may take several months and not end before end 2022.
Whereas the Commission’s plan doesn’t extensively explore the full potential Computer Modelling and Simulation (CM&S) could bring to the HERA, High Performance Computing is recognised as a useful enabler for data gathering on new variants and vaccine development. The Commission hence establishes the consideration that qualitative data collection will be key in advancing research on the front of tackling infectious disease outbreaks, and that this goes hand in hand with computing.
It is also interesting to note that the creation of the HERA Incubator and the establishment of a new Agency (HERA), reflects inspiration from the U.S. Biomedical Advanced Research and Development Authority (BARDA), as an agency that had not necessarily been required by the EU until now. With its creation of the new Agency is widely supported by the Commission, the new HERA will seek to strengthen the EU’s preparedness and response to serious cross-border health threats and the EU’s global position on bio-defense, by having at its disposal significant research and development resources.

By launching the HERA incubator, the Commission is proposing a plan to lay the groundwork to undertake the urgent activities on bio-defence preparedness, including actions on the coronavirus and its emerging variants. It provides a forecast on what the upcoming new HERA’s activities could be busy with, while remaining strongly focused on the urgent needs of the COVID-19 pandemic.