HERA, A Matriach's Device to Save Europeans from the Next COVID

Applied Clinical Trials, Applied Clinical Trials-08-01-2021, Volume 30, Issue 7/8

European Commission proposes new bio-defense preparedness plan.

The cavalcade of European Union initiatives on health continues unchecked. Early in September, the European Commission’s president, Ursula von der Leyen, is scheduled to propose yet another plan to “get ahead of the curve” in protecting European citizens against infections. The European Health Emergency Preparedness and Response Authority is designed to up the EU’s game in bio-defense preparedness by bringing together science, industry and public authorities in response to major health challenges like COVID-19. This is intended to provide “a permanent structure for risk modeling, global surveillance, technology transfers, manufacturing capacity, supply chain risk mapping, flexible manufacturing capacity and vaccine and medicine research and development,” according to the Commission. And von der Leyen’s project is to be known as HERA–which may amuse lovers of Greek mythology, who will be familiar with the vengeful matriarch of that name.

HERA is one of the remedies that von der Leyen has envisaged for the “structural weaknesses and market failures in our foresight, preparedness and ability to respond coherently, rapidly and appropriately to protect our citizens from health crises.” It will be a dedicated European authority to strengthen the EU’s response capability for new and emerging cross-border threats, portrayed as something of a European counterpart to the US BARDA.

The mission will be to enable the EU and its member states to rapidly deploy the most advanced measures in the event of a health emergency, by covering the whole value chain from conception to distribution and use, engaging both the public and private sectors. At the end likely to be of most interest to readers of ACT, it will “support the development of cross-cutting technologies and solutions sustaining multiple potential future threat responses (e.g. vaccine platform technologies, or the application of digital tools and artificial intelligence) as well as the development of specific countermeasures, including through clinical trials and data infrastructure.”

It will also undertake horizon scanning to anticipate specific threats, identify promising potential countermeasures and relevant underpinning competences. And in practical terms it will monitor and pool production capacity and development facilities, raw material requirements and availability, and ensure that supply chain vulnerabilities are addressed. That will extend to ensuring sufficient production capacity, as well as arrangements for stockpiling and distribution.

Already von der Leyen has used the HERA label to marshal the pharmaceutical industry in Europe into combining its capacities to combat the COVID-19 pandemic. She set up the ‘HERA Incubator’ in February this year “to prevent, mitigate and respond to the impact of the virus and its variants.” She has been personally involved in getting CEOs round the table with her key subordinates in a bid to counter the delays, disruptions and bottlenecks that characterized the early EU responses to the pandemic–and that led to criticism of her management. The incubator has brought together researchers, biotech companies, manufacturers, regulators and public authorities to monitor variants, exchange data and cooperate on adapting vaccines. And it is working towards the ‘EU FAB’ project, a network for single or multi-user, single or multi-technology emergency response production capacity for vaccine and medicine manufacturing at the European level. This will in due course become one of the central assets of HERA.

The activity within the incubator has been focusing on detecting and analyzing new variants of the virus, supporting development of vaccines against resistant new variants, and preparations for producing them at scale and speed. As part of the drive, the Commission is funding new research projects to speed up approval processes and ramp up production. Support for companies working on the adaptation of vaccines or development of new vaccines includes facilitating clinical trials with the launch of an EU-wide network of clinical trials, and backing new technologies to develop adapted or new vaccines. To accelerate approval of adapted vaccines, the incubator is exploring the introduction of emergency authorization of vaccines at EU level, providing guidance on data requirements, and supporting research to include children in clinical trials. And the incubator is helping speed up certification of new or repurposed manufacturing infrastructures. “The pandemic has shown us three things: We have to act early. We have to invest at large scale. We have to partner up”, said von der Leyen, summarizing the core tasks of the HERA incubator.

Just before Europe’s still almost religiously-observed summer break, the first meeting of the HERA incubator’s expert group on COVID variants and treatments held its first discussions. “With our new group of variant experts, we are improving the HERA incubator’s radar screen and warning system,” said von der Leyen’s chief health official, Stella Kyriakides. The group’s contributions “will help us better identify, understand and anticipate variants and will guide us in our work to develop countermeasures,” she said. It will also propose selection criteria for a list of 10 promising treatments for COVID as part of the EU’s therapeutic strategy.

But that summer break for many EU officials–and most of the Brussels bubble–is not being observed by the virus. The World Health Organization and the European Centre for Prevention and Disease Control joined forces as the annual exodus began, to warn that “in much of the European Region efforts must be reinforced to prevent transmission.” The Delta variant “is spreading quickly across Europe and has now become the dominant strain,” it said. WHO’s director general for Europe, Hans Kluge, made clear “we are far from out of the woods in terms of the pandemic ending,” and EDCD director Andrea Ammon insisted on the “need to remain vigilant” to “prevent the spread of disease without having to shut down large parts of society.” Holiday-makers heading for the beaches and mountains were bluntly reminded: “Travel is not risk free.”

If the situation continues to deteriorate and Europe’s plans for preparedness prove insufficient, HERA and the woman who designed it will come in for renewed criticism–and given the duality in von der Leyen’s own normally benignant profile, with its simultaneous capacity for revenge (as AstraZeneca’s boss can testify), any of her subordinates who have failed to deliver will doubtless face torments of their own come the autumn.

Peter O'Donnell is a freelance journalist who specializes in European health affairs and is based in Brussels, Belgium