HERA, the European Answer to Pandemic Preparedness

By Richard Zwaal, Senior Consultant

The European Union’s response to the COVID-19 pandemic was slow to start and lacked both a central strategy and a cross-border organizational structure to support vaccine development and roll-out. Recognizing more coordination at the European level is needed to step up the fight against the COVID-19 pandemic and future health emergencies. The EU is working to set up something like the U.S. Biomedical Advanced Research and Development Authority (BARDA). This agency is responsible for the development and stockpiling of vaccines and treatments to use during public health emergencies as part of a federal preparedness and response strategy.

From early 2020 to now, BARDA awarded over 10 billion dollars in the development of COVID-19 vaccines alone. The BARDA COVID-19 Medical Countermeasure Portfolio currently consists of 81 products in various stages of development, including vaccines, diagnostics, therapeutics and others.

In September last year, European Commission (EC) president Ursula von der Leyen announced a plan to set up an equivalent to BARDA called the European Health Emergency Response Authority (HERA). Full details are not yet clear but are expected to be revealed later this year.

Strong budgets are needed to combat COVID-19 and protect against future threats. How HERA will be funded remains a question for now. The EU budget for the next seven years is settled and contains no provisions for anything like HERA. So far, the EU funding for late-stage development and manufacturing is miles short of what the U.S. government has made available, and budget will remain a major challenge in the coming years.

In anticipation of the HERA, the EC launched its first programs. A first tranche of €150 million and a second tranche of €123 million were dedicated for research on emerging coronavirus variants, clinical development of therapeutic or vaccine candidates and support of research infrastructures. However, no new budget was allocated. Instead, funding was mobilized from Horizon Europe, the EU research & innovation framework program for 2021-2027. Calls closed earlier this month.

Although efforts so far were focused mainly on vaccines, direct antiviral therapeutics are another set of essential tools to tackle the current COVID-19 pandemic. The EU presented its “end-to-end” strategy on COVID-19 therapeutics in May, including research, development, authorization, production and the procurement of safe and effective novel or repurposed therapeutics. As part of the strategy, the EU will fund a €40 million preparatory action to support flexible manufacturing and access for COVID-19 therapeutics. Such an emergency response production capacity for vaccine and medicine manufacturing at European level will become an important asset over time for the future HERA.

 

Modis Life Sciences offers expertise with managing BARDA-funded projects on COVID-19 and pandemic influenza. Modis Project Managers facilitate the interactions with BARDA and make sure your project is executed in line with the U.S. government reporting requirements. Modis also continuously monitors the funding landscape. It can help you match your R&D projects to existing and upcoming funding schemes, including COVID-19-related topics. Modis’ experienced consultants have submitted many winning proposals, and its skilled project leaders help you drive your projects to success.

– Richard Zwaal, Senior Consultant