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The Commission 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.
We must stay ahead of the threat of new coronavirus variants.
With the new HERA Incubator, our goal is clear: be prepared to rapidly produce on a large scale vaccines effective against those variants.#HealthUnion #SafeVaccines
— European Commission ?? (@EU_Commission) February 17, 2021
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.