The EU Commission is proposing immediate action to prepare Europe for the increased threat of coronavirus variants. The new European bio-defence preparedness plan against COVID-19 variants called “HERA Incubator” will work with researchers, biotech companies, manufacturers and public authorities in the EU and globally to detect new variants, provide incentives to develop new and adapted vaccines, speed up the approval process for these vaccines, and ensure scaling up of manufacturing capacities. Taking action now is important as new variants continue to emerge and challenges with scaling up vaccine production are arising. The HERA Incubator will also serve as a blueprint for the EU's long‑term preparedness for health emergencies. Key actions to boost preparedness, develop vaccines for the variants and increase industrial production:
1) Detect, analyse and assess variants
- Developing specialised tests for new variants, and to support genomic sequencing in the Member States with at least €75 million in EU funding;
- Reaching the target of 5% of genome sequencing of positive tests to help identify variants, monitor their spread in populations, and screen their impact on transmissibility;
- Stepping up research and data exchange on variants with €150 million funding;
- Launching the VACCELERATE COVID-19 clinical trial network, bringing together 16 EU Member States and five associated countries including Switzerland and Israel to exchange data and progressively also include children and young adults as participants in clinical trials.
2) Speed up regulatory approval of adapted vaccines: based on the annual influenza vaccine model, the EU will provide accelerated approval for adapted COVID-19 vaccines by:
- Adapting the regulatory framework, such as amending the regulatory procedure to enable the approval of an adapted vaccine with a smaller set of additional data submitted to EMA on a rolling basis;
- Providing guidance on data requirements for developers from the European Medicines Agency so that the requirements for variants are known in advance;
- Facilitating certification of new or repurposed manufacturing sites through early involvement of regulatory authorities;
- Considering a new category of emergency authorisation of vaccines at EU level with shared liability among the Member States.
3) Ramp up production of COVID-19 vaccines:
- the EU will update or conclude new Advance Purchase Agreements to support the development of new and adapted vaccines through EU funding, with a detailed and credible plan showing the capability to produce vaccines in the EU, on a reliable timescale.
- This should not prevent the EU from considering sources from outside the EU if needed, provided they meet the EU safety requirements;
- Work closely with manufacturers to help monitoring supply chains and addressing identified production bottlenecks;
- Support the manufacturing of additional vaccines addressing new variants; Develop a voluntary dedicated licensing mechanism to facilitate technology transfer;
- Support cooperation between undertakings; Ensure the EU's manufacturing capacity by building up the “EU FAB” project.