Ursula von der Leyen – Photo EC
(BRUSSELS) – The EU Commission put forward plans Wednesday for a new European bio-defence preparedness plan to pull together available resources to ready the EU against the increased threat of coronavirus variants.
The plan, called the “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.
“The aim is to use our combined strength to get ahead of the curve for the next phase of this virus” said EC president Ursula von der Leyen: “The pandemic has shown us three things: We have to act early. We have to invest at large scale. We have to partner up.”
The EU executive says that taking action now is important as new variants continue to emerge and challenges with scaling up vaccine production are arising. The HERA Incubator is expected to 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:
Detect, analyse and assess variants
- Developing specialised tests for new variants, and to support genomic sequencing in 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.
- 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 Member States.
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 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.
The actions will go hand-in-hand with global cooperation via the World Health Organisation and global initiatives on vaccines. They will also prepare the ground for the European Health Emergency Preparedness and Response Authority (HERA). HERA will provide a permanent structure for risk modelling, global surveillance, technology transfers, manufacturing capacity, supply chain risk mapping, flexible manufacturing capacity and vaccine and medicine research and development.
HERA Incubator - Anticipating COVID-19 variants - background guide
