The initative will seek to speed up the approval process for vaccines, particularly for those adjusted to fight new coronavirus variants. It will also provide incentives to develop new and adapted vaccines and ensure scaling up of manufacturing capabilities.
The HERA Incubator will draw together researchers, biotech companies, manufacturers and public authorities in the EU and further afield.
"New variants are already present in Europe and the ECDC assesses the risk of further spread from variants as high to very high," says the European Commission, announcing the plan yesterday.
"Some variants appear to be more transmissible and could become the dominant strain, or even reduce the efficacy of vaccination campaigns. Likewise, future variants may not be receptive to current vaccines and Europe has to anticipate this risk.
“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.”
In this way, HERA seeks to 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.
Key actions for the plan are centered around boosting preparedness, developing vaccines for variants and increasing production. They are spilt across three areas:
1) Detect, analyse and assess variants
- Develop specialised tests for new variants, and to support genomic sequencing with €75m of EU funding;
- Reach a target of 5% of genome sequencing of positive tests to help identify variants and their spread;
- Step up research and data exchange on variants with €150 million funding;
- Launch 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:
- Accelerate approval for adapted COVID-19 vacines based on the annual influenza model
- Adapt 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; and provide guidance on data requirements in advance
- Facilitate certification of new or repurposed manufacturing sites through early involvement of regulatory authorities;
- Consider a new category of emergency authorisation of vaccines at EU level with shared liability among Member States.
3) Ramp up production of COVID-19 vaccines:
- 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 production bottlenecks;
- Support the manufacturing of additional vaccines addressing new variants;
- Develop a voluntary dedicated licensing mechanism to facilitate technology transfer;
- Ensure the EU's manufacturing capacity by building up the “EU FAB” project a (network of single or multi-user, single or multi-technology emergency response production capacity for vaccine and medicine manufacturing at European level).
