The European Commission (EC) has proposed an action plan called the “HERA Incubator” to shape the European Union’s (EU’s) strategy for combating the threat of future COVID-19 variants. The initiative is modelled on the annual influenza vaccine programme.
The plan is founded on researchers, manufacturers and regulators working together to implement the proposed strategy which consists of three key components outlined below.
Detect, analyse and assess variants
- At least €75 million in EU funds has been pledged to developing specialised tests for new variants and genomic sequencing.
- A target has been set for 5% of positive tests to undergo genome sequencing to help identify variants, monitor their spread in populations and thereby assess their transmissibility.
- Use of the VACCELERATE COVID-19 project, a clinical trial network between 16 EU member states and five associated countries. It aims to facilitate data sharing and to promote the inclusion of children and young adults as clinical trial participants.
Speed up regulatory approval of adapted vaccines
- Adapt the regulatory framework to enable the approval of a vaccine with a smaller set of additional data that is submitted to the European Medicines Agency (EMA) on a rolling basis.
- Facilitate quick certification of new or repurposed manufacturing sites.
- The EMA will also provide guidance on data requirements for vaccine developers.
Ramp up COVID-19 vaccine production
- Update/conclude new Advance Purchase Agreements (between the EU and manufacturers) to support the timely development of new and/or adapted vaccines using EU funding.
- Identify and address supply chain issues which may lead to production bottlenecks by working closely with manufacturers.
- Develop a voluntary dedicated licensing mechanism to facilitate technology transfer
- Use the EU FAB project to ensure the EU will have an adequate manufacturing capacity.
The HERA Incubator’s success relies on collaboration between the EU, the World Health Organisation and global vaccine initiatives. The programme will lay the foundation for the formation of the European Health Emergency Preparedness and Response Authority (HERA), a newly unveiled body within the EU.
To read the full notice on the HERA Incubator, click here.