The European Commission announced in February the launch of the plan which aims to mobilise an additional 30 million euros to Horizon 2020 and up to 150 million euros in Horizon Europe. The call is part of the Hera Incubator plan, which aims to develop and rapidly produce efficient vaccines against the variants of the virus.
Some of the key actions of this new plan are:
1. Detect, analyse and assess new variants:
- Develop specialised tests for new variants and support genomic sequencing in the Member States
- Achieve the target of 5% genomic sequencing of positive tests to help identify variants, monitor their spread in the population and analyse their impact on transmissibility
- Intensify research and data sharing on variants
- Launch of COVID-19 VACCELERATE clinical trials network
2. Accelerate regulatory approval of adapted vaccines. Based on the annual influenza vaccine model, the EU will provide accelerated licensing for adapted COVID-19 vaccines through the following actions:
- Adapting the regulatory framework, for example by amending the regulatory procedure to allow approval of a suitable vaccine with a smaller set of additional data submitted to the European Medicines Agency (EMA).
- Providing guidance for developers on EMA data requirements
- Facilitate certification of new or adapted manufacturing sites through the involvement of regulatory authorities
- Establish a new category of emergency authorisation of vaccines at the EU level with shared responsibility between Member States
3. Increase vaccine production:
- Update and create new advance procurement opportunities to support the development of new and adapted vaccines through EU funding.
- Engage with manufacturers to help monitor supply chains and address identified obstacles
- Support the manufacture of additional new variant-adapted vaccines
- Develop a dedicated voluntary licensing mechanism
- Support co-operation between companies
- Ensure EU manufacturing capacity
A webinar is expected to be held to provide information on the features of the call.