Variants, vaccines and HERA Incubator in Europe

New variants are already present in Europe and the EU is setting up a European bio-defence preparedness plan “HERA Incubator”. The ECDC assesses the risk of further spread from variants as high to very high. Some variants appear to be more transmissible and could become the dominant strain. Also they may reduce the efficacy of vaccination campaigns. Likewise, future variants may not be receptive to current vaccines and Europe has to anticipate this risk.

Right now we’re at a very critical stage in many parts of the world. We really need to be focusing on bringing down the transmission and that in turn will help in reducing how much this virus can actually change.

Dr Soumya Swaminathan, WHO’s Chief Scientist

Health and Emergency Preparedness and Response Agency (HERA)

The EU is setting up a European bio-defence preparedness plan “HERA Incubator” against COVID-19 variants . HERA Incubator will bring together researchers, biotech companies, manufacturers, regulators and public authorities. They will monitor variants, exchange data and cooperate on adapting vaccines. The plan will focus on:

• Detecting, analysing and adapting to virus variants;
• Speeding up regulatory approval of vaccines, providing guidance on data requirements. Also facilitating the certification of new or repurposed manufacturing infrastructures; and
• Supporting the speedy mass production of adapted or novel COVID-19 vaccines.

What is the Health and Emergency Preparedness and Response Agency (HERA)?

The bio-defence preparedness plan “HERA Incubator” will start off immediately. It will lay the foundations for a future fully-fledged bio-preparedness authority, the European Health Emergency Preparedness and Response Authority (HERA). An EU authority for bio-preparedness would remediate structural gaps in the EU’s health preparedness and response capacities with regard to biomedical development, production and surge capacity development. It will also provide a horizon scanning function. It will focus on emerging biomedical technologies that can be scaled-up for real-world application during times of crisis. The authority will engage with industry, science, academia and clinical research organisation networks. HERA Incubator will join forces with the aim of implementing successful public-private cooperation.

A consultation on the inception impact assessment for a European Health Preparedness and Response Authority is ongoing. The preparatory actions on new variants announced will also contribute to shaping the new agency. The EU investment into creating state-of-the-art vaccine and drug research, development and manufacturing capacities will be one of the core blocks for future pandemic response. It will also contribute to EU strategic autonomy in the area of health and the strategic positioning of the European healthcare industry.

Great concern. Is HERA Incubator the solution?

A number of variants of coronavirus are already causing great concern as they are more transmissible and spreading rapidly across Europe. According to the European Centre for Disease Prevention and Control (ECDC), the B.1.1.7 variant first reported in Britain appears to be on course to become dominant over the previous strains in the EU. Other strains and mutations may emerge in the future. HERA Incubator anticipates these developments and proposes a number of actions to reduce the risk from future variants.

How can Advance Purchase Agreements help address new variants?

Advance Purchase Agreements help de-risk private investments in the early development of production capacity for vaccine candidates still in early clinical trial stages. Companies that successfully developed COVID-19 vaccines are already closely monitoring the efficacy of their vaccines against emerging variants and looking into the possibilities of adapting their vaccines. This is a very important point that vaccine developers keep in mind. 

The Commission will use existing Advance Purchase Agreements to ensure rapid access to and delivery of the next generation of vaccines, if necessary. Existing agreements may have to be updated to cover protection against variants. Based on the lessons learned, a detailed and credible plan showing capability to produce vaccines in the EU on a reliable timescale will be a prerequisite to any new or updated agreement. This should not prevent the EU from considering sources from outside the EU if needed, provided they meet the EU safety requirements

In addition to Advance Purchase Agreements, capacity support will be considered, notably for smaller firms. It will facilitate the production of vaccines and ensure the availability of intermediary inputs and infrastructures, such as laboratories.

Why is the EU only accelerating its procedures for regulatory approval now?

EU has already considerably accelerated the procedure for approving new vaccines and medicines over the last year. The European Medicines Agency undertakes rolling reviews of new vaccines or therapeutics, allowing it to recommend a conditional marketing authorisation much quicker than in the past.

European Union is proposing to speed up the procedures for approving adapted versions of existing vaccines, in case new variants becoming less receptive to current vaccines. We will base the framework on that used for the annual flu vaccine, which has worked successfully for many years. This means speedy approval based on a rolling review of data and clear guidance on data requirements from the European Medicines Agency, and a clear path to certification of new or repurposed manufacturing sites. Is HERA Incubator the solution?

WHO explains the link between Variants & Vaccines

We’re hearing about variants of the SARS-CoV-2 virus that causes COVID-19. How concerned should we be? How concerned should we be about the new variants of SARS CoV 2 which cause COVID-19? Is it unusual for viruses to change and mutate? Do vaccines protect against these variants and what can you do to protect yourself? WHO’s Chief Scientist Dr Soumya Swaminathan explains in Science in 5.

What is EU-FAB?

“EU FAB” project will set up a network of single or multi-user, single or multi-technology emergency response production capacity for vaccine and medicine manufacturing at European level. The project is being set up with the long-term perspective of becoming over time an asset for the future European Health Emergency Preparedness and Response Authority (HERA).

Who will participate in the VACCELERATE clinical trials network?

16 Member States and five associated countries including Israel and Switzerland will participate in VACCELERATE, the clinical trials network launched. The network will make cooperation and data exchange during clinical trials on COVID-19 therapeutics and vaccines much smoother. It will also focus on setting up paediatric trials to look into the effectiveness of vaccines in children and young people.

eudebates HERA Incubator