The European Commission proposed on 17 February the “HERA Incubator”, the Health Emergency Preparedness and Response Authority (HERA) Incubator to prepare Europe for the increased threat of coronavirus variants.
Advertisement
Why is the Commission making proposals on dealing with new virus variants today?
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. Today’s announcement anticipates these developments and proposes a number of actions to reduce the risk from future variants.
The EU is setting up a European bio-defence preparedness plan “HERA Incubator” against COVID-19 variants to bring together researchers, biotech companies, manufacturers, regulators and public authorities to 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 and facilitating the certification of new or repurposed manufacturing infrastructures; and
- Supporting the speedy mass production of adapted or novel COVID-19 vaccines.
What threat do variants pose in Europe?
New variants are already present in Europe and 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, 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.
Sequencing capacity varies greatly across the EU but is below 10% in all but one EU country. As efforts and capacity around sequencing increase, additional variants may be detected that will require surveillance and evaluation.
The Commission will support EU countries to carry out more testing and genome sequencing by developing specialised tests for new variants, with at least 75 million in EU funding and prepare for adapting vaccine and vaccine production capacity.
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.
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, to 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?
We have 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.
Today we are 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.
How will the EU support industry in ramping up production and preparing for future strains of the virus?
Private-public cooperation will be key to improving vaccine production capacity and overcoming bottlenecks in the supply chain. The bio-defence preparedness plan “HERA Incubator” will facilitate contacts and cooperation between regulators, other public authorities and industry and between industry players involved in the supply chain. The Task Force for Industrial Scale Up will act as a one-stop-shop helpdesk for any queries and operational support to address bottlenecks in production and supply of raw materials;
The Commission will foster the creation, if need be, of a voluntary, dedicated licensing mechanism to enable sharing of technical know-how through pre-production industrial partnerships in order to increase production.
The Commission will support the cooperation between undertakings necessary to achieve the specific objective in terms of research and development, production or supply, which the companies acting alone would not be in a position to do. The Commission stands ready to provide competition law guidance in relation to the production of vaccines or treatments, including in light of the criteria set out in the Antitrust Temporary Framework Communication.
The Commission will set up the EU-FAB flexible manufacturing capacity reserve.
The Commission will build on the ongoing mapping of industrial capacities.
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 today. 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.
How will the proposed actions be funded?
The Commission will invest in various aspects of the platform, including:
- 75 million to support genomic sequencing in Member States and to develop new standardised tests for variants;
- 150 million for existing and new research projects on variants under Horizon Europe;
- Topping up the Emergency Support Instrument and using the Horizon 2020 InnovFin Infectious Diseases Finance Facility and under InvestEU to finance new or extended advance purchase agreements.
How is today’s announcement linked to the future 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). The EU bio-preparedness authority was part of the Commission’s legislative package on building resilience to health threats of 11 November 2020.
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, focusing 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, 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 today will also contribute to shaping the new agency. The Commission will make a legislative proposal towards the end of the year.
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, but will also contribute to EU strategic autonomy in the area of health and the strategic positioning of the European healthcare industry.
Source: European Commission
