Annexes to COM(2021)78 - HERA Incubator: Anticipating together the threat of COVID-19 variants

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dossier COM(2021)78 - HERA Incubator: Anticipating together the threat of COVID-19 variants.
document COM(2021)78 EN
date February 17, 2021
Agreements for the next generation of vaccines

Companies that successfully developed COVID-19 vaccines are already closely monitoring the efficacy of their vaccines against the emerging variants of concern. They are looking into the possibilities of adapting their vaccines to emerging variants. The Commission will continue to use the instrument of Advanced Purchase Agreements and, building on its successful track-record, it will continue to ensure the rapid access to and delivery of the next generation of vaccines.

This approach to help de-risk private investments in the early development of production capacity for vaccine candidates still in early clinical trial stages has shown its worth and offers a ready-made structure on which to build.

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 and deliver on a reliable timescale will be a prerequisite. This should not prevent the EU from considering sources from outside the EU if needed, provided they meet the EU safety requirements.

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.

KEY ACTIONS

·The Commission, Member States and vaccine developers will continuously review which vaccines should be adapted to new variants of concern.

·Where necessary, the Commission, with the Member States, will update current or sign new Advance Purchase Agreements as soon as possible, to be financed through the Emergency Support Instrument.

·The Commission is ready to mobilise all necessary funding for the purpose of these agreements.

·Additional resources will be made available by teaming up with the European Investment Bank via the Horizon 2020 InnovFin Infectious Diseases Finance Facility (IDFF) and under InvestEU.


2.Enabling conditions for delivery

2.1.An accelerated regulatory framework

A predictable and streamlined regulatory framework which guarantees safety is essential to ensuring citizens’ trust and is a cornerstone of protecting public health. As part of this, there is scope to adapt procedures to reflect the particular circumstances of the variants. While the EMA will continue to support vaccine developers, all proposed changes will fully safeguard the scientific independence and excellence of the Agency.

The Commission, together with EMA and the Member States, will continue to make the greatest use of regulatory flexibilities to accelerate the authorisation of vaccines against COVID-19. In addition, the regulatory procedure will be amended to accelerate the approval of COVID-19 vaccines to the new variants 9 , as is currently done with human influenza vaccines. This will enable the approval of an adapted vaccine with a smaller set of additional data 10 submitted to EMA on a rolling basis, also using the rolling review concept for post-authorisation changes. It will guarantee an EU tailor-made system for adapted vaccines and complement efforts by vaccine manufacturers.

The EMA is developing guidance on clear scientific requirements for developers, so that the requirements for variants are known in advance. The EMA will also continue to work closely on monitoring and assessing the possibilities for vaccine development for children and adolescents, in accordance with the agreed paediatric investigation plans. It is essential that paediatric patients of all ages are included in clinical trials 11 and the new VACCELERATE network is ready to enable this where possible.

Early involvement of regulatory authorities for the certification of the new production lines is also essential. This applies for the preparation of new or repurposed manufacturing sites and/or for transferring technology between sites. The early and rapid development of the necessary process control, validation and stability data by companies is key in order to enable the review by EMA on a rolling basis and rapid authorisation of the new production facilities. To achieve this objective, the Commission counts on the full cooperation of manufacturers and Member States.

The Commission is also ready to propose a targeted amendment of pharmaceutical legislation to introduce an emergency authorisation of vaccines at EU level with shared liability among Member States.

KEY ACTIONS

·The Commission will put forward a proposal to adapt the regulatory framework for the authorisation of new vaccines adapted for already authorised ones.

·EMA and national regulatory authorities will reinforce their support to research and manufacturers to reduce by a maximum the necessary time for approving new vaccines and new production lines.

·The Commission will mobilise research projects, notably VACCELERATE, to include paediatric patients in clinical trials.


2.2.Ramping up industrial production of vaccines

To successfully and rapidly manufacture at scale new or modified vaccines against variants, the EU cannot afford problems in the supply chain or insufficient manufacturing capacities.

Many non-COVID-19 vaccines today are produced in integrated sites that cover various parts of the production process. Producers face or will face bottlenecks in many parts of the supply chain. This includes access to raw and packaging materials, including lipid nanoparticles supply for mRNA vaccines, expert personnel, production equipment as well as vials and needles. A more distributed, synchronised and flexible model of production can help address these bottlenecks in the short run. Europe has a large and innovative pharmaceutical and chemical industry that can step up further to address these challenges. We have already seen positive examples where companies are partnering to increase production capacity.

The Commission will also continue to address potential bottlenecks in production and supply of raw materials and other essential input required for vaccines manufacturing. It will build on the ongoing mapping of existing industrial capacities for vaccine production in Europe, as well as facilities which can be potentially repurposed to produce vaccines. For example, these could include pharmaceutical companies not producing vaccines or veterinary medicine manufacturers. To support this, one of the responsibilities of the Task Force for Industrial Scale-up is to act as a one stop shop helpdesk for any queries and operational support.

The vaccine development and production require highly specialised and skilled professionals. To that end, the Commission will continue building strong skills partnerships under its Pact for Skills.

One of the fastest ways to increase production is to engage those European facilities that have relevant capacities available. Increasing manufacturing and ‘fill and finish’ capacities can mean sharing the technological know-how and intellectual property behind the vaccines and their corresponding technology, with a view to shortening the time necessary for technology transfer. The Commission will foster the creation, if need be, of a voluntary dedicated licensing mechanism, which would allow technology owners to retain a continued control over their rights whilst guaranteeing that technology, know-how and data are effectively shared with a wider group of manufacturers.

The Commission will support the pre-production cooperation between undertakings for building-up manufacturing capacities 12 . The cooperation should be limited to what is strictly 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 pro-competition legal guidance in relation to the production of vaccines or treatments, including in light of the criteria set out in the Antitrust Temporary Framework.

The EU’s investment into creating state-of-the-art vaccine and drug research, development and manufacturing capacities will be one of the cornerstones of any future pandemic preparedness and response. It will also strengthen open strategic autonomy in the area of health and the strategic positioning of the European healthcare industry.


The above actions will contribute to the creation of an “EU Fab” project, a network of ‘ever-warm’, single and/or multi-user, single and/or multi-technology production capacities for vaccine and medicine manufacturing at European level, thus becoming over time an asset of the future HERA.


KEY ACTIONS

The Commission will:

·Work closely with manufacturers to help monitoring supply chains and addressing identified production bottlenecks.

·Support the manufacturing of additional vaccines addressing new variants.

·Develop a dedicated voluntary licensing mechanism to facilitate technology transfer.

·Support pre-production cooperation between undertakings.

·Ensure EU’s manufacturing capacity by building up the “EU Fab” project.


CONCLUSION

This virus is adapting fast and Europe’s response must do the same. Europe will continue ramping up the production and roll out of authorised vaccines, whilst in parallel getting prepared for addressing the urgent and emergent threats of variants. In order to stay ahead of the curve, Europe can rely on the experience, knowledge and lessons of the crisis to date. It must anticipate problems earlier, detect issues faster and respond together – pooling our strengths in a public-private approach and response. This is the concept and action of the HERA Incubator launched today by the Commission.

HERA Incubator will ensure continuous exchanges and operational cooperation between regulators, public authorities and industry involved in the value and supply chain. It will be operated and driven by the Commission and form the backbone of a cooperation between researchers, technological companies, developers, manufacturers and regulators and public authorities.

A primary objective of HERA Incubator is to ensure the EU can swiftly secure access the volume of vaccines needed to face the variant threats. Given the uncertainty of success to find a suitable new or adapted vaccines, HERA Incubator should initially facilitate and encourage several concurrent projects to identify and develop the most promising vaccine candidates. It should then ensure the availability of manufacturing capacity to allow production and supply at scale of new or adapted vaccines. A well-functioning Single Market with undisrupted supply chains and free movement will remain essential in that respect.

In operating HERA Incubator, the Commission will act on behalf of the EU, in a public-private cooperation with Member States, regulators, business and the scientific community, ensuring transparent reporting to Member States and the European Parliament, subject to contractual confidentiality rules needed for the success of this operation.

Since EU vaccine production is critical for global supply this initiative will be of benefit far beyond the EU’s borders. HERA Incubator’s activity will entail outreach to and cooperation with the EU’s external and global partners such as CEPI, GAVI and WHO on the challenge of variants. In the medium and long-term, the EU should cooperate with lower and middle-income countries, in particular in Africa to help scale up local manufacturing and production capacities.

Given the race against time, sufficient funding will need to be made quickly available, and the Commission is ready to mobilise all means at its disposal, including through the Emergency Support Instrument. The HERA Incubator will start rolling out its activities immediately.

The Commission invites the European Heads of State and Government meeting on 25 February to endorse and properly mandate the HERA Incubator and to mobilise the relevant national actors and capacities in this coordinated effort.


(1) As announced by President von der Leyen in the State of the Union Speech and subsequently included in the Communication of 11 November 2020 on ‘Building a European Health Union: Reinforcing the EU’s resilience for cross-border health threats’.
(2) Findable, accessible, interoperable and re-usable https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A52020PC0767  
(3) https://www.gisaid.org/  
(4) https://www.veo-europe.eu/  
(5) https://www.covid19dataportal.org/
(6) Further details on how waste water sampling can be used to track COVID-19 can be found at: https://ec.europa.eu/environment/water/water-urbanwaste/info/pdf/Waste%20Waters%20and%20Covid%2019%20MEMO.pdf  
(7) https://www.who.int/influenza/gisrs_laboratory/en/  
(8) The network includes already 16 EU Member States and 5 Associated Countries (including Switzerland and Israel), and more countries have expressed interest to participate in a later stage.
(9) EMA will also coordinate with other regulatory authorities at national level and in third party countries, such as the US Food and Drug Administration. Aligning regulatory pathways will help to streamline the process for concerned industry stakeholders and increase supply security.
(10) https://www.ema.europa.eu/en/news/ema-preparing-guidance-tackle-covid-19-variants
(11) https://www.ema.europa.eu/en/news/ema-recommends-first-covid-19-vaccine-authorisation-eu ; https://www.ema.europa.eu/en/news/ema-recommends-covid-19-vaccine-moderna-authorisation-eu ; https://www.ema.europa.eu/en/news/ema-recommends-covid-19-vaccine-astrazeneca-authorisation-eu  
(12) https://ec.europa.eu/info/sites/info/files/framework_communication_antitrust_issues_related_to_cooperation_between_competitors_in_covid-19.pdf