Seqirus

Derived from the expression 'securing health for all of us', Seqirus has public health protection at its core.

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ID: 359267936537-45

Lobbying Activity

Response to European Health Emergency Response Authority

24 Feb 2021

The COVID-19 pandemic has demonstrated the need for a well-coordinated and resilient preparedness and response ecosystem to allow health emergencies with pandemic potential, such as influenza, to be addressed effectively. As one of the world’s largest influenza vaccine providers and a global partner in pandemic preparedness, Seqirus commends the EU’s intention to establish a Health Emergency Preparedness and Response Authority (HERA). Seqirus does not consider either the baseline scenario or option 1 in the proposed form to be sufficiently structured or funded to be able to effectively prepare for and respond to public health emergencies. However, we believe that there are elements in both options 2 and 3 which have potential. HERA should be embedded in the existing preparedness and response ecosystem both within the EU and globally, with clear established responsibilities that complement those of existing bodies, such as the ECDC, EMA, DG SANTE, WHO and BARDA HERA should be solution and product-oriented, capable of end-to-end support from advanced research and clinical development through to product manufacturing and procurement in areas of health security threats. HERA needs to be staffed by individuals with a high level of subject matter, regulatory and industry knowledge, as well as contractual expertise. HERA should have a structured and transparent approach to the selection of priorities and sufficient funding to support long-term commitments. There should also be a strong spirit of partnership and continuous dialogue with industry from project definition to commercialization, with clear boundaries to ensure rationale and independent decision making. We would encourage HERA to have regular interactions with industry on objectives and priorities, allowing industry stakeholders to engage in discussion around the HERA goals and to enable the decisions to be based on robust science and the best network of providers. The ability to award contracts to single companies, irrespective of their size, is essential if HERA is to address gaps in late-stage and competitive R&D. Scientific excellence, safety, and quality should be considered when choosing where activities are perforordmed and HERA should work with manufacturers to coordinate post-marketing safety and effectiveness evaluation. Contracts should be awarded independent of geographical location (companies should be able to rely upon their global network to perform contracted activities). It is also important to have legally binding agreements with very specific scopes of work that clearly outline milestones, deliverables and IP protection conditions. The Commission should also consider appropriate mechanisms for risk-sharing and liability management to expand access to life-saving medical countermeasures. HERA’s success will be greatly enhanced by adopting a pragmatic and flexible operating model, the features of which should include: informal discussions with industry to understand available capabilities in order to shape Request For Proposals (RFPs) via Requests for Information (RFIs), reasonable timeframes for proposal preparation and submission; a competitive acquisition process; a flexible approach to project selection allowing for dialogue during negotiations; contract awards with a clear scope of work with flexibility to revise priorities and repurpose activities during a public health crisis; flexible contract durations (i.e., options to extend) and the ability to quickly increase budgets at times of crisis or increased public health need.

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Response to A European Health Data Space

4 Feb 2021

Seqirus is one of the world’s largest influenza vaccine providers, a major contributor to influenza prevention and a key partner in pandemic preparedness. We believe evolving data innovations in health technology can help unlock particular challenges associated with influenza and improve influenza prevention. Influenza causes up to 72000 deaths in Europe each year and is associated with significant health and economic costs. The unique nature of the mutable influenza virus challenges manufacturers to develop new vaccine formulations each year to match the circulating strains and provide robust mechanisms to measure vaccine effectiveness. Despite the introduction of novel innovations including adjuvanted, cell-based, high-dose and recombinant vaccines approved for use with specific demographic groups, the need remains for high quality data to understand the relative effectiveness of these new technologies from season to season, including in comparison to standard egg-based vaccines. Although clinical trials remain the foundational method of establishing the safety and efficacy of vaccines prior to approval, robust Real World Data (RWD) can provide timely insights into performance of newly formulated influenza vaccines each season, providing an important tool to inform influenza policy, clinical practice and regulatory decisions. In recognition of this, the DRIVE project, a public-private partnership in which Seqirus is a partner, was established in 2017 to develop a sustainable platform for the generation of robust brand-specific influenza vaccine effectiveness data. Progress has been made, however challenges remain. Generating vaccine effectiveness RWD is dependent upon the data source that is characterized by (1) Size - to provide sufficient power, (2) Variability - patient demographics, platform/exposures/uptake, and (3) Robustness - completeness and consistency. Additionally, the ability to link different health datasets from diverse settings provides a more comprehensive view of the patient experience within a given healthcare system, improving the quality of analysis and enabling better evidence generation. For example, in the US, Seqirus has established a one of the largest datasets for influenza vaccine research, integrating de-identified EMR data from primary care with pharmacy and medical claims data for a population of 123 million people. Recent analyses based on this dataset have generated robust, reliable evidence that has been published in peer reviewed journals. Protection of personal health information contained in real world datasets is paramount. Personal data should be maintained in strict accordance with GDPR guidelines, ensuring confidentiality and security at all data handling points across the data lifecycle. Embedding these data characteristics in the design of a European integrated health dataset will greatly enhance the evaluation of important health outcomes, including primary care utilization, lab-confirmed influenza illness, strain predominance, hospitalisation and emergency visits, and onset of new and worsening of pre-existing co-morbidities. The vaccines industry would be a valuable partner in a multi-stakeholder collaboration to develop a European Integrated Health Dataset. The participation of all Member States is critical to success. Access to de-identified data for research purposes, including to industry, would be important in maximising the public health utility of the integrated dataset and should be factored into any legal framework governing its use. Given the seriousness of influenza and its unique characteristics, as well as the foundations already built by initiatives like DRIVE, the development of real world datasets for influenza vaccine effectiveness research is a strong candidate for a EHDS pilot, and could be used as a blue print to answer important public health questions in other vaccine-preventable disease areas, including for pandemics.

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Response to Pharmaceutical Strategy - Timely patient access to affordable medicines

2 Jul 2020

As one of the world’s largest influenza vaccine manufacturers, and a major supplier of innovative vaccines to Europe, Seqirus is committed to protecting communities from seasonal influenza and pandemic threats. The WHO estimates that influenza annually infects up to 20% of the population, and causes up to 72,000 deaths in Europe. Despite a 2009 European Council Recommendation to increase influenza vaccination and attain coverage of 75% for older people, no European country has reached this goal. For example, the median rate for influenza vaccine uptake in Europe in 2018 was just 41%. Seqirus welcomes the Pharmaceutical Strategy and supports Vaccines Europe’s response. We are pleased to provide additional points related to influenza vaccines which warrant special consideration due to the variability of influenza viruses, unique annual production cycle, sustained sub-optimal uptake across Europe and the importance of influenza pandemic preparedness. 1. The EU has the opportunity to make greater investments in the promotion and support of research and innovation in Europe, especially for differentiated influenza vaccines where current, one-size-fits-all approaches may not achieve public health goals. 2. Joint Procurement (JP) mechanisms for seasonal influenza vaccines could harm already sub-optimal uptake and the long-standing influenza vaccination system. • JP may be best for emergencies, but the current, well-established process annually delivers over 100 million influenza vaccines. • Each EU country has separate recommendations based upon epidemiology and healthcare resources, and targeted populations vary (e.g. children, at-risk adults, etc.). • Countries use different vaccines for populations. Some procure at the national level, whereas others procure regionally, or at the level of individual GPs. • Countries distribute vaccines through different sites, and sophisticated networks exist to deliver vaccines to as many as 14,000 addresses in one country alone. 3. The re-shoring of pharmaceutical production is unlikely to avoid influenza vaccine shortages. • There are many reasons for influenza vaccine shortages including complex life cycle management, unpredictable demand, suboptimal and late forecasting practices, and inflexible purchasing requirements. • Supportive immunization policies and earlier demand planning from member states are the best ways to achieve both sustained influenza vaccine supply and avoid “boom and bust” cycles. • Given set annual lead-times for time-critical supply of influenza vaccines, moving procurement decisions to at least 12 months in advance of supply allows for better planning. 4. Strong seasonal influenza vaccine supply and demand across the EU will enhance preparedness and response for an influenza pandemic. Additionally, the EU and member states should consider innovative influenza pandemic stockpiles, such as an adaptive stockpile, under a strategy to enhance public confidence in preparedness. 5. Use of real-world evidence (RWE) can help assess the effectiveness of seasonal and pandemic vaccines in different populations, support the enhancement of product labels, and help satisfy post-approval requirements. • Randomized controlled trials (RCTs) are well-established for determining vaccine safety and efficacy, but influenza’s annual variability presents a challenge. • RCTs take years to plan, implement, and analyse while RWE provides an ever-growing data set in a timely manner, with large and diverse patients and healthcare settings. • Regulatory bodies should develop guidelines for the evaluation and inclusion of RWE in licensing considerations (where RWE can be used from already-licensed places), product label review, and post-licensing obligations. 6. Common packs, label, and e-leaflets improve production efficiency and can facilitate the transfer of influenza vaccines between EU Member States if needed, and manufacturers should be consulted on changes given lead times.

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