OpenLobby.EU
Explore

Vaccines Europe

VE

Vaccines Europe advocates for sustainable vaccine environments in Europe, protecting people against infectious diseases at all life stages.

Lobbying Activity

Meeting with Maria Pilar Aguar Fernandez (Director Research and Innovation) and

15 Jan 2026 · Exchange of views with private members of the Innovative Health Initiative Joint Undertaking (IHI-JU).

Meeting with Adam Jarubas (Member of the European Parliament, Committee chair)

27 Nov 2025 · advancing human and animal health through innovative vaccines

Meeting with Massimo Suardi (Director Economic and Financial Affairs) and FIPRA International SRL

25 Nov 2025 · Continuing need for Member States to prioritise investments in prevention amidst current political, security and economic headwinds

Vaccines Europe calls for strategic investment in immunisation programmes

29 Oct 2025
Topic — EU plan for coordinated prevention, preparedness and response to cross-border health threats.
Message — The organization requests that immunisation be recognized as strategic capital investment under EU budget rules, not mere expenditure. They want accelerated regulatory mechanisms, digital immunisation records, and limits on joint procurement to pandemic situations only.123
Why — This would protect their market access through national programmes and avoid supply disruption from expanded joint procurement.45
Impact — Member states lose potential cost savings from collective bargaining power on routine vaccine purchases.67
Read full response

Meeting with Olga Solomon (Head of Unit Health and Food Safety) and European Federation of Pharmaceutical Industries and Associations and

3 Oct 2025 · The discussion focused on simplifying Annex II to foster innovation while aligning with ICH guidelines, with ideas for legacy products to gradually transition.

Meeting with Olivér Várhelyi (Commissioner) and

2 Oct 2025 · All pressing portfolio topics

Meeting with Tomislav Sokol (Member of the European Parliament, Rapporteur) and Teva Pharmaceuticals Europe BV

24 Sept 2025 · Health policy

Meeting with Christophe Clergeau (Member of the European Parliament, Shadow rapporteur)

23 Sept 2025 · SANT

Vaccines Europe urges inclusion of immunisation in EU heart plan

12 Sept 2025
Topic — The EU is developing a strategy to reduce cardiovascular disease through prevention.
Message — Vaccines Europe advocates for incorporating immunisation as a core prevention measure within the plan. They request a flagship initiative on respiratory infections and updated coverage targets. They also support using electronic records to boost vaccine uptake.123
Why — This proposal would lead to increased public funding and market growth for vaccines.45
Read full response

Meeting with Jeannette Baljeu (Member of the European Parliament)

10 Sept 2025 · Critical Medicines Act

Meeting with Dimitris Tsiodras (Member of the European Parliament)

10 Sept 2025 · EU health policies

Meeting with Marion Walsmann (Member of the European Parliament, Rapporteur for opinion)

10 Sept 2025 · CMA

Meeting with Tilly Metz (Member of the European Parliament, Shadow rapporteur) and Moderna, Inc.

10 Sept 2025 · Critical Medicines Act

Meeting with Laurent Castillo (Member of the European Parliament)

17 Jun 2025 · pharma

Vaccines Europe Urges Faster Approvals to Boost Lagging Innovation

11 Jun 2025
Topic — The Biotech Act seeks to streamline the transition of biotechnology from labs to market.
Message — The group requests harmonized clinical trial frameworks and the expansion of fast-track regulatory pathways used during the pandemic. They also propose adopting common packaging standards and digital leaflets to ensure faster access and prevent supply shortages.123
Why — These reforms would lower operating costs and help the region attract more global clinical research funding.4
Impact — National governments might face pressure to surrender authority over vaccine reimbursement and health budgets.5
Read full response

Meeting with Florika Fink-Hooijer (Director-General Health Emergency Preparedness and Response Authority)

3 Jun 2025 · Immunisation return on investment for societies

Meeting with Olivér Várhelyi (Commissioner) and

27 May 2025 · Contribution of Vaccines industry to European health union priorities

Meeting with Vytenis Povilas Andriukaitis (Member of the European Parliament)

13 May 2025 · Vaccination

Response to Evaluation of the European Centre for Disease Prevention and Control

9 May 2025

Vaccines Europe (VE) welcomes the evaluation of the European Centre for Disease Prevention and Control (ECDC). In a context of growing public distrust in science and declining routine vaccination rates, a well-funded, resilient ECDC, anchored in evidence-based governance and collaborative frameworks is more essential than ever. While ECDC has increased its crisis preparedness and public health risk assessment capabilities since its 2022 mandate extension, important gaps persist in the following areas. -Collaboration and Public-Private Partnership Most successful public health agencies and authorities have built effective, structured models for engagement with the vaccine industry, demonstrating that transparent collaboration supports public health without compromising independence. However, there has been limited dialog between ECDC and the vaccine industry over the past 7 years. Insufficient collaboration has led to fragmented vaccine monitoring systems (e.g., VEBIS, VMP, DARWIN EU) and missed opportunities to pool constrained resources through public-private partnerships (e.g., DRIVE, COVIDRIVE). Such disconnect threatens Europes ability to address health emergencies as during the COVID-19 pandemic when industry did not have access to ECDCs epidemiologic scenarios to support vaccine R&D and supply planning. ECDC should also increase collaboration with other global Centres for Disease Control, to align practices and controls, enhance diagnostic capabilities and reporting mechanisms. - Data Infrastructure and Real-Time Surveillance ECDCs dependence on limited and heterogeneous Member State (MS) data and limited engagement with stakeholders hinder its effectiveness. Key gaps remain in vaccination coverage data (e.g., by age/risk group), real-world effectiveness and epidemiological forecasting. As of today, ECDC does not have sufficient capacity to share surveillance data in a timely manner to enable cross border health threat assessment, impairing the EU Early Warning and Response System. -Evidence-Based Evaluation Framework To ensure full transparency, ECDCs scientific reports should incorporate diverse evidence of the highest standard and allow for consultation and input from all stakeholders, including manufacturers. Protocols, peer reviews, and quality control processes should be posted before initiation. Transparent methodologies aligned with international best practices are critical to maintaining trust and scientific integrity. While ECDCs role in providing technical and scientific assistance to National Immunisation Technical Advisory Groups (NITAGs) has the potential to improve consistency, efficiency, and timeliness of vaccination policy across Europe, its scope and processes should be clarified to avoid overlaps and be more transparent to the public. -Recommendations Institutionalise an annual VEECDC meeting for structured strategic and scientific dialogue Establish horizon-scanning meetings with individual companies to enhance health readiness Clarify ECDCs role vis-à-vis NITAGs (recommendations), EMA (vaccine effectiveness), HERA (surveillance for health threats preparedness) to prevent dysfunctions and strengthen collaboration Improve international exchanges to bolster reporting within Europe Strengthen data infrastructure and provide data collection guidance to support interoperability across MSs Ensure timely data availability to support procurement and supply through accurate demand forecast Guarantee transparency in systematic reviews and stakeholder consultation processes -Conclusion Europes health security requires an inclusive, collaborative and transparent ECDC, firmly rooted in evidence-based practices and capable of fostering trust, innovation and international cooperation. To meet future public health challenges, it is essential ECDC works closely and transparently with all relevant stakeholders, including the vaccine industry. Vaccines Europe stands ready to support this vision.
Read full response

Response to Single Market Strategy 2025

31 Jan 2025

Vaccines Europe (VE) concurs with the response from the European Federation of Pharmaceutical Industries and Associations (EFPIA) to this consultation. In addition, VE wishes to highlight specific challenges that the vaccine sector face. 1. Divergence in national vaccine access pathways Challenge: Vaccines follow complicated market access pathways and are subjected to mandatory local standards, which add complexity and time to the recommendation and reimbursement of national immunisation programs (NIP). In a third of EU countries, median time to population access is more than six years. Not only complex and lengthy, but those pathways are also significantly heterogeneous across EU countries, being at the source of inequity in the availability of vaccines and the gaps in levels of health protection. In addition, the enormous language diversity of vaccines packaging and leaflets requirements across EU countries may significantly reduce supply chains efficiency, slow down emergency response to shortages and limit availability in small markets. Recommendations - Ensure an aligned approach to decision-making on vaccination through a common European value framework. - Enhance the timeliness of national decision-making on vaccination programmes. - Introduce EU common pack and electronic Product Information (ePIL) for vaccines 2. Lack of vaccine specificities implementation in the EU HTA Regulation Challenge: One of the goals of the EU HTA Regulation is to improve the availability of innovative health technologies. However, applying the same processes and methodologies used for the clinical assessment of drugs to vaccines would impose serious risks, such as delayed or limited access to new vaccines. Recognition of vaccine specificities in the joint HTA activities is necessary for recognising the broad value of vaccination and improving the time to population access and benefits for public health, the economy, and society. Recommendations - Involve NITAGs and the ECDC in appropriate joint scientific consultations and joint clinical assessment steps for their respective roles and expertise. - Address the unique HTA framework and expertise requirements of vaccines in the interim EU HTAR evaluation in 2028. 3. Lack of interoperable immunisation information systems Challenge: In the case of immunisation systems, data and evidence are needed for a wide range of purposes, e.g. to inform decisions on the introduction of new vaccines and vaccination programmes. However, there are important gaps in the data and evidence currently available to national policy-makers, which need to be addressed in order to optimise vaccination programmes. Recommendations: - Enhance data collection and evidence generation to support the strengthening of vaccination policies. - Expand ECDC data collection and reporting on vaccination coverage rates for adolescent and adult vaccines. - Prioritise digitalisation and interoperability of immunization programmes within the European Health Data Space. 4. Undervalued role of prevention for economic growth Challenge: Over the last decade, the EU economy has experienced slow growth. The ongoing demographic and epidemiological transition is increasing pressure on public finances, particularly healthcare and social expenditure. The EU has introduced the New Economic Governance Framework (NEGF), which provides an opportunity to consider investments in the healthcare sector especially in prevention as social security investments. Studies suggest that every 1 euro spent on adult vaccination generates a 19 euro return to the health and social care economy. Recommendations: - Recognise investments in prevention as beneficial for long-term fiscal sustainability and grant greater flexibility within the Member States fiscal structural plans. - Exclude prevention and immunisation investments from the calculations of Member States deficit or debt levels when assessing compliance with fiscal rules.
Read full response

Meeting with Andrea Wechsler (Member of the European Parliament)

30 Jan 2025 · EU Health policy

Meeting with Michalis Hadjipantela (Member of the European Parliament)

17 Dec 2024 · Follow up meeting after event

Meeting with Pierre Jouvet (Member of the European Parliament)

10 Dec 2024 · Politiques d'immunisation en Europe

Meeting with Vytenis Povilas Andriukaitis (Member of the European Parliament) and European Cancer Organisation and Insightec Ltd.

13 Nov 2024 · EU health policy

Response to Health technology assessment – Joint scientific consultations on medicinal products for human use

29 Oct 2024

Vaccines Europe welcomes the openness of the EU JSC for vaccines early January 2025. However, its applicability to vaccines seems unlikely as no specific methodological approaches for vaccines are planned, nor the inclusion of NITAGs (National Immunization Technical Advisory Group), multidisciplinary bodies of national experts that provide evidence-based recommendations to policy-makers and immunisation programme managers. HTDs see this as a missed opportunity to get advice on their evidence generation plans. NITAGs assess vaccines in all 27 EU member states, whereas HTA bodies are involved in vaccine appraisals in only 14 EU member states. Including NITAGs in JSCs could increase alignment between the JSC, JCA, and national assessment processes, reducing duplicate efforts. Joint scientific consultations can enable NITAGs to anticipate innovative vaccines and advise developers on appropriate evidence generation plans. Scientific advice is thoughtfully planned many months in advance as clinical development timelines are tight. Designing and executing a successful clinical development plan for any candidate vaccine requires a solid scientific, medical, operational and regulatory knowledge and expertise, to comply with regulations and assure adequate benefit-risk balance for the product to be used in mass vaccination of healthy populations. Phase 3 studies as well as preparation for regulatory filing can take between 3 and 5 years, meaning that the preparation of the protocol of vaccines that will be eligible for JCA (eg: with a submission to EMA planned after January 2030) is likely to take place in the coming months. In the methodological guidelines published so far, no specific methodological approaches for vaccines are mentioned. The paper entitled Guiding Principles for Evaluating Vaccines in Joint Health Technology Assessment in the European Union recently published in a peer-reviewed journal, proposes standardized and vaccine-specific methodologies and processes that could ensure consistent, transparent, and timely access to new vaccines (Largeron et al., 2024). Vaccine Europe strongly recommend the involvement of NITAGs as well as the use of the guidelines mentioned above, which were developed using a robust methodology and endorsed by leading vaccine experts, to take in account the unique aspects of vaccines and tailoring the assessment processes to address these specificities.
Read full response

Meeting with Olivier Chastel (Member of the European Parliament)

19 Sept 2024 · Politique de santé de l'Union européenne

Meeting with Marta Temido (Member of the European Parliament)

9 Sept 2024 · EU Immunisation Strategy

Meeting with Ruggero Razza (Member of the European Parliament) and Pfizer Inc.

17 Jul 2024 · Incontro conoscitivo e scambio di vedute sul mandato del Parlamento europeo

Vaccines Europe urges EU to recognize vaccine-specific assessment needs

1 Apr 2024
Topic — This consultation establishes rules for joint clinical assessments of medicinal products across Europe.
Message — Vaccines Europe calls for including national immunization groups and the ECDC in assessments. Methodologies should account for vaccine-specific data like herd immunity and modeling. Developers must also be involved when reports are re-evaluated.1234
Why — This would ensure that joint assessments are accepted nationally and avoid market delays.5
Read full response

Response to Evaluation of the Regulation on serious cross-border threats to health

12 Feb 2024

VE welcomes the opportunity to contribute to the evaluation of the Regulation 2022/2371. In our response, we focus on two points related to 1/Reporting on prevention preparedness and response planning and 2/Joint procurement of medical countermeasures. The Regulation acknowledges the prevention, including primary one, as one of the essential steps in the crisis management cycle and is a cornerstone for early warning, monitoring and combatting cross-border threats to health. The Regulation explicitly mentions the monitoring of vaccination coverage for communicable diseases as one of the prevention activities falling within its scope (Recital 21). Despite that, the Regulation fails to directly list the implementation of national immunisation plans as an element of emergency prevention, preparedness and response planning (Art.7). Such a mention would allow for better uptake monitoring of all vaccines included in the national immunisation plans via Member States obligation to submit reports on prevention, preparedness and response planning, and thereby, better fulfil the spirit of the Regulation. Investments in strengthening immunisation systems have the potential to enhance vaccination coverage and equity, reduce the burden of vaccine-preventable diseases, and contribute to better preparedness and resilience of health systems. Art.7 indicates resources as one of the elements of emergency prevention, preparedness and response planning. As such, immunisation budget should be listed as one of resources to be reported by Member States. VE acknowledges the HERA competences, including on the use of joint procurement, are heavily fragmented. Clarity on mandate and scope is needed, e.g. within the establishing act. There needs to be more clarity on products that are considered medical countermeasures and therefore can be procured under the joint procurement (Art.3). Moreover, Art.12.3 requires that the joint procurement procedure does not discriminate nor distort competition. Nevertheless, there is little detail on the guarantees for equal access for vaccines manufacturers to the joint procurement (e.g. multi-winner awards, agreements adaptability to technology advancements). The definition of serious cross-border threat to public health is paramount to triggering the application of measures under the Regulation. The list of communicable diseases and related special health issues (Art.13.10) should provide a clearer indication of the scope of joint procurement. The use of joint procurement of vaccines should be limited to pandemic or serious cross-border health threats, have a clearly defined scope, and be feasible and sustainable. The Regulation does not foresee the possibility for the EC to act as a central purchasing body on behalf of the participating states, contrary to the Regulation 2022/2372. VE would welcome more precision on the contracting mechanism in both Regulations, and especially regarding the deadlines for Member States to opt-out/opt-in. With the attached document and based on the experience of companies that concluded joint procurement agreements with the EC during the Covid-19 pandemic, VE would like to share considerations on lessons learnt and areas for improvements. We see a positive step in preparation of pandemic procurement guidelines, and are looking forward to contributing to the discussion around these as a critical stakeholder. Beyond pandemic situation, the EC should issue general guidelines on vaccine tendering to ensure timely and consistent availability of vaccines for EU citizens. Such guidelines should specify that: - Clear and well-defined tender specifications and award criteria should systematically be based on the MEAT criterion, the availability of a portfolio of diverse technologies, a call for tender participation, and a robust framework agreement. - Tender practices should reflect the authorities accountability for immunisation programme continuity, monitoring and performance.
Read full response

Meeting with Pernille Weiss-Ehler (Member of the European Parliament, Rapporteur)

19 Jan 2024 · Directive on Medicinal products for human use

Meeting with Nicolás González Casares (Member of the European Parliament, Shadow rapporteur)

14 Dec 2023 · Vaccines

Meeting with Isabella Tovaglieri (Member of the European Parliament, Committee chair)

13 Nov 2023 · Union code relating to medicinal products for human use

Meeting with Laura Ballarín Cereza (Member of the European Parliament, Shadow rapporteur for opinion) and Johnson Johnson

30 Oct 2023 · Pharmaceutical Package (Regulation)

Meeting with Mohammed Chahim (Member of the European Parliament)

24 Oct 2023 · Pharmaceutical Strategy

Meeting with Tomislav Sokol (Member of the European Parliament, Shadow rapporteur)

24 Oct 2023 · Pharmaceutical legislation

Meeting with Pernille Weiss-Ehler (Member of the European Parliament, Rapporteur) and European Federation of Pharmaceutical Industries and Associations

20 Oct 2023 · Directive on Medicinal products for human use

Meeting with Kateřina Konečná (Member of the European Parliament, Shadow rapporteur)

18 Oct 2023 · Pharmaceutical package legislation

Vaccines Europe Warns New Rules Threaten Vaccine Innovation

4 Oct 2023
Topic — Evaluation and revision of the EU pharmaceutical framework to ensure affordable medicine access.
Message — The group opposes linking market protection to product launches in all member states. They want medical needs to include disease prevention and community protection. They also advocate for digital leaflets and shared European packaging.12
Why — This prevents loss of market protection caused by unpredictable national approval delays.3
Impact — Citizens in smaller countries might face persistent delays in vaccine availability.4
Read full response

Meeting with Max Orville (Member of the European Parliament)

8 Sept 2023 · Remise du rapport annuel

Meeting with Frances Fitzgerald (Member of the European Parliament)

20 Jul 2023 · Vaccination programme

Meeting with Juozas Olekas (Member of the European Parliament)

12 Jul 2023 · Vaccinations in EU

Meeting with Karsten Lucke (Member of the European Parliament)

6 Jun 2023 · COVI Report

Meeting with Max Orville (Member of the European Parliament)

1 Jun 2023 · Suite de la pandémie de COVID-19

Meeting with István Ujhelyi (Member of the European Parliament) and Novartis International AG

24 May 2023 · Health

Meeting with Pernille Weiss-Ehler (Member of the European Parliament, Rapporteur)

24 May 2023 · Medicinal products for human use

Meeting with Nicolás González Casares (Member of the European Parliament, Shadow rapporteur)

12 Apr 2023 · Vaccines

Meeting with Nicolás González Casares (Member of the European Parliament, Shadow rapporteur)

8 Mar 2023 · Vaccines

Meeting with Cristian-Silviu Buşoi (Member of the European Parliament)

2 Mar 2023 · the future vaccine innovation and the revision of EU General Pharmaceutical Legislation

Meeting with Nathalie Colin-Oesterlé (Member of the European Parliament) and SANOFI

15 Feb 2023 · Pharmaceutical review

Response to Vaccine-Preventable Cancers

6 Feb 2023

Approximately 13% of cancers diagnosed globally in 2018 were attributed to carcinogenic infections, such as viruses and bacteria. Among the most important infections associated with cancers are Human Papillomavirus (HPV) and Hepatitis B (HBV) for which vaccines are available. HPV infection causes cervical, vaginal, vulvar, anal, penile, and oropharyngeal cancers and HBV causes liver cancer. Raising rates of vaccination can help Europe towards the goal of eliminating vaccine-preventable cancers and address the inequality gap that currently exists among countries. One million cancer cases every year worldwide can be prevented through vaccination against hepatitis B and HPV. Highly effective vaccines against hepatitis B have been available for decades and many EU countries offer hepatitis B vaccination in their routine immunization programmes for children and adults. The efficacy and effectiveness of HPV vaccination and protection against HPV infection, including a reduced risk of invasive cervical cancer hav been established. Yet, inequity and discrepancies persist in Europe for both HPV and hepatitis B vaccination. For example, the East-West divide in fighting HPV-related burden is characterized by Central and Eastern countries lagging for primary prevention, thus subsequently bearing a higher load of HPV-related cancers, in particular cervical cancer incidence and mortality. In relation to hepatitis B, there remain sizeable, unprotected cohorts of adults who were not vaccinated as children and sub-optimal coverage for risk-based recommendations across Europe. Vaccines Europe calls on the European Commission to support Member States in updating their National Cancer Control Plans and Strategies to reflect EBCPs objectives and targets, and encourage Member States to: 1. Leverage forums and platforms to share best practices and monitor progress: Promote the use of vaccination as an effective and safe strategy to prevent and control cancers with policymakers, and the general public; Ensure that the deliverables of the EU4Health projects aimed at improving vaccination through evidence on vaccination programmes, implementation and monitoring, data systems, and communication are shared widely; Implement a European Council Recommendation on vaccine-preventable cancers, with clear KPIs for Member States; Call on the ECDC to further develop the monitoring of current HPV and HBV vaccination at EU level; Use the new expert group on public health from the European Commission to monitor progress made in vaccination rates and implementation of the EBCP; Expand sites for vaccination to increase uptake, especially for adults, such as community pharmacies. Monitor the implementation of health components of national Rescue and Resilience Plans; Improve access to vaccination against Hepatitis B to achieve WHO goals of a 90% reduction in cases by 2030; 2. Ensure robust program performance by investing in digitalization and data systems: Vaccinate at least 90% of the target population with HPV vaccines by 2030 and, expand recommendations and objectives beyond cervical cancer, to target other HPV-related cancers and diseases in both genders with a comprehensive HPV prevention approach; Screen at least 95% of the eligible population by 2025, and treat at least 90% of HPV-related cases and precancerous lesions; Strengthen electronic monitoring and registry systems for vaccines preventable cancers coverage rates; Develop the European Cancer Information system and improve health literacy for cancer prevention and care; 3. Encourage sustainable immunization financing at MS level: Invest in health service and implementation research for strategies to reach under-served and at-risk (adult) population groups and increase and maintain confidence in vaccines; Develop action plans for hepatitis prevention and control with sufficient funding in Europe; Raise awareness of the various EU tools for investment in sustainable cancer-related financing.
Read full response

Meeting with Dolors Montserrat (Member of the European Parliament, Rapporteur) and Johnson Johnson

30 Nov 2022 · Lessons learned on impact of COVID-19 pandemic

Meeting with Nicolás González Casares (Member of the European Parliament, Shadow rapporteur)

25 Oct 2022 · vaccines

Meeting with Sara Cerdas (Member of the European Parliament)

28 Sept 2022 · R&D na União Europeia

Meeting with Kathleen Van Brempt (Member of the European Parliament, Committee chair)

27 Sept 2022 · Update on the work of the COVI Committee

Meeting with Nicolás González Casares (Member of the European Parliament, Shadow rapporteur)

13 Sept 2022 · Vaccines

Meeting with Kathleen Van Brempt (Member of the European Parliament, Committee chair) and European Federation of Pharmaceutical Industries and Associations

14 Jul 2022 · The current situation of the pandemic and the work of the COVI Committee

Meeting with Karsten Lucke (Member of the European Parliament)

21 Jun 2022 · Corona Impfstoffe

Response to Recommendation for strengthened actions against antimicrobial resistance

23 Mar 2022

Vaccines Europe, representing vaccine companies of all sizes operating in Europe welcomes the opportunity to take part in this public call for evidence on anti-microbial resistance (AMR). The European Commission proposal for a Council Recommendation on AMR goes into the right direction, and Vaccines Europe supports the idea of a coordinated, holistic and multi-sectoral attitude, in line with the EU ‘One Health’ approach. AMR is a silent pandemic that is estimated to cause approximately 33,000 deaths each year in Europe. An abundance of evidence demonstrates that vaccines are critical in helping to combat the growing AMR crisis, by helping prevent both bacterial and viral diseases, as well as commonly-acquired bacterial infections, including hospital-acquired infections (HAIs). In contrast with the WHO Immunization Agenda 2030 that includes a policy roadmap targeting the role of vaccines in mitigating AMR, the latest ECDC report on the topic scarcely mention the value of vaccines against AMR. We believe a true ‘One Health’ approach should give a more central place to vaccines. -Pneumococcal conjugate vaccines (PCV) bear great potential to affect infections; either by reducing resistant, invasive pneumococcal disease, or by reducing antibiotic use, or both. In the United States of America, the introduction of the seven-valent PCV was associated with an 84% reduction in multidrug-resistant invasive pneumococcal disease. Sadly, we do not have such data available for EU countries, creating a distortion in the value assessment of the benefits of vaccines against AMR in Europe. -Vaccines can help prevent HAIs, via bacterial vaccines that could be administered on a targeted basis among high-risk populations, to protect against infections such as Clostridioides difficile (C. difficile) and infections from the ‘ESKAPEE’ group. However, there are currently no licensed vaccines in this category, despite the dire need. It is critical to have sustained investment and incentives, to keep pace with increasing resistance. -Vaccines prevent viral infections, which are often treated inappropriately with antibiotics, and can also give rise to secondary infections that require antibiotic treatment. For instance, influenza vaccines decrease the likelihood of secondary bacterial infections, such as pneumonia and otitis media. We need to optimise the impact of vaccination on AMR, by increasing the uptake of existing vaccines, notably in adult population, and bring to market new vaccines for dangerous pathogens, especially for those resistant to antimicrobial medicines. National AMR action plans and immunisation programmes of all EU Member States should recognise the unique potential of vaccines to prevent antibiotic use for viral and bacterial vaccine-preventable infections, as well as supporting the uptake across the life course. Vaccines should be included as a key component of AMR prevention strategies. In addition, the value of AMR-relevant vaccines should be clearly acknowledged in the assessment procedures by HTAs or NITAGs, incorporating the health and economic benefits of such products. Appropriate funding and incentives for innovative vaccines should be ensured across the EU to address existing unmet medical needs and reduce the burden of AMR. There is a need for clearer direction on which pathogens to prioritize for the development of new vaccines, for instance by adapting the WHO priority pathogen list for antibiotic research to vaccines. As part of concerted action in the fight against AMR, we call all stakeholders to continue working together, finding ways to increase the uptake of vaccines, stimulate R&D for the development of new vaccines that tackle harmful pathogens, and close remaining evidence gaps, notably via data monitoring and collection. Only a coordinated action can maximize the impact of vaccination on combatting AMR.
Read full response

Meeting with Romana Jerković (Member of the European Parliament)

7 Feb 2022 · Vaccines procurement

Response to Evaluation and revision of the general pharmaceutical legislation

27 Apr 2021

Vaccines Europe (VE) believes that this evaluation is an opportunity to implement learnings from COVID-19 to ensure a future-proof and resilient healthcare system. The pandemic shows the importance of: EU crisis preparedness, a flexible regulatory environment, maintaining and enhancing innovative research and development, and an industrial capability and capacity in the EU. VE concurs with the response submitted by EFPIA to this consultation and herewith focuses on vaccine specific aspects: 1) accelerated vaccine development and authorization, 2) accelerated and equal access to vaccines and 3) sustainability of supply. 1)Accelerated vaccine development and authorization Regulatory pathways should be re-designed to allow for swift regulatory approval of new vaccines for use in emergencies or addressing other unmet medical needs and should sustain flexibilities that demonstrated benefits in terms of accelerating access to new vaccines. To this effect, the following should be leveraged to shape appropriate and fit for the future regulatory pathways: the concept of mock-up dossier as successfully used for pandemic flu vaccines, the use of master files and innovative study designs to facilitate the review and approval of new technological platforms, or the regulatory flexibilities applied in the development of COVID-19 vaccines. 2)Accelerated and equal access to vaccines In Europe, despite the far-reaching health and economic benefits that immunization provides, less than 0.5% of healthcare expenditure is on average allocated to vaccination and the proportion is even decreasing in some Member States (MSs). Due to budget constraints and the complexity of regulatory and market access processes, it often takes many years (estimated median times range from 2 to 6.4 years) from authorisation of a vaccine to its adoption in a National Immunisation Program (NIP). Low immunisation budgets do not support vaccination program implementation and monitoring, nor inclusion of new vaccines in NIPs. This also induces price-only procurement practices that do not consider innovation, broader benefits of vaccines, nor the sustainability and timeliness of supply. In the long run, suboptimal investments in vaccination stifles future R&D investment, downsizes manufacturing capacity and supply chains’ stability, and results in insufficient vaccination protection impacting public health and economics. Vaccination programmes with life-course approach should be prioritised by MSs and be supported with sufficient funding, expansion of vaccination pathways, education and awareness, and digital systems to ensure high coverage and protection. Exploring novel incentive options should consider the specificity of market access for vaccines. 3)Sustainability of supply Considering the global nature of vaccine supply chains, an adequate process to ensure timely import and export of vaccines and its components in and out the EU is of paramount. Despite manufacturers’ efforts, shortages of vaccines have been reported as an increasing concern in the EU. The revision of the pharmaceutical legislation is one of the initiatives undertaken by the EU to address the problem. VE conducted an analysis of the root causes of vaccine shortages in the EU. While a number of these causes are intrinsic to vaccine manufacturing, most are related to external factors. Vaccine shortages is multifactorial, making it essential that all root causes are appropriately addressed. Finding solutions require a concerted effort and dialogue with all stakeholders to which VE is keen to contribute by bringing expert industry perspectives and engage in developing recommendations. To summarise, simplification/optimisation of regulatory and market access processes, inclusive and sustained comprehensive immunization plans, dialogue between governments and industry, and adapted procurement practices will enable better manufacturing planning and improve vaccine supply and access.
Read full response

Response to Evaluation of patient rights in cross-border healthcare

11 Feb 2021

A clear lesson learned from the Covid-19 pandemic is how important prevention and vaccination is to EU citizens. Vaccines play a crucial role in protecting individuals against serious vaccine preventable diseases, improving public health and health care provisions through prevention, generating subsequent cost savings, and supporting both society and economy at large. Vaccines Europe (VE), a trade association representing the major innovative research-based vaccine companies as well as small and medium sized enterprises operating in Europe welcomes the evaluation roadmap for the Cross-Border Healthcare Directive. VE concurs with the response submitted by EFPIA to this consultation. To avoid redundancy, VE’s response is limited to topics not covered by EFPIA. The evaluation of the Cross-border Health Directive provides an opportunity to further set the foundations for a revamped approach to prevention and vaccination at the EU level, ensuring that European citizens have access to vaccine preventable disease interventions across their life course. As such, in order for the Directive’s objectives to be in line with the evolving needs of patients and citizens in cross-border healthcare, Vaccines Europe call for: - Extension of the scope of the Directive to apply to public vaccination programmes against infectious diseases (Article 1.3); - Establishment of connected immunization information systems with enhanced surveillance networks on infectious disease epidemiology, as part of the eHealth network activities (Article 13); - Inclusion of the vaccination status in the patient digital medical records (Article 3 m); - Enhanced collaboration between NITAGs in order to support more timely and transparent access to innovative/new vaccines across the EU; - Publication of vaccination coverage rates every 6 months by EU Member States for all vaccinations. Vaccines Europe remains open for a further discussion on this topic.
Read full response

Response to Proposal for a Regulation establishing a European Centre for Disease Prevention and Control (ECDC)

2 Feb 2021

Vaccines Europe (VE) representing vaccine companies operating in Europe welcomes the EC proposal to expand the ECDC’s mandate. In light of increased pandemic risks, it is critical to strengthen the role of ECDC. In particular, VE welcomes the ECDC’s expanded role in epidemiological surveillance; the creation of a platform to monitor the safety and effectiveness of vaccines; and preparedness and response planning, reporting and auditing. In the view of the critical role the vaccine industry plays in pandemic preparedness, response and post-marketing in general, VE would like to highlight the added value of collaboration and continuous dialogue between the industry experts and EU institutions to ensure efficient use of resources and state-of-the art know-how. While supporting the current proposal in principle, we would like to propose concrete actions to strengthen it in the following areas: 1. ECDC engagement with industry 2. Functioning of the vaccine platform and phase IV studies by avoiding resource duplication 3. Defining clear ECDC’s governance and improving its decision-making VE calls for an extended, continuous engagement between the ECDC and industry. Mindful of the ECDC’s institutional independence which we fully support, and to avoid any unnecessary perception of conflict of interest, we advocate for a sound regulation of this engagement according to state-of-the-art standards regulating stakeholder engagement with public institutions. The CDC approach to private public partnerships could be a guiding example [1]. Considering Article 5a part 4 on post-marketing studies, VE would like to remark that extensive phase IV studies are already required by the EMA and implemented in vaccine developers’ RMPs, for which EMA relies on engagement with industry. Having independent vaccine effectiveness and safety monitoring studies conducted by the ECDC may generate an important duplication, and waste of resources. VE calls for vaccine companies to be involved in the establishment of the new vaccines monitoring platform and the framework for these studies. In addition, a clear definition of the respective roles of the ECDC and the EMA for this vaccine platform is needed to ensure optimal collaboration and alignment between both agencies. With regards to the ECDC’s governance, VE believes that a revision of ECDC’s decision-making process should also be part of the proposed Regulation, addressed by relevant modifications to the Article 18 to guarantee that the ECDC can take decisions by itself, via its management team, according to its endorsed strategic roadmap and extended mission. The role of the Advisory Forum should be consistent with Chapter 18.3 of the ECDC Regulation: “support the director in ensuring the scientific excellence and independence of activities and opinions” and shall not overlap with the role of the ECDC management team or of the Management Board. While Article 3 invites the ECDC to “provide evidence-based messages to the public”, there is a low awareness among EU citizens and HCPs about the ECDC with a limited access to its communication and educational material. MSs shall ensure that communication from the ECDC is shared broadly at national level acknowledging the collaboration between the ECDC, MSs and other relevant stakeholders in a clear and transparent way. In increasing its communication on the effectiveness and safety of vaccines, the ECDC could play a positive role in increasing vaccine confidence across EU. VE welcomes the intention to further develop digital platforms and applications to support epidemiological surveillance via the revision of the Article 5 part 2.g and 4.g of the Regulation. Cross-border health threats can only be tackled by a stepped-up ECDC coordinating role and collaboration with all relevant public (MS’s public health institutions, EMA, HERA and WHO) and private partners, the industry included. [1] https://www.cdc.gov/partners/partnering.html
Read full response

Response to Proposal for a Regulation on serious cross-border threats to health

2 Feb 2021

The Covid-19 pandemic represents an unprecedented experience for all of us and for the EU’s remit in responding to cross-border health threats. In this regard, Vaccines Europe believes that the proposals from the Commission to strengthen the resilience and preparedness of Europe against serious cross border health threats should build on the lessons learned from the COVID-19 pandemic and provide for a clear allocation of responsibilities, procedures, and for an effective governance structure and should involve all relevant stakeholders, including the vaccines industry. It should aim to ensure the free movement of medical countermeasures and essential workers in emergency situations, prevent unilateral and uncoordinated decisions by Member States from threatening the supply of essential medical countermeasures and should protect a global supply chain of ingredients and finished products. Vaccines manufacturing is a complex process, which involves a large series of raw material, sourced throughout the world. Potential measures like border closures, export restrictions or other measures to retain important materials or vaccines in a certain territory might have serious impact on production, supply and finally timely availability of vaccines in EU and globally in the times of serious cross-border threats to health [1]. The vaccine industry is an important partner to end this crisis and we are an integral part of future solutions. Continued and proactive dialogue between EU health authorities and manufacturers during the pandemic has proven successful in, among others, detecting challenges related to the supply of vaccines, as well as identifying policy options to address such challenges. Vaccines Europe believes that to enhance informed decision-making and improve EU-wide coordination, the Health Security Committee (Article 4) and the Advisory Committee on public health emergencies (Article 24) should be allowed to consult stakeholders, including manufacturers, on specific topics relevant to their activities and decisions. This could be done, for example, via the creation of a dedicated Vaccines stakeholder group. Vaccines Europe strongly recommends that any further future measures foreseen on joint procurement of vaccines (Article 12), as well as stockpiling are limited to future pandemic or serious cross border health threats. These measures should have a clearly defined scope, be feasible and sustainable. • In principle VE supports joint procurement of vaccines as an important mechanism for Europe to secure more equitable access and an improved security of supply of those countermeasures to address an outbreak of a serious cross-border threats, such as pandemics. Vaccines Europe however believes that joint procurement is not a feasible solution for more sustainable supply of vaccines in Europe in general [2]. • From VE perspective, stockpiling could be explored as an investment in preparedness against disease outbreaks in Europe if limited to action on serious cross border threats to health. However, creating vaccine stockpiles raises a number of important challenges in relation with vaccines characteristics and global supply dynamics. VE remains open to discuss with the EU institutions what could be feasible solutions. As shown during the pandemic, improved product demand forecast is critical to ensure timely and effective crisis response, and dialogue between EU authorities and pharmaceutical manufacturers has been one of the cornerstones of the resilience of the system, allowing well-informed authorities to take the necessary decisions to ensure the continuity of supply. [1] https://www.vaccineseurope.eu/news/press-releases/vaccines-europe-efpia-statement-on-covid-19-vaccine-supply-to-the-eu [2] https://www.vaccineseurope.eu/news/position-papers/vaccines-europes-position-on-joint-procurement-of-vaccines-in-europe
Read full response

Response to Proposal for a Regulation on a Union framework addressing public health emergencies (EMA)

2 Feb 2021

The COVID-19 pandemic revealed the need for improvement in Europe’s capacity to respond to public health emergencies. Vaccines Europe (VE), a trade association representing the major innovative research-based vaccine companies as well as small and medium sized enterprises operating in Europe welcomes the Commission’s proposal to complement and further develop the core tasks of the EMA, to enhance the Union's capacity to react quickly, efficiently, and in a coordinated manner to health emergencies. VE concurs with the response submitted by EFPIA to this consultation. To avoid redundancy, VE’s response is limited to topics not covered by EFPIA. The establishment of the Emergency Task Force as part of the Agency is considered useful as a tool to ensure a fast reaction to a crisis but insufficient to improve EU preparedness for potential emergency situations caused by infectious pathogens. VE’s understanding is that the ETF would be activated when health emergencies are declared. In order to have a proactive approach in terms of preparedness, a permanent regulatory structure should be in place within EMA. The role of such a permanent structure should include the implementation of learnings from previous crises, a reflection on priorities, regulatory support to HERA, and engagement with external stakeholders such as WHO, FDA, ICMRA, and CEPI with the ambition of working on global preparedness plans. This permanent structure should be composed of relevant experts working in close collaboration with the existing EMA committees. Article 14(7) of the proposed regulation stipulates that the ETF shall perform its tasks without prejudice to the tasks of the scientific committees of the Agency. VE supports this ambition but is concerned by the limited number of vaccine experts in the European network. The creation of the ETF should not have an impact on the availability of experts involved in the development, assessment and life cycle management of vaccines not intended to address ongoing emergencies. VE has developed a document listing the main bottlenecks to the rapid development and authorisation of COVID-19 vaccines which was submitted to the EC on 11 May 2020 (also attached to this response). Some of the challenges and recommendations highlighted in this document are not specific to COVID-19 and should therefore be addressed in anticipation of future crises. For instance, the COVID-19 crisis underlines the need for better global harmonisation of regulatory requirements and processes related to pharmacovigilance, CMC life cycle management labelling/packaging, and genetically modified organisms. The COVID-19 experience confirms the importance of collaborations between manufacturers or with academics for the rapid development of vaccines. Appropriate regulatory mechanisms should be put in place to preserve commercially sensitive information and technical know-how when two (or more) partners contribute to the development and/or manufacture of the same vaccine, while allowing regulatory authorities to assess the quality, safety and efficacy of the products. Appropriate regulatory pathways should also be established to allow regulatory approval of vaccines as soon as possible after the declaration of an emergency. The concept of mock-up dossier has shown its value for pandemic flu vaccines. The same approach could be considered for other infectious agents (e.g. coronaviruses). Regulatory pathways should also be considered for the review and approval of technological platforms in anticipation of emergencies, e.g. via master files. VE, as key stakeholder, is ready to contribute to the learnings related to the development of COVID-19 vaccines and to the reflection on improved EU preparedness against emergency situations caused by infectious diseases.
Read full response

Meeting with Stella Kyriakides (Commissioner) and European Chemical Industry Council and

6 Nov 2020 · Videoconference with Pharmaceutical Industry Associations to discuss shortages of medicines and medical devices including diagnostic tests in the context of COVID-19 pandemic

Meeting with Stella Kyriakides (Commissioner) and

30 Sept 2020 · Call with pharmaceutical and medical device supply Chain on COVID-19

Response to Pharmaceutical Strategy - Timely patient access to affordable medicines

6 Jul 2020

Vaccines Europe welcomes the EU Pharmaceutical Strategy Roadmap and its reflection on COVID-19 crisis lessons learned, such as the need to build a future-proof and crisis-proof system. Vaccines Europe supports EFPIA’s reply to this and would like to highlight specific points relevant to the vaccine industry. The Strategy should build on existing EU initiatives (e.g. Joint Action on Vaccination), prioritize prevention and vaccination, recognize the full value of vaccination, and strengthen immunization systems. Europe has a long history of vaccine discovery, development and manufacturing and benefits from a strong industrial infrastructure with 76% of vaccine doses produced by Vaccines Europe’s member companies manufactured in Europe. Yet, the vaccine sector faces unique challenges due to the complexity of vaccine development and manufacturing, risks associated with vaccine manufacturing and low recognition of the value of vaccination with on average less than 0,5% of healthcare budget dedicated to immunization across EU Member States. This raises fundamental sustainability questions and Vaccines Europe believes that the future Pharmaceutical Strategy needs to make the link with the EU industrial policy and to foresee measures to keep a robust vaccine sector in Europe. 1.Need for resilient immunization systems Vaccines are an investment in health, a true smart spending. From prevention to elimination of diseases, vaccines can also help reducing AMR by preventing the use of antibiotics. The adoption of the EU Pharmaceutical Strategy could be a turning point towards building stronger and more resilient immunization systems across Europe, able to protect the entire population against vaccine preventable diseases. This requires an environment that: (1) Recognizes and rewards the value of vaccination 2) Invests in immunisation programs that increase uptake and coverage of existing and new vaccines across the life course; (3) Promotes mutual efforts towards more sustainable supply of vaccines by improving forecasting and procurement practices, and facilitate the transfer of vaccines between EU Member States (EU packs, labels and e-leaflet); (4) Supports an EU R&D ecosystem to prevent more diseases, addresses AMR and progresses therapeutic vaccines, (5) Promotes use of electronic immunization records, interoperability of databases to measure outcomes and prevent outbreaks; (6) Educates HCPs and general population on vaccination. The actions above should be accompanied by defined key performance indicators (KPIs). 2.Preparing for future pandemics and innovative vaccines To secure the development and availability of innovative vaccines, Vaccines Europe believes that an effective EU Pharmaceutical Strategy should ensure proactive, predictable, and sustainable vaccine development, demand, and lifecycle funding. Lessons learned from the COVID-19 crisis can help to better prepare for future pandemics and ensure long-term health and economic resilience of the EU and its Member States. The crisis has underlined the need for a common EU approach, rather than Member States attempting separately to improve preparedness. We should draw on a wide range of EU instruments, including those supporting industrial policy, R&D, digitalisation and funding. Therefore, to prepare for future pandemics, the Pharmaceutical Strategy should address the following points: (1) Support to increase of manufacturing capacity and capabilities for emergencies; (2) Put in place appropriate pandemic liability protection and injury compensation mechanisms; (3) Define and streamline the Emergency Infectious Disease (EID)/pandemic regulatory pathways; (4) Coordinate supplies of pandemic vaccines across EU Member States to ensure efficient distribution in an emergency environment; (5) Monitor and share data efficiently to help identify emerging health threats across the EU, also by giving the ECDC a strengthened mandate.
Read full response

Meeting with Stella Kyriakides (Commissioner) and

29 Jun 2020 · Call with pharmaceutical and medical device industry associations on COVID-19

Meeting with Stella Kyriakides (Commissioner) and European Chemical Industry Council and

29 Jun 2020 · Videoconference with Pharmaceutical Industry Associations to discuss shortages of medicines and medical devices including diagnostic tests in the context of COVID-19 pandemic

Meeting with Stella Kyriakides (Commissioner) and European Federation of Pharmaceutical Industries and Associations and

29 May 2020 · Video call with Pharmaceutical Industrial Associations, the European Medicines Agency and the European Centre for Disease Prevention and Control, to discuss Possible shortages of medicines and medical devices for the Covid-19 outbreak

Meeting with Stella Kyriakides (Commissioner) and European Chemical Industry Council and

15 May 2020 · Video call with Pharmaceutical Industrial Associations, the European Medicines Agency and the European Centre for Disease Prevention and Control, to discuss Possible shortages of medicines and medical devices for the Covid-19 outbreak

Meeting with Thierry Breton (Commissioner) and European Federation of Pharmaceutical Industries and Associations and

8 May 2020 · Video call with Pharmaceutical Industrial Associations, the European Medicines Agency and the European Centre for Disease Prevention and Control, to discuss Possible shortages of medicines and medical devices for the Covid-19 outbreak

Meeting with Stella Kyriakides (Commissioner) and European Chemical Industry Council and

8 May 2020 · Video call with Pharmaceutical Industrial Associations, the European Medicines Agency and the European Centre for Disease Prevention and Control, to discuss Possible shortages of medicines and medical devices for the Covid-19 outbreak

Meeting with Stella Kyriakides (Commissioner) and European Chemical Industry Council and

29 Apr 2020 · Video call with Pharmaceutical Industrial Associations, the European Medicines Agency and the European Centre for Disease Prevention and Control, to discuss Possible shortages of medicines and medical devices for the Covid-19 outbreak

Meeting with Thierry Breton (Commissioner) and European Federation of Pharmaceutical Industries and Associations and

29 Apr 2020 · Video call with Pharmaceutical Industrial Associations, the European Medicines Agency and the European Centre for Disease Prevention and Control, to discuss Possible shortages of medicines and medical devices for the Covid-19 outbreak

Meeting with Thierry Breton (Commissioner) and European Federation of Pharmaceutical Industries and Associations and

23 Apr 2020 · Video call with Pharmaceutical Industrial Associations, the European Medicines Agency and the European Centre for Disease Prevention and Control, to discuss Possible shortages of medicines and medical devices for the Covid-19 outbreak

Meeting with Stella Kyriakides (Commissioner) and European Chemical Industry Council and

23 Apr 2020 · Video call with Pharmaceutical Industrial Associations, the European Medicines Agency and the European Centre for Disease Prevention and Control, to discuss Possible shortages of medicines and medical devices for the Covid-19 outbreak

Meeting with Stella Kyriakides (Commissioner) and European Chemical Industry Council and

17 Apr 2020 · Video call with Pharmaceutical Industrial Associations, the European Medicines Agency and the European Centre for Disease Prevention and Control, to discuss Possible shortages of medicines and medical devices for the Covid-19 outbreak

Meeting with Thierry Breton (Commissioner) and European Federation of Pharmaceutical Industries and Associations and

9 Apr 2020 · Video call with Pharmaceutical Industrial Associations and the European Medicines Agency to discuss Possible shortages of medicines and medical devices for the Covid-19 outbreak

Meeting with Stella Kyriakides (Commissioner) and European Chemical Industry Council and

9 Apr 2020 · Video call with Pharmaceutical Industrial Associations and the European Medicines Agency to discuss Possible shortages of medicines and medical devices for the Covid-19 outbreak

Meeting with Thierry Breton (Commissioner) and European Federation of Pharmaceutical Industries and Associations and

3 Apr 2020 · Video call with Pharmaceutical Industrial Associations and the European Medicines Agency to discuss Possible shortages of medicines and medical devices for the Covid-19 outbreak

Meeting with Stella Kyriakides (Commissioner) and European Federation of Pharmaceutical Industries and Associations and

3 Apr 2020 · Video call with Pharmaceutical Industrial Associations and the European Medicines Agency to discuss Possible shortages of medicines and medical devices for the Covid-19 outbreak

Meeting with Thierry Breton (Commissioner) and European Federation of Pharmaceutical Industries and Associations and

27 Mar 2020 · Video call with Pharmaceutical Industrial Associations and the European Medicines Agency to discuss Possible shortages of medicines and medical devices for the Covid-19 outbreak

Meeting with Stella Kyriakides (Commissioner) and European Federation of Pharmaceutical Industries and Associations and

27 Mar 2020 · Video call with Pharmaceutical Industrial Associations and the European Medicines Agency to discuss Possible shortages of medicines and medical devices for the Covid-19 outbreak

Meeting with Thierry Breton (Commissioner) and European Federation of Pharmaceutical Industries and Associations and

20 Mar 2020 · Video call with Pharmaceutical Industrial Associations, the European Medicines Agency and the European Centre for Disease Prevention and Control, to discuss Possible shortages of medicines and medical devices for the Covid-19 outbreak

Meeting with Stella Kyriakides (Commissioner) and European Federation of Pharmaceutical Industries and Associations and

20 Mar 2020 · Video call with Pharmaceutical Industrial Associations, the European Medicines Agency and the European Centre for Disease Prevention and Control, to discuss Possible shortages of medicines and medical devices for the Covid-19 outbreak

Meeting with Stella Kyriakides (Commissioner) and European Federation of Pharmaceutical Industries and Associations and

13 Mar 2020 · Video call with Pharmaceutical Industrial Associations and the European Medicines Agency to discuss possible shortages of medicines and medical devices for the Covid-19 outbreak

Response to Europe’s Beating Cancer Plan

3 Mar 2020

Vaccines Europe, representing major innovative research-based vaccine companies as well as small and medium sized enterprises operating in Europe, welcomes the draft Europe Beating’s Cancer Roadmap which acknowledges the critical role vaccination can play in cancer prevention relative to hepatitis B and human papillomavirus (HPV). Infections with certain viruses, bacteria, and parasites are strong risk factors for specific cancers[1]. Vaccines can prevent infection-attributable cancers related to hepatitis B and HPV. Their success depends largely on access to vaccines to all eligible population as well as effective implementation and uptake of the immunization programmes aiming at reaching high vaccination coverage rates. 1. The European Commission should encourage Member States to set vaccination goals to prevent infection-attributable cancers as per WHO recommendation (90% HPV, 95% VHB) and to put in place a set of measures that will strengthen the immunization programmes in order to achieve coverage targets: - Provide the population access to reliable information on infections’ transmission, vaccines and vaccination; - Provide access to vaccination via all eligible healthcare professionals (beyond traditional HCPs) and where relevant to non-healthcare settings (work place, schools); - Invest in data system (Immunisation Information Systems) to monitor programme performance, level of coverage; - Establish resilient immunization systems, able to face challenges and recover quickly without affecting the immunisation programme or other parts of the health system. Vaccines Europe is concerned that strengthening immunization programmes and providing equal access to vaccination within countries (for example vaccination of adults) and across Europe[2] would not be feasible with the current low level of healthcare budget allocated to it. On average, prevention expenditure is 3% of a country’s total health budget in the EU, while the national immunization program represents on average less than 0.5% of the overall health budget[3] . 2. The European Commission should issue recommendations for Member States to prioritise investment towards adequate and sustainable funds for immunization programmes, in the context of recently conducted the 2019 State of Health in the EU initiative, that accommodate for equity in uptake of new vaccines throughout the EU as well as vaccination across the lifespan. [1]Plummer et al. (2016)., Global burden of cancers attributable to infections in 2012 : a synthetic analysis, Lancet Global Health, 2016. [2]Sheik et al.(2018), A report on the status of vaccination in Europe, Vaccine, Volume 36, Issue 33, 9 August 2018, Pages 4979-4992. [3]Ethgen et al. (2018): Vaccination Budget in Europe: an update. Human Vaccines & Immunotherapeutics 2018, Vol. 14, (12), 2911-2915. https://www.tandfonline.com/doi/full/10.1080/21645515.2018.1504528.
Read full response

Meeting with Anne Bucher (Director-General Health and Food Safety)

21 Feb 2019 · introductory meeting

Meeting with Xavier Prats Monné (Director-General Health and Food Safety)

23 May 2018 · Discussion on Vaccination communication

Response to Protecting citizens against health threats

23 Apr 2018

Vaccines Europe reply to Commission Roadmap on protecting citizens against health threats Vaccines Europe, which is a group formed of major and medium size R&D vaccine companies operating in Europe, welcomes the Commission Roadmap to strengthen the EU framework for more effective and comprehensive crisis preparedness and management. The globalised environment of interdependence that we live plays an important role in the rise, emergence and re-emergence of infectious disease, which demands a coordinated and global response to prevent and respond to the spread of epidemics more effectively. Vaccines play an essential role in containing infections with epidemic or pandemic potential, to prevent them from becoming public health emergencies, contain loss of life, and limit social and economic disruption. Recent outbreaks of diseases such as SARS, MERS, Ebola and Zika have highlighted the need to better anticipate and prepare for future health threats, which is one of the greatest challenges of our time. The industry is at the forefront in developing solutions to address pandemic threats often working in partnership with supranational organisations to pool resources and expertise and accelerate these efforts. In addition, member companies contribute to global vaccine stockpiles that are an essential component of preparedness plans to mitigate the risk posed by global epidemic diseases such as: yellow fever, cholera, meningitis and pandemic influenza. The Vaccines Europe members continue to be committed to addressing these challenges and to work together to be better prepared in case of emergencies. To accelerate the development of innovative medical (therapeutic and prophylactic) countermeasures, Vaccines Europe encourages the Commission to promote new effective models of collaboration with the private sector. This could be built on the experience and resourcing strategies of partnerships and creating critical mass in view of mobilizing and sharing knowledge, expertise, technology and financial resources. In this respect, the US Biomedical Advanced Research and Development Authority (BARDA), which supports the advanced development and procurement of drugs, vaccines and other products considered priorities for health security, could inspire a potential EU specific mechanism. This Public Private Partnership supports innovation through strategic initiatives and investment in technologies and research tools and ensures continuity of funding for medical countermeasures developed by industry or emerging from the basic research and preclinical development activities. Also with regards to the objective of strengthening the impact of research and innovation by embedding research gap analysis and priority setting on Preparedness and Response Planning, Vaccine Europe would like to call the attention of the Commission on the Innovation Partnership for a Roadmap on Vaccines in Europe (IPROVE), which Identifies needs, gaps & bottlenecks and suggest solutions and priorities on vaccines research, development and innovation. This roadmap, which was developed through a broad consultation of stakeholder in Europe, offers a view across the entire innovation and impact chain and moves across EU national boundaries to get a Pan-European view for therapeutic and prophylactic vaccines. The roadmap is accessible at: http://iprove-roadmap.eu/ Beyond R&D investment, preparing for potential epidemics or pandemics means that we need to create concrete solutions around accelerated clinical development and clinical platforms, improved monitoring and surveillance systems, as raised in the roadmap, as well as lean regulatory pathways and accurate forecasting for timely and appropriate scaling up of manufacturing capacity.
Read full response

Response to Strengthened cooperation against vaccine preventable diseases

21 Dec 2017

Vaccines Europe, which is a group formed of major and medium-size R&D vaccine companies operating in Europe, welcomes the Commission Roadmap on “Strengthened cooperation against preventable diseases” as a major opportunity to jointly address the common challenges the Member States face as highlighted in the Council Conclusions on vaccinations as an effective tool in public health adopted in 2014. Vaccination is one of the most cost-effective public health interventions ever implemented, significantly decreasing the incidence of numerous deadly diseases and associated mortality, which however, has become a victim of its own success. Europe has a long history of vaccine discovery, development and manufacture. More than 80% of vaccine doses produced by the major research and development led companies are produced in Europe and exported for worldwide use. Keeping Europe’s lead in such a key sector and ensuring European citizens benefit from the value of vaccination requires a concerted and coordinated effort by all stakeholders as proposed in the Roadmap. Vaccines Europe members are committed to engaging in these stakeholders’ discussions in view of finding solutions to the challenges Europe is facing on vaccine preventable diseases. The Roadmap provides the needed political leadership to improve public health in Europe that will help the Member States to meet their public health objectives according to their National Immunisation Strategies/Programmes. Vaccines Europe agrees that suboptimal uptake of available effective vaccines is a major factor in the continued vaccine preventable diseases outbreaks in the EU. The reasons for these outbreaks are multiple but increased hesitancy towards vaccination has been identified as a leading cause. The most effective role industry can play in this regard is to continue to develop and manufacture safe and effective vaccines of the highest quality and to support initiatives that enhance fact-based information about vaccines and vaccination. Vaccines Europe believes that the challenges affecting vaccines and vaccination are multifaceted in nature and these can only be overcome with a strategic and forward-looking approach based on scientific evidence and with actions required across a range of stakeholders. Vaccines Europe has identified a number of key areas, such as improving European surveillance capabilities to provide the data required to support the national immunisation strategies; addressing the vaccine hesitancy determinants of confidence, complacency and convenience, including engaging physicians, nurses and pharmacists in actively increasing vaccination coverage; addressing the root causes of vaccine shortages to improve the sustainability of vaccine supply and ensuring a continuous interaction with all stakeholders to overcome barriers/blocking factors to the discovery and development of the next generation of vaccines. Vaccines Europe also believes that the setting-up of evidence-based, cost-effective, safe and efficient Information Immunisation Systems (IIS) should be an integral part of a well-functioning health system. Realising the full potential of these systems will require a focused collaborative effort fully aligned with the European Commission’s Digital Single Market strategy. These together provide unprecedented opportunity to harmonise and strengthen the use of IIS across Europe for the benefit of healthcare systems and European citizens. Infectious communicable diseases know no borders. Vaccines Europe is of the opinion that the Roadmap helps to set a common agenda involving all stakeholders with the aim of implementing a coherent EU strategy for vaccination to protect European citizens of all ages against infectious diseases today and in the future. Full position on our priorities for vaccination policies in Europe available at: http://www.vaccineseurope.eu/wp-content/uploads/2017/06/VE-paper_priorities_vaccination_policy-22-05-2017.pdf
Read full response

Response to Definition of the concept "similar medicinal product"

27 Nov 2017

Proposed change in Art. 1 (2.2): Amending the 1st paragraph (see attachment) The 2nd paragraph should be removed. Comments/Rationale : This vaccine example is not appropriate to illustrate similarity/non-similarity between two products containing polysaccharide substances, because it does not take into consideration the chemical and biological complexity of conjugated vaccine antigens. Similarity in the context of vaccines cannot be defined or characterized as it is described in the proposed Commission Regulation, because of the complexity of these products. Even if 2 polysaccharide vaccines are derived from the same antigen and/or are using similar methods of conjugation, the resulting immunogenicity properties of the 2 vaccines, and thus their intrinsic biological characteristics, are likely to differ. Regulatory Authorities in Europe, in US and other parts of the world have defined complex criteria for assessing similarity between two vaccines, and very often require a head-to-head comparability assessment on the basis of non-clinical and/or clinical and data. Manufacturers of biotechnological/biological products make frequent changes to manufacturing processes of products both during development and post-approval. For the implementation of even minor changes to the manufacturing process, production scale, facilities, equipment, raw materials, etc, the Marketing Authorisation Holder (MAH) is expected to assess and present evidence that the relevant quality attributes of the product are not impacted by the proposed change(s) [cfr. Commission Reg. (EC) No 1234/2008 concerning variations to marketing authorisations]. Comparability assessment is performed in accordance with the ICH Q5E guideline (“Comparability Of Biotechnological/Biological Products Subject To Changes In Their Manufacturing Process”) and the CHMP Guideline on “Comparability of Biotechnology-Derived Medicinal Products after a Change in the Manufacturing Process”, and should normally include the evaluation of the impact of the change(s) on product stability. If the MAH can provide evidence of comparability through physico-chemical and quality-related biological studies, then non-clinical or clinical studies with the post-change product may not be warranted. In other cases, additional non-clinical and/or clinical data will be required. As further highlighted in the ICH Q5E Guideline, although in some cases, pre- and post-change products may appear highly similar, “the manufacturer should consider employing additional testing (e.g., further characterisation) or nonclinical and/or clinical studies to reach a definitive conclusion”. As explained in the article “Vaccines and biosimilarity: a solution or a problem?”, M. J. Corbel and M. de los Angeles Cortes Castillo [Expert Reviews Vaccines 8(10), 1439-1449 (2009)], many factors can affect the physiochemical and biological properties of products even though these may appear very similar, and even if they contain the same polysaccharide and carrier protein. These factors “can influence key features such as immunogenicity and stability. Inability to precisely define the molecular composition of the active component would specifically exclude these products from the EMA definition of biosimilarity”. This is further discussed in a number of other scientific publications, including: - “Vaccine Analysis: Strategies, Principles, and Control” B.K. Nunnally et al. (eds.). Springer-Verlag Berlin Heidelberg 2015. p. 301-381. - “Factors contributing to the immunogenicity of meningococcal conjugate vaccines”, Bröker et al. Human Vaccines & Immunotherapeutics, 2016, VOL. 12, NO. 7, 1808–1824. - “The design of semi-synthetic and synthetic glycoconjugate vaccines”, P.Costantino,R.Rappuoli, F. Berti; Expert Opin. Drug Discov. (2011) 6(10):1045-1066. - “Lot-Release Criteria, Postlicensure Quality Control, and the Haemophilus influenzae Type b Conjugate Vaccines”, Egan, Frasch, Anthony, JAMA 273: 888-889 (1995).
Read full response

Meeting with Xavier Prats Monné (Director-General Health and Food Safety)

19 Oct 2017 · Discussion on vaccination

Meeting with Xavier Prats Monné (Director-General Health and Food Safety)

20 Jan 2016 · Health programme on vaccination