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Quarterly Newsletter:
December 2025
Issue #18
Editorial
Innovating for Tomorrow: How Immunisation Can Reinforce Europe’s Health Resilience
Charlotte Vernhes, Director Scientific and Medical Affairs, Vaccines Europe
Vaccines have always been one of Europe’s great public health success stories. Yet in a world of demographic changes, antimicrobial resistance (AMR) and climate change, immunisation is more important than ever. Scientific innovation is accelerating rapidly, but the path from discovery to market remains one of the longest and most complex in healthcare. To fully benefit from this moment, Europe must strengthen both its scientific ecosystem and its preparedness to turn innovation into impact.
What is often underestimated is just how difficult it is to develop a vaccine or prophylactic monoclonal antibody (mAb). Unlike treatments indicated for people who are already sick, prophylactics such as vaccines are typically developed to prevent disease in healthy populations which means safety standards must be exceptionally stringent. This requires clinical trials involving not hundreds but thousands or even tens of thousands of participants, both to ensure results are adequately powered to demonstrate efficacy, and to identify potential rare adverse events. The R&D process typically spans 10 to 15 years, beginning with a long pre-clinical phase spent understanding pathogens and immune responses, followed by extensive non-clinical safety testing, multiple clinical trial phases, strict regulatory assessment, and finally lifelong post-marketing monitoring.
This journey is not only long but uncertain, with only a fraction of potential candidates being approved. Manufacturing adds another layer of complexity: vaccine production cycles can last 12 to 36 months, and as much as 70% of manufacturing time is devoted to regulatory-mandated quality control.
That is why today’s wave of innovation across Europe’s vaccine ecosystem is so remarkable. The Vaccines Europe Pipeline Review 2025 published this month reveals 91 candidates are currently in clinical development using 12 technologies, and more than 40% of them target diseases for which no vaccine exists today. These include candidates targeting AMR-related bacteria, climate-sensitive pathogens and zoonotic threats with pandemic potential. Many others focus on improving protection for adults and older adults, supporting a true life-course approach to immunisation.
This innovation aligns with Europe’s most urgent health challenges. Novel respiratory vaccines could ease winter pressures on health systems; candidates targeting sexually-transmitted infections respond to rising incidence; and travel-related and climate-sensitive infectious diseases underscore how interconnected the global disease landscape has become. Meanwhile, new evidence on the broader benefits of vaccination, from reducing cardiovascular events to preventing cancers linked to infection, and potentially even lowering neurodegenerative disease risk, shows that immunisation can reshape not just infectious disease outcomes but long-term health trajectories.
Europe now has an opportunity to lead. By reinforcing regulatory expertise, embracing modernised and flexible approval pathways, investing in research capacity, and strengthening vaccination across the life course, Europe can ensure that groundbreaking science becomes real-world protection. The innovations are already in motion; the question is whether we will be ready to use them.
Vaccines have always delivered extraordinary returns for society. If Europe seizes this moment, the next generation of immunisation could not only protect against today’s diseases but significantly strengthen our resilience for the future.
Vaccines Europe External Engagement
Closing immunisation gaps: A comprehensive EU framework for respiratory infection prevention
On 15 October 2025, over 60 people gathered at the European Parliament to participate in the 2025 #EURespiDay event. Kindly hosted by MEP Billy Kelleher (Renew Europe, Ireland) with remarks by Steering Group Co-Chair MEP Dolors Montserrat (European People’s Party, Spain), the event marked the official launch of the Steering Group’s new manifesto calling for a Council Recommendation on the value of immunisation against respiratory infections.
The event brought together policymakers, academics, health professionals, and industry leaders to highlight the influenza policy framework as a model for effective EU health policy on immunisation and make the case for extending similar frameworks to COVID-19, RSV, and pneumococcal disease. Participants underlined the importance of harmonised EU immunisation targets, integrated surveillance systems, and promoting public and healthcare practitioner confidence in immunisation.
The event showcased the importance of identifying respiratory infection immunisation as a strategic priority for the EU and laid the groundwork for coordinated, resilient, and future-proof public health action across Europe.
Investing in vaccine R&D to support health security and preparedness
On 4 December 2025, it was a pleasure to co-organise the Joint Roundtable "Investing in vaccine R&D to support health security and preparedness" at the European Parliament, together with CEPI, IAVI and PATH. At the event, we reiterated that:
1️⃣ Vaccine innovation is preparedness: Vaccines remain our strongest shield for safeguarding public health and ensuring our societies stay resilient.
2️⃣ Prevention pays off: Investing in prevention is one of the smartest choices we can make. Adult immunisation programmes return up to 19 times their initial investment.
3️⃣ Europe must lead on R&D and prevention: Strengthening R&D and immunisation strategies across Europe is essential to building our first line of defence in an unpredictable world. Sustained investment in R&D, immunisation and infrastructure including surveillance - and a coordinated approach - is critical.
By prioritising innovation and prevention today, we equip ourselves to face tomorrow’s challenges.
Other events we participated in
- Soldier's Health - The Challenge of a Safe Future - 12 December, virtual. Video intervention: Prevention as a backbone of resilient civilian healthcare systems.
- The future of vaccine development: research, data, participation - 3 December, Brussels (Belgium)
- Danish Presidency of the Council of the EU High-Level Conference on AMR - 19 November, Aarhus (Denmark)
- Celebrating 5 Years of VAC4EU - 4 November, Brussels (Belgium)
- World Vaccine Congress Europe - 13-16 October, Amsterdam (The Netherlands):
- Keynote panel: "Beyond borders: Europe’s strategic role in powering vaccine innovation and transforming the global vaccine landscape";
- Panel: “Advancing Vaccines and Antibodies for Drug-Resistant Infections”;
- Keynote panel: "Frontier Technologies in Vaccine Innovation: What are the market trends and how is innovation addressing evolving health threats” .
- Immunity for Health - 1-2 October, Ghent (Belgium)
- European Health Forum Gastein 2025 - 30 September - 3 October, Bad Hofgastein (Austria) and online: Session "Securing Europe’s health information ecosystems"
Communications Highlights
Vaccines Europe Pipeline Review 2025
Vaccines Europe published the fourth annual Pipeline Review today, 1st December 2025. The report provides an overview of the innovative preventive and therapeutic vaccines against infectious diseases, as well as prophylactic monoclonal antibodies (mAbs) currently in clinical development by Vaccines Europe member companies. 41% of candidates target pathogens or diseases for which no vaccines or prophylactic mAbs have been registered, such as acne, Lyme disease, Epstein-Barr virus (EBV) infection and HIV.
Highlights from the report include:
- 91 candidates in development, comprising 86 prophylactic and 2 therapeutic vaccines, as well as 3 prophylactic mAbs all targeting infectious agents.
- The candidates are developed using 12 distinct immunisation technologies, such as mRNA, protein-based vaccines, glycoconjugate vaccines and others.
- 46 candidates for routine immunisation, including human papillomavirus (HPV), measles, mumps, rubella, varicella (MMRV combination vaccine), meningococcal diseases and others.
- 68 candidates targeting respiratory-transmitted infections, including coronaviruses, influenza, respiratory syncytial virus (RSV), pneumococcal disease and others.
- 17 candidates targeting 8 bacteria associated with significant antibiotic resistance, 7 of which are on the World Health Organization Bacterial Priority Pathogens list: E. coli, P. aeruginosa, Salmonella spp., Shigella spp., S. aureus, Group B Streptococci and S. pneumoniae.
- 31 candidates are for infections originating from animals, including dengue fever, Lyme disease, Nipah virus, yellow fever and others.
The Role of NITAGs in the EU HTA Regulation’s implementation for vaccines
On 17 September 2025, Vaccines Europe facilitated a roundtable discussion to explore if and how the European Health Technology Assessment Regulation (EU HTAR) can support the evaluation of vaccines at the national level and ultimately improve population access to vaccination. The regulation, in force since January 2025, establishes a joint EU process for the clinical assessment of new health
technologies.
Vaccines and Antimicrobial Resistance: Connecting the Dots
As we marked this year’s World AMR Awareness Week, Charlotte Vernhes reflected on how much progress has been made in the past two years on the intersection of
vaccines and antimicrobial resistance, and how much remains to be done.
Learn more in the blog.
World Pneumonia Day: Protecting Europe’s Ageing Population Through Prevention
On World Pneumonia Day, Europe faced a stark reminder: pneumonia is not only a deadly disease, but a warning sign of the wider challenge posed by respiratory infections. Flu, COVID-19, RSV in newborns and in elderly, and pneumococcal disease continue to claim thousands of lives each year, stretching health systems already under strain. One of the most effective ways to reduce this burden is through immunisation - a proven, preventive tool that saves lives and strengthens resilience.
Learn more in the blog by Nicoletta Luppi.
Key Figures
Ukraine
Ukraine: Immunisation in a time of war
In the three and a half years since Russia stepped up its military assault on Ukraine, there have been over 2,500 attacks on healthcare facilities. For those working in immunisation services, protecting people against infectious diseases – while the country is defending against military bombardment – is enormously challenging.
Read more in this Vaccines Today article.
Health Policy Highlights
Safe Hearts Plan
On December 16, the European Commission unveiled its Safe Hearts Plan, intended to combat cardiovascular diseases (CVD), currently Europe’s biggest killer. The initiative introduces a range of measures to tackle CVD from multiple angles. Critically, the plan includes a proposal for a Council recommendation for vaccination against four major respiratory diseases: influenza, COVID-19, RSV, and pneumococcal disease, as well as herpes zoster, with the aim to encourage all Member States to report vaccination coverage data in individuals with chronic conditions, including cardiovascular diseases by 2029. Vaccines Europe welcomes the Commission’s proposal as a much-needed step towards ensuring a robust prevention pillar capable of protecting Europe’s population from the worst consequences of CVD.
General Pharmaceutical Legislation
On 11 December, the European Parliament, Commission, and Council reached a final agreement on the General Pharmaceutical Legislation, almost three years after it was first proposed.
The conclusion of the pharmaceutical package marks a significant moment for one of Europe’s most strategically important sectors. The agreement is particularly relevant at a time of intensifying global competition, geopolitical instability and growing health challenges across Europe.
Vaccines Europe recognises the critical importance of the pharmaceutical package, but delivering positive transformation will ultimately depend on the delivery of ambitious reforms, effective implementation at national level, close cooperation between institutions and industry, and a continued focus on making Europe a more attractive home for innovation in medicines and vaccines over the long term.
Union Prevention, Preparedness, and Health Crisis Response Plan
On 28 November, the European Commission presented a Union prevention, preparedness and response plan for health crises.
The plan follows the Niinistö Report on the EU’s preparedness for evolving security challenges, including health threats, and is set within the EU Preparedness Union Strategy. It adopts a One Health approach, linking human, animal and environmental health, and outlines cooperation with international partners such as the WHO.
Covering a broad range of health threats, the plan sets out the EU’s crisis governance framework across all phases of crisis management. Notably, it highlights vaccination as a key element of healthcare system preparedness and resilience, and clarifies the roles of the Commission, the EMA and the ECDC in supporting Member States’ vaccination strategies, including coverage, programme sustainability and vaccine supply.
Vaccines Europe welcomes the prominence given to vaccination in the plan, recognising its role in strengthening preparedness, resilience and security of vaccine supply across Europe.
What We Are Reading & Watching
Inside EMA – Episode 2: Next pandemic: are we ready? - podcast by the European Medicines Agency
US vaccine misinformation is having “frightening” ripple effect in Europe, leaders warn - article in the British Medical Journal
How misinformation can fuel epidemics – and what we can do about it - article by Gavi, the Vaccine Alliance
The 5 Cs of Vaccination - podcast by the European Centre for Disease Prevention and Control (ECDC)
