The 2025 World Vaccine Congress, held in Washington, D.C., brought together a global community of vaccine developers, public health leaders and scientific innovators to address some of the most pressing challenges in immunisation and pandemic preparedness. As one of the premier events in the field, the Congress attracted over 4,000 attendees for knowledge sharing through presentations and speakers and facilitated over 1,000 partnering meetings to foster vital connections. Each year, stakeholders from across industry, academia and government agencies convene at the Congress, though this year, notably, with a reduced regulatory presence. The energy and urgency throughout the congress was high, with a strong focus on innovation, long-term safety, and pragmatic solutions for a rapidly evolving vaccine ecosystem.
Themes of innovation amidst uncertainty
A recurring theme throughout the conference was the growing need for resource-efficient approaches to vaccine development. Sponsors and researchers are increasingly looking to technology to drive smarter, more streamlined trials. From gamification strategies designed to enhance participant engagement, to rapid point-of-care lab assessments, the message was clear: the future of vaccine research demands agility, scalability and creative problem-solving at all levels.
Industry stakeholders are navigating increased pressure from new mandates around post-market surveillance and long-term safety data collection without clear insight from regulators. Technology took centre stage as the practical pathway through the uncertainty. Attendees shared how innovations in data and technology are facilitating efficiency and offering new ways of safeguarding trial integrity and continuity. For example, tokenisation can support passive long-term follow-up to gain richer vaccine safety data without placing additional burden on patients. These capabilities are increasingly crucial, particularly as the US government continues to place strong emphasis on the long-term safety of vaccines.
Throughout multiple sessions, we saw renewed attention on real-world evidence (RWE) as a mechanism to solve the problem of increasing trial size and complexity while ensuring data relevance. As access to representative patient populations remains a challenge, RWE may help bridge critical gaps and better position trials for regulatory compliance. This may be especially helpful in underserved or high-risk communities.
Panel discussion highlights: RSV, influenza and biothreat preparedness
The recent approval of the first maternal vaccine for RSV is a landmark step for protecting vulnerable populations, including geriatric groups. With this success, discussions are now turning to expanding coverage to other populations, filling a critical gap in respiratory virus prevention. Attendees also examined the unique challenges posed by mRNA vaccines in pediatric populations and the need for alternative vaccine types to meet diverse immunisation needs.
Another topic of perpetual urgency was influenza. There is growing concern around avian flu strains such as H5N1 in the US, which has the potential to drift into human populations with significant consequences. Despite influenza receiving less public attention in recent years, a recent publication highlighted the worst pediatric mortality rates from influenza in the US since 2010—underscoring the continued importance of vigilance and vaccine development in this area.
A panel on biothreat preparedness reiterated the increasing government focus on long-term vaccine safety. While efficacy and short-term safety data are more readily available, sustained investment and infrastructure for long-term monitoring remain lacking. The panel urged the development of systems that enable data-driven follow-up beyond traditional subject tracking, aligning with the broader call for smarter, tech-enabled solutions.
ICON’s perspective: Leading the conversation on tokenisation
ICON was proud to be part of the 2025 World Vaccine Congress again this year, contributing thought leadership in the rapidly advancing area of data tokenisation. Our presentation on “Unlocking the power of tokenisation in clinical development and product commercialisation”, explored how this technology, data and analytics are together reshaping post-marketing surveillance and longitudinal safety assessments.
Tokenisation, the process of replacing personally identifiable information with unique, non-identifying codes, enables the secure collection of health data across different care settings over time. This approach allows researchers to monitor trends in safety and effectiveness long after a trial has ended—even if a participant is lost to follow-up or switches providers. This is important for long-term follow-up as the extended periods now span up to 15 years.
ICON’s Clinical Trial Tokenisation solution remains the only fully compliant, end-to-end tokenisation offering in the industry. By reducing patient burden while improving data quality and continuity, tokenisation is emerging as a powerful tool in meeting evolving regulatory expectations and maintaining public trust in vaccine safety.
Recognition and industry leadership
In recognition of our commitment to innovation and client partnerships, ICON received ‘Highly Commended’ recognition in the Best Contract Research Organisation category at the prestigious ViE Awards held during the Congress. This honour reflects ICON’s excellence in delivering high-quality services, our ability to meet critical development milestones, foster long-term relationships, and continually enhance performance through forward-thinking solutions.
Preparing for the challenges ahead
The tone at this year’s Congress reflected a field in transition. Amid the uncertainty, we are collectively striving to uphold safety, integrity and innovation while navigating a shifting regulatory, funding, and medical landscape and the industry showed resilience and creativity in moving forward with innovation.
Our participation at this year’s Congress, including our expert-led presentation on tokenisation, highlighted the importance of our role we are helping to solve challenges in vaccine development. ICON remains a trusted partner to sponsors navigating a complex and fast-moving global landscape to support their therapeutic innovations, ultimately advancing public health through innovation, agility and excellence.
Connect with us to learn how ICON can help drive forward-thinking solutions for your vaccine development program.
In this section
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Digital Disruption
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Clinical strategies to optimise SaMD for treating mental health
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Digital Disruption: Surveying the industry's evolving landscape
- AI and clinical trials
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Clinical trial data anonymisation and data sharing
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Clinical Trial Tokenisation
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Closing the evidence gap: The value of digital health technologies in supporting drug reimbursement decisions
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Digital disruption in biopharma
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Disruptive Innovation
- Remote Patient Monitoring
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Personalising Digital Health
- Real World Data
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The triad of trust: Navigating real-world healthcare data integration
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Clinical strategies to optimise SaMD for treating mental health
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Patient Centricity
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Agile Clinical Monitoring
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Capturing the voice of the patient in clinical trials
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Charting the Managed Access Program Landscape
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Developing Nurse-Centric Medical Communications
- Representation and inclusion in clinical trials
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Exploring the patient perspective from different angles
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Patient safety and pharmacovigilance
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A guide to safety data migrations
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Taking safety reporting to the next level with automation
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Outsourced Pharmacovigilance Affiliate Solution
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The evolution of the Pharmacovigilance System Master File: Benefits, challenges, and opportunities
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Sponsor and CRO pharmacovigilance and safety alliances
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Understanding the Periodic Benefit-Risk Evaluation Report
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A guide to safety data migrations
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Patient voice survey
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Patient Voice Survey - Decentralised and Hybrid Trials
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Reimagining Patient-Centricity with the Internet of Medical Things (IoMT)
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Using longitudinal qualitative research to capture the patient voice
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Prioritising patient-centred research for regulatory approval
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Agile Clinical Monitoring
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Regulatory Intelligence
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An innovative approach to rare disease clinical development
- EU Clinical Trials Regulation
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Using innovative tools and lean writing processes to accelerate regulatory document writing
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Current overview of data sharing within clinical trial transparency
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Global Agency Meetings: A collaborative approach to drug development
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Keeping the end in mind: key considerations for creating plain language summaries
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Navigating orphan drug development from early phase to marketing authorisation
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Procedural and regulatory know-how for China biotechs in the EU
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RACE for Children Act
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Early engagement and regulatory considerations for biotech
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Regulatory Intelligence Newsletter
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Requirements & strategy considerations within clinical trial transparency
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Spotlight on regulatory reforms in China
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Demystifying EU CTR, MDR and IVDR
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Transfer of marketing authorisation
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Exploring FDA guidance for modern Data Monitoring Committees
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Streamlining dossier preparation
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An innovative approach to rare disease clinical development
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Therapeutics insights
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Endocrine and Metabolic Disorders
- Cardiovascular
- Cell and Gene Therapies
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Central Nervous System
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A mind for digital therapeutics
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Challenges and opportunities in traumatic brain injury clinical trials
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Challenges and opportunities in Parkinson’s Disease clinical trials
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Early, precise and efficient; the methods and technologies advancing Alzheimer’s and Parkinson’s R&D
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Key Considerations in Chronic Pain Clinical Trials
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ICON survey report: CNS therapeutic development
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A mind for digital therapeutics
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Glycomics
- Infectious Diseases
- NASH
- Obesity
- Oncology
- Paediatrics
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Respiratory
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Rare and orphan diseases
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Advanced therapies for rare diseases
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Cross-border enrollment of rare disease patients
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Crossing the finish line: Why effective participation support strategy is critical to trial efficiency and success in rare diseases
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Diversity, equity and inclusion in rare disease clinical trials
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Identify and mitigate risks to rare disease clinical programmes
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Leveraging historical data for use in rare disease trials
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Natural history studies to improve drug development in rare diseases
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Patient Centricity in Orphan Drug Development
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The key to remarkable rare disease registries
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Therapeutic spotlight: Precision medicine considerations in rare diseases
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Advanced therapies for rare diseases
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Endocrine and Metabolic Disorders
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Transforming Trials
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Accelerating biotech innovation from discovery to commercialisation
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Ensuring the validity of clinical outcomes assessment (COA) data: The value of rater training
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Linguistic validation of Clinical Outcomes Assessments
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Optimising biotech funding
- Adaptive clinical trials
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Best practices to increase engagement with medical and scientific poster content
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Decentralised clinical trials
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Biopharma perspective: the promise of decentralised models and diversity in clinical trials
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Decentralised and Hybrid clinical trials
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Practical considerations in transitioning to hybrid or decentralised clinical trials
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Navigating the regulatory labyrinth of technology in decentralised clinical trials
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Biopharma perspective: the promise of decentralised models and diversity in clinical trials
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eCOA implementation
- Blended solutions insights
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Implications of COVID-19 on statistical design and analyses of clinical studies
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Improving pharma R&D efficiency
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Increasing Complexity and Declining ROI in Drug Development
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Innovation in Clinical Trial Methodologies
- Partnership insights
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Risk Based Quality Management
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Transforming the R&D Model to Sustain Growth
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Accelerating biotech innovation from discovery to commercialisation
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Value Based Healthcare
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Strategies for commercialising oncology treatments for young adults
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US payers and PROs
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Accelerated early clinical manufacturing
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Cardiovascular Medical Devices
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CMS Part D Price Negotiations: Is your drug on the list?
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COVID-19 navigating global market access
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Ensuring scientific rigor in external control arms
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Evidence Synthesis: A solution to sparse evidence, heterogeneous studies, and disconnected networks
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Health technology assessment
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Perspectives from US payers
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ICER’s impact on payer decision making
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Making Sense of the Biosimilars Market
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Medical communications in early phase product development
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Navigating the Challenges and Opportunities of Value Based Healthcare
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Payer Reliance on ICER and Perceptions on Value Based Pricing
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Payers Perspectives on Digital Therapeutics
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Precision Medicine
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RWE Generation Cross Sectional Studies and Medical Chart Review
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Survey results: How to engage healthcare decision-makers
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The affordability hurdle for gene therapies
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The Role of ICER as an HTA Organisation
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Strategies for commercialising oncology treatments for young adults
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