As 2025 draws to a close, we pause to reflect on a year defined by collaboration, learning, and shared commitment across the global vaccine safety community.
At SPEAC, our work is grounded in a simple but vital goal: to strengthen the evidence base for vaccine safety—particularly for vaccines against epidemic-prone diseases—so that decisions can be made with confidence, clarity, and speed. This year, that goal was advanced through collective effort: across continents, disciplines, and institutions.
Building Capacity Through DSMB Training
One of the most impactful areas of growth in 2025 was our expanded focus on Data and Safety Monitoring Board (DSMB) training. Through multiple training cohorts, we worked with clinicians, researchers, and regulators—many based in low- and middle-income countries—to strengthen practical understanding of DSMB roles, responsibilities, and best practices.
These sessions emphasized real-world decision-making, ethical oversight, and interpretation of safety data in the context of emerging and epidemic-prone pathogens. Participant feedback consistently highlighted the value of applied examples, peer exchange, and scenario-based discussion—reinforcing the importance of investing in sustainable safety oversight capacity.
Advancing Evidence Through Living Systematic Reviews
Our Living Systematic Reviews (LSRs) continued to serve as a cornerstone of SPEAC’s evidence-generation work in 2025. Updated on a rolling basis, these reviews provide continuously refreshed syntheses of vaccine safety data—particularly for use in pregnancy and pediatric populations.
By maintaining LSRs as “living” resources rather than static publications, SPEAC supports timely access to evolving evidence for regulators, manufacturers, and public health decision-makers navigating fast-moving vaccine development and deployment environments.
Expanding Access to Real-World Safety Data
In 2025, we also made meaningful progress in expanding access to real-world safety data through practical, decision-focused tools.
The Active Safety Surveillance Dashboard continued to evolve as a resource for transparent, harmonized review of post-vaccination safety signals. Designed with end users in mind, the dashboard supports monitoring of adverse events of special interest across diverse settings and surveillance systems—helping translate complex data into actionable insights.
This year also marked the beta release of the CEPI Safety Intelligence Dashboard, developed in collaboration with Coalition for Epidemic Preparedness Innovations. The dashboard brings together curated safety evidence, tools, and guidance to support vaccine safety decision-making across the product lifecycle. SPEAC contributions helped ensure that safety concepts, AESI frameworks, and evidence syntheses were grounded in current science and aligned with real-world needs.
Together, these tools reflect SPEAC’s broader commitment to usability—ensuring that safety resources are not only scientifically robust, but also accessible and relevant for regulators, manufacturers, and public health stakeholders working in fast-moving epidemic contexts.
Keeping Pace With Emerging Risks: Updated AESI Lists
As vaccine development accelerates for emerging and re-emerging pathogens, keeping safety frameworks current is essential. In 2025, SPEAC released updated Adverse Events of Special Interest (AESI) lists, reflecting the latest scientific understanding and expert consensus.
These updates support more consistent safety monitoring across clinical trials and post-authorization surveillance, helping align global efforts around shared definitions, methodologies, and safety priorities.
Contributing to the Scientific Literature
SPEAC collaborators continued to contribute to the peer-reviewed literature in 2025, with new publications spanning epidemiology, clinical research, and pharmacovigilance. These publications strengthen the global evidence base for vaccine safety and reflect the depth and diversity of expertise across the SPEAC network.
With Gratitude, Looking Ahead
None of this work happens in isolation. We are deeply grateful to our collaborators, contributors, trainers, reviewers, and partners who bring their expertise, time, and trust to this shared mission.
As our Scientific Director Bob Chen often reminds us, strong vaccine safety systems are built through collaboration—across sectors, across regions, and across disciplines. That spirit defined 2025, and it will continue to guide our work in the year ahead.
We wish our global community a restful holiday season and a healthy, hopeful start to 2026.
Happy Holidays from the SPEAC team.
