Launched in 2019 through a partnership between CEPI and Brighton Collaboration, SPEAC was established to provide standardized tools, expert guidance, and scientific support for vaccine safety monitoring across CEPI-funded vaccine development programs. Over the past seven years, the project has grown into a comprehensive platform supporting vaccine developers, researchers, regulators, and public health stakeholders worldwide.
A new publication, “Safety Assessment of Vaccines Against Priority Pathogens: The CEPI Safety Platform for Emergency Vaccines (SPEAC) Project, 2019–2026,” provides an overview of SPEAC’s work to strengthen vaccine safety assessment and support vaccine development for epidemic and pandemic threats.
Building a Framework for Harmonized Vaccine Safety Monitoring
A core objective of SPEAC has been to improve the consistency and quality of vaccine safety assessment through the development of standardized resources and methodologies.
Key outputs highlighted in the publication include:
- Adverse Events of Special Interest (AESI) Lists for priority pathogens and vaccine platforms
- Brighton Collaboration Case Definitions and Companion Guides
- BRAVATO Vaccine Safety Templates
- Living Systematic Reviews
- Guidance and tools for evaluating vaccine safety in pregnant women, children, and other special populations
- Active vaccine safety surveillance support DSMB and Meta-DSMB support for CEPI-funded clinical trials
- Digital transformation of Brighton Collaboration/SPEAC tools and resources in the SPEAC/CEPI vaccine safety intelligence platform
Together, these tools help strengthen vaccine safety monitoring, improve comparability across studies, and facilitate timely safety evaluations during vaccine development.
Supporting Pandemic and Epidemic Preparedness
The publication also highlights SPEAC’s role in supporting CEPI-funded vaccine development programs by providing expert consultation, tools for robust, harmonized safety assessment, and digital resources designed to make safety information more accessible and actionable.
As global efforts continue to focus on preparedness and response for epidemic and pandemic threats, standardized approaches to vaccine safety assessment remain essential for generating reliable evidence and supporting public confidence in vaccines. Developing and facilitating use of Brighton’s SPEAC tools and resources has been a key component supporting CEPI’s 100 Days Mission to make vaccines available within 100 days of the identification of outbreaks of priority pathogens.
Looking Ahead
The publication reflects on the progress achieved since the SPEAC Project’s launch in 2019 while underscoring the continued importance of global collaboration, scientific rigor, and harmonized safety methodologies.
SPEAC remains committed to advancing vaccine safety science through providing practical tools, expert networks, and innovative approaches that support the safety evaluation of vaccines developed against emerging infectious diseases from early clinical development to post-authorization implementation.
Read the full publication here:
https://www.insights.bio/vaccine-insights/journal/article/3842/safety-assessment-of-vaccines-against-priority-pathogens-the-cepi-safety-platform-for-emergency-vaccines-speac-project-20192026