Safety Platform for Emergency vACcines (SPEAC)

Work Package Leads: Steve Black and Corry Dekker

• Optimizes vaccine safety data review for CEPI-funded trials by providing liaison observers who are highly experienced in this work to study DSMBs
• Oversees the work of SPEAC Meta-DSMB via monthly virtual meetings to discuss updates as a group
• Trains potential new DSMB members in different geographical regions where CEPI-funded trials are planned via online lectures by safety experts and weekly sessions with a facilitator
• Connects CEPI awardees with potential DSMB members from target countries by maintaining a pool of trained, experienced vaccine safety experts

Work Package Lead: Barbara Law

• Develops specialized knowledge tools for CEPI priority pathogens including
  AESI case definitions and associated companion guides which include AESI ICD9/10, SNOMED and MedDRA codes; AESI risk factors; AESI background rates; AESI data collection forms and algorithms for assessing the level of certainty; training resources and online AESI Automated Brighton Classification (ABC) tools. 
• Develops educational videos and webinars on specific vaccine safety topics.

Work Package Leads: Marc Gurwith and Emily Smith

• BRAVATO Vaccine Safety Templates summarize available information for each novel vaccine into standardized benefit-risk templates.
• The templates are electronically available and allow for continuous updates.
• The applicability/use of safety data from developed to less developed countries and the identification of safety data that can and cannot be implied from clinical trials from one region to another will be provided.
• A separate optional module will allow structured benefit-risk analyses and presentations for a variety of new and existing vaccines/technology platforms; this module will help meet regulatory requirements.

Work Package Lead: Dale Nordenberg

• Transforms SPEAC products from all Work Packages to standards-based structured data for efficient electronic data exchange across vaccine developers, regulators, public health agencies, and other stakeholders
• For specific information products, FIND-compliant tools provide user-friendly, efficient access to SPEAC products and services. Examples include data collection forms that stakeholders may import in their e-Case Report Form (CRF), and an Automated Brighton Classification (ABC) tool that can be incorporated to automatically assess the level of certainty for a case definition.
• To oversee product safety of many different vaccines across platforms, the Meta-DSMB needs to be supported by a system that allows for reporting and aggregation of safety issues, across different vaccine platforms.
• The SPEAC Safety Services Portal will support the effective engagement of members of the global vaccine safety community leaders in order to promote collaboration, innovation, and improved operations.
• Digital transformation for vaccine safety will be supported by workforce development through WP4 educational and training programs.

Work Package Leads: Flor Muñoz and Manu Chaudhary

• This Work Package addresses the inclusion of three special population groups—children and adolescents, pregnant and lactating women, and immunocompromised and medically at-risk hosts—in clinical trials.
• Specialists in each area of expertise are engaged to support the process of vaccine development, evaluation, and implementation by providing population-level expertise, specific guidance, and tool development such as template protocols, informed consent documents, communication tools, key characteristics of each of the special population groups, and unique aspects relevant to disease burden and vaccine research and implementation.

Work Package Lead: Andy Stergachis

• Contribute to strategies for generation of evidence of vaccine safety at CEPI Clinical Research Preparedness Network Sites
• Assist with formulating plans by providing tools for peri- and post-introduction safety data collection using active surveillance techniques in LMICs
• Strengthen the sustainability of such pharmacovigilance activities for ongoing benefit-risk evaluation in LMICs. 

Work Package Lead: Wan-Ting Huang

• Evaluates the quality and uptake of SPEAC products.
• Proposes continuous improvement plans for SPEAC standards and tools.

Project Managers at WeDo and the Task Force for Global Health support the SPEAC project. 

Work Package Leads: Bob Chen and Miriam Sturkenboom

• Provides the overall scientific direction and drives innovation and effective coordination and management of the SPEAC 2.0 project
• Together with WP8, creates strategic partnerships and develops and maintains communication channels with the stakeholders, while ensuring proper dissemination, implementation, and impact of the project outputs.

Work Package Leads: Bob Chen and Miriam Sturkenboom

Work Package 10 includes contingency resources to help mitigate risks by addressing safety issues that may arise during the development of candidate vaccines vs. Disease X, ensuring coordination of activities across WPs and changes in the work plan as well as administrative needs with CEPI