Priority List of Adverse events of special interest: Rift Valley Fever (SO1-D2.3)

To maximize the value of vaccine safety data in clinical trials given their relatively limited sample size, it is essential to standardize their collection, presentation and analysis when possible. Given serious adverse events following immunization (AEFIs) are fortuitously rare, this need for globally accepted standard case definitions that allow for valid comparisons extend to individual case reports, surveillance systems, and retrospective epidemiologic studies.

This need for standardization was recognized by Dr. Robert Chen at a vaccine conference in Brighton, England in 1999. Harald Heijbel, Ulrich Heininger, Tom Jefferson, and Elisabeth Loupi joined his call one year later to launch the Brighton Collaboration as an international voluntary organization, now with more than 750 scientific experts. It aims to facilitate the development, evaluation and dissemination of high-quality information about the safety of human vaccines.

The goals of the Brighton Collaboration in the domain of case definitions have been to:

1. Develop standardized case definitions for specific AEFI’s.

2. Prepare guidelines for their data collection, analysis and presentation for global use.

3. Develop and implement study protocols for evaluation of case definitions and guidelines in clinical trials

and surveillance systems.

4. Raise global awareness of their availability and to educate about their benefit, monitor their global use,

and facilitate access.

Safety monitoring during clinical trials is a crucial component for vaccine development. Before a vaccine can receive regulatory approval for marketing, rigorous safety monitoring and reporting is required. In the CEPI funded vaccine development programs, the CEPI funded developers are the sponsors and responsible for safety monitoring of their products and have the responsibility to comply with regulatory requirements. Since CEPI funds several developers that develop vaccines for the same target, using different vaccines and platforms, harmonization of safety monitoring is essential to allow for meaningful analysis and interpretation of the safety profiles of CEPI funded vaccines.

CEPI has contracted with the Brighton Collaboration, through the Task Force for Global Health, to harmonize the safety assessment of CEPI-funded vaccines via its Safety Platform for Emergency vACcines(SPEAC) Project. As part of its landscape analysis of Rift Valley Fever (RVF), this document describes the methods and results SPEAC used to arrive at the list of adverse events of special interest (AESI).