Brighton Collaboration – setting standards in vaccine safety

The Brighton Collaboration⁸⁵ is an international volun­ta­ry collaboration of scientific experts, launched in 2000. It facilitates the development, evaluation and dissemination of high-quality information about the safety of human vaccines.

The main objectives of the collaboration are.⁴⁰

• To raise global awareness of the availability of standardized case definitions and guidelines for data collection, analysis and presentation, and to educate about the benefit of and monitor their global use and to facilitate access,
• To develop single standardized case definitions⁸⁶ for specific AEFIs,
• To prepare guidelines for data collection, analysis and presentation for global use,
• To develop and implement study protocols for evaluation of case definitions and guidelines in clinical trials and surveillance systems.

Case definitions

In Module 4 AEFI surveillance: Detection and repor­ting you have learnt about the use of standard case definitionsStandard case definitionA common, formal definition for the health-related event under surveillance. The case definition of a health-related event can include clinical manifestations (i.e., symptoms), laboratory results, epidemiologic information (e.g., person, place, and time), and/or specified behaviors, as well as levels of certainty (e.g., confirmed/definite, probable/presumptive, or possible/suspected). The use of a standard case definition increases the specificity of reporting and improves the comparability of the health-related event reported from different sources of data, including geographic areas.and guidelines. Without globally accepted standard case definitions for assessing AEFIs, it is difficult, if not impossible, to compare safety data across trials with any validity. Standard case definitions serve to define the levels of diagnostic certainty or specificity of the reported AEFI. They also indicate if the AEFI was diagnosed solely on clinical signs and symptoms (lower specificitySpecificityIn the context of surveillance, the measure of the degree to which cases detected through a surveillance system actually have the disease.) or confirmed by laboratory test (higher specificity).