Our Workflow of Developing Case Definitions and Complementary Guidelines

International consensus is achieved through a global network of individuals and organizations concerned with immunization safety or with associated medical and methodological aspects. The resulting accrual of expertise and the sharing of knowledge within and outside the Collaboration along with the availability of case definitions and guidelines will lead to data comparability. This will benefit vaccine recipients, scientists, health officials and healthcare providers, who need to obtain, interpret, provide, and report information on immunization safety and make scientifically sound decisions.



For each defined adverse event following immunization (AEFI) a document is developed including four sections:

ØØ A preamble to highlight the rationale for essential decisions made and to briefly describe the methodology of how working groups arrived at a particular Brighton document.

ØØ The case definition itself, which is structured in a three-level format taking into account current scientific evidence and different levels of resources available in different research and geographic settings.

ØØ Guidelines for data collection, analysis, and presentation of a given AEFI.

ØØ References for selected points discussed in the preamble.



Step-By-Step: Developing Case Definitions and Complementary Guidelines



Selection of Topic

AEFI Prioritization

Based on severity, frequency  of reporting, enhanced public interest and emerging scientific needs.

Working Groups

Call for Volunteers 


Composition of Groups

Announcement on our website, contacting of pertinent scientific authors and request for referrals.



Based on the balanced composition of professional expertise and geographical location.

Exploratory Review





Systematic  search and compilation  of relevant published and unpublished     evidence.



Evaluation  of inventory through discussions by the Working Group.

Draft Definition


A draft document is developed based on the exploratory
review and group consensus.

Reference Group

Call for Reviewers

Announcement on our website, contacting of pertinent scientific authors and request for referrals.

Peer Review




An online survey guides structured review of the draft document  to  stimulate critical  review.



Survey data are compiled and discussed by the Working Group.





The draft is revised based on Reference Group comments.



The final document is harmonized with other case definition documents.


Cyclical Revision

Case definition documents are revised in 3-5 year intervals or upon the availability of new scientific information or critical feedback from evaluation and implementation of documents.

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