Standardized case definitions for global use
The Brighton Collaboration is committed to develop standardized, widely disseminated and globally accepted case definitions for an exhaustive number of AEFI complemented by guidelines facilitating their use. A common understanding of each AEFI worldwide and in all settings builds a basis for meaningful research and communication in immunization safety.
Brighton case definitions and associated guidelines are intended to enhance data comparability within and across clinical trials, surveillance systems, and post-licensure clinical studies. They neither provide a causal assessment of a given adverse event with immunization, nor are they intended to establish criteria for management of patients. The case definitions are designed to define the levels of diagnostic certainty of reported adverse events following immunization.
Working Groups work as multidisciplinary teams consisting of 5 - 20 volunteers with relevant experience in patient care, public health, clinical trials, safety surveillance and safety assessment from developed and developing countries. Volunteers are actively sought by the Brighton Team, can be recommended, or can volunteer themselves.
Case definition development follows an established standard "Brighton method". This is based on systematic review of current evidence, consensus formation, structured peer review and scientific publication.
Brighton case definitions
Our published case definitions are endorsed by the World Health Organization (WHO) and the UN Council for International Organizations of Medical Sciences (CIOMS), they are recommended for use by the US Food and Drug Administration (FDA), the European medicines Agency (EMA), the US Centers for Disease Control and Prevention (CDC), the European Centre for Disease Prevention and Control (ECDC).
- Cellulitis at injection site
- Chronic Fatigue
- Crying, persistent
- Eczema Vaccinatum
- Encephalitis, Myelitis and ADEM
- Generalized Vaccinia
- Guillain Barre Syndrome and Fisher Syndrome
- Hypotonic Hyperesponsive Episode
- Inadvert inoculation
- Induration at injection site
- Local Reaction
- Meningitis, aseptic
- Nodule at injection site
- Pain, injection site
- Progressive Vaccinia
- Robust take
- Unexplained sudden infant death
- Viscerotropic Disease
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