The Brighton Collaboration is a successful international voluntary collaboration to facilitate the development, evaluation, and dissemination of high quality information about the safety of human vaccines. It may serve as a useful model to advance the science of drug and other realms of product/patient safety.

Background

Scientifically, "safety" can not be assessed directly, but only inferred indirectly from the relative absence of multiple measured adverse events. In vaccinology, the lack of common definitions for Adverse Events Following Immunization (AEFI; e.g., fever, seizure); acceptable and suitable for various settings has hindered meaningful research on and communication about immunization safety. This lack of standardization represented a major "missed opportunity" since safety assessment requires collating rare events across time and space.

The Brighton Collaboration

The Brighton Collaboration was founded in 1999 at a meeting in Brighton, England by five of its current steering committee members from public health, academia, clinical care and industry to fill this scientific gap. It aims to develop widely disseminated and globally accepted standardized case definitions for the critical AEFIs as well as guidelines for collection, analysis, and presentation permitting comparability of vaccine safety data.

Objectives of the Brighton Collaboration

1. Global Collaboration: To establish a global collaboration of professionals and organizations concerned with immunization safety.

2. Development: To develop a single standardized case definition for each AEFI and guidelines for data collection, analysis, and presentation for global use.

3. Evaluation: To develop and implement study protocols for evaluation of case definitions and guidelines in clinical trials and surveillance systems.

4. Implementation: To raise global awareness of the availability of standardized case definitions and guidelines for data collection, analysis and presentation; provide education on the benefits of their use; and facilitate access to and monitoring of their worldwide use.

The Brighton Collaboration case definitions and guidelines are intended for use in prelicensure and post-licensure clinical trials, surveillance systems and retrospective epidemiologic studies of vaccine safety throughout the world.

Our target groups are the various stakeholders, who carry out immunization studies; who make clinical decisions about immunizations; and who need to get, interpret, provide, and report information on immunization safety.

Current status

As of May 2004, the Collaboration consists of >500 participants from patient care, public health, academic, pharmaceutical, regulatory and professional organizations in both developed and developing countries. The first six Brighton case definitions and guidelines have been finalized (fever, generalized convulsive seizure, hypotonic-hyporesponsive episode, intussusception, nodule at injection site, and persistent crying). Three additional documents have been reviewed by reference groups (abscess at injection site, cellulitis at injection site, and generic guidelines for investigators), 9 working groups are currently working on 14 additional topics, i.e. anaphylaxis, encephalitis, fatiguing illness including chronic fatigue syndrome, local reactions including swelling and induration at injection site, aseptic meningitis, rash, sudden infant death syndrome including sudden unexpected death syndrome, thrombocytopenia, and adverse events following exposure to vaccinia virus including eczema vaccinatum, generalized vaccinia, inadvertent inoculation, progressive vaccinia, and robust take. Formal evaluation studies of definitions are underway. Over 67 investigators in 30 countries have begun or are considering implementation of the definitions and guidelines.

The Brighton Collaboration is supported by the Centers for Disease Control and Prevention, the World Health Organization and for the first three years also the European Research Grant for Improved Vaccine Safety Surveillance (EUSAFEVAC).

Volunteers are Welcome!

We offer anyone interested in any aspect of vaccine safety, immunization, public health or any of the related medical specialties to participate in the effort of the Brighton Collaboration. To find out more how to participate including download of finalized case definition and guidelines documents, visit our website at http://brightoncollaboration.org, or contact us at: secretariat@brightoncollaboration.org.

Other realms of product/patient safety may wish to adopt a similar model to create a common "vocabulary" to allow the scientific advancement of their field.

*The Brighton Collaboration Secretariat and Steering Committee
Katrin S Kohl, Jan Bonhoeffer, Bakary Drammeh, M Miles Braun, Robert T Chen, Philippe Duclos, Harald Heijbel, Ulrich Heininger, Elisabeth Loupi, S Michael Marcy

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