The Brighton Collaboration: addressing the need for standardized case definitions of adverse events following immunization (AEFI)

International collaboration to assess the risk of Guillain Barré Syndrome following Influenza A (H1N1) 2009 monovalent vaccines

“…A steering group 2 from the World Health Organization (WHO), United States Food and Drug Administration (FDA) and Centers for Disease Control and Prevention (CDC), European CDC, Erasmus Medical Center, Cincinnati Children's Hospital, and the Brighton Collaboration [7], provided standardized methods and definitions for a study that included investigators from Australia, Canada, China, Denmark, Finland, France, Israel, Mexico, The Netherlands, Norway, Singapore, Spain, Sweden, the United Kingdom, and the United States.…”

Real-life versus package insert: A post-marketing study on adverse-event rates of the virosomal hepatitis A vaccine Epaxal® in healthy travellers

“…The process of reconciliation of unsolicited terms (mapped with SOC based on MedDRA) with SPC terms on the questionnaire has not been independently validated in a prospective study. Since this data was collected in 1999-2000 substantial effort has gone into standardizing the reporting of AEs caused by vaccines [4], and thus, the methodology might deviate slightly from the one that would have been employed if the study were undertaken today. However, while the study-specific conclusions were relevant to conditions at the time the study was conducted, the consistency of the findings between this and the other Epaxal ® studies indicates that the conclusions are still applicable to the current practices.…”

“…For vaccines, major efforts have been undertaken in recent years to standardize reporting methods of Adverse Events Following Immunization (AEFI). The Brighton Collaboration, an international voluntary collaboration [4], has worked on the development of standardized case definitions and corresponding guidelines for data collection, analysis, and presentation of adverse events (AEs) with vaccines used in human populations. However, while definitions of AE are becoming more standardized, there is no consensus on which AE collection methods to use in clinical vaccine trials in the various stages of the vaccine development.…”

Safety assessment of adjuvanted vaccines: Methodological considerations

“…To this end, standardized case definitions of a range of adverse events following immunization have been produced by the Brighton Collaboration. 52,53 For example, for adjuvanted vaccines there is theoretical concern that the adjuvant may increase the risk of an abnormal immune response which may lead to the development of immune-mediated disease. 54,55 Regulatory authorities have therefore introduced special measures for safety assessment of adjuvanted vaccines.…”