title: Strengthening of causality assessment of adverse events following immunization in the WHO South East Asia and Western Pacific regions: Lessons from the 2014 SEAR inter-country workshop.
abstract: BACKGROUND
  Poorly managed AEFI undermine immunization programs. Improved surveillance in SEAR countries means more AEFIs but management varies. SEAR brought countries together to share AEFI experiences, and learn more about causality assessment.
  
  
  METHODS
  Three day 10 country workshop (9 SEAR; 1 WPR). Participants outlined county AEFI experiences, undertook causality assessment for 8 AEFIs using WHO methodology, critiqued the process by questionnaire and had a discussion.
  
  
  RESULTS
  All 10 valued AEFI monitoring and causality assessment, and praised the opportunity to share experiences. Participants determined a range of AEFI and causality assessment needs in SEAR such as adapting WHO Algorithm, CIOMS/Brighton definitions, WHO verbal autopsy to fit context, requesting a practical guide--AEFI definition, time interval, rates of AEFI for different vaccines and evidence for vaccine related causes of death under 24h.
  
  
  CONCLUSIONS
  LMIC need WHO AEFI tools adapted to better fit LMIC. Learning from each other builds capacity. Sharing AEFI experiences, case reviews help LMIC improve practices.
authors.affiliation: Department of Paediatrics, Dalhousie University, IWK Health Centre, Halifax, Canada. Electronic address: noni.macdonald@dal.ca.
authors.forename: Noni E
authors.initials: NE
authors.lastname: MacDonald
authors.affiliation: Vaccine Supply and Quality, IVD, SEARO, Bangkok, Thailand.
authors.forename: Stephane
authors.initials: S
authors.lastname: Guichard
authors.affiliation: Epidemiology Unit, Ministry of Health, Colombo, Sri Lanka.
authors.forename: Ananda
authors.initials: A
authors.lastname: Amarasinghe
authors.affiliation: Safety and Vigilance, Regulation of Medicines and Other Health Technologies, Department of Essential Medicines and Health Products, Health Systems and Innovation, WHO HQ, Geneva, Switzerland.
authors.forename: Madhava Ram
authors.initials: MR
authors.lastname: Balakrishnan
mesh_terms: D001210:Asia, Southeastern / Q000453:epidemiology; D015984:Causality; D064420:Drug-Related Side Effects and Adverse Reactions / Q000453:epidemiology* / Q000209:etiology*; D004493:Education; D005260:Female; D006801:Humans; D007114:Immunization / Q000009:adverse effects*; D007223:Infant; D007231:Infant, Newborn; D008297:Male; D010139:Pacific Islands / Q000453:epidemiology; D011358:Product Surveillance, Postmarketing / Q000379:methods*; D014944:World Health Organization
keywords: AEFI; Adverse events following immunization; Causality assessment; South East Asia Region; World Health Organization