title: Bacillus Calmette-Guérin (BCG) vaccine adverse events in Victoria, Australia: analysis of reports to an enhanced passive surveillance system.
abstract: BACKGROUND
  Bacillus Calmette-Guérin (BCG) vaccine is used worldwide, with high efficacy against childhood Mycobacterium tuberculosis (TB) meningitis and miliary TB. BCG vaccine is considered safe, with serious systematic adverse events following immunization (AEFI) of immunocompetent recipients being rare, although adverse event rates vary between differing BCG strains. In Victoria, Australia, AEFI are reported to SAEFVIC (Surveillance of Adverse Events Following Vaccination In the Community), an enhanced passive surveillance system operational since 2007.
  
  
  OBJECTIVE
  To describe the epidemiology of reported BCG AEFI in Victoria, Australia, particularly following the 2012 recall of Connaught BCG vaccine, substitution with Denmark-SSI vaccine and subsequent programme delivery adjustments.
  
  
  METHODS
  Retrospective analysis of reported BCG AEFI in Victoria, Australia, for the 6-year period 2008-2013. Incidence rates were calculated using available doses-distributed, doses-administered and population data denominators with 95 % confidence intervals.
  
  
  RESULTS
  The predominant BCG AEFI reported were abscess and lymphadenopathy, with higher reports for males than for females (p = 0.039).The rates of AEFI per 10,000 doses distributed were similar for the Connaught and Denmark-SSI strains, at 11.6 and 15.4, respectively (p = 0.414). When doses administered rather than doses distributed were considered, the rate of reported Denmark-SSI AEFI was much higher, at 62.8 per 10,000 doses administered. Meaningful result interpretation was hampered by a lack of a BCG vaccination register, multiple disparate providers and absent doses-administered data prior to the recall.
  
  
  CONCLUSIONS
  Effective AEFI surveillance is of paramount importance as countries are faced with unplanned vaccine strain changes following the 2012 BCG recall and subsequent global vaccine supply shortages. The Australian experience and lessons learned serve as a timely reminder to BCG vaccination programmes worldwide to review AEFI surveillance systems.
authors.affiliation: SAEFVIC, Murdoch Childrens Research Institute, The Royal Children's Hospital, Flemington Road, Parkville, Melbourne, VIC, 3052, Australia, hazel.clothier@mcri.edu.au.
authors.forename: Hazel J
authors.initials: HJ
authors.lastname: Clothier
authors.forename: Laine
authors.initials: L
authors.lastname: Hosking
authors.forename: Nigel W
authors.initials: NW
authors.lastname: Crawford
authors.forename: Melissa
authors.initials: M
authors.lastname: Russell
authors.forename: Mee Lee
authors.initials: ML
authors.lastname: Easton
authors.forename: Julie-Ann
authors.initials: JA
authors.lastname: Quinn
authors.forename: Jim P
authors.initials: JP
authors.lastname: Buttery
mesh_terms: D016907:Adverse Drug Reaction Reporting Systems / Q000706:statistics & numerical data*; D001500:BCG Vaccine / Q000008:administration & dosage / Q000009:adverse effects*; D002675:Child, Preschool; D005260:Female; D006801:Humans; D007114:Immunization / Q000009:adverse effects*; D015994:Incidence; D007223:Infant; D007231:Infant, Newborn; D008297:Male; D011159:Population Surveillance; D012189:Retrospective Studies; D014376:Tuberculosis / Q000517:prevention & control*; D014739:Victoria / Q000453:epidemiology; D055815:Young Adult
chemical_list: D001500:BCG Vaccine