title: Adverse events following immunisation with bacille Calmette-Guérin vaccination: baseline data to inform monitoring in Australia following introduction of new unregistered BCG vaccine.
abstract: In recent years there has been a global shortage of bacille Calmette-Guérin (BCG) vaccine and, from September 2012, unregistered vaccines have needed to be used in Australia (a Danish product initially until the end of 2015, and a Polish product used in some jurisdictions from early 2016). We examined rates and types of adverse events following immunisation (AEFI) with BCG vaccine reported to the Therapeutic Goods Administration between 2009 and 2014 in children aged less than 7 years. Reporting rates of AEFI with BCG vaccine increased from 87 per 100,000 doses (registered Sanofi Pasteur product) in 2009 to 201 per 100,000 doses (unregistered Danish Statens Serum Institute product) in 2014, with Victoria having the highest rate each year. Substantial variation between jurisdictions exists, suggesting differential reporting of BCG vaccine doses administered and/or BCG vaccine-related AEFI. The most commonly reported reactions were abscess (31%), injection site reaction (27%) and lymphadenopathy/lymphadenitis (17%). This study provides baseline data on BCG vaccine safety to inform surveillance. Given the current use of unregistered vaccines in the context of vaccine supply issues, improved recording of both administered BCG vaccine doses and the reporting of BCG vaccine-related AEFI are required to facilitate close monitoring of vaccine safety.
authors.affiliation: National Centre for Immunisation Research and Surveillance of Vaccine Preventable Diseases, The Children's Hospital at Westmead, New South Wales.
authors.forename: Alexandra J
authors.initials: AJ
authors.lastname: Hendry
authors.affiliation: National Centre for Immunisation Research and Surveillance of Vaccine Preventable Diseases, The Children's Hospital at Westmead, New South Wales.|Discipline of Paediatrics and Child Health, University of Sydney, New South Wales.
authors.forename: Aditi
authors.initials: A
authors.lastname: Dey
authors.affiliation: National Centre for Immunisation Research and Surveillance of Vaccine Preventable Diseases, The Children's Hospital at Westmead, New South Wales.|Discipline of Paediatrics and Child Health, University of Sydney, New South Wales.
authors.forename: Frank H
authors.initials: FH
authors.lastname: Beard
authors.affiliation: National Centre for Immunisation Research and Surveillance of Vaccine Preventable Diseases, The Children's Hospital at Westmead, New South Wales.|Discipline of Paediatrics and Child Health, University of Sydney, New South Wales.
authors.forename: Gulam
authors.initials: G
authors.lastname: Khandaker
authors.affiliation: Adverse Event Monitoring and Vaccine Safety, Pharmacovigilance and Special Access Branch, Therapeutic Goods Administration, Canberra, Australian Capital Territory.
authors.forename: Richard
authors.initials: R
authors.lastname: Hill
authors.affiliation: National Centre for Immunisation Research and Surveillance of Vaccine Preventable Diseases, The Children's Hospital at Westmead, New South Wales.|Discipline of Paediatrics and Child Health, University of Sydney, New South Wales.
authors.forename: Kristine K
authors.initials: KK
authors.lastname: Macartney
mesh_terms: D001315:Australia / Q000453:epidemiology; D001500:BCG Vaccine / Q000008:administration & dosage / Q000009:adverse effects* / Q000276:immunology; D002648:Child; D002675:Child, Preschool; D016208:Databases, Factual; D005260:Female; D006801:Humans; D007114:Immunization / Q000009:adverse effects*; D015994:Incidence; D007223:Infant; D007231:Infant, Newborn; D008297:Male; D015995:Prevalence; D012042:Registries; D014376:Tuberculosis / Q000453:epidemiology / Q000517:prevention & control*; D014611:Vaccination / Q000009:adverse effects
chemical_list: D001500:BCG Vaccine