Surveillance of adverse events following immunisation in Australia, 2012
DOI:
https://doi.org/10.33321/cdi.2014.38.38Keywords:
AEFI, adverse events, vaccines, surveillance, immunisation, vaccine safetyAbstract
This report summarises Australian passive surveillance data for adverse events following immunisation (AEFI) reported to the Therapeutic Goods Administration (TGA) for 2012. It also describes reporting trends over the 13-year period 1 January 2000 to 31 December 2012. There were 1,897 AEFI records for vaccines administered in 2012, a decrease of 22% from 2,417 in 2011. The decrease in 2012 compared with 2011 was mainly attributable to a drop in the reports following receipt of the 23-valent pneumococcal polysaccharide vaccine (405 reduced to 133). However, reporting rates for some other vaccines such as rotavirus and varicella vaccines were higher in 2012 than 2011. Although an increase was observed in estimated reporting rates for rotavirus and varicella in children aged < 7 years in 2012 compared with 2011, it was not statistically significant. There were 370 AEFI records (37.2 per 100,000 doses) for the pneumococcal conjugate vaccine in 2012, which was fewer than in 2011 (43.4 per 100,000 doses). The most commonly reported reactions were injection site reactions (40%), fever (22%), allergic reactions (19%) and rash (10%). Only 7% of all the reported adverse events were categorised as serious. There were 2 reports of death, which were investigated by the TGA and no clear causal relationship with vaccination was found. Commun Dis Intell 2014;38(3):E232–E246.
Downloads
References
Council for International Organizations of Medical Sciences (CIOMS) c/o World Health Organization. Definition and Application of Terms for Vaccine Pharmacovigilance: Report of CIOMS/WHO Working Group on Vaccine Pharmacovigilance. 2012. Accessed on 16 August 2012. Available from: http://www.cioms.ch/frame_vaccine_pharmacovigilance.htm
Lawrence G, Menzies R, Burgess M, McIntyre P, Wood N, Boyd I, et al. Surveillance of adverse events following immunisation: Australia, 2000–2002. Commun Dis Intell 2003;27(3):307–323.
Lawrence G, Boyd I, McIntyre P, Isaacs D. Surveillance of adverse events following immunisation: Australia 2002 to 2003. Commun Dis Intell 2004;28(3):324–338.
Lawrence GL, Boyd I, McIntyre PB, Isaacs D. Annual report: surveillance of adverse events following immunisation in Australia, 2004. Commun Dis Intell 2005;29(3):248–262.
Lawrence G, Boyd I, McIntyre P, Isaacs D. Annual report: surveillance of adverse events following immunisation in Australia, 2005. Commun Dis Intell 2006;30(3):319–333.
Lawrence GL, Aratchige PE, Boyd I, McIntyre PB, Gold MS. Annual report on surveillance of adverse events following immunisation in Australia, 2006. Commun Dis Intell 2007;31(3):269–282.
Lawrence G, Gold MS, Hill R, Deeks S, Glasswell A, McIntyre PB. Annual report: surveillance of adverse events following immunisation in Australia, 2007. Commun Dis Intell 2008;32(4):371–387.
Menzies R, Mahajan D, Gold MS, Roomiani I, McIntyre P, Lawrence G. Annual report: surveillance of adverse events following immunisation in Australia, 2008. Commun Dis Intell 2009;33(4):365–381.
Mahajan D, Roomiani I, Gold M, Lawrence G, McIntyre P, Menzies R. Annual report: surveillance of adverse events following immunisation in Australia, 2009. Commun Dis Intell 2010;34(3):259–276.
Mahajan D, Cook J, Mclntyre P, Macartney K, Menzies R. Annual report: surveillance of adverse events following immunisation in Australia, 2010. Commun Dis Intell 2011;35(4):263–280.
Mahajan D, Cook J, Dey A, Macartney K, Menzies R. Annual report: surveillance of adverse events following immunisation in Australia, 2011. Commun Dis Intell 2012;36(4):E315–E332.
Australian Government Department of Health and Ageing. Immunise Australia program. Pneumococcal Disease: Recent changes to pneumococcal vaccine for children Program providing a supplementary dose of Prevenar 13®. Accessed on 7 August 2013. Available from: http://immunise.health.gov.au/internet/immunise/publishing.nsf/Content/immunise-pneumococcal
Centre for Disease Control. Change to Northern Territory Childhood Immunisation Schedule to introduce 13 valent pneumococcal vaccine 1 October 2011. Northern Territory Disease Control Bulletin 2011;18:37.
Australian Technical Advisory Group on Immunisation. The Australian Immunisation Handbook. 8th edn. Canberra: Australian Government Department of Health and Ageing, 2003.
National Health and Medical Council. The Australian Immunisation Handbook. 9th edn. Canberra: Australian Government Department of Health and Ageing, 2008.
Uppsala Monitoring Centre. WHO Collaborating Centre for International Drug Monitoring. Accessed on 30 August 2010. Available from: http://www.who-umc.org/
Zhou W, Pool V, Iskander JK, English-Bullard R, Ball R, Wise RP, et al. Surveillance for safety after immunization: Vaccine Adverse Event Reporting System (VAERS)–United States, 1991–2001. [Erratum appears in MMWR Morb Mortal Wkly Rep 2003(06):113]. MMWR Morb Mortal Wkly Rep 2003;52(SS–1):1–24.
Brown EG, Wood L, Wood S. The medical dictionary for regulatory activities (MedDRA). Drug Saf 1999;20(2):109–117.
The SAS system for Windows [computer program]. Version 9.3. Cary, N.C.: SAS Institute Inc, 2012.
Australian Bureau of Statistics. Population by Age and Sex, Australian States and Territories, June 2011. Australian Bureau of Statistics: Cat no. 31010DO002_201106; 2011.
Australian Institute of Health and Welfare. 2009 Adult Vaccination Survey: summary results. Cat. No. PHE 135 Canberra: Australian Institute of Health and Welfare; 2011.
Additional reports – Childhood immunisation coverage. Commun Dis Intell 2008;32(2):288–289.
Varricchio F, Iskander J, DeStefano F, Ball R, Pless R, Braun MM, et al. Understanding vaccine safety information from the Vaccine Adverse Event Reporting System. Pediatr Infect Dis J 2004;23(4):287–294.
Therapeutic Goods Administration. Database of Adverse Event Notifications. 1 August 2012. Accessed on 28 August 2012. Available from: http://www.tga.gov.au/safety/daen.htm
Joura EA, Leodolter S, Hernandez-Avila M, Wheeler CM, Perez G, Koutsky LA, et al. Efficacy of a quadrivalent prophylactic human papillomavirus (types 6, 11, 16, and 18) L1 virus-like-particle vaccine against high-grade vulval and vaginal lesions: a combined analysis of three randomised clinical trials. Lancet 2007;369(9574):1693–1702.
Reisinger KS, Block SL, Lazcano-Ponce E, Samakoses R, Esser MT, Erick J, et al. Safety and persistent immunogenicity of a quadrivalent human papillomavirus types 6, 11, 16, 18 L1 virus-like particle vaccine in preadolescents and adolescents: a randomized controlled trial. Pediatr Infect Dis J 2007;26(3):201–209.
Therapeutic Goods Administration. Australian Public Assessment Report for Pneumococcal Polysaccharide Conjugate Vaccine (Prevenar 13®). Accessed on 7 August 2013. Available from: http://www.tga.gov.au/pdf/auspar/auspar-prevenar13.pdf
Simon LS. Pharmacovigilance: towards a better understanding of the benefit to risk ratio. Ann Rheum Dis 2002;61(Suppl II):ii88–ii89.
Downloads
Published
How to Cite
License
Copyright (c) 2014 Communicable Diseases Intelligence

This work is licensed under a Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International License.
