Annual report: surveillance of adverse events following immunisation in Australia, 2011
DOI:
https://doi.org/10.33321/cdi.2012.36.27Keywords:
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 2011, and describes reporting trends over the 12-year period 2000 to 2011. There were 2,327 AEFI records for vaccines administered in 2011, a decrease of 40% from 3,894 in 2010. The decrease in 2011 was attributable to a decline in reporting following seasonal influenza (2,354 to 483) and pandemic H1N1 (pH1N1) influenza vaccines (514 to 2). However, reporting rates for some other vaccines were higher in 2011 compared with 2010. The 13-valent pneumococcal conjugate vaccine (13vPCV) replaced the 7-valent pneumococcal conjugate vaccine (7vPCV) and was suspected of involvement in 236 AEFI cases (48 per 100,000 doses). An increase in the number of reports following rotavirus (from 40 to 56 per 100,000 doses), and the hexavalent infant vaccine (from 27 to 40 per 100,000 doses), may have been due at least in part to co-administration with 13vPCV. Reports following DTPa-IPV also increased (from 94 to 139 per 100,000 doses), continuing a trend since 2009. AEFI reports following receipt of the 23-valent pneumococcal vaccine also increased markedly in those aged ≥65 years, from 155 to 288 records. In response to the increase in reports following 23vPPV, boosters are no longer recommended for those without medical risk factors. The most commonly reported reactions were injection site reactions, fever, allergic reactions and malaise. Only 7% of all the reported adverse events were categorised as serious, as per the database definitions, although some events classified as non-serious may have caused severe illness. Three deaths were temporally associated with vaccination; however, all were attributed to causes other than vaccination. The increase in 2011 was predominately due to reports of injection site reactions (49% increase in 2011). Increases in some instances may also be partly attributable to an increasing propensity to report AEFI. Commun Dis Intell 2012;36(4):E315–E332.
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;27:307–323.
Lawrence G, Boyd I, McIntyre P, Isaacs D. Surveillance of adverse events following immunisation: Australia 2002 to 2003. Commun Dis Intell 2004;28:324–338.
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):248–62.
Lawrence G, Boyd I, McIntyre P, Isaacs D. Annual report: surveillance of adverse events following immunisation in Australia, 2005. Commun Dis Intell 2006;30:319–333.
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;31:269–282.
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;32:371–387.
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.
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 16 August 2012. Available from: http://immunise.health.gov.au/internet/immunise/publishing.nsf/Content/immunise-pneumococcal
Northern Territory Government, Department of Health. NT Immunisation Schedule. Accessed on 16 August 2012. Available from: http://www.health.nt.gov.au/library/scripts/objectifyMedia.aspx?file=pdf/10/78.pdf&siteID=1&str_title=Childhood Vaccination Schedule.pdf
Australian Government Department of Health and Ageing, TGA. Pneumovax® 23: Recall of vaccine batch N3336. 25 March 2011.Accessed on 16 August 2012. Available from: http://www.tga.gov.au/safety/alerts-medicine-pneumovax-110325.htm.
Australian Government Department of Health and Ageing, TGA. Pneumovax 23 – Recommendation about revaccination. 18 April 2011. Accessed on 16 August 2012. Available from: http://www.tga.gov.au/safety/alerts-medicine-pneumovax-110416.htm
Australian Government Department of Health and Ageing, Immunise Australia program. Australian Technical Advisory Group on Immunisation (ATAGI) Statement – Updated recommendations for revaccination of adults with 23-valent pneumococcal polysaccharide vaccine (23vPPV), Pneumovax 23®. December 2011. Accessed on 16 August 2012. Available from: http://immunise.health.gov.au/internet/immunise/publishing.nsf/Content/pneumo23-atagi-statement-cnt.htm
National Health and Medical Research Council. The Australian Immunisation Handbook. 8th ed. Canberra: Australian Government Department of Health and Ageing, 2003.
National Health and Medical Research Council. The Australian Immunisation Handbook. 9th ed. Canberra: Australian Government Department of Health and Ageing, 2008.
Adverse Events following Immunisation (AEFI): Causality assessment. WHO. Accessed on 6 December2012. Available from: http://www.who.int/vaccines-documents/DocsPDF05/815.pdf
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;52(06):113]. MMWR Morb Mortal Surveill Summ 2003;52(SS–1):1–24.
Brown EG, Wood L, Wood S. The medical dictionary for regulatory activities (MedDRA). Drug Saf 1999;20:109–117.
The SAS system for Windows [computer program]. Version 9.3. Cary, N.C.: SAS Institute Inc, 2012.
Australian Institute of Health and Welfare. 2009 Adult Vaccination Survey: summary results. Cat. No. PHE 135 Canberra: AIHW, 2011.
Additional reports – Childhood immunisation coverage. Commun Dis Intell 2008;32:288–289.
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;23:287–294.
Australian Government Department of Health and Ageing, TGA. Database of Adverse Event Notifications. 1 August 2012. Accessed on 28th 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;369:1693–1702.
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;26:201–209.
Australian Government Department of Health and Ageing, TGA. Seasonal influenza vaccines: safety advisory. 11 March 2011. Accessed on 1 June 2012. Available from: http://www.tga.gov.au/safety/alerts-medicine-seasonal-flu-110310.htm
Australian Government Department of Health and Ageing, Immunise Australia program. Chief Medical Officer advice: Seasonal influenza vaccination. 7 March 2011. Accessed on 1 June 2012. Available from: http://www.immunise.health.gov.au/internet/immunise/publishing.nsf/Content/immunise-cmo
Blyth CC. Currie AJ. Wiertsema SP. Conway N. Kirkham LA. Fuery A. et al. Trivalent influenza vaccine and febrile adverse events in Australia, 2010:clinical features and potential mechanisms. Vaccine 2011;29(32):5107–13.
Australian Government Department of Health and Ageing, TGA. Australian Public Assessment Report for Pneumococcal Polysaccharide Conjugate Vaccine (Prevenar 13®). Accessed on 16 August 2012. Available from: http://www.tga.gov.au/pdf/auspar/auspar-prevenar13.pdf
Simon L S. Pharmacovigilance: towards a better understanding of the benefit to risk ratio. Ann Rheum Dis 2002;61(Suppl II):ii88–ii89.
Rennels MB. Extensive swelling reactions occurring after booster doses of Diphtheria-tetanus-Acellular Pertussis vaccines. Seminars in Pediatr Infect Dis J 2003;14(3):196–198.
Liese JG, Stojanov S, Zink TH, et al. Safety and immunogenicity of Biken acellular pertussis vaccine in combination with diphtheria and tetanus toxoid as a fifth dose at four to six years of age. Pediatr Infect Dis J 2001;20:981–988.
NNDSS Annual report writing group. Australia’s notifiable disease status, 2009: Annual report of the National Notifiable Disease Surveillance System. Commun Dis Intell 2011;35(2):61–131.
Hull B, Dey A, Mahajan D, Menzies, RI, McIntyre PB. Immunisation coverage annual report, 2009. Commun Dis Intell 2011;35(2):132–148.
Downloads
Published
How to Cite
License
Copyright (c) 2012 Communicable Diseases Intelligence
This work is licensed under a Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International License.
