Annual report: Surveillance of adverse events following immunisation in Australia, 2007
DOI:
https://doi.org/10.33321/cdi.2008.32.37Keywords:
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 for 2007, and describes reporting trends over the 8-year period 2000 to 2007. There were 1,538 AEFI records for vaccines administered in 2007. This is an annual AEFI reporting rate of 7.3 per 100,000 population, the highest since 2003 and an 85% increase compared with 2006 (835 AEFI records; 4.0 records per 100,000 population). The increase was almost entirely due to reports following the commencement of the national 3-dose human papillomavirus (HPV) vaccine program for females aged 12 to 26 years in April 2007 (n=705 reports) and the national infant rotavirus vaccine program in July 2007 (n=72 reports). AEFI reporting rates in 2007 were 2.3 per 100,000 administered doses of influenza vaccine for adults aged ≥18 years, 18.6 per 100,000 administered doses of pneumococcal polysaccharide vaccine for those aged ≥65 years and 12.7 per 100,000 administered doses of scheduled vaccines for children aged <7 years. The majority of the 1,538 AEFI reports for 2007 described non-serious events while 9% (n=141) were classified as serious. Two deaths temporally associated with immunisation were reported; there was no evidence to suggest a causal association. The most significant AEFI reported following HPV vaccine were anaphylaxis (n=11) and convulsion (n=18), mostly associated with syncope. The most commonly reported reactions were allergic reaction, injection site reaction, headache and nausea. The data confirm that, despite the low rate of AEFI reporting in Australia, the passive surveillance system is sufficiently robust to detect safety signals which are expected following changes in the immunisation program, allowing these to be investigated further. Commun Dis Intell 2008;32:371–387.
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References
Duclos P. A global perspective on vaccine safety. Vaccine 2004;22:2059–2063.
Chen RT, DeStefano F, Pless R, Mootrey G, Kramarz P, Hibbs B. Challenges and controversies in immunization safety. Infect Dis Clin North Am 2001;15:21–39.
National Health and Medical Research Council. The Australian Immunisation Handbook. 8th edn. Canberra: Australian Government Department of Health and Ageing, 2003.
National Health and Medical Research 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. Available from: http://www.who-umc.org/ Accessed on 27 July 2005.
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 G, Boyd I. Surveillance of adverse events following immunisation for children aged less than 7 years, 1 January to 30 June 2004. Commun Dis Intell 2004;28:490–492.
Lawrence GL, Boyd I, McIntyre PB, Isaacs D. Annual report: surveillance of adverse events following immunisation in Australia, 2004. [erratum appears in Commun Dis Intell 2005;29:416. Commun Dis Intell 2005;29:248–262.
Lawrence G, Boyd I. Supplementary report: surveillance of adverse events following immunisation among children aged less than 7 years in Australia, 1 January to 30 June 2005. Commun Dis Intell 2005;29:413–416.
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 G, Boyd I. Supplementary report: surveillance of adverse events following immunisation among children aged <7 years in Australia, 1 January to 30 June 2006. Commun Dis Intell 2006;30:438–442.
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 GL, Aratchige PE, Hill R. Supplementary report: surveillance of adverse events following immunisation among children aged less than 7 years in Australia, 1 January to 30 June 2007. Commun Dis Intell 2007;31:379–382.
Australian Government Department of Health and Ageing. Immunisation programs and initiatives. 2007. Available from: http://immunise.health.gov.au/internet/immunise/publishing.nsf/Content/programs Accessed on 1 August 2007.
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 ;52:113.] MMWR Morb Surveill Summ 2003;52:1–24.
Brown EG, Wood L, Wood S. The medical dictionary for regulatory activities (MedDRA). Drug Saf 1999;20:109–117.
Ruggeberg JU, Gold MS, Bayas JM, Blum MD, Bonhoeffer J, Friedlander S, et al. Anaphylaxis: case definition and guidelines for data collection, analysis, and presentation of immunization safety data. Vaccine 2007;25:5675–5684.
Bonhoeffer J, Gold MS, Heijbel H, Vermeer P, Blumberg D, Braun M, et al. Hypotonic-hyporesponsive episode (HHE) as an adverse event following immunization: case definition and guidelines for data collection, analysis, and presentation. Vaccine 2004;22:563–568.
The SAS system for Windows [computer program]. Version 9.1.3. Cary, N.C.: SAS Institute Inc, 2005.
Australian Government Department of Health and Ageing. 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.
State Government of Victoria, Department of Human Services. SAEFVIC: Surveillance of adverse events following vaccination in the community. Available from: http://www.health.vic.gov.au/immunisation/general/saefvic Accessed on 1 October 2008.
Brotherton JM, Gold MS, Kemp AS, McIntyre PB, Burgess MA, Campbell-Lloyd S, et al. Anaphylaxis following quadrivalent human papillomavirus vaccination. CMAJ 2008;179:525–533.
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, Therapeutic Goods Administration. Human papillomavirus vaccine (GARDASIL). Updated 4 July 2008. Available from: http://www.tga.gov.au/safety/alerts-medicine-gardasil-070624.htm Accessed on 1 October 2008.
Halsey NA. The human papillomavirus vaccine and risk of anaphylaxis. CMAJ 2008;179:509–510.
Buttery JP, Madin S, Crawford NW, Elia S, La Vincente S, Hanieh S, et al. Mass psychogenic response to human papillomavirus vaccination. Med J Aust 2008;189:261–262.
Clements CJ. Mass psychogenic illness after vaccination. Drug Saf 2003;26:599–604.
Ruiz-Palacios GM, Pérez-Schael I, Velázquez FR, Abate H, Breuer T, Costa Clemens S, et al. Safety and efficacy of an attenuated vaccine against severe rotavirus gastroenteritis. N Engl J Med 2006;354:11–22.
Vesikari T, Matson DO, Dennehy P, Van Damme P, Santosham M, Rodriguez Z, et al. Safety and efficacy of a pentavalent human-bovine (WC3) reassortant rotavirus vaccine. N Engl J Med 2006;354:23–33.
Murphy TV, Gargiullo PM, Massoudi MS, Nelson DB, Jumaan AO, Okoro CA, et al. Intussusception among infants given an oral rotavirus vaccine. [erratum appears in N Engl J Med 2001;344:1564.] N Engl J Med 2001;344:564–572.
Kramarz P, France EK, DeStefano F, Black SB, Shinefield H, Ward JI, et al. Population-based study of rotavirus vaccination and intussusception. Pediatr Infect Dis J 2001;20:410–416.
Haber P, Patel M, Izurieta HS, Baggs J, Gargiullo P, Weintraub E, et al. Postlicensure monitoring of intussusception after RotaTeq vaccination in the United States, February 1, 2006, to September 25, 2007. Pediatrics 2008;121:1206–1212.
Rennels MB, Deloria MA, Pichichero ME, Losonsky GA, Englund JA, Meade BD, et al. Extensive swelling after booster doses of acellular pertussis-tetanus-diphtheria vaccines. Pediatrics 2000;105:e12.
Gold MS, Noonan S, Osbourn M, Precepa S, Kempe AE. Local reactions after the fourth dose of acellular pertussis vaccine in South Australia. Med J Aust 2003;179:191–194.
Vermeer-de Bondt PE, van der Maas NA. The effect of age and dose number on the risk of collapse (hypotonic-hyporesponsive episode) after pertussis vaccination. Pediatr Infect Dis J 2008;27:355–357.
Brotherton J, Wang H, Schaffer A, Quinn H, Menzies R, Hull B, et al. Vaccine preventable diseases and vaccination coverage in Australia, 2003 to 2005. Commun Dis Intell 2007;31(Suppl):viii–S152.
Begg K, Roche P, Owen R, Liu C, Kaczmarek M, Hii A, et al. Australia's notifiable diseases status, 2006: annual report of the National Notifiable Diseases Surveillance System. Commun Dis Intell 2008;32:139–207.
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