Human papillomavirus vaccine safety in Australia: experience to date and issues for surveillance
Michael S. Gold A D , Jim Buttery B and Peter McIntyre CA Discipline of Paediatrics, School of Paediatrics and Reproductive Health, University of Adelaide, SA 5001, Australia.
B SAEFVIC, Department of General Medicine, Murdoch Children’s Research Institute, Royal Children’s Hospital Melbourne and Infectious Diseases Unit, Department of Paediatrics, Monash Children’s Hospital, Monash University, Melbourne, Parkville, Vic 3052, Australia.
C The National Centre for Immunisation Research, The Children’s Hospital at Westmead, Locked Bag 4001, Westmead, NSW 2145, Australia.
D Corresponding author. Email: michael.gold@adelaide.edu.au
Sexual Health 7(3) 320-324 https://doi.org/10.1071/SH09153
Submitted: 29 December 2009 Accepted: 23 March 2010 Published: 19 August 2010
Abstract
Australia was one of the first countries to licence a quadrivalent human papillomavirus (HPV) vaccine, rapidly followed by a federally funded program of universal vaccination of a broad age group of females through schools (12 to 18 years) and primary care (19 to 26 years). As of August 2009, more than 5.8 million doses of Gardasil® (quadrivalent; Merck, New Jersey, USA) have been distributed in Australia and a total of 1394 suspected adverse events following immunisation (AEFI) have been reported to the passive surveillance system. Most reports are of common and expected reactions. Case series of more uncommon and serious AEFI, both known to be potentially vaccine related (anaphylaxis, conversion disorders and lipoatrophy) and otherwise (multiple sclerosis and pancreatitis) have been published.
Additional keywords: adverse events following immunisations, HPV vaccine, vaccine safety.
[1]
[2]
[3] Postila V. Sample size required for detecting at least one case of an adverse event with different incidence rates. Vaccine 2004; 22 2076–9.
| Crossref | GoogleScholarGoogle Scholar | PubMed | [verified May 2010]
[5] 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; 32 371–87.
| PubMed |
[6] 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; 33 365–81.
| PubMed |
[7] Brotherton JM, Gold MS, Kemp AS, McIntyre PB, Burgess MA, Campbell-Lloyd S, et al. Anaphylaxis following quadrivalent human papillomavirus vaccination. CMAJ 2008; 179 525–33.
| Crossref | GoogleScholarGoogle Scholar | PubMed |
[8] 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; 189 261–2.
| PubMed |
[9] Ojaimi S, Buttery JP, Korman TM. Quadrivalent human papillomavirus recombinant vaccine associated lipoatrophy. Vaccine 2009; 27 4876–8.
| Crossref | GoogleScholarGoogle Scholar | CAS | PubMed |
[10] Sutton I, Lahoria R, Tan I, Clouston P, Barnett M. CNS demyelination and quadrivalent HPV vaccination. Mult Scler 2009; 15 116–9.
| Crossref | GoogleScholarGoogle Scholar | CAS | PubMed |
[11] Kang LW, Crawford N, Tang ML, Buttery J, Royle J, Gold M, et al. Hypersensitivity reactions to human papillomavirus vaccine in Australian schoolgirls: retrospective cohort study. BMJ 2008; 337 a2642.
| Crossref | GoogleScholarGoogle Scholar | PubMed |
[12] Das A, Chang D, Biankin AV, Merrett ND. Pancreatitis following human papillomavirus vaccination. MJA 2008; 189 178.
| PubMed |
[13] Slade BA, Leidel L, Vellozzi C, Woo EJ, Hua W, Sutherland A, et al. Postlicensure safety surveillance for quadrivalent human papillomavirus recombinant vaccine. JAMA 2009; 302 750–7.
| Crossref | GoogleScholarGoogle Scholar | CAS | PubMed |
[14] Rüggeberg 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 5675–84.
| Crossref | GoogleScholarGoogle Scholar | PubMed |
[15] D’Souza RM, Campbell-Lloyd S, Isaacs D, Gold M, Burgess M, Turnbull F, et al. Adverse events following immunisation associated with the 1998 Australian measles control campaign. Commun Dis Intell 2000; 24 27–33.
| CAS | PubMed |
[16] Siegrist CA, Lewis EA, Eskola J, Evans S, Black SB. Human papillomavirus immunization in adolescent and young adults: a cohort study to illustrate what events might be mistaken for adverse reactions. Pediatr Infect Dis J 2007; 26 979–84.
| Crossref | GoogleScholarGoogle Scholar | PubMed |
[17] Lucas RM, Ponsonby AL, McMichael AJ, van der Mei I, Chapman C, Coulthard A, et al. Observational analytic studies in multiple sclerosis: controlling bias through study design and conduct. The Australian Multicentre Study of Environment and Immune Function. Mult Scler 2007; 13 827–39.
| Crossref | GoogleScholarGoogle Scholar | CAS | PubMed |
[18] Tourbah A, Gout O, Liblau R, Lyon-Caen O, Bougniot C, Iba-Zizen MT, Cabanis EA. Encephalitis after hepatitis B vaccination: recurrent disseminated encephalitis or MS? Neurology 1999; 53 396–401.
| CAS | PubMed |
[19] DeStefano F, Verstraeten T, Chen RT. Hepatitis B vaccine and risk of multiple sclerosis. Expert Rev Vaccines 2002; 1 461–6.
| Crossref | GoogleScholarGoogle Scholar | PubMed |
[20] Watson M, Shaw D, Molchanoff L, McInnes C. Challenges, lessons learned and results following the implementation of a human papillomavirus school vaccination program in South Australia. Aust NZ J Public Health 2009; 33 365–70.
| Crossref | GoogleScholarGoogle Scholar |
[21] Brotherton JM, Deeks SL, Campbell-Lloyd S, Misrachi A, Passaris I, Peterson K, et al. Interim estimates of human papillomavirus vaccination coverage in the school-based program in Australia. Commun Dis Intell 2008; 32 457–61.
| PubMed |
