Connect
MJA
MJA

Human papillomavirus vaccine in boys: background rates of potential adverse events

Hazel J Clothier, Katherine J Lee, Vijaya Sundararajan, Jim P Buttery and Nigel W Crawford
Med J Aust 2013; 198 (10): 554-558. || doi: 10.5694/mja12.11751

Summary

Objectives: To determine background rates of potential adverse events following immunisation (AEFI) before expansion of the quadrivalent human papillomavirus (4vHPV) vaccination program to adolescent boys.

Design, patients and setting: Retrospective analysis of hospital discharge data obtained from the Victorian Admitted Episodes Dataset and emergency department visit data obtained from the Victorian Emergency Minimum Dataset for boys aged 12 to < 16 years during the period 1 July 2004 to 30 June 2009.

Main outcome measures: Numbers of and incidence rates for Guillain-Barré syndrome, anaphylaxis, seizures, syncope and other potential AEFI from 1 July 2004 to 30 June 2009, and estimated numbers of events after 4vHPV vaccination assuming no association (other than temporal) with the vaccine.

Results: We estimated background rates of neurological and allergic events in adolescent boys to be 252.9 and 175.2 per 100 000 person-years, respectively. Assuming an 80% vaccination rate with three doses per person — which equates to 1 440 000 doses administered nationally per year in the first 2 years of the program — about 2.4 episodes of Guillain-Barré syndrome would be expected to occur in the 6 weeks following vaccination. Within 1 day of vaccination, about 3.9 seizures, 0.3 episodes of anaphylaxis and 6.5 acute allergy presentations would be expected.

Conclusions: Routinely collected health outcome administration data can inform postlicensure safety surveillance of target conditions that might be perceived as AEFI.

  • Hazel J Clothier1,2
  • Katherine J Lee3
  • Vijaya Sundararajan4
  • Jim P Buttery1,5
  • Nigel W Crawford1,6

  • 1 Surveillance of Adverse Events Following Vaccination in the Community (SAEFVIC), Murdoch Childrens Research Institute, Melbourne, VIC.
  • 2 School of Population and Global Health, University of Melbourne, Melbourne, VIC.
  • 3 Clinical Epidemiology and Biostatistics Unit, Murdoch Childrens Research Institute, Melbourne, VIC.
  • 4 Department of Medicine, Monash University, Melbourne, VIC.
  • 5 Department of Infectious Diseases and Department of Paediatrics, Monash University, Melbourne, VIC.
  • 6 Department of General Medicine, Royal Children’s Hospital, Melbourne, VIC.


Acknowledgements: 

We thank Lalitha Sundaresan of the Victorian Department of Health for initial data extractions.

Competing interests:

Hazel Clothier and Jim Buttery are members of the Advisory Committee on the Safety of Vaccines.

  • 1. Cutts FT, Franceschi S, Goldie S, et al. Human papillomavirus and HPV vaccines: a review. Bull World Health Organ 2007; 85: 719-726.
  • 2. McCormack PL, Joura EA. Quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine (Gardasil®): a review of its use in the prevention of premalignant genital lesions, genital cancer and genital warts in women. Drugs 2010; 70: 2449-2474.
  • 3. Lu B, Kumar A, Castellsagué X, Giuliano AR. Efficacy and safety of prophylactic vaccines against cervical HPV infection and diseases among women: a systematic review and meta-analysis. BMC Infect Dis 2011; 11: 13.
  • 4. Fairley CK, Hocking JS, Gurrin LC, et al. Rapid decline in presentations of genital warts after the implementation of a national quadrivalent human papillomavirus vaccination programme for young women. Sex Transm Infect 2009; 85: 499-502.
  • 5. Donovan B, Franklin N, Guy R, et al. Quadrivalent human papillomavirus vaccination and trends in genital warts in Australia: analysis of national sentinel surveillance data. Lancet Infect Dis 2011; 11: 39-44.
  • 6. Garland SM, Skinner SR, Brotherton JM. Adolescent and young adult HPV vaccination in Australia: achievements and challenges. Prev Med 2011; 53 Suppl 1: S29-S35.
  • 7. Pharmaceutical Benefits Advisory Committee. November 2011 PBAC meeting outcomes — positive recommendations. http://www. health.gov.au/internet/main/publishing.nsf/Content/DF3D2BF61025D73CCA25796600 80CA50/$File/PBAC%20Outcomes%20Nov% 202011%20-%20Positive%20recommen dations.pdf (accessed Feb 2013).
  • 8. Department of Health and Ageing. HPV vaccine extended to boys [media release]. 12 Jul 2012. http://www.health.gov.au/internet/ministers/publishing.nsf/Content/mr-yr12-tp-tp059.htm (accessed Feb 2013).
  • 9. Hillman RJ, Giuliano AR, Palefsky JM, et al. Immunogenicity of the quadrivalent human papillomavirus (type 6/11/16/18) vaccine in males 16 to 26 years old. Clin Vaccine Immunol 2012; 19: 261-267.
  • 10. Siegrist CA, Lewis EM, Eskola J, et al. Human papilloma virus 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: 979-984.
  • 11. Callréus T, Svanström H, Nielsen NM, et al. Human papillomavirus immunisation of adolescent girls and anticipated reporting of immune-mediated adverse events. Vaccine 2009; 27: 2954-2958.
  • 12. Gold MS, McIntyre P. Human papillomavirus vaccine safety in Australia: experience to date and issues for surveillance. Sex Health 2010; 7: 320-324.
  • 13. Chang J, Campagnolo D, Vollmer TL, Bomprezzi R. Demyelinating disease and polyvalent human papilloma virus vaccination. J Neurol Neurosurg Psychiatry 2011; 82: 1296-1298.
  • 14. Brotherton JM, Gold MS, Kemp AS, et al. Anaphylaxis following quadrivalent human papillomavirus vaccination. CMAJ 2008; 179: 525-533.
  • 15. Buttery JP, Madin S, Crawford NW, et al. Mass psychogenic response to human papillomavirus vaccination. Med J Aust 2008; 189: 261-262. <MJA full text>
  • 16. Crawford NW, Clothier HJ, Elia S, et al. Syncope and seizures following human papillomavirus vaccination: a retrospective case series. Med J Aust 2011; 194: 16-18. <MJA full text>
  • 17. Department of Health (Victoria). Victorian data linkages. http://www.health.vic.gov.au/vdl (accessed Feb 2013).
  • 18. National Centre for Classification in Health. International statistical classification of diseases and related health problems. 10th revision, Australian modification (ICD-10-AM). Sydney: NCCH, 2008. http://meteor.aihw.gov.au/content/index.phtml/itemId/360927 (accessed Feb 2013).
  • 19. Clothier H, Lee K, Crawford N, et al. Background rates of conditions that may present as potential adverse events following H1N1 vaccination in Australia [abstract]. 28th Annual Meeting of the European Society of Paediatric Infectious Diseases; 2010 May 4-8; Nice, France. http://meetings.espid.org/espid2010/abstracts/pdf/376.pdf (accessed Mar 2013).
  • 20. Australian Bureau of Statistics. State and regional Indicators, Victoria, Jun 2010. Canberra: ABS, 2010. (ABS Cat. No. 1367.2.) http://www.abs.gov.au/AUSSTATS/abs@.nsf/DetailsPage/1367.2Jun+2010 (accessed Feb 2013).
  • 21. Gee J, Naleway A, Shui I, et al. Monitoring the safety of quadrivalent human papillomavirus vaccine: findings from the Vaccine Safety Datalink. Vaccine 2011; 29: 8279-8284.
  • 22. Agorastos T, Chatzigeorgiou K, Brotherton JM, Garland SM. Safety of human papillomavirus (HPV) vaccines: a review of the international experience so far. Vaccine 2009; 27: 7270-7281.
  • 23. Slade BA, Gee J, Broder KR, Vellozzi C. Comment on the contribution by Souayah et al., “Guillain-Barré syndrome after Gardasil vaccination: data from Vaccine Adverse Event Reporting System 2006-2009” [letter]. Vaccine 2011; 29: 865-866.
  • 24. Poulos LM, Waters AM, Correll PK, et al. Trends in hospitalizations for anaphylaxis, angioedema, and urticaria in Australia, 1993–1994 to 2004–2005. J Allergy Clin Immunol 2007; 120: 878-884.
  • 25. Mulla ZD, Lin RY, Simon MR. Perspectives on anaphylaxis epidemiology in the United States with new data and analyses. Curr Allergy Asthma Rep 2011; 11: 37-44.
  • 26. Black S, Eskola J, Siegrist CA, et al. Importance of background rates of disease in assessment of vaccine safety during mass immunisation with pandemic H1N1 influenza vaccines. Lancet 2009; 374: 2115-2122.
  • 27. Brotherton JM, Deeks SL, Campbell-Lloyd S, et al. Interim estimates of human papillomavirus vaccination coverage in the school-based program in Australia. Commun Dis Intell Q Rep 2008; 32: 457-461.
  • 28. Watson M, Shaw D, Molchanoff L, McInnes C. Challenges, lessons learned and results following the implementation of a human papilloma virus school vaccination program in South Australia. Aust N Z J Public Health 2009; 33: 365-370.
  • 29. Farrington CP, Whitaker HJ, Hocine MN. Case series analysis for censored, perturbed, or curtailed post-event exposures. Biostatistics 2009; 10: 3-16.
  • 30. Svanström H, Callréus T, Hviid A. Temporal data mining for adverse events following immunization in nationwide Danish healthcare databases. Drug Saf 2010; 33: 1015-1025.
  • 31. Yih WK, Kulldorff M, Fireman BH, et al. Active surveillance for adverse events: the experience of the Vaccine Safety Datalink project. Pediatrics 2011; 127 Suppl 1: S54-S64.
  • 32. Gold MS, Effler P, Kelly H, et al. Febrile convulsions after 2010 seasonal trivalent influenza vaccine: implications for vaccine safety surveillance in Australia. Med J Aust 2010; 193: 492-493. <MJA full text>

Author

remove_circle_outline Delete Author
add_circle_outline Add Author

Comment
Do you have any competing interests to declare? *

I/we agree to assign copyright to the Medical Journal of Australia and agree to the Conditions of publication *
I/we agree to the Terms of use of the Medical Journal of Australia *
Email me when people comment on this article

Responses are now closed for this article.