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Evaluation of ‘SAEFVIC’, A Pharmacovigilance Surveillance Scheme for the Spontaneous Reporting of Adverse Events Following Immunisation in Victoria, Australia

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Abstract

Introduction

Australia is traditionally an early adopter of vaccines, therefore comprehensive and effective post-licensure vaccine pharmacovigilance is critical to maintain confidence in immunisation, both nationally and internationally. With adverse event following immunisation (AEFI) surveillance the responsibility of Australian jurisdictions, Victoria operates an enhanced passive AEFI surveillance system integrated with clinical services, called ‘SAEFVIC’ (Surveillance of Adverse Events Following Vaccination In the Community).

Objective

The aim of this study was to evaluate Victoria’s current AEFI surveillance system ‘SAEFVIC’ and inform ongoing quality improvement of vaccine pharmacovigilance in Victoria and Australia.

Methods

We conducted a retrospective structured desktop evaluation of AEFI reporting received by SAEFVIC from 2007 to 2014, to evaluate the system according to its stated objectives, i.e. to improve AEFI reporting; provide AEFI signal detection; and to maintain consumer confidence in vaccination.

Results

AEFI reporting has tripled since SAEFVIC commenced (incidence risk ratio [IRR] 3.04, 95% confidence interval [CI] 2.35–3.93), raising Victoria to be the lead jurisdiction by AEFI reporting volume and to rank third by population reporting rate nationally. The largest increase was observed in children. Data were utilised to investigate potential signal events and inform vaccine policy. Signal detection required clinical suspicion by surveillance nurses, or prior vaccine-specific concerns. Subsequent vaccination post-AEFI was documented for 56.2% (95% CI 54.1–58.4) of reports, and the proportion of children due or overdue for vaccination was 2.3% higher for those reporting AEFI compared with the general population.

Conclusion

SAEFVIC has improved AEFI surveillance, facilitates signal investigation and validation, and supports consumer confidence in immunisation. Expansion of the system nationally has the potential to improve capacity and capability of vaccine pharmacovigilance, particularly through data consistency and jurisdictional comparability in Australia.

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Notes

  1.  Life-threatening event is an event/reaction in which the client was at risk of death at the time of the event/reaction; it does not refer to an event/reaction that hypothetically might have caused death if it were more severe.

References

  1. Brotherton JM, Gold MS. Monitoring vaccine safety: a critical component of every immunisation program. Med J Aust. 2008;189(5):243–4.

    PubMed  Google Scholar 

  2. Amarasinghe A, Black S, Bonhoeffer J, Carvalho SMD, Dodoo A, Eskola J, et al. Effective vaccine safety systems in all countries: a challenge for more equitable access to immunization. Vaccine. 2013;31(Suppl 2):B108–14.

    Article  PubMed  Google Scholar 

  3. Waldman EA, Luhm KR, Monteiro SA, Freitas FR. Surveillance of adverse effects following vaccination and safety of immunization programs. Rev Saude Publica. 2011;45(1):173–84.

    Article  PubMed  Google Scholar 

  4. Ball R. Perspectives on the future of postmarket vaccine safety surveillance and evaluation. Expert Rev Vaccines. 2014;13(4):455–62.

    Article  CAS  PubMed  Google Scholar 

  5. Chen RT, Shimabukuro TT, Martin DB, Zuber PL, Weibel DM, Sturkenboom M. Enhancing vaccine safety capacity globally: a lifecycle perspective. Vaccine. 2015;33(Suppl 4):D46–54.

    Article  PubMed  PubMed Central  Google Scholar 

  6. World Health Organization. Global vaccine safety blueprint. Geneva: World Health Organization; 2012. WHO/IVB/12.07. http://vaccine-safety-training.org/tl_files/vs/pdf/WHO_IVB_12.07_eng.pdf. Accessed 5 Nov 2016.

  7. Mahajan D, Cook J, Dey A, Macartney K, Menzies RI. Annual report: surveillance of adverse events following immunisation in Australia, 2011. Commun Dis Intell Q Rep. 2012;36(4):E315–32.

    PubMed  Google Scholar 

  8. Bonhoeffer J, Kohl K, Chen R, Duclos P, Heijbel H, Heininger U, et al. The Brighton Collaboration: addressing the need for standardized case definitions of adverse events following immunization (AEFI). Vaccine. 2002;21(3–4):298–302.

    Article  PubMed  Google Scholar 

  9. Postila V, Kilpi T. Use of vaccine surveillance data in the evaluation of safety of vaccines. Vaccine. 2004;22(15–16):2076–9.

    Article  PubMed  Google Scholar 

  10. Letourneau M, Wells G, Walop W, Duclos P. Improving global monitoring of vaccine safety: a survey of national centres participating in the WHO Programme for International Drug Monitoring. Drug Saf. 2008;31(5):389–98.

    Article  PubMed  Google Scholar 

  11. Bonhoeffer J, Black S, Izurieta H, Zuber P, Sturkenboom M. Current status and future directions of post-marketing vaccine safety monitoring with focus on USA and Europe. Biologicals. 2012;40(5):393–7.

    Article  PubMed  Google Scholar 

  12. Graham JE, Borda-Rodriguez A, Huzair F, Zinck E. Capacity for a global vaccine safety system: the perspective of national regulatory authorities. Vaccine. 2012;30(33):4953–9.

    Article  PubMed  Google Scholar 

  13. Lopalco PL, Johansen K, Ciancio B, De Carvalho Gomes H, Kramarz P, Giesecke J. Monitoring and assessing vaccine safety: a European perspective. Expert Rev Vaccines. 2010;9(4):371–80.

    Article  PubMed  Google Scholar 

  14. 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. MMWR Surveill Summ. 2003;52(1):1–24.

    PubMed  Google Scholar 

  15. Duclos P. A global perspective on vaccine safety. Vaccine. 2004;22(15–16):2059–63.

    Article  PubMed  Google Scholar 

  16. Hazell L, Shakir SA. Under-reporting of adverse drug reactions: a systematic review. Drug Saf. 2006;29(5):385–96.

    Article  PubMed  Google Scholar 

  17. McNeil MM, Li R, Pickering S, Real TM, Smith PJ, Pemberton MR. Who is unlikely to report adverse events after vaccinations to the Vaccine Adverse Event Reporting System (VAERS)? Vaccine. 2013;31(24):2673–9.

    Article  PubMed  Google Scholar 

  18. Monteiro SA, Takano OA, Waldman EA. Evaluation of the Brazilian surveillance system for adverse events following vaccination [in Portuguese]. Rev Bras Epidemiol. 2011;14(3):361–71.

    Article  PubMed  Google Scholar 

  19. 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):287–94.

    Article  PubMed  Google Scholar 

  20. Crawford NW, Clothier H, Hodgson K, Selvaraj G, Easton ML, Buttery JP. Active surveillance for adverse events following immunization. Expert Rev Vaccines. 2014;13(2):265–76.

    Article  CAS  PubMed  Google Scholar 

  21. Horvath J. Review of the management of adverse effects associated with Panvax and Fluvax. Canberra: Commonwealth of Australia; 2011. http://www.immunise.health.gov.au/internet/immunise/publishing.nsf/Content/53AE51CDFBC05086CA257D7A001A758A/$File/adverse-event-march-2011.pdf. Accessed 5 Oct 2015.

  22. Australian Government Department of Health. Therapeutic Goods Administration Canberra, Australia. http://www.tga.gov.au/. Accessed 22 Feb 2016.

  23. Crawford NW, Cheng A, Andrews N, Charles PG, Clothier HJ, Day T, et al. Guillain–Barré syndrome following influenza A (H1N1/09) immunisation in Victoria Australia: a self-controlled case series. Med J Aust. 2012;197(10):574–8.

    Article  PubMed  Google Scholar 

  24. Dodd CN, Romio SA, Black S, Vallozi C, Andrews N, Sturkenboom M, et al. International collaboration to assess the risk of Guillain–Barré syndrome following influenza A (H1N1) 2009 monovalent vaccines. Vaccine. 2013;31(40):4448–58.

    Article  PubMed  Google Scholar 

  25. Wood N, Sheppeard V, Cashman P, Palasanthiran P, Casacelli M, Cannings K, et al. Influenza vaccine safety in children less than 5 years old. The 2010 and 2011 experience in Australia. Pediatr Infect Dis J. 2012;31(2):199–202.

    Article  PubMed  Google Scholar 

  26. Gold MS, Effler P, Kelly H, Richmond PC, Buttery JP. Febrile convulsions after 2010 seasonal trivalent influenza vaccine: implications for vaccine safety surveillance in Australia. Med J Aust. 2011;193(9):492–3.

    Google Scholar 

  27. Maraskovsky E, Rockman S, Dyson A, Koernig S, Becher D, Morelli AB, et al. Scientific investigations into febrile reactions observed in the paediatric population following vaccination with a 2010 Southern Hemisphere trivalent influenza vaccine. Vaccine. 2012;30(51):7400–6.

    Article  PubMed  Google Scholar 

  28. Australian Government Department of Health. Seasonal flu vaccine remains suspended for young children without risk factors—advice from the Chief Medical Officer. 2010. http://www.health.gov.au/internet/main/publishing.nsf/Content/mr-yr10-dept-dept010610.htm. Accessed 8 June 2014.

  29. Stokes B. Ministerial review into the public health response into the adverse events to the seasonal influenza vaccine. Government of Western Australia Department of Health, Australia. 2010. https://www.health.wa.gov.au/publications/documents/Stokes_Report.pdf. Accessed 8 June 2015.

  30. Moulton E. Parents of Saba Button who was a victim of flu vaccine debacle receive payout from WA Government Perth. PerthNow Sunday Times. Newspaper article; 2014. http://www.perthnow.com.au/news/western-australia/parents-of-saba-button-who-was-victim-of-flu-vaccine-debacle-receive-payout-from-wa-government/story-fnhocxo3-1226945651845. Accessed 1 Oct 2016.

  31. Mahajan D, Dey A, Cook J, Harvey B, Menzies R, Macartney K. Surveillance of adverse events following immunisation in Australia annual report, 2013. Commun Dis Intell Q Rep. 2015;39(3):E369–86.

    PubMed  Google Scholar 

  32. Australian Bureau of Statistics. 2011 Census QuickStats. http://www.censusdata.abs.gov.au/census_services/getproduct/census/2011/quickstat/2. Accessed 26 Sep 2013.

  33. Lawrence G, Boyd I, McIntyre P, Isaacs D. Surveillance of adverse events following immunisation: Australia 2002 to 2003. Commun Dis Intell Q Rep. 2004;28(3):324–38.

    PubMed  Google Scholar 

  34. Clothier HJ, Crawford NW, Kempe A, Buttery JP. Surveillance of adverse events following immunisation: the model of SAEFVIC, Victoria. Commun Dis Intell Q Rep. 2011;35(4):294–8.

    PubMed  Google Scholar 

  35. German RR, Lee LM, Horan JM, Milstein RL, Pertowski CA, Waller MN, et al. Updated guidelines for evaluating public health surveillance systems: recommendations from the Guidelines Working Group. MMWR Recomm Rep. 2001;50(RR-13):1–35.

  36. Lawrence GL, Boyd I, McIntyre PB, Isaacs D. Annual report: surveillance of adverse events following immunisation in Australia, 2004. Commun Dis Intell Q Rep. 2005;29(3):248–62.

    PubMed  Google Scholar 

  37. 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 Q Rep. 2007;31(3):269–82.

    PubMed  Google Scholar 

  38. 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 Q Rep. 2008;32(4):371–87.

    PubMed  Google Scholar 

  39. 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 Q Rep. 2009;33(4):365–81.

    PubMed  Google Scholar 

  40. Mahajan D, Roomiani I, Gold MS, Lawrence GL, McIntyre PB, Menzies RI. Annual report: surveillance of adverse events following immunisation in Australia, 2009. Commun Dis Intell. 2010;34(3):259–76.

    Google Scholar 

  41. Mahajan D, Cook J, McIntyre PB, Macartney K, Menzies RI. Annual report: surveillance of adverse events following immunisation in Australia, 2010. Commun Dis Intell Q Rep. 2011;35(4):263–80.

    PubMed  Google Scholar 

  42. Mahajan D, Dey A, Cook J, Harvey B, Menzies RI, Macartney KM. Surveillance of adverse events following immunisation in Australia, 2012. Commun Dis Intell Q Rep. 2014;38(3):E232–46.

    PubMed  Google Scholar 

  43. Dey A, Wang H, Quinn HE, Hill R, Macartney K. Surveillance of adverse events following immunisation in Australia annual report, 2014. Commun Dis Intell Q Rep. 2016;40(3):14.

    Google Scholar 

  44. Australian Bureau of Statistics. Australian Demographic Statistics, June 2012. Estimated resident population by single year of age, Victoria 2012. http://www.abs.gov.au/AUSSTATS/abs@.nsf/DetailsPage/3101.0Jun2012?OpenDocument. Accessed 23 May 2014.

  45. World Health Organization. Definition and application of terms for vaccine pharmacovigilance. Report of CIOMS/WHO Working Group on Vaccine Pharmacovigilance. Geneva: Council for International Organizations of Medical Sciences; 2012. http://www.who.int/vaccine_safety/initiative/tools/CIOMS_report_WG_vaccine.pdf. Accessed 23 June 2015.

  46. National Health and Medical Research Council. Australian Immunisation Handbook. 10th ed. Canberra: National Capital Press; 2015. http://www.immunise.health.gov.au/internet/immunise/publishing.nsf/Content/Handbook10-home. Accessed 23 June 2015.

  47. Australian Bureau of Statistics. Australian Statistical Geographic Standard (ASGS): correspondences, July 2011, Postcode 2011 to Local Government Area 2011. Released 27 Jun 2012. http://www.abs.gov.au/AUSSTATS/abs@.nsf/DetailsPage/1270.0.55.006July%202011?OpenDocument. Accessed 23 May 2014.

  48. Australian Government Department of Human Services. Australian Childhood Immunisation Register for health professionals. http://www.humanservices.gov.au/health-professionals/services/australian-childhood-immunisation-register/. Accessed 17 Sep 2015.

  49. Littlejohn ES, Clothier HJ, Perrett KP, Danchin M. Surveillance of adverse events following the introduction of 13-valent pneumococcal conjugate vaccine in infants, and comparison with adverse events following 7-valent pneumococcal conjugate vaccine, in Victoria, Australia. Hum Vaccin Immunother. 2015;11(7):1828–35.

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  50. 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(5):261–2.

    PubMed  Google Scholar 

  51. Richards S, Chalkiadis G, Lakshman R, Buttery JP, Crawford NW. Complex regional pain syndrome following immunisation. Arch Dis Child. 2012;97(10):913–5.

    Article  PubMed  Google Scholar 

  52. Crawford NW, Clothier HJ, Elia S, Lazzaro T, Royle J, Buttery JP. Syncope and seizures following human papillomavirus vaccination: a retrospective case series. Med J Aust. 2011;194(1):16–8.

    PubMed  Google Scholar 

  53. Cheng DR, Perrett KP, Choo S, Danchin M, Buttery JP, Crawford NW. Pediatric anaphylactic adverse events following immunization in Victoria, Australia from 2007 to 2013. Vaccine. 2015;33(13):1602–7.

    Article  PubMed  Google Scholar 

  54. Clifford V, Crawford NW, Royle J, Lazzaro T, Danchin M, Perrett KP, et al. Recurrent apnoea post immunisation: informing re-immunisation policy. Vaccine. 2011;29(34):5681–7.

    Article  PubMed  Google Scholar 

  55. Clothier HJ, Hosking L, Crawford NW, Russell M, Easton ML, Quinn JA, et al. Bacillus Calmette–Guerin (BCG) vaccine adverse events in Victoria, Australia: analysis of reports to an enhanced passive surveillance system. Drug Saf. 2015;38(1):79–86.

    Article  CAS  PubMed  Google Scholar 

  56. Australian Government Department of Health. Immunise Australia Program ACIR—current data. http://www.immunise.health.gov.au/internet/immunise/publishing.nsf/Content/acir-curr-data.htm. Accessed 23 Feb 2016.

  57. Clothier HJ, Selvaraj G, Easton ML, Lewis G, Crawford NW, Buttery JP. Consumer reporting of adverse events following immunization. Hum Vaccin Immunother. 2014;10(12):3726–30.

    Article  PubMed  PubMed Central  Google Scholar 

  58. Clothier HJ, Selvaraj G, McMinn A, Lewis G, Crawford NW, Buttery JP. SAEFVIC: surveillance of adverse events following immunisation (AEFI) in Victoria, 2012. Vic Infect Dis Bull. 2014;17(1):2–9.

    Google Scholar 

  59. Australian Government Department of Health Immunise Australia Program. Catch-up: incentives for vaccination providers and general practitioners. 2015. http://www.immunise.health.gov.au/internet/immunise/publishing.nsf/Content/news-20150412. Accessed 15 Dec 2015.

  60. Hull BP, Deeks SL, McIntyre PB. The Australian Childhood Immunisation Register: a model for universal immunisation registers? Vaccine. 2009;27(37):5054–60.

    Article  PubMed  Google Scholar 

  61. Chin LK, Crawford NW, Rowles G, Buttery JP. Australian immunisation registers: established foundations and opportunities for improvement. Euro Surveill. 2012;17(16). http://www.eurosurveillance.org/ViewArticle.aspx?ArticleId=20148

  62. Skull SA, Nolan TM. Australia needs an expanded immunisation register for further improvements in vaccine delivery and program evaluation. Med J Aust. 2007;187(9):504–5.

    PubMed  Google Scholar 

  63. Australian Immunisation Register Bill 2015: explanatory memorandum 2015. http://www.aph.gov.au/Parliamentary_Business/Bills_Legislation/Bills_Search_Results/Result?bId=r5526. Accessed 5 Nov 2016.

  64. Department of Health Western Australia. Western Australia Vaccine Safety Surveillance: annual report, 2013. http://www.public.health.wa.gov.au/cproot/5660/2/WAVSS_2013_Annual_report.pdf. Accessed 26 Nov 2015.

  65. Parrella A, Braunack-Mayer A, Gold M, Marshall H, Baghurst P. Healthcare providers’ knowledge, experience and challenges of reporting adverse events following immunisation: a qualitative study. BMC Health Serv Res. 2013;15:313.

    Article  Google Scholar 

  66. Eberth JM, Kline KN, Moskowitz DA, Montealegre JR, Scheurer ME. The role of media and the Internet on vaccine adverse event reporting: a case study of human papillomavirus vaccination. J Adolesc Health. 2014;54(3):289–95.

    Article  PubMed  Google Scholar 

  67. Benchimol EI, Smeeth L, Guttmann A, Harron K, Moher D, Petersen I, et al. The REporting of studies Conducted using Observational Routinely-collected health Data (RECORD) statement. PLoS Med. 2015;12(10):e1001885.

    Article  PubMed  PubMed Central  Google Scholar 

  68. Black S, Eskola J, Siegrist CA, Halsey N, Macdonald N, Law B, et al. Importance of background rates of disease in assessment of vaccine safety during mass immunisation with pandemic H1N1 influenza vaccines. Lancet. 2009;374(9707):2115–22.

    Article  PubMed  PubMed Central  Google Scholar 

  69. Dyda A, MacIntyre CR, Banks E, Kaldor J, Newall AT, McIntyre P, et al. Medicare Benefits Schedule data to monitor influenza immunisation in Australian adults. Public Health Res Pract. 2015;25(4):e2541543.

    Article  PubMed  Google Scholar 

  70. Parrella A, Gold M, Marshall H, Braunack-Mayer A, Watson M, Baghurst P. Parental views on vaccine safety and future vaccinations of children who experienced an adverse event following routine or seasonal influenza vaccination in 2010. Hum Vacc Immunother. 2014;8(5):662–7.

    Article  Google Scholar 

  71. Casiday RE, Cox AR. Restoring confidence in vaccines by explaining vaccine safety monitoring: is a targeted approach needed? Drug Saf. 2006;29(12):1105–9.

    Article  PubMed  Google Scholar 

  72. Parrella A, Gold M, Marshall H, Braunack-Mayer A, Baghurst P. Parental perspectives of vaccine safety and experience of adverse events following immunisation. Vaccine. 2013;31(16):2067–74.

    Article  PubMed  Google Scholar 

  73. Australian Government, Department of Health and Ageing. Review of the management of adverse events associated with Panvax and Fluvax (Horvath Review): outcome of recommendations. http://immunise.health.gov.au/internet/immunise/publishing.nsf/Content/E8085119AE9E28B3CA257D7F000019A5/$File/Horvath-review-outcomes.pdf. Accessed 2 Aug 2013.

  74. Carcione D, Blyth CC, Mak DB, Effler PV. User satisfaction with the Western Australian Vaccine Safety Surveillance (WAVSS) System. Aust NZ J Public Health. 2013;37(3):296.

    Article  Google Scholar 

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Acknowledgements

The authors wish to thank the SAEFVIC nursing and administration staff, the paediatricians supporting clinical services, and the SAEFVIC Advisory Board who support the development of SAEFVIC.

Author information

Authors and Affiliations

  1. SAEFVIC, Murdoch Childrens Research Institute, Melbourne, VIC, Australia

    Hazel J. Clothier, Nigel W. Crawford & Jim P. Buttery

  2. School of Population and Global Health, University of Melbourne, Melbourne, VIC, Australia

    Hazel J. Clothier & Melissa Russell

  3. Department of Paediatrics, University of Melbourne, Melbourne, VIC, Australia

    Nigel W. Crawford

  4. Immunisation Service, General Medicine, Royal Children’s Hospital, Melbourne, VIC, Australia

    Nigel W. Crawford

  5. National Centre of Epidemiology and Population Health, Australian National University, Canberra, ACT, Australia

    Heath Kelly

  6. Department of Epidemiology and Preventive Medicine, Monash University, The Ritchie Centre, Hudson Institute, Clayton, VIC, Australia

    Jim P. Buttery

  7. Department of Paediatrics, Monash University, The Ritchie Centre, Hudson Institute, Clayton, VIC, Australia

    Jim P. Buttery

  8. Infection and Immunity, Monash Children’s Hospital and Monash Immunisation, Monash Health, Clayton, VIC, Australia

    Jim P. Buttery

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  1. Hazel J. Clothier
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  2. Nigel W. Crawford
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  3. Melissa Russell
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  4. Heath Kelly
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  5. Jim P. Buttery
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Corresponding author

Correspondence to Hazel J. Clothier.

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Funding

SAEFVIC is funded by the Department of Health and Human Services, Melbourne, VIC, Australia. Hazel Clothier is the recipient of an Australian Government Research Training Program Scholarship.

Conflict of interest

Hazel Clothier, Nigel Crawford and Jim Buttery receive salary for their respective employee roles with SAEFVIC. Jim Buttery also serves on data safety monitoring committees for the vaccine manufacturer Seqirus Pty Ltd, for which his employer, Monash Health, receives compensation. Melissa Russell and Heath Kelly have no conflicts of interest that are directly relevant to the content of this study.

Ethical approval

The Human Research Ethics Committee, Royal Childrens Hospital, granted approval for this study (DA017-2013-04).

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Clothier, H.J., Crawford, N.W., Russell, M. et al. Evaluation of ‘SAEFVIC’, A Pharmacovigilance Surveillance Scheme for the Spontaneous Reporting of Adverse Events Following Immunisation in Victoria, Australia. Drug Saf 40, 483–495 (2017). https://doi.org/10.1007/s40264-017-0520-7

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