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Drug Safety

, Volume 38, Issue 1, pp 79–86 | Cite as

Bacillus Calmette-Guérin (BCG) Vaccine Adverse Events in Victoria, Australia: Analysis of Reports to an Enhanced Passive Surveillance System

  • Hazel J. Clothier
  • Laine Hosking
  • Nigel W. Crawford
  • Melissa Russell
  • Mee Lee Easton
  • Julie-Ann Quinn
  • Jim P. Buttery
Original Research Article

Abstract

Background

Bacillus Calmette–Guérin (BCG) vaccine is used worldwide, with high efficacy against childhood Mycobacterium tuberculosis (TB) meningitis and miliary TB. BCG vaccine is considered safe, with serious systematic adverse events following immunization (AEFI) of immunocompetent recipients being rare, although adverse event rates vary between differing BCG strains. In Victoria, Australia, AEFI are reported to SAEFVIC (Surveillance of Adverse Events Following Vaccination In the Community), an enhanced passive surveillance system operational since 2007.

Objective

To describe the epidemiology of reported BCG AEFI in Victoria, Australia, particularly following the 2012 recall of Connaught BCG vaccine, substitution with Denmark-SSI vaccine and subsequent programme delivery adjustments.

Methods

Retrospective analysis of reported BCG AEFI in Victoria, Australia, for the 6-year period 2008–2013. Incidence rates were calculated using available doses-distributed, doses-administered and population data denominators with 95 % confidence intervals.

Results

The predominant BCG AEFI reported were abscess and lymphadenopathy, with higher reports for males than for females (p = 0.039).The rates of AEFI per 10,000 doses distributed were similar for the Connaught and Denmark-SSI strains, at 11.6 and 15.4, respectively (p = 0.414). When doses administered rather than doses distributed were considered, the rate of reported Denmark-SSI AEFI was much higher, at 62.8 per 10,000 doses administered. Meaningful result interpretation was hampered by a lack of a BCG vaccination register, multiple disparate providers and absent doses-administered data prior to the recall.

Conclusion

Effective AEFI surveillance is of paramount importance as countries are faced with unplanned vaccine strain changes following the 2012 BCG recall and subsequent global vaccine supply shortages. The Australian experience and lessons learned serve as a timely reminder to BCG vaccination programmes worldwide to review AEFI surveillance systems.

Keywords

Vaccine Strain Adverse Event Follow Immunization Passive Surveillance System Drug Administration Error Adverse Event Follow Immunization Report 
These keywords were added by machine and not by the authors. This process is experimental and the keywords may be updated as the learning algorithm improves.

Notes

Acknowledgments

This study would not be possible without the valued contribution of the SAEFVIC nurses and paediatricians, who respond to AEFI reports and provide clinical review of cases. We thank the parents for permission to use the photograph in Fig. 2 and Kana Volin for BCG doses-distributed data.

Funding and conflicts of interest

No sources of funding were used in the preparation of this study. Hazel J. Clothier, Laine Hosking, Nigel W. Crawford, Melissa Russell, Mee Lee Easton, Julie-Ann Quinn and Jim P. Buttery have no conflicts of interest that are directly relevant to the content of this study. Hazel Clothier is a recipient of an Australian Postgraduate Award.

References

  1. 1.
    World Health Organization. BCG vaccine. WHO position paper. Wkly Epidemiol Rec. 2004;79(4):27–38.Google Scholar
  2. 2.
    Barry C, Waring J, Stapledon R, Konstantinos A, National Tuberculosis Advisory Committee CDNA. Tuberculosis notifications in Australia, 2008 and 2009. Commun Dis Intell Q Rep. 2012;36(1):82–94.Google Scholar
  3. 3.
    World Health Organization. Information sheet: observed rate of vaccine reactions bacille Calmette–Guerin (BCG) vaccine. Geneva: World Health Organization; 2012.Google Scholar
  4. 4.
    Ritz N, Curtis N. Mapping the global use of different BCG vaccine strains. Tuberculosis. 2009;89(4):248–51.PubMedCrossRefGoogle Scholar
  5. 5.
    National Health and Medical Research Council. The Australian immunisation handbook. 9th ed. Australia: Australian Government, Department of Health and Aging; 2008. p. 297–302.Google Scholar
  6. 6.
    National Tuberculosis Advisory Committee. The BCG vaccine: information and recommendations for use in Australia. Commun Dis Intell Q Rep. 2006;30:109–15.Google Scholar
  7. 7.
    The BCG vaccine: information and recommendations for use in Australia. National Tuberculosis Advisory Committee update October 2012. Commun Dis Intell Q Rep. 2013;37(1):E65–72.Google Scholar
  8. 8.
    World Health Organization. Global tuberculosis report. 2013. http://www.who.int/tb/publications/global_report/en/. Accessed 1 June 2014.
  9. 9.
    Fitzgerald MJ, Duclos P. The reporting and management of adverse reactions to bacillus Calmette–Guerin (BCG) vaccination. Can Dis Wkly Rep (Rapport hebdomadaire des maladies au Canada). 1991;17(19):98–100.Google Scholar
  10. 10.
    Murphy D, Corner LA, Gormley E. Adverse reactions to Mycobacterium bovis bacille Calmette–Guerin (BCG) vaccination against tuberculosis in humans, veterinary animals and wildlife species. Tuberculosis. 2008;88(4):344–57.PubMedCrossRefGoogle Scholar
  11. 11.
    Grange J. Complications of bacille Calmette–Guérin (BCG) vaccination and immunotherapy and their management. Commun Dis Public Health. 1998;1:84–8.PubMedGoogle Scholar
  12. 12.
    Casanova JL, Blanche S, Emile JF, Jouanguy E, Lamhamedi S, Altare F, et al. Idiopathic disseminated bacillus Calmette–Guerin infection: a French national retrospective study. Pediatrics. 1996;98(4 Pt 1):774–8.PubMedGoogle Scholar
  13. 13.
    Deeks SL, Clark M, Scheifele DW, Law BJ, Dawar M, Ahmadipour N, et al. Serious adverse events associated with bacille Calmette–Guerin vaccine in Canada. Pediatr Infect Dis J. 2005;24(6):538–41.PubMedCrossRefGoogle Scholar
  14. 14.
    Dawar M, Clark M, Deeks SL, Walop W, Ahmadipour N. A fresh look at an old vaccine: does BCG have a role in 21st century Canada? Int J Circumpolar Health. 2004;63(Suppl 2):230–6.PubMedGoogle Scholar
  15. 15.
    Marciano BE, Huang CY, Joshi G, Rezaei N, Carvalho BC, Allwood Z, et al. BCG vaccination in patients with severe combined immunodeficiency: complications, risks, and vaccination policies. J Allergy Clin Immunol. 2014;133(4):1134–41.PubMedCrossRefGoogle Scholar
  16. 16.
    Turnbull FM, McIntyre PB, Achat HM, Wang H, Stapledon R, Gold M, et al. National study of adverse reactions after vaccination with bacille Calmette–Guerin. Clinical Infect Dis. 2002;34(4):447–53.CrossRefGoogle Scholar
  17. 17.
    Department of Health and Ageing. Tuberculosis (BCG) vaccine: urgent medicine recall. 2012. http://www.tga.gov.au/safety/recalls-medicine-tuberculosis-bcg-vaccine-120620.htm. Accessed 29 Sept 2013.
  18. 18.
    Department of Health and Ageing. Tuberculosis bacillus Calmette–Guerin (BCG) vaccine recall fact sheet. Health alerts. 2012. http://www.health.gov.au/internet/main/publishing.nsf/Content/bcg-factsheet.htm. Accessed 26 Oct 2013.
  19. 19.
    Department of Health Victoria. Bacille Calmette–Geurin (BCG) vaccine for tuberculosis: frequently asked questions. In: Department of Health, editor. Information for health professionals. Melbourne: Victoria; 2012.Google Scholar
  20. 20.
    Zwerling A, Behr MA, Verma A, Brewer TF, Menzies D, Pai M. The BCG world atlas: a database of global BCG vaccination policies and practices. PLoS Med. 2011;8(3):e1001012.PubMedCentralPubMedCrossRefGoogle Scholar
  21. 21.
    Lotte A, Wasz-Hockert O, Poisson N, Dumitrescu N, Verron M, Couvet E. BCG complications. Estimates of the risks among vaccinated subjects and statistical analysis of their main characteristics. Adv Tuberc Res (Fortschritte der Tuberkuloseforschung Progres de l’exploration de la tuberculose). 1984;21:107–93.Google Scholar
  22. 22.
    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.
  23. 23.
    Clothier HJ, Crawford NW, Kempe A, Buttery JP. Surveillance of adverse events following immunisation: the model of SAEFVIC, Victoria. Commun Dis Intell. 2011;35(4):294–8.Google Scholar
  24. 24.
    Department of Health Victoria. Adverse events reporting. immunisation. 2012. http://www.health.vic.gov.au/immunisation/saefvic.htm.
  25. 25.
    FitzGerald JM. Management of adverse reactions to bacille Calmette–Guerin vaccine. Clin Infect Dis. 2000;31(Suppl 3):S75–6.PubMedCrossRefGoogle Scholar
  26. 26.
    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. 2013;16(4) (in press).Google Scholar
  27. 27.
    Al Awaidy S, Bawikar S, Prakash KR, Al Rawahi B, Mohammed AJ. Surveillance of adverse events following immunization: 10 years’ experience in Oman. East Mediterr Health J. 2010;16(5):474–80.Google Scholar
  28. 28.
    Bongaarts J. The implementation of preferences for male offspring. Popul Dev Rev. 2013;39(2):23.CrossRefGoogle Scholar
  29. 29.
    Golebiowska M, Andrzejewska E, Stryjewska I, Baranowska H, Drazkiewicz A. Adverse events following BCG vaccination in infants and children up to 36 months of age. Przegl Epidemiol. 2008;62(1):71–5.PubMedGoogle Scholar
  30. 30.
    Dommergues MA, de La Rocque F, Guy C, Lecuyer A, Jacquet A, Guerin N, et al. Local and regional adverse reactions to BCG-SSI vaccination: a 12-month cohort follow-up study. Vaccine. 2009;27(50):6967–73.PubMedCrossRefGoogle Scholar
  31. 31.
    Trunz BB, Fine P, Dye C. Effect of BCG vaccination on childhood tuberculous meningitis and miliary tuberculosis worldwide: a meta-analysis and assessment of cost-effectiveness. Lancet. 2006;367(9517):1173–80.PubMedCrossRefGoogle Scholar
  32. 32.
    Linehan MF, Nurmatov U, Frank TL, Niven RM, Baxter DN, Sheikh A. Does BCG vaccination protect against childhood asthma? Final results from the Manchester Community Asthma Study retrospective cohort study and updated systematic review and meta-analysis. J Allergy Clin Immunol. 2014;133(3):688–95 e14.Google Scholar
  33. 33.
    Freyne B, Curtis N. Does neonatal BCG vaccination prevent allergic disease in later life? Archiv Dis Child. 2014;99(2):182–4.CrossRefGoogle Scholar
  34. 34.
    Hesseling AC, Schaaf HS, Hanekom WA, Beyers N, Cotton MF, Gie RP, et al. Danish bacille Calmette–Guerin vaccine-induced disease in human immunodeficiency virus-infected children. Clin Infect Dis. 2003;37(9):1226–33.PubMedCrossRefGoogle Scholar
  35. 35.
    Lugosi L. BCG and immunotherapy for tumors. Prevention of adverse effects of BCG vaccination. Orvosi hetilap. 1972;113(13):757–9.PubMedGoogle Scholar

Copyright information

© Springer International Publishing Switzerland 2014

Authors and Affiliations

  • Hazel J. Clothier
    • 1
    • 2
  • Laine Hosking
    • 1
  • Nigel W. Crawford
    • 1
    • 3
    • 4
  • Melissa Russell
    • 2
  • Mee Lee Easton
    • 1
  • Julie-Ann Quinn
    • 1
  • Jim P. Buttery
    • 1
    • 5
    • 6
  1. 1.SAEFVIC, Murdoch Childrens Research InstituteThe Royal Children’s HospitalMelbourneAustralia
  2. 2.School of Population and Global HealthUniversity of MelbourneMelbourneAustralia
  3. 3.Department of PaediatricsUniversity of MelbourneMelbourneAustralia
  4. 4.Immunisation Service, General MedicineRoyal Children’s HospitalMelbourneAustralia
  5. 5.Department of Paediatrics, Monash University, Infectious Diseases DepartmentMonash Children’s HospitalMelbourneAustralia
  6. 6.Monash ImmunisationMonash HealthMelbourneAustralia

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