Adverse events following immunisation with bacille Calmette-Guérin vaccination: baseline data to inform monitoring in Australia following introduction of new unregistered BCG vaccine

Authors

  • Alexandra J Hendry National Centre for Immunisation Research and Surveillance of Vaccine Preventable Diseases, The Children’s Hospital at Westmead, New South Wales
  • Aditi Dey National Centre for Immunisation Research and Surveillance of Vaccine Preventable Diseases, The Children’s Hospital at Westmead, New South Wales; Discipline of Paediatrics and Child Health, University of Sydney, New South Wales
  • Frank H Beard National Centre for Immunisation Research and Surveillance of Vaccine Preventable Diseases, The Children’s Hospital at Westmead, New South Wales; Discipline of Paediatrics and Child Health, University of Sydney, New South Wales
  • Gulam Khandaker National Centre for Immunisation Research and Surveillance of Vaccine Preventable Diseases, The Children’s Hospital at Westmead, New South Wales; Discipline of Paediatrics and Child Health, University of Sydney, New South Wales
  • Richard Hill Adverse Event Monitoring and Vaccine Safety, Pharmacovigilance and Special Access Branch, Therapeutic Goods Administration, Canberra, Australian Capital Territory
  • Kristine K Macartney National Centre for Immunisation Research and Surveillance of Vaccine Preventable Diseases, The Children’s Hospital at Westmead, New South Wales; Discipline of Paediatrics and Child Health, University of Sydney, New South Wales

DOI:

https://doi.org/10.33321/cdi.2016.40.52

Keywords:

adverse events, bacille Calmette-Guérin, vaccination

Abstract

In recent years there has been a global shortage of bacille Calmette-Guérin (BCG) vaccine and, from September 2012, unregistered vaccines have needed to be used in Australia (a Danish product initially until the end of 2015, and a Polish product used in some jurisdictions from early 2016). We examined rates and types of adverse events following immunisation (AEFI) with BCG vaccine reported to the Therapeutic Goods Administration between 2009 and 2014 in children aged less than 7 years. Reporting rates of AEFI with BCG vaccine increased from 87 per 100,000 doses (registered Sanofi Pasteur product) in 2009 to 201 per 100,000 doses (unregistered Danish Statens Serum Institute product) in 2014, with Victoria having the highest rate each year. Substantial variation between jurisdictions exists, suggesting differential reporting of BCG vaccine doses administered and/or BCG vaccine-related AEFI. The most commonly reported reactions were abscess (31%), injection site reaction (27%) and lymphadenopathy/lymphadenitis (17%). This study provides baseline data on BCG vaccine safety to inform surveillance. Given the current use of unregistered vaccines in the context of vaccine supply issues, improved recording of both administered BCG vaccine doses and the reporting of BCG vaccine-related AEFI are required to facilitate close monitoring of vaccine safety. Commun Dis Intell 2016;40(4):E470–E474.

Downloads

Download data is not yet available.

References

Australian Technical Advisory Group on Immunisation. The Australian Immunisation Handbook. 10th edn. Canberra: Australian Government Department of Health and Ageing; 2013.

National Tuberculosis Advisory Committee. The BCG vaccine: information and recommendations for use in Australia: National Tuberculosis Advisory Committee Update October 2012. Commun Dis Intell 2013;37(1):E65–E72.

Wittes R. Immunology of bacille Calmette-Guérin and related topics. Clin Infect Dis 2000;31 Suppl 3:S59–S63.

Ritz N, Hanekom WA, Robins-Browne R, Britton WJ, Curtis N. Influence of BCG vaccine strain on the immune response and protection against tuberculosis. FEMS Microbiol Rev 2008;32(5):821–841.

Therapeutic Goods Administration. Tuberculosis vaccine: urgent medicine recall. 2012. Accessed on 10 April 2016. Available from: http://www.tga.gov.au/safety/recalls-medicine-tuberculosis-bcg-vaccine-120620.htm#.UqZVM6wf6OQ

Commonwealth of Australia. Therapeutic Goods Act 1989. Accessed on 17 March 2016. Available from: http://www5.austlii.edu.au/au/legis/cth/consol_act/tga1989191/

NSW Health. BCG 10 anti-tuberculosis vaccine fact sheet. Information for patients and their families. 2016. Accessed on 17 March 2016. Available from: http://www.health.nsw.gov.au/Infectious/tuberculosis/Documents/factsheet-unregistered-BCG.pdf

Marais B, Seddon JA, Detjen AK, van der Werf MJ, Grzemska M, Hesseling AC, et al. Interrupted BCG vaccination is a major threat to global child health. Lancet Respir Med 2016;4(4):251–253.

Krysztopa-Grzybowska K, Paradowska-Stankiewicz I, Lutynska A. The rate of adverse events following BCG vaccination in Poland. Przegl Epidemiol 2012;66(3):465–469.

Fine P, Carneiro I, Milstein J, Clements C. Issues relating to the use of BCG in immunization programmes: A discussion document. Geneva: World Health Organization; 1999.

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):474–480.

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

Turnbull FM, McIntyre PB, Achat HM, Wang H, Stapledon R, Gold M, et al. National study of adverse reactions after vaccination with bacille Calmette-Guérin. Clin Infect Dis 2002;34(4):447–453.

World Health Organization. Information Sheet. Observed rate of vaccine reactions bacille Calmette-Guérin (BCG) vaccine. 2012. Accessed on 9 February 2016. Available from: http://www.who.int/vaccine_safety/initiative/tools/BCG_Vaccine_rates_information_sheet.pdf?ua=1

Isaacs D, Lawrence G, Boyd I, Ronaldson K, McEwen J. Reporting of adverse events following immunization in Australia. J Paediatr Child Health 2005;41(4):163–166.

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 2015;39(3):E369–E386.

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):294–298.

Downloads

Published

01/12/16

How to Cite

Hendry, Alexandra J, Aditi Dey, Frank H Beard, Gulam Khandaker, Richard Hill, and Kristine K Macartney. 2016. “Adverse Events Following Immunisation With Bacille Calmette-Guérin Vaccination: Baseline Data to Inform Monitoring in Australia Following Introduction of New Unregistered BCG Vaccine”. Communicable Diseases Intelligence 40 (December):470-74. https://doi.org/10.33321/cdi.2016.40.52.

Issue

Vol. 40 (2016)

Section

Original article

Categories

License

Copyright (c) 2016 Communicable Diseases Intelligence

Creative Commons License

This work is licensed under a Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International License.

Most read articles by the same author(s)

1 2 3 4 5 6 7 8 9 > >>