Bacillus Calmette-Guérin (BCG) Vaccine Adverse Events in Victoria, Australia: Analysis of Reports to an Enhanced Passive Surveillance System
- 5 December 2014
- journal article
- Published by Springer Science and Business Media LLC in Drug Safety
- Vol. 38 (1), 79-86
- https://doi.org/10.1007/s40264-014-0248-6
Abstract
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. 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. 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. 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. 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
This publication has 28 references indexed in Scilit:
- The Implementation of Preferences for Male OffspringPopulation and Development Review, 2013
- The BCG World Atlas: A Database of Global BCG Vaccination Policies and PracticesPLoS Medicine, 2011
- Local and regional adverse reactions to BCG-SSI® vaccination: A 12-month cohort follow-up studyVaccine, 2009
- Mapping the global use of different BCG vaccine strainsTuberculosis, 2009
- Adverse reactions to Mycobacterium bovis bacille Calmette–Guérin (BCG) vaccination against tuberculosis in humans, veterinary animals and wildlife speciesTuberculosis, 2008
- Effect of BCG vaccination on childhood tuberculous meningitis and miliary tuberculosis worldwide: a meta-analysis and assessment of cost-effectivenessThe Lancet, 2006
- Serious Adverse Events Associated with Bacille Calmette-Guérin Vaccine in CanadaThe Pediatric Infectious Disease Journal, 2005
- Danish Bacille Calmette-Guerin Vaccine-Induced Disease in Human Immunodeficiency Virus-Infected ChildrenClinical Infectious Diseases, 2003
- National Study of Adverse Reactions after Vaccination with Bacille Calmette-GuérinClinical Infectious Diseases, 2002
- Management of Adverse Reactions to Bacille Calmette-Guérin VaccineClinical Infectious Diseases, 2000