Khandaker Gulam, Beard Frank H, Dey Aditi, Coulter Chris, Hendry Alexandra J, Macartney Kristine K
National Centre for Immunisation Research and Surveillance of Vaccine Preventable Diseases, The Children's Hospital at Westmead, Westmead, New South Wales.
University of Sydney, Westmead, New South Wales .
Commun Dis Intell Q Rep. 2017 Mar 31;41(1):E33-E48.
bacille Calmette-Guérin (BCG) immunisation programs in Australia are funded and operated by the individual states and territories. In recent years BCG vaccine shortages have required use of unregistered products. We aimed to evaluate BCG immunisation programs in Australia, with particular reference to program implementation and national consistency. Methods: Between September and November 2015, 12 key stakeholders, representing Australian states and territories, completed surveys. We analysed BCG vaccination coverage data from the Australian Childhood Immunisation Register (ACIR), and data on adverse events following immunisation (AEFI) with BCG vaccine from the Therapeutic Goods Administration's Adverse Drug Reactions System, for 2001 to 2014. Results: Access to BCG vaccination varies between jurisdictions, with some states providing this only in major city locations. Analysis of ACIR data suggests significant differences in vaccine delivery between jurisdictions, but varying levels of under-reporting to the ACIR were also acknowledged. The rate of BCG AEFI appeared to increase between 2011 and 2014; however, these data need to be interpreted with caution due to small numbers, likely under-reporting of both numerator (AEFI) and denominator (vaccine doses administered), and the general increase in reporting of AEFI related to other vaccines in children over this period. Conclusions: BCG immunisation programs aim to prevent severe forms of tuberculosis in young children who live in or travel to high burden settings. A range of factors, particularly inconsistent vaccine supply are leading to low, variable and inequitable vaccine delivery across Australian jurisdictions. Improved BCG vaccination uptake and AEFI data quality are required for accurate monitoring of program delivery and vaccine safety - this is particularly important given the current need to use unregistered vaccines. Improved and consistent access to BCG vaccine is suggested to optimise equity for at-risk children Australia-wide.
澳大利亚的卡介苗（BCG）免疫计划由各个州和领地提供资金并负责实施。近年来，卡介苗短缺导致使用了未经注册的产品。我们旨在评估澳大利亚的卡介苗免疫计划，特别关注计划的实施情况和全国的一致性。
2015年9月至11月期间，代表澳大利亚各州和领地的12名主要利益相关者完成了调查。我们分析了澳大利亚儿童免疫登记册（ACIR）中的卡介苗接种覆盖率数据，以及2001年至2014年期间治疗用品管理局药品不良反应系统中卡介苗免疫接种后不良事件（AEFI）的数据。
不同司法管辖区获得卡介苗接种的机会各不相同，一些州仅在主要城市地区提供接种服务。对ACIR数据的分析表明，不同司法管辖区之间疫苗接种情况存在显著差异，但也认识到向ACIR报告的数据存在不同程度的漏报。2011年至2014年期间，卡介苗AEFI的发生率似乎有所上升；然而，由于数量较少、分子（AEFI）和分母（接种疫苗剂量）可能漏报以及同期儿童中与其他疫苗相关的AEFI报告总体增加，这些数据需要谨慎解读。
卡介苗免疫计划旨在预防生活在高负担地区或前往高负担地区的幼儿患严重形式的结核病。一系列因素，特别是疫苗供应不一致，导致澳大利亚各司法管辖区的疫苗接种率低、情况各异且不公平。需要提高卡介苗接种率和AEFI数据质量，以准确监测计划实施情况和疫苗安全性——鉴于目前需要使用未经注册的疫苗，这一点尤为重要。建议改善并统一卡介苗的获取途径，以优化全澳大利亚高危儿童的公平性。
