Hendry Alexandra J, Dey Aditi, Beard Frank H, Khandaker Gulam, Hill Richard, Macartney Kristine K
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.
Commun Dis Intell Q Rep. 2016 Dec 24;40(4):E470-E474.
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.
近年来，全球范围内卡介苗（BCG）短缺，自2012年9月起，澳大利亚开始使用未注册疫苗（2015年底前最初使用丹麦产品，2016年初起一些辖区使用波兰产品）。我们调查了2009年至2014年向治疗用品管理局报告的7岁以下儿童接种卡介苗后的不良事件发生率和类型。卡介苗不良事件报告率从2009年每10万剂87例（赛诺菲巴斯德注册产品）增至2014年每10万剂201例（丹麦国家血清研究所未注册产品），维多利亚州每年的报告率最高。各辖区之间存在显著差异，这表明卡介苗接种剂量和/或卡介苗相关不良事件的报告存在差异。最常报告的反应是脓肿（31%）、注射部位反应（27%）和淋巴结病/淋巴结炎（17%）。本研究提供了卡介苗安全性的基线数据，以指导监测工作。鉴于目前在疫苗供应问题背景下使用未注册疫苗，需要改进卡介苗接种剂量的记录以及卡介苗相关不良事件的报告，以便密切监测疫苗安全性。
