Dey Aditi, Wang Han, Quinn Helen, Hiam Rona, Wood Nicholas, Beard Frank, Macartney Kristine
National Centre for Immunisation Research and Surveillance, The University of Sydney and The Children’s Hospital at Westmead, Sydney, Australia
Pharmacovigilance and Special Access Branch, Therapeutic Goods Administration, Canberra, Australia
Commun Dis Intell (2018). 2019 Jul 16;43. doi: 10.33321/cdi.2019.43.29.
This report summarises Australian passive surveillance data for adverse events following immunisation (AEFI) for 2017 reported to the Therapeutic Goods Administration and describes reporting trends over the 18-year period 1 January 2000 to 31 December 2017. There were 3,878 AEFI records for vaccines administered in 2017; an annual AEFI reporting rate of 15.8 per 100,000 population. There was a 12% increase in the overall AEFI reporting rate in 2017 compared with 2016. This increase in reported adverse events in 2017 compared to the previous year was likely due to the introduction of the zoster vaccine (Zostavax®) provided free for people aged 70–79 years under the National Immunisation Program (NIP) and also the state- and territory-based meningococcal ACWY conjugate vaccination programs. AEFI reporting rates for most other individual vaccines in 2017 were similar to 2016. The most commonly reported reactions were injection site reaction (34%), pyrexia (17%), rash (15%), vomiting (8%) and pain (7%). The majority of AEFI reports (88%) described non-serious events. Two deaths were reported that were determined to have a causal relationship with vaccination; they occurred in immunocompromised people contraindicated to receive the vaccines.
本报告总结了2017年向治疗用品管理局报告的澳大利亚免疫接种后不良事件(AEFI)的被动监测数据,并描述了2000年1月1日至2017年12月31日这18年期间的报告趋势。2017年有3878条疫苗接种后AEFI记录;AEFI年报告率为每10万人口15.8例。与2016年相比,2017年AEFI总体报告率增加了12%。2017年报告的不良事件较上一年有所增加,这可能是由于根据国家免疫规划(NIP)为70至79岁人群免费提供了带状疱疹疫苗(Zostavax®),以及各州和领地开展的脑膜炎球菌ACWY结合疫苗接种计划。2017年大多数其他单一疫苗的AEFI报告率与2016年相似。最常报告的反应为注射部位反应(34%)、发热(17%)、皮疹(15%)、呕吐(8%)和疼痛(7%)。大多数AEFI报告(88%)描述的是非严重事件。报告了两例被判定与疫苗接种有因果关系的死亡病例;死亡发生在被禁忌接种疫苗的免疫功能低下人群中。