Callréus Torbjörn, Svanström Henrik, Nielsen Nete Munk, Poulsen Sigrid, Valentiner-Branth Palle, Hviid Anders
Division of Vaccine, Statens Serum Institut, Copenhagen, Denmark.
Vaccine. 2009 May 14;27(22):2954-8. doi: 10.1016/j.vaccine.2009.02.106. Epub 2009 Mar 13.
Determining incidence rates of potential adverse events before and after an immunisation programme is initiated, provides a useful framework for the evaluation of vaccine safety concerns. Human papillomavirus vaccination (HPV) of adolescent girls has recently been introduced in Denmark. Using a nationwide hospitalisation registry we estimated incidence rates of immune-mediated disorders before HPV vaccination in a cohort of 418,289 Danish girls aged 12-15 years. We further estimated the expected number of cases of immune-mediated disorders occurring in temporal relationship to a hypothetical HPV vaccination schedule purely by chance. Our results and analytical approach provides a framework for the evaluation of adverse event reports following immunisation of adolescent girls.
在启动免疫规划之前和之后确定潜在不良事件的发病率，为评估疫苗安全性问题提供了一个有用的框架。丹麦最近开始对青春期女孩进行人乳头瘤病毒疫苗接种（HPV）。我们利用全国住院登记系统，估计了418289名年龄在12至15岁的丹麦女孩在接种HPV疫苗之前免疫介导疾病的发病率。我们还纯粹通过偶然因素估计了与假设的HPV疫苗接种计划在时间上相关的免疫介导疾病病例的预期数量。我们的研究结果和分析方法为评估青春期女孩接种疫苗后的不良事件报告提供了一个框架。
