Importance of background rates of disease in assessment of vaccine safety during mass immunisation with pandemic H1N1 influenza vaccines.
Importance of background rates of disease in assessment of vaccine safety during mass immunisation with pandemic H1N1 influenza vaccines.
复制标题
DOI：
10.1016/s0140-6736(09)61877-8
复制
发表时间：
2009-12-19
期刊：
影响因子：
168.9
通讯作者：
Vellozzi, Claudia
中科院分区：
文献类型：
--
作者：
Black, Steven;Eskola, Juhani;Siegrist, Claire-Anne;Halsey, Neal;MacDonald, Noni;Law, Barbara;Miller, Elizabeth;Andrews, Nick;Stowe, Julia;Salmon, Daniel;Vannice, Kirsten;Izurieta, Hector S.;Akhtar, Aysha;Gold, Mike;Oselka, Gabriel;Zuber, Patrick;Pfeifer, Dina;Vellozzi, Claudia
由于新的甲型H1N1流感病毒株的出现，许多国家已经开始大规模免疫接种计划。了解可能的不良事件的背景发生率将是评估可能的疫苗安全性问题的关键部分，并将有助于将合理的安全性问题与时间上与疫苗接种相关但不是由疫苗接种引起的事件分开。我们确定了几个国家选定医疗事件的背景发生率。疾病事件的发生率因年龄、性别、确定方法和地理位置而异。高度可见的健康状况，如格林-巴利综合征、自然流产甚至死亡，将与新型流感疫苗接种同时发生。根据审查的数据，如果在英国接种了1000万人的队列，预计在接种疫苗后6周内将发生21.5例格林-巴利综合征和5.75例猝死，作为符合的背景病例。在美国的女性疫苗接种者中，每1000万人口中有86.3例视神经炎病例预计在疫苗接种后6周内发生。每100万名接种疫苗的孕妇中，预计有397名在接种疫苗后1天内发生自然流产。
Because of the advent of a new influenza A H1N1 strain, many countries have begun mass immunisation programmes. Awareness of the background rates of possible adverse events will be a crucial part of assessment of possible vaccine safety concerns and will help to separate legitimate safety concerns from events that are temporally associated with but not caused by vaccination. We identified background rates of selected medical events for several countries. Rates of disease events varied by age, sex, method of ascertainment, and geography. Highly visible health conditions, such as Guillain-Barré syndrome, spontaneous abortion, or even death, will occur in coincident temporal association with novel influenza vaccination. On the basis of the reviewed data, if a cohort of 10 million individuals was vaccinated in the UK, 21·5 cases of Guillain-Barré syndrome and 5·75 cases of sudden death would be expected to occur within 6 weeks of vaccination as coincident background cases. In female vaccinees in the USA, 86·3 cases of optic neuritis per 10 million population would be expected within 6 weeks of vaccination. 397 per 1 million vaccinated pregnant women would be predicted to have a spontaneous abortion within 1 day of vaccination.