Bivalent human papillomavirus vaccine and the risk of fatigue syndromes in girls in the UK
Bivalent human papillomavirus vaccine and the risk of fatigue syndromes in girls in the UK
复制标题
DOI：
10.1016/j.vaccine.2013.08.024
复制
发表时间：
2013-10-09
期刊：
影响因子：
5.5
通讯作者：
Bryan, Philip
中科院分区：
文献类型：
--
作者：
Donegan, Katherine;Beau-Lejdstrom, Raphaelle;Bryan, Philip
超过70%的宫颈癌与人乳头瘤病毒16型和18型有关。2008年，针对这两种毒株的疫苗cervarix被引入英国12-13岁女孩的常规免疫接种计划，并在18岁以下的女孩中迎头赶上。作为这一新活动的风险管理计划的一部分，药品和保健品管理局（MHRA）预计了一系列疾病，包括慢性疲劳综合征，这些疾病可能被报告为与疫苗时间相关的不良事件。近-进行了真实的时间“观察与预期”分析，比较了通过MHRA的黄牌被动提交的疲劳综合征报告的数量使用临床实践研究数据链（CPRD）计算的背景率和疫苗接种覆盖率的估计值，将监测计划与预期数量进行比较。随后，生态分析和自我对照病例系列（SCCS），都使用CPRD，比较疲劳综合征的发病率在女孩之前和之后开始的疫苗接种运动和风险在接种后的一年相比，其他periods.Results：自发报告的数量Cervarix接种后慢性疲劳与估计的背景率一致，即使假设低报告。生态学分析表明，尽管接种率很高，但12-20岁女孩的疲劳综合征发病率没有变化（IRR：0.94，95% CI：0.78-1.14）。包括187名女孩在内的SCCS也没有显示出在第一次接种疫苗后一年内疲劳综合征风险增加的证据（IRR：1.07，95% CI：0.57-2.00，p = 0.84）。加强药物警戒计划的成功实施提供了直接可靠的证据，证明接种Cervarix与慢性疾病风险增加之间没有关联。疲劳综合征更全面的流行病学研究也进一步证明了这一点。皇冠版权所有（C）2013由爱思唯尔有限公司出版。保留所有权利。
Introduction: Over 70% of cervical cancers are related to human papillomavirus types 16 and 18. In 2008, the vaccine cervarix, protecting against these two strains, was introduced into the routine UK immunisation programme for girls aged 12-13 years, with a catch-up in girls aged up to 18 years. As part of the risk management planning for this new campaign, the Medicines and Healthcare products Regulatory Agency (MHRA) anticipated a range of conditions, including chronic fatigue syndrome, which might be reported as adverse events in temporal association with the vaccine.Methods: Near-real time 'observed vs. expected' analyses were conducted comparing the number of reports of fatigue syndromes submitted via the MHRA's Yellow Card passive surveillance scheme to the expected number, using background rates calculated from the Clinical Practice Research Datalink (CPRD) and estimates of vaccination coverage. Subsequently, an ecological analysis and a self-controlled case series (SCCS), both using CPRD, compared the incidence rate of fatigue syndromes in girls before and after the start of the vaccination campaign and the risk in the year post-vaccination compared to other periods.Results: The number of spontaneous reports of chronic fatigue following Cervarix vaccination was consistent with estimated background rates even assuming low reporting. Ecological analyses suggested that there had been no change in the incidence of fatigue syndromes in girls aged 12-20 years after the introduction of the vaccination despite high uptake (IRR: 0.94, 95% CI: 0.78-1.14). The SCCS, including 187 girls, also showed no evidence of an increased risk of fatigue syndromes in the year post first vaccination (IRR: 1.07,95% CI: 0.57-2.00, p = 0.84).Discussion: The successful implementation of an enhanced pharmacovigilance plan provided immediate reassuring evidence that there was no association between vaccination with Cervarix and an increased risk of chronic fatigue syndromes. This has now also been further demonstrated in more comprehensive epidemiological studies. Crown Copyright (C) 2013 Published by Elsevier Ltd. All rights reserved.