From the The National Institute for Health Research Applied Research Collaboration West (NIHR ARC West) at University Hospitals Bristol NHS Foundation Trust, Bristol, United Kingdom.
Population Health Sciences, Bristol Medical School, University of Bristol, Bristol, United Kingdom.
Epidemiology. 2024 Nov 1;35(6):813-822. doi: 10.1097/EDE.0000000000001784. Epub 2024 Sep 30.
Human papillomavirus (HPV) vaccination has been offered in over a hundred countries worldwide (including the United Kingdom, since September 2008). Controversy around adverse effects persists, with inconsistent evidence from follow-up of randomized controlled trials and confounding by indication limiting the conclusions drawn from larger-scale observational studies. This study aims to estimate the association between receiving a quadrivalent HPV vaccine and the reporting of short-term adverse effects and to demonstrate the utility of regression discontinuity design for examining side effects in routine data.
We applied a novel regression discontinuity approach to a retrospective population-based cohort using primary care data from the UK Clinical Practice Research Datalink linked to hospital and social deprivation data. We examined the new onset of gastrointestinal, neuromuscular, pain, and headache/migraine symptoms using READ and International Classification of Diseases, tenth revision diagnostic codes. For each year between 2012 and 2017, we compared girls in school year 8 (born July/August) who were eligible to receive the vaccine with girls in year 7 (born September/October) who were not eligible.
Of the 21,853 adolescent girls in the cohort, 10,881 (50%) were eligible for HPV vaccination. There was no evidence of increased new gastrointestinal symptoms (adjusted odds ratio [OR]: 0.99; 95% confidence interval [CI]: 0.85, 1.15), headache/migraine symptoms (OR: 0.84; 95% CI: 0.70, 1.01), or pain symptoms (OR: 1.05; 95% CI: 0.95, 1.16) when comparing those eligible and ineligible for HPV vaccination.
This study found no evidence that HPV vaccination eligibility is associated with reporting short-term adverse effects among adolescent girls.
人乳头瘤病毒（HPV）疫苗已在全球 100 多个国家（包括英国，自 2008 年 9 月起）提供。关于不良反应的争议仍然存在，随机对照试验的随访结果不一致，且由于指示性混杂，从更大规模的观察性研究中得出的结论受到限制。本研究旨在估计接受四价 HPV 疫苗接种与报告短期不良反应之间的关联，并展示回归不连续性设计在常规数据中检查副作用的效用。
我们使用英国临床实践研究数据链接到医院和社会贫困数据的初级保健数据，应用一种新颖的回归不连续性方法对回顾性基于人群的队列进行了研究。我们使用 READ 和国际疾病分类，第十版诊断代码检查胃肠道、神经肌肉、疼痛和头痛/偏头痛症状的新发病例。对于 2012 年至 2017 年的每一年，我们比较了有资格接种疫苗的 8 年级（7 月/8 月出生）女孩和没有资格接种疫苗的 7 年级（9 月/10 月出生）女孩。
在队列中的 21853 名青春期女孩中，有 10881 名（50%）有资格接种 HPV 疫苗。在比较有资格和无资格接种 HPV 疫苗的女孩时，没有证据表明新胃肠道症状（调整后的优势比 [OR]：0.99；95%置信区间 [CI]：0.85，1.15）、头痛/偏头痛症状（OR：0.84；95% CI：0.70，1.01）或疼痛症状（OR：1.05；95% CI：0.95，1.16）增加。
本研究没有发现 HPV 疫苗接种资格与青春期女孩报告短期不良反应之间存在关联的证据。
