Merck & Co., Inc, Center for Observational and Real-World Evidence (CORE), Rahway, NJ, USA.
OXON Epidemiology Ltd, Epidemiology & Statistics, Madrid, Spain.
BMC Public Health. 2023 Jan 30;23(1):201. doi: 10.1186/s12889-023-14982-8.
The 7-valent pneumococcal conjugate vaccine (PCV7) was introduced in 2006 and the 13-valent pneumococcal conjugate vaccine (PCV13) in 2010 in the UK. PCVs are active immunization for the prevention of invasive disease, pneumonia and acute otitis media (AOM) caused by Streptococcus pneumoniae in children. The aim of this observational study was to estimate incidence rates (IRs) of AOM in children ≤17 years from 2003 to 2019 in England, before and after the introduction of pneumococcal conjugate vaccines (PCVs).
AOM episodes were identified using Read diagnosis codes in children aged ≤17 years in the Clinical Practice Research Datalink (CPRD) Gold database from 2003 to 2019. Annual IRs with 95% confidence intervals (CI) by age group were calculated as the number of episodes/person-years (PY) at risk. Interrupted time series analyses were conducted to estimate incidence rate ratios (IRR) across post-PCV7 (2007-2009), early post-PCV13 (2011-2014) and late post-PCV13 (2015-2019) periods compared to the pre-PCV7 period (2003-2005) using generalized linear models.
From 2003 to 2019, 274,008 all-cause AOM episodes were identified in 1,500,686 children. The overall AOM IR was 3690.9 (95% CI 3677.1-3704.8) per 100,000 PY. AOM IRs were highest in children aged < 5 years and decreased by age; < 2 years: 8286.7 (95% CI 8216.8-8357.1); 2-4 years: 7951.8 (95% CI 7902.5-8001.4); 5-17 years: 2184.4 (95% CI 2172.1-2196.8) (per 100,000 PY). Overall AOM IRs declined by 40.3% between the pre-PCV7 period and the late-PCV13 period from 4451.9 (95% CI 4418.1-4485.9) to 2658.5 (95% CI 2628.6-2688.7) per 100,000 PY, and across all age groups. IRRs indicated a significant decrease in AOM IRs in all the post-vaccination periods, compared to the pre-PCV7 period: post-PCV7 0.87 (95% CI 0.85-0.89), early post-PCV13 0.88 (95% CI 0.86-0.91), and late post-PCV13 0.75 (95% CI 0.73-0.78).
The AOM IRs declined during the 2003-2019 period; however, the clinical burden of AOM remains substantial among children ≤17 years in England.
2006 年在英国引入了 7 价肺炎球菌结合疫苗（PCV7），2010 年引入了 13 价肺炎球菌结合疫苗（PCV13）。PCV 用于预防儿童侵袭性疾病、肺炎和由肺炎链球菌引起的急性中耳炎（AOM）。本观察性研究旨在评估 2003 年至 2019 年期间英格兰≤17 岁儿童 AOM 的发病率（IR），在此之前和之后引入了肺炎球菌结合疫苗（PCV）。
在 2003 年至 2019 年期间，在临床实践研究数据链接（CPRD）黄金数据库中，使用 Read 诊断代码识别≤17 岁儿童的 AOM 发作。根据年龄组计算每 100000 人年（PY）风险的病例数/人年（PY）的年度 IR 及其 95%置信区间（CI）。使用广义线性模型，在 PCV7 后（2007-2009）、PCV13 早期后（2011-2014）和 PCV13 后期后（2015-2019）期间，与 PCV7 前（2003-2005）期间相比，估计发病率比值比（IRR）。
2003 年至 2019 年期间，在 1500686 名儿童中发现了 274008 例所有病因 AOM 发作。总体 AOM IR 为每 100000PY 3690.9（95%CI 3677.1-3704.8）。AOM IR 在年龄<5 岁的儿童中最高，并随年龄下降；<2 岁：8286.7（95%CI 8216.8-8357.1）；2-4 岁：7951.8（95%CI 7902.5-8001.4）；5-17 岁：2184.4（95%CI 2172.1-2196.8）（每 100000PY）。与 PCV7 前时期相比，2003 年至 2019 年期间，整体 AOM IR 下降了 40.3%，从 4451.9（95%CI 4418.1-4485.9）下降至 2658.5（95%CI 2628.6-2688.7）每 100000PY，并且在所有年龄组中均如此。IRR 表明，与 PCV7 前时期相比，所有接种疫苗后的时期 AOM IR 均显著下降：接种 PCV7 后 0.87（95%CI 0.85-0.89）、接种 PCV13 早期后 0.88（95%CI 0.86-0.91）和接种 PCV13 后期后 0.75（95%CI 0.73-0.78）。
2003 年至 2019 年期间，AOM IR 下降；然而，在英格兰≤17 岁的儿童中，AOM 的临床负担仍然很大。
