Liu Yuanhua, Song Yang, Liu Fengfeng, Chen Yue, Liu Yang, Shi Jin, Li Ke, Yin Yun, Liang Qingqing, Liu Na, Ming Ming, Hua Lei, Shi Qian, Xu Jiayao, Yuan Rui, Li Shuting, Zhang Lele, Zhao Yu, Wang Na, Zhang Jidan, Zhang Yanping, Chang Zhaorui, Zhang Zhijie
Department of Epidemiology and Health Statistics, School of Public Health, Fudan University, Shanghai, China; Key Laboratory of Public Health Safety, Ministry of Education, Shanghai, China.
Division of Infectious Disease, Key Laboratory of Surveillance and Early-Warning on Infectious Disease, National Key Laboratory of Intelligent Tracking and Forecasting for Infectious Diseases, Chinese Center for Disease Control and Prevention, Beijing, China.
Clin Microbiol Infect. 2025 Feb;31(2):258-265. doi: 10.1016/j.cmi.2024.09.020. Epub 2024 Sep 27.
For the prevention of hand, foot, and mouth disease (HFMD), enterovirus A71 (EV-A71) vaccines have been used in China since 2016. To better inform vaccination strategies, we assess the real-world effectiveness of EV-A71 vaccination in China.
The analysis was based on surveillance data of HFMD caused by EV-A71 in children under the age of 5 in China, along with meteorological and demographic data. The seasonal autoregressive integrated moving average model and the interrupted time series analysis were used to estimate the effectiveness of the EV-A71 vaccination on the EV-A71 HFMD incidence and to predict the counterfactual cases with no EV-A71 vaccine.
Between 2010 and 2018, 6 712 613 cases of HFMD caused by EV-A71 were reported in children under 5 years old in 260 Chinese cities. During 2017-2018, the EV-A71 vaccination was associated with a reduction in EV-A71 HFMD incidence, with a relative risk of 0.83 (95% CI, 0.81-0.86), and an estimated reduction of 297 946 (95% CI, 250 534-346 658) cases. However, this association varied across cities (I = 85.6%, p < 0.001) and the effectiveness of the EV-A71 vaccination decreased as population density increased. Higher vaccination coverage was associated with greater effectiveness of the EV-A71 vaccination and an earlier point in EV-A71 case reduction. Specifically, when the vaccination coverage exceeded ∼20%, the relative risk was rapidly reduced to below 0.71 (95% CI, 0.69-0.72).
Our study demonstrated that the EV-A71 vaccination was associated with a reduction in the incidence of EV-A71 HFMD, but the association varied with regions and was influenced by vaccination coverage and population density. To optimize EV-A71 HFMD prevention, increasing vaccination coverage (>20%) is recommended for children under 5 years old.
为预防手足口病（HFMD），自2016年起中国开始使用肠道病毒A71型（EV - A71）疫苗。为更好地为疫苗接种策略提供依据，我们评估了中国EV - A71疫苗接种的真实世界效果。
该分析基于中国5岁以下儿童中由EV - A71引起的手足口病监测数据，以及气象和人口数据。采用季节性自回归积分滑动平均模型和中断时间序列分析来估计EV - A71疫苗接种对EV - A71手足口病发病率的效果，并预测未接种EV - A71疫苗情况下的反事实病例数。
2010年至2018年期间，中国260个城市共报告了6712613例5岁以下儿童由EV - A71引起的手足口病病例。在2017 - 2018年期间，EV - A71疫苗接种与EV - A71手足口病发病率降低相关，相对风险为0.83（95%CI，0.81 - 0.86），估计减少了297946例（95%CI，250534 - 346658）。然而，这种关联在不同城市之间存在差异（I = 85.6%，p < 0.001），并且随着人口密度增加，EV - A71疫苗接种的效果会降低。更高的疫苗接种覆盖率与EV - A71疫苗接种的更大效果以及EV - A71病例减少的更早时间点相关。具体而言，当疫苗接种覆盖率超过约20%时，相对风险迅速降至0.71以下（95%CI，0.69 - 0.72）。
我们的研究表明，EV - A71疫苗接种与EV - A71手足口病发病率降低相关，但这种关联因地区而异，并受疫苗接种覆盖率和人口密度的影响。为优化EV - A71手足口病预防，建议对5岁以下儿童提高疫苗接种覆盖率（>20%）。
