Hu Quanman, Xie Yaqi, Ji Fucang, Zhao Fei, Song Xiaoru, Lu Saiwei, Li Zijie, Geng Juan, Yang Haiyan, Long Jinzhao, Jin Yuefei, Chen Shuaiyin, Duan Guangcai
College of Public Health, Zhengzhou University, Zhengzhou 450001, China.
Center for Disease Control and Prevention of Zhengyang, Zhengyang, Zhumadian 463600, China.
Vaccines (Basel). 2024 Sep 8;12(9):1028. doi: 10.3390/vaccines12091028.
Vaccination is a highly effective strategy for the prevention of enterovirus A71 (EV-A71)-hand, foot, and mouth disease (HFMD). Three inactivated EV-A71 vaccines in China have demonstrated remarkable efficacy against EV-A71-HFMD during clinical trials, exhibiting vaccine effectiveness (VE) exceeding 90% and few adverse events (AEs). However, the effectiveness of vaccines in the real world and its impact on the epidemiological characteristics of HFMD after the use of EV-A71 inactivated vaccine are uncertain.
The odd ratio (OR) and 95% confidence (CI) were used as the effect estimates of the meta-analysis in the test-negative design (TND), and the OR was used to calculate VE: VE = (1 - OR) × 100%.
According to the literature search strategy, a comprehensive search was conducted in PubMed, Web of Science (including Chinese Science Citation Database and MEDLINE), and Embase, and 18 records were ultimately included in this study. Subsequently, the overall VE and 95% CI of different vaccine doses were analyzed, with the one-dose vaccine at 66.9% (95% CI: 45.2-80.0%) and the two-dose vaccine at 84.2% (95% CI: 79.4-87.9%). Additionally, the most reported AEs were mild general reactions without any rare occurrences. Simultaneously, the widespread use of the EV-A71 vaccine would lead to a reduction in both the incidence of EV-A71-associated HFMD and severe cases caused by EV-A71.
The administration of the two-dose EV-A71 vaccine is highly effective in preventing HFMD in the real world, and the widespread use of the EV-A71 vaccine leads to a reduction in the incidence of EV-A71-associated HFMD and that of severe cases caused by EV-A71. The findings suggest that administering the two-dose EV-A71 inactivated vaccine to children aged 6 months to 71 months can be effective in preventing EV-A71-associated HFMD, highlighting the need for developing a multivalent HFMD vaccine for preventing cases not caused by EV-A71.
接种疫苗是预防肠道病毒A71型（EV - A71）手足口病（HFMD）的一种高效策略。中国的三种EV - A71灭活疫苗在临床试验期间已证明对EV - A71手足口病具有显著疗效，疫苗有效性（VE）超过90%，且不良事件（AE）较少。然而，疫苗在现实世界中的有效性及其在使用EV - A71灭活疫苗后对手足口病流行病学特征的影响尚不确定。
比值比（OR）和95%置信区间（CI）用作检测阴性设计（TND）中荟萃分析的效应估计值，OR用于计算VE：VE = (1 - OR)×100%。
根据文献检索策略，在PubMed、科学网（包括中国科学引文数据库和MEDLINE）以及Embase中进行了全面检索，最终本研究纳入18条记录。随后，分析了不同疫苗剂量的总体VE和95%CI，单剂量疫苗为66.9%（95%CI：45.2 - 80.0%），两剂量疫苗为84.2%（95%CI：79.4 - 87.9%）。此外，报告最多的不良事件为轻度全身反应，无罕见事件发生。同时，EV - A71疫苗的广泛使用将导致EV - A71相关手足口病的发病率以及由EV - A71引起的重症病例数均下降。
两剂量EV - A71疫苗接种在现实世界中预防手足口病非常有效，EV - A71疫苗的广泛使用导致EV - A71相关手足口病的发病率以及由EV - A71引起的重症病例数下降。研究结果表明，给6个月至71个月大的儿童接种两剂量EV - A71灭活疫苗可有效预防EV - A71相关手足口病，这凸显了开发一种用于预防非EV - A71引起病例的多价手足口病疫苗的必要性。
