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Population-Level Impact of the Enterovirus A71 Vaccination Program on Hand, Foot, and Mouth Disease: Ecological
Ye Tong1, Huan Fan1, Jing Wang1
1Department of Acute Infectious Disease Control and Prevention, Jiangsu Provincial Center for Disease Control and Prevention, 172 Jiangsu Road, Nanjing, 210009, China, 86 25-83759421.
Background:
Hand, foot, and mouth disease (HFMD), a common childhood illness caused by various enteroviruses, poses a significant public health threat in the Asia-Pacific region, where severe cases associated with enterovirus A71 (EV71) are a major concern. The EV71 vaccination program was introduced in China in late 2016. Although randomized controlled trials have established the robust efficacy and safety of these vaccines, assessing their real-world performance remains crucial. Subsequent studies have evaluated its real-world effectiveness in several provinces, including Zhejiang and Guangdong. However, evidence on its real-world impact in reducing EV71-associated HFMD in Jiangsu Province remains limited.
Objective:
This study aimed to describe HFMD epidemiological characteristics and to evaluate the population-level effectiveness of the EV71 vaccination program in Jiangsu Province.
Methods:
We characterized the temporal distribution of EV71-related HFMD cases based on longitudinal surveillance data collected through the National Notifiable Diseases Surveillance System in Jiangsu Province from 2012 to 2019 and assessed the impact of vaccination using a Bayesian structural time series model under a counterfactual framework. The intervention effect of the EV71 vaccine was estimated by comparing the observed data with predictions from a counterfactual model scenario without vaccination.
Results:
A total of 932,274 HFMD cases were reported in Jiangsu from 2012 to 2019, including 5190 (0.56%) severe cases. An estimated 140,876 (15.11%) cases were attributed to EV71. EV71-associated HFMD cases showed a marked decline, with estimated numbers of 22,303, 9796, and 3900 in 2017, 2018, and 2019, respectively. We estimated that 30,117 EV71 cases (95% credible interval -1777 to 93,601) were prevented by the vaccination program from 2017 to 2019, corresponding to a reduction of 45.55% (95% credible interval -5.19% to 72.22%). The effectiveness of vaccination increased annually, with reductions of -1.03% (95% credible interval -94.85% to 48.29%) in 2017, 55.54% (95% credible interval 13.94%-77.56%) in 2018, and 82.28% (95% credible interval 65.77%-90.89%) in 2019. Furthermore, we observed that children younger than 4 years obtained greater benefits compared with those older than 4 years, with the greatest reduction of 57.68% (95% credible interval 13.04%-79.65%) in the 3- to 4-year age group, followed by a 48.09% (95% credible interval 28.00%-62.98%) reduction in the 0- to 2-year age group. In contrast, the reduction was markedly lower, at 16.75 % (95% credible interval -96.53% to 65.47%) in children older than 4 years during the 2017 to 2019 period.
Conclusions:
EV71 vaccination is an effective measure to prevent HFMD. The sharp decline in EV71-associated HFMD cases following the implementation of the EV71 vaccination program suggests a potential causal relationship. Therefore, strengthening vaccine coverage remains a public health priority.
