Effectiveness of the enterovirus A71 vaccine on hand, foot, and mouth disease: a real-world study in China.

Objectives: 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.

Methods: 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.

Results: 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 (I² = 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).

Discussion: 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.