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Vaccine Efficacy / Ev-a71 Vaccine / Vaccine Effectiveness (ve) · Journal article
Human Vaccines & Immunotherapeutics · September 9, 2026
Well-designed and adequately powered for the question it asks.
In a 15-year real-world surveillance study in Shanghai, EV-A71 vaccination achieved 89.9% effectiveness against EV-A71-associated HFMD and herpangina with two-dose series, and 67.9% with one dose, measured via test-negative design. Population-level incidence, severity, and fatality rates of HFMD declined substantially (56.7%, 95.2%, and 100% respectively) following vaccine implementation, though immunity coverage remained 50% and vaccine-driven serotype shifts toward non-EV-A71 strains occurred.
Test-negative case-control study with population-based surveillance data. All residents of Minhang district, Shanghai with laboratory-confirmed HFMD or herpangina (cases) or negative HFMD test result (controls) during 2009-2023; no age or other eligibility restrictions explicitly stated.. Intervention: EV-A71 vaccine (licensed in China 2016); one-dose or two-dose series. Compared with: Unvaccinated (test-negative controls with negative HFMD test result). n = 73,160. Minhang district, Shanghai, China.
Two-dose EV-A71 vaccine effectiveness against EV-A71-associated HFMD and herpangina: 89.9% (95% CI: 74.5-96.0) One-dose vaccine effectiveness: 67.9% (95% CI: 2.6-89.6) Post-vaccination HFMD incidence declined 56.7%, case-severity rate declined 95.2%, fatality rate declined 100%
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Clinicians and public health officials in regions with EV-A71 vaccination programs can expect robust protection against severe EV-A71-associated HFMD with two-dose series; however, the emergence of non-EV-A71 serotypes (CV-A6, CV-A10) as dominant strains suggests that current vaccines do not fully control HFMD epidemiology and multivalent vaccine development is warranted.
Rigorous test-negative design study with large real-world population (73,160 cases) over 15 years demonstrating vaccine effectiveness against the target pathogen with precise confidence intervals; not practice-changing because vaccination policy was already implemented.
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Clinicians and public health officials in regions with EV-A71 vaccination programs can expect robust protection against severe EV-A71-associated HFMD with two-dose series; however, the emergence of non-EV-A71 serotypes (CV-A6, CV-A10) as dominant strains suggests that current vaccines do not fully control HFMD epidemiology and multivalent vaccine development is warranted.
Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.
A significant reduction in hand-foot-mouth disease (HFMD) cases has occurred across the country, since EV-A71 vaccine was licensed for use in China in 2016. We compared the epidemiology and virological characteristics before and after the implementation of EV-A71 vaccination over a 15-y period in Minhang district, Shanghai, and conducted a test-negative design to estimate the vaccine effectiveness (VE) of EV-A71 vaccine against HFMD. A total of 73,160 HFMD cases, 361 severe cases, and 3 fatalities were reported in the Minhang district, Shanghai during 2009-2023. After the implementation of EV-A71 vaccine program, the incidence rate, case-severity rate, and fatality rate of HFMD showed a significant decline by 56.7%, 95.2%, and 100.0%, respectively. The proportion of age group 6-10 y increased by 105.7%. The predominance of EV-A71 and CV-A16 was replaced by CV-A6 and CV-A10 in the post-2017 period. Full-dose immunization coverage rate maintained 50% during 2019-2023. The overall VE against EV-A71-associated HFMD and herpangina was 89.9% (95% CI: 74.5-96.0) for two-dose series and 67.9% (95% CI: 2.6-89.6) for one-dose vaccination. The VE for two-dose vaccination was 92.2%, 88.1%, and 100% against EV-A71-associated outpatient visit, non-severe hospitalization, and severe complications, respectively. There was no cross-protective effect of EV-A71 vaccination against non-EV-A71 serotype infection. EV-A71 vaccination program substantially reduced HFMD burden in Shanghai, with two-dose series providing robust protection against EV-A71-associated HFMD and herpangina. The shift of non-EV-A71 serotypes warrants an effort to develop multivalent vaccines to control HFMD epidemics.
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