Key result
Inactivated EV-A71 vaccines cut EV-A71-associated hand, foot, and mouth disease risk by ~98% in children.
Why the study?
Enterovirus 71 is a principal cause of hand, foot, and mouth disease leading to severe neurological complications, prompting evaluation of the immunogenicity, safety, and efficacy of introduced inactivated vaccines versus placebo.
Does inactivated EV-A71 vaccine improve immunogenicity and prevent EV-A71-associated HFMD compared to placebo in children?
Meta-Analysis (n=36,659)
Does inactivated EV-A71 vaccine improve immunogenicity and prevent EV-A71-associated HFMD compared to placebo in children?
Relative Risk: 0.02 (95% CI 0.01–0.09)
p-value: p=0.0028
Inactivated EV-A71 vaccines provide robust immunogenicity and >98% efficacy against EV-A71-associated HFMD with an acceptable safety profile in children.
Supports EV-A71 vaccine use in endemic pediatric HFMD prevention; leaves open long-term durability and multivalent needs.
Introduction Enterovirus 71 (EV-A71) is a principal cause of hand, foot, and mouth disease (HFMD), potentially leading to severe neurological complications in children. Inactivated EV-A71 vaccines have been introduced. This study compares the immunogenicity, safety, and efficacy of EV-A71 vaccines versus placebo in pediatric populations.Research design and methods Following a PROSPERO-registered protocol, RCTs involving EV-A71 in children were identified via PubMed, Scopus, Cochrane, and ClinicalTrials.gov. Two independent reviewers performed screening, extraction, and RoB assessments (RoB 2.0).Results Five phase III RCTs involving 36,659 children were included. EV-A71 vaccination significantly increased seropositivity across follow-up periods, including early (RR 5.8), medium-term (RR 3.09), and long-term (RR 2.95) response. Seroconversion was significantly higher in the vaccinated group (pooled RR 13.04, 95% CI 2.80–60.61; p < 0.001). Geometric mean titers, analyzed using the ratio of means approach, were significantly higher in the vaccinated group during early and medium-term follow-up. Vaccine efficacy against EV-A71-associated HFMD exceeded 98% (pooled RR 0.02, 95% CI 0.01–0.09; p = 0.0028; I2 = 50%). Solicited local and systemic adverse events were mild and comparable between groups.Conclusion Inactivated EV-A71 vaccines robust immunogenicity, high clinical efficacy, and an acceptable safety profile in children. Future studies should explore long-term protection, booster schedules, and multivalent formulations against non-EV-A71 serotypes.
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Putra et al. (2026) conducted a meta-analysis in Enterovirus 71 (EV-A71) infection / Hand, foot, and mouth disease (HFMD) (n=36,659). Inactivated EV-A71 vaccines vs. Placebo was evaluated on EV-A71-associated HFMD (RR 0.02, 95% CI 0.01-0.09, p=0.0028). Inactivated EV-A71 vaccines demonstrated >98% efficacy against EV-A71-associated hand, foot, and mouth disease in children (pooled RR 0.02; 95% CI 0.01-0.09; p=0.0028).
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