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EV-A71 vaccine provides over 98% efficacy against EV-A71-associated hand, foot, and mouth disease in childrenEV-A71 vaccine shows high efficacy against hand, foot, and mouth disease

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Key Takeaway
Note that the EV-A71 vaccine provides over 98% efficacy against HFMD with a favorable safety profile in children.

This meta-analysis evaluated the efficacy of the EV-A71 vaccine against hand, foot, and mouth disease (HFMD) in children across 36,659 participants. The analysis synthesized data from multiple trials to assess primary outcomes including clinical efficacy and secondary outcomes such as seropositivity, seroconversion, and geometric mean titers.

The meta-analysis reported a vaccine efficacy of over 98% against EV-A71-associated HFMD (RR 0.02; 95% CI 0.01-0.09; p = 0.0028). Significant increases in seropositivity were observed across all follow-up periods, with RR values of 5.8 (early), 3.09 (medium-term), and 2.95 (long-term). Furthermore, the vaccinated group showed a significantly higher rate of seroconversion (RR 13.04; 95% CI 2.80-60.61; p < 0.001) and higher geometric mean titers during early and medium-term follow-up.

Safety data indicated that solicited local and systemic adverse events were mild, with tolerability comparable between the vaccine and placebo groups. While the meta-analysis suggests robust immunogenicity and high clinical efficacy for the inactivated EV-A71 vaccine in children, specific limitations regarding long-term protection or booster schedules were not reported in the source data.

Hand, foot, and mouth disease can be a stressful experience for parents when their children fall ill. A large review of clinical trials involving over 36,000 children looked at how well an inactivated EV-A71 vaccine protects against this specific virus.

The data shows the vaccine is highly effective, with a success rate of over 98% in preventing cases caused by the EV-A71 virus. The study also found that children who received the vaccine showed much higher levels of antibodies early on and maintained those levels over the medium and long term.

Safety was another key focus for the researchers. They found that local and systemic side effects were mild, and the vaccine was well tolerated by the children compared to those who received a placebo. While these results are very promising for protecting children from this virus, always talk to your doctor about the best vaccination schedule for your child.

What this means for you:
The EV-A71 vaccine is over 98% effective at protecting children from hand, foot, and mouth disease.

Common questions

How effective is the EV-A71 vaccine for children?

The study found that the EV-A71 vaccine has an efficacy of over 98% against hand, foot, and mouth disease caused by the EV-A71 virus. This high rate of success was observed across the group of children studied.

Is the vaccine safe for kids?

Yes, the study reported that the vaccine had an acceptable safety profile. The local and systemic side effects were described as mild, and the vaccine was found to be well tolerated by the children who received it.

Does the protection from the vaccine last a long time?

The data shows that children who were vaccinated had higher levels of antibodies (seropositivity) in the early, medium-term, and long-term follow-up periods compared to those who did not receive the vaccine.

Study Details

Study typeMeta analysis
EvidenceLevel 1
PublishedDec 2026
View Original Abstract ↓
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;  < 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; = 0.0028; I = 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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