Evidence map›Paper›PMID 40402938›Full record

SynthesisPloS one2025

The efficacy and effectiveness of enterovirus A71 vaccines against hand, foot, and mouth disease: A systematic review and meta-analysis.

Xuemei Yan, Yuanhua Liu, Fengkun Chen, Zhaorui Chang, Zhijie Zhang, Margarita Pons-Salort, Nicholas C Grassly

Abstract readSystematic ReviewMeta-Analysis
In one paragraph

Synthesis in PloS one, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

7 citing papers in PubMed.

  1. Article
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

7 authors.

Xuemei YanMRC Centre for Global Infectious Disease Analysis, School of Public Health, Imperial College London, London, United Kingdom.ORCID https://orcid.org/0000-0001-9134-3444
Yuanhua LiuDepartment of Epidemiology and Health Statistics, School of Public Health, Fudan University, Shanghai, China.
Fengkun ChenDepartment of Epidemiology and Health Statistics, School of Public Health, Fudan University, Shanghai, China.
Zhaorui ChangDivision of Infectious Disease, Key Laboratory of Surveillance and Early-warning on Infectious Disease, Chinese Center for Disease Control and Prevention, Beijing, China.
Zhijie ZhangDepartment of Epidemiology and Health Statistics, School of Public Health, Fudan University, Shanghai, China.
Margarita Pons-SalortMRC Centre for Global Infectious Disease Analysis, School of Public Health, Imperial College London, London, United Kingdom.
Nicholas C GrasslyMRC Centre for Global Infectious Disease Analysis, School of Public Health, Imperial College London, London, United Kingdom.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Enterovirus A71 (EV-A71) is a major cause of severe hand, foot, and mouth disease (HFMD) among children in the Asia-Pacific region. Here we review randomised clinical trial data and post-licensure effectiveness studies of inactivated EV-A71 vaccines following their development and licensure in China since late 2015. We searched PubMed, Web of Science Core Collection, Elsevier ScienceDirect, China National Knowledge Infrastructure (CNKI), and Wanfang Data on 20 May 2024 with no date restriction in English and Mandarin, using key terms including "EV-A71", "enterovirus 71", "hand, foot, and mouth disease", "HFMD", "vaccine", "efficacy", "effectiveness", "protection" and "impact". Phase III randomized controlled trials (RCTs) reporting vaccine efficacy and observational studies on effectiveness were eligible for inclusion. We excluded studies that evaluated non-laboratory confirmed HFMD associated outcomes, abstracts, reviews, comments, animal studies, cross-sectional studies, and modelling studies. Summary measures of vaccine efficacy and effectiveness were based on random-effects models. After screening, 14 articles were eligible for inclusion, including 6 reporting 4 different phase III RCTs. Estimated efficacy of 2 doses of EV-A71 vaccine against EV-A71 associated HFMD 1 year after vaccination ranged from 90.0% to 97.9%, with an overall estimate for all products of 95.6% (95% Confidence Interval: 92.1, 97.5). Efficacy remained high at 26 months post-vaccination, ranging from 94.7% to 94.8%. The estimated overall effectiveness of 2-dose vaccination against any EV-A71-HFMD across five test-negative case-control studies was 84.3% (95% CI: 75.2, 90.0) among children aged 0-12 years. Effectiveness was higher in older children compared to younger children (85.3% (72.9, 92.1) vs. 79.8% (61.2, 89.5)) and higher against severe compared with non-severe EV-A71-HFMD (90.0% (80.0, 95.0) vs. 76.5% (50.0, 89.0)). The effectiveness declined in more recent studies with longer follow-up. Inactivated EV-A71 vaccines offer a high level of protection against EV-A71 HFMD. Longer term studies are needed to evaluate the persistence of protection beyond 2 years post-vaccination.

Indexed as

Enterovirus A, HumanHand, Foot and Mouth DiseaseVaccine EfficacyViral VaccinesHumansInfantRandomized Controlled Trials as TopicViral Vaccines

Identifiers

PMID40402938
PMCPMC12097632

What OpenQuestion holds

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LicenceCC BY
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Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.