Evidence map›Paper›PMID 41125425›Full record

ArticlePharmacoepidemiology and drug safety2025

Impact and Effectiveness of COVID-19 mRNA Vaccination Against COVID-19 Hospitalisation in Paediatrics: A Cohort Study Using Two Linked Data Sources in Spain.

Belén Castillo-Cano, Fabio Riefolo, Felipe Villalobos, Mar Martín-Pérez, Davide Messina, Roel Elbers, Dorieke Brink-Kwakkel, Carlo Alberto Bissacco, Elena Segundo, Luis Carlos Saiz and 6 more

Abstract read
In one paragraph

Article in Pharmacoepidemiology and drug safety, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

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

What it found

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2 · The registry

The trial behind it

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3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Article
4 · The record

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5 · Who and what money

Authors and funding

16 authors.

Belén Castillo-CanoDivision of Pharmacoepidemiology and Pharmacovigilance, Spanish Agency of Medicines and Medical Devices (AEMPS), Madrid, Spain.ORCID 0000-0001-8280-7489
Fabio RiefoloVAccine Monitoring Collaboration for Europe, Brussels, Belgium.
Felipe VillalobosVAccine Monitoring Collaboration for Europe, Brussels, Belgium.
Mar Martín-PérezDivision of Pharmacoepidemiology and Pharmacovigilance, Spanish Agency of Medicines and Medical Devices (AEMPS), Madrid, Spain.
Davide MessinaAgenzia Regionale di Sanita' Toscana, Florence, Italy.
Roel ElbersDepartment of Data Science and Biostatistics, University Medical Center Utrecht, Utrecht, the Netherlands.
Dorieke Brink-KwakkelDepartment of Data Science and Biostatistics, University Medical Center Utrecht, Utrecht, the Netherlands.
Carlo Alberto BissaccoFundació Institut Universitari per a la Recerca a L'atenció Primària de Salut Jordi Gol i Gurina (IDIAPJGol), Barcelona, Spain.
Elena SegundoFundació Institut Universitari per a la Recerca a L'atenció Primària de Salut Jordi Gol i Gurina (IDIAPJGol), Barcelona, Spain.
Luis Carlos SaizUnit of Innovation and Organization, Navarre Health Service, Pamplona, Spain.
Leire LeacheUnit of Innovation and Organization, Navarre Health Service, Pamplona, Spain.
Elisa BarbieriVAccine Monitoring Collaboration for Europe, Brussels, Belgium.
Tiago VazDepartment of Data Science and Biostatistics, University Medical Center Utrecht, Utrecht, the Netherlands.
Rosa GiniVAccine Monitoring Collaboration for Europe, Brussels, Belgium.ORCID 0000-0002-6250-877X
Olaf KlungelDivision of Pharmacoepidemiology & Clinical Pharmacology, Utrecht Institute for Pharmaceutical Sciences, Utrecht University, Utrecht, the Netherlands.
Elisa Martín-MerinoDivision of Pharmacoepidemiology and Pharmacovigilance, Spanish Agency of Medicines and Medical Devices (AEMPS), Madrid, Spain.ORCID 0000-0002-3576-8605

Funding

European Medicines Agency EMA/2020/46/TDA/L5.06
6 · The paper itself

Abstract

purposeDespite Spain's > 2 million COVID-19 paediatric cases before 2024, few required hospitalisations (8900). We aimed to estimate the effectiveness of two-dose COVID-19 vaccinations against hospitalisation 'with' and 'for' COVID-19 in paediatrics.

methodsAll individuals aged 5-14 years between January 2021 and February 2022 in two databases in Spain (SIDIAP and BIFAP) vaccinated against COVID-19 (two doses) were matched 1:1 to unvaccinated controls with the same age, sex, region and comorbidities on the dates of vaccination. Individuals with previous SARS-CoV-2 infections were excluded. COVID-19 was identified as the main reason (hospitalisation 'for' COVID-19; SIDIAP) or as one of the reasons (hospitalisation 'with' COVID-19; BIFAP) for hospitalisation with a positive SARS-CoV-2 test ±30 days. Incidence rate differences and vaccine effectiveness (VE; 95% CI; controlled by inverse probability weights) against hospitalisations 'for' and 'with' COVID-19 were calculated.

resultsThe cohorts included 75 361 (SIDIAP) and 178 589 (BIFAP) pairs. Among vaccinated individuals (99.99% with mRNA vaccines) and controls, < 5 and 15 hospitalisations 'for' COVID-19 were identified (SIDIAP), whereas 21 and 32 hospitalisations 'with' COVID-19 (BIFAP), all aged 12-14 years old. Vaccination prevented 2.5 hospitalisations 'for' and 0.5 'with' COVID-19 during the Delta period, and 0.8 hospitalisations 'with' COVID-19 during Omicron predominance per 10

conclusionsGiven the low incidence of hospitalised COVID-19, two-dose series mRNA vaccination showed moderate-high effectiveness with few averted cases. Including hospitalisation 'with' COVID-19 underestimated the effectiveness. If paediatric severe COVID-19 remains rare, larger databases are required to understand precisely the effectiveness and impact of new vaccines.

trial registrationEU PAS Register number: EUPAS47725.

Indexed as

COVID-19COVID-19 VaccinesHospitalizationVaccine EfficacyAdolescentChildChild, PreschoolCohort StudiesDatabases, FactualFemaleHumansInformation SourcesMalemRNA VaccinesSARS-CoV-2SpainCOVID-19 VaccinesmRNA Vaccineschildren and adolescentsCOVID‐19 vaccine effectivenesshospital COVID‐19 recordspaediatricsreal‐word dataretrospective cohort study

Identifiers

PMID41125425
PMCPMC12544726

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Registered trials

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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.