{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,19]],"date-time":"2026-10-19T12:04:46Z","timestamp":1792411486178,"version":"4.4.0"},"reference-count":39,"publisher":"Wiley","issue":"11","license":[{"start":{"date-parts":[[2025,10,22]],"date-time":"2025-10-22T00:00:00Z","timestamp":1761091200000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"DOI":"10.13039\/501100013120","name":"European Medicines Agency","doi-asserted-by":"publisher","award":["EMA\/2020\/46\/TDA\/L5.06"],"award-info":[{"award-number":["EMA\/2020\/46\/TDA\/L5.06"]}],"id":[{"id":"10.13039\/501100013120","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Pharmacoepidemiology and Drug"],"published-print":{"date-parts":[[2025,11]]},"abstract":"<jats:title>ABSTRACT<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Purpose<\/jats:title>\n                    <jats:p>Despite Spain's\u2009&gt;\u20092 million COVID\u201019 paediatric cases before 2024, few required hospitalisations (8900). We aimed to estimate the effectiveness of two\u2010dose COVID\u201019 vaccinations against hospitalisation \u2018with\u2019 and \u2018for\u2019 COVID\u201019 in paediatrics.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>All individuals aged 5\u201314\u2009years between January 2021 and February 2022 in two databases in Spain (SIDIAP and BIFAP) vaccinated against COVID\u201019 (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\u2010CoV\u20102 infections were excluded. COVID\u201019 was identified as the main reason (hospitalisation \u2018for\u2019 COVID\u201019; SIDIAP) or as one of the reasons (hospitalisation \u2018with\u2019 COVID\u201019; BIFAP) for hospitalisation with a positive SARS\u2010CoV\u20102 test \u00b130\u2009days. Incidence rate differences and vaccine effectiveness (VE; 95% CI; controlled by inverse probability weights) against hospitalisations \u2018for\u2019 and \u2018with\u2019 COVID\u201019 were calculated.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>\n                      The cohorts included 75\u2009361 (SIDIAP) and 178\u2009589 (BIFAP) pairs. Among vaccinated individuals (99.99% with mRNA vaccines) and controls, &lt;\u20095 and 15 hospitalisations \u2018for\u2019 COVID\u201019 were identified (SIDIAP), whereas 21 and 32 hospitalisations \u2018with\u2019 COVID\u201019 (BIFAP), all aged 12\u201314\u2009years old. Vaccination prevented 2.5 hospitalisations \u2018for\u2019 and 0.5 \u2018with\u2019 COVID\u201019 during the Delta period, and 0.8 hospitalisations \u2018with\u2019 COVID\u201019 during Omicron predominance per 10\n                      <jats:sup>6<\/jats:sup>\n                      person\u2010days. The VE was 94% (95% CI: 52%\u201399%; SIDIAP) and 53% (95% CI: 18%\u201374%; BIFAP).\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>Given the low incidence of hospitalised COVID\u201019, two\u2010dose series mRNA vaccination showed moderate\u2010high effectiveness with few averted cases. Including hospitalisation \u2018with\u2019 COVID\u201019 underestimated the effectiveness. If paediatric severe COVID\u201019 remains rare, larger databases are required to understand precisely the effectiveness and impact of new vaccines.<\/jats:p>\n                    <jats:p>\n                      <jats:bold>Trial Registration:<\/jats:bold>\n                      EU PAS Register number: EUPAS47725\n                    <\/jats:p>\n                  <\/jats:sec>","DOI":"10.1002\/pds.70239","type":"journal-article","created":{"date-parts":[[2025,10,23]],"date-time":"2025-10-23T01:38:44Z","timestamp":1761183524000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":3,"title":["Impact and Effectiveness of\n                    <scp>COVID<\/scp>\n                    \u201019\n                    <scp>mRNA<\/scp>\n                    Vaccination Against\n                    <scp>COVID<\/scp>\n                    \u201019 Hospitalisation in Paediatrics: A Cohort Study Using Two Linked Data Sources in Spain"],"prefix":"10.1002","volume":"34","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-8280-7489","authenticated-orcid":false,"given":"Bel\u00e9n","family":"Castillo\u2010Cano","sequence":"first","affiliation":[{"name":"Division of Pharmacoepidemiology and Pharmacovigilance Spanish Agency of Medicines and Medical Devices (AEMPS)  Madrid Spain"},{"name":"VAccine Monitoring Collaboration for Europe  Brussels Belgium"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Fabio","family":"Riefolo","sequence":"additional","affiliation":[{"name":"VAccine Monitoring Collaboration for Europe  Brussels Belgium"},{"name":"Teamit Institute, Partnership, Barcelona Health Hub  Barcelona Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Felipe","family":"Villalobos","sequence":"additional","affiliation":[{"name":"VAccine Monitoring Collaboration for Europe  Brussels Belgium"},{"name":"Fundaci\u00f3 Institut Universitari per a la Recerca a L'atenci\u00f3 Prim\u00e0ria de Salut Jordi Gol i Gurina (IDIAPJGol)  Barcelona Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mar","family":"Mart\u00edn\u2010P\u00e9rez","sequence":"additional","affiliation":[{"name":"Division of Pharmacoepidemiology and Pharmacovigilance Spanish Agency of Medicines and Medical Devices (AEMPS)  Madrid Spain"},{"name":"VAccine Monitoring Collaboration for Europe  Brussels Belgium"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Davide","family":"Messina","sequence":"additional","affiliation":[{"name":"Agenzia Regionale di Sanita' Toscana  Florence Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Roel","family":"Elbers","sequence":"additional","affiliation":[{"name":"Department of Data Science and Biostatistics University Medical Center Utrecht  Utrecht the Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Dorieke","family":"Brink\u2010Kwakkel","sequence":"additional","affiliation":[{"name":"Department of Data Science and Biostatistics University Medical Center Utrecht  Utrecht the Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Carlo Alberto","family":"Bissacco","sequence":"additional","affiliation":[{"name":"Fundaci\u00f3 Institut Universitari per a la Recerca a L'atenci\u00f3 Prim\u00e0ria de Salut Jordi Gol i Gurina (IDIAPJGol)  Barcelona Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Elena","family":"Segundo","sequence":"additional","affiliation":[{"name":"Fundaci\u00f3 Institut Universitari per a la Recerca a L'atenci\u00f3 Prim\u00e0ria de Salut Jordi Gol i Gurina (IDIAPJGol)  Barcelona Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Luis Carlos","family":"Saiz","sequence":"additional","affiliation":[{"name":"Unit of Innovation and Organization, Navarre Health Service  Pamplona Spain"},{"name":"IdiSNA, Navarra Institute for Health Research  Pamplona Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Leire","family":"Leache","sequence":"additional","affiliation":[{"name":"Unit of Innovation and Organization, Navarre Health Service  Pamplona Spain"},{"name":"IdiSNA, Navarra Institute for Health Research  Pamplona Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Elisa","family":"Barbieri","sequence":"additional","affiliation":[{"name":"VAccine Monitoring Collaboration for Europe  Brussels Belgium"},{"name":"Division of Paediatric Infectious Diseases, Department of Women's and Children's Health University of Padova  Padua Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tiago","family":"Vaz","sequence":"additional","affiliation":[{"name":"Department of Data Science and Biostatistics University Medical Center Utrecht  Utrecht the 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