Effectiveness of the BNT162b2 XBB.1.5-adapted vaccine against COVID-19 hospitalization related to the JN.1 variant in Europe: a test-negative case-control study using the id.DRIVE platform

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Institut Català de la Salut
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[Nguyen JL, Volkman HR, Marques C] Pfizer Inc., New York, NY, United States. [Mitratza M, de Munter L, Tran TMP] P95 Epidemiology and Pharmacovigilance, Leuven, Belgium. [Antón A] Servei de Microbiologia, Vall d’Hebron Hospital Universitari, Barcelona, Spain. Vall d’Hebron Institut de Recerca (VHIR), Barcelona, Spain. Universitat Autònoma de Barcelona, Bellaterra, Spain. [Otero-Romero S] Servei de Medicina Preventiva i Epidemiologia, Vall d’Hebron Hospital Universitari, Barcelona, Spain. Vall d’Hebron Institut de Recerca (VHIR), Barcelona, Spain. Universitat Autònoma de Barcelona, Bellaterra, Spain. Servei de Neurologia-Neuroimmunologia, Centre d’Esclerosi Múltiple de Catalunya (CEMCAT), Barcelona, Spain. Vall d’Hebron Hospital Universitari, Barcelona, Spain. Vall d’Hebron Institut de Recerca (VHIR), Barcelona, Spain. Universitat Autònoma de Barcelona, Bellaterra, Spain
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Vall d'Hebron Barcelona Hospital Campus
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Nguyen, Jennifer
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Mitratza, Marianna
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Volkman, Hannah R
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de Munter, Leonie
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Tran, Thao Mai Phuong
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Marques, Cátia
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Otero-Romero, Susana
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Antón Pagarolas, Andrés
dc.date.issued
2025-03-12T07:59:37Z
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2025-03-12T07:59:37Z
dc.date.issued
2024
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2025-01
dc.identifier
Nguyen JL, Mitratza M, Volkman HR, de Munter L, Tran TMP, Marques C, et al. Effectiveness of the BNT162b2 XBB.1.5-adapted vaccine against COVID-19 hospitalization related to the JN.1 variant in Europe: a test-negative case-control study using the id.DRIVE platform. eClinicalMedicine. 2025 Jan;79:102995.
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2589-5370
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http://hdl.handle.net/11351/12748
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10.1016/j.eclinm.2024.102995
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39726669
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001434970100001
dc.description.abstract
COVID-19 vaccination; SARS-CoV-2; Vaccine effectiveness
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Vacunació contra la COVID-19; SARS-CoV-2; Eficàcia de la vacuna
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Vacunación contra la COVID-19; SARS-CoV-2; Efectividad de la vacuna
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Background Prior studies have reported lower effectiveness of XBB.1.5-adapted vaccines against hospitalization related to the Omicron JN.1 variant than the XBB variant. This study evaluated the effectiveness and durability of the BNT162b2 XBB.1.5-adapted vaccine against JN.1-related hospitalization during the 2023–2024 season in Europe. Methods A test-negative case–control study was carried out in adults (≥18 y) hospitalized between 2 October 2023 and 2 April 2024 with severe acute respiratory infection (SARI) within the id.DRIVE partnership. This study included nine sites across Belgium, Germany, Italy, and Spain. Cases had a laboratory-confirmed JN.1 infection or a positive SARS-CoV-2 test with symptom onset during JN.1 predominance; controls had a negative SARS-CoV-2 test and symptom onset during JN.1 predominance. The primary objective was to estimate BNT162b2 XBB.1.5-adapted vaccine effectiveness (VE) against COVID-19 hospitalization. One case was matched with up to four controls, according to symptom onset date and site. Multivariable analyses were adjusted for symptom onset date, age, sex, and number of chronic conditions. Findings Among 308 test-positive cases and 1117 test-negative controls, BNT162b2 XBB.1.5-adapted VE against hospitalization compared to no vaccination this season was 53.8% (95% CI 38.4–65.4) after a median of 63 days following vaccination. Protection was sustained through five months; VE was 52.2% (95% CI 41.3–61.1) 2 to <4 weeks after vaccination, 48.9% (95% CI 17.9–68.2) at 4 to <8 weeks, and ranged from 54.6% to 59.5% at 4-week intervals from 8 to <22 weeks. Interpretation BNT162b2 XBB.1.5-adapted vaccine provided protection against JN.1-related hospitalization, regardless of prior vaccination history, with no evidence of waning through five months. These data support yearly vaccination against COVID-19 to prevent severe illness during the respiratory virus season.
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Pfizer.
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application/pdf
dc.language
eng
dc.publisher
Elsevier
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eClinicalMedicine;79
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https://doi.org/10.1016/j.eclinm.2024.102995
dc.rights
Attribution-NonCommercial 4.0 International
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http://creativecommons.org/licenses/by-nc/4.0/
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info:eu-repo/semantics/openAccess
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Scientia
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COVID-19 (Malaltia) - Vacunació
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Avaluació de resultats (Assistència sanitària)
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Hospitals - Ingressos i altes
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DISEASES::Virus Diseases::RNA Virus Infections::Nidovirales Infections::Coronaviridae Infections::Coronavirus Infections
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Other subheadings::Other subheadings::Other subheadings::/prevention & control
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CHEMICALS AND DRUGS::Complex Mixtures::Biological Products::Vaccines
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ANALYTICAL, DIAGNOSTIC AND THERAPEUTIC TECHNIQUES, AND EQUIPMENT::Therapeutics::Patient Care::Hospitalization
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CHEMICALS AND DRUGS::Amino Acids, Peptides, and Proteins::Proteins::Blood Proteins::Immunoproteins::Immunoglobulins::Antibodies::Antibodies, Viral
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ANALYTICAL, DIAGNOSTIC AND THERAPEUTIC TECHNIQUES, AND EQUIPMENT::Diagnosis::Prognosis::Treatment Outcome
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ENFERMEDADES::virosis::infecciones por virus ARN::infecciones por Nidovirales::infecciones por Coronaviridae::infecciones por Coronavirus
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Otros calificadores::Otros calificadores::Otros calificadores::/prevención & control
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COMPUESTOS QUÍMICOS Y DROGAS::mezclas complejas::productos biológicos::vacunas
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TÉCNICAS Y EQUIPOS ANALÍTICOS, DIAGNÓSTICOS Y TERAPÉUTICOS::terapéutica::asistencia al paciente::hospitalización
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COMPUESTOS QUÍMICOS Y DROGAS::aminoácidos, péptidos y proteínas::proteínas::proteínas sanguíneas::inmunoproteínas::inmunoglobulinas::anticuerpos::anticuerpos víricos
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TÉCNICAS Y EQUIPOS ANALÍTICOS, DIAGNÓSTICOS Y TERAPÉUTICOS::diagnóstico::pronóstico::resultado del tratamiento
dc.title
Effectiveness of the BNT162b2 XBB.1.5-adapted vaccine against COVID-19 hospitalization related to the JN.1 variant in Europe: a test-negative case-control study using the id.DRIVE platform
dc.type
info:eu-repo/semantics/article
dc.type
info:eu-repo/semantics/publishedVersion


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