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 platformResearch in context

Summary: 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 hospi...

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Main Authors: Jennifer L. Nguyen, Marianna Mitratza, Hannah R. Volkman, Leonie de Munter, Thao Mai Phuong Tran, Catia Marques, Mustapha Mustapha, Srinivas Valluri, Jingyan Yang, Andrés Antón, Irma Casas, Eduardo Conde-Sousa, Laura Drikite, Beate Grüner, Giancarlo Icardi, Gerrit Luit ten Kate, Charlotte Martin, Ainara Mira-Iglesias, Alejandro Orrico-Sánchez, Susana Otero-Romero, Gernot Rohde, Luis Jodar, John M. McLaughlin, Kaatje Bollaerts
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Language:English
Published: Elsevier 2025-01-01
Series:EClinicalMedicine
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Online Access:http://www.sciencedirect.com/science/article/pii/S2589537024005741
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author Jennifer L. Nguyen
Marianna Mitratza
Hannah R. Volkman
Leonie de Munter
Thao Mai Phuong Tran
Catia Marques
Mustapha Mustapha
Srinivas Valluri
Jingyan Yang
Andrés Antón
Irma Casas
Eduardo Conde-Sousa
Laura Drikite
Beate Grüner
Giancarlo Icardi
Gerrit Luit ten Kate
Charlotte Martin
Ainara Mira-Iglesias
Alejandro Orrico-Sánchez
Susana Otero-Romero
Gernot Rohde
Luis Jodar
John M. McLaughlin
Kaatje Bollaerts
author_facet Jennifer L. Nguyen
Marianna Mitratza
Hannah R. Volkman
Leonie de Munter
Thao Mai Phuong Tran
Catia Marques
Mustapha Mustapha
Srinivas Valluri
Jingyan Yang
Andrés Antón
Irma Casas
Eduardo Conde-Sousa
Laura Drikite
Beate Grüner
Giancarlo Icardi
Gerrit Luit ten Kate
Charlotte Martin
Ainara Mira-Iglesias
Alejandro Orrico-Sánchez
Susana Otero-Romero
Gernot Rohde
Luis Jodar
John M. McLaughlin
Kaatje Bollaerts
author_sort Jennifer L. Nguyen
collection DOAJ
description Summary: 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. Funding: Pfizer.
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spelling doaj-art-6a4716f5380547dc8a0d0874277b77152025-01-22T05:43:25ZengElsevierEClinicalMedicine2589-53702025-01-0179102995Effectiveness 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 platformResearch in contextJennifer L. Nguyen0Marianna Mitratza1Hannah R. Volkman2Leonie de Munter3Thao Mai Phuong Tran4Catia Marques5Mustapha Mustapha6Srinivas Valluri7Jingyan Yang8Andrés Antón9Irma Casas10Eduardo Conde-Sousa11Laura Drikite12Beate Grüner13Giancarlo Icardi14Gerrit Luit ten Kate15Charlotte Martin16Ainara Mira-Iglesias17Alejandro Orrico-Sánchez18Susana Otero-Romero19Gernot Rohde20Luis Jodar21John M. McLaughlin22Kaatje Bollaerts23Pfizer Inc., 66 Hudson Blvd. E., New York, NY 10001, United States; Corresponding author. 66 Hudson Blvd E, New York, NY 10001, United States.P95 Epidemiology and Pharmacovigilance, Koning Leopold III Laan 1, Leuven 3001, BelgiumPfizer Inc., 66 Hudson Blvd. E., New York, NY 10001, United StatesP95 Epidemiology and Pharmacovigilance, Koning Leopold III Laan 1, Leuven 3001, BelgiumP95 Epidemiology and Pharmacovigilance, Koning Leopold III Laan 1, Leuven 3001, BelgiumPfizer Inc., 66 Hudson Blvd. E., New York, NY 10001, United StatesPfizer Inc., 66 Hudson Blvd. E., New York, NY 10001, United StatesPfizer Inc., 66 Hudson Blvd. E., New York, NY 10001, United StatesPfizer Inc., 66 Hudson Blvd. E., New York, NY 10001, United StatesMicrobiology Department, Hospital Universitari Vall d'Hebron, Vall d'Hebron Institut de Recerca (VHIR), Universitat Autònoma de Barcelona, Paseo del Valle de Hebrón 119-129, Barcelona 08035, SpainHospital Universitari Germans Trias i Pujol, Carretera del Canyet, Badalona, Barcelona 08916, SpainP95 Epidemiology and Pharmacovigilance, Koning Leopold III Laan 1, Leuven 3001, BelgiumP95 Epidemiology and Pharmacovigilance, Koning Leopold III Laan 1, Leuven 3001, BelgiumUniversity Hospital Ulm, Division of Infectious Diseases, Department of Internal Medicine III, Alber-Einstein-Allee 23, Ulm 89081, GermanyCentro Interuniversitario per la Ricerca sull’Influenza e le altre Infezioni Trasmissibili - IRCCS Policlinico San Martino Hospital, Largo Benzi 10, Genoa 16132, ItalyUniversitair Ziekenhuis Antwerpen, Drie Eikenstraat 655, Edegem 2650, BelgiumLe Centre Hospitalier Universitaire St Pierre, Rue Haute 322, Brussels 1000, BelgiumVaccine Research Department, Fisabio – Public Health, Avda. Cataluña 21, Valencia 46020, Spain; Biomedical Research Consortium of Epidemiology and Public Health (CIBER-ESP), Instituto de Salud Carlos III, Madrid, SpainVaccine Research Department, Fisabio – Public Health, Avda. Cataluña 21, Valencia 46020, Spain; Biomedical Research Consortium of Epidemiology and Public Health (CIBER-ESP), Instituto de Salud Carlos III, Madrid, SpainPreventive Medicine and Epidemiology Department, Hospital Universitari Vall d'Hebron, Vall d'Hebron Institut de Recerca (VHIR), Universitat Autònoma de Barcelona, Paseo del Valle de Hebrón 119-129, Barcelona 08035, Spain; Centro de Esclerosis Múltiple de Catalunya (Cemcat), Department of Neurology/Neuroimmunology, Hospital Universitari Vall d'Hebron, Vall d'Hebron Institut de Recerca (VHIR), Universitat Autònoma de Barcelona, Paseo del Valle de Hebrón 119-129, Barcelona 08035, SpainGoethe University Frankfurt, University Hospital, Medical Clinic I, Department of Respiratory Medicine, Theodor-Stern-Kai 7, Frankfurt/Main 60590, GermanyPfizer Inc., 66 Hudson Blvd. E., New York, NY 10001, United StatesPfizer Inc., 66 Hudson Blvd. E., New York, NY 10001, United StatesP95 Epidemiology and Pharmacovigilance, Koning Leopold III Laan 1, Leuven 3001, BelgiumSummary: 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. Funding: Pfizer.http://www.sciencedirect.com/science/article/pii/S2589537024005741COVID-19SARS-CoV-2COVID-19 vaccinationVaccine effectivenessBNT162b2XBB adapted vaccine
spellingShingle Jennifer L. Nguyen
Marianna Mitratza
Hannah R. Volkman
Leonie de Munter
Thao Mai Phuong Tran
Catia Marques
Mustapha Mustapha
Srinivas Valluri
Jingyan Yang
Andrés Antón
Irma Casas
Eduardo Conde-Sousa
Laura Drikite
Beate Grüner
Giancarlo Icardi
Gerrit Luit ten Kate
Charlotte Martin
Ainara Mira-Iglesias
Alejandro Orrico-Sánchez
Susana Otero-Romero
Gernot Rohde
Luis Jodar
John M. McLaughlin
Kaatje Bollaerts
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 platformResearch in context
EClinicalMedicine
COVID-19
SARS-CoV-2
COVID-19 vaccination
Vaccine effectiveness
BNT162b2
XBB adapted vaccine
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 platformResearch in context
title_full 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 platformResearch in context
title_fullStr 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 platformResearch in context
title_full_unstemmed 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 platformResearch in context
title_short 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 platformResearch in context
title_sort 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 platformresearch in context
topic COVID-19
SARS-CoV-2
COVID-19 vaccination
Vaccine effectiveness
BNT162b2
XBB adapted vaccine
url http://www.sciencedirect.com/science/article/pii/S2589537024005741
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