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

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

doi:10.1016/j.eclinm.2024.102995

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. 2024 Dec 9:79:102995. doi: 10.1016/j.eclinm.2024.102995. eCollection 2025 Jan.

Authors

Jennifer L Nguyen¹, Marianna Mitratza², Hannah R Volkman¹, Leonie de Munter², Thao Mai Phuong Tran², Catia Marques¹, Mustapha Mustapha¹, Srinivas Valluri¹, Jingyan Yang¹, Andrés Antón³, Irma Casas⁴, Eduardo Conde-Sousa², Laura Drikite², Beate Grüner⁵, Giancarlo Icardi⁶, Gerrit Luit Ten Kate⁷, Charlotte Martin⁸, Ainara Mira-Iglesias^{9

10}, Alejandro Orrico-Sánchez^{9

10}, Susana Otero-Romero^{11

12}, Gernot Rohde¹³, Luis Jodar¹, John M McLaughlin¹, Kaatje Bollaerts²

Affiliations

¹ Pfizer Inc., 66 Hudson Blvd. E., New York, NY 10001, United States.
² P95 Epidemiology and Pharmacovigilance, Koning Leopold III Laan 1, Leuven 3001, Belgium.
³ Microbiology 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.
⁴ Hospital Universitari Germans Trias i Pujol, Carretera del Canyet, Badalona, Barcelona 08916, Spain.
⁵ University Hospital Ulm, Division of Infectious Diseases, Department of Internal Medicine III, Alber-Einstein-Allee 23, Ulm 89081, Germany.
⁶ Centro Interuniversitario per la Ricerca sull'Influenza e le altre Infezioni Trasmissibili - IRCCS Policlinico San Martino Hospital, Largo Benzi 10, Genoa 16132, Italy.
⁷ Universitair Ziekenhuis Antwerpen, Drie Eikenstraat 655, Edegem 2650, Belgium.
⁸ Le Centre Hospitalier Universitaire St Pierre, Rue Haute 322, Brussels 1000, Belgium.
⁹ Vaccine Research Department, Fisabio - Public Health, Avda. Cataluña 21, Valencia 46020, Spain.
¹⁰ Biomedical Research Consortium of Epidemiology and Public Health (CIBER-ESP), Instituto de Salud Carlos III, Madrid, Spain.
¹¹ Preventive 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.
¹² 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, Spain.
¹³ Goethe University Frankfurt, University Hospital, Medical Clinic I, Department of Respiratory Medicine, Theodor-Stern-Kai 7, Frankfurt/Main 60590, Germany.

Abstract

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.

Keywords: BNT162b2; COVID-19; COVID-19 vaccination; JN.1; SARS-CoV-2; Vaccine effectiveness; XBB adapted vaccine.