Vaccine effectiveness of JCOVDEN single-dose against COVID-19 hospitalisation in Europe: An id.DRIVE test-negative case-control study
- PMID: 40014936
- DOI: 10.1016/j.jiph.2025.102700
Vaccine effectiveness of JCOVDEN single-dose against COVID-19 hospitalisation in Europe: An id.DRIVE test-negative case-control study
Abstract
Background: JCOVDEN (Ad26.COV2.S), a viral-vector vaccine, was granted conditional marketing authorisation in the European Union for the prevention of COVID-19 in early 2021. We present JCOVDEN single-dose vaccine effectiveness (VE) estimates against COVID-19 hospitalisation.
Methods: The id.DRIVE (previously COVIDRIVE) COVID-19 VE study is an ongoing European non-interventional, multi-centre study with a test-negative case-control design. Study participants were adults ≥ 18 years old, hospitalised with severe acute respiratory infection between 1 May 2021 and 28 February 2023. Estimated as a single measure over the entire study period, VE was stratified by risk group, time since vaccination intervals (14 days-12 weeks, 12-to-25 weeks, 25-to-52 weeks, >52 weeks), SARS-CoV-2 variant and calendar time categories. All estimates were adjusted for symptom-onset date, age, sex, and number of pre-defined chronic conditions.
Results: Overall, VE was 55.6 % (95 % CI 23.6; 74.2) for a median time since vaccination of 146 days. For 18- to 49-year-olds, VE was 61.6 % (95 % CI 16.2; 82.4), 57.7 % (95 % CI 3.4; 81.5) for 50- to-64-years-olds, and 40.8 % (95 % CI -6.0; 66.9) for ≥ 65-year-olds. Most precise estimates were obtained for time since vaccination 12-to- 25-week interval (59.2 % [95 % CI 25.0; 77.8]) and for the calendar time period 1 Aug 2021 -30 Nov 2021 (Delta predominant; 51.2 % [95 % CI 21.7; 69.6]).
Conclusion: The JCOVDEN single-dose protected against COVID-19 hospitalisation. It is effective for at least six months, with VE estimates comparatively lower in the older age groups. Results had low to medium levels of certainty and are to be interpreted with caution.
Keywords: Ad26.COV2.S; Effectiveness; Post-authorization; SARS-CoV-2; Severe acute respiratory infection; Study.
Copyright © 2025 The Authors. Published by Elsevier Ltd.. All rights reserved.
Conflict of interest statement
Declaration of Competing Interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: NP declares employment by Janssen Pharmaceuticals and ownership of Janssen Pharmaceuticals shares. ECN declares employment by Janssen Pharmaceuticals and ownership of Janssen Pharmaceuticals stocks during the time of the study and the writing of the manuscript, and support for attending meetings and/or travel by Janssen Pharmaceuticals. CW-T, KYN, LD, LdM, NV, and KB are employed by P95. AD was employed by P95 during the time of the study and the writing of the manuscript. P95 received consulting fees from different COVID-19 vaccine manufacturers, including Janssen, for the id.DRIVE study. KB declares consulting fees from AstraZeneca, Bavarian Nordic, CureVac, Janssen, GSK, Pfizer, Novavax, Valneva and WHO, ownership of P95 stocks, and royalties for the book “Vaccination Programmes: epidemiology, monitoring, evaluation’ by Hahné, Bollaerts, Farrington. AOS declares partial funding from Janssen, GlaxoSmithKline, Pfizer, and AstraZeneca of the hospital network for the identification of cases in The Valencia Region of Spain. AM-I declares as Co-PI from VAHNSI (FISABIO) that her foundation received funding from P95 via id.DRIVE to conduct the study. SB declares payment for lecture from GlaxoSmithKline and meeting invitation by MSD. IC declares support from Pfizer to attend a congress. GLtK, AA, CM, and XH declare no conflicts of interest. SO-R declares payment for presentations from GlaxoSmithKline and Sanofi. GI declares payment for participation as an expert in the Medical Education Steering Committee (MESC) Vaccines of 2021.
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