Modifiers of COVID-19 vaccine efficacy: Results from four COVID-19 prevention network efficacy trials

Christine B, Turley, Wake Forest University School of Medicine; LaKesha K, Tables, Morehouse School of Medicine; Trevon, Fuller, Hospital Federal dos Servidores do Estado; Lisa J, Sanders, Morsani College of Medicine; Hyman, Scott, San Francisco Department of Public Health; Amaran, Moodley, University of California, San Diego; Amanda, Woodward Davis, Fred Hutchinson Cancer Research Center; Brett, Leav, Moderna Therapeutics; Jacqueline, Miller, Moderna Therapeutics; Kathryn, Schoemaker, AstraZeneca; An, Vandebosch, Janssen Vaccines &amp; Prevention B.V.; Jerald, Sadoff, Janssen Vaccines &amp; Prevention B.V.; Wayne, Woo, Novavax, Inc.; Iksung, Cho, Novavax, Inc.; Lisa M, Dunkle, Novavax, Inc.; Sijia, Li, University of Washington; Lars, van der Laan, University of Washington; Peter B, Gilbert, Fred Hutchinson Cancer Research Center; Dean, Follmann, National Institute of Allergy and Infectious Diseases (NIAID); Holly, Jaynes, Fred Hutchinson Cancer Research Center; James G, Kublin, Fred Hutchinson Cancer Research Center; Lindsey R, Baden, Brigham and Women's Hospital; Paul, Goepfert, The University of Alabama at Birmingham; Karen, Kotloff, University of Maryland School of Medicine; Cynthia L, Gay, UNC School of Medicine; Ann R, Falsey, University of Rochester; Hana M, El Sahly, Baylor College of Medicine; Magdalena E, Sobieszczyk, Columbia University Irving Medical Center; Yunda, Huang, Fred Hutchinson Cancer Research Center; Kathleen M, Neuzil, University of Maryland School of Medicine; Lawrence, Corey, Fred Hutchinson Cancer Research Center; Beatriz, Grinsztejn, Instituto Nacional de Infectologia Evandro Chagas (INI); Glenda, Gray, University of the Witwatersrand Faculty of Health Sciences; Nadine, Rouphael, Emory University; Alex, Luedtke, University of Washington

Persistent URL

https://open.library.emory.edu/purl/7612ngf31v-emory

Last modified

06/25/2025

Type of Material

Article

Authors

Christine B Turley, Wake Forest University School of Medicine

LaKesha K Tables, Morehouse School of Medicine

Trevon Fuller, Hospital Federal dos Servidores do Estado

Lisa J Sanders, Morsani College of Medicine

Hyman Scott, San Francisco Department of Public Health

Amaran Moodley, University of California, San DiegoAmanda Woodward Davis, Fred Hutchinson Cancer Research CenterBrett Leav, Moderna TherapeuticsJacqueline Miller, Moderna TherapeuticsKathryn Schoemaker, AstraZenecaAn Vandebosch, Janssen Vaccines & Prevention B.V.Jerald Sadoff, Janssen Vaccines & Prevention B.V.Wayne Woo, Novavax, Inc.Iksung Cho, Novavax, Inc.Lisa M Dunkle, Novavax, Inc.Sijia Li, University of WashingtonLars van der Laan, University of WashingtonPeter B Gilbert, Fred Hutchinson Cancer Research CenterDean Follmann, National Institute of Allergy and Infectious Diseases (NIAID)Holly Jaynes, Fred Hutchinson Cancer Research CenterJames G Kublin, Fred Hutchinson Cancer Research CenterLindsey R Baden, Brigham and Women's HospitalPaul Goepfert, The University of Alabama at BirminghamKaren Kotloff, University of Maryland School of MedicineCynthia L Gay, UNC School of MedicineAnn R Falsey, University of RochesterHana M El Sahly, Baylor College of MedicineMagdalena E Sobieszczyk, Columbia University Irving Medical CenterYunda Huang, Fred Hutchinson Cancer Research CenterKathleen M Neuzil, University of Maryland School of MedicineLawrence Corey, Fred Hutchinson Cancer Research CenterBeatriz Grinsztejn, Instituto Nacional de Infectologia Evandro Chagas (INI)Glenda Gray, University of the Witwatersrand Faculty of Health SciencesNadine Rouphael, Emory UniversityAlex Luedtke, University of Washington

Language

English

Date

2023-07-25

Publisher

Elsevier Ltd

Publication Version

Final Published Version

Copyright Statement

© 2023 Elsevier Ltd. All rights reserved.

Final Published Version (URL)

http://dx.doi.org/10.1016/j.vaccine.2023.06.066

Title of Journal or Parent Work

Vaccine

Volume

41

Issue

33

Start Page

4899

End Page

4906

Supplemental Material (URL)

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10288314/bin/mmc1.pdf

Abstract

Questions remain regarding the effect of baseline host and exposure factors on vaccine efficacy (VE) across pathogens and vaccine platforms. We report placebo-controlled data from four Phase 3 COVID-19 trials during the early period of the pandemic. This was a cross-protocol analysis of four randomized, placebo-controlled efficacy trials (Moderna/mRNA1273, AstraZeneca/AZD1222, Janssen/Ad26.COV2.S, and Novavax/NVX-CoV2373) using a harmonized design. Trials were conducted in the United States and international sites in adults ≥ 18 years of age. VE was assessed for symptomatic and severe COVID-19. We analyzed 114,480 participants from both placebo and vaccine arms, enrolled July 2020 to February 2021, with follow up through July 2021. VE against symptomatic COVID-19 showed little heterogeneity across baseline socio-demographic, clinical or exposure characteristics, in either univariate or multivariate analysis, regardless of vaccine platform. Similarly, VE against severe COVID-19 in the single trial (Janssen) with sufficient endpoints for analysis showed little evidence of heterogeneity. COVID-19 VE is not influenced by baseline host or exposure characteristics across efficacy trials of different vaccine platforms and countries when well matched to circulating virus strains. This supports use of these vaccines, regardless of platform type, as effective tools in the near term for reducing symptomatic and severe COVID-19, particularly for older individuals and those with common co-morbidities during major variant shifts. Clinical trial registration numbers: NCT04470427, NCT04516746, NCT04505722, and NCT04611802.

Author Notes