Journal article
Assessment and mitigation of bias in influenza and COVID-19 vaccine effectiveness analyses — IVY Network, September 1, 2022–March 30, 2023
Vaccine, Vol.43, 126492
01/01/2025
DOI: 10.1016/j.vaccine.2024.126492
PMCID: PMC12229715
PMID: 39515195
Abstract
In test-negative studies of vaccine effectiveness (VE), including patients with co-circulating, vaccine-preventable, respiratory pathogens in the control group for the pathogen of interest can introduce a downward bias on VE estimates.
A multicenter sentinel surveillance network in the US prospectively enrolled adults hospitalized with acute respiratory illness from September 1, 2022–March 31, 2023. We evaluated bias in estimates of VE against influenza–associated and COVID-19–associated hospitalization based on: inclusion vs exclusion of patients with a co-circulating virus among VE controls; observance of VE against the co-circulating virus (rather than the virus of interest), unadjusted and adjusted for vaccination against the virus of interest; and observance of influenza or COVID-19 against a sham outcome of respiratory syncytial virus (RSV).
Overall VE against influenza–associated hospitalizations was 6 percentage points lower when patients with COVID-19 were included in the control group, and overall VE against COVID-19–associated hospitalizations was 2 percentage points lower when patients with influenza were included in the control group. Analyses of VE against the co-circulating virus and against the sham outcome of RSV showed that downward bias was largely attributable the correlation of vaccination status across pathogens, but also potentially attributable to other sources of residual confounding in VE models.
Excluding cases of confounding respiratory pathogens from the control group in VE analysis for a pathogen of interest can reduce downward bias. This real-world analysis demonstrates that such exclusion is a helpful bias mitigation strategy, especially for measuring influenza VE, which included a high proportion of COVID-19 cases among controls.
Details
- Title: Subtitle
- Assessment and mitigation of bias in influenza and COVID-19 vaccine effectiveness analyses — IVY Network, September 1, 2022–March 30, 2023
- Creators
- Nathaniel M. Lewis - National Center for Immunization and Respiratory DiseasesElizabeth J. Harker - National Center for Immunization and Respiratory DiseasesAleda Leis - University of MichiganYuwei Zhu - Vanderbilt University Medical CenterH. Keipp Talbot - Vanderbilt University Medical CenterCarlos G. Grijalva - Vanderbilt University Medical CenterNatasha Halasa - Vanderbilt University Medical CenterJames D. Chappell - Vanderbilt University Medical CenterCassandra A. Johnson - Vanderbilt University Medical CenterTodd W. Rice - Vanderbilt University Medical CenterJonathan D. Casey - Vanderbilt University Medical CenterAdam S. Lauring - University of MichiganManjusha Gaglani - Baylor Scott & White HealthShekhar Ghamande - Baylor College of MedicineCristie Columbus - Baylor College of MedicineJay S. Steingrub - Baystate Medical CenterNathan I. Shapiro - Beth Israel Deaconess Medical CenterAbhijit Duggal - Cleveland ClinicJamie Felzer - Emory UniversityMatthew E. Prekker - Hennepin County Medical CenterIthan D. Peltan - University of UtahSamuel M. Brown - University of UtahDavid N. Hager - Johns Hopkins University School of MedicineMichelle N. Gong - Albert Einstein College of MedicineAmira Mohamed - Albert Einstein College of MedicineMatthew C. Exline - The Ohio State UniversityAkram Khan - Oregon Health & Science UniversityJennifer G. Wilson - Stanford University School of MedicineJarrod Mosier - University of ArizonaNida Qadir - Ronald Reagan UCLA Medical CenterSteven Y. Chang - Ronald Reagan UCLA Medical CenterAdit A. Ginde - University of Colorado Anschutz Medical CampusNicholas M. Mohr - University of IowaChristopher Mallow - University of MiamiEstelle S. Harris - University of UtahNicholas J. Johnson - University of WashingtonVasisht Srinivasan - University of WashingtonKevin W. Gibbs - Wake Forest UniversityJennie H. Kwon - Washington University in St. LouisIvana A. Vaughn - Henry Ford Health SystemMayur Ramesh - Henry Ford Health SystemBasmah Safdar - Yale UniversityJennifer DeCuir - National Center for Immunization and Respiratory DiseasesDiya Surie - Division of COVID-19 and Other Respiratory Viral Diseases, CDC, United StatesFatimah S. Dawood - Division of COVID-19 and Other Respiratory Viral Diseases, CDC, United StatesSascha Ellington - National Center for Immunization and Respiratory DiseasesWesley H. Self - Vanderbilt University Medical CenterEmily T. Martin - University of Michigan
- Resource Type
- Journal article
- Publication Details
- Vaccine, Vol.43, 126492
- DOI
- 10.1016/j.vaccine.2024.126492
- PMID
- 39515195
- PMCID
- PMC12229715
- NLM abbreviation
- Vaccine
- ISSN
- 0264-410X
- eISSN
- 1873-2518
- Publisher
- Elsevier Ltd
- Grant note
- US Centers for Disease Control and Prevention, National Center for Immunization and Respiratory Diseases: 75D30122C12914, 75D30122C14944
Financial support for this work was supported by the US Centers for Disease Control and Prevention, National Center for Immunization and Respiratory Diseases (contract numbers 75D30122C12914 and 75D30122C14944 to Wesley H. Self) .
- Language
- English
- Date published
- 01/01/2025
- Academic Unit
- Epidemiology; Emergency Medicine; Anesthesia; Injury Prevention Research Center
- Record Identifier
- 9984745355702771
Metrics
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