Effectiveness of mRNA Booster Vaccine Against Coronavirus Disease 2019 Infection and Severe Outcomes Among Persons With and Without Immune Dysfunction: A Retrospective Cohort Study of National Electronic Medical Record Data in the United States.

Publication date: Feb 01, 2024

Real-world evidence of coronavirus disease 2019 (COVID-19) messenger RNA (mRNA) booster effectiveness among patients with immune dysfunction are limited. We included data from patients in the United States National COVID Cohort Collaborative (N3C) who completed ≥2 doses of mRNA vaccination between 10 December 2020 and 27 May 2022. Immune dysfunction conditions included human immunodeficiency virus infection, solid organ or bone marrow transplant, autoimmune diseases, and cancer. We defined incident COVID-19 BTI as positive results from laboratory tests or diagnostic codes 14 days after at least 2 doses of mRNA vaccination; and severe COVID-19 BTI as hospitalization, invasive cardiopulmonary support, and/or death. We used propensity scores to match boosted versus nonboosted patients and evaluated hazards of incident and severe COVID-19 BTI using Cox regression after matching. Among patients without immune dysfunction, the relative effectiveness of booster (3 doses) after 6 months from the primary (2 doses) vaccination against BTI ranged from 69% to 81% during the Delta-predominant period and from 33% to 39% during the Omicron-predominant period. Relative effectiveness against BTI was lower among patients with immune dysfunction but remained statistically significant in both periods. Boosted patients had lower risk of COVID-19-related hospitalization (hazard ratios [HR] ranged from 0. 5 [95% confidence interval {CI}, .48-. 53] to 0. 63 [95% CI, .56-. 70]), invasive cardiopulmonary support, or death (HRs ranged from 0. 46 [95% CI, .41-. 52] to 0. 63 [95% CI, .50-. 79]) during both periods. Booster vaccines remain effective against severe COVID-19 BTI throughout the Delta- and Omicron-predominant periods, regardless of patients’ immune status.

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Concepts Keywords
Cancer COVID-19 vaccination
Coronavirus immune dysfunction
December people with HIV
Open real-world evidence
Vaccination solid organ transplant


Type Source Name
disease VO effectiveness
disease VO vaccine
disease MESH Coronavirus Disease 2019
disease MESH Infection
disease VO vaccination
disease MESH autoimmune diseases
disease MESH cancer
disease MESH death
disease VO effective
disease MESH Coronavirus Infection
disease VO USA
disease VO population
disease MESH Infectious Diseases
disease VO immunization
disease IDO immunodeficiency
disease MESH virus infection
drug DRUGBANK Methylphenidate
drug DRUGBANK Coenzyme M
disease MESH breakthrough infection
disease VO primary vaccination
disease VO time
disease VO Gap
disease VO dose
disease VO vaccine dose
disease VO vaccine effectiveness
disease MESH HIV infection
disease MESH emergency
disease IDO immune response
disease IDO history
disease MESH leukemia
disease MESH lymphoma
disease MESH heart disease
disease MESH vascular disease
disease MESH stroke
disease MESH dementia
disease MESH pulmonary diseases
disease MESH liver disease
disease MESH diabetes mellitus
disease MESH morbidities

Original Article

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