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Effectiveness of mRNA COVID-19 Vaccine Boosters Against Infection, Hospitalization, and Death: A Target Trial Emulation in the Omicron (B.1.1.529) Variant Era.
Ann Intern Med. 2022 12; 175(12):1693-1706.AIM

Abstract

BACKGROUND

The effectiveness of a third mRNA COVID-19 vaccine dose (booster dose) against the Omicron (B.1.1.529) variant is uncertain, especially in older, high-risk populations.

OBJECTIVE

To determine mRNA booster vaccine effectiveness (VE) against SARS-CoV-2 infection, hospitalization, and death in the Omicron era by booster type, primary vaccine type, time since primary vaccination, age, and comorbidity burden.

DESIGN

Retrospective matched cohort study designed to emulate a target trial of booster vaccination versus no booster, conducted from 1 December 2021 to 31 March 2022.

SETTING

U.S. Department of Veterans Affairs health care system.

PARTICIPANTS

Persons who had received 2 mRNA COVID-19 vaccine doses at least 5 months earlier.

INTERVENTION

Booster monovalent mRNA vaccination (Pfizer-BioNTech's BNT162b2 or Moderna's mRNA-1273) versus no booster.

MEASUREMENTS

Booster VE.

RESULTS

Each group included 490 838 well-matched persons, who were predominantly male (88%), had a mean age of 63.0 years (SD, 14.0), and were followed for up to 121 days (mean, 79.8 days). Booster VE more than 10 days after a booster dose was 42.3% (95% CI, 40.6% to 43.9%) against SARS-CoV-2 infection, 53.3% (CI, 48.1% to 58.0%) against SARS-CoV-2-related hospitalization, and 79.1% (CI, 71.2% to 84.9%) against SARS-CoV-2-related death. Booster VE was similar for different booster types (BNT162b2 or mRNA-1273), age groups, and primary vaccination regimens but was significantly higher with longer time since primary vaccination and higher comorbidity burden.

LIMITATION

Predominantly male population.

CONCLUSION

Booster mRNA vaccination was highly effective in preventing death and moderately effective in preventing infection and hospitalization for up to 4 months after administration in the Omicron era. Increased uptake of booster vaccination, which is currently suboptimal, should be pursued to limit the morbidity and mortality of SARS-CoV-2 infection, especially in persons with high comorbidity burden.

PRIMARY FUNDING SOURCE

U.S. Department of Veterans Affairs.

Links

PMC Free PDF

Authors+Show Affiliations

Ioannou GN
Division of Gastroenterology, University of Washington, and Research and Development and Division of Gastroenterology, Veterans Affairs Puget Sound Health Care System, Seattle, Washington (G.N.I.).
Bohnert ASB
Department of Anesthesiology, University of Michigan Medical School, and Center for Clinical Management Research, VA Ann Arbor Health System, Ann Arbor, Michigan (A.S.B.B.).
O'Hare AM
Nephrology, Veterans Affairs Puget Sound Health Care System, and University of Washington, Seattle, Washington (A.M.O.).
Boyko EJ
General Internal Medicine, Veterans Affairs Puget Sound Health Care System, and University of Washington, Seattle, Washington (E.J.B.).
Maciejewski ML
Center of Innovation to Accelerate Discovery and Practice Transformation (ADAPT), Durham Veterans Affairs Health Care System, and Department of Population Health Sciences, Duke-Margolis Center for Health Policy, and Division of General Internal Medicine, Duke University School of Medicine, Durham, North Carolina (M.L.M.).
Smith VA
Center of Innovation to Accelerate Discovery and Practice Transformation (ADAPT), Durham Veterans Affairs Health Care System, and Department of Population Health Sciences and Division of General Internal Medicine, Duke University School of Medicine, Durham, North Carolina (V.A.S.).
Bowling CB
Durham Veterans Affairs Geriatric Research Education and Clinical Center, Durham Veterans Affairs Medical Center (VAMC), and Department of Medicine, Duke University, Durham, North Carolina (C.B.B.).
Viglianti E
Center for Clinical Management Research, VA Ann Arbor Health System, and Division of Pulmonary and Critical Care Medicine, Department of Internal Medicine, University of Michigan, Ann Arbor, Michigan (E.V., T.J.I.).
Iwashyna TJ
Center for Clinical Management Research, VA Ann Arbor Health System, and Division of Pulmonary and Critical Care Medicine, Department of Internal Medicine, University of Michigan, Ann Arbor, Michigan (E.V., T.J.I.).
Hynes DM
Center of Innovation to Improve Veteran Involvement in Care, VA Portland Healthcare System, Portland, Oregon, and Health Management and Policy, School of Social and Behavioral Health Sciences, College of Public Health and Human Sciences, and Health Data and Informatics Program, Center for Quantitative Life Sciences, Oregon State University, Corvallis, Oregon (D.M.H.).
Berry K
Research and Development, Veterans Affairs Puget Sound Health Care System, Seattle, Washington (K.B.).
COVID-19 Observational Research Collaboratory (CORC)
No affiliation info available

MeSH

United StatesHumansMaleAgedMiddle AgedFemale2019-nCoV Vaccine mRNA-1273BNT162 VaccineCOVID-19COVID-19 VaccinesCohort StudiesRetrospective StudiesSARS-CoV-2Hospitalization

Pub Type(s)

Journal Article
Research Support, U.S. Gov't, Non-P.H.S.

Language

eng

PubMed ID

36215715

Citation

Ioannou, George N., et al. "Effectiveness of mRNA COVID-19 Vaccine Boosters Against Infection, Hospitalization, and Death: a Target Trial Emulation in the Omicron (B.1.1.529) Variant Era." Annals of Internal Medicine, vol. 175, no. 12, 2022, pp. 1693-1706.
Ioannou GN, Bohnert ASB, O'Hare AM, et al. Effectiveness of mRNA COVID-19 Vaccine Boosters Against Infection, Hospitalization, and Death: A Target Trial Emulation in the Omicron (B.1.1.529) Variant Era. Ann Intern Med. 2022;175(12):1693-1706.
Ioannou, G. N., Bohnert, A. S. B., O'Hare, A. M., Boyko, E. J., Maciejewski, M. L., Smith, V. A., Bowling, C. B., Viglianti, E., Iwashyna, T. J., Hynes, D. M., & Berry, K. (2022). Effectiveness of mRNA COVID-19 Vaccine Boosters Against Infection, Hospitalization, and Death: A Target Trial Emulation in the Omicron (B.1.1.529) Variant Era. Annals of Internal Medicine, 175(12), 1693-1706. https://doi.org/10.7326/M22-1856
Ioannou GN, et al. Effectiveness of mRNA COVID-19 Vaccine Boosters Against Infection, Hospitalization, and Death: a Target Trial Emulation in the Omicron (B.1.1.529) Variant Era. Ann Intern Med. 2022;175(12):1693-1706. PubMed PMID: 36215715.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Effectiveness of mRNA COVID-19 Vaccine Boosters Against Infection, Hospitalization, and Death: A Target Trial Emulation in the Omicron (B.1.1.529) Variant Era. AU - Ioannou,George N, AU - Bohnert,Amy S B, AU - O'Hare,Ann M, AU - Boyko,Edward J, AU - Maciejewski,Matthew L, AU - Smith,Valerie A, AU - Bowling,C Barrett, AU - Viglianti,Elizabeth, AU - Iwashyna,Theodore J, AU - Hynes,Denise M, AU - Berry,Kristin, AU - ,, Y1 - 2022/10/11/ PY - 2022/10/11/pubmed PY - 2022/12/22/medline PY - 2022/10/10/entrez SP - 1693 EP - 1706 JF - Annals of internal medicine JO - Ann Intern Med VL - 175 IS - 12 N2 - BACKGROUND: The effectiveness of a third mRNA COVID-19 vaccine dose (booster dose) against the Omicron (B.1.1.529) variant is uncertain, especially in older, high-risk populations. OBJECTIVE: To determine mRNA booster vaccine effectiveness (VE) against SARS-CoV-2 infection, hospitalization, and death in the Omicron era by booster type, primary vaccine type, time since primary vaccination, age, and comorbidity burden. DESIGN: Retrospective matched cohort study designed to emulate a target trial of booster vaccination versus no booster, conducted from 1 December 2021 to 31 March 2022. SETTING: U.S. Department of Veterans Affairs health care system. PARTICIPANTS: Persons who had received 2 mRNA COVID-19 vaccine doses at least 5 months earlier. INTERVENTION: Booster monovalent mRNA vaccination (Pfizer-BioNTech's BNT162b2 or Moderna's mRNA-1273) versus no booster. MEASUREMENTS: Booster VE. RESULTS: Each group included 490 838 well-matched persons, who were predominantly male (88%), had a mean age of 63.0 years (SD, 14.0), and were followed for up to 121 days (mean, 79.8 days). Booster VE more than 10 days after a booster dose was 42.3% (95% CI, 40.6% to 43.9%) against SARS-CoV-2 infection, 53.3% (CI, 48.1% to 58.0%) against SARS-CoV-2-related hospitalization, and 79.1% (CI, 71.2% to 84.9%) against SARS-CoV-2-related death. Booster VE was similar for different booster types (BNT162b2 or mRNA-1273), age groups, and primary vaccination regimens but was significantly higher with longer time since primary vaccination and higher comorbidity burden. LIMITATION: Predominantly male population. CONCLUSION: Booster mRNA vaccination was highly effective in preventing death and moderately effective in preventing infection and hospitalization for up to 4 months after administration in the Omicron era. Increased uptake of booster vaccination, which is currently suboptimal, should be pursued to limit the morbidity and mortality of SARS-CoV-2 infection, especially in persons with high comorbidity burden. PRIMARY FUNDING SOURCE: U.S. Department of Veterans Affairs. SN - 1539-3704 UR - https://www.unboundmedicine.com/medline/citation/36215715/Effectiveness_of_mRNA_COVID_19_Vaccine_Boosters_Against_Infection_Hospitalization_and_Death:_A_Target_Trial_Emulation_in_the_Omicron__B_1_1_529__Variant_Era_ DB - PRIME DP - Unbound Medicine ER -
Grapherence [↓3 ↑28]

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