학술논문
Effectiveness of monovalent COVID-19 booster/additional vaccine doses in the United States.
Document Type
Academic Journal
Author
Layton JB; RTI Health Solutions, Research Triangle Park, NC, USA.; Peetluk L; Optum Epidemiology, Boston, MA, USA.; Wong HL; US Food and Drug Administration, Center for Biologics Evaluation and Research, Silver Spring, MD, USA.; Jiao Y; Acumen, LLC, Burlingame, CA, USA.; Djibo DA; Safety, Surveillance & Collaboration, CVS Health, Blue Bell, PA, USA.; Bui C; RTI Health Solutions, Research Triangle Park, NC, USA.; Lloyd PC; US Food and Drug Administration, Center for Biologics Evaluation and Research, Silver Spring, MD, USA.; Gruber JF; US Food and Drug Administration, Center for Biologics Evaluation and Research, Silver Spring, MD, USA.; Miller M; Optum Epidemiology, Boston, MA, USA.; Ogilvie RP; Optum Epidemiology, Boston, MA, USA.; Deng J; Optum Epidemiology, Boston, MA, USA.; Parambi R; Optum Epidemiology, Boston, MA, USA.; Song J; Optum Epidemiology, Boston, MA, USA.; Weatherby LB; Optum Epidemiology, Boston, MA, USA.; Lo AC; Acumen, LLC, Burlingame, CA, USA.; Matuska K; Acumen, LLC, Burlingame, CA, USA.; Wernecke M; Acumen, LLC, Burlingame, CA, USA.; Clarke TC; US Food and Drug Administration, Center for Biologics Evaluation and Research, Silver Spring, MD, USA.; Cho S; US Food and Drug Administration, Center for Biologics Evaluation and Research, Silver Spring, MD, USA.; Bell EJ; Optum Epidemiology, Boston, MA, USA.; Seeger JD; Optum Epidemiology, Boston, MA, USA.; Yang GW; Optum Serve, Falls Church VA, USA.; Illei D; RTI International, Washington, DC, USA.; Forshee RA; US Food and Drug Administration, Center for Biologics Evaluation and Research, Silver Spring, MD, USA.; Anderson SA; US Food and Drug Administration, Center for Biologics Evaluation and Research, Silver Spring, MD, USA.; McMahill-Walraven CN; Safety, Surveillance & Collaboration, CVS Health, Blue Bell, PA, USA.; Chillarige Y; Acumen, LLC, Burlingame, CA, USA.; Amend KL; Optum Epidemiology, Boston, MA, USA.; Anthony MS; RTI Health Solutions, Research Triangle Park, NC, USA.; Shoaibi A; US Food and Drug Administration, Center for Biologics Evaluation and Research, Silver Spring, MD, USA.
Source
Publisher: Elsevier Ltd Country of Publication: England NLM ID: 101748769 Publication Model: eCollection Cited Medium: Internet ISSN: 2590-1362 (Electronic) Linking ISSN: 25901362 NLM ISO Abbreviation: Vaccine X Subsets: PubMed not MEDLINE
Subject
Language
English
Abstract
Background: Monovalent booster/additional doses of COVID-19 vaccines were first authorized in August 2021 in the United States. We evaluated the real-world effectiveness of receipt of a monovalent booster/additional dose of COVID-19 vaccine compared with receiving a primary vaccine series without a booster/additional dose.
Methods: Cohorts of individuals receiving a COVID-19 booster/additional dose after receipt of a complete primary vaccine series were identified in 2 administrative insurance claims databases (Optum, CVS Health) supplemented with state immunization information system data between August 2021 and March 2022. Individuals with a complete primary series but without a booster/additional dose were one-to-one matched to boosted individuals on calendar date, geography, and clinical factors. COVID-19 diagnoses were identified in any medical setting, or specifically in hospitals/emergency departments (EDs). Propensity score-weighted hazards ratios (HRs) and 95% confidence intervals (CI) were estimated with Cox proportional hazards models; vaccine effectiveness (VE) was estimated as 1 minus the HR by vaccine brand overall and within subgroups of variant-specific eras, immunocompromised status, and homologous/heterologous booster status.
Results: Across both data sources, we identified 752,165 matched pairs for BNT162b2, 410,501 for mRNA-1273, and 11,398 for JNJ-7836735. For any medically diagnosed COVID-19, meta-analyzed VE estimates for BNT162b2, mRNA-1273, and JNJ-7836735, respectively, were: BNT162b2, 54% (95% CI, 53%-56%); mRNA-1273, 58% (95% CI, 56%-59%); JNJ-7836735, 34% (95% CI, 23%-44%). For hospital/ED-diagnosed COVID-19, VE estimates ranged from 70% to 76%. VE was generally lower during the Omicron era than the Delta era and for immunocompromised individuals. There was little difference observed by homologous or heterologous booster status.
Conclusion: The original, monovalent booster/additional doses were reasonably effective in real-world use among the populations for which they were indicated during the study period. Additional studies may be informative in the future as new variants emerge and new vaccines become available.Registration: The study protocol was publicly posted on the BEST Initiative website (https://bestinitiative.org/wp-content/uploads/2022/03/C19-VX-Effectiveness-Protocol_2022_508.pdf).
Competing Interests: The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: JBL, WGA, ATK, CB, and MSA are employees of RTI International, an independent nonprofit institute that performs research on behalf of governmental and commercial clients, including manufacturers of COVID-19 vaccines. LP, MM, RPO, JD, RP, JS, LBW, EJB, JDS, GWY, and KLA are employees of Optum and may own stock in UnitedHealth Group. DAD and CNMW are employees of CVS Health, which performs research on behalf of governmental and commercial clients, including manufacturers of COVID-19 vaccines. All other authors have no conflicts to declare.
(© 2024 The Authors.)
Methods: Cohorts of individuals receiving a COVID-19 booster/additional dose after receipt of a complete primary vaccine series were identified in 2 administrative insurance claims databases (Optum, CVS Health) supplemented with state immunization information system data between August 2021 and March 2022. Individuals with a complete primary series but without a booster/additional dose were one-to-one matched to boosted individuals on calendar date, geography, and clinical factors. COVID-19 diagnoses were identified in any medical setting, or specifically in hospitals/emergency departments (EDs). Propensity score-weighted hazards ratios (HRs) and 95% confidence intervals (CI) were estimated with Cox proportional hazards models; vaccine effectiveness (VE) was estimated as 1 minus the HR by vaccine brand overall and within subgroups of variant-specific eras, immunocompromised status, and homologous/heterologous booster status.
Results: Across both data sources, we identified 752,165 matched pairs for BNT162b2, 410,501 for mRNA-1273, and 11,398 for JNJ-7836735. For any medically diagnosed COVID-19, meta-analyzed VE estimates for BNT162b2, mRNA-1273, and JNJ-7836735, respectively, were: BNT162b2, 54% (95% CI, 53%-56%); mRNA-1273, 58% (95% CI, 56%-59%); JNJ-7836735, 34% (95% CI, 23%-44%). For hospital/ED-diagnosed COVID-19, VE estimates ranged from 70% to 76%. VE was generally lower during the Omicron era than the Delta era and for immunocompromised individuals. There was little difference observed by homologous or heterologous booster status.
Conclusion: The original, monovalent booster/additional doses were reasonably effective in real-world use among the populations for which they were indicated during the study period. Additional studies may be informative in the future as new variants emerge and new vaccines become available.Registration: The study protocol was publicly posted on the BEST Initiative website (https://bestinitiative.org/wp-content/uploads/2022/03/C19-VX-Effectiveness-Protocol_2022_508.pdf).
Competing Interests: The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: JBL, WGA, ATK, CB, and MSA are employees of RTI International, an independent nonprofit institute that performs research on behalf of governmental and commercial clients, including manufacturers of COVID-19 vaccines. LP, MM, RPO, JD, RP, JS, LBW, EJB, JDS, GWY, and KLA are employees of Optum and may own stock in UnitedHealth Group. DAD and CNMW are employees of CVS Health, which performs research on behalf of governmental and commercial clients, including manufacturers of COVID-19 vaccines. All other authors have no conflicts to declare.
(© 2024 The Authors.)