Effectiveness of monovalent COVID-19 booster/additional vaccine doses in the United States
J. Bradley Layton,
Lauren Peetluk,
Hui Lee Wong,
Yixin Jiao,
Djeneba Audrey Djibo,
Christine Bui,
Patricia C. Lloyd,
Joann F. Gruber,
Michael Miller,
Rachel P. Ogilvie,
Jie Deng,
Ron Parambi,
Jennifer Song,
Lisa B. Weatherby,
An-Chi Lo,
Kathryn Matuska,
Michael Wernecke,
Tainya C. Clarke,
Sylvia Cho,
Elizabeth J. Bell,
John D. Seeger,
Grace Wenya Yang,
Dóra Illei,
Richard A. Forshee,
Steven A. Anderson,
Cheryl N. McMahill-Walraven,
Yoganand Chillarige,
Kandace L. Amend,
Mary S. Anthony,
Azadeh Shoaibi
Affiliations
J. Bradley Layton
RTI Health Solutions, Research Triangle Park, NC, USA; Corresponding author at: RTI Health Solutions, 3040 East Cornwallis Rd, PO Box 12194, Research Triangle Park, NC 27709-2194, USA.
Lauren Peetluk
Optum Epidemiology, Boston, MA, USA
Hui Lee Wong
US Food and Drug Administration, Center for Biologics Evaluation and Research, Silver Spring, MD, USA
Yixin Jiao
Acumen, LLC, Burlingame, CA, USA
Djeneba Audrey Djibo
Safety, Surveillance & Collaboration, CVS Health, Blue Bell, PA, USA
Christine Bui
RTI Health Solutions, Research Triangle Park, NC, USA
Patricia C. Lloyd
US Food and Drug Administration, Center for Biologics Evaluation and Research, Silver Spring, MD, USA
Joann F. Gruber
US Food and Drug Administration, Center for Biologics Evaluation and Research, Silver Spring, MD, USA
Michael Miller
Optum Epidemiology, Boston, MA, USA
Rachel P. Ogilvie
Optum Epidemiology, Boston, MA, USA
Jie Deng
Optum Epidemiology, Boston, MA, USA
Ron Parambi
Optum Epidemiology, Boston, MA, USA
Jennifer Song
Optum Epidemiology, Boston, MA, USA
Lisa B. Weatherby
Optum Epidemiology, Boston, MA, USA
An-Chi Lo
Acumen, LLC, Burlingame, CA, USA
Kathryn Matuska
Acumen, LLC, Burlingame, CA, USA
Michael Wernecke
Acumen, LLC, Burlingame, CA, USA
Tainya C. Clarke
US Food and Drug Administration, Center for Biologics Evaluation and Research, Silver Spring, MD, USA
Sylvia Cho
US Food and Drug Administration, Center for Biologics Evaluation and Research, Silver Spring, MD, USA
Elizabeth J. Bell
Optum Epidemiology, Boston, MA, USA
John D. Seeger
Optum Epidemiology, Boston, MA, USA
Grace Wenya Yang
Optum Serve, Falls Church VA, USA
Dóra Illei
RTI International, Washington, DC, USA
Richard A. Forshee
US Food and Drug Administration, Center for Biologics Evaluation and Research, Silver Spring, MD, USA
Steven A. Anderson
US Food and Drug Administration, Center for Biologics Evaluation and Research, Silver Spring, MD, USA
Cheryl N. McMahill-Walraven
Safety, Surveillance & Collaboration, CVS Health, Blue Bell, PA, USA
Yoganand Chillarige
Acumen, LLC, Burlingame, CA, USA
Kandace L. Amend
Optum Epidemiology, Boston, MA, USA
Mary S. Anthony
RTI Health Solutions, Research Triangle Park, NC, USA
Azadeh Shoaibi
US Food and Drug Administration, Center for Biologics Evaluation and Research, Silver Spring, MD, USA
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).
