Effectiveness of the Ad26.COV2.S (Johnson & Johnson) Coronavirus Disease 2019 (COVID-19) Vaccine for Preventing COVID-19 Hospitalizations and Progression to High Disease Severity in the United States.

Background . Adults in the United States (US) began receiving the adenovirus vector coronavirus disease 2019 (COVID-19) vaccine, Ad26.COV2.S (Johnson & Johnson [Janssen]), in February 2021. We evaluated Ad26.COV2.S vaccine effectiveness (VE) against COVID-19 hospitalization and high disease severity during the first 10 months of its use. Methods . In a multicenter case-control analysis of US adults (≥18 years) hospitalized 11 March to 15 December 2021, we estimated VE against susceptibility to COVID-19 hospitalization (VEs), comparing odds of prior vaccination with a single dose Ad26.COV2.S vaccine between hospitalized cases with COVID-19 and controls without COVID-19. Among hospitalized patients with COVID-19, we estimated VE against disease progression (VEp) to death or invasive mechanical ventilation (IMV), comparing odds of prior vaccination between patients with and without progression. Results . After excluding patients receiving mRNA vaccines, among 3979 COVID-19 case-patients (5% vaccinated with Ad26.COV2.S) and 2229 controls (13% vaccinated with Ad26.COV2.S), VEs of Ad26.COV2.S against COVID-19 hospitalization was 70% (95% confidence interval [CI]: 63-75%) overall, including 55% (29-72%) among immunocompromised patients, and 72% (64-77%) among immunocompetent patients, for whom VEs was similar at 14-90 days (73% [59-82%]), 91-180 days (71% [60-80%]), and 181-274 days (70% [54-81%]) postvaccination. Among hospitalized COVID-19 case-patients, VEp was 46% (18-65%) among immunocompetent patients. Conclusions . The Ad26.COV2.S COVID-19 vaccine reduced the risk of COVID-19 hospitalization by 72% among immunocompetent adults without waning through 6 months postvaccination. After hospitalization for COVID-19, vaccinated immunocompetent patients were less likely to require IMV or die compared to unvaccinated immunocompetent patients.

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Published by Oxford University Press on behalf of the Infectious Diseases Society of America 2022.

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Potential conflicts of interest. M. G.: CDC: Baylor Scott & White Health (BSWH) US Flu/COVID VE Network, HAIVEN, Synergy studies; CDC-Abt: BSWH FluVax Trial and RECOVER-PROTECT Cohort Studies; CDC-Westat: BSWH VISION COVID-Flu VE Study; Janssen: BSWH Respiratory Syncytial Virus (RSV) Severity App Birth Cohort Study; Co-Chair of Infectious Diseases and Immunization Committee—Texas Pediatric Society—Texas Chapter of American Academy of Pediatrics. A. G.: National Institutes of Health (NIH), Department of Defense; Faron Pharmaceuticals; AbbVie; D Douin: NIH/National Institute of General Medical Sciences (NIGMS) Institutional Training Grant. J. C.: NIH and Department of Defense grants unrelated to this work. T. A. M.: Panelist for Society of Hospital Medicine Updates in Heart Failure; Board member for Scott & White Clinic Physicians Board of Directors. K. G.: NECTAR Executive Committee member ACTIV4-HT; D. C. F.: Cytovale consulting fees; Medpace Data Safety Monitoring Board. D. N. H.: National Heart, Lung, and Blood Institute (NIHLBI) participant in the ACTIV4d-Host Tissue Trial; Chair DSMD—SAFE EVICT Trial of VIT C in COVID-19. M. N. G.: Grants from NHLBI and Agency for Healthcare Research and Quality (AHRQ); Consulting fees for Endpoint for scientific advisory panel; Honoraria—Medicine Grand Rounds from Westchester Medical Center; Support for attending ATS Board of Directors meeting; Data and Safety Monitoring Board (DSMB) for Regeneron study and REPLENISH trial. N. J. J.: IH grants paid to University of Washington Royalty Research Fund; Department of Defense grants; Medic One Foundation grants; WA Department of Health expert testimony payment; DSMB for Opticyte, Inc.; Chair, ACEP Critical Care Section. I. P.: NIH grants; Regeneron Pharmaceuticals grant; Intermountain Research & Medical Foundation grant; Asahi Kasei Pharma grant; Janssen Pharmaceuticals grant. S. B.: NIH grants and Department of Defense grants; DSMB for Hamilton ventilators and NYU. E. T. M.: Merck grant. A. S. M.: NIH grant. A. K.: NIH grants; United Therapeutics grants; Eli Lily grants; Johnson & Johnson—BOA Medical—4DMedical research grants; rA. D.: Center PI for PETAL network through NHLBI grant; on steering committee for A Lung technologies. J. G. W.: NIH/NHLBI funding for ACTIV-3 and ACTIV-4 trials; American Board of Internal Medicine—member of Critical Care Exam Committee. S. Y. C.: Consulting fees for PureTech Health and Kiniska Pharmaceuticals; Honoraria for La Jolla. H. M. B.: CDC grant for HCP COVID vaccine effectiveness. J. H. K.: NIAID grant. M. C. E.: Abbott Labs honoraria for speaking on ASPEN on nutrition in critical illness from COVID. A. L.: grants from CDC, NIH, and Burroughs Wellcome Fund; consulting fees from Sanofi on antiviral drugs and for Roche on baloxavir trial steering committee. N. H.: grants from NIH, Quidel, and Sanofi; Honoraria for speaking at CME event at AAP. C. G. G.: grants from Campbell Alliance/Syneos Health, Sanofi, CDC, AHRQ, NIH, and FDA; consulting fees from Merck, Pfizer, and Sanofi-Pasteur. T. W. R.: grants from NIH, Department of Defense and AbbVie; consulting fees for Cumberland Pharmaceuticals, Inc. and Cytovale, Inc.; DSMB for Sanofi, Inc.; Immediate Past President—ASPEN; Stock in Cumberland Pharmaceuticals, Inc. for consulting work. W. B. S.: NIH training grants. C. J. L.: grants from NIH, Department of Defense; CDC; bioMerieux; Entegrion, Inc.; Endpoint Health; AbbVie; Patents for risk stratification in sepsis and septic shock issued to Cincinnati Children’s Hospital Medical Center; DSMBs for clinical trials for Study Principal Investigators; Association for Clinical and Translational Science (Executive Committee, Immediate Past President, and Board of Directors); stock options in Bioscape Digita. All other authors report no potential conflicts. All authors have submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest. Conflicts that the editors consider relevant to the content of the manuscript have been disclosed.