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Analysis of the Effectiveness of the Ad26.COV2.S Adenoviral Vector Vaccine for Preventing COVID-19

Educational Objective
To identify the key insights or developments described in this article
Key Points

Question  How effective is the Ad26.COV2.S adenoviral vector vaccine from Johnson & Johnson at preventing SARS-CoV-2 infection?

Findings  This comparative effectiveness research study found that, through large-scale longitudinal retrospective curation of electronic health records from the multistate Mayo Clinic Health System, the Ad26.COV2.S vaccine had an effectiveness of 74%.

Meaning  This study suggests that a single dose of the Ad26.COV2.S vaccine appears highly effective at preventing SARS-CoV-2 infection.

Abstract

Importance  Continuous assessment of the effectiveness and safety of the US Food and Drug Administration–authorized SARS-CoV-2 vaccines is critical to amplify transparency, build public trust, and ultimately improve overall health outcomes.

Objective  To evaluate the effectiveness of the Johnson & Johnson Ad26.COV2.S vaccine for preventing SARS-CoV-2 infection.

Design, Setting, and Participants  This comparative effectiveness research study used large-scale longitudinal curation of electronic health records from the multistate Mayo Clinic Health System (Minnesota, Arizona, Florida, Wisconsin, and Iowa) to identify vaccinated and unvaccinated adults between February 27 and July 22, 2021. The unvaccinated cohort was matched on a propensity score derived from age, sex, zip code, race, ethnicity, and previous number of SARS-CoV-2 polymerase chain reaction tests. The final study cohort consisted of 8889 patients in the vaccinated group and 88 898 unvaccinated matched patients.

Exposure  Single dose of the Ad26.COV2.S vaccine.

Main Outcomes and Measures  The incidence rate ratio of SARS-CoV-2 infection in the vaccinated vs unvaccinated control cohorts, measured by SARS-CoV-2 polymerase chain reaction testing.

Results  The study was composed of 8889 vaccinated patients (4491 men [50.5%]; mean [SD] age, 52.4 [16.9] years) and 88 898 unvaccinated patients (44 748 men [50.3%]; mean [SD] age, 51.7 [16.7] years). The incidence rate ratio of SARS-CoV-2 infection in the vaccinated vs unvaccinated control cohorts was 0.26 (95% CI, 0.20-0.34) (60 of 8889 vaccinated patients vs 2236 of 88 898 unvaccinated individuals), which corresponds to an effectiveness of 73.6% (95% CI, 65.9%-79.9%) and a 3.73-fold reduction in SARS-CoV-2 infections.

Conclusions and Relevance  This study’s findings are consistent with the clinical trial–reported efficacy of Ad26.COV2.S and the first retrospective analysis, suggesting that the vaccine is effective at reducing SARS-CoV-2 infection, even with the spread of variants such as Alpha or Delta that were not present in the original studies, and reaffirm the urgent need to continue mass vaccination efforts globally.

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Article Information

Accepted for Publication: September 2, 2021.

Published: November 2, 2021. doi:10.1001/jamanetworkopen.2021.32540

Open Access: This is an open access article distributed under the terms of the CC-BY-NC-ND License. © 2021 Corchado-Garcia J et al. JAMA Network Open.

Corresponding Authors: Tyler Wagner, PhD (tyler@nference.net), and Venky Soundararajan, PhD (venky@nference.net), nference, One Main St, E Arcade, Cambridge, MA 02142.

Author Contributions: Dr Soundararajan had full access to all of the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis. Drs Corchado-Garcia and Zemmour are co–first authors.

Concept and design: Corchado-Garcia, Zemmour, Lenehan, O’Horo, Badley, Halamka, Virk, Swift, Wagner, Soundararajan.

Acquisition, analysis, or interpretation of data: Corchado-Garcia, Zemmour, Hughes, Bandi, Cristea-Platon, Lenehan, Pawlowski, Bade, O’Horo, Gores, Williams, Badley, Wagner, Soundararajan.

Drafting of the manuscript: Corchado-Garcia, Zemmour, Hughes, Bade, Soundararajan.

Critical revision of the manuscript for important intellectual content: Corchado-Garcia, Zemmour, Hughes, Bandi, Cristea-Platon, Lenehan, Pawlowski, O'Horo, Gores, Williams, Badley, Halamka, Virk, Swift, Wagner, Soundararajan.

Statistical analysis: Corchado-Garcia, Zemmour, Hughes, Bandi, Cristea-Platon, Pawlowski, Bade.

Obtained funding: Badley.

Administrative, technical, or material support: Bade, O’Horo, Badley, Soundararajan.

Supervision: O’Horo, Gores, Badley, Halamka, Wagner, Soundararajan.

Conflict of Interest Disclosures: Dr Corchado-Garcia reported receiving personal fees from and holding stock in nference Inc outside the submitted work. Dr Zemmour reported receiving personal fees from nference Inc outside the submitted work. Dr Hughes reported receiving personal fees from nference Inc during the conduct of the study; and personal fees from nference Inc outside the submitted work. Mr Lenehan reported receiving other fees from Janssen (nference collaborates with Janssen on data science projects unrelated to this manuscript, and this relationship did not impact the study design or interpretation of its results) outside the submitted work. Dr Pawlowski reported receiving personal fees from nference Inc outside the submitted work. Dr O’Horo reported receiving personal fees from Elsevier and Bates College; and grants from nference Inc, outside the submitted work. Dr Badley reported being a consultant for AbbVie and Gilead; serving on scientific advisory boards for Freedom Tunnel, Pinetree Therapeutics, Primmune, Immunome, Flambeau Diagnostics, nference, and Zentalis; serving on data safety and monitoring boards for Corvus, Equillium, and Excision Biotherapeutics; and being founder and president of Splissen Therapeutics. Dr Virk reported being an inventor for Mayo Clinic Travel App interaction with Smart Medical Kit and Medical Kit for Pilgrims. Dr Swift reported receiving grants from Pfizer during the conduct of the study. Dr Wagner reported receiving personal fees from and holding stock in nference Inc outside the submitted work. Dr Soundararajan reported other from Janssen (nference collaborates with Janssen and other biopharmaceutical companies on data science initiatives unrelated to this study, and these collaborations had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript outside the submitted work. The Mayo Clinic may stand to gain financially from the successful outcome of this research. This research has been reviewed by the Mayo Clinic Conflict of Interest Review Board and was in compliance with Mayo Clinic Conflict of Interest policies. No other disclosures were reported.

Additional Information: The data will be made available on reasonable request to the corresponding author. A proposal with detailed description of study objectives and the statistical analysis plan will be needed for evaluation of the reasonability of requests. Deidentified data will be provided after approval from the corresponding author and the Mayo Clinic.

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