lancet-header

Preprints with The Lancet is part of SSRN´s First Look, a place where journals identify content of interest prior to publication. Authors have opted in at submission to The Lancet family of journals to post their preprints on Preprints with The Lancet. The usual SSRN checks and a Lancet-specific check for appropriateness and transparency have been applied. Preprints available here are not Lancet publications or necessarily under review with a Lancet journal. These preprints are early stage research papers that have not been peer-reviewed. The findings should not be used for clinical or public health decision making and should not be presented to a lay audience without highlighting that they are preliminary and have not been peer-reviewed. For more information on this collaboration, see the comments published in The Lancet about the trial period, and our decision to make this a permanent offering, or visit The Lancet´s FAQ page, and for any feedback please contact preprints@lancet.com.

Real-World Effectiveness of Ad26.COV2.S Adenoviral Vector Vaccine for COVID-19

18 Pages Posted: 10 May 2021

See all articles by Juan Corchado-Garcia

Juan Corchado-Garcia

nference, Inc.

David Puyraimond-Zemmour‬

nference, Inc.

Travis Hughes

nference, Inc.

Tudor Cristea-Platon

nference, Inc.

Patrick Lenehan

nference, Inc.

Colin Pawlowski

nference, Inc.

Sairam Bade

nference Labs

John C. O'Horo

Mayo Clinic

Gregory J. Gores

Mayo Clinic

Amy W. Williams

Mayo Clinic

Andrew D. Badley

Mayo Clinic

John Halamka

Mayo Clinic

Abhinash Virk

Mayo Clinic

Melanie D. Swift

Mayo Clinic

Tyler Wagner

nference, Inc.

Venky Soundararajan

nference, Inc.

More...

Abstract

In light of the massive and rapid vaccination campaign against COVID-19, continuous real-world effectiveness and safety assessment of the FDA-authorized vaccines is critical to amplify transparency, build public trust, and ultimately improve overall health outcomes. In this study, we leveraged large-scale longitudinal curation of electronic health records (EHRs) from the multi-state Mayo Clinic health system (MN, AZ, FL, WN, IA). We compared the infection rate of 2,195 individuals who received a single dose of the Ad26.COV2.S vaccine from Johnson & Johnson (J&J) to the infection rate of 21,950 unvaccinated, propensity-matched individuals between February 27th and April 14th 2021. Of the 1,779 vaccinated individuals with at least two weeks of follow-up, only 3 (0.17%) tested positive for SARS-CoV-2 15 days or more after vaccination compared to 128 of 17,744 (0.72%) unvaccinated individuals (4.34 fold reduction rate). This corresponds to a vaccine effectiveness of 76.7% (95% CI: 30.3-95.3%) in preventing SARS-CoV-2 infection with onset at least two weeks after vaccination. This data is consistent with the clinical trial-reported efficacy of Ad26.COV2.S in preventing moderate to severe COVID-19 with onset at least 14 days after vaccine administration (66.9%; 95% CI: 59.0-73.4%). Due to the recent authorization of the Ad26.COV2.S vaccine, there are not yet enough hospitalizations, ICU admissions, or deaths within this cohort to robustly assess the effect of vaccination on COVID-19 severity, but these outcomes will be continually assessed in near-real-time with our platform. Collectively, this study provides further evidence that a single dose of Ad26.COV2.S is highly effective in preventing SARS-CoV-2 infection and reaffirms the urgent need to continue mass vaccination efforts globally.

Funding Statement: No external funding was received for this study.

Declaration of Interests: JCO receives personal fees from Elsevier and Bates College, and receives small grants from nference, Inc, outside the submitted work. ADB is a consultant for Abbvie, is on scientific advisory boards for nference and Zentalis, and is founder and President of Splissen therapeutics. The Mayo Clinic may stand to gain financially from the successful outcome of the research. nference collaborates with Janssen and other bio-pharmaceutical companies on data science initiatives unrelated to this study. These collaborations had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript. This research has been reviewed by the Mayo Clinic Conflict of Interest Review Board and is being conducted in compliance with Mayo Clinic Conflict of Interest policies. All other authors have nothing to declare.

Ethics Approval Statement: This study was reviewed by the Mayo Clinic Institutional Review Board (IRB) and determined to be exempt from the requirement for IRB approval (45 CFR 46.104d, category 4).

Suggested Citation

Corchado-Garcia, Juan and Puyraimond-Zemmour‬, David and Hughes, Travis and Cristea-Platon, Tudor and Lenehan, Patrick and Pawlowski, Colin and Bade, Sairam and O'Horo, John C. and Gores, Gregory J. and Williams, Amy W. and Badley, Andrew D. and Halamka, John and Virk, Abhinash and Swift, Melanie D. and Wagner, Tyler and Soundararajan, Venky, Real-World Effectiveness of Ad26.COV2.S Adenoviral Vector Vaccine for COVID-19. Available at SSRN: https://ssrn.com/abstract=3835737 or http://dx.doi.org/10.2139/ssrn.3835737

Juan Corchado-Garcia

nference, Inc. ( email )

One Main Street
East Arcade
Cambridge, MA 02142
United States

David Puyraimond-Zemmour‬

nference, Inc. ( email )

One Main Street
East Arcade
Cambridge, MA 02142
United States

Travis Hughes

nference, Inc.

One Main Street
East Arcade
Cambridge, MA 02142
United States

Tudor Cristea-Platon

nference, Inc. ( email )

One Main Street
East Arcade
Cambridge, MA 02142
United States

Patrick Lenehan

nference, Inc. ( email )

One Main Street
East Arcade
Cambridge, MA 02142
United States

Colin Pawlowski

nference, Inc. ( email )

One Main Street
East Arcade
Cambridge, MA 02142
United States

Sairam Bade

nference Labs ( email )

2nd Floor, 22 3rd Cross Rd
Murgesh Pallya
Bengaluru, Karnataka 560017
India

John C. O'Horo

Mayo Clinic ( email )

200 First Street SW
Rochester, MN (507) 284-2511 55905
United States

Gregory J. Gores

Mayo Clinic ( email )

200 First Street SW
Rochester, MN (507) 284-2511 55905
United States

Amy W. Williams

Mayo Clinic ( email )

200 First Street SW
Rochester, MN (507) 284-2511 55905
United States

Andrew D. Badley

Mayo Clinic ( email )

200 First Street SW
Rochester, MN (507) 284-2511 55905
United States

John Halamka

Mayo Clinic ( email )

200 First Street SW
Rochester, MN (507) 284-2511 55905
United States

Abhinash Virk

Mayo Clinic ( email )

200 First Street SW
Rochester, MN (507) 284-2511 55905
United States

Melanie D. Swift

Mayo Clinic ( email )

200 First Street SW
Rochester, MN (507) 284-2511 55905
United States

Tyler Wagner

nference, Inc. ( email )

One Main Street
East Arcade
Cambridge, MA 02142
United States

Venky Soundararajan (Contact Author)

nference, Inc. ( email )

One Main Street
East Arcade
Cambridge, MA 02142
United States