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ORIGINAL RESEARCH article

Front. Public Health
Sec. Infectious Diseases: Epidemiology and Prevention
Volume 12 - 2024 | doi: 10.3389/fpubh.2024.1501919

An Observational Post-Authorization Study to Assess the Effectiveness of a Single Dose Ad26.COV2.S for the Prevention of COVID-19 Using Real-world Data

Provisionally accepted
Mawuli Nyaku Mawuli Nyaku 1*Amelia Boehme Amelia Boehme 2Raymond A Harvey Raymond A Harvey 1Ann Madsen Ann Madsen 2Lexie Rubens Lexie Rubens 2Astra Toyip Astra Toyip 2Michael Batech Michael Batech 2Deborah Ricci Deborah Ricci 1
  • 1 Johnson & Johnson (United States), Bridgewater, United States
  • 2 Aetion Inc., New York, United States

The final, formatted version of the article will be published soon.

    The goal of this FDA-committed, post authorization study was to assess the real-world effectiveness of Ad26.COV2.S in preventing observed COVID-19 disease in individuals in the United States interacting with the healthcare system who were vaccinated according to the national immunization recommendations.The study cohort consisted of individuals ≥18 years in the U.S. between March 1, 2021 and July 31, 2022. Two exposure groups were considered: those who received a single dose of COVID-19 Ad26.COV2.S vaccine and individuals who were unvaccinated. Individuals eligible for the referent group, defined as those who were unvaccinated, were identified through exact matching on age, sex, location, and Gagne comorbidity score. Propensity-score (PS) matched Cox proportional hazards models were used to evaluate COVID-19 related outcomes.Results: A total of 478,162 vaccinated, and 1,897,759 risk set sampled (RSS) and PS-matched unvaccinated referent individuals were included. The vaccine effectiveness (VE) against any observed COVID-19 disease was 20% (95% CI, 19% to 21%). VE increased as the outcome severity increased. The VE against COVID-19 related hospitalizations was 43% (95% CI, 40% to 45%). VE was highest, 53% (95% CI, 42% to 61%), against all-cause mortality temporally associated with COVID-19. The results of subgroup analyses generally showed a similar pattern as the main analyses with VE increasing in parallel with seriousness of outcomes, albeit with lower VE in groups thought to be at higher risk of COVID-19.Discussion: This population-representative cohort study in U.S. clinical practice showed that a single dose of Ad26.COV2.S is effective for at least 12 months against several COVID-19 related outcomes. Individuals who were vaccinated with a single dose of Ad26.COV2.S were at lower risk for developing COVID-19, for being hospitalized for COVID-19, and for all-cause mortality temporally associated with COVID-19 compared to unvaccinated individuals in the U.S. during Alpha, Delta, and Omicron BA.1, BA.2, BA.212.1, and BA.5 variants circulation.

    Keywords: COVID-19, Vaccination, Vaccine effectiveness, Real-world evidence, Ad26.Cov2.S

    Received: 25 Sep 2024; Accepted: 21 Nov 2024.

    Copyright: © 2024 Nyaku, Boehme, Harvey, Madsen, Rubens, Toyip, Batech and Ricci. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.

    * Correspondence: Mawuli Nyaku, Johnson & Johnson (United States), Bridgewater, United States

    Disclaimer: All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article or claim that may be made by its manufacturer is not guaranteed or endorsed by the publisher.