Effectiveness of Heterologous and Homologous Ad26.COV2.S Vaccine Boosting in Preventing COVID-19-Related Outcomes Among Individuals with a Completed Primary Vaccination Series in the United States
<b>Background/Objectives:</b> COVID-19 vaccines have significantly reduced the mortality and morbidity associated with SARS-CoV-2. In the fall of 2021, the U.S. Food and Drug Administration amended its emergency use authorization guidelines for COVID-19 vaccines to allow the administrati...
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MDPI AG
2025-02-01
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| Online Access: | https://www.mdpi.com/2076-393X/13/2/166 |
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| author | Mawuli Nyaku Lara S. Yoon Deborah Ricci Lexie Rubens Paige Sheridan Monica Iyer Thomas Zhen Raymond A. Harvey Ann Madsen |
| author_facet | Mawuli Nyaku Lara S. Yoon Deborah Ricci Lexie Rubens Paige Sheridan Monica Iyer Thomas Zhen Raymond A. Harvey Ann Madsen |
| author_sort | Mawuli Nyaku |
| collection | DOAJ |
| description | <b>Background/Objectives:</b> COVID-19 vaccines have significantly reduced the mortality and morbidity associated with SARS-CoV-2. In the fall of 2021, the U.S. Food and Drug Administration amended its emergency use authorization guidelines for COVID-19 vaccines to allow the administration of booster vaccine doses based on sound scientific evidence of the increase in effectiveness conferred by boosters. The effectiveness of the Ad26.COV2.S COVID-19 booster vaccine during the periods of Delta and Omicron variant dominance is unknown. This study used real-world data to estimate the effectiveness of booster heterologous or homologous Ad26.COV2.S vaccination compared to that of a primary Ad26.COV2.S or mRNA COVID-19 vaccination series. <b>Methods:</b> A retrospective, observational, longitudinal cohort study design was used with a total eligible sample population consisting of 72,461,026 individuals in the HealthVerity dataset. The study cohort consisted of individuals ≥18 years in the United States with evidence of a COVID-19 primary vaccination series (Ad26.COV2.S or mRNA) administered between 1 January 2021 and 6 July 2022. Two exposure groups were considered based on retrospective database classification: a heterologous Ad26.COV2.S booster and a homologous Ad26.COV2.S booster. Individuals eligible for the referent groups, defined as those with a primary vaccine series alone, were identified through exact matching by age, sex, time since primary series vaccine, location, and Gagne comorbidity score. Propensity score-matched Cox proportional hazards models were used to evaluate outcomes, including COVID-19-related hospitalization and medically attended COVID-19. <b>Results:</b> Depending on the comparison group of interest, the adjusted hazard ratios for COVID-19-related hospitalization ranged from 0.63 (95% CI: 0.56, 0.72) to 0.82 (95% CI: 0.75, 0.90), and 0.93 (95% CI: 0.90, 0.96) to 0.94 (95% CI: 0.91, 0.97) for medically attended COVID-19, both favoring booster vaccination. <b>Conclusions:</b> The results of this study demonstrate the effectiveness of an Ad26.COV2.S booster vaccination compared to primary series vaccination in preventing COVID-19 hospitalization and medically attended COVID-19 for at least 12 months. This study adds to the scientific evidence that demonstrates the importance of COVID-19 booster vaccinations to support public health policy. |
| format | Article |
| id | doaj-art-d074eeebe509420bb692fffca0a29e5d |
| institution | DOAJ |
| issn | 2076-393X |
| language | English |
| publishDate | 2025-02-01 |
| publisher | MDPI AG |
| record_format | Article |
| series | Vaccines |
| spelling | doaj-art-d074eeebe509420bb692fffca0a29e5d2025-08-20T03:12:16ZengMDPI AGVaccines2076-393X2025-02-0113216610.3390/vaccines13020166Effectiveness of Heterologous and Homologous Ad26.COV2.S Vaccine Boosting in Preventing COVID-19-Related Outcomes Among Individuals with a Completed Primary Vaccination Series in the United StatesMawuli Nyaku0Lara S. Yoon1Deborah Ricci2Lexie Rubens3Paige Sheridan4Monica Iyer5Thomas Zhen6Raymond A. Harvey7Ann Madsen8Johnson & Johnson Innovative Medicine, Data Science and Digital Health, Spring House, PA 19002, USAAetion Inc., New York, NY 10001, USAJohnson & Johnson Innovative Medicine, Data Science and Digital Health, Spring House, PA 19002, USAAetion Inc., New York, NY 10001, USAAetion Inc., New York, NY 10001, USAAetion Inc., New York, NY 10001, USAAetion Inc., New York, NY 10001, USAJohnson & Johnson Innovative Medicine, Data Science and Digital Health, Spring House, PA 19002, USAAetion Inc., New York, NY 10001, USA<b>Background/Objectives:</b> COVID-19 vaccines have significantly reduced the mortality and morbidity associated with SARS-CoV-2. In the fall of 2021, the U.S. Food and Drug Administration amended its emergency use authorization guidelines for COVID-19 vaccines to allow the administration of booster vaccine doses based on sound scientific evidence of the increase in effectiveness conferred by boosters. The effectiveness of the Ad26.COV2.S COVID-19 booster vaccine during the periods of Delta and Omicron variant dominance is unknown. This study used real-world data to estimate the effectiveness of booster heterologous or homologous Ad26.COV2.S vaccination compared to that of a primary Ad26.COV2.S or mRNA COVID-19 vaccination series. <b>Methods:</b> A retrospective, observational, longitudinal cohort study design was used with a total eligible sample population consisting of 72,461,026 individuals in the HealthVerity dataset. The study cohort consisted of individuals ≥18 years in the United States with evidence of a COVID-19 primary vaccination series (Ad26.COV2.S or mRNA) administered between 1 January 2021 and 6 July 2022. Two exposure groups were considered based on retrospective database classification: a heterologous Ad26.COV2.S booster and a homologous Ad26.COV2.S booster. Individuals eligible for the referent groups, defined as those with a primary vaccine series alone, were identified through exact matching by age, sex, time since primary series vaccine, location, and Gagne comorbidity score. Propensity score-matched Cox proportional hazards models were used to evaluate outcomes, including COVID-19-related hospitalization and medically attended COVID-19. <b>Results:</b> Depending on the comparison group of interest, the adjusted hazard ratios for COVID-19-related hospitalization ranged from 0.63 (95% CI: 0.56, 0.72) to 0.82 (95% CI: 0.75, 0.90), and 0.93 (95% CI: 0.90, 0.96) to 0.94 (95% CI: 0.91, 0.97) for medically attended COVID-19, both favoring booster vaccination. <b>Conclusions:</b> The results of this study demonstrate the effectiveness of an Ad26.COV2.S booster vaccination compared to primary series vaccination in preventing COVID-19 hospitalization and medically attended COVID-19 for at least 12 months. This study adds to the scientific evidence that demonstrates the importance of COVID-19 booster vaccinations to support public health policy.https://www.mdpi.com/2076-393X/13/2/166COVID-19adenovirus vaccinebooster vaccinereal-world datareal-world evidence |
| spellingShingle | Mawuli Nyaku Lara S. Yoon Deborah Ricci Lexie Rubens Paige Sheridan Monica Iyer Thomas Zhen Raymond A. Harvey Ann Madsen Effectiveness of Heterologous and Homologous Ad26.COV2.S Vaccine Boosting in Preventing COVID-19-Related Outcomes Among Individuals with a Completed Primary Vaccination Series in the United States Vaccines COVID-19 adenovirus vaccine booster vaccine real-world data real-world evidence |
| title | Effectiveness of Heterologous and Homologous Ad26.COV2.S Vaccine Boosting in Preventing COVID-19-Related Outcomes Among Individuals with a Completed Primary Vaccination Series in the United States |
| title_full | Effectiveness of Heterologous and Homologous Ad26.COV2.S Vaccine Boosting in Preventing COVID-19-Related Outcomes Among Individuals with a Completed Primary Vaccination Series in the United States |
| title_fullStr | Effectiveness of Heterologous and Homologous Ad26.COV2.S Vaccine Boosting in Preventing COVID-19-Related Outcomes Among Individuals with a Completed Primary Vaccination Series in the United States |
| title_full_unstemmed | Effectiveness of Heterologous and Homologous Ad26.COV2.S Vaccine Boosting in Preventing COVID-19-Related Outcomes Among Individuals with a Completed Primary Vaccination Series in the United States |
| title_short | Effectiveness of Heterologous and Homologous Ad26.COV2.S Vaccine Boosting in Preventing COVID-19-Related Outcomes Among Individuals with a Completed Primary Vaccination Series in the United States |
| title_sort | effectiveness of heterologous and homologous ad26 cov2 s vaccine boosting in preventing covid 19 related outcomes among individuals with a completed primary vaccination series in the united states |
| topic | COVID-19 adenovirus vaccine booster vaccine real-world data real-world evidence |
| url | https://www.mdpi.com/2076-393X/13/2/166 |
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