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.

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.

Publication date: Sep 25, 2024

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. 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. 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.

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Concepts Keywords
12months Ad26.COV2.S
July Ad26COVS1
March Ad26COVS1
Vaccinated Adult
Aged
Cohort Studies
COVID-19
COVID-19
COVID-19 Vaccines
COVID-19 Vaccines
Female
Humans
Male
Middle Aged
Propensity Score
Proportional Hazards Models
real-world evidence
SARS-CoV-2
United States
vaccination
vaccine effectiveness
Vaccine Efficacy

Semantics

Type Source Name
disease MESH COVID-19
disease MESH comorbidity
drug DRUGBANK Coenzyme M
pathway REACTOME Reproduction
disease IDO replication
disease MESH death
disease IDO nucleic acid
disease MESH COPD
disease MESH pulmonary fibrosis
disease MESH HIV infection
pathway REACTOME HIV Infection
disease IDO blood
disease MESH liver disease
disease MESH malignancies
disease MESH melanoma
pathway KEGG Melanoma
disease MESH skin cancer
disease MESH asthma
pathway KEGG Asthma
disease MESH cerebrovascular disease
disease MESH chronic kidney disease
disease MESH hypertension
disease MESH obesity
disease MESH thalassemia
disease IDO process
disease MESH pulmonary diseases
disease MESH Congestive heart failure
disease MESH Cardiac arrhythmias
disease MESH cardiovascular disease
disease MESH neurological disorders
disease IDO immunosuppression
drug DRUGBANK Isoxaflutole

Original Article

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