Dataset Information

Effectiveness of the Ad26.COV2.S (Johnson & Johnson) Coronavirus Disease 2019 (COVID-19) Vaccine for Preventing COVID-19 Hospitalizations and Progression to High Disease Severity in the United States.

ABSTRACT: Background . Adults in the United States (US) began receiving the adenovirus vector coronavirus disease 2019 (COVID-19) vaccine, Ad26.COV2.S (Johnson & Johnson [Janssen]), in February 2021. We evaluated Ad26.COV2.S vaccine effectiveness (VE) against COVID-19 hospitalization and high disease severity during the first 10 months of its use. Methods . In a multicenter case-control analysis of US adults (≥18 years) hospitalized 11 March to 15 December 2021, we estimated VE against susceptibility to COVID-19 hospitalization (VEs), comparing odds of prior vaccination with a single dose Ad26.COV2.S vaccine between hospitalized cases with COVID-19 and controls without COVID-19. Among hospitalized patients with COVID-19, we estimated VE against disease progression (VEp) to death or invasive mechanical ventilation (IMV), comparing odds of prior vaccination between patients with and without progression. Results . After excluding patients receiving mRNA vaccines, among 3979 COVID-19 case-patients (5% vaccinated with Ad26.COV2.S) and 2229 controls (13% vaccinated with Ad26.COV2.S), VEs of Ad26.COV2.S against COVID-19 hospitalization was 70% (95% confidence interval [CI]: 63-75%) overall, including 55% (29-72%) among immunocompromised patients, and 72% (64-77%) among immunocompetent patients, for whom VEs was similar at 14-90 days (73% [59-82%]), 91-180 days (71% [60-80%]), and 181-274 days (70% [54-81%]) postvaccination. Among hospitalized COVID-19 case-patients, VEp was 46% (18-65%) among immunocompetent patients. Conclusions . The Ad26.COV2.S COVID-19 vaccine reduced the risk of COVID-19 hospitalization by 72% among immunocompetent adults without waning through 6 months postvaccination. After hospitalization for COVID-19, vaccinated immunocompetent patients were less likely to require IMV or die compared to unvaccinated immunocompetent patients.

SUBMITTER: Lewis NM

PROVIDER: S-EPMC9214149 | biostudies-literature | 2022 Oct

REPOSITORIES: biostudies-literature

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Effectiveness of the Ad26.COV2.S (Johnson & Johnson) Coronavirus Disease 2019 (COVID-19) Vaccine for Preventing COVID-19 Hospitalizations and Progression to High Disease Severity in the United States.

Lewis Nathaniel M NM Self Wesley H WH Gaglani Manjusha M Ginde Adit A AA Douin David J DJ Keipp Talbot H H Casey Jonathan D JD Mohr Nicholas M NM Zepeski Anne A Ghamande Shekhar A SA McNeal Tresa A TA Shapiro Nathan I NI Gibbs Kevin W KW Files D Clark DC Hager David N DN Shehu Arber A Prekker Matthew E ME Erickson Heidi L HL Gong Michelle N MN Mohamed Amira A Johnson Nicholas J NJ Srinivasan Vasisht V Steingrub Jay S JS Peltan Ithan D ID Brown Samuel M SM Martin Emily T ET Monto Arnold S AS Khan Akram A Busse Laurence W LW Lohuis Caitlin C Ten CCT Duggal Abhijit A Wilson Jennifer G JG Gordon Alexandra June AJ Qadir Nida N Chang Steven Y SY Mallow Christopher C Rivas Carolina C Babcock Hilary M HM Kwon Jennie H JH Exline Matthew C MC Lauring Adam S AS Halasa Natasha N Chappell James D JD Grijalva Carlos G CG Rice Todd W TW Rhoads Jillian P JP Jones Ian D ID Stubblefield William B WB Baughman Adrienne A Womack Kelsey N KN Lindsell Christopher J CJ Hart Kimberly W KW Zhu Yuwei Y Adams Katherine K Patel Manish M MM Tenforde Mark W MW

Clinical infectious diseases : an official publication of the Infectious Diseases Society of America 20221001 Suppl 2

Background . Adults in the United States (US) began receiving the adenovirus vector coronavirus disease 2019 (COVID-19) vaccine, Ad26.COV2.S (Johnson & Johnson [Janssen]), in February 2021. We evaluated Ad26.COV2.S vaccine effectiveness (VE) against COVID-19 hospitalization and high disease severity during the first 10 months of its use. Methods . In a multicenter case-control analysis of US adults (≥18 years) hospitalized 11 March to 15 December 2021, we estimated VE against susceptibility to C ...[more]

PMID: 35675695

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Project description:Background/Objectives: 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. Methods: 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. Results: 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. Conclusions: 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.

Project description:ImportanceContinuous 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.ObjectiveTo evaluate the effectiveness of the Johnson & Johnson Ad26.COV2.S vaccine for preventing SARS-CoV-2 infection.Design, setting, and participantsThis 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.ExposureSingle dose of the Ad26.COV2.S vaccine.Main outcomes and measuresThe incidence rate ratio of SARS-CoV-2 infection in the vaccinated vs unvaccinated control cohorts, measured by SARS-CoV-2 polymerase chain reaction testing.ResultsThe 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 relevanceThis 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.

Project description:ImportanceControl of the global COVID-19 pandemic will require the development and deployment of safe and effective vaccines.ObjectiveTo evaluate the immunogenicity of the Ad26.COV2.S vaccine (Janssen/Johnson & Johnson) in humans, including the kinetics, magnitude, and phenotype of SARS-CoV-2 spike-specific humoral and cellular immune responses.Design, setting, and participantsTwenty-five participants were enrolled from July 29, 2020, to August 7, 2020, and the follow-up for this day 71 interim analysis was completed on October 3, 2020; follow-up to assess durability will continue for 2 years. This study was conducted at a single clinical site in Boston, Massachusetts, as part of a randomized, double-blind, placebo-controlled phase 1 clinical trial of Ad26.COV2.S.InterventionsParticipants were randomized to receive 1 or 2 intramuscular injections with 5 × 1010 viral particles or 1 × 1011 viral particles of Ad26.COV2.S vaccine or placebo administered on day 1 and day 57 (5 participants in each group).Main outcomes and measuresHumoral immune responses included binding and neutralizing antibody responses at multiple time points following immunization. Cellular immune responses included immunospot-based and intracellular cytokine staining assays to measure T-cell responses.ResultsTwenty-five participants were randomized (median age, 42; age range, 22-52; 52% women, 44% male, 4% undifferentiated), and all completed the trial through the day 71 interim end point. Binding and neutralizing antibodies emerged rapidly by day 8 after initial immunization in 90% and 25% of vaccine recipients, respectively. By day 57, binding and neutralizing antibodies were detected in 100% of vaccine recipients after a single immunization. On day 71, the geometric mean titers of spike-specific binding antibodies were 2432 to 5729 and the geometric mean titers of neutralizing antibodies were 242 to 449 in the vaccinated groups. A variety of antibody subclasses, Fc receptor binding properties, and antiviral functions were induced. CD4+ and CD8+ T-cell responses were induced.Conclusion and relevanceIn this phase 1 study, a single immunization with Ad26.COV2.S induced rapid binding and neutralization antibody responses as well as cellular immune responses. Two phase 3 clinical trials are currently underway to determine the efficacy of the Ad26.COV2.S vaccine.Trial registrationClinicalTrials.gov Identifier: NCT04436276.

Project description:BackgroundThe Ad26.COV2.S vaccine is a recombinant, replication-incompetent human adenovirus type 26 vector encoding full-length severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) spike protein in a prefusion-stabilized conformation.MethodsIn an international, randomized, double-blind, placebo-controlled, phase 3 trial, we randomly assigned adult participants in a 1:1 ratio to receive a single dose of Ad26.COV2.S (5×1010 viral particles) or placebo. The primary end points were vaccine efficacy against moderate to severe-critical coronavirus disease 2019 (Covid-19) with an onset at least 14 days and at least 28 days after administration among participants in the per-protocol population who had tested negative for SARS-CoV-2. Safety was also assessed.ResultsThe per-protocol population included 19,630 SARS-CoV-2-negative participants who received Ad26.COV2.S and 19,691 who received placebo. Ad26.COV2.S protected against moderate to severe-critical Covid-19 with onset at least 14 days after administration (116 cases in the vaccine group vs. 348 in the placebo group; efficacy, 66.9%; adjusted 95% confidence interval [CI], 59.0 to 73.4) and at least 28 days after administration (66 vs. 193 cases; efficacy, 66.1%; adjusted 95% CI, 55.0 to 74.8). Vaccine efficacy was higher against severe-critical Covid-19 (76.7% [adjusted 95% CI, 54.6 to 89.1] for onset at ≥14 days and 85.4% [adjusted 95% CI, 54.2 to 96.9] for onset at ≥28 days). Despite 86 of 91 cases (94.5%) in South Africa with sequenced virus having the 20H/501Y.V2 variant, vaccine efficacy was 52.0% and 64.0% against moderate to severe-critical Covid-19 with onset at least 14 days and at least 28 days after administration, respectively, and efficacy against severe-critical Covid-19 was 73.1% and 81.7%, respectively. Reactogenicity was higher with Ad26.COV2.S than with placebo but was generally mild to moderate and transient. The incidence of serious adverse events was balanced between the two groups. Three deaths occurred in the vaccine group (none were Covid-19-related), and 16 in the placebo group (5 were Covid-19-related).ConclusionsA single dose of Ad26.COV2.S protected against symptomatic Covid-19 and asymptomatic SARS-CoV-2 infection and was effective against severe-critical disease, including hospitalization and death. Safety appeared to be similar to that in other phase 3 trials of Covid-19 vaccines. (Funded by Janssen Research and Development and others; ENSEMBLE ClinicalTrials.gov number, NCT04505722.).

Dataset Information

Effectiveness of the Ad26.COV2.S (Johnson & Johnson) Coronavirus Disease 2019 (COVID-19) Vaccine for Preventing COVID-19 Hospitalizations and Progression to High Disease Severity in the United States.

Publications

Effectiveness of the Ad26.COV2.S (Johnson & Johnson) Coronavirus Disease 2019 (COVID-19) Vaccine for Preventing COVID-19 Hospitalizations and Progression to High Disease Severity in the United States.

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