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    Phase 3 Safety and Efficacy of AZD1222 (ChAdOx1 nCoV-19) Covid-19 Vaccine

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    Author
    Falsey, Ann R
    Sobieszczyk, Magdalena E
    Hirsch, Ian
    Sproule, Stephanie
    Robb, Merlin L
    Corey, Lawrence
    Neuzil, Kathleen M
    Hahn, William
    Hunt, Julie
    Mulligan, Mark J
    McEvoy, Charlene
    DeJesus, Edwin
    Hassman, Michael
    Little, Susan J
    Pahud, Barbara A
    Durbin, Anna
    Pickrell, Paul
    Daar, Eric S
    Bush, Larry
    Solis, Joel
    Carr, Quito Osuna
    Oyedele, Temitope
    Buchbinder, Susan
    Cowden, Jessica
    Vargas, Sergio L
    Benavides, Alfredo Guerreros
    Call, Robert
    Keefer, Michael C
    Kirkpatrick, Beth D
    Pullman, John
    Tong, Tina
    Isaacs, Margaret Brewinski
    Benkeser, David
    Janes, Holly E
    Nason, Martha C
    Green, Justin A
    Kelly, Elizabeth J
    Maaske, Jill
    Mueller, Nancy
    Shoemaker, Kathryn
    Takas, Therese
    Marshall, Richard P
    Pangalos, Menelas N
    Villafana, Tonya
    Gonzalez-Lopez, Antonio
    Show allShow less

    Date
    2021-09-29
    Journal
    New England Journal of Medicine
    Publisher
    Massachusetts Medical Society
    Type
    Article
    
    Metadata
    Show full item record
    See at
    https://doi.org/10.1056/NEJMoa2105290
    http://www.ncbi.nlm.nih.gov/pmc/articles/pmc8522798/
    Abstract
    Background: The safety and efficacy of the AZD1222 (ChAdOx1 nCoV-19) vaccine in a large, diverse population at increased risk for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection in the United States, Chile, and Peru has not been known. Methods: In this ongoing, double-blind, randomized, placebo-controlled, phase 3 clinical trial, we investigated the safety, vaccine efficacy, and immunogenicity of two doses of AZD1222 as compared with placebo in preventing the onset of symptomatic and severe coronavirus disease 2019 (Covid-19) 15 days or more after the second dose in adults, including older adults, in the United States, Chile, and Peru. Results: A total of 32,451 participants underwent randomization, in a 2:1 ratio, to receive AZD1222 (21,635 participants) or placebo (10,816 participants). AZD1222 was safe, with low incidences of serious and medically attended adverse events and adverse events of special interest; the incidences were similar to those observed in the placebo group. Solicited local and systemic reactions were generally mild or moderate in both groups. Overall estimated vaccine efficacy was 74.0% (95% confidence interval [CI], 65.3 to 80.5; P<0.001) and estimated vaccine efficacy was 83.5% (95% CI, 54.2 to 94.1) in participants 65 years of age or older. High vaccine efficacy was consistent across a range of demographic subgroups. In the fully vaccinated analysis subgroup, no severe or critical symptomatic Covid-19 cases were observed among the 17,662 participants in the AZD1222 group; 8 cases were noted among the 8550 participants in the placebo group (<0.1%). The estimated vaccine efficacy for preventing SARS-CoV-2 infection (nucleocapsid antibody seroconversion) was 64.3% (95% CI, 56.1 to 71.0; P<0.001). SARS-CoV-2 spike protein binding and neutralizing antibodies increased after the first dose and increased further when measured 28 days after the second dose. Conclusions: AZD1222 was safe and efficacious in preventing symptomatic and severe Covid-19 across diverse populations that included older adults. (Funded by AstraZeneca and others; ClinicalTrials.gov number, NCT04516746.).
    Rights/Terms
    Copyright © 2021 Massachusetts Medical Society.
    Keyword
    AZD1222
    COVID-19 Vaccines
    Clinical Trial, Phase III
    Identifier to cite or link to this item
    http://hdl.handle.net/10713/16909
    ae974a485f413a2113503eed53cd6c53
    10.1056/NEJMoa2105290
    Scopus Count
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    UMB Coronavirus Publications
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