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    Efficacy and Safety of the mRNA-1273 SARS-CoV-2 Vaccine

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    Author
    Baden, Lindsey R
    El Sahly, Hana M
    Essink, Brandon
    Kotloff, Karen
    Frey, Sharon
    Novak, Rick
    Diemert, David
    Spector, Stephen A
    Rouphael, Nadine
    Creech, C Buddy
    McGettigan, John
    Khetan, Shishir
    Segall, Nathan
    Solis, Joel
    Brosz, Adam
    Fierro, Carlos
    Schwartz, Howard
    Neuzil, Kathleen
    Corey, Larry
    Gilbert, Peter
    Janes, Holly
    Follmann, Dean
    Marovich, Mary
    Mascola, John
    Polakowski, Laura
    Ledgerwood, Julie
    Graham, Barney S
    Bennett, Hamilton
    Pajon, Rolando
    Knightly, Conor
    Leav, Brett
    Deng, Weiping
    Zhou, Honghong
    Han, Shu
    Ivarsson, Melanie
    Miller, Jacqueline
    Zaks, Tal
    Show allShow less

    Date
    2020-12-30
    Journal
    New England Journal of Medicine
    Publisher
    Massachusetts Medical Society
    Type
    Article
    
    Metadata
    Show full item record
    See at
    https://doi.org/10.1056/NEJMoa2035389
    Abstract
    BACKGROUND Vaccines are needed to prevent coronavirus disease 2019 (Covid-19) and to protect persons who are at high risk for complications. The mRNA-1273 vaccine is a lipid nanoparticle-encapsulated mRNA-based vaccine that encodes the prefusion stabilized full-length spike protein of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the virus that causes Covid-19. METHODS This phase 3 randomized, observer-blinded, placebo-controlled trial was conducted at 99 centers across the United States. Persons at high risk for SARS-CoV-2 infection or its complications were randomly assigned in a 1:1 ratio to receive two intramuscular injections of mRNA-1273 (100 μg) or placebo 28 days apart. The primary end point was prevention of Covid-19 illness with onset at least 14 days after the second injection in participants who had not previously been infected with SARS-CoV-2. RESULTS The trial enrolled 30,420 volunteers who were randomly assigned in a 1:1 ratio to receive either vaccine or placebo (15,210 participants in each group). More than 96% of participants received both injections, and 2.2% had evidence (serologic, virologic, or both) of SARS-CoV-2 infection at baseline. Symptomatic Covid-19 illness was confirmed in 185 participants in the placebo group (56.5 per 1000 person-years; 95% confidence interval [CI], 48.7 to 65.3) and in 11 participants in the mRNA-1273 group (3.3 per 1000 person-years; 95% CI, 1.7 to 6.0); vaccine efficacy was 94.1% (95% CI, 89.3 to 96.8%; P<0.001). Efficacy was similar across key secondary analyses, including assessment 14 days after the first dose, analyses that included participants who had evidence of SARS-CoV-2 infection at baseline, and analyses in participants 65 years of age or older. Severe Covid-19 occurred in 30 participants, with one fatality; all 30 were in the placebo group. Moderate, transient reactogenicity after vaccination occurred more frequently in the mRNA-1273 group. Serious adverse events were rare, and the incidence was similar in the two groups. CONCLUSIONS The mRNA-1273 vaccine showed 94.1% efficacy at preventing Covid-19 illness, including severe disease. Aside from transient local and systemic reactions, no safety concerns were identified.
    Rights/Terms
    Copyright © 2020 Massachusetts Medical Society.
    Keyword
    mRNA-1273 vaccine
    COVID-19 Vaccines
    SARS-CoV-2
    RNA, Messenger
    Identifier to cite or link to this item
    http://hdl.handle.net/10713/14768
    ae974a485f413a2113503eed53cd6c53
    10.1056/NEJMoa2035389
    Scopus Count
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    UMB Coronavirus Publications
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