학술논문
Efficacy and Safety of NVX-CoV2373 in Adults in the United States and Mexico
Document Type
article
Author
Dunkle, Lisa M; Kotloff, Karen L; Gay, Cynthia L; Áñez, Germán; Adelglass, Jeffrey M; Barrat Hernández, Alejandro Q; Harper, Wayne L; Duncanson, Daniel M; McArthur, Monica A; Florescu, Diana F; McClelland, R Scott; Garcia-Fragoso, Veronica; Riesenberg, Robert A; Musante, David B; Fried, David L; Safirstein, Beth E; McKenzie, Mark; Jeanfreau, Robert J; Kingsley, Jeffrey K; Henderson, Jeffrey A; Lane, Dakotah C; Ruíz-Palacios, Guillermo M; Corey, Lawrence; Neuzil, Kathleen M; Coombs, Robert W; Greninger, Alex L; Hutter, Julia; Ake, Julie A; Smith, Katherine; Woo, Wayne; Cho, Iksung; Glenn, Gregory M; Dubovsky, Filip
Source
New England Journal of Medicine. 386(6)
Subject
Language
Abstract
BackgroundNVX-CoV2373 is an adjuvanted, recombinant spike protein nanoparticle vaccine that was shown to have clinical efficacy for the prevention of coronavirus disease 2019 (Covid-19) in phase 2b-3 trials in the United Kingdom and South Africa, but its efficacy had not yet been tested in North America.MethodsWe conducted a phase 3, randomized, observer-blinded, placebo-controlled trial in the United States and Mexico during the first half of 2021 to evaluate the efficacy and safety of NVX-CoV2373 in adults (≥18 years of age) who had not had severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection. Participants were randomly assigned in a 2:1 ratio to receive two doses of NVX-CoV2373 or placebo 21 days apart. The primary objective was to determine vaccine efficacy against reverse-transcriptase-polymerase-chain-reaction-confirmed Covid-19 occurring at least 7 days after the second dose. Vaccine efficacy against moderate-to-severe disease and against different variants was also assessed.ResultsOf the 29,949 participants who underwent randomization between December 27, 2020, and February 18, 2021, a total of 29,582 (median age, 47 years; 12.6% ≥65 years of age) received at least one dose: 19,714 received vaccine and 9868 placebo. Over a period of 3 months, 77 cases of Covid-19 were noted - 14 among vaccine recipients and 63 among placebo recipients (vaccine efficacy, 90.4%; 95% confidence interval [CI], 82.9 to 94.6; P