1. Efficacy and Safety of NVX-CoV2373 in Adults in the United States and Mexico
- Author
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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, and Dubovsky, Filip
- Subjects
Biomedical and Clinical Sciences ,Clinical Sciences ,Immunization ,Coronaviruses ,Vaccine Related ,Clinical Research ,Infectious Diseases ,Clinical Trials and Supportive Activities ,Prevention ,Emerging Infectious Diseases ,6.1 Pharmaceuticals ,Infection ,Good Health and Well Being ,Adolescent ,Adult ,Aged ,COVID-19 ,COVID-19 Nucleic Acid Testing ,COVID-19 Vaccines ,Humans ,Incidence ,Male ,Mexico ,Middle Aged ,SARS-CoV-2 ,Single-Blind Method ,United States ,Vaccine Efficacy ,2019nCoV-301 Study Group ,Medical and Health Sciences ,General & Internal Medicine ,Biomedical and clinical sciences ,Health sciences - 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
- Published
- 2022