Randomized Controlled Trial Multicenter Study
Efficacy and Safety of NVX-CoV2373 in Adults in the United States and Mexico.
Nuvaxoid is safe and 90% effective against the Alpha (B.1.1.7) SARS-CoV-2 variant.pearl
- Lisa M Dunkle, Karen L Kotloff, Cynthia L Gay, Germán Áñez, Jeffrey M Adelglass, Alejandro Q Barrat Hernández, Wayne L Harper, Daniel M Duncanson, Monica A McArthur, Diana F Florescu, R Scott McClelland, Veronica Garcia-Fragoso, Robert A Riesenberg, David B Musante, David L Fried, Beth E Safirstein, Mark McKenzie, Robert J Jeanfreau, Jeffrey K Kingsley, Jeffrey A Henderson, Dakotah C Lane, Guillermo M Ruíz-Palacios, Lawrence Corey, Kathleen M Neuzil, Robert W Coombs, Alex L Greninger, Julia Hutter, Julie A Ake, Katherine Smith, Wayne Woo, Iksung Cho, Gregory M Glenn, Filip Dubovsky, and 2019nCoV-301 Study Group.
- From Novavax, Gaithersburg (L.M.D., G.A., K.S., W.W., I.C., G.M.G., F.D.), the University of Maryland School of Medicine, Baltimore (K.L.K., M.A.M., K.M.N.), the National Institute of Allergy and Infectious Diseases, Bethesda (J.H.), and Walter Reed Army Institute of Research, Silver Spring (J.A.A.) - all in Maryland; FAICIC Clinical Research, Veracruz (A.Q.B.H.), and Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.) - both in Mexico; Research Your Health, Plano (J.M.A.) and the Texas Center for Drug Development, Houston (V.G.-F.) - both in Texas; M3-Wake Research, Raleigh (W.L.H.), M3-Emerging Medical Research, Durham (D.B.M.), and the University of North Carolina School of Medicine, Chapel Hill (C.L.G.) - all in North Carolina; SIMEDHealth, Gainesville (D.M.D.), and Velocity Clinical Research, Hallandale Beach (B.E.S.) - both in Florida; the University of Nebraska Medical Center, Omaha (D.F.F.); the University of Washington Medical Center (R.S.M., R.W.C., A.L.G.) and Fred Hutchinson Cancer Research Center (L.C.), Seattle, and Lummi Indian Health Center, Bellingham (D.C.L.) - all in Washington; the Atlanta Center for Medical Research, Atlanta (R.A.R.), and IACT Health, Columbus (J.K.K.) - both in Georgia; Velocity Clinical Research-Providence, Warwick, RI (D.L.F.); WR ClinSearch, Chattanooga, TN (M.M.); MedPharmics, Metairie, LA (R.J.J.); and Black Hills Center for American Indian Health, Rapid City, SD (J.A.H.).
- N. Engl. J. Med. 2022 Feb 10; 386 (6): 531-543.
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<0.001). Ten moderate and 4 severe cases occurred, all in placebo recipients, yielding vaccine efficacy against moderate-to-severe disease of 100% (95% CI, 87.0 to 100). Most sequenced viral genomes (48 of 61, 79%) were variants of concern or interest - largely B.1.1.7 (alpha) (31 of the 35 genomes for variants of concern, 89%). Vaccine efficacy against any variant of concern or interest was 92.6% (95% CI, 83.6 to 96.7). Reactogenicity was mostly mild to moderate and transient but was more frequent among NVX-CoV2373 recipients than among placebo recipients and was more frequent after the second dose than after the first dose.ConclusionsNVX-CoV2373 was safe and effective for the prevention of Covid-19. Most breakthrough cases were caused by contemporary variant strains. (Funded by Novavax and others; PREVENT-19 ClinicalTrials.gov number, NCT04611802.).Copyright © 2021 Massachusetts Medical Society.
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