N Engl J Med 2022 Feb 15;386(6):531-543. Epub 2021 Dec 15.
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.).
Background: NVX-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.
Methods: We 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. Read More