N Engl J Med 2022 May 11. Epub 2022 May 11.
From the Vanderbilt Vaccine Research Program, Department of Pediatrics, Vanderbilt University Medical Center (C.B.C.), and Meharry Medical College (V.B.) - both in Nashville; the Center for Childhood Infections and Vaccines of Children's Healthcare of Atlanta and the Department of Pediatrics, Emory University School of Medicine - both in Atlanta (E.A.); the Department of Pediatrics, Yale School of Medicine, the Department of Epidemiology of Microbial Diseases, Yale School of Public Health, and the Yale Institute for Global Health - all in New Haven, CT (I.Y.); the Medical University of South Carolina (A.M.A.) and Coastal Pediatric Associates (R.A.C.) - both in Charleston; Boca Raton Clinical Research Global, Edinburg (I.M.B.), Tekton Research, Austin (P.P.), Highland Woods Health, The Woodlands (C.Y.), Texas Health Care, Privia Medical Group-North Texas, Fort Worth, and Forest Lane Pediatrics, Dallas (R.B.) - all in Texas; Capitol Medical Group, Chevy Chase (D.F.), and the Department of Pediatrics, Center for Vaccine Development and Global Health, University of Maryland School of Medicine, Baltimore (J.D.C.) - both in Maryland; Privia Medical Group, Arlington, VA (D.F., C.Y.); Velocity Clinical Research, Banning, CA (J.K.); Javara, Winston-Salem (C.Y., R.B.), and the Department of Surgery, Duke University Medical Center, Durham (D.C.M.) - both in North Carolina; Quality Clinical Research, Omaha, NE (M.D.); and Moderna, Cambridge, MA (J.E.T., X.Z., W.D., H.Z., D.R.S., K.H., B.G., K.S., R.M., R.P., R.D., J.M.M., S.S.G.).
Background: Vaccination of children to prevent coronavirus disease 2019 (Covid-19) is an urgent public health need. The safety, immunogenicity, and efficacy of the mRNA-1273 vaccine in children 6 to 11 years of age are unknown.
Methods: Part 1 of this ongoing phase 2-3 trial was open label for dose selection; part 2 was an observer-blinded, placebo-controlled expansion evaluation of the selected dose. Read More