Evaluation of mRNA-1273 Covid-19 Vaccine in Children 6 to 11 Years of Age.
| Title: | Evaluation of mRNA-1273 Covid-19 Vaccine in Children 6 to 11 Years of Age. |
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| Authors: | Creech CB; 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.).; Anderson E; 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.).; Berthaud V; 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.).; Yildirim I; 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.).; Atz AM; 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.).; Melendez Baez I; 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.).; Finkelstein D; 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.).; Pickrell P; 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.).; Kirstein J; 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.).; Yut C; 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.).; Blair R; 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.).; Clifford RA; 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.).; Dunn M; 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.).; Campbell JD; 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.).; Montefiori DC; 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.).; Tomassini JE; 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.).; Zhao X; 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.).; Deng W; 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.).; Zhou H; 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.).; Ramirez Schrempp D; 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.).; Hautzinger K; 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.).; Girard B; 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.).; Slobod K; 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.).; McPhee R; 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.).; Pajon R; 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.).; Das R; 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.).; Miller JM; 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.).; Schnyder Ghamloush S; 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.). |
| Corporate Authors: | KidCOVE Study Group |
| Source: | The New England journal of medicine [N Engl J Med] 2022 May 26; Vol. 386 (21), pp. 2011-2023. Date of Electronic Publication: 2022 May 11. |
| Publication Type: | Clinical Trial, Phase II; Clinical Trial, Phase III; Journal Article; Randomized Controlled Trial; Equivalence Trial |
| Language: | English |
| Journal Info: | Publisher: Massachusetts Medical Society Country of Publication: United States NLM ID: 0255562 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1533-4406 (Electronic) Linking ISSN: 00284793 NLM ISO Abbreviation: N Engl J Med Subsets: MEDLINE |
| Imprint Name(s): | Original Publication: Boston, Massachusetts Medical Society. |
| MeSH Terms: | 2019-nCoV Vaccine mRNA-1273*/adverse effects ; 2019-nCoV Vaccine mRNA-1273*/immunology ; 2019-nCoV Vaccine mRNA-1273*/therapeutic use ; COVID-19*/blood ; COVID-19*/complications ; COVID-19*/immunology ; COVID-19*/prevention & control; Antibodies, Neutralizing/blood ; Antibodies, Neutralizing/immunology ; Antibodies, Viral/blood ; Antibodies, Viral/immunology ; COVID-19 Vaccines/adverse effects ; COVID-19 Vaccines/therapeutic use ; Adolescent ; Adult ; Child ; Double-Blind Method ; Humans ; SARS-CoV-2 ; Systemic Inflammatory Response Syndrome ; Vaccine Efficacy ; Young Adult |
| Abstract: | 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. In part 2, we randomly assigned children (6 to 11 years of age) in a 3:1 ratio to receive two injections of mRNA-1273 (50 μg each) or placebo, administered 28 days apart. The primary objectives were evaluation of the safety of the vaccine in children and the noninferiority of the immune response in these children to that in young adults (18 to 25 years of age) in a related phase 3 trial. Secondary objectives included determination of the incidences of confirmed Covid-19 and severe acute respiratory syndrome coronavirus 2 infection, regardless of symptoms. Interim analysis results are reported.; Results: In part 1 of the trial, 751 children received 50-μg or 100-μg injections of the mRNA-1273 vaccine, and on the basis of safety and immunogenicity results, the 50-μg dose level was selected for part 2. In part 2 of the trial, 4016 children were randomly assigned to receive two injections of mRNA-1273 (50 μg each) or placebo and were followed for a median of 82 days (interquartile range, 14 to 94) after the first injection. This dose level was associated with mainly low-grade, transient adverse events, most commonly injection-site pain, headache, and fatigue. No vaccine-related serious adverse events, multisystem inflammatory syndrome in children, myocarditis, or pericarditis were reported as of the data-cutoff date. One month after the second injection (day 57), the neutralizing antibody titer in children who received mRNA-1273 at a 50-μg level was 1610 (95% confidence interval [CI], 1457 to 1780), as compared with 1300 (95% CI, 1171 to 1443) at the 100-μg level in young adults, with serologic responses in at least 99.0% of the participants in both age groups, findings that met the prespecified noninferiority success criterion. Estimated vaccine efficacy was 88.0% (95% CI, 70.0 to 95.8) against Covid-19 occurring 14 days or more after the first injection, at a time when B.1.617.2 (delta) was the dominant circulating variant.; Conclusions: Two 50-μg doses of the mRNA-1273 vaccine were found to be safe and effective in inducing immune responses and preventing Covid-19 in children 6 to 11 years of age; these responses were noninferior to those in young adults. (Funded by the Biomedical Advanced Research and Development Authority and the National Institute of Allergy and Infectious Diseases; KidCOVE ClinicalTrials.gov number, NCT04796896.).; (Copyright © 2022 Massachusetts Medical Society.) |
| References: | MMWR Morb Mortal Wkly Rep. 2022 Feb 18;71(7):271-278. (PMID: 35176003); Science. 2022 Jan 07;375(6576):43-50. (PMID: 34812653); Clin Infect Dis. 2021 May 4;72(9):e206-e214. (PMID: 32674114); N Engl J Med. 2021 Dec 23;385(26):2485-2487. (PMID: 34731553); Pediatrics. 2022 Mar 1;149(3):. (PMID: 35194642); N Engl J Med. 2021 Dec 9;385(24):2241-2251. (PMID: 34379915); Lancet Child Adolesc Health. 2022 Apr;6(4):230-239. (PMID: 35143770); N Engl J Med. 2021 Sep 2;385(10):954-956. (PMID: 34289272); MMWR Morb Mortal Wkly Rep. 2022 Jan 14;71(2):52-58. (PMID: 35025852); MMWR Morb Mortal Wkly Rep. 2020 Aug 14;69(32):1081-1088. (PMID: 32790664); MMWR Morb Mortal Wkly Rep. 2021 Sep 10;70(36):1255-1260. (PMID: 34499627); N Engl J Med. 2022 Mar 17;386(11):1088-1091. (PMID: 35081298); N Engl J Med. 2022 Jan 6;386(1):35-46. (PMID: 34752019); N Engl J Med. 2021 Nov 4;385(19):1774-1785. (PMID: 34551225); BMJ. 2021 Dec 15;375:e068848. (PMID: 34911691); Pediatrics. 2021 Dec 22;149(1):. (PMID: 34935038); Vaccines (Basel). 2022 Mar 23;10(4):. (PMID: 35455241); Front Pediatr. 2021 Aug 23;9:721257. (PMID: 34497784) |
| Grant Information: | UM1 AI148372 United States AI NIAID NIH HHS; K76 AG064548 United States AG NIA NIH HHS; UL1 TR001453 United States TR NCATS NIH HHS; UM1 AI148452 United States AI NIAID NIH HHS; UM1 AI148684 United States AI NIAID NIH HHS; UM1 AI148689 United States AI NIAID NIH HHS; UM1 AI148450 United States AI NIAID NIH HHS; UM1 AI148575 United States AI NIAID NIH HHS; UM1 AI148576 United States AI NIAID NIH HHS |
| Contributed Indexing: | Investigator: AK Gupta; B Gandhi; S Acharya; S Boppana; S Pinninti; M Purser Latting; G Berman; K Sullivan; A Roehl; H Olson; B Rizzardi; V Abad; L Luth; K Luzuriaga; JL Sullivan; J Pagano-Therrien; M Turner; N Tuttle; A Weslowski; LB Weiner; K Fluno; LJ Ferguson; CB Creech; S Rolsma; S Walker; S Phillips; S Nachman; B Chakraborty; J Russell; FB Garner; JP Balsamo; SO Crespo; CA Smith; D Allen; M Morgan; WJ Muller; L Fearn; S Berlatsky; EJ Anderson; CA Rostad; S Kamidani; L Macoy; JM Martin; A Hoberman; GB Muniz; J Clinton; E Thomas; K Bundy; D Finkelstein; A Merkovic; R Vallarta; S Bhatt; DF Jativa; M Jativa; J Garcia; ML Leonardi; JB Etheridge; S Judkins; M Levin; T Rutherford; J Randlemon; D Barton; CW Yut; T Douangboupha; J Pleitez; W Dehority; HH Raissy; M Kadish; JS Gerber; R Lawler; WR Otto; JG Newland; DA Hunstad; C Kao; DS Hsia; AN Thomassie; C Hazlett; JL Kirstein; H He; J Kasarjian; EG Nicholson; CM Healy; HM El Sahly; MT Caserta; J Nayak; GC Paulsen; R Frenk; J Whitaker; WJ Towner; R Kendrick; M Barron; W Hartman; J Conway; S Henderson; M Zervos; M Ramesh; C Barone; SA Spector; A Moodley; M Loughran; KR Ali; BE Colville; B Ferrero; KA Palanpurwala; A Starr; C Schmitt; M Ampajwala; H Marwah; J Meadors; C Chronis; R Ma; A Sana; O Valle; NA Valdes; E Reyes; F Vitug; R Blair; R Scurlark; D Martinez; S Villa; NG Forbush; CK Smith; AM Hutchinson; R Garg; RK Ohnmacht; L Haughey; A Stanton; CS Plimpton; J Wallace; V Quiah; MA Rausch; A Welty; M Burton; JG Sainz; D Leiman; H Minkowitz; RA Clifford; J Hitchcock; C Butler; L Zharsky; MM Pfeffer; JD Campbell; EA Hammershaimb; G Cummings; AA Berry; AM Atz; NM Ruth; JM Costello; K Milks; S Chava; N Lopez; M Lopez; M Rathore; E Zornes; J Tejan; M Dunn; S Shannon; E Olan; M Frampton; KA Johnson; H Beitz; J Becker; DJ Leonard; K Johnson; D Gydesen; A Piramzadian; M Decosta; B Bruggeman; KM Reddy; M Reynoso; N Cruz; RL Bennett; R Call; B Tuner; QO Carr; N Chavez; M Rascon; C Ilboudo; A Padhye; B Brown; A Siesennop; B Chow; V Iyer; I Melendez; A Orfanos; B Vizcayno; C Del Ángel; V Berthaud; XD Bean; S Choudhury; CJ Keefer; M Bolton; J Hollingsworth; M Klumpp; WJ Rok; T Ferland; AM Rezendes; R Reese; J Steinmetz; C Andrews; D Hensley; CA Rodriguez; R Ryan; A Morton; M Dietrich; L Smitley; N Falgout; GJ Fuchs; J Bauer; RH Leggett; D Gerloff; E Castillo; S McAllister; J Foster; G Fischer; R Rouhbakhsh; J Johnson; K Gooch; I Yildirim; H Zapata; K Anastasio; CP Griffin; C Rojo; D Tovar; W Shreffler; L Yonker; K Vrbicky; C Harper; C Nutsch; FS Eder; A Wine; C Grausgruber; LB De Leon; JA Villanueva Vasco; C Villanueva; PK Pickrell; HS Malbari; CA Linebarger; RP Yankyera |
| Molecular Sequence: | ClinicalTrials.gov NCT04796896 |
| Substance Nomenclature: | 0 (Antibodies, Neutralizing); 0 (Antibodies, Viral); 0 (COVID-19 Vaccines); EPK39PL4R4 (2019-nCoV Vaccine mRNA-1273) |
| SCR Disease Name: | pediatric multisystem inflammatory disease, COVID-19 related |
| SCR Organism: | SARS-CoV-2 variants |
| Entry Date(s): | Date Created: 20220511 Date Completed: 20220527 Latest Revision: 20260120 |
| Update Code: | 20260130 |
| PubMed Central ID: | PMC9127699 |
| DOI: | 10.1056/NEJMoa2203315 |
| PMID: | 35544369 |
| Database: | MEDLINE |
Clinical Trial, Phase II; Clinical Trial, Phase III; Journal Article; Randomized Controlled Trial; Equivalence Trial