Evaluation of mRNA-1273 Covid-19 Vaccine in Children 6 to 11 Years of Age

In part 1 of a phase 2–3 trial, a 50-μg dose of mRNA-1273 vaccine was safe and immunogenic. In part 2, nearly 4000 6-to-11-year-olds received two doses of vaccine or placebo and were followed for a median of 82 days. The vaccine had mainly mild adverse effects and was immunogenic in 99%, similar to...

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Published in:The New England journal of medicine Vol. 386; no. 21; pp. 2011 - 2023
Main Authors: Creech, C. Buddy, Anderson, Evan, Berthaud, Vladimir, Yildirim, Inci, Atz, Andrew M., Melendez Baez, Ivan, Finkelstein, Daniel, Pickrell, Paul, Kirstein, Judith, Yut, Clifford, Blair, Ronald, Clifford, Robert A., Dunn, Michael, Campbell, James D., Montefiori, David C., Tomassini, Joanne E., Zhao, Xiaoping, Deng, Weiping, Zhou, Honghong, Ramirez Schrempp, Daniela, Hautzinger, Kelly, Girard, Bethany, Slobod, Karen, McPhee, Roderick, Pajon, Rolando, Das, Rituparna, Miller, Jacqueline M., Schnyder Ghamloush, Sabine
Format: Journal Article
Language:English
Published: United States Massachusetts Medical Society 26.05.2022
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ISSN:0028-4793, 1533-4406, 1533-4406
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Abstract In part 1 of a phase 2–3 trial, a 50-μg dose of mRNA-1273 vaccine was safe and immunogenic. In part 2, nearly 4000 6-to-11-year-olds received two doses of vaccine or placebo and were followed for a median of 82 days. The vaccine had mainly mild adverse effects and was immunogenic in 99%, similar to the results in 18-to-25-year-olds. Vaccine efficacy during a delta-variant period was 88%.
AbstractList AbstractBackgroundVaccination 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.MethodsPart 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.ResultsIn 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.ConclusionsTwo 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.)
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. 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. 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. 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.).
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.BACKGROUNDVaccination 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.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.METHODSPart 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.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.RESULTSIn 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.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.).CONCLUSIONSTwo 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.).
In part 1 of a phase 2–3 trial, a 50-μg dose of mRNA-1273 vaccine was safe and immunogenic. In part 2, nearly 4000 6-to-11-year-olds received two doses of vaccine or placebo and were followed for a median of 82 days. The vaccine had mainly mild adverse effects and was immunogenic in 99%, similar to the results in 18-to-25-year-olds. Vaccine efficacy during a delta-variant period was 88%.
Author Melendez Baez, Ivan
McPhee, Roderick
Yildirim, Inci
Ramirez Schrempp, Daniela
Creech, C. Buddy
Dunn, Michael
Girard, Bethany
Campbell, James D.
Miller, Jacqueline M.
Kirstein, Judith
Clifford, Robert A.
Berthaud, Vladimir
Anderson, Evan
Yut, Clifford
Das, Rituparna
Slobod, Karen
Zhao, Xiaoping
Atz, Andrew M.
Hautzinger, Kelly
Blair, Ronald
Deng, Weiping
Zhou, Honghong
Tomassini, Joanne E.
Pajon, Rolando
Pickrell, Paul
Schnyder Ghamloush, Sabine
Finkelstein, Daniel
Montefiori, David C.
Author_xml – sequence: 1
  givenname: C. Buddy
  surname: Creech
  fullname: Creech, C. Buddy
  organization: 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.)
– sequence: 2
  givenname: Evan
  orcidid: 0000-0002-1576-4420
  surname: Anderson
  fullname: Anderson, Evan
  organization: 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.)
– sequence: 3
  givenname: Vladimir
  surname: Berthaud
  fullname: Berthaud, Vladimir
  organization: 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.)
– sequence: 4
  givenname: Inci
  surname: Yildirim
  fullname: Yildirim, Inci
  organization: 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.)
– sequence: 5
  givenname: Andrew M.
  surname: Atz
  fullname: Atz, Andrew M.
  organization: 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.)
– sequence: 6
  givenname: Ivan
  surname: Melendez Baez
  fullname: Melendez Baez, Ivan
  organization: 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.)
– sequence: 7
  givenname: Daniel
  surname: Finkelstein
  fullname: Finkelstein, Daniel
  organization: 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.)
– sequence: 8
  givenname: Paul
  surname: Pickrell
  fullname: Pickrell, Paul
  organization: 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.)
– sequence: 9
  givenname: Judith
  surname: Kirstein
  fullname: Kirstein, Judith
  organization: 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.)
– sequence: 10
  givenname: Clifford
  surname: Yut
  fullname: Yut, Clifford
  organization: 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.)
– sequence: 11
  givenname: Ronald
  surname: Blair
  fullname: Blair, Ronald
  organization: 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.)
– sequence: 12
  givenname: Robert A.
  surname: Clifford
  fullname: Clifford, Robert A.
  organization: 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.)
– sequence: 13
  givenname: Michael
  surname: Dunn
  fullname: Dunn, Michael
  organization: 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.)
– sequence: 14
  givenname: James D.
  surname: Campbell
  fullname: Campbell, James D.
  organization: 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.)
– sequence: 15
  givenname: David C.
  surname: Montefiori
  fullname: Montefiori, David C.
  organization: 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.)
– sequence: 16
  givenname: Joanne E.
  surname: Tomassini
  fullname: Tomassini, Joanne E.
  organization: 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.)
– sequence: 17
  givenname: Xiaoping
  surname: Zhao
  fullname: Zhao, Xiaoping
  organization: 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.)
– sequence: 18
  givenname: Weiping
  surname: Deng
  fullname: Deng, Weiping
  organization: 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.)
– sequence: 19
  givenname: Honghong
  surname: Zhou
  fullname: Zhou, Honghong
  organization: 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.)
– sequence: 20
  givenname: Daniela
  surname: Ramirez Schrempp
  fullname: Ramirez Schrempp, Daniela
  organization: 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.)
– sequence: 21
  givenname: Kelly
  surname: Hautzinger
  fullname: Hautzinger, Kelly
  organization: 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.)
– sequence: 22
  givenname: Bethany
  surname: Girard
  fullname: Girard, Bethany
  organization: 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.)
– sequence: 23
  givenname: Karen
  surname: Slobod
  fullname: Slobod, Karen
  organization: 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.)
– sequence: 24
  givenname: Roderick
  surname: McPhee
  fullname: McPhee, Roderick
  organization: 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.)
– sequence: 25
  givenname: Rolando
  surname: Pajon
  fullname: Pajon, Rolando
  organization: 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.)
– sequence: 26
  givenname: Rituparna
  surname: Das
  fullname: Das, Rituparna
  organization: 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.)
– sequence: 27
  givenname: Jacqueline M.
  surname: Miller
  fullname: Miller, Jacqueline M.
  organization: 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.)
– sequence: 28
  givenname: Sabine
  surname: Schnyder Ghamloush
  fullname: Schnyder Ghamloush, Sabine
  organization: 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.)
BackLink https://www.ncbi.nlm.nih.gov/pubmed/35544369$$D View this record in MEDLINE/PubMed
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Purser Latting, Misty
Ramesh, Mayur
Thomas, Evelyn
Chakraborty, Barsha
Hazlett, Claire
Luth, Lori
Caserta, Mary T
Weiner, Leonard B
Ferguson, Lori J
Merkovic, Ana
Nicholson, Erin G
Muniz, Gysella B
Clinton, John
Levin, Myron
Hartman, William
Luzuriaga, Katherine
Randlemon, Julianne
Moodley, Amaran
Macoy, Lisa
Healy, C Mary
Nachman, Sharon
Gerber, Jeffrey S
Martin, Judith M
Nayak, Jennifer
Bundy, Kimberly
He, Hanna
Rostad, Christina A
Fluno, Kristen
Phillips, Shanda
Kadish, Matthew
Garner, Fredric B
Sullivan, John L
Rolsma, Stephanie
Hoberman, Alejandro
Lawler, Rasheeda
Pagano-Therrien, Jesica
Olson, Heidi
Newland, Jason G
Russell, Jennifer
Morgan, Melinda
Loughran, Megan
Etheridge, J Bruce
Otto, William R
Spector, Stephen A
Kirstein, Judith L
Tuttle, Nick
Garcia, Johanna
Pleitez, Jenny
Paulsen, Grant C
Weslowski, Audra
Kendrick, Randi
Frenk, Robert
Douangboupha, Thipsavanh
Smith, Christopher A
Kasarjian, Julie
Kamidani, Satoshi
Berman, Gary
Allen, Danielle
Jativa, David F
Barton, Deina
Berlatsky, Sarah
Muller, William J
Gupta, Anil
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Copyright Copyright © 2022 Massachusetts Medical Society. All rights reserved.
Copyright © 2022 Massachusetts Medical Society.
Copyright © 2022 Massachusetts Medical Society. All rights reserved. 2022 Massachusetts Medical Society
Copyright_xml – notice: Copyright © 2022 Massachusetts Medical Society. All rights reserved.
– notice: Copyright © 2022 Massachusetts Medical Society.
– notice: Copyright © 2022 Massachusetts Medical Society. All rights reserved. 2022 Massachusetts Medical Society
CorporateAuthor KidCOVE Study Group
CorporateAuthor_xml – name: KidCOVE Study Group
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Snippet In part 1 of a phase 2–3 trial, a 50-μg dose of mRNA-1273 vaccine was safe and immunogenic. In part 2, nearly 4000 6-to-11-year-olds received two doses of...
Vaccination of children to prevent coronavirus disease 2019 (Covid-19) is an urgent public health need. The safety, immunogenicity, and efficacy of the...
AbstractBackgroundVaccination of children to prevent coronavirus disease 2019 (Covid-19) is an urgent public health need. The safety, immunogenicity, and...
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StartPage 2011
SubjectTerms 2019-nCoV Vaccine mRNA-1273 - adverse effects
2019-nCoV Vaccine mRNA-1273 - immunology
2019-nCoV Vaccine mRNA-1273 - therapeutic use
Adolescent
Adolescent Medicine
Adult
Adverse events
Age
Age groups
Antibodies
Antibodies, Neutralizing - blood
Antibodies, Neutralizing - immunology
Antibodies, Viral - blood
Antibodies, Viral - immunology
Child
Childhood Diseases
Children
Coronavirus
Coronaviruses
COVID-19 - blood
COVID-19 - complications
COVID-19 - immunology
COVID-19 - prevention & control
COVID-19 vaccines
COVID-19 Vaccines - adverse effects
COVID-19 Vaccines - therapeutic use
Double-Blind Method
FDA approval
Heart diseases
Humans
Immune response
Immunization
Immunogenicity
Infections
Infectious Disease
Infectious diseases
Inflammation
Injection
Injections
mRNA
Multisystem inflammatory syndrome in children
Myocarditis
Original
Pediatrics
Pericarditis
Placebos
Population
Public health
Safety
SARS-CoV-2
Severe acute respiratory syndrome coronavirus 2
Systemic Inflammatory Response Syndrome
Teenagers
Vaccination
Vaccine Efficacy
Vaccines
Viral Infections
Young Adult
Young adults
SubjectTermsDisplay Adolescent Medicine
Childhood Diseases
Coronavirus
Immunization
Infectious Disease
Pediatrics
Vaccines
Viral Infections
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Title Evaluation of mRNA-1273 Covid-19 Vaccine in Children 6 to 11 Years of Age
URI https://nejm.org/doi/full/10.1056/NEJMoa2203315
https://www.ncbi.nlm.nih.gov/pubmed/35544369
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Volume 386
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