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Evaluation of mRNA-1273 Vaccine in Children 6 Months to 5 Years of Age.
Anderson, Evan J; Creech, C Buddy; Berthaud, Vladimir; Piramzadian, Arin; Johnson, Kimball A; Zervos, Marcus; Garner, Fredric; Griffin, Carl; Palanpurwala, Khozema; Turner, Mark; Gerber, Jeffrey; Bennett, Richard L; Ali, Kashif; Ampajwala, Madhavi; Berman, Gary; Nayak, Jennifer; Chronis, Carey; Rizzardi, Barbara; Muller, William J; Smith, Christopher A; Fuchs, George; Hsia, Daniel; Tomassini, Joanne E; DeLucia, Dianne; Reuter, Caroline; Kuter, Barbara; Zhao, Xiaoping; Deng, Weiping; Zhou, Honghong; Ramirez Schrempp, Daniela; Hautzinger, Kelly; Girard, Bethany; Slobod, Karen; McPhee, Roderick; Pajon, Rolando; Aunins, Anne; Das, Rituparna; Miller, Jacqueline M; Schnyder Ghamloush, Sabine.
  • Anderson EJ; From the Center for Childhood Infections and Vaccines, Children's Healthcare of Atlanta, and the Department of Pediatrics, Emory University School of Medicine, Atlanta (E.J.A.), and IResearch Atlanta, Decatur (K.A.J.) - all in Georgia; the Vanderbilt Vaccine Research Program, Department of Pediatric
  • Creech CB; From the Center for Childhood Infections and Vaccines, Children's Healthcare of Atlanta, and the Department of Pediatrics, Emory University School of Medicine, Atlanta (E.J.A.), and IResearch Atlanta, Decatur (K.A.J.) - all in Georgia; the Vanderbilt Vaccine Research Program, Department of Pediatric
  • Berthaud V; From the Center for Childhood Infections and Vaccines, Children's Healthcare of Atlanta, and the Department of Pediatrics, Emory University School of Medicine, Atlanta (E.J.A.), and IResearch Atlanta, Decatur (K.A.J.) - all in Georgia; the Vanderbilt Vaccine Research Program, Department of Pediatric
  • Piramzadian A; From the Center for Childhood Infections and Vaccines, Children's Healthcare of Atlanta, and the Department of Pediatrics, Emory University School of Medicine, Atlanta (E.J.A.), and IResearch Atlanta, Decatur (K.A.J.) - all in Georgia; the Vanderbilt Vaccine Research Program, Department of Pediatric
  • Johnson KA; From the Center for Childhood Infections and Vaccines, Children's Healthcare of Atlanta, and the Department of Pediatrics, Emory University School of Medicine, Atlanta (E.J.A.), and IResearch Atlanta, Decatur (K.A.J.) - all in Georgia; the Vanderbilt Vaccine Research Program, Department of Pediatric
  • Zervos M; From the Center for Childhood Infections and Vaccines, Children's Healthcare of Atlanta, and the Department of Pediatrics, Emory University School of Medicine, Atlanta (E.J.A.), and IResearch Atlanta, Decatur (K.A.J.) - all in Georgia; the Vanderbilt Vaccine Research Program, Department of Pediatric
  • Garner F; From the Center for Childhood Infections and Vaccines, Children's Healthcare of Atlanta, and the Department of Pediatrics, Emory University School of Medicine, Atlanta (E.J.A.), and IResearch Atlanta, Decatur (K.A.J.) - all in Georgia; the Vanderbilt Vaccine Research Program, Department of Pediatric
  • Griffin C; From the Center for Childhood Infections and Vaccines, Children's Healthcare of Atlanta, and the Department of Pediatrics, Emory University School of Medicine, Atlanta (E.J.A.), and IResearch Atlanta, Decatur (K.A.J.) - all in Georgia; the Vanderbilt Vaccine Research Program, Department of Pediatric
  • Palanpurwala K; From the Center for Childhood Infections and Vaccines, Children's Healthcare of Atlanta, and the Department of Pediatrics, Emory University School of Medicine, Atlanta (E.J.A.), and IResearch Atlanta, Decatur (K.A.J.) - all in Georgia; the Vanderbilt Vaccine Research Program, Department of Pediatric
  • Turner M; From the Center for Childhood Infections and Vaccines, Children's Healthcare of Atlanta, and the Department of Pediatrics, Emory University School of Medicine, Atlanta (E.J.A.), and IResearch Atlanta, Decatur (K.A.J.) - all in Georgia; the Vanderbilt Vaccine Research Program, Department of Pediatric
  • Gerber J; From the Center for Childhood Infections and Vaccines, Children's Healthcare of Atlanta, and the Department of Pediatrics, Emory University School of Medicine, Atlanta (E.J.A.), and IResearch Atlanta, Decatur (K.A.J.) - all in Georgia; the Vanderbilt Vaccine Research Program, Department of Pediatric
  • Bennett RL; From the Center for Childhood Infections and Vaccines, Children's Healthcare of Atlanta, and the Department of Pediatrics, Emory University School of Medicine, Atlanta (E.J.A.), and IResearch Atlanta, Decatur (K.A.J.) - all in Georgia; the Vanderbilt Vaccine Research Program, Department of Pediatric
  • Ali K; From the Center for Childhood Infections and Vaccines, Children's Healthcare of Atlanta, and the Department of Pediatrics, Emory University School of Medicine, Atlanta (E.J.A.), and IResearch Atlanta, Decatur (K.A.J.) - all in Georgia; the Vanderbilt Vaccine Research Program, Department of Pediatric
  • Ampajwala M; From the Center for Childhood Infections and Vaccines, Children's Healthcare of Atlanta, and the Department of Pediatrics, Emory University School of Medicine, Atlanta (E.J.A.), and IResearch Atlanta, Decatur (K.A.J.) - all in Georgia; the Vanderbilt Vaccine Research Program, Department of Pediatric
  • Berman G; From the Center for Childhood Infections and Vaccines, Children's Healthcare of Atlanta, and the Department of Pediatrics, Emory University School of Medicine, Atlanta (E.J.A.), and IResearch Atlanta, Decatur (K.A.J.) - all in Georgia; the Vanderbilt Vaccine Research Program, Department of Pediatric
  • Nayak J; From the Center for Childhood Infections and Vaccines, Children's Healthcare of Atlanta, and the Department of Pediatrics, Emory University School of Medicine, Atlanta (E.J.A.), and IResearch Atlanta, Decatur (K.A.J.) - all in Georgia; the Vanderbilt Vaccine Research Program, Department of Pediatric
  • Chronis C; From the Center for Childhood Infections and Vaccines, Children's Healthcare of Atlanta, and the Department of Pediatrics, Emory University School of Medicine, Atlanta (E.J.A.), and IResearch Atlanta, Decatur (K.A.J.) - all in Georgia; the Vanderbilt Vaccine Research Program, Department of Pediatric
  • Rizzardi B; From the Center for Childhood Infections and Vaccines, Children's Healthcare of Atlanta, and the Department of Pediatrics, Emory University School of Medicine, Atlanta (E.J.A.), and IResearch Atlanta, Decatur (K.A.J.) - all in Georgia; the Vanderbilt Vaccine Research Program, Department of Pediatric
  • Muller WJ; From the Center for Childhood Infections and Vaccines, Children's Healthcare of Atlanta, and the Department of Pediatrics, Emory University School of Medicine, Atlanta (E.J.A.), and IResearch Atlanta, Decatur (K.A.J.) - all in Georgia; the Vanderbilt Vaccine Research Program, Department of Pediatric
  • Smith CA; From the Center for Childhood Infections and Vaccines, Children's Healthcare of Atlanta, and the Department of Pediatrics, Emory University School of Medicine, Atlanta (E.J.A.), and IResearch Atlanta, Decatur (K.A.J.) - all in Georgia; the Vanderbilt Vaccine Research Program, Department of Pediatric
  • Fuchs G; From the Center for Childhood Infections and Vaccines, Children's Healthcare of Atlanta, and the Department of Pediatrics, Emory University School of Medicine, Atlanta (E.J.A.), and IResearch Atlanta, Decatur (K.A.J.) - all in Georgia; the Vanderbilt Vaccine Research Program, Department of Pediatric
  • Hsia D; From the Center for Childhood Infections and Vaccines, Children's Healthcare of Atlanta, and the Department of Pediatrics, Emory University School of Medicine, Atlanta (E.J.A.), and IResearch Atlanta, Decatur (K.A.J.) - all in Georgia; the Vanderbilt Vaccine Research Program, Department of Pediatric
  • Tomassini JE; From the Center for Childhood Infections and Vaccines, Children's Healthcare of Atlanta, and the Department of Pediatrics, Emory University School of Medicine, Atlanta (E.J.A.), and IResearch Atlanta, Decatur (K.A.J.) - all in Georgia; the Vanderbilt Vaccine Research Program, Department of Pediatric
  • DeLucia D; From the Center for Childhood Infections and Vaccines, Children's Healthcare of Atlanta, and the Department of Pediatrics, Emory University School of Medicine, Atlanta (E.J.A.), and IResearch Atlanta, Decatur (K.A.J.) - all in Georgia; the Vanderbilt Vaccine Research Program, Department of Pediatric
  • Reuter C; From the Center for Childhood Infections and Vaccines, Children's Healthcare of Atlanta, and the Department of Pediatrics, Emory University School of Medicine, Atlanta (E.J.A.), and IResearch Atlanta, Decatur (K.A.J.) - all in Georgia; the Vanderbilt Vaccine Research Program, Department of Pediatric
  • Kuter B; From the Center for Childhood Infections and Vaccines, Children's Healthcare of Atlanta, and the Department of Pediatrics, Emory University School of Medicine, Atlanta (E.J.A.), and IResearch Atlanta, Decatur (K.A.J.) - all in Georgia; the Vanderbilt Vaccine Research Program, Department of Pediatric
  • Zhao X; From the Center for Childhood Infections and Vaccines, Children's Healthcare of Atlanta, and the Department of Pediatrics, Emory University School of Medicine, Atlanta (E.J.A.), and IResearch Atlanta, Decatur (K.A.J.) - all in Georgia; the Vanderbilt Vaccine Research Program, Department of Pediatric
  • Deng W; From the Center for Childhood Infections and Vaccines, Children's Healthcare of Atlanta, and the Department of Pediatrics, Emory University School of Medicine, Atlanta (E.J.A.), and IResearch Atlanta, Decatur (K.A.J.) - all in Georgia; the Vanderbilt Vaccine Research Program, Department of Pediatric
  • Zhou H; From the Center for Childhood Infections and Vaccines, Children's Healthcare of Atlanta, and the Department of Pediatrics, Emory University School of Medicine, Atlanta (E.J.A.), and IResearch Atlanta, Decatur (K.A.J.) - all in Georgia; the Vanderbilt Vaccine Research Program, Department of Pediatric
  • Ramirez Schrempp D; From the Center for Childhood Infections and Vaccines, Children's Healthcare of Atlanta, and the Department of Pediatrics, Emory University School of Medicine, Atlanta (E.J.A.), and IResearch Atlanta, Decatur (K.A.J.) - all in Georgia; the Vanderbilt Vaccine Research Program, Department of Pediatric
  • Hautzinger K; From the Center for Childhood Infections and Vaccines, Children's Healthcare of Atlanta, and the Department of Pediatrics, Emory University School of Medicine, Atlanta (E.J.A.), and IResearch Atlanta, Decatur (K.A.J.) - all in Georgia; the Vanderbilt Vaccine Research Program, Department of Pediatric
  • Girard B; From the Center for Childhood Infections and Vaccines, Children's Healthcare of Atlanta, and the Department of Pediatrics, Emory University School of Medicine, Atlanta (E.J.A.), and IResearch Atlanta, Decatur (K.A.J.) - all in Georgia; the Vanderbilt Vaccine Research Program, Department of Pediatric
  • Slobod K; From the Center for Childhood Infections and Vaccines, Children's Healthcare of Atlanta, and the Department of Pediatrics, Emory University School of Medicine, Atlanta (E.J.A.), and IResearch Atlanta, Decatur (K.A.J.) - all in Georgia; the Vanderbilt Vaccine Research Program, Department of Pediatric
  • McPhee R; From the Center for Childhood Infections and Vaccines, Children's Healthcare of Atlanta, and the Department of Pediatrics, Emory University School of Medicine, Atlanta (E.J.A.), and IResearch Atlanta, Decatur (K.A.J.) - all in Georgia; the Vanderbilt Vaccine Research Program, Department of Pediatric
  • Pajon R; From the Center for Childhood Infections and Vaccines, Children's Healthcare of Atlanta, and the Department of Pediatrics, Emory University School of Medicine, Atlanta (E.J.A.), and IResearch Atlanta, Decatur (K.A.J.) - all in Georgia; the Vanderbilt Vaccine Research Program, Department of Pediatric
  • Aunins A; From the Center for Childhood Infections and Vaccines, Children's Healthcare of Atlanta, and the Department of Pediatrics, Emory University School of Medicine, Atlanta (E.J.A.), and IResearch Atlanta, Decatur (K.A.J.) - all in Georgia; the Vanderbilt Vaccine Research Program, Department of Pediatric
  • Das R; From the Center for Childhood Infections and Vaccines, Children's Healthcare of Atlanta, and the Department of Pediatrics, Emory University School of Medicine, Atlanta (E.J.A.), and IResearch Atlanta, Decatur (K.A.J.) - all in Georgia; the Vanderbilt Vaccine Research Program, Department of Pediatric
  • Miller JM; From the Center for Childhood Infections and Vaccines, Children's Healthcare of Atlanta, and the Department of Pediatrics, Emory University School of Medicine, Atlanta (E.J.A.), and IResearch Atlanta, Decatur (K.A.J.) - all in Georgia; the Vanderbilt Vaccine Research Program, Department of Pediatric
  • Schnyder Ghamloush S; From the Center for Childhood Infections and Vaccines, Children's Healthcare of Atlanta, and the Department of Pediatrics, Emory University School of Medicine, Atlanta (E.J.A.), and IResearch Atlanta, Decatur (K.A.J.) - all in Georgia; the Vanderbilt Vaccine Research Program, Department of Pediatric
N Engl J Med ; 387(18): 1673-1687, 2022 11 03.
Article in English | MEDLINE | ID: covidwho-2077202
ABSTRACT

BACKGROUND:

The safety, reactogenicity, immunogenicity, and efficacy of the mRNA-1273 coronavirus disease 2019 (Covid-19) vaccine in young children 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 evaluation of the selected dose. In part 2, we randomly assigned young children (6 months to 5 years of age) in a 31 ratio to receive two 25-µg injections of mRNA-1273 or placebo, administered 28 days apart. The primary objectives were to evaluate the safety and reactogenicity of the vaccine and to determine whether the immune response in these children was noninferior to that in young adults (18 to 25 years of age) in a related phase 3 trial. Secondary objectives were to determine the incidences of Covid-19 and severe acute respiratory syndrome coronavirus 2 infection after administration of mRNA-1273 or placebo.

RESULTS:

On the basis of safety and immunogenicity results in part 1 of the trial, the 25-µg dose was evaluated in part 2. In part 2, 3040 children 2 to 5 years of age and 1762 children 6 to 23 months of age were randomly assigned to receive two 25-µg injections of mRNA-1273; 1008 children 2 to 5 years of age and 593 children 6 to 23 months of age were randomly assigned to receive placebo. The median duration of follow-up after the second injection was 71 days in the 2-to-5-year-old cohort and 68 days in the 6-to-23-month-old cohort. Adverse events were mainly low-grade and transient, and no new safety concerns were identified. At day 57, neutralizing antibody geometric mean concentrations were 1410 (95% confidence interval [CI], 1272 to 1563) among 2-to-5-year-olds and 1781 (95% CI, 1616 to 1962) among 6-to-23-month-olds, as compared with 1391 (95% CI, 1263 to 1531) among young adults, who had received 100-µg injections of mRNA-1273, findings that met the noninferiority criteria for immune responses for both age cohorts. The estimated vaccine efficacy against Covid-19 was 36.8% (95% CI, 12.5 to 54.0) among 2-to-5-year-olds and 50.6% (95% CI, 21.4 to 68.6) among 6-to-23-month-olds, at a time when B.1.1.529 (omicron) was the predominant circulating variant.

CONCLUSIONS:

Two 25-µg doses of the mRNA-1273 vaccine were found to be safe in children 6 months to 5 years of age and elicited immune responses that were noninferior to those in young adults. (Funded by the Biomedical Advanced Research and Development Authority and National Institute of Allergy and Infectious Diseases; KidCOVE ClinicalTrials.gov number, NCT04796896.).
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Full text: Available Collection: International databases Database: MEDLINE Main subject: Immunogenicity, Vaccine / COVID-19 / 2019-nCoV Vaccine mRNA-1273 Type of study: Cohort study / Experimental Studies / Observational study / Prognostic study / Randomized controlled trials Topics: Vaccines / Variants Limits: Adolescent / Adult / Child / Child, preschool / Humans / Infant / Young adult Language: English Journal: N Engl J Med Year: 2022 Document Type: Article

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Full text: Available Collection: International databases Database: MEDLINE Main subject: Immunogenicity, Vaccine / COVID-19 / 2019-nCoV Vaccine mRNA-1273 Type of study: Cohort study / Experimental Studies / Observational study / Prognostic study / Randomized controlled trials Topics: Vaccines / Variants Limits: Adolescent / Adult / Child / Child, preschool / Humans / Infant / Young adult Language: English Journal: N Engl J Med Year: 2022 Document Type: Article