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Evaluation of mRNA-1273 SARS-CoV-2 Vaccine in Adolescents.
Ali, Kashif; Berman, Gary; Zhou, Honghong; Deng, Weiping; Faughnan, Veronica; Coronado-Voges, Maria; Ding, Baoyu; Dooley, Jacqueline; Girard, Bethany; Hillebrand, William; Pajon, Rolando; Miller, Jacqueline M; Leav, Brett; McPhee, Roderick.
  • Ali K; From Kool Kids Pediatrics, DM Clinical Research, Houston (K.A.); the Clinical Research Institute, Minneapolis (G.B.); and Moderna, Cambridge, MA (H.Z., W.D., V.F., M.C.-V., B.D., J.D., B.G., W.H., R.P., J.M.M., B.L., R.M.).
  • Berman G; From Kool Kids Pediatrics, DM Clinical Research, Houston (K.A.); the Clinical Research Institute, Minneapolis (G.B.); and Moderna, Cambridge, MA (H.Z., W.D., V.F., M.C.-V., B.D., J.D., B.G., W.H., R.P., J.M.M., B.L., R.M.).
  • Zhou H; From Kool Kids Pediatrics, DM Clinical Research, Houston (K.A.); the Clinical Research Institute, Minneapolis (G.B.); and Moderna, Cambridge, MA (H.Z., W.D., V.F., M.C.-V., B.D., J.D., B.G., W.H., R.P., J.M.M., B.L., R.M.).
  • Deng W; From Kool Kids Pediatrics, DM Clinical Research, Houston (K.A.); the Clinical Research Institute, Minneapolis (G.B.); and Moderna, Cambridge, MA (H.Z., W.D., V.F., M.C.-V., B.D., J.D., B.G., W.H., R.P., J.M.M., B.L., R.M.).
  • Faughnan V; From Kool Kids Pediatrics, DM Clinical Research, Houston (K.A.); the Clinical Research Institute, Minneapolis (G.B.); and Moderna, Cambridge, MA (H.Z., W.D., V.F., M.C.-V., B.D., J.D., B.G., W.H., R.P., J.M.M., B.L., R.M.).
  • Coronado-Voges M; From Kool Kids Pediatrics, DM Clinical Research, Houston (K.A.); the Clinical Research Institute, Minneapolis (G.B.); and Moderna, Cambridge, MA (H.Z., W.D., V.F., M.C.-V., B.D., J.D., B.G., W.H., R.P., J.M.M., B.L., R.M.).
  • Ding B; From Kool Kids Pediatrics, DM Clinical Research, Houston (K.A.); the Clinical Research Institute, Minneapolis (G.B.); and Moderna, Cambridge, MA (H.Z., W.D., V.F., M.C.-V., B.D., J.D., B.G., W.H., R.P., J.M.M., B.L., R.M.).
  • Dooley J; From Kool Kids Pediatrics, DM Clinical Research, Houston (K.A.); the Clinical Research Institute, Minneapolis (G.B.); and Moderna, Cambridge, MA (H.Z., W.D., V.F., M.C.-V., B.D., J.D., B.G., W.H., R.P., J.M.M., B.L., R.M.).
  • Girard B; From Kool Kids Pediatrics, DM Clinical Research, Houston (K.A.); the Clinical Research Institute, Minneapolis (G.B.); and Moderna, Cambridge, MA (H.Z., W.D., V.F., M.C.-V., B.D., J.D., B.G., W.H., R.P., J.M.M., B.L., R.M.).
  • Hillebrand W; From Kool Kids Pediatrics, DM Clinical Research, Houston (K.A.); the Clinical Research Institute, Minneapolis (G.B.); and Moderna, Cambridge, MA (H.Z., W.D., V.F., M.C.-V., B.D., J.D., B.G., W.H., R.P., J.M.M., B.L., R.M.).
  • Pajon R; From Kool Kids Pediatrics, DM Clinical Research, Houston (K.A.); the Clinical Research Institute, Minneapolis (G.B.); and Moderna, Cambridge, MA (H.Z., W.D., V.F., M.C.-V., B.D., J.D., B.G., W.H., R.P., J.M.M., B.L., R.M.).
  • Miller JM; From Kool Kids Pediatrics, DM Clinical Research, Houston (K.A.); the Clinical Research Institute, Minneapolis (G.B.); and Moderna, Cambridge, MA (H.Z., W.D., V.F., M.C.-V., B.D., J.D., B.G., W.H., R.P., J.M.M., B.L., R.M.).
  • Leav B; From Kool Kids Pediatrics, DM Clinical Research, Houston (K.A.); the Clinical Research Institute, Minneapolis (G.B.); and Moderna, Cambridge, MA (H.Z., W.D., V.F., M.C.-V., B.D., J.D., B.G., W.H., R.P., J.M.M., B.L., R.M.).
  • McPhee R; From Kool Kids Pediatrics, DM Clinical Research, Houston (K.A.); the Clinical Research Institute, Minneapolis (G.B.); and Moderna, Cambridge, MA (H.Z., W.D., V.F., M.C.-V., B.D., J.D., B.G., W.H., R.P., J.M.M., B.L., R.M.).
N Engl J Med ; 385(24): 2241-2251, 2021 12 09.
Article in English | MEDLINE | ID: covidwho-1352004
ABSTRACT

BACKGROUND:

The incidence of coronavirus disease 2019 (Covid-19) among adolescents between 12 and 17 years of age was approximately 900 per 100,000 population from April 1 through June 11, 2021. The safety, immunogenicity, and efficacy of the mRNA-1273 vaccine in adolescents are unknown.

METHODS:

In this ongoing phase 2-3, placebo-controlled trial, we randomly assigned healthy adolescents (12 to 17 years of age) in a 21 ratio to receive two injections of the mRNA-1273 vaccine (100 µg in each) or placebo, administered 28 days apart. The primary objectives were evaluation of the safety of mRNA-1273 in adolescents and the noninferiority of the immune response in adolescents as compared with that in young adults (18 to 25 years of age) in a phase 3 trial. Secondary objectives included the efficacy of mRNA-1273 in preventing Covid-19 or asymptomatic severe acute respiratory syndrome coronavirus 2 infection.

RESULTS:

A total of 3732 participants were randomly assigned to receive mRNA-1273 (2489 participants) or placebo (1243 participants). In the mRNA-1273 group, the most common solicited adverse reactions after the first or second injections were injection-site pain (in 93.1% and 92.4%, respectively), headache (in 44.6% and 70.2%, respectively), and fatigue (in 47.9% and 67.8%, respectively); in the placebo group, the most common solicited adverse reactions after the first or second injections were injection-site pain (in 34.8% or 30.3%, respectively), headache (in 38.5% and 30.2%, respectively), and fatigue (in 36.6% and 28.9%, respectively). No serious adverse events related to mRNA-1273 or placebo were noted. The geometric mean titer ratio of pseudovirus neutralizing antibody titers in adolescents relative to young adults was 1.08 (95% confidence interval [CI], 0.94 to 1.24), and the absolute difference in serologic response was 0.2 percentage points (95% CI, -1.8 to 2.4), which met the noninferiority criterion. No cases of Covid-19 with an onset of 14 days after the second injection were reported in the mRNA-1273 group, and four cases occurred in the placebo group.

CONCLUSIONS:

The mRNA-1273 vaccine had an acceptable safety profile in adolescents. The immune response was similar to that in young adults, and the vaccine was efficacious in preventing Covid-19. (Funded by Moderna and the Biomedical Advanced Research and Development Authority; Teen COVE ClinicalTrials.gov number, NCT04649151.).
Subject(s)

Full text: Available Collection: International databases Database: MEDLINE Main subject: Antibodies, Neutralizing / Immunogenicity, Vaccine / COVID-19 / 2019-nCoV Vaccine mRNA-1273 / Antibodies, Viral Type of study: Experimental Studies / Observational study / Prognostic study / Randomized controlled trials Topics: Vaccines Limits: Adolescent / Child / Female / Humans / Male Language: English Journal: N Engl J Med Year: 2021 Document Type: Article

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Full text: Available Collection: International databases Database: MEDLINE Main subject: Antibodies, Neutralizing / Immunogenicity, Vaccine / COVID-19 / 2019-nCoV Vaccine mRNA-1273 / Antibodies, Viral Type of study: Experimental Studies / Observational study / Prognostic study / Randomized controlled trials Topics: Vaccines Limits: Adolescent / Child / Female / Humans / Male Language: English Journal: N Engl J Med Year: 2021 Document Type: Article