Cited by 377SARS-CoV-2 and COVID-19 ResearchCOVID-19 Clinical Research StudiesVaccine Coverage and Hesitancy

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Evaluation of mRNA-1273 SARS-CoV-2 Vaccine in Adolescents

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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·2021·New England Journal of Medicine

DOI 10.1056/nejmoa2109522PMC PMC8385554

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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 2:1 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.).

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Authors: Ali, K., Berman, G., Zhou, H., Deng, W., Faughnan, V., Coronado-Voges, M., Ding, B., Dooley, J., Girard, B., Hillebrand, W., Pajon, R., Miller, J. M., Leav, B., & McPhee, R.
Affiliations: 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.).
Corresponding author: McPhee, Roderick
ORCID: Girard, Bethany
Venue: New England Journal of Medicine
Publisher: Massachusetts Medical Society
Published: 2021-12-09
Volume: 385
Issue: 24
Pages: 2241-2251
ISSN: 0028-4793 (ISSN-L)
1533-4406
DOI: 10.1056/nejmoa2109522
PMC: PMC8385554
OpenAlex: W3189261358
Cited by: 377
References: 20
Citations by year: 2026: 12 · 2025: 29 · 2024: 54 · 2023: 87 · 2022: 160 · 2021: 35
FWCI: 26.58
Type: journal article
Language: en
Open access: green
www.ncbi.nlm.nih.gov
Licence: www.nejmgroup.org/legal/terms-of-use.htm (vor)
Locations: New England Journal of Medicine (publishedVersion)
PubMed Central (publishedVersion)
PubMed (publishedVersion)
Topics: Health Sciences › Medicine › Infectious Diseases › SARS-CoV-2 and COVID-19 Research
Health Sciences › Medicine › Infectious Diseases › COVID-19 Clinical Research Studies
Social Sciences › Health › Vaccine Coverage and Hesitancy
Keywords: mRNA-1273 vaccine, SARS-CoV-2, COVID-19 vaccines, adolescents, vaccine safety, immunogenicity, neutralizing antibodies, non-inferiority, vaccine efficacy, asymptomatic infection, adverse events, serological response, pseudovirus neutralization assay, Omicron variant, Omicron BA.1
MeSH terms: Immunogenicity, Vaccine, COVID-19, Vaccine Efficacy, 2019-nCoV Vaccine mRNA-1273, Adolescent, Antibodies, Viral, Child, Female, Humans, Male, Single-Blind Method, Antibodies, Neutralizing

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Evaluation of mRNA-1273 SARS-CoV-2 Vaccine in Adolescents

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