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Evaluation of mRNA-1273 SARS-CoV-2 Vaccine in Adolescents
Open accessAbstract
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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In the citing paper
“94.1% efficacy at preventing COVID-19 illness, including severe disease in participants 18 years or older995% efficacy in 12- to 17-year olds84”
From COVID-19 mRNA vaccines: Platforms and current developments (2022) · cites this paper as [84]
In the citing paper
“with similar immune responses among adolescents aged 12 to 17.410,412–414”
From Advances in COVID-19 mRNA vaccine development (2022) · cites this paper as [412]
In the citing paper
“In a phase III clinical trial involving 30,420 people, participants aged 18 or older were given two doses of 100 μg of mRNA-1273 with a 28-day interval, and vaccine efficacy was 94.1% (Table 5)”
From Advances in COVID-19 mRNA vaccine development (2022) · cites this paper as [412]
In the citing paper
“In 12- to 17-year-olds, mRNA-1273 showed 95% vaccine efficacy and had an acceptable safety profile.84”
From COVID-19 mRNA vaccines: Platforms and current developments (2022) · cites this paper as [84]
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Metadata
- 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
- 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
- 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
About these checks
Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.
Statistics and arithmetic are recomputed, not judged.
Confidence bands are shown only for fields calibrated on our annotated test set. None is calibrated yet, so no band is shown.
What counts as a claim ›How we measure confidence ›How we check this ›
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