1. The Moderna mRNA vaccine significantly decreased the risk of contracting coronavirus disease 2019 (COVID-19) in adolescents.
2. For adolescents aged 12 to 17, the Moderna mRNA vaccine had an acceptable safety profile.
Evidence Rating Level: 1 (Excellent)
Study Rundown: The Moderna COVID-19 vaccine, mRNA-1273, is a lipid nanoparticle dispersion containing an mRNA that encodes the SARS-CoV-2 S glycoprotein which is stabilized in the prefusion conformation. The safety, efficacy, and immunogenicity of the mRNA-1273 vaccine have already been demonstrated in several ongoing clinical trials involving adults. However, there is a gap in knowledge as to understanding the efficacy and safety of the mRNA-1273 vaccine among adolescents. Elucidating this is critical as children can have severe disease leading to hospitalization, augmented by the opening of schools in many countries increasing COVID-19 transmission. Moreover, adolescents continue to be disproportionately affected by the COVID-19 pandemic due to heavy social costs, such as school closures and loss of social support. The present study found that the mRNA-1273 vaccine has an acceptable safety profile for use in adolescents and prevents COVID-19 infection as compared to a placebo control. This study was limited by a lack of sociodemographic diversity in the trial population. As well, there was difficulty determining the efficacy of the COVID-19 vaccine due to the increased proportion of mild cases and lower incidence of disease in adolescents as compared to adults. Overall, the findings of the present study demonstrate that the mRNA-1273 vaccine is safe and effective in adolescents and confers protection against COVID-19 infection.
Click to read the study in NEJM.
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In-Depth [randomized control trial]: This placebo-controlled randomized trial was conducted in the United States, with participants randomly assigned to receive the mRNA-1273 vaccine or a placebo control. Patients who were between the ages of 12 and 17 were eligible for the study if they were considered to be in good general health. Patients who had traveled outside of the United States in the 28 days before screening, were breastfeeding or pregnant, reported acute illness or fever 24 hours before or at screening, or had prior vaccination against SARS-CoV-2 were excluded from the study. The primary outcome measures were safety, reactogenicity, immunogenicity, and efficacy determined by comparing serum antibody responses. Outcomes in the primary analysis were assessed via per-protocol immunogenicity subpopulation analysis. Regarding safety, the most common adverse reactions reported after first or second injections in the mRNA-1273 group were injection-site pain, headache, and fatigue. In the placebo group, the most common adverse reactions were also injection-site pain, headache, and fatigue. No serious adverse events related to the mRNA-1273 vaccine or the placebo were reported. Regarding immunogenicity, the geometric mean titer ratio of pseudovirus neutralizing antibody titers in adolescents relative to young adults (aged 18 to 25) was 1.08 (95% Confidence Interval [CI], 0.94 to 1.24), and the absolute difference in serologic response was 0.2% (95% CI, -1.8 to 2.4). Thus, the mRNA-1273 vaccine is non-inferior in adolescents as compared to young adults. Overall, this study demonstrates that the mRNA-1273 vaccine provides an acceptable safety profile and is effective in adolescents in preventing COVID-19 infection.
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