The vaccine demonstrated an acceptable safety profile in the adolescent population.
A recent study conducted by investigators from the pharmaceutical and biotechnology company, Moderna, has found that their COVID-19 vaccine, mRNA-1273, was both safe and efficacious in preventing COVID-19 in adolescents.
Results from the study were published in The New England Journal of Medicine.
The incidence of COVID-19 in adolescents between the ages of 12 and 17 years was 900 per 100,000 during the time period of April and June of 2021. The aim of the study was to evaluate the safety, efficacy and immunogenicity of the Moderna vaccine in that population.
The ongoing, phase 2-3, placebo-controlled trial randomly assigned healthy adolescents between the ages of 12 and 17 in a 2:1 ratio to receive 2 doses of the vaccine or a placebo, 28 days apart.
The trial included 3,732 participants, of which 2,489 received the therapy and 1,243 received the placebo.
The primary objective was to evaluate the safety of mRNA-1273 in adolescents as compared to that in young adults between the ages of 18 to 25 years. The secondary objectives included an evaluation of the efficacy in preventing either symptomatic or asymptomatic disease.
Findings from the study demonstrated that the most commonly reported adverse reactions in the vaccine group were injection site pain, headache and fatigue. The most commonly reported adverse reactions in the placebo group were similar and no serious adverse events were noted in either group.
Mean ratio of pseudovirus neutralizing antibody titers in the adolescents relative to the young adults was 1.08, with the absolute difference in serologic response being 0.2 percentage points.
There were no reported cases of COVID-19 with an onset of 14 days after the second injection in the vaccine group and 4 cases reported in the placebo group.
“The mRNA-1273 vaccine had an acceptable safety profile in adolescents,” the authors wrote. “The immune response was similar to that in young adults, and the vaccine was efficacious in preventing COVID-19.”