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Moderna Vaccine in Adolescents

 Safety of the Moderna Vaccine in Adolescents
    With the reopening of schools this August and through September, many adolescents will be subject to a much higher chance of potential COVID-19 exposure. As proven by multiple studies and real-world events, COVID-19 vaccines are the best way to minimize infection. Although multiple COVID-19 vaccines are available to adults, as of August 2021, the Pfizer vaccine is the only vaccine available to children aged 12-17 years. However, a recent study published on August 11, 2021 in the New England Journal of Medicine examined the safety and efficacy of the Moderna vaccine, which is currently available for ages 18 and up, in adolescents between 12 and 17 years. While only the Pfizer and Moderna vaccines have published studies with children, if more vaccines are studied and deemed safe and effective in adolescents, adolescents would not only have more vaccine options, but a greater availability of vaccines for their age group.

About the Study

    The study was conducted between December 9, 2020 and February 28, 2021. A total of 3,732 adolescents, aged 12-17 years and in good health, were randomly assigned in a 2:1 ratio to either receive two-100 microgram doses of the Moderna vaccine or a saline placebo. Researchers evaluated the safety and efficacy of the Moderna vaccine in adolescents compared to that of young adults aged 18-25 years. A sample of 340 young adults from the Moderna phase 3 coronavirus efficacy (COVE) trial were used for comparison. The mean age of participants was 14.3 years and 84% of the participants were white. The young adults from the phase 3 study had a similar demographic as the adolescents. It's important to keep in mind that this publication only covered the interim analysis of the study and the adolescent trial is still ongoing. 

Study Results

    Out of the 2,477 adolescents who received the Moderna vaccine, 68.5% reported adverse events after the first injection and 86.1% after the second injection. The most common side effects were fatigue, headache, muscle pain, and chills. The incidence of adverse events among study participants were similar to that of young adults. However, incidence of skin redness was higher among adolescents than young adults. No serious adverse events in the placebo or vaccine groups were noted. In other words, the Moderna vaccine was deemed to have an acceptable safety profile in adolescents.

See here for graph details

    Measuring the immunogenicity, or immune response, of a vaccine is an important factor to determine how the immune system reacts to the vaccine and the antibody levels that are produced. Among the vaccinated participants, 98.8% seroconverted, or developed the necessary antibodies to fight off COVID-19. In comparison, 98.6% of young adults from the phase 3 COVE trial had a serological response. Vaccine efficacy was measured in different populations. In the intention-to-treat population, the Moderna vaccine was 92.7% effective against symptomatic COVID-19 and 59.5% effective against asymptomatic COVID-19 in adolescents with an onset of 14 days after the first injection. However, this interim analysis has a limited number of participants, even in the control group, so more research needs to be conducted before the efficacy of the Moderna vaccine in adolescents can be concluded.

See here for graph details

Discussion

    In this study, researchers ultimately measured the safety, immunogenicity, and efficacy of the Moderna vaccine in adolescents compared to adults. The overall benefit-risk profile of the Moderna vaccine as concluded to be favorable in adolescents. It was determined that the safety of the vaccine in adolescents was similar to that in adults and the immunogenicity of Moderna in adolescents "was noninferior to that of young adults in the phase 3 trial." However, the authors note that efficacy analysis was a secondary objective in the trial because of a small sample size. Further research must be conducted to determine the efficacy of the Moderna vaccine in adolescents since "the number of documented cases of COVID-19 [in this study] is too small to generate robust assessments of efficacy.

Sources

1. Ali, Kashif, et al. “Evaluation of MRna-1273 SARS-CoV-2 Vaccine in Adolescents.” New England Journal of Medicine, 11 Aug. 2021, doi:10.1056/nejmoa2109522.

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