Article 1 (Frenck et al., 2021)

The research in the article cited above was conducted in order to answer the research questions; can the BNT162b2 Covid-19 vaccine be approved for emergency use in adolescents younger than 16 years? Can the vaccine be used safely and effectively in this population? One of the main reasons the study was conducted was because of the higher Covid-19 incidence reported among 12-to-17-year-olds in comparison to children of a younger age. The study uses a retrospective cohort design to compare the immune response of two different cohorts to the BNT162b2 Covid-19 vaccine. A cohort study differentiates between two groups, one that was exposed to a risk factor for a duration of time, and another that was not exposed to the risk factor, for analysis (Song & Chung, 2010). This specific study analyzed the difference in two sample groups. One group received the vaccine while the other received a placebo. The immune response in 12- to 15-year-old participants was then compared to that of 16- to 25-year-old participants. Immune response noninferiority, safety and efficacy were then analyzed according to the results.
The study used simple random sampling to obtain 2260 participants from the United States and globally. Among them, 49 % were female, 12% Latinx or Hispanic and 86% white. A web-based interactive response system was used for randomization. Qualified participants were of relatively healthy state with those with a previous Covid-19 diagnosis or any immunodeficiency disorder being excluded from the study. Out of this sample, 1129 got the placebo while 1131 got the BNT162b2 vaccine. An estimated 90.8% power was established in each age cohort for affirming immune response noninferiority. The variables used in the study are the vaccine’s safety, efficacy and immunogenicity.

The immune response of the 12–15-year-old group was found to be noninferior in comparison to that of 16–25-year-old group. For safety, both cohorts reported systemic and local events of mild to moderate severity that resolved within 2 days. Among the participants of the study, no Covid-19 cases were reported in the vaccine recipients and only 34 cases were reported in the placebo group. This brought the overall efficacy of the vaccine to 100%. The confidence level was greater than 75% which is similar to the efficacy levels observed in participants older than 16 years. The outcome on safety and efficacy of the vaccine in 12- to 15-year-old children according to this study justifies the authorization of the emergency use of the vaccine in younger children. One implication of the results in this study apart from preventing Covid-19 in this age group is the benefit of vaccinating adolescents that contributes to the overall community protection against the virus. Despite having a lower symptomatic Covid-19 burden compared to adults, they are more likely to transmit the disease in schools, sport facilities and similar community gatherings even with a high adult immunization rate. Vaccination allows adolescents to rejoin the society and continue in-person education safely, an important aspect, especially considering the adverse mental effects of the Covid-19 pandemic. Additionally, with the reported efficacy and safety levels, asymptomatic infection is likely to be avoided in vaccinated children, resulting in a safer broader community. However, one area that needs further research is the efficacy duration of the vaccine in children. This is important in knowing how long the effect lasts. Additionally, Covid-19 vaccines from other manufacturing companies need to be tested for their efficacy and safety in the same age-group in order to maximize the safety effect to all people vaccinated regardless of vaccine manufacturer.

References

Frenck, R., Klein, N., Kitchin, N., Gurtman, A., Absalon, J., & Lockhart, S. et al. (2021). Safety, Immunogenicity, and Efficacy of the BNT162b2 Covid-19 Vaccine in Adolescents. New England Journal Of Medicine, 385(3), 239-250. https://doi.org/10.1056/nejmoa2107456

Song, J., & Chung, K. (2010). Observational Studies: Cohort and Case-Control Studies. Plastic And Reconstructive Surgery, 126(6), 2234-2242. https://doi.org/10.1097/prs.0b013e3181f44abc