Current best evidence for clinical care (more info)
BACKGROUND: Until very recently, vaccines against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) had not been authorized for emergency use in persons younger than 16 years of age. Safe, effective vaccines are needed to protect this population, facilitate in-person learning and socialization, and contribute to herd immunity.
METHODS: In this ongoing multinational, placebo-controlled, observer-blinded trial, we randomly assigned participants in a 1:1 ratio to receive two injections, 21 days apart, of 30 µg of BNT162b2 or placebo. Noninferiority of the immune response to BNT162b2 in 12-to-15-year-old participants as compared with that in 16-to-25-year-old participants was an immunogenicity objective. Safety (reactogenicity and adverse events) and efficacy against confirmed coronavirus disease 2019 (Covid-19; onset, =7 days after dose 2) in the 12-to-15-year-old cohort were assessed.
RESULTS: Overall, 2260 adolescents 12 to 15 years of age received injections; 1131 received BNT162b2, and 1129 received placebo. As has been found in other age groups, BNT162b2 had a favorable safety and side-effect profile, with mainly transient mild-to-moderate reactogenicity (predominantly injection-site pain [in 79 to 86% of participants], fatigue [in 60 to 66%], and headache [in 55 to 65%]); there were no vaccine-related serious adverse events and few overall severe adverse events. The geometric mean ratio of SARS-CoV-2 50% neutralizing titers after dose 2 in 12-to-15-year-old participants relative to 16-to-25-year-old participants was 1.76 (95% confidence interval [CI], 1.47 to 2.10), which met the noninferiority criterion of a lower boundary of the two-sided 95% confidence interval greater than 0.67 and indicated a greater response in the 12-to-15-year-old cohort. Among participants without evidence of previous SARS-CoV-2 infection, no Covid-19 cases with an onset of 7 or more days after dose 2 were noted among BNT162b2 recipients, and 16 cases occurred among placebo recipients. The observed vaccine efficacy was 100% (95% CI, 75.3 to 100).
CONCLUSIONS: The BNT162b2 vaccine in 12-to-15-year-old recipients had a favorable safety profile, produced a greater immune response than in young adults, and was highly effective against Covid-19. (Funded by BioNTech and Pfizer; C4591001 ClinicalTrials.gov number, NCT04368728.).
| Discipline / Specialty Area | Score |
|---|---|
| Pediatrics (General) | |
| Public Health | |
| Infectious Disease | |
| Family Medicine (FM)/General Practice (GP) | |
| General Internal Medicine-Primary Care(US) | |
Important though likely well known among primary care physicians.
The absence of racial/ethnic diversity in the 12-15 year-old group limits the global validity of these findings. The high percentage of so called minor side-effects is a worry from an ethical perspective in this population of children at relatively low risk of very symptomatic COVID-19: the vaccine appears to affect their health in the short term more than the disease it prevents. Longer term results are imperatively needed to provide information about the duration of symptoms such as fatigue in this age group.
Infection with SARS-CoV-2 leading to COVID-19 disease is currently a topical issue in the world as medical researchers work tirelessly to find control measures. Vaccines have been developed at rapid rates never witnessed before but most of these have only been tested in older populations. This article is very relevant as it tests the safety and efficacy of vaccines in adolescents, an important group that will contribute towards herd immunity. The results reported in this article showing good safety and efficacy of the vaccine in adolescents is good news towards using vaccination to achieve herd immunity against COVID-19.
A relevant RCT that demonstrates the efficacy and safety of the BNT162b2 Covid-19 Vaccine in adolescents (12-15 y).