Comparison of immune response in 12-to-15 years cohort vs 16-to-25 years
Efficacy against confirmed COVID-19 ≥7 days after dose 2
1131 received vaccine | 1129 received placebo
BNT162b2 had a favorable safety and side-effect profile, with the following common symptoms
Injection-site pain: 79 to 86% of participants
Fatigue: 60 to 66%
Headache: 55 to 65%
In general, local and systemic reactogenicity events were mild to moderate in severity
Frequency of events were similar between groups
Resolution within 1 to 2 days
No vaccine-related serious adverse events
Few overall severe adverse events
Antibody response was greater in the 12 to 15-year-old cohort vs 16 to 25-year-olds
COVID-19 cases identified
Among vaccine group: 0
Among placebo group: 16 cases
Observed vaccine efficacy: 100% (95% CI, 75.3 to 100)
The Pfizer-BioNTech vaccine was highly effective at preventing COVID-19 in adolescents aged 12 to 15
Reactogenicity events were mild to moderate in severity and similar between groups
There were no major vaccine-related adverse effects
The authors conclude
Given the safety, immune response, and efficacy of the BNT162b2 vaccine in adolescents 12 to 15 years of age reported in this analysis, studies are ongoing to evaluate these measures in younger children and in other special populations, such as pregnant women
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