Evaluation of BNT162b2 Covid-19 Vaccine in Children Younger than 5 Years of Age

This clinical study assesses the safety, immunogenicity, and efficacy of a three-dose 3-µg BNT162b2 vaccine regimen in children aged 6 months to 4 years. Initial phase 1 dose-finding confirmed tolerability, leading to the phase 2–3 trial, which demonstrated immunobridging success based on neutralizing titers and seroresponse when compared with young adults (16–25 years). Among 873 vaccinated participants, observed vaccine efficacy was 73.2% (95% CI, 43.8–87.6) against symptomatic Covid-19 during the Omicron-dominant phase. Reactogenicity was generally mild to moderate; no serious safety concerns emerged. The findings support BNT162b2's use in this age group to prevent Covid-19 and curb transmission.

This clinical study assesses the safety, immunogenicity, and efficacy of a three-dose 3-µg BNT162b2 vaccine regimen in children aged 6 months to 4 years. Initial phase 1 dose-finding confirmed tolerability, leading to the phase 2–3 trial, which demonstrated immunobridging success based on neutralizing titers and seroresponse when compared with young adults (16–25 years). Among 873 vaccinated participants, observed vaccine efficacy was 73.2% (95% CI, 43.8–87.6) against symptomatic Covid-19 during the Omicron-dominant phase. Reactogenicity was generally mild to moderate; no serious safety concerns emerged. The findings support BNT162b2's use in this age group to prevent Covid-19 and curb transmission.