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

ABSTRACT:

Background

Safe and effective vaccines against coronavirus disease 2019 (Covid-19) are urgently needed in young children.

Methods

We conducted a phase 1 dose-finding study and are conducting an ongoing phase 2-3 safety, immunogenicity, and efficacy trial of the BNT162b2 vaccine in healthy children 6 months to 11 years of age. We present results for children 6 months to less than 2 years of age and those 2 to 4 years of age through the data-cutoff dates (April 29, 2022, for safety and immunogenicity and June 17, 2022, for efficacy). In the phase 2-3 trial, participants were randomly assigned (in a 2:1 ratio) to receive two 3-μg doses of BNT162b2 or placebo. On the basis of preliminary immunogenicity results, a third 3-μg dose (≥8 weeks after dose 2) was administered starting

SUBMITTER: Munoz FM 

PROVIDER: S-EPMC9947923 | biostudies-literature | 2023 Feb

REPOSITORIES: biostudies-literature