Data from a phase 2/3 trial evaluating the efficacy, safety, and immunogenicity of the Pfizer-BioNTech COVID-19 vaccine in children 5 to less than 12 years of age have been submitted to the Food and Drug Administration (FDA).

The trial ( Identifier: NCT04816643) included 2268 participants who received a 2-dose regimen of 10mcg administered 21 days apart. Topline results showed that the 10mcg dose level vaccine elicited strong neutralizing antibody responses and demonstrated a safety profile comparable to that observed in individuals 16 to 25 years of age.

A formal request for Emergency Use Authorization in children 5 to less than 12 years of age will be submitted to the FDA in the coming weeks.

Study results in children under 5 years of age are expected later this year. A 2-dose series of 3mcg each is being investigated for this age group.


Pfizer and BioNTech submit initial data to US FDA from pivotal trial of COVID-19 vaccine in children 5 to <12 years of age. News release. Pfizer Inc. and BioNTech SE. Accessed September 28, 2021.