RALEIGH, N.C. (WNCN) — Pfizer Inc. and BioNTech SE announced Tuesday that they have officially submitted for approval data to the U.S. Food and Drug Administration from the Phase 2/3 trial of their COVID-19 vaccine for kids ages 5 to 11.
Pfizer kicked off the clinical trial months ago, working with more than 4,500 kids from around the world and studying the antibody response and safety of the vaccines in different age groups.
The trial in children 5 to 11 years of age involved 2,268 participants and the companies said they saw “positive topline results.”
Pfizer reported that a lower dose of the vaccine used in adults is safe and effective.
“The vaccine demonstrated a favorable safety profile and elicited robust neutralizing antibody responses using a two-dose regimen of 10 μg doses,” the companies said in a joint press release.
The release went on to say that, “These results – the first from a pivotal trial of any COVID-19 vaccine in this age group – were comparable to those recorded in a previous Pfizer-BioNTech study in people 16 to 25 years of age, who were immunized with 30 μg doses.”
The companies have shared their data with the FDA for initial review. In the coming weeks, the companies plan to formally submit a request for Emergency Use Authorization (EUA) in children 5 to 11 years old.
The trial also looked at the vaccine for children ages 2 to 4 and from 6 months to less than 2 years. Those results are expected as soon as the fourth quarter of this year, the companies said.
You can read the full press release here.