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# Pfizer to Seek Covid Vaccine EUA for Children 5-12
- URL: https://www.fdaweb.com/pfizer-to-seek-covid-vaccine-eua-for-children-5-12/
- Published: 2021-09-28T12:00:00.000Z
- Updated: 2026-09-14T17:16:28.000Z
- Author: David McFarland
- Tags: Biologics, #legacy-id-D5150235

Pfizer and BioNTech say they have submitted Phase 2/3 clinical trial data on their mRNA Covid-19 vaccine in children aged 5 to under 12 to FDA and will seek an emergency use authorization for that group in the coming weeks. The companies announced 9/20 positive topline results from the trial that included 2,268 children ages 5 to under 12.

The companies [say](https://www.pfizer.com/news/press-release/press-release-detail/pfizer-and-biontech-submit-initial-data-us-fda-pivotal?ref=fdaweb.com) the vaccine demonstrated a favorable safety profile and elicited robust neutralizing antibody responses using a two-dose regimen of 10 μg doses.

Topline immunogenicity and safety readouts for the other two age cohorts from the trial — children 2 to under 5 years of age and children 6 months to under 2 years of age — are expected as soon as the fourth quarter of this year, the companies say.