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# Pfizer Seeks Covid Vaccine EUA for Children 5-12
- URL: https://www.fdaweb.com/pfizer-seeks-covid-vaccine-eua-for-children-5-12/
- Published: 2021-10-07T12:00:00.000Z
- Updated: 2026-09-14T17:18:11.000Z
- Author: David McFarland
- Tags: Biologics, #legacy-id-D5150325

Pfizer and BioNTech say they have formally submitted an emergency use authorization request to permit use of their mRNA Covid-19 vaccine in children aged 5 to under 12 years of age. Last week, the companies submitted FDA Phase 2/3 clinical trial data that they said 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 before the end of this year, the companies say.