Pfizer and BioNTech said Thursday they are seeking US Food and Drug Administration emergency use authorization from for their Covid-19 vaccine for children ages 5 to 11.
Last month, Pfizer released details of a Phase 2/3 trial that showed its Covid-19 vaccine was safe and generated a"robust" antibody response in children ages 5 to 11. The trial included 2,268 participants ages 5 to 11 and used a two-dose regimen of the vaccine administered 21 days apart. This trial used a 10-microgram dose -- smaller than the 30-microgram dose that has been used for those 12 and older.
Pfizer began submitting its data on the vaccine for younger children to the FDA late last month, but had not formally requested authorization until now.
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