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Pfizer and BioNTech’s request would make them the first vaccine accessible to individuals under the age of 12.
Pfizer and BioNTech requested an emergency use authorization (EUA) from FDA on Oct. 7th, 2021, for the use of their COVID-19 vaccine on children aged 5 to 11. This would make it the first vaccine to be authorized for use in individuals under the age of 12.
Pfizer and BioNTech reported positive results in a recent clinical vaccine trial of the 5-11 age bracket on Sept. 20, 2021. The study found that, when given a two-dose regimen of 10 µg (selected due to concerns of safety, tolerability, and immunogenicity), children in this age bracket showed comparable results to individuals aged 16-25 who were immunized with 30 µg doses.
“We’re committed to working with the FDA with the ultimate goal of helping protect children against this serious public health threat.” said Pfizer on Twitter.
FDA will review the request with a panel of outside experts on Oct. 26th, 2021. The Pfizer / BioNTech vaccine has currently received an EUA for individuals aged 12 to 15 and is fully approved for individuals aged 16 and older.