Pfizer-BioNTech file for FDA EUA for COVID-19 vaccine in children

Oct. 8, 2021

Pfizer-BioNTech have officially filed a request for emergency use authorization (EUA) with the U.S. food and Drug Administration (FDA) to administer the companies’ COVID-19 vaccine in children ages 5-11 years old, according to a tweet from Pfizer on Twitter.

In anticipation of this request, the FDA had scheduled meeting of its Vaccines and Related Biological Products Advisory Committee (VRBPAC) on October 26.

In September, Pfizer and BioNTech announced results from a Phase 2/3 trial showing a favorable safety profile and robust neutralizing antibody responses in children 5 to 11 years of age using a two-dose regimen of 10 µg administered 21 days apart, which is a smaller dose than the 30-µg dose used for people 12 and older.

The data summarized from this Phase 2/3 study was for 2,268 participants who were 5-11 years of age, although the study is enrolling children from 6 months to 11 years of age.

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