Vaccines and Related Biological Products Advisory Committee Meeting: EUA Amendment Request for Pfizer-BioNTech COVID-19 Vaccine for Use in Children 5 Through 11 Years of Age   [open pdf - 481KB]

From the Executive Summary: "On October 6, 2021, Pfizer submitted a request to FDA to amend its Emergency Use Authorization (EUA) to expand use of Pfizer-BioNTech COVID-19 [coronavirus disease 2019] Vaccine (BNT162b2) for prevention of COVID-19 caused by SARS-CoV-2 [severe acute respiratory syndrome coronavirus 2] in individuals 5 through 11 years of age (hereafter 5-11 years of age). The proposed dosing regimen is a 2-dose primary series, 10 µg mRNA/per dose, administered 3 weeks apart. This EUA request initially included safety data from 1,518 BNT162b2 recipients and 750 placebo (saline) recipients 5-11 years of age who are enrolled in the Phase 2/3 portion (Cohort 1) of an ongoing randomized, double-blinded, placebo-controlled clinical trial, C4591007. [...] This October 26, 2021 VRPBAC [sic] [Vaccines and Related Biological Products Advisory Committee] meeting is being held to discuss whether, based on the totality of scientific evidence available, the benefits of the Pfizer-BioNTech COVID-19 Vaccine when administered as a 2-dose series (10 µg each dose, 3 weeks apart) outweigh its risks for use in children 5-11 years of age."