FDA Paves Way for Pfizer/BioNTech's COVID-19 Shot In Young Children - Pfizer (NYSE:PFE), BioNTech (NASDAQ:BNTX)

In line with the expectations, the FDA has given emergency use authorization to Pfizer Inc PFE - BioNTech SE's BNTX COVID-19 vaccine for children 5 through 11 years of age.
Related Link: FDA May Clear First COVID-19 Vaccine For Younger Kids, Probably Today: NYT.
With this authorization, the Pfizer-BioNTech vaccine is currently the only COVID-19 jab available in the U.S. for use in this age group.
The vaccine must be administered in a two-dose regimen of 10-µg doses given 21 days apart for this age group.
The authorization is supported by clinical data showing a favorable safety profile and high vaccine efficacy of 90.7% in children 5 through 11 years of age.
The companies will begin shipping 10-µg pediatric doses immediately.
The CDC's Advisory Committee will meet next week to discuss a potential recommendation for the use and rollout of the vaccine to younger kids.
Initial data from the other two age cohorts (2 to 5 years and six months - 2 years) are expected in Q4 of 2021 or Q1 of 2022.
Related content: FDA Delays Approval For Moderna's COVID-19 Shot In Teenagers: What You Need To Know
Price Action: PFE shares are up 0.62% at $44.01, and BNTX stock is down 0.08% at $278.51 during the premarket session on the last check Monday.