FDA Authorizes Pfizer/BioNtech's Updated COVID-19 Booster Shots For Kids 5-11 Years

The FDA has granted Emergency Use Authorization for Pfizer Inc PFE and BioNTech SE's BNTX 10-µg booster dose of Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine in children 5 through 11 years of age.
Pending recommendation from the Centers for Disease Control and Prevention, 10-µg doses will be shipped immediately.
Clinical data from a Phase 2/3 trial showed a booster dose of 30-µg Omicron BA.1-adapted vaccine elicited a superior immune response compared to the companies' original COVID-19 vaccine, with a favorable safety profile.
Related: Pfizer's Executive Says European COVID-19 Vaccine Contract Negotiations Did Not Happen Over Text Message.
Additionally, preclinical data showed that a booster dose of the 30-µg BA.4/BA.5-adapted bivalent vaccine generated a strong neutralizing antibody response.
Pfizer and BioNTech have submitted an application to the European Medicines Agency requesting a variation of the companies' marketing authorization to include a 10-µg booster dose of Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine in this age group.
A Phase 1/2/3 pediatric study is currently underway to evaluate different dosing regimens and dose levels of the Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine across age groups.
Price Action: BNTX shares are up 6.41% at $137.79, and PFE stock is up 1.59% at $42.58 on the last check Wednesday.