FDA Expands Emergency Use Of Pfizer/BioNTech's COVID-19 Booster To 16 Years & Older

The FDA has expanded the Emergency Use Authorization (EUA) of a booster dose of Pfizer Inc PFE and BioNTech SE's BNTX COVID-19 vaccine to include individuals 16 years of age and older. 

• The booster dose will be administered at least six months after completion of the primary series and is the same formulation and dosage strength as the primary series.
• The FDA previously authorized a booster dose of the Pfizer-BioNTech COVID-19 vaccine for emergency use in individuals 18 years of age and older and eligible individuals who have completed primary vaccination with a different authorized COVID-19 vaccine.
• Pfizer and BioNTech plan to submit a marketing application to approve a booster dose of their COVID-19 vaccine in individuals 16 years of age and older. 
• The application will include efficacy and safety data from a Phase 3 trial showing that a 30-µg booster dose demonstrated a relative vaccine efficacy of 95% compared to those who did not receive a booster. 
• Related Link: Pfizer/BioNTech COVID-19 Shot Provides Partial Protection Against Omicron, Study Shows.
• Price Action: PFE shares are up 1.99% at $52.43, while BNTX stock is down 1.62% at $287.22 during the market session on the last check Thursday.