Pfizer, BioNTech request FDA expand COVID vaccine for EU in children 12 to 15 years old
Pfizer and BioNTech's FDA filing is based on data from a Phase 3 trial of 2,260 children ages 12 to 15 that they said shows the two-dose vaccine is 100% effective in this age group.
Pfizer and BioNTech on Friday requested the FDA expand the emergency use of their Covid-19 vaccine in adolescents aged 12 to 15.
In March, the drugmakers said the vaccine was found to be safe, effective and produced robust antibody responses in 12- to 15-year olds in a clinical trial.
The companies plan to request similar rulings by other regulatory authorities globally in the coming days.
The Pfizer/BioNTech two-shot vaccine is already authorized for use in people as young as 16.