Pfizer/BioNTech has officially filed with the Food and Drug Administration seeking to expand their emergency use authorization for their COVID-19 vaccine in children aged 12 to 15 years old.
When the Pfizer COVID-19 vaccine was approved for emergency use by the FDA in December, it was for those aged 16 and older. Since then, the company has conducted studies on the vaccine's efficacy in younger teens.
"Pending regulatory decision, our hope is to make this vaccine available to the 12-15-year-old age group before the start of the 2021 school year," the company tweeted Friday.
In March, they published data showing their COVID-19 two-shot vaccine was safe and produced a robust antibody response in trial participants aged 12 to 15.
The findings recorded 100% efficacy against the virus in the study of 2,260 adolescents between 12 and 15 years of age.
Of the 1,000 participants given the vaccine, none developed a COVID-19 infection. In the more than 1,000 participants given the placebo, 18 contracted COVID-19.
BREAKING: Today, with @BioNTech_Group, we submitted a request to US FDA to expand emergency use of our COVID-19 vaccine to adolescents 12 to 15 years of age. pic.twitter.com/AHjc2khnUj— Pfizer Inc. (@pfizer) April 9, 2021