Pfizer asks FDA to authorize COVID-19 vaccine in children ages 5-11
Pfizer and BioNTech officially submitted a request to the U.S. Food and Drug Administration (FDA) for emergency use authorization of its novel coronavirus (COVID-19) vaccine in children ages 5 to 11 years old, according to a post on Twitter last week.
The FDA approved the vaccine for individuals ages 16 years and older in August. Currently, the vaccine is available to children ages 12 to 15 years old under an emergency use authorization originally granted in May 2021. The request would make the vaccine available to children ages 5 to 11 years old under an emergency use authorization.
The company announced trial results for children ages 5 to 11 years old last month, which showed the vaccine produced a robust antibody response with favorable safety outcomes.
“With new cases in children in the U.S. continuing to be at a high level, this submission is an important step in our ongoing effort against COVID-19,” the company said Thursday.