October 7 (WNN) — Pfizer and BioNTech said Thursday that they have formally requested emergency authorization from the Food and Drug Administration to use their COVID-19 vaccine in children ages 5 to 11.
The emergency use authorization would allow companies nationwide to administer the vaccine to children, as was done before it was fully approved for adults.
Pfizer reported a significant increase in cases in the last half of September, with children accounting for 16% of the total cases.
“With the high number of new cases in children in the US, this submission is an important step in our ongoing effort against [COVID-19],” the company tweeted.
“We are committed to working with the FDA with the ultimate goal of helping to protect children against this serious public health threat.”
The drug manufacturer recommends that children be given one-third of the adult dose, which may require a new vial and syringe.
According to the American Academy of Pediatrics, nearly 6 million children had tested positive for COVID-19 as of September 30. Over 173,000 cases were added in the last week and around 850,000 were added in the last four weeks.
Pfizer and BioNTech said last month that a clinical study of more than 2,000 children showed the vaccine was safe and produced a significant antibody response in children ages 5 to 11. The study was the first to be based on late-stage clinical data in young children.