Pfizer and BioTech Request Emergency-Use Authorization for Vaccine for 5 to 11 Year-Olds
Pfizer and BioNTech requested the US Food and Drug Administration (FDA) to grant emergency-use authorization of their COVID-19 vaccine for children who are 5 to 11-years-old, the companies announced Thursday.
The FDA has scheduled an advisory committee meeting on Oct. 26 to announce its decision on whether it will authorize the Pfizer-BioNTech vaccine for younger children.
"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 #COVID19,” Pfizer wrote on Twitter this morning.
The news comes just over a week after Pfizer-BioNTech submitted clinical trial data from a COVID-19 vaccine study of its effects on 2,268 kids ages 5-11 to the FDA.
The data from the trial found a smaller dose of the shot was safe, well tolerated, and effective in generating protective responses to COVID-19 and its variants. As a result of the study, Pfizer and BioNTech selected a two-dose regimen of 10 microgram (ug) doses for kids ages 5-11, versus the two-dose regimen of 30 ug doses used for everyone 12 and older.
"We know from our vast experience with other pediatric vaccines that children are not small adults, and we will conduct a comprehensive evaluation of clinical trial data submitted in support of the safety and effectiveness of the vaccine used in a younger pediatric population, which may need a different dosage or formulation from that used in an older pediatric population or adults," Acting FDA Commissioner Dr. Janet Woodcock said in anticipation of Pfizer-BioNTech's request for use of the vaccine in younger age groups.
The companies previously announced that their trial results on younger age groups, such as children ages 6 months to 4 years old, will be forthcoming, as well.
"We are ready, willing, and able to give the vaccine to children, as soon as we get the authorization," said Mayor Bill de Blasio this morning at his press conference. "We will only do so, however, with a parent present or with a parent's written permission.
"We know there are going to be a lot of questions, and we are going to answer them."
(Photo by: Darren McGee- Office of Former Governor Andrew M. Cuomo)