Pfizer officially asks the FDA to authorize its COVID vaccine for kids aged 5-11
Pfizer and BioNTech are officially asking the Biden administration to authorize the use of their COVID-19 vaccine for children ages 5 to 11.
Pfizer tweeted on Thursday that the companies had submitted their formal request for Emergency Use Authorization of the vaccine to the Food and Drug Administration.
Updated October 7, 2021 at 9:27 AM ET
"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," the pharmaceutical giant said.
The submission is the latest development in the push to expand use of the vaccine to younger children, a process being closely watched by many anxious parents as the new school year gets underway.
The Pfizer-BioNTech vaccine has full FDA approval for people ages 16 and older, and those between the ages of 12 and 15 can get the shot under the current emergency use authorization.
The application was widely expected after Pfizer and BioNTech submitted data to the government last month showing that their vaccine produced a "robust" antibody response in kids from 5-11 and had "favorable" safety outcomes.
The FDA has scheduled a meeting with an independent advisory committee for Oct. 26 to discuss Pfizer's request to authorize its vaccine for children aged 5-11.
The FDA could then decide quickly to grant the authorization, though that could be held up if the committee has issues with the application. [Copyright 2021 NPR]