Pfizer Inc. announced Thursday that it has asked the U.S. Food and Drug Administration for emergency approval for its coronavirus vaccine to be given to children between the ages of 5 and 11.
“We’re committed to working with the FDA with the ultimate goal of helping protect children against this serious public health threat,” the company said in a tweet announcing the FDA filing.
What this means
Meanwhile, the FDA has already scheduled an Oct. 26 meeting to consider Pfizer’s request, with a ruling expected between Halloween and Thanksgiving, the New York Times reported.
Pfizer has proposed giving children one-third of the adult dosage, which may require adding more diluent to each injection or using a different vial or syringe, the Times reports. Vaccine doses for children will likely require new labeling and special codes that would enable the U.S. Centers for Disease Control and Prevention to track specific vaccine lots in the event of reports of serious side effects.
If the Pfizer vaccine is authorized for these younger children, it could offer protection to an additional 28 million Americans, according to the Times.
How COVID is affecting children
According to the American Academy of Pediatrics, nearly 5.9 million Americans younger than 18 have been infected with the coronavirus. Of the roughly 500 Americans under 18 who have died, about 125 were children ages 5 to 11.
“It really bothers me when people say kids don’t die of COVID,” Dr. Grace Lee, an associate chief medical officer at Stanford Children’s Health who also leads a key advisory committee to the CDC says.
“They die of COVID. It’s heartbreaking,” she tells the Times.
People younger than 18 have accounted for about 1 in every 6 Americans infected since the start of the pandemic, but that increased to as many as 1 in 4 infections last month as the Delta variant dominated the country.
Addressing parents’ concerns
In May, the FDA granted emergency use of the Pfizer vaccine in 12- to 15-year-olds.
The FDA’s review of a Pfizer dose for children ages 5 to 11 is likely to be closely scrutinized, public health experts say. Approval will not only