With the extremely contagious delta variant estimated to be causing most COVID-19 cases in the U.S., some parents might be tempted to ask doctors to fudge the rules and give their underage kids a vaccination.
Not a good idea, the Itasca-based American Academy of Pediatrics advised recently.
Children 11 and younger are not eligible for shots yet, although clinical trials are underway.
“We need to see the data from those studies before we give this vaccine to younger children,” said Dr. Lee Savio Beers, president of the pediatrics group. “The dose may be different for younger ages.”
It’s not a hypothetical situation, longtime pediatrician Michael Bauer said.
The U.S. Food and Drug Administration fully approved Pfizer’s COVID-19 vaccine in late August. Since then, “I’ve had requests (from parents) to vaccinate their 10- and 11-year-olds,” said Bauer, medical director at Northwestern Lake Forest Hospital.
He tells them, “Full approval is only for 16 and older.”
The FDA has given emergency use authorization for Pfizer’s vaccine to children ages 12 through 15.
When vaccines for younger kids are authorized, “in all likelihood, it’s going to be a different dose that the younger kids get. Less of a dose. So we don’t want people going off-label, so to speak,” Bauer said.
American Academy of Pediatrics experts said the adult dose is much higher than ones being tested in individuals younger than 12.
When will Pfizer ask the FDA to approve its vaccine for young children?
There have been delays because in July, the FDA asked Pfizer to double the number of children in their clinical trials and to provide more follow-up data, Bauer said.
“That’s what’s causing it to take this extra amount of time,” he said. “They’re being extremely cautious.”
Bauer expects “by end of 2021, we will see 5-year-olds and up getting vaccinated. Under age 5, probably not until the early part of 2022. But we’re getting close.”