DeLAND, Fla. – As concerns over coronavirus in the classroom grow, top pediatricians are urging doctors to not give the COVID-19 vaccine to children under the age of 12.
The American Academy of Pediatrics issued the warning against off-label use of COVID vaccines after the FDA granted full approval for the Pfizer vaccine on Monday.
“The clinical trials for the COVID-19 vaccine in children ages 11 years old and younger are underway, and we need to see the data from those studies before we give this vaccine to younger children,” said AAP President Lee Savio Beers, MD, FAAP. “The dose may be different for younger ages. The AAP recommends against giving the vaccine to children under 12 until authorized by the FDA.”
The FDA said the term off-label is used to describe the unapproved use of an approved drug. The agency said health care providers may prescribe an off-label drug if they feel it’s medically appropriate for their patient.
Dr. Bruce Rankin is conducting pediatric COVID-19 vaccine trials at Accel Research Sites in DeLand. He said administering the vaccine off-label to children younger than 12 comes with risk.
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“If you start deciding to do something that hasn’t been studied then you’re taking an inherent risk because we don’t know what the bad effects could be,” Rankin said.
Rankin said vaccines for children and adults are different.
“Kids are just not small adults. It’s very important to look at them as that group: age difference, weight difference, body composition still developing,” he said.
Rankin said he understands parents may be anxious, but he said they should wait to get their younger kids vaccinated until all the clinical trial data is collected, reviewed and approved.
“All of us want our children vaccinated as soon as possible but we have to do it the same way we did it with the adult trials,” Rankin said. “We need to go through the scientific approach and make sure that we do all of the steps.”
Pediatric pulmonologist Dr. Akinyemi Ajayi said some parents are desperate and may be willing to take the risk.
“They’re trying to do all they can to protect their kids,” Ajayi said.
But he is urging families to be patient.
“We don’t have yet all the of the information that will allow us to know what is going to be the dose that is effective and safe for children,” Ajayi said.
Both doctors said they believe physicians would be hesitant to provide the COVID vaccine off-label to younger kids. Rankin added pharmacies won’t administer the shot if your child isn’t old enough.
Rankin said they are still conducting pediatric COVID vaccine trials. He hopes there could be an approved vaccine for kids younger than 12 by the end of this year or early next year.