‘We need to see the data:’ Pediatricians warn against vaccinating kids under 12 now that Pfizer shot is fully approved

DeLAND, Fla. – With concerns about the coronavirus mounting in the classroom, top pediatricians are urging doctors not to give the COVID-19 vaccine to children under 12.

The American Academy of Pediatrics warned against off-label use of COVID vaccines after the FDA granted full approval for the Pfizer vaccine on Monday.

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“Clinical trials for the COVID-19 vaccine in children 11 years and younger are ongoing, and we need to see the data from those trials before giving this vaccine to younger children,” said AAP President Lee Savio Beers, MD, FAAP. “For younger ages, the dose may be different. The AAP recommends not giving the vaccine to children under the age of 12 until it is approved 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 can prescribe an off-label drug if they believe it is medically appropriate for their patient.

dr. Bruce Rankin conducts pediatric COVID-19 vaccine trials at Accel Research Sites in DeLand. He said there are risks associated with administering the vaccine off-label to children under the age of 12.

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“If you decide to do something that hasn’t been researched yet, you’re taking an inherent risk because we don’t know what the bad effects might be,” Rankin said.

Rankin said vaccines for children and adults are different.

“Children are just not little adults. It’s very important to see them as that group: age difference, weight difference, body composition still developing,” he said.

Rankin said he understands parents can be anxious, but he said they should wait to have their younger children vaccinated until all clinical trial data has been collected, reviewed and approved.

“We all want our children to be vaccinated as soon as possible, but we need to do it the same way we did the adult trials,” Rankin said. “We have to go through the scientific approach and make sure we do all the steps.”

Pediatric pulmonologist Dr. Akinyemi Ajayi said some parents are desperate and may be willing to take the risk.


“They try to do everything they can to protect their children,” Ajayi said.

But he urges the families to be patient.

“We don’t yet have all the information that will allow us to know what the dose will be that will be effective and safe for children,” Ajayi said.

Both doctors said they believe doctors would be hesitant to provide the COVID vaccine off-label to younger children. The pharmacies added by Rankin will not administer the injection if your child is not old enough.

Rankin said they are still conducting pediatric COVID vaccine trials. He hopes there could be an approved vaccine for children under 12 by the end of this year or early next year.

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