Pfizer Vaccine Not for Off-Label Use in Young Kids: FDA

Carolyn Crist

August 24, 2021

Editor's note: Find the latest COVID-19 news and guidance in Medscape's Coronavirus Resource Center.

Although the FDA granted full approval for the Pfizer COVID-19 vaccine for ages 16 and up on Monday, officials have added a note of caution to parents and doctors — the shot isn't yet intended for use in kids.

In particular, the first fully approved COVID-19 vaccine shouldn't be given to ages 12 or younger through "off-label use," when medical providers use a drug for an unapproved age group, medical condition or dosage.

"We do not have data on the proper dose, nor do we have the full data on the safety in children younger than what is in the [emergency use authorization], and so that would be a great concern that people would vaccinate children," Janet Woodstock, MD, the FDA commissioner, said during a call with reporters.

The vaccine continues to be available for ages 12-15 through FDA emergency use authorization, but children under age 12 shouldn't receive the shot, she added.

"They are not just small adults," she said. "And we've learned that time and time again, so we really would have to have the data and the appropriate dose before recommending that children be vaccinated."

Pfizer, Moderna and Johnson & Johnson are running vaccine trials in children as young as 6 months. Pfizer has said that it will submit vaccine safety data for ages 5-11 by the end of September, and Moderna has said it will submit data for the age group sometime in the fall, according to ABC News.

Although children will receive the same vaccine formulation, the dosage will be lower. For Pfizer, children under 12 will likely receive 10 micrograms, versus the 30-microgram dose given to teens and adults.

"In kids [ages] 5 to 12, we found that 10 micrograms, so one-third of the [adult] dose, gives you the same immune response," Robert Frenck, MD, the lead investigator of the COVID-19 vaccine trials at Cincinnati Children's Hospital, told ABC News.

"If they give it off label and they give the 30 micrograms, I think they're going to have kids that are going to have a lot more reactogenicity," he said. "Kids with fevers, headaches."

The American Academy of Pediatrics also urged caution about using the vaccine in younger kids. Although it is "legally permissible" for doctors to give the shot through off-label use, the group "strongly discourages that practice."

"We do not want individual physicians to be calculating doses and dosing schedules one-by-one for younger children based on the experience with the vaccine in older patients," Yvonne Maldonado, MD, chair of the AAP Committee on Infectious Diseases, said in a statement.

"We should do this based on all of the evidence for each age group, and for that we need the trials to be completed," she said. "I know parents are anxious to protect their children, but we want to make sure children have the full benefit of ongoing clinical trials."

Ages 5-11 will likely receive vaccine approval in late 2021, Francis Collins, MD, director of the National Institutes of Health, said on Tuesday. The timing for children younger than 5 is less certain, but officials hope approval will follow soon after that.

"Keep in mind kids are not just scaled down adults," Collins told "Good Morning America."

"They have different immune systems and metabolism," he said. "You really have to do the careful trials to make sure you got the dose right and there aren't any surprises."


FDA: "FDA Approves First COVID-19 Vaccine."

FDA: "Media Call: First COVID-19 Vaccine Approval – 8/23/2021."

ABC News: "FDA-approved Pfizer vaccine not OK for off-label use in kids, official says."

American Academy of Pediatrics: "American Academy of Pediatrics Cautions Against Off-Label Use of COVID-19 Vaccines in Children Under 12."

Good Morning America: "NIH director talks about full FDA approval for Pfizer vaccine."