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AAP Warns Against Off-Label Use of COVID-19 Vaccine for Children

Completion of trials, regulatory approval will ensure correct dosing information

August 24, 2021

This week, the American Academy of Pediatrics (AAP) strongly discouraged the off-label use of the Pfizer-BioNTech vaccine for children younger than 12.

The statement from the AAP reminded providers and the general public that the Pfizer-BioNTech vaccine has been approved for emergency use in people 12 and older and that more information was needed before administering the vaccine to children who are not currently eligible.

“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.”

In its statement, the AAP emphasized:

  • The clinical trials with children younger than 12 use a much smaller dose of the vaccine than the adult version
  • Pediatricians are urged to wait until the clinical trials for children are complete and are advised against calculating doses for children without U.S. Food and Drug Administration (FDA) approval and guidance
  • With the spread of the Delta variant, the FDA must “must work aggressively” to continue the review and authorize the vaccine for children 11 and younger

“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,” said Yvonne Maldonado, MD, FAAP, chair of the AAP Committee on Infectious Diseases. “We should do this based on all of the evidence for each age group, and for that we need the trials to be completed. I know parents are anxious to protect their children, but we want to make sure children have the full benefit of ongoing clinical trials.”

In its weekly report, the AAP notes that more than 180,000 child COVID-19 cases were reported last week, a four-fold increase during the past month.

HAP joins the AAP to encourage everyone who is eligible to receive the vaccine to make an appointment. Getting more people vaccinated will help protect those who are not yet eligible to receive the vaccine.

The vaccines are safe and free, and provide outstanding protection against severe cases of the virus.