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Experts Warn Against Off-Label Use of COVID-19 Vaccines for Children Under 12

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Key Takeaways

  • The FDA and American Academy of Pediatricians warns against the off-label use of the vaccine for children younger than 12 years.
  • The Pfizer/BioNTech vaccine is now approved for people 16 years and older, and authorized for adolescents 12 to 16 years old.
  • Experts say that upcoming clinical data will provide more clarity on the most safe and effective dosage and administration schedule for 5- to 11-year-olds.

The Food and Drug Administration (FDA) on Monday granted full approval for Pfizer's COVID-19 vaccine for people aged 16 and above. Adolescents as young as 12 years old can still receive the vaccine under emergency use authorization.

Once a drug has been FDA-approved, doctors can generally prescribe the drug for an unapproved ("off-label") use if they decide that it's medically appropriate. But health authorities are warning against using the vaccine off-label in children younger than 12.

During a media brief on Monday, acting FDA Commissioner Janet Woodcock, MD said "it would not be appropriate" to recommend vaccinating children under the age of 12 without sufficient clinical data.

Following the approval, the American Academy of Pediatrics (AAP)—the nation’s largest group of pediatricians—reiterated the same concern and urged doctors to avoid off-label vaccinations for this age group.

“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. “I know parents are anxious to protect their children, but we want to make sure children have the full benefit of ongoing clinical trials.”

What Is Off-Label Vaccination?

The FDA only approves a drug after carefully examining its risks and benefits for its intended use. An approved drug labeling allows healthcare providers to understand how the drug is used to treat specific conditions.

At times, physicians may prescribe a different dosage of a drug than what the manufacturer indicates, or use chemotherapy approved for one type of cancer to treat a different type.

Medical practitioners have a responsibility to explain why the drug is being used off-label, and what the potential risks are, Don Shifrin, MD, spokesperson for the AAP, tells Verywell.

While other medications have been successfully used off-label, he says, the same may not be true for the COVID-19 vaccines because the optimal dosage, expected side effects, and most effective schedule may differ for children and adults.

“Kids are not small adults,” Shifrin says. “The side effects could be magnified with them, and that's why they're using different dosage forms for the testing for youngsters under the age of 12.”

The approved dosage of vaccine depends on a person's weight and age. In its clinical trials, Pfizer is giving children between the ages of 5 and 11 a lower dose than vaccines for adults and adolescents.

The CDC said that providers who use the vaccine off-label could lose certain privileges like eligibility for compensation after an adverse event, payment, and eligibility to provide COVID-19 vaccines, according to the AAP.

“We realize parents are eager, there's no question, but I'm firmly convinced that going ahead with off label use of this vaccine is going to be perhaps a scientific conundrum,” Shifrin says.

Vaccination Rates Among Teenagers

So far, nearly 35% of 12- to 15-year-olds and 45% of adolescents aged between 16-17 are fully vaccinated.

Moderna and Pfizer are testing their vaccines for children as young as 6 months old. Clinical trials for both companies are scheduled to conclude in the summer of 2023.

While the FDA may authorize Pfizer's vaccine for emergency use in children between 5 and 11 years old this fall, National Institutes of Health Director Francis Collins said that he doesn’t expect full approval to come before the end of 2021.

In a letter to the FDA earlier this month, the AAP urged the agency to speed the timeline of vaccine approval for children 5 to 11 years old.

“They really want to keep it to on-label use because that is what they can speak to. When there is a complication or side effect, they can go back to their studies for what it was actually tested for and make claims on what has happened,” says Jessica Shepherd, MD, Verywell's chief medical officer.

She adds that the turnaround time for FDA's vaccine approval and emergency use authorization has still been relatively quick.

What This Means For You

If you have a child that is younger than 12, health experts recommend against vaccinating them against COVID-19 until the FDA has authorized it for that age group. Contact your child’s physician for any questions you have about how to best protect your child from infection against COVID-19.

What You Can Do Now

As students go back to school in-person, younger children will be at higher risk of exposure to the virus. The AAP reported 180,000 cases among kids and adolescents this week, with a four-fold increase this past month.

“The American Academy of Pediatrics has strongly recommended since May that 12- to 17-year-olds that are eligible to get the vaccine be vaccinated,” Shrifin says.

Until COVID-19 vaccines are made available to younger students, experts recommend that they continue to take other protective measures. One of the best ways to decrease children’s risk of infection, Shifrin says, is to encourage all members of a family and community older than 12 to be vaccinated to ensure children have a “cocoon” of protection.

Additionally, encouraging children to wear masks, wash their hands thorough and often, and socially distance themselves from others will decrease their chances of becoming infected.

“We still face an issue of people who do have access to an authorized vaccine who are still unvaccinated,” Shepherd says. “It would be great if we could get that tomorrow for our pediatric population, but we still have so much work to do for adults that are not getting vaccinated.”

The information in this article is current as of the date listed, which means newer information may be available when you read this. For the most recent updates on COVID-19, visit our coronavirus news page.

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3 Sources
Verywell Health uses only high-quality sources, including peer-reviewed studies, to support the facts within our articles. Read our editorial process to learn more about how we fact-check and keep our content accurate, reliable, and trustworthy.
  1. Food and Drug Administration. Understanding Unapproved Use of Approved Drugs “Off Label.” Updated February 5, 2018.

  2. Centers for Disease Control and Prevention. COVID-19 Data Tracker. Updated August 24, 2021.

  3. American Academy of Pediatrics. Children and COVID-19: State-Level Data Report. Updated August 23, 2021.