Lurie Children’s Discourages Off-Label Prescribing of Pfizer-BioNTech COVID-19 Vaccine

On the heels of the Food and Drug Administration’s (FDA) authorization of the Pfizer-BioNTech COVID-19 vaccine Monday, the American Academy of Pediatrics (AAP) strongly discourages the use of the vaccine in off-labeling prescribing to youth under 12. “Lurie Children’s fully supports the AAP’s recommendation and does not condone off-label prescribing of the Pfizer COVID-19 vaccine to individuals under 12,” says Kate Sunderbruch, MD, Pediatrician and Medical Director of Lurie Children’s Pediatric Partners.

According to the FDA, unapproved use of an approved drug is often called “off-label” use. Currently, the FDA’s licensure of the Pfizer COVID-19 vaccine applies to individuals 16 years of age and older. Providers and clinicians must abide by CDC COVID-19 Vaccination Program Provider Agreement and the FDA.

“Kids are not small adults,” said Dr. Sunderbruch. “It’s important that the data for children under 12 are fully collected and that researchers finish studying this age group before providers administer the vaccine to them.” It’s critical that trials first test the safety and efficacy of the vaccine in these age groups.

“Pediatric studies are very challenging relatively to adult studies in the sense that you have to progressively go to younger and younger age groups and often times you have to start at very low doses and increase them,” explained Bill Muller, MD, PhD, Scientific Director, Clinical and Community Trials, Stanley Manne Children's Research Institute and pediatric Infectious Diseases physician. “They’re trying to balance the potential side effects of the vaccines with the benefits of the vaccines. Although we anticipate that children will likely respond similar to adults in terms of generating an immune response. We don’t know if they need as much of the vaccine as adults need to get to that level.”

While parents are anxious to get their younger children protected as the school year begins and cases of the highly transmissible Delta variant increase across the nation, doctors remind families with children too young to be vaccinated to continue to take precautions we know have worked throughout the pandemic.  “As we wait for approval to come for youth under 12, families can continue to practice social distancing, mask wearing and good hand hygiene to protect against COVID-19,” reminded Larry Kociolek, MD, Medical Director of Infection Prevention and Control. “Additionally, we strongly urge all who are eligible to receive the vaccine to get vaccinated.”

Once data from current clinical trials are available and demonstrates that the vaccines are immunogenic and safe, an Emergency Use Authorization (EUA) for use in children 5-11 years will be issued. At that time, Lurie Children’s will work with healthcare providers and community pediatricians to make the vaccine readily available. Click here for more information on vaccines and COVID-19 resources.