Pediatricians urge patience in giving vaccines to children aged younger than 12 years
After the FDA granted full approval to the Pfizer-BioNTech COVID-19 vaccine on Monday, the AAP strongly discouraged providers from administering it off-label to children aged younger than 12 years.
The FDA approval applies only to patients aged 16 years or older, but the vaccine is also available under an emergency use authorization for children aged 12 to 15 years.
In a statement, the AAP said that although physicians are legally permitted to give the vaccine off-label to children younger than age 12 years, it is advising against the practice, with AAP President Lee Savio Beers, MD, citing a need for more data from clinical trials to properly determine a dose.
“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,” Beers said in the statement. “The dose may be different for younger ages. The AAP recommends against giving the vaccine to children under 12 until authorized by the FDA.”
Beers also said that data from clinical trials and experience with the vaccine over the past 4 months do show that it is “safe and very effective” among adolescents aged 12 to 15 years.
C. Buddy Creech, MD, MPH, an associate professor of pediatrics at Vanderbilt University School of Medicine and director of the school’s Vaccine Research Program, echoed Beers’ comments in an interview with Healio.
“Full approval of the vaccine does not give permission for providers to overinterpret and step out of line with the FDA,” said Creech, an Infectious Diseases in Children Editorial Board Member. “We don’t know the exact dose to give younger children.”
Creech said he expects clinical trial data for patients as young as 6 months to be published “soon.”
Yvonne Maldonado, MD, FAAP, chair of the AAP Committee on Infectious Diseases, also urged physicians to hold off on vaccinating younger patients until the clinical trials are complete.
“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,” Maldonado 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. 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 the week ending Aug. 19, the AAP said more than 180,000 new cases of COVID-19 were reported among children and adolescents.