The American Academy of Pediatrics is urging against off-label use of the COVID-19 vaccine in children under 12. This comes after the FDA fully approved Pfizer's shot Aug. 23 for people ages 16 and older.
Pfizer's vaccine, which is available for those ages 12-15 under an emergency use authorization, is still being studied in younger children and should not be administered off-label at the discretion of individual physicians, the organization cautioned.
"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," Lee Savio Beers, MD, AAP president, said in an Aug. 23 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."
Off-label prescribing — a common and legal practice in medicine — refers to the use of a product in a way that it wasn't specifically approved, such as when a chemotherapy drug approved for one cancer type is used for another because it targets different types of tumors.
"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, chair of the AAP's committee on infectious diseases. "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 an Aug. 5 letter, the organization urged the FDA to work aggressively to authorize a vaccine for children ages 11 and younger. Pfizer, Moderna and Johnson & Johnson are all conducting studies in children. Pfizer has said it hopes to submit trial data from children ages 5 to 11 and seek approval in September. Moderna anticipates it will be able to seek emergency authorization for its shot in younger children by winter 2021 or early 2022.