One concern is that off-label prescribing has been linked to a higher rate of side effects — 44 percent greater compared to when medications are given for indications for which they are approved, according to a 2016 JAMA Internal Medicine study of 46,021 adults.
Another is that the dose of the adult vaccine is much higher than the doses being tested in children younger than 12, the AAP said in a statement. Health officials don't want children getting doses that are too large because it could expose them to more side effects. Nor do they want doctors trying to calculate what dose would be safe for young children.
Instead, says Yvonne Maldonado, M.D., FAAP, chair of the AAP Committee on Infectious Diseases, in the 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."
Clinical trials for the COVID-19 vaccine in children younger than 12 are currently underway. In July, the FDA urged Pfizer-BioNTech and Moderna, makers of the two mRNA vaccines, to expand their clinical trials in children ages 5 to 11 to 3,000 children, according to The New York Times. Doing so will help uncover any side effects, such as a rare heart inflammation that's been seen in vaccinated people younger than 30.
"With the possibility of different ages requiring different dosages, waiting for the results of those studies before emergency authorization for use and/or approval for use is granted follows those tenets of making decisions based on the best interests of the patients and the public," Combs says. "We are all hoping for rapid but thorough research that will allow approval for all children as soon as possible to end this pandemic."
In the meantime, Combs recommends that patients continue to practice social distancing when and where possible, limit trips and exposure, continue with wearing masks for age-appropriate groups, taking appropriate measures to prevent spread (such as hand-washing and not touching one's own face or mask), and quarantining if they become ill with the virus.
"While we wait for a vaccine to be authorized for younger children, it's important that everyone who is eligible now get the vaccine," adds AAP President Lee Savio Beers, M.D., FAAP, in the statement. "That will help reduce the spread of the virus and protect those who are too young to be vaccinated."