AAP warns against off-label COVID-19 vaccination for patients under 12

The organization says the medical community should wait for results from the clinical trials for vaccinating patients under 12.

The American Academy of Pediatrics (AAP) is warning physicians to not give off-label COVID-19 vaccinations to children under the age of 12.

According to a news release, the organization strongly discourages administering the currently available vaccines to patients 11 and younger citing the lack of data on dosing in this cohort.

“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,” AAP President Lee Savio Beers, MD, FAAP, says in the release. “The dose may be different for younger ages. The AAP recommends against giving the vaccine to children under 12 until authorized by the FDA.”

Back in May, the Food and Drug Administration (FDA) expanded the emergency use authorization (EUA) for the Pfizer COVID-19 vaccine to allow administration to patients between 12 and 15 years of age.

AAP strongly recommends that all eligible adolescents be vaccinated against COVID-19 as soon as possible as data from clinical trials and experience with the vaccine show it to be safe and effective in the age group, the release says.

Currently, the doses being tested in children younger than 12 are much lower than those doses being offered to adults, according to the release.

“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, FAAP, chair of the AAP Committee on Infectious Diseases, says in the release. “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.”

Despite early belief that children may not be susceptible to COVID-19, a report from the AAP found that as of July 29, nearly 4.2 million children have tested positive for the disease since the beginning of the pandemic and that infections steadily increased in July after declining earlier in the summer, Contemporary Pediatrics reports.

AAP has called on the FDA to work aggressively toward authorizing a vaccine for children under 12 but increasing vaccination rates among those who are now eligible is key to protecting children while the clinical trials continue, the release says.

“We know parents are eager to be able to give their children the protection of this vaccine, and the American Academy of Pediatrics shares that feeling of urgency,” Beers says. “The Delta variant has led to significant increases in the number of children and adults infected 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. That will help reduce the spread of the virus and protect those who are too young to be vaccinated.”