Pressure mounts over COVID vaccines for kids; docs warn against off-label use

After Pfizer’s COVID-19 vaccine earned full regulatory approval Monday, pressure is mounting to have the vaccine available to children under 12 years old—and so are concerns that it will be given to them prematurely.

The approval from the Food and Drug Administration covers use of the vaccine in people ages 16 and up, while the agency’s Emergency Use Authorization still allows for its use in adolescents between the ages of 12 and 15. Some experts expect the FDA will grant full approval for use in 12- to 15-year-olds relatively soon.

But many parents and pediatricians are most eager for the green light to offer the vaccine to children under 12. Vaccinating young children has become a particularly pressing issue with the wild spread of the hypertransmissible delta variant, new school terms beginning, disputes over masks, and big holidays just around the corner. In a letter sent to the FDA earlier this month, the American Academy of Pediatrics urged the agency to authorize the vaccine for children under 12 “as swiftly as possible.”

For now, the FDA is awaiting data on which to base a decision. Clinical trials in children ages 5 to 11, 2 to 5, and 6 months to 2, are still ongoing. The trials will provide critical data on vaccine safety and what dosages provide optimal immune responses in each age group. The trials included multiple dosage options for each age group.

US officials have offered slightly different estimates for when the vaccines will get the go ahead from the FDA. In a Tuesday morning interview with the Today, top infectious disease expert Anthony Fauci said vaccines for kids under 12 will be available “hopefully by the mid-late fall and early winter.”

Meanwhile, Francis Collins, director of the National Institutes of Health, offered a slightly longer timeline in an interview with NPR’s Morning Edition, also on Tuesday. “I don’t see the approval for kids 5 to 11 coming much before the end of 2021,” he said.

Urgency

The FDA’s decision could have potentially come earlier, however. Last month, the FDA urged Pfizer and its partner BioNTech, as well as Moderna, to boost the size and design of their trials to be better able to detect potential rare side effects, particularly myocarditis, or inflammation of the heart muscle. Data from older groups suggested that myocarditis is a rare, though generally mild, side effect of the mRNA-based COVID-19 vaccines, which includes the Pfizer/BioNTech and Moderna vaccines. The risk is low, with one estimate at about 13 cases after a million vaccine doses administered. But the risk appears greatest, so far, in young males ages 12 to 17.

In the AAP’s letter to the FDA earlier this month, the doctor’s group wrote that it appreciated the FDA’s rigorous commitment to review safety but said the expansion of the trials shouldn’t delay authorization.

“In our view, the rise of the delta variant changes…