Generally, FDA approvals open vaccines up for off-label use, a common practice in which physicians prescribe a drug or vaccine beyond its approved use or populations. However, the CDC said off-label use of Pfizer’s vaccine for children under 12 is not authorized, as clinical trials for this age group are ongoing. The American Academy of Pediatrics also warned against off-label use Aug. 24, noting that dosing may be different for younger children.
Pfizer is expected to share the results of its vaccine trial involving 5- to 11-year-olds with the FDA in September. National Institutes of Health Director Francis Collins, MD, PhD, said it could take months for the agency to review the data and authorize the vaccine for this age group.
“I got to be honest, I don’t see approval for kids 5 to 11 coming much before the end of 2021,” he told NPR.
Parents told the Journal they’ve had mixed success securing vaccination appointments for their children. Clinicians who use the vaccine off label may not be reimbursed for the shots or protected under public health emergency legislation that shields providers from liability, the Journal reported.
Pfizer’s vaccine is approved for everyone 16 and older, and authorized under emergency use for kids 12 to 15.
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