We have been hearing from providers who are wondering if they could make exceptions to the age limitations on the COVID-19 vaccines and administer the drug “off-label” or under an expanded use exception.  While it may be tempting to consider, and there are certainly high-risk scenarios in which it feels like it might be best for a child or adolescent to receive the vaccine as soon as possible, the regulatory status of this vaccine makes that inadvisable at this time. “Off-label” use is allowed for FDA-regulated products that have received full approval, but not in the case of products offered under an emergency use authorization (EUA).

The FDA has only authorized use of the currently available COVID-19 vaccines for individuals ages 18 and older (and in the case of the Pfizer vaccine, those 16 years and older). The reason for that is the need to gather safety data in younger populations through ongoing clinical trials. While the FDA offers other categories of expanded use that make investigational products available to individuals with an immediately life-threatening condition or serious disease, it is not clear that those expanded uses would apply to a preventive vaccine. Furthermore, expanded use in these single patient situations requires the concurrence of the FDA, the company that makes the product and the local Institutional Review Board (IRB) — a fairly time-consuming process.

We expect the FDA to include children 12 and above under the EUA for the Pfizer vaccine as early as next week. Additional clinical trials involving younger children are underway, and our hope is that we will soon see the vaccine EUAs expanded to include more children and adolescents. At that time we will have sufficient safety data to feel confident in administering the vaccines to a larger portion of the pediatric population.

A signed, in-person consent from the parent or legal guardian is necessary when vaccinating a minor with the Pfizer COVID-19 vaccine and any subsequent COVID-19 vaccine that may be authorized for use in minors. The investigational designation of these vaccines makes this particularly important.

For more information: Contact Doug Diekema, MD, MPH, education director of the Treuman Katz Center for Pediatric Bioethics, member of the Vaccine Program Leadership Team at Seattle Children’s at Douglas.Diekema@seattlechildrens.org