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Understanding the Call to Permit Off-Label Use of a COVID-19 Vaccine in Children

January 25, 2022

Children under 5-years-old are currently ineligible to be vaccinated against COVID-19 and the infection rate in this age group has increased substantially with the Omicron surge. In response, a group of physicians, calling themselves, “Protecting Their Future,” sent an open letter to Acting Commissioner of the U.S. Food and Drug Administration (FDA) Janet Woodcock. They requested her to make COVID-19 vaccines available to young children by making the Pfizer-BioNTech 10µg vaccine available off-label and removing the “the age de-escalation barrier” to permit the FDA to approve the 3µg dose for children from 6 months to 2-years-old. To date, the FDA has approved the 10µg dose of the Pfizer-BioNTech vaccine under an Emergency Use Authorization for children 5- to 12-years-old. Clinical trials of 2 3µg doses in children 2- to 4-years-old did not show efficacy and Pfizer-BioNTech is conducting trails utilizing a third 3µg dose.

This urgent letter coincides with an interesting Pediatrics Ethics Rounds (10.1542/peds.2021-054578), early releasing this month, that analyzes off-label use of COVID-19 vaccines in children and provides additional context to this request to the FDA. Once the FDA has granted “full approval” for a Biologics License Application, as it did for the Pfizer-BioNTech 30 µg COVID-19 vaccine (Comirnaty) for individuals 16 and older on August 23, 2021, off-label prescription for other clinical conditions, doses, and/or patient populations becomes possible. Off-label prescription is common in pediatrics and requires consideration of the potential benefits, risks, and alternatives including the uncertainty regarding these factors.

COVID-19 vaccines, however, are an exception. The FDA, Centers for Disease Control and Prevention (CDC), and the American Academy of Pediatrics have recommended against their use off-label.  Such use is constrained by federal agreements requiring providers to adhere to “all requirements and recommendations of CDC and CDC’s Advisory Committee on Immunization Practice (ACIP).” The justification for this restriction is not clear as off-label use would not prevent completion of clinical trials or the allocation of vaccine to high-risk individuals. Altering these restrictions is not, however, under the FDA’s purview but rather the Department of Health and Human Services’ and the CDC’s.

To learn more about the ethical and legal issues in off-label use of the COVID-19 vaccines read this month’s Ethics Rounds. 

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