‘Off-label’ use is common in medicine – a bioethicist and legal philosopher explains why COVID-19 vaccines are different

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<p>Children ages 5 to 11 can now be vaccinated against COVID-19 following the Food and Drug Administration’s emergency use approval of the Pfizer Bio-NTech vaccine for this age group and the Centers for Disease Control and Prevention’s approval in early November 2021.</p>
<p>Some parents remain hesitant to vaccinate their children.  But many around the country report enthusiastically and stand up to have their primary school students vaccinated.  Still, parents of children are under 5 years old <a rel=still wondering when their children should be vaccinated. Experts suggest it may not be until next year.

This waiting period may cause both parents and physicians to consider vaccinating against COVID-19 “off-label”. Off-label refers to the administration of an FDA-approved product to a different population, use, or dosage than that for which it was approved. It is a common practice in health care.

However, the FDA and the American Academy of Pediatrics have warned against off-label use of COVID-19 vaccines in children. And the CDC bans it based on the COVID-19 vaccine provider agreement it has with pharmacies, hospitals and clinics that administer COVID-19 vaccines.

But is it ethical to withhold available vaccines from young children?

We are philosophers with expertise in bioethics, legal philosophy and the application of philosophy to public order. Our recently published analysis examines how bans on off-label use of COVID-19 vaccines in children deviate from ethical and legal norms.

Off-label vaccination is not a strategy for mass vaccination. However, our research suggests that off-label use of COVID-19 vaccines is an ethically permissible option on a case-by-case basis. This is especially true for children at high risk for severe COVID-19 infection due to underlying conditions, or children with increased exposure to COVID-19.

What is off-label use?

While off-label use may be a new concept for many, in medical practice it is relatively routine. Studies suggest that approximately 20% of all prescriptions are administered off-label.

In pediatrics, off-label use is even more common because fewer clinical trials of the kind required for the FDA approval process are performed on children. The American Academy of Pediatrics supports off-label use as an accessible tool “for the benefit of the individual patient” based on a pediatrician’s clinical assessment and the best available evidence. A recent study suggests that over half of pediatric admissions involve treatment with at least one off-label medication.

The reasons for off-label use vary. In practice, the time and cost of performing additional clinical trials with an already approved drug is burdensome. Some products that have been shown to be safe to use for a specific reason later prove to be effective for a new purpose. Off-label use helps make these treatments more accessible to other populations who may benefit from them.

In the field of medicine, off-label use is an ethically and legally sound practice. The FDA does not allow physicians to perform experimental research on patients outside of clinical trials. But the law allows doctors to prescribe FDA-approved products off-label for the purpose of improving a patient’s well-being. Physicians do not face an increased risk of malpractice liability when following informed consent processes, when clinical data suggest that the expected benefits are likely to outweigh known risks, and when the medication was prescribed for the benefit of the patient rather than for research.

But what about COVID-19 vaccines?

Despite the ethical and legal norms that support off-label use, it is more complicated when it comes to COVID-19 vaccines.

When the FDA “fully approved” the Pfizer vaccine for people 16 years and older in August 2021, some parents, pediatricians, and scientists began discussing whether it could be administered “off-label” to younger children who were not yet eligible.

A child with long hair wearing a mask receives a Pfizer COVID-19 shot.

A child with long hair wearing a mask receives a Pfizer COVID-19 shot.

Off-label vaccination is less common than prescribing off-label medications. However, other vaccines are sometimes administered off-label, especially during outbreaks of diseases such as measles. The MMR vaccine (measles, mumps and rubella) is only approved for children over 12 months. Nevertheless, even the CDC’s advisory committee on immunization practice recommends administering the MMR vaccine off-label to children between 6 and 12 months of age when traveling internationally.

However, in the case of COVID-19 vaccines, the CDC Vaccine Provider Agreement restricts off-label vaccination. The agreement prohibits the use of federally purchased COVID-19 vaccines outside the ages for which vaccines are approved or approved. The CDC has indicated that providers who do not comply with this agreement risk legal and financial liability and may be removed from the vaccine provider program. As all COVID-19 vaccines administered in the United States are purchased and supplied by the United States Government, the agreement effectively prohibits any off-label use in children.

This means that doctors are not able to offer off-label vaccination even to the children for whom it may be most ethically justified, namely those with underlying health conditions that give them an increased risk of complications from COVID-19.

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Look forward to

The CDC has not explained its departure from ethical and legal standards for off-label use of COVID-19 vaccines.

When considering emergency use of the Pfizer vaccine for 5- to 11-year-olds, FDA advisory committee members drew attention to the possibility of extremely rare side effects in children, which can only occur when the vaccine is administered more widely. The CDC has stressed that the safety of the vaccines will continue to be closely monitored.

Because of this, some members of the FDA’s Vaccine Committee expressed concern about approving the vaccine for all children at this age, even while emphasizing its importance for high-risk children. The committee ultimately voted to recommend approval. However, had the off-label use of COVID-19 vaccines been on the table, some high-risk children would have already had access to the vaccine. The same would children under 5 years.

For children under the age of 5 with high-risk illnesses or those living in communities that continue to have low overall vaccination rates, high community prevalence, or bans on other evidence-based prevention strategies such as indoor masking, their parents and pediatricians may decide that the benefits of off-label vaccination outweighs the risks. But they can not.

Increased awareness of off-label use practices may cause parents to wonder – or worry – about its frequent and routine use in pediatric care. One way to reduce off-label use in children in general is to increase pediatric clinical trials. It requires funding and interest from researchers and participants – including children and their parents. COVID-19 vaccines sparked a great deal of interest in enrolling in clinical trials. This expansion of interest may provide more and faster access to “on-label” vaccines and other drugs for children in the future.

This article is republished from The Conversation, a nonprofit news site dedicated to sharing ideas from academic experts. It was written by: Elizabeth Lanphier, University of Cincinnati and Shannon Fyfe, George Mason University.

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The authors do not work for, consult, own shares in, or receive funding from any company or organization that would benefit from this article, and have not disclosed any relevant affiliations other than their academic appointment.

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