‘Off-label’ use is common in medicine but not permitted in COVID-19 vaccines

Children ages 5 to 11 can now be vaccinated against COVID-19 after emergency use authorization from the Food and Drug Administration for Pfizer Bio-NTech Vaccine for this age group and the Accreditation by the Centers for Disease Control and Prevention In early November 2021.

Some parents still hesitating about vaccinating their children. But many across the country enthusiastically subscribe And line up To vaccinate primary school students. However, parents of children under the age of five are still wondering When their children are vaccinated. Experts suggest It may not be before next year.

This wait may prompt parents and clinicians alike to consider vaccinating against COVID-19.”off-label. “Off-label refers to the administration of an FDA-approved product for a different population, use, or dose which has been approved. It is a common practice in healthcare.

but, Food and Drug Administration and the American Academy of Pediatrics They caution against off-label use of COVID-19 vaccines in children. And the Center for Disease Control prohibit it Based on the COVID-19 Vaccine Provider Agreement with pharmacies, hospitals and clinics providing COVID-19 vaccines.

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

We are philosophers with Experience in bioethicsAnd Legal Philosophy The application of philosophy to public policy. Our newly published analysis It explores how banning off-label use of COVID-19 vaccines in children is deviating from ethical and legal standards.

Off-label vaccination is not a strategy for mass vaccination. But our research indicates 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 risk of severe COVID-19 infection due to underlying conditions, or those with high exposure to COVID-19.

What is off-label use?

While off-label use may be a new concept to many, it is so in medical practice relatively routine. Studies indicate that about 20% Of all prescriptions administered off-label.

In pediatrics, use is off-label Most common Because fewer clinical trials of the kind required for the FDA’s approval process for children are being conducted. American Academy of Pediatrics Supports off-label use As a tool available “for the benefit of the individual patient” based on the pediatrician’s clinical judgment and the best available evidence. a recent study It is suggested that more than half of children’s hospital admissions involve treatment with at least one off-label drug.

Reasons for off-label use is changing. In practice, the time and cost of additional clinical trials of an approved drug is burdensome. Some products that have been shown to be safe to use for a specific reason are later shown 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 medicine, off-label use is an ethically and legally sound practice. The Food and Drug Administration does not allow doctors to conduct experimental research on patients outside of clinical trials. but the The law does not allow Physicians must prescribe FDA-approved products off-label for the purpose of enhancing patient well-being. Clinicians face no increased risks of malpractice when they follow informed consent processes, when clinical data indicate that expected benefits are likely to outweigh known risks and when medication is prescribed for the benefit of the patient rather than research.

But what about COVID-19 vaccines?

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

When the FDA”Fully approvedPfizer Vaccines for People 16 and Up in August 2021, Some Parents, Pediatricians and Scientists Discussion started Whether it can be given ‘off-label’ to younger children who are not yet eligible.

Off-label vaccination is less common than prescribing off-label medications. But sometimes other off-label vaccines are given, in particular During outbreaks from diseases such as measles. The MMR (measles, mumps, and rubella) vaccine is Approved for children over 12 months only. However, even the Centers for Disease Control and Prevention’s Immunization Practices Advisory Committee recommend Give the measles, mumps, and rubella vaccine off-label to children between 6 and 12 months of age when traveling internationally.

But 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 of the ages for which the vaccines are authorized or approved. Center for Disease Control inclusive Providers who do not follow this agreement risk legal and financial liability and may be excluded from the vaccine provider’s program. as All COVID-19 vaccines given in the United States Purchased and provided by the United States government, the agreement effectively prohibits any off-label use in children.

This means that medical providers are unable to offer vaccination outside the ID even to those children who may be more ethically justified, i.e. those with underlying health conditions that put them in high risk of complications from COVID-19.

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looking forward

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

When considering an emergency use authorization for Pfizer Vaccine for children ages 5-11, FDA Advisory Committee Members Draw attention to the possibility of extremely rare side effects in children that may only appear once the vaccine is given on a larger scale. The CDC stressed that the safety of vaccines will be achieved Keep watching it closely.

Because of this, some members of the Food and Drug Administration’s Vaccines Committee Expressed concern about licensing the vaccine for all children of this age, even while emphasizing its importance for children at high risk. Committee in the end Vote for the recommendation Authorization. But had the use of off-label COVID-19 vaccines been on the table, some children at high risk could already get the vaccine. As well as children under the age of five.

For children under the age of five with high-risk medical conditions or those who live in communities that are still declining overall Vaccination rateshigh society spread or taboo On the other hand Evidence-based Mitigation strategies such as internal masking, parents and pediatricians may wish to determine that the benefits of off-label vaccination outweigh the risks. But they can’t.

Increased awareness of unlabeled use practices may lead parents to question – or worry – about its frequent and routine use in childcare. One way to reduce off-label use in children in general is to Increased clinical trials for children. This requires funding and attention from researchers and participants – including children and their parents. COVID-19 vaccines have generated significant interest in enrolling in clinical trials. This expanding interest may lead to more and faster access to “label” vaccines and other pediatric pharmaceuticals in the future.


Elizabeth LanverAssociate Professor of Philosophy and Bioethics, University of Cincinnati And Shannon FifeAssociate Professor of Philosophy and Associate Professor of Law, George Mason University

This article has been republished from Conversation Under a Creative Commons License. Read the original article.

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