Child with bandaid on arm.

Should Vaccinating Children Off-Label Against COVID-19 Be Universally Prohibited?

By Govind PersadPatricia J. Zettler, and Holly Fernandez Lynch

As children are experiencing the highest rates of COVID-19 in many states, can efforts to universally preclude vaccination of those under 12 until the U.S. Food and Drug Administration (FDA) specifically authorizes use in that age group be justified?

In a case commentary published today in Pediatrics, we argue that the answer is no.

This view diverges from the positions of the American Association of Pediatrics, FDA, and the U.S. Centers for Disease Control and Prevention (CDC). In fact, the CDC, which controls the nation’s supply of COVID-19 vaccines, has taken steps to currently ban the practice of vaccinating youth under the age of 12.

We acknowledge that recommendations to widely vaccinate 5-11 year olds should await FDA and CDC guidance (which is expected soon, given upcoming advisory committee meetings). But, especially at the lower dose offered in pediatric clinical trials, we think that off-label pediatric administration of approved COVID-19 vaccines, like Pfizer’s Comirnaty mRNA vaccine, should be treated like other off-label uses and left to the individual risk-benefit judgments of doctors and patients (or here, parents).

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Blue stethoscope with gavel on white background

Equipping the Next Generation of Health Justice Leaders

By Yael Cannon

Health justice begins with exploring and understanding health disparities and the role of law in facilitating the social, political, and economic determinants at their roots. It requires naming structural racism — and the many forms of subordination that flow from it — as a public health crisis and recognizing that health justice is racial justice. Most importantly, health justice requires us to partner with affected communities to leverage law and policy to address and eliminate the root causes of disparities.

Those of us at schools of law and medicine, and other academic institutions who are training the next generation of lawyers, policy advocates and policymakers, doctors, nurses, and other health professionals have a special responsibility to equip our students with the knowledge, skills, and values they need to ensure that everyone has an equal chance at health and well-being.

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Empty classroom.

Can Schools Require the COVID-19 Vaccine? Education, Equity, and the Courts

By Emily Caputo and Blake N. Shultz

As school systems consider policy options for the spring semester, both vaccination requirements and proposals to address inequities in access to education may be top of mind. However, policymakers should be aware of the possible legal challenges they may face.

The COVID-19 pandemic has created an educational crisis in the United States by disrupting the learning of millions of students across the country. School closures, remote learning, and generalized societal stress have all raised serious concerns about persistent harm to adolescent learning and development — particularly among low-income and minority students.

While the pandemic has exposed widespread inequities in educational opportunity, it has also revealed the relative inability of the courts to promote access to education. A recent California lawsuit illustrates the manner in which students must rely on state-level, rather than federal, protections to ensure equal access to education. And COVID-19 vaccination requirements, which could facilitate a return to in-person education, are likely to result in lawsuits, and may be struck down by a skeptical and conservative Supreme Court.

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child getting vaccinated

How Can Policymakers Encourage COVID-19 Vaccine Trials for Children?

Cross-posted from Written Description, where it originally appeared on December 18, 2020. 

By Jacob S. Sherkow, Lisa Larrimore Ouellette, Nicholson Price, and Rachel Sachs

The past two weeks have been full of exciting COVID-19 vaccine news, including the FDA’s emergency use authorizations (EUAs) for the Pfizer–BioNTech and Moderna vaccines and the nationwide rollout of Pfizer’s vaccine. Choosing how to allocate access to vaccine doses has been left to individual states, leaving policymakers with difficult decisions about how to prioritize their populations, complicated in part by the federal government’s reduction in some vaccine shipments.

With a limited supply of doses, who should get the first shots? Some commentators have suggested prioritizing children early for a host of reasons, including hope about children returning to school. Last month a New York Times column asserted that “saving the most lives could mean prioritizing the vaccination of children and young adults.” But there is an important reason that kids can’t be part of the vaccine line yet: we don’t know whether these vaccines work for them. In this post, we explain why COVID-19 vaccines are only just starting to be tested in children and what policymakers can do to spur pediatric vaccine trials.

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graphic of DNA fingerprinting

Responsibility, culpability, and parental views on genomic testing for seriously ill children

Janet Malek, PhD
Center for Medical Ethics and Health Policy, Baylor College of Medicine, Houston, TX

Imagine being a parent and finding out your child is seriously ill.  Imagine how it feels to sit in a chair in the doctor’s office and hear the news that your child has cancer.  Imagine the worry and guilt you might feel and how these thoughts and emotions might shape your reactions to whatever comes next.

Being a parent comes with a special set of obligations to protect and promote the well-being of your child. A cancer diagnosis puts those obligations front and center, making it impossible to repress questions about what you could have done differently and what you can do to help your child moving forward.

Enter genome-scale sequencing (GS).  Both sequencing of blood – sometimes called germline sequencing (to find gene changes that the child was born with and that might be passed from parent to child) as well as tumor sequencing (to find gene changes that happen randomly in the cells of the body which may cause the tumor to develop) are being used more and more often in clinical settings.  The idea is that this genetic information will help doctors discover what caused a patient’s condition and give clues about how to treat it, even for cancer.  Parents are increasingly be given the option to have their child undergo GS as the technology becomes less expensive and more useful.

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Several vaping devices on a table

E-Cigarette Laws that Work for Everyone

By Daniel Aaron

The Trump Administration has retreated from proposed tobacco regulations that experts generally agree would benefit public health. The regulations would have included a ban on flavored e-cigarettes, a favorite of children who use e-cigarettes. Currently millions of youth are estimated to be addicted to e-cigarettes.

The rules also could have reduced nicotine in cigarettes to non-addictive levels. Nicotine is the addicting substance largely responsible for continued smoking. If nicotine were “decoupled” from smoking, smokers might turn to other sources of nicotine, rather than continuing to smoke. Smoking is the leading cause of preventable death in the U.S., killing about 500,000 Americans each year, or just about the number of Americans who died in World War I and World War II combined.

Part of the difficulty in regulating e-cigarettes is that, unlike cigarettes, they offer benefits and harms that differ across generations. This concern is called intergenerational equity. How can a solution be crafted that serves all Americans?

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