Baby held in someone's arms.

Remember the Babies: The Need for Off-Label Pediatric Use of COVID-19 Vaccines

By Carmel Shachar

As trials stall and the omicron variant surges, the U.S. Centers for Disease Control and Prevention (CDC) is failing parents by preventing off-label use of our existing COVID-19 vaccines in the under-five set.

The cries of frustration, anger, and fear from parents of small children have reached a new pitch amidst the ruckus of 2022. Parents of children under five years old need to navigate omicron-fueled rising pediatric hospitalization rates while their kids remain entirely unvaccinated. They must also juggle childcare and work responsibilities amid unpredictable, lengthy daycare and schooling closures. Give us the vaccine to help protect our kids, shorten quarantines, and keep children in care they all clamor.

But where are the vaccines for the pediatric set — the same vaccines that have been proven safe, both in adult populations and in older children? So far the story has focused on disappointing efficacy results and delays in studies from Pfizer and Moderna. But that is not the entire explanation for why parents of small children are blocked from vaccinating their offspring.

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A half face dust mask and HEPA filter over white background.

Being an Adult in the Face of Omicron

By Jennifer S. Bard

To those who believe that the federal government is a benign force doing the best they can to fight the COVID-19 pandemic and keep us all safe, I have two words of advice: Grow up.

Neither the U.S. Food and Drug Administration (FDA), Centers for Disease Control and Prevention (CDC), or Dr. Fauci should be anthropomorphized into a benevolent but perhaps out-of-touch parental figure. They are not.

As a matter of law, the government, in contrast to your parents, or school, or perhaps even your employer, does not have a fiduciary duty to protect your (or any individual’s) health and safety. As the Supreme Court said in Deshaney v. Winnebago Country Dept of Social Services, 489 U.S. 189 (1980) and again in Castlerock v. Gonzales, 545 U.S. 748 (2005), individuals do not have an enforceable right to government protection unless the state itself creates the danger. Their duty, if it exists, is to the public in general, which can encompass many factors beyond any one person’s health.

Just knowing that the government, duly elected or not, has no obligation to protect you or your family should be enough to look at its pandemic guidance as minimum, rather than maximum, standards. It should also encourage you to be proactive in taking precautions beyond those “recommended,” rather than seeing these minimal standards as unwarranted restrictions that can be negotiated down.

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Freeway on-ramp

The Government Needs to Construct On, Not Off, Ramps to Combat the Latest Wave of COVID

By Jennifer S. Bard

Over the past two weeks, the news coming in about the spread of COVID-19 has been eerily familiar. Cases are rising all over Europe, not just in under-vaccinated Eastern European countries, but in England, the Netherlands, and Germany — all of whom have much higher rates of vaccination than the U.S. At the same time, cases across the U.S., including in cities like LA, DC, and Chicago have stopped falling, and are rising rapidly in the Mountain West, including the Navajo Nation. Hospitals in Colorado have already reached crisis capacity.

Whether the increase is attributable to the emergence of yet another variant, or perhaps is a natural artifact of waning immunity, it is very real and demands a level of attention from our federal government that, once again, it is failing to provide.

Yet in the face of now too familiar signs of resurgence, already being called a “Fifth Wave,” not only are the usual minimizers advocating reducing existing measures to prevent spread, but cities and states are rolling back what few protections remain intact. It is in the face of this foolish movement to drop our guard that the federal government is, again, failing to use the powers it has beyond vaccine mandates to create much needed on-ramps for mitigation measures as the country heads into winter.

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NEW YORK, NEW YORK - APRIL 05: Emergency medical technician wearing protective gown and facial mask amid the coronavirus pandemic on April 5, 2020 in New York City.

Déjà Vu All Over Again

By Jennifer S. Bard

The COVID-19 pandemic has shown us time and time again that whatever progress we make in curbing transmission of the virus is tenuous, fragile, and easily reversed.

And yet, we continue on a hapless path of declaring premature victory and ending mitigation measures the moment cases begin to fall. We need only look back to recent history to see why relaxing at this present moment of decline is ill-advised.

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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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Empty Classroom In Elementary School With Whiteboard And Desks.

Addressing School Discipline Disparities Through the Health Justice Framework

By Alexis Etow and Thalia González*

As an interdisciplinary legal scholar and public health attorney studying how education policies fit into the broader antiracist health equity agenda, health justice serves as both a conceptual framework for reform for legal academics and an accessible roadmap for change for policymakers and public health law professionals. Health justice functions to extend what has been previously accepted as within the health domain beyond traditional health care settings, systems, or laws. This broad applicability leaves ripe the opportunity to employ it to a broad range of health-impacting laws, policies, and systems that may not be designed or previously conceptualized as public health.

Consider, for example, school discipline and policing. Researchers and advocates have long-documented the disparate punishment and policing of Black, Indigenous, people of color (BIPOC) students compared to their white peers. For students with disabilities, especially those with intersectional identities, the risk factors and impacts of such policies are amplified. In the case of Black girls with disabilities, data shows that they experience the highest disparity for rates of referrals to law enforcement: six times more than white, non-disabled female students.

During COVID-19 and school closures, the disproportionality of these practices not only persist, but schools now employ new models of exclusion and police practices. This includes students remaining in Zoom waiting rooms during instructional time, resulting in unexcused absences, learning loss, and eventually truancy prosecution.

Despite evidence of the significant co-influential nature of health and education and specific health-harming effects of school discipline and policing — e.g., negative effect on students’ mental health, diminished health protective factors, disrupted educational attainment, threat to safety and wellbeing, and increased risk for justice system involvement — public health has been largely underemphasized in reform efforts and overlooked by the health law community. This is where a health justice approach is critical: it knits together and affirms that health and public health law professionals have key roles to play in education policy, law, and practice. It also places the health-harming effects of school discipline and policing squarely in the domain of public health law and prioritizes legal and policy responses with health equity at the forefront.

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Brown Gavel With Medical Stethoscope Near Book At Wooden Desk In Courtroom.

Health Justice, Structural Change, and Medical-Legal Partnerships

By Liz Tobin-Tyler and Joel Teitelbaum

To us, health justice means change.

Changes to norms and attitudes, to systems and environments, to law and policy, to resource and opportunity distribution. Not cosmetic or peripheral change, but wide-scale, systemic change. For health justice to be realized — for all people to reach their full health potential — laws and policies must be geared toward restructuring the systems, practices, and norms that have heretofore advantaged some groups over others, and thus given them greater opportunity for good health, economic and social prosperity, and greater longevity.

We recognize that this kind of change is profoundly challenging, both biologically and structurally. Biologically, because humans are programmed to do what’s comfortable, and what’s comfortable is what’s already known. Structurally, because of the nation’s unique political, social, and cultural attributes. Some of these attributes include a strong sense of individualism, and thus an entrenched unwillingness to prioritize community benefit over individual choice; limited governmental power; capitalism; unprecedented wealth with massive inequality; resistance to growing racial and ethnic diversity; over-spending on the downstream consequences of the failure to invest in upstream wellness; and a willingness to enact and maintain policies and practices that privilege some lives over others.

For these reasons, we are not naïve about the prospects for major change in a relatively short period of time, but neither are we cowed by the challenge. We embrace the opportunity to get uncomfortable, to challenge the racist, gender-based, and ableist norms and attitudes in all forms that harm health and well-being, to raise awareness of the inert systems that perpetuate health injustice, and to promote innovative and progressive law and policy change.

One of the ways that we apply our approach to health justice is our work to develop and advance medical-legal partnerships (MLPs), as both an expert consultant (Liz) to and Co-Director (Joel) of the National Center for Medical-Legal Partnership.

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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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WASHINGTON, DC - OCT. 8, 2019: Rally for LGBTQ rights outside Supreme Court as Justices hear oral arguments in three cases dealing with discrimination in the workplace because of sexual orientation.

The Many Harms of State Bills Blocking Youth Access to Gender-Affirming Care

By Chloe Reichel

State legislation blocking trans youth from accessing gender-affirming care puts kids at risk, thwarts physician autonomy, and potentially violates a number of federal laws, write Jack L. Turban, Katherine L. Kraschel, and I. Glenn Cohen in a viewpoint published today in JAMA.

So far this year, 15 states have proposed bills that would limit access to gender-affirming care. One of these bills, Arkansas’ HB1570/SB347, already has become law.

This legislative trend should be troubling to all, explained Cohen, Faculty Director of the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School. In an email interview, he highlighted “how exceptionally restrictive these proposed laws are,” adding that they are “out of step with usual medical, ethical, and legal rules regarding discretion of the medical profession and space for parental decision-making.”

Turban, child and adolescent psychiatry fellow at Stanford University School of Medicine also offered further insight as to the medical and legal concerns these bills raise over email.

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