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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hospital equipment

Balancing Health Care Rationing and Disability Rights in a Pandemic

By Yolanda Bustillo and Rachel Perler

Amid the present surge of the coronavirus pandemic, it is crucial that disability rights are a factor in the development of triage protocols.

During the last week of December, the CDC recorded a record of 225,269 new coronavirus cases and 118,948 total hospitalizations. Health care systems across the country have predicted that they soon may face shortages of ventilators, personal protective equipment (PPE), and other limited resources.

In Utah, for example, hospital administrators have implemented informal triage protocols that prioritize patients based on health status, clinical factors, and the time sensitivity of their needed procedures. Hospitals in California have similarly begun rationing care.

If these dire circumstances worsen, hospital systems may apply triage protocols that deviate from best practices and impermissibly discriminate against people with disabilities.

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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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organ transplant

New Regulations for Organ Procurement Organizations Pose Concerns

By Alexandra Glazier

The United States has one of the highest organ donation and transplant rates in the world. A poorly crafted regulatory change could disrupt our world-leading system and put patients at risk.

Recently, new performance regulations for organ procurement organizations (OPOs) were promulgated by CMS in the last stretch of the Trump Administration, which should be reviewed by the incoming Biden Administration.

While there is widespread support for reform to the system of organ donation and transplantation, including consensus that changes to the CMS metrics measuring OPO performance are warranted, there are significant differences in opinion on how that can be accomplished best.

Bipartisan groups and delegations of both Democrats and Republicans, donor families, the medical community, and donation and transplant professionals as well as OPOs have raised a range of concerns about specific aspects of the proposed and final regulations, making suggestions on how the regulations could be improved to achieve the goal of transplanting more patients.

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Hundred dollar bills rolled up in a pill bottle

AbbVie Wins First Round in Humira Antitrust Lawsuit

By Ryan Knox and Gregory Curfman

Since receiving FDA approval for Humira® (adalimumab) in 2002, AbbVie, the drug’s manufacturer, has filed hundreds of submissions to the U.S. Patent and Trademark Office for secondary patents – almost half of which were filed after 2014, just two years before the expiration of its core patent.

These patents were largely directed to methods of use and potential formulation changes, but they did not include claims that affect the clinical efficacy of the biologic, which is used in the treatment of rheumatoid arthritis, Crohn’s disease, and psoriasis, among other conditions. Instead, the purpose of the secondary patent filings was to assemble a thicket of patents, 132 in all, to prohibit competition from biosimilar companies.

And so far, the strategy has worked. AbbVie remains the sole U.S. manufacturer of the biologic, and has successfully defended its domain: in June 2020, a federal district court judge in Chicago dismissed an antitrust lawsuit against AbbVie.

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Police car.

Police Should Not Be Enforcing Emergency Public Health Orders

Cross-posted from COVID-19 and The Law, where it originally appeared on November 9, 2020. 

By Daniel Polonsky

On a weekend when police officers were handing masks to white residents in parks around New York City, NYPD Officer Francisco Garcia forced Donni Wright, a 33-year-old Black man, to the ground and knelt on his neck. Officer Garcia was one of 1,000 NYPD officers dispatched to enforce social distancing and mask-wearing. He had been investigating a report of individuals not wearing masks, although he himself was not wearing one. Police Chief Terence Monahan had previously assured reporters that the police would be educating the public and only breaking up large gatherings, not bothering individuals merely walking outside—“They don’t have a mask, we’ll give them a mask.” But Officer Garcia, who has settled six lawsuits for police misconduct for a combined $182,500, did more than educate that day. Multiple officers were in the middle of arresting two individuals after allegedly spotting a bag of marijuana when Mr. Wright spoke up in their defense. In response, Officer Garcia called him a racial epithet and accosted him, causing severe injuries to Mr. Wright’s back, ribs, and chest. What started as social distancing enforcement ended in racist, excessive use of force.

This incident highlights the overlap between the twin crises state and local governments face: halting the spread of COVID-19 and grappling with the systemic racism that characterizes the American system of policing.

Click here to read the full post on COVID-19 and The Law.

Cartoon of contact tracing for COVID-19.

The Constitutionality of Technology-Assisted Contact Tracing

Cross-posted from COVID-19 and The Law, where it originally appeared on December 1, 2020. 

By

The COVID-19 pandemic has posed an impossible set of choices for governments, forcing them to weigh the competing interests of protecting public health, ending social isolation, and safeguarding privacy and civil rights. Each of these ends offer distinct societal benefits, but without a vaccine or effective COVID treatment, governments can only accomplish two of the three at one time. South Korea provides an interesting example of the tradeoffs countries have made in pursuit of these competing objectives. The country is widely regarded as a model for successfully managing the pandemic, averaging approximately 77 new cases a day since April—roughly the equivalent of 480 cases a day in U.S. population terms. South Korea’s story is especially impressive given that, in March, the country was considered one of the biggest infection hot spots outside of China. Comparing these statistics with the actual infection rate in the U.S. illustrates the success of the South Korean approach: on November 23, 2020, the CDC reported 147,840 new cases, for a total of 12,175,921 known infections in the U.S. since the pandemic began.

Click here to read the full post on COVID-19 and The Law.

Person receiving vaccine.

What You Should Know About the COVID-19 Vaccine

Cross-posted from Harvard Law Today, where it originally appeared on December 3, 2020. 

By Jeff Neal

The race to approve and distribute a vaccine for COVID-19 got a huge shot in the arm this week.

On Tuesday, the United Kingdom approved a vaccine developed by pharmaceutical giant Pfizer. On the same day in the United States, a panel of experts advising the Centers for Disease Control and Prevention recommended a first-stage plan for distributing the vaccine to some of the most at-risk Americans. Separately, another advisory committee is set to meet twice in the coming weeks to evaluate for the U.S. Food and Drug Administration the safety and efficacy of both the Pfizer vaccine and a similar one produced by Moderna.

To better understand the impact of these developments, Harvard Law Today recently spoke with public health expert Carmel Shachar J.D./M.P.H. ’10, the executive director of the Petrie-Flom Center for Health Policy, Biotechnology, and Bioethics at Harvard Law School, about the vaccine, who is likely to get it first, and whether employers and states can require people to get vaccinated.

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Spoonful of sugar.

From “A Spoonful of Sugar” to Operation Warp Speed: COVID-19 Vaccines and Their Metaphors

By Ross D. Silverman, Katharine J. Head, and Emily Beckman

As professors studying public health policy, narrative medicine, and how providers and the public communicate about vaccines, we recognize the power and peril of using the rhetorical tool of metaphors in vaccination and, more broadly, the COVID-19 response efforts.

Metaphors can be an effective shorthand to help people understand complex ideas, but we also must remain cognizant of the many ways metaphors may distort, divide, or misrepresent important details.

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Field with sky and clouds.

COVID-19 in Rural America and the Indian Nations

Cross-posted from COVID-19 and The Law, where it originally appeared on October 22, 2020. 

By Chris Zheng

For many, the COVID-19 pandemic is likely to conjure scenes of once-bustling urban centers grinding to a halt. However, for the one in five Americans that live in rural communities, the reality of the pandemic has been markedly different from that of its metropolitan neighbors. The combination of insufficient resources and a particularly vulnerable population has resulted in disproportionate and devastating effects on remote communities.

COVID-19 has also exacerbated gaps in access to care for the 54% of American Indian and Alaska Native people who live in rural towns or reservations. As such, there have been many questions as to what legal measures native groups can take to protect their communities. This piece will first address the unique public health challenges facing rural and native communities during the COVID-19 pandemic. Then, it will conclude by proposing group-specific solutions towards mitigating further harm.

Click here to read the full post on COVID-19 and The Law.