Passport in suitcase.

Ethical, Legal, and Scientific Challenges for COVID-19 Vaccine Passports

By Chloe Reichel

As COVID-19 vaccines become more widespread, passports that certify immunization status may facilitate a return to normalcy, write Lawrence O. Gostin, I. Glenn Cohen, and Jana Shaw in a viewpoint published today in JAMA.

But these vaccine passports, or digital health passes, are not without scientific, legal, and ethical challenges.

I asked Gostin, Faculty Director of the O’Neill Institute for National and Global Health Law at Georgetown University Law Center, Cohen, Faculty Director of the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School, and Shaw, a professor of pediatrics at Upstate Medical University, about the key areas of concern and promise for vaccine passports. Our conversation, which has been edited and condensed, follows.

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Bill of Health - A worker gives directions as motorists wait in lines to get the coronavirus (COVID-19) vaccine in a parking lot at Dodger Stadium, Friday, Jan. 15, 2021, in Los Angeles, covid vaccine distribution

Can Vaccine Allocation Plans Legally Respond to Racial Disparities?

By Govind Persad

Recently, Missouri expanded phase 2 vaccination eligibility with the goal of addressing disproportionate COVID-19 impacts.

Specifically, Missouri’s policy applies to “Disproportionately Affected Populations,” which is further defined as: “Populations at increased risk of acquiring or transmitting COVID-19, with emphasis on racial/ethnic minorities not otherwise included in 1B.”

This presents a much-debated and often misunderstood question I explore in a forthcoming University of Illinois Law Review article: can COVID-19 vaccine allocation legally recognize the outsized burden of cases and deaths that racial/ethnic minority communities have borne during the pandemic?

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3D rendering of COVID-19 virus.

Consider the Fundamentals of Viruses When Crafting Law and Policy Responses

By Jennifer S. Bard

Lawyers and law professors are very much part of the ongoing efforts to make policy in response to the COVID-19 pandemic. Like everyone else involved, we face the particular challenge of being confronted daily with what seems to be an ever-changing flow of information about a newly emerged and rapidly mutating virus.

But what may help us better make or evaluate policy is a better understanding of some typical characteristics of viruses that make all of them very difficult to contain, rather than just the unique features of the one threatening us now.

Knowing more about the ways that viruses spread could help us avoid the pitfalls of declaring victory too early, rolling back existing infection control measures, and ending up worse off than we have been at any stage of this pandemic.

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Los Angeles, California / USA - May 1, 2020: People in front of Los Angeles’ City Hall protest the state’s COVID-19 stay at home orders in a “Fully Open California” protest.

5 Questions About COVID-19 and Religious Exemptions

By Chloe Reichel

On February 26th, the Supreme Court of the United States issued a shadow docket decision that could foretell sweeping limitations for public health measures, both within and outside the COVID-19 pandemic context.

The Court’s ruling in the case, Gateway City Church v. Newsom, blocked a county-level ban on church services, despite the fact that the ban applied across the board to all indoor gatherings. This religious exceptionalism is emerging as a key trend in recent Supreme Court decisions, particularly those related to COVID-19 restrictions.

To better understand what these rulings might mean for public health, free exercise of religion, the future of the COVID-19 pandemic, and potential vaccine mandates, I spoke with Professor Elizabeth Sepper, an expert in religious liberty, health law, and equality at the University of Texas at Austin School of Law.

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Empty classroom.

Can Colleges and Universities Require Student COVID-19 Vaccination?

This post originally appeared on the Harvard Law Review Blog.

By I. Glenn Cohen and Dorit Rubinstein Reiss

In the last year, colleges and universities across the U.S. struggled with how to operate during the COVID-19 pandemic. The most recent data, from January 2021, shows a mix of online and in-person modes of instruction.

Pie chart of modes of instruction for higher education institutions during the pandemic.

At the same time, a study of the experience in early fall 2020 found an association between colleges and universities with in-person instruction and increased infection incidence in the counties within which the schools were located. With vaccine authorization in the U.S. and the promise of potential availability for student populations in late spring and summer 2021 (in most states’ allocation plans these students are among the last groups in prioritization), there is increasing interest by higher education institutions in moving more of their fall 2021 educational instruction and non-instructional activities to in-person modes. Vaccinating students is a key step to safely reopening campuses, in whole or in part, in a way that is safe for students, faculty, staff, and local communities. At the same time, university leaders are likely reasonably concerned about the legality of mandating COVID-19 vaccines. Not all students, faculty or staff may appreciate such a requirement, and anti-vaccine groups are more than ready to assist in litigation — as, for example, they did when the University of California required influenza vaccines for on-campus attendance (a preliminary injunction in that case was denied). In this essay, we discuss whether universities can legally require vaccination as a condition of attendance and with what accommodations.

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people waiting in a line.

How the Government Can Prevent Individuals from Using Wealth to Cut the Vaccine Line

Cross-posted from COVID-19 and The Law, where it originally appeared on January 27, 2021. 

By

Since the Food & Drug Administration granted emergency use authorization for the COVID-19 vaccines produced by Pfizer-BioNTech and Moderna in December 2020, there have been many debates on vaccine allocation and prioritization.

As noted by Harvard Law School Professor Glenn Cohen in a recent interview with Annie Kapnick for the COVID-19 and The Law series, the issue of vaccine distribution is “complicated” because of competing factors decision-makers must consider. The relative weights placed on these factors has led to very different prioritization schemes. Initially, the Centers for Disease Control and Prevention (CDC) recommended a hybrid plan that appeared to prioritize individuals who were most likely to contract the virus (e.g., first responders, grocery store workers) over individuals most vulnerable to severe symptoms or death from the virus if contracted (e.g., individuals over the age of 65 not in long-term care facilities). In the United Kingdom, the prioritization groups were primarily based on vulnerability. Similarly, when looking more narrowly at the various plans being implemented at the state level in the United States, there are high degrees of variation.

This post does not seek to evaluate the merits of these or other specific vaccine allocation plans. Rather, it will address a risk that all plans likely face: the potential of individuals using their wealth and access to “cut the line” and be vaccinated ahead of schedule.
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Vial and syringe.

4 Things to Know About Intellectual Property, Patent Pledges, and COVID-19 Vaccines

By Chloe Reichel

High-profile commentators have argued recently that vaccine scarcity needn’t exist. If vaccine manufacturers simply shared their patents with other pharmaceutical companies, supply would quickly ramp up. 

Others have pointed out that numerous bottlenecks exist in the manufacturing process, from the glass vials that hold the vaccine, to the lipids that encase the vaccine’s active ingredient, mRNA.

And even if these bottlenecks didn’t exist, the intellectual property argument may be a straw man.    

In fact, this past October, Moderna made a gesture toward opening access to its intellectual property, by pledging that it would not enforce its patents against “those making vaccines intended to combat the pandemic.” That month, Jorge L. Contreras, a Presidential Scholar and Professor of Law at the University of Utah, covered the patent pledge and its potential implications for Bill of Health.

We checked in with Contreras to ask about the implications of Moderna’s patent pledge now that its vaccine has been proven safe and effective. Here are the highlights from the conversation:

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Health care workers in personal protective equipment attend to a patient.

How Can Policymakers Overcome the Hurdles to Scaling up Antibody Manufacturing?

Cross-posted from Written Description, where it originally appeared on February 18, 2021. 

By Rachel SachsJacob S. SherkowLisa Larrimore Ouellette, and Nicholson Price

In our last post, we introduced some of the clinical evidence supporting the use of therapeutic antibodies against COVID-19—including Regeneron’s casirivimab and imdevimab and Eli Lilly’s bamlanivimab—and analyzed the existing problems in the distribution and administration of those therapies. Even in just the last few weeks, further clinical evidence has supported the use of these technologies, leading the FDA to issue an additional emergency use authorization for Lilly’s bamlanivimab and etesevimab cocktail. In the near future, though, problems in administering our existing supply of these new drugs may give way to problems producing enough of them—a challenge that is also affecting the vaccine rollout. In this post, we consider the difficult manufacturing issues involved in the therapeutic antibody context (a subject we’ve previously explored regarding vaccines), and what might be done to address them.

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