Law Commons^™

Covid-19 Pediatric Vaccine Authorization, Fda Authority, And Individual Misperception Of Risk, Joanna K. Sax, Neal Doran

Faculty Scholarship

Vaccines are one component to the public health strategies to alleviate the COVID-19 pandemic. Hesitancy regarding COVID-19 vaccines in the United States has been problematic, which is not surprising given increasing overall vaccine hesitancy in recent decades. Most vaccines are administered during childhood years. Consequently, understanding hesitancy toward administration of vaccines in this age group may provide insight into possible interventions to reduce vaccine hesitancy. The present study analyzed a subset of over 130,000 public comments posted in response to a notice of meeting of the vaccine advisory group to the Food and Drug Administration. The meeting addressed whether to …

A Critical Juncture For Human Rights In Global Health: Strengthening Human Rights Through Global Health Law Reforms, Benjamin Mason Meier, Luciano Bottini Filho, Judith Bueno De Mesquita, Roojin Habibi, Sharifah Sekalala, Lawrence O. Gostin

Georgetown Law Faculty Publications and Other Works

The 1948 Universal Declaration of Human Rights (UDHR), establishing a human rights foundation under the United Nations (UN), has become a cornerstone of global health, central to public health policies throughout the world. As the world commemorates the 75th anniversary of the UDHR on 10 December, this “Human Rights Day” celebration arrives at a critical juncture for human rights in global health, raising an imperative for World Health Organization (WHO) reforms to strengthen the right to health and health-related human rights.

The Psychology Of Science Denialism And Lessons For Public Health Authorities, Brenna Moreno, Molly J. Walker Wilson

All Faculty Scholarship

As it wreaked tragedy on the world, the outbreak of COVID-19 helped expose a pandemic of a different kind, one steeped in distrust and contrarianism. This movement, termed science denialism, has been lurking and undermining public health efforts for decades. Specifically, it is “the employment of rhetorical arguments to give the appearance of legitimate debate where there is none, an approach that has the ultimate goal of rejecting a proposition on which a scientific consensus exists.” Unlike skepticism, which is “doubt as to the truth of something” and works to progress both science and society, denialism is characterized by individuals’ …

Commentary: The Workplace Vaccine Decision And Its Implications For Federal Regulatory Power, John M. Greabe

Law Faculty Scholarship

[Excerpt] "In a recent commentary, I contrasted the pragmatic consequentialism of retiring Supreme Court Justice Stephen Breyer – and, more generally, the other two members of the court’s liberal bloc (Justices Sonia Sotomayor and Elena Kagan) – with the structural formalism of the court’s six-justice conservative supermajority. I also suggested that this framework may provide a more useful way to understand many of the court’s recent and upcoming blockbuster decisions than the partisan angle that court watchers so frequently use."

Confronting Intellectual Property Nationalism, Cynthia M. Ho

Faculty Publications & Other Works

Stories about nations engaging in vaccine (and medical) nationalism by hoarding limited COVID-19 vaccines and treatments are widespread, but there is a hidden phenomenon that has exacerbated vaccine nationalism and prolonged the pandemic: intellectual property nationalism or “IP nationalism.” This Article coins and explains this term and highlights its negative impacts. Essentially, some nations, primarily of the Global North, are hoarding essential knowledge protected by intellectual property (IP). This Article argues that IP nationalism has contributed to millions of unnecessary deaths and limited the growth of the global economy. Meanwhile, countries and pharmaceutical companies obscure the role of IP nationalism …

Non-Patent Intellectual Property Barriers To Covid-19 Vaccines, Treatment And Containment, Sean Flynn, Erica Nkrumah, Luca Schirru

Joint PIJIP/TLS Research Paper Series

As the World Trade Organization considers a proposal to waive or otherwise address intellectual property barriers to the global response to the COVID-19 pandemic, most of the attention given by scholars and policy makers has been focused on patents. The original proposals by South Africa and India, as well as the groundbreaking support of the United States, however, explicitly applied to all forms of intellectual property. This paper documents many instances where non-patent forms of intellectual property create barriers to the global scale up of access to vaccines, treatments, and the ability to contain the virus through social distancing. Addressing …

2nd Annual Women In Law Leadership Lecture: A Fireside Chat With Debra Katz, Esq. 03-03-2021, Roger Williams University School Of Law

School of Law Conferences, Lectures & Events

No abstract provided.

Child-Proofing Global Public Health In Anticipation Of Emergency, Frederick M. Abbott

Scholarly Publications

No abstract provided.

Vaccine Clinical Trials And Data Infrastructure, Ana Santos Rutschman

All Faculty Scholarship

We find ourselves at a momentous turn in the history of vaccines. The COVID-19 pandemic triggered a quasi-global vaccine race that not only compressed vaccine research and development (R&D) timelines, but also paved the way for the administration of a new type of vaccine technology – mRNA vaccines, which work in substantially different ways from the vaccines in use before the pandemic.

While the process of bringing emerging COVID-19 vaccines to market has taken place in an unusually short timeframe, it was largely predicated on the same scientific and regulatory processes that govern the development, approval and deployment of new …

Social Media Self-Regulation And The Rise Of Vaccine Misinformation, Ana Santos Rutschman

All Faculty Scholarship

This essay examines the main characteristics and shortcomings of mainstream social media responses to vaccine misinformation and disinformation. Parts I and II contextualize the recent expansion of vaccine information and disinformation in the online environment. Part III provides a survey and taxonomy of ongoing responses to vaccine misinformation adopted by mainstream social media. It further notes the limitations of current self-regulatory modes and illustrates these limitations by presenting a short case study on Facebook—the largest social media vehicle for vaccine-specific misinformation, currently estimated to harbor approximately half of the social media accounts linked to vaccine misinformation. Part IV examines potential …

Equitable Allocation Of Covid-19 Vaccines: An Analysis Of The Initial Allocation Plans Of Cdc's Jurisdictions With Implications For Disparate Impact Monitoring, Harald Schmidt, Rebecca Weintraub, Michelle A. Williams, Alison Buttenheim, Emily Sadecki, Helen Wu, Lawrence O. Gostin, Angela A. Shen

Georgetown Law Faculty Publications and Other Works

Major global and national vaccine allocation guidelines urge planners to allocate vaccines in ways that recognize, and ideally reduce, existing societal inequities within countries. However, allocation plans of the US will be determined individually by each of the CDC’s 64 jurisdictions (states, the District of Columbia, five cities, and territories). We analyzed whether jurisdictions have incorporated novel approaches to reduce inequity, based on plans published by the CDC in early November 2020 (63 summaries [98% of all jurisdictions] and 47 full guidance documents [73% of all, including all 50 states]).

Eighteen states adopted a novel proposal to use a disadvantage …

FacebookʼS Latest Attempt To Address Vaccine Misinformation — And Why ItʼS Not Enough, Ana Santos Rutschman

All Faculty Scholarship

On October 13, 2020 Facebook announced the adoption of a series of measures to promote vaccine trust “while prohibiting ads with misinformation that could harm public health efforts.” In the post written by Kang-Xing Jin (head of health) and Rob Leathern (director of product management), the company explained that the new measures were designed with an emphasis on encouraging widespread use of this yearʼs flu vaccine, as well as in anticipation of potential COVID-19 vaccines becoming available in the near future.

The changes focus mainly on the establishment of a multiprong informational campaign about the seasonal flu vaccine, which includes …

A Global Survey Of Potential Acceptance Of A Covid-19 Vaccine, Jeffrey V. Lazarus, Scott C. Ratzan, Adam Palayew, Lawrence O. Gostin, Heidi J. Larson, Kenneth Rabin, Spencer Kimball, Ayman El-Mohandes

Georgetown Law Faculty Publications and Other Works

Several coronavirus disease 2019 (COVID-19) vaccines are currently in human trials. In June 2020, we surveyed 13,426 people in 19 countries to determine potential acceptance rates and factors influencing acceptance of a COVID-19 vaccine. Of these, 71.5% of participants reported that they would be very or somewhat likely to take a COVID-19 vaccine, and 61.4% reported that they would accept their employer’s recommendation to do so. Differences in acceptance rates ranged from almost 90% (in China) to less than 55% (in Russia). Respondents reporting higher levels of trust in information from government sources were more likely to accept a vaccine …

Facilitating Access To Cross-Border Supplies Of Patented Pharmaceuticals: The Case Of The Covid-19 Pandemic, Frederick M. Abbott

Scholarly Publications

The COVID-19 pandemic has brought into stark relief the gaps in global preparedness to address widespread outbreaks of deadly viral infections. This article proposes legal mechanisms for addressing critical issues facing the international community in terms of providing equitable access to vaccines, treatments, diagnostics, and medical equipment. On the supply side, the authors propose the establishment of mandatory patent pools ('Licensing Facilities') on a global or regional, or even national basis, depending upon the degree of cooperation that maybe achieved. The authors also discuss the importance of creating shared production facilities. On the demand side, the authors propose the establishment …

Facilitating Access To A Covid-19 Vaccine Through Global Health Law, Lawrence O. Gostin, Safura Abdool Karim, Benjamin Mason Meier

Georgetown Law Faculty Publications and Other Works

This column explores the global health law reforms necessary to progressively realize universal access to a future COVID-19 vaccine. We begin by explaining the importance of global health law in the distribution of essential vaccines as a determinant of public health. The column then turns to examine the human rights foundations of global health law, conceptualizing vaccination access as a universal human right. We find that it will be crucial to develop legal commitments to ensure vaccine access prior to a scientific breakthrough, analyzing the legal barriers that impede global access and the global health law reforms necessary to facilitate …

Why The Government Shouldn't Pay People To Get Vaccinated Against Covid-19, Ana Santos Rutschman

All Faculty Scholarship

As several pharmaceutical companies approach the Food and Drug Administration (FDA) seeking authorization to bring COVID-19 vaccines to market, concerns about vaccine mistrust cloud the prospects of imminent vaccination efforts across the globe. These concerns have prompted some commentators to suggest that governments may nudge vaccine uptake by paying people to get vaccinated against COVID-19. This post argues that, even if potentially viable, this idea is undesirable against the backdrop of a pandemic marked by the intertwined phenomena of health misinformation and mistrust in public health authorities. Even beyond the context of COVID-19, paying for vaccination is likely to remain …

Vaccine Hesitancy: Experimentalism As Regulatory Opportunity, Ana Santos Rutschman, Timothy L. Wiemken

All Faculty Scholarship

This symposium on patient innovation has prompted us to explore problems related to departures from official vaccination schedules. At a time in which vaccine confidence has been plummeting across the world, we argue that a more granular understanding—and ultimately a more finely tuned regulatory framework—is needed to reflect the current behavioral heterogeneity among indicated patients who choose to forego or delay administration of recommended vaccines. In particular, we focus on a phenomenon we term “vaccine staggering:” a departure from vaccination schedules in the form of delays in receiving one or more vaccines, which is motivated by the desire to boost …

The Mosaic Of Coronavirus Vaccine Development: Systemic Failures In Vaccine Innovation, Ana Santos Rutschman

All Faculty Scholarship

Scientists are racing to develop vaccines against the novel coronavirus. While some vaccine candidates may enter the market in record time, the current vaccine innovation ecosystem exposes governance lacunas at both the international and domestic levels.

The Reemergence Of Vaccine Nationalism, Ana Santos Rutschman

All Faculty Scholarship

This short essay explores the reemergence of vaccine nationalism during the COVID-19 pandemic. The essay traces the pre-COVID origins of vaccine nationalism and explains how it can have detrimental effects on equitable access to newly developed vaccines.

The Trump Administration’S Flawed Decision On Coronavirus Vaccine Injury Compensation: Recommendations For Changes, Peter H. Meyers

GW Law Faculty Publications & Other Works

This article discusses the problems with the Countermeasures Injury Compensation Program (CICP), the Federal program to compensate individuals who have suffered injuries from COVID vaccines and other COVID countermeasures. The article compares the CICP with the other, better federal compensation program for injuries caused by childhood vaccines (the VICP), and proposes a number of changes to improve the CICP.

Revisionist History? Responding To Gun Violence Under Historical Limitations, Michael Ulrich

Faculty Scholarship

In the D.C. Circuit case Heller v. District of Columbia (Heller II), Judge Kavanaugh wrote that “Heller and McDonald leave little doubt that courts are to assess gun bans and regulations based on text, history, and tradition, not by a balancing test such as strict or intermediate scrutiny.” Now Justice Kavanaugh, will he find support on the highest court for what was then a dissenting view? Chief Justice Roberts, during oral arguments for Heller I, asked “Isn’t it enough to…look at the various regulations that were available at the time…and determine how these—how this restriction and the scope of this …

To Accommodate Or Not To Accommodate: (When) Should The State Regulate Religion To Protect The Rights Of Children And Third Parties?, Hillel Y. Levin, Allan J. Jacobs, Kavita Arora

Scholarly Works

When should we accommodate religious practices? When should we demand that religious groups instead conform to social and legal norms? Who should make these decisions, and how? These questions lie at the very heart of our contemporary debates in the field of Law and Religion.

Particularly thorny issues arise where religious practices may impose health-related harm to children within a religious group or to third parties. Unfortunately, legislators, scholars, courts, ethicists, and medical practitioners have not offered a consistent way to analyze such cases and the law is inconsistent. This Article suggests that the lack of consistency is a troubling …

Shots For Tots?, Eric A. Feldman

All Faculty Scholarship

By endorsing the use of a vaccine that makes the experience of puffing on a cigarette deeply distasteful, Lieber and Millum have taken the first few tentative steps into a future filled with medical interventions that manipulate individual preferences. It is tempting to embrace the careful arguments of “Preventing Sin” and celebrate the possibility that the profound individual and social costs of smoking will finally be tamed. Yet there is something unsettling about the possibility that parental discretion may be on the cusp of a radical expansion, one that involves a new and unexplored approach to behavior modification.

Patent Landscape Of Influenza A Virus Prophylactic Vaccines And Related Technologies, Jon R. Cavicchi, Stanley P. Kowalski, David L. Pflugh, Jeremy Barton, Jeffrey Janovetz, John Schroeder

Law Faculty Scholarship

Executive Summary: This report focuses on patent landscape analysis of technologies related to prophylactic vaccines targeting pandemic strains of influenza. These technologies include methods of formulating vaccine, methods of producing of viruses or viral subunits, the composition of complete vaccines, and other technologies that have the potential to aid in a global response to this pathogen. The purpose of this patent landscape study was to search, identify, and categorize patent documents that are relevant to the development of vaccines that can efficiently promote the development of protective immunity against pandemic influenza virus strains.

The search strategy used keywords which the …

The Technological Edge, Elizabeth I. Winston

Scholarly Articles

To grant a patent to natural phenomena hinders innovation, taking back from the public that which the public has a right to possess. To deny a patent to man’s manufacture undercuts the fundamental bargain of the patent system. All inventions, at their core, may be deemed natural, rendering it difficult to distinguish between man’s manufacture and natural phenomena. Determining whether the innovative aspect of the product is a technological one, rather than a natural one, can clarify whether the patent grant promotes the progress of science and the useful arts. The higher the level of skill in the art required …

Fixing The Flaws In The Federal Vaccine Injury Compensation Program, Peter H. Meyers

GW Law Faculty Publications & Other Works

The Federal Vaccine Injury Compensation Program was a pioneering no-fault federal tort reform innovation when it was created two decades ago, but it is no longer the fast, generous, and less adversarial program that Congress originally created or that the Supreme Court recently described in Bruesewitz v. Wyeth. This article describes the serious problems that exist in the Vaccine Injury Compensation Program today, and proposes several legislative and other suggestions to fix these problems. Important lessons on how to improve the Vaccine Injury Compensation Program can be learned from several other recent federal compensation programs, including the Smallpox Compensation Program …

Foreword – Will Hpv Vaccines Prevent Cervical Cancers Among Poor Women Of Color?: Global Health Policy At The Intersection Of Human Rights And Intellectual Property Law, Kevin Outterson

Faculty Scholarship

Cervical cancer is a disease of social inequality. Women with access to effective screening and treatment rarely die from cervical cancer. The burden of cervical cancer mortality falls most heavily among the poorer women of the world. Cervical cancer starkly illustrates global inequality across race, sex and class. Cervical cancer disproportionately kills poor women of color. The HPV vaccine is a triumph of science.

Human Rights In Health Equity: Cervical Cancer And Hpv Vaccines, Joanna Erdman

Articles, Book Chapters, & Popular Press

This article seeks to demonstrate that health equity, as an empirical and normative concept, is reflected in the human rights to health and equality under international law. The obligations on government that flow from health equity as a human right are then examined. These include the obligation to act in pursuit of health equity as a policy objective, and the obligation to enact measures to ensure health equity as a policy outcome. These obligations are considered in relation to a promising remedial measure for social disparities in cervical cancer: HPV vaccines.

Franklin Pierce Law Center Educational Report: Patent Landscape Of Dna Vaccines For Hiv, Jon R. Cavicchi, Stanley P. Kowalski

Law Faculty Scholarship

No abstract provided.

The 800 Pound Gorilla Sleeps: The Federal Government's Lackadaisical Liability And Compensation Policies In The Context Of Pre-Event Vaccine Immunization Programs, Michael Greenberger

Faculty Scholarship

On July 21, 2004, President Bush signed the Project Bioshield Act, which authorizes the spending of $5.6 billion to advance the development and acquisition of vaccines and other countermeasures to biological agents. While the funding and progress are welcome signs for our national biodefense strategy, the failure of the federal Phase I smallpox vaccination program demonstrated that other serious obstacles remain to the implementation of a successful pre-event vaccine immunization program. Specifically, as demonstrated by a field study of several states' health departments, performed at the ANSER Institute for Homeland Security, the federal government's inability to provide both sufficient liability …