Vaccine Law and Policy (eBook)

Vaccine Law and Policy is the first book on vaccine law and policy written specifically for the general public or an educated lay audience without legal background. It offers comprehensive but accessible coverage of key aspects of vaccine law and policy, from product development and intellectual property protections, to regulation, public mandates, and vaccine injury claims. The COVID-19 pandemic sparked a growing interest in learning more about vaccine law and policy, as vaccine development, access, safety and requirements became relevant to hundreds of millions of people worldwide. This book covers United States law in most detail, but the developments and trends described have parallels in many countries, and the United States model and its actions influence others. Some of the most widely used vaccines against COVID-19 - mRNA vaccines - were developed in the United States, and choices made in the United States impact other countries.

United States law currently has so much to say about vaccines. From the federal mandate President Biden enacted requiring federal employees to be vaccinated against COVID-19, to the growing number of private employers requiring vaccines to return to work, vaccine law has become a prevalent topic in everyday life. But there is little writing about the legal aspects of vaccines directed at the general public or an educated lay audience without a legal background. Vaccine Law and Policy will not only be invaluable to professionals implementing vaccine law and policy, but also to regulators, public health officials, and scientific researchers.

Vaccine Law and Policy covers the wide range of laws and policies that impact the field. These include, among others, regulatory oversight by the FDA, one of the most influential bodies in drug and vaccines regulation worldwide, enforcement, and regulation of the research and development of vaccines; vaccine mandates for children and in the workplace, and medical, religious, and philosophical exemptions to them; patent law and other intellectual property protections such as trademark, trade secret, unfair competition, and copyright law; compensation for vaccine injuries under the National Vaccine Injury Compensation Program (NVICP) and other avenues of liability; safety monitoring; access to vaccines, their promotion, and issues related to funding and costs. The book will also discuss issues related to anti-vaccine movements and vaccine advocacy.

Y. Tony Yang, ScD, LLM, MPH, is an endowed Professor of Health Policy (with tenure) at the George Washington University in the Washington, D.C. His main scholarly interest is in policy issues at the intersection of the legal and health systems, especially in vaccination policy. He takes an empirical approach to most of his research, blending methods from the econometrical and statistical sciences with more traditional legal research methods. He has authored more than 150 peer-reviewed articles. His first-authored work has appeared in leading journals, including NEJM, JAMA, Lancet, Health Affairs, and American Journal of Public Health. The impact of his scholarship is observable in media coverage such as CNN, NPR, NY Times, Washington Post, and Wall Street Journal. He has been awarded more than $5.5 million U.S. federal grants as principal investigator. Also, he has been supported by various foundation funders as principal investigator, including Robert Wood Johnson Foundation (Policy for Action, Interdisciplinary Research Leaders, and Public Health Law Research). He has received honors such as the Early Career Award for Excellence from American Public Health Association. He was a postdoctoral researcher at the MIT, FDA Regulatory Science Fellow (jointly organized by the National Academy of Medicine), and CDC-National Center of Health Statistics Health Policy Fellow. He is a member of AcademyHealth Education Council. He holds graduate degrees in Public Health (Harvard), Health Policy (Harvard), and Law (Penn).

Dorit R. Reiss, PhD, is Professor of Law and the James Edgar Hervey '50 Chair of Litigation at UC Hastings Law, San Francisco. Her undergraduate degree in Law and Political Science (1999, Magna cum Laude) is from the Faculty of Law in the Hebrew University of Jerusalem where she served as Editor in Chief of the Law Review. Following graduation from law school, Professor Reiss clerked for a year and a half in the Israeli Ministry of Justice's Department of Public Law, working on a variety of constitutional and administrative law issues. She received her Ph.D. from the Jurisprudence and Social Policy program in UC Berkeley, writing her dissertation on accountability in the liberalized telecommunications and electricity sectors in England, France and Sweden. Since 2013, her research and activities are focused on legal and policy issues related to vaccines. She writes about school mandate, policy responses to non-vaccinating, tort issues and administrative issues related to vaccines.