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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.
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