Book

Vaccine, Vaccination, and Immunization Law

Vaccine, Vaccination, and Immunization Law comprehensively addresses all areas of law relating to vaccines and vaccination, including regulation of product development, public health controls, mandates, government promotional efforts, intellectual property protection, common law and constitutional objections to vaccination, recovery for vaccine-related injury, and more.

 

Prices reflect AHLA member discount.

Price: $229.50 Main Volume


Meet The Authors

John R. Thomas
Contributor
Peter O. Safir
Contributor
book-image

Description

 

Published by Bloomberg Law’s Book Division with the American Health Lawyers Association (AHLA)

 

This treatise provides thorough coverage of all issues encountered in the practice of the law related to vaccines and vaccination, from product development and intellectual property protections, to regulation, public mandates, and vaccine injury claims. Vaccine, Vaccination, and Immunization Law will be invaluable not only to lawyers and business professionals in the health care industry, but also to regulators, public health officials, and scientific researchers.  

Vaccine, Vaccination, and Immunization Law covers the wide range of laws and issues that impact the field, including:

  • FDA oversight, enforcement, and regulation of the research and development process

  • Public mandates, including mandatory child vaccinations, opposition, and the legal consequences of failure to vaccinate, as well as medical, religious, and philosophical exemptions

  • State-by-state coverage of each jurisdiction's common requirements and unique legal characteristics related to childhood and adult vaccinations, state exemptions, administration of vaccines, and isolation and quarantine matters

  • Patent law elements important to securing and enforcing protection for vaccines, as well as 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), injuries listed in the Vaccine Injury Table, jurisdictional prerequisites, filings, and substantive and post-judgment proceedings

  • Injury claims outside the NVICP such as products liability, failure to warn, medical malpractice, punitive damages and more

  • Reporting via the Vaccine Adverse Event Reporting System (VAERS), with specifics on who may or must report and what are reportable events

  • Specific vaccines, mandated, unmandated, or in development, as well as other ingredients in vaccines

  • Access to, and promotion of, vaccines, and funding and cost issues


 

 

Chapter 1. Introduction to Vaccine Law

 

  • Scientific Basis for Vaccination

  • History of Legal Considerations Pertaining to Vaccination

 

Chapter 2. Regulation of Vaccines

 

  • Overview of the FDA’s Regulation

  • FDA’s Regulation of the Research and Development Process

  • FDA Enforcement Tools for Vaccines

  • Regulation of Animal Vaccines

 

Chapter 3. Vaccine Patents

 

  • Introduction to Vaccine IP                           

  • Patent Eligibility                               

  • Utility                   

  • Novelty                               

  • Nonobviousness                             

  • The Patent Instrument                 

  • Patent Acquisition Procedures

  • Duration of Rights

  • Scope of Patent Rights

  • Regulatory Exclusivities

 

Chapter 4. Other Intellectual Property Protection for Vaccines

 

  • Trademark

  • Trade Secret

  • Unfair Competition

  • Copyright

 

Chapter 5. Vaccination Funding, Payment, and Access Issues

 

  • The Cost of Vaccines

  • Funding for Distribution and Administration of Vaccines

  • Efforts to Promote Vaccination

  • Vaccine Access

  • Epidemic and Bioterrorism Response

 

Chapter 6. Vaccine Mandates and Requirements

 

  • History of Vaccination Mandates

  • Vaccine Mandates Under U.S. State Law

  • Vaccine Mandates Under United States Federal Law

  • Vaccination Mandates for Incarcerated Persons

  • Exemptions

  • Legal Consequences of Failure to Vaccinate

  • Vaccine Mandates in Other Countries

  • Activism in Opposition to Vaccination

 

Chapter 7. U.S. State Vaccine Laws

 

  • Overview

  • U.S. State and Territorial Laws

 

Chapter 8. Vaccine Adverse Event Reporting

 

  • VAERS

  • U.S. Reporting Outside of VAERS

  • International requirements

 

Chapter 9. Vaccine Injury Claims

 

  • A Brief History of Responses to Vaccine Injury Claims

  • Jurisdictional Prerequisites to Litigating Vaccine Act Claims

  • Procedure for Filing of Vaccine Claims

  • Substantive Proceedings Under the Vaccine Act

  • Post-Judgment Proceedings Under the Vaccine Act

  • Public Readiness and Emergency Preparedness Act

  • Vaccine Injury Claims Outside the NVICP

  • Vaccine Injury Compensation in Other Countries

 

Chapter 10. Specific Vaccines and Components

 

  • Currently Mandated Vaccines

  • Currently Unmandated Vaccines

  • Vaccines in Development

  • Other Vaccine Ingredients

 

Appendices

 

  • CDC Table of Vaccine Names

  • CDC Table of Vaccine Acronyms & Abbreviations

  • CDC Vaccine Price List

  • FDA Guidance for Industry on Review of Vaccine Labeling Requirements

  • Afluria® vaccine package insert, by Seqirus®

  • Vaccine Information Statement (VIS) for Varicella (Chickenpox) Vaccine

  • IAC Model standing order for Administering Influenza Vaccine to Adults

  • 42 U.S.C. Part F - Licensing of Biological Products and Clinical Laboratories

  • 42 U.S.C. Subchapter XIX, Part 1 - National Vaccine Program

  • 42 U.S.C. Subchapter XIX, Part 2 - NVICP

  • 26 U.S.C. § 9510 - Vaccine Injury Compensation Trust Fund

  • 42 U.S.C. § 1396s - Program for Distribution of Pediatric Vaccines

  • 42 U.S.C. § 247d-6d – Targeted liability protections for pandemic and epidemic products and security countermeasures

  • Jacobson v. Massachusetts, 197 U.S. 11 (1905)

  • Zucht v. King, 260 U.S. 174 (1922)

  • VAERS Table of Reportable Events Following Vaccination

  • Industry Guidance for Filing VAERS Reports

  • Vaccine Injury Table

  • Vaccine Rules of the United States Court of Federal Claims

  • Guidelines for Practice Under the National Vaccine Injury Compensation Program

 

Table of Cases

 

Index

 

Authors

 

Brian Dean Abramson has practiced intellectual property law and authored the vaccine injury claims chapter of Court of Federal Claims: Jurisdiction, Practice, and Procedure. Mr. Abramson was a law clerk for the Honorable Pauline Newman of the U.S. Court of Appeals for the Federal Circuit, where he took an exceptional interest in the court’s vaccine injury docket. He received his JD from the Florida International University College of Law, and an LLM in intellectual property law from George Washington University Law School.

 

 

John R. Thomas is a professor of law at Georgetown University in Washington, DC. He has served as the inaugural Thomas Alva Edison Visiting Scholar at the U.S. Patent and Trademark Office.  

 

 

Peter O. Safir is senior counsel to the firm of Covington & Burling, and a professorial lecturer at George Washington University Law School. Mr. Safir has been practicing in the food and drug field for nearly 30 years.

 

 

As the nation’s largest, nonpartisan, nonprofit organization devoted to legal issues in the health care field, the American Health Lawyers Association (AHLA) leads in providing just-in-time education, establishing trusted resources, and encouraging robust dialogue among its members and the greater health law community. With nearly 14,000 members, AHLA boasts deep expertise among practitioners who represent clients across the entire health care industry spectrum. As a result, AHLA resources

 

benefit not only attorneys, but also anyone who advises physicians, hospitals, health systems, specialty providers, payers, life sciences companies, and many other health care stakeholders. If you have an

 

interest in health law, you have a home in AHLA. For more information about the education and resources of AHLA, please visit us at www.healthlawyers.org.

 

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