Introduction

The World Health Organization named “vaccine hesitancy” as one of the top global health threats in 2019. In the United States, widespread utilization of non-medical exemptions to mandatory vaccination laws has led to statistically significant outbreaks of measles and other vaccine-preventable illnesses, and many headlines forecast that if vaccination exemptions continue the trajectory they are on, this country may well face a public health emergency. In early 2019, then-U.S. Food and Drug Administration Commissioner, Scott Gottlieb, made a public call for states to act to reduce vaccine exemptions, warning that if the states failed to do so, the federal government would be forced to step in. Health care practitioners are on the front lines of this potential public health crisis, regularly facing well-meaning parents who feel unfettered in their personal choice to accept or reject vaccinations for their children.

This article provides an in-depth look at the legal issues underlying the current vaccination crisis by providing background on the history and development of vaccination laws in the United States; the public health ramifications of permissive, non-medical exemptions to vaccine requirements for school children; and the legal impediments to federal intervention as urged by Gottlieb. This article is intended to provide practitioners and health care lawyers alike with background and insight into the legal issues behind this public health debate in order to support and enhance their ability to effectively interact personally and professionally with parents and other community stakeholders, and who may themselves be in a position to instruct and influence their community toward informed debate on this vital public health topic. While intended for a broader audience interested in the public health and policy debate over vaccine exemptions, practical guidance for front-line medical practitioners facing vaccine-resistant parents is also provided.

History of Vaccines and Vaccination Exemptions

Prior to the development of effective vaccinations, over twenty percent of children died from disease before reaching adolescence, and diseases that have now been made wholly preventable through vaccine technologies were a significant threat to the health, well-being, and even survival of citizens in the United States and across the world. Vaccination development was slow until the 20th century, when scientific understandings and advances grew dramatically and worked to profoundly impact public health through the prevention of communicable diseases. By 1999, the considerable effects of the implementation of regular and systematic vaccination on the health of the public was undeniable. Since their inception n the early 1900s, vaccines have led to the complete eradication of smallpox, the elimination of polio from North America, and the reduction and control of measles, rubella, tetanus, diphtheria, influenza type b, and other infectious diseases in the United States. This remarkable progress prompted the Centers for Disease Control and Prevention (CDC) to emphatically declare that since the start of the 20th century, the health of people living in the United States had “dramatically improved” and that the life expectancy of U.S. citizens had increased by thirty years. By the time the 20th century came to an end, statisticians estimated that for each year vaccines had been available to the public, approximately five million lives had been saved by the vaccination-related controls that led to the near eradication of poliomyelitis, measles, and tetanus.

Despite the clear scientific evidence of the efficacy of vaccination and its measurable impact on public health, the federal government has never established a compulsory vaccination program in the United States. Instead, federal power, authority, and U.S. resources have always centered on encouraging and promoting individual states to implement compulsory vaccination programs on their own as an exercise of each state’s police power. Thus, the first compulsory immunization law in the United States was not passed by the federal government, but by the state of Massachusetts in 1809.

Public Health Enforcement Powers

In order to efficiently and effectively oversee a large and diverse population, such as that found in the United States, divisions of power and responsibility must be made. Therefore, the federal government and each state government has its own zone of power in which it can act for the benefit of its citizens.

The U.S. Constitution

The health and safety of the communities of people that make up the United States are regulated through the powers of both federal and state governments. The Constitution grants powers and rights to the federal government, state governments, and to individual citizens. The concept of federalism—the way power is vertically divided between state and federal governments—also stems from the Constitution. The Tenth Amendment states that “[t]he powers not delegated to the United States by the Constitution, nor prohibited by it to the States, are reserved to the States respectively, or to the people.” Although the federal government has a “long tradition of regulating for the community’s welfare by regulating individuals, professionals, institutions, and businesses through the use of its broad powers,” the Tenth Amendment has consistently been interpreted by the courts as leaving what has been termed the “police power” to the states. This power grants to states, as sovereign governments, the right “to secure and preserve the public’s health and safety . . . [and] to secure the general welfare of the people[.]” State constitutions work in turn to further these goals by “delegate[ing] this authority to local government and local public health departments[.]"

Thus, when the smallpox vaccine was developed by Edward Jenner in 1796, state and local governments took note and began passing laws aimed at using this medical breakthrough to protect the health and welfare of the people who resided within their bounds. However, much like today, the compulsory vaccination laws of that time were controversial and were strongly resisted by certain members of the community. Those that disagreed with this type of government intrusion or who doubted the safety or effectiveness of being vaccinated turned to the Court to test the validity and limits of the state’s police power.

The complete article was first published by the American Health Law Assocation's Journal of Health & Life Sciences Law in February 2020. Read the full article, which can be accessed in the materials provided above.