Experts examine the legality and efficacy of vaccine mandates.
The end of the COVID-19 pandemic may be in sight. Over 82 million Pfizer and Moderna COVID-19 vaccines have been administered in the United States so far. In addition to the Pfizer and Moderna vaccines, the U.S. Food and Drug Administration (FDA) just approved a new single-dose vaccine from Johnson & Johnson for an emergency use authorization (EUA) at the end of February.
Vaccines train the immune system to recognize and fight viruses without causing major sickness in the vaccine recipient. Although the vaccinated person becomes immunized, a population must reach herd immunity to establish widespread immunity from a virus. Herd immunity is “the indirect protection from an infectious disease that happens when a population is immune either through vaccination or immunity developed through previous infection.”
Experts estimate that about 90 percent of the population must be immune to the COVID-19 virus to achieve herd immunity. Although President Joe Biden has pledged to administer a minimum of 100 million vaccines in his first 100 days in office, logistical challenges and vaccine hesitancy pose barriers to efficient and widespread vaccine administration.
Is a COVID-19 vaccine mandate the answer?
The government uses vaccine mandates to penalize or deny services to people who refuse vaccines. Although a majority of states allow religious or philosophical exemptions from vaccine mandates, U.S. courts have not recognized a federal constitutional right to religious or philosophical exemptions.
State governments have enforced vaccine mandates for school-aged children for over a century. In the 1850s, Massachusetts enacted the United States’ first school vaccine mandate by requiring the smallpox vaccine for all students.
Since then, courts have generally supported vaccine mandates for school-aged children. States have also enforced vaccine mandates for health care providers and employees in health care facilities. Private employers can also mandate vaccinations.
Proponents of vaccine mandates argue that vaccines are most effective when a population achieves herd immunity and, in a time of high rates of vaccine hesitancy, mandates are the best way to ensure appropriate immunization rates. Some experts, however, question the efficacy of vaccine mandates at increasing vaccination rates.
This week’s Saturday Seminar focuses on the potential benefits as well as the legal challenges of vaccine mandates.
Vaccine Mandate Enforcement and Alternatives:
- Vaccines “are only effective when enough people receive them,” Carmel Shachar of Harvard Law School and Dorit Rubinstein Reiss of the University of California Hastings College of the Law argue in the AMA Journal of Ethics. Shachar and Reiss claim that states can infringe on an individual’s autonomy to protect public health and safety. Shachar and Reiss note that courts have held that “higher levels of risk justify” greater restrictions on liberty. According to Shachar and Reiss, in certain circumstances, states can use this well-established power to enforce vaccine mandates with criminal sanctions or limits on unvaccinated people’s access to school, work, and other public places. They warn, however, that vaccine mandates could backfire and result in “resistance and resentment.”
- Vaccinating children saves lives and saves tremendous health care costs, Katie Attwell and coauthors claim in Pediatrics. Various jurisdictions have taken different approaches to encourage parents to vaccinate their children, the authors note. For instance, California has removed religious exemptions, and countries such as Italy and France imposed fines on parents who do not vaccinate their children. In addition, the authors observe that Australia has taken a unique approach to encourage childhood vaccinations by tethering government support to vaccines. The authors caution, however, that the data on childhood vaccinations in Australia do not show that its vaccine mandate had a substantial impact on childhood vaccination rates and warn against other policymakers presuming that the Australian mandate was effective.
- In an article in the University of Pennsylvania Law School Journal of Constitutional Law, Dorit Rubinstein Reiss of the University of California Hastings examines the litigation around a 2015 California law that eliminated the personal belief exemption in school vaccine mandates. Reiss explains that to prevail, opponents of the California law must refute public policy arguments in favor of strong vaccine mandates—such as health care cost reduction and illness prevention—as well as a long line of precedent in support of mandates for school children.
- Parents are seeking exemptions from vaccinating their children more often, Mark Navin of Oakland University and Mark Largent of Michigan State University assert in a Public Health Ethics article. Navin and Largent analyze how some states, such as California, have tried to restrict nonmedical exemptions while other states, such as Vermont, have prioritized religious exemptions over exemptions based on personal belief. Prioritizing religious exemptions is not only unfair but also presents serious moral problems, Navin and Largent claim. Instead, states should allow for exemptions on both religious and personal belief grounds but ought to make the exemption process more burdensome and inconvenient to increase vaccination rates, Navin and Largent argue.
A COVID-19 Vaccine Mandate:
- Mandates for COVID-19 vaccines face an additional legal obstacle because FDA, so far, has only granted them emergency use authorization, Efthimios Parasidis of the Ohio State University Moritz College of Law and Aaron S. Kesselheim of Harvard Medical School explain in a Health Affairs article. The emergency use authorization provision of the Federal Food, Drug, and Cosmetic Act requires informing individuals of their option to “accept or refuse administration” of products authorized for emergency use and the consequences of refusal. Parasidis and Kesselheim argue that the provision’s term “consequences” seems to refer to the health consequences rather than consequences imposed by governments or employers. Based on Parasidis and Kesselheim’s interpretation, the provision would prohibit vaccine mandates based on emergency use authorization alone.
- In an article in the Journal of the American Medical Association, Lawrence O. Gostin of Georgetown University, Daniel A. Salmon of Johns Hopkins University, and Heidi J. Larson of the London School of Hygiene and Tropical Medicine consider whether the COVID-19 vaccine should be mandatory. They argue that vaccine mandates may signal the government’s support and drive resources to vaccine infrastructure, but caution that overriding personal autonomy via a mandate may actually undermine public support. Gostin, Salmon, and Larson also observe that no way exists to track a widespread mandate effectively. They conclude that, although limited vaccine mandates in high-risk populations may be useful, a national mandate would not be appropriate.
- The University of Washington’s Douglas J. Opel and Douglas S. Diekema, along with University of Chicago’s Lainie Friedman Ross, consider COVID-19 vaccine mandates for children in an article in JAMA Pediatrics. The authors propose a framework to determine whether policymakers should mandate COVID-19 vaccines. Opel, Diekema, and Ross suggest that governments should only enact a vaccine mandate for children after considering the efficacy and affordability of the vaccine, the severity of the illness, the scientific legitimacy of the vaccine, and the administrability of the vaccine.
The Saturday Seminar is a weekly feature that aims to put into written form the kind of content that would be conveyed in a live seminar involving regulatory experts. Each week, The Regulatory Review publishes a brief overview of a selected regulatory topic and then distills recent research and scholarly writing on that topic.