Ethics Forum: Vaccine Mandates

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With the ongoing COVID‑19 pandemic, several tools and strategies have been developed and implemented to reduce the spread of disease. These include social distancing, adequate ventilation, masks, monoclonal antibody treatment and vaccination.¹ As of December 2021, 60% of all Americans have been fully vaccinated, and 8 in 10 adults in the U.S. have received at least one dose of a COVID-19 vaccine.² However, vaccination rates have been disparate among different communities, undercutting attempts to blunt transmission. Making things worse, the appearance of several COVID-19 variants has led to a resurgence of disease.³ In response, the federal government, states, and public and private organizations have issued vaccine mandates. But what are the legal and ethical bases for these vaccine mandates?

In this Ethics Forum, we dissect this issue from legal and ethical standpoints.

Vaccine Mandates & the Law

Vaccinations have been present since antiquity, with evidence suggesting inoculation practices emerging in India, China and Turkey, among other places.^4-6 Edward Jenner introduced the concept to Western populations in the 1700s, and vaccination practices were adopted in the U.S. in the coming centuries. As now, adoption was uneven and, at times, controversial.⁷

The first major court case regarding the authority of a government to mandate vaccines was in 1905. In Jacobson v. Massachusetts, the U.S. Supreme Court ruled that states may require vaccination via a mandate accompanied by a criminal fine.⁸

The Supreme Court elaborated on its decision, stating that “the liberty secured by the Constitution of the United States to every person within its jurisdiction does not import an absolute right in each person to be, at all times and in all circumstances, wholly freed from restraint. There are manifold restraints to which every person is necessarily subject for the common good. On any other basis, organized society could not exist with safety to its members.”⁹

This court case provided precedent for vaccine mandates, but in the intervening 116 years, major changes have ensued in the science and art of medicine, healthcare ethics and legal concepts of individual freedom, creating greater nuance. In general, the U.S. court system tends to uphold individual freedoms but considers limitations based on four criteria: 1) proportionality, 2) precedent, 3) context and 4) sufficient access.¹⁰

Proportionality refers to the balance of risks from the disease (and transmission thereof) vs. the risks of restricting individual freedom.¹¹ In the case of COVID-19, differing perceptions about the mortality and morbidity of COVID-19 have led to differing perspectives regarding whether vaccine mandates approach the proportionality standard. The deaths of more than 800,000 individuals in the U.S. so far, accompanying at least 50 million cases, make the argument that vaccine mandates fulfill this level of proportionality.¹²

The increased transmissibility of the Delta and Omicron variants, the risks to children and those with immune deficiencies, and the absence of easily available treatments for the disease further bolster this argument.

Precedent is also important in determining vaccine mandates. Generally, restrictive approaches should be avoided in favor of less coercive approaches, and only be used when less coercive approaches cannot provide for public safety.¹⁰ With respect to COVID-19, since the introduction of the vaccines in late 2020, several approaches have been used to encourage vaccination. Mass education, social media campaigns and provisions of incentives have all been utilized, with varying degrees of success. Because we have not yet reached the threshold to prevent community transmission, it can be argued that a more restrictive approach (i.e., mandates) is justifiable.

The sociocultural context of re­strictions on individual liberties is also considered. Vaccine mandates have drawn conster­nation from several corners of society as an intervention that reduces trust in societal and governmental institutions. As of Dec. 16, 2021, all COVID-19 vaccines (except the Pfizer vaccine, which has an approved BLA for most indications) fall under the Emergency Use Authorization (EUA) issued by the U.S. Food & Drug Admini­stration (FDA).¹³ Although the EUA enabled the rapid distribution of vaccines, the absence of full Biologics License Application (BLA) approval for boosters has triggered concerns about how implementable vaccine mandates are.

Of note, as per the FDA, vaccine recipients must be informed of “the option to accept or refuse administration of the product.”¹⁴ Although several cases contesting the legality of COVID-19 vaccine mandates are still pending in federal courts, the point of contention appears to be about Constitutional limits of federal and executive power to regulate public health, as opposed to legislative authority or mandates at the state level.¹⁵

Last, there must be sufficiency of access to vaccines. It would be considered unfair to mandate vaccines if the supply of vaccines could not keep up with the demand generated by a mandate. In early 2021, a shortage of vaccines required judicious distribution. However, at this point, production has increased sufficiently to keep up with demand.

Based on these four considerations, there does appear to be a legal basis for COVID-19 vaccine mandates. Yet what is legal may not necessarily be ethical.

The Ethics of the Vaccine Mandate

The core ethical dilemma underpinning vaccine mandates is the balance between upholding public health priorities while honoring the right to individual autonomy.¹⁶ Framing the dilemma according to Beauchamp and Childress’s four principles, we can see it as a conflict between the ethical principles of beneficence (i.e., actions to ensure the well-being of others) and justice (i.e., distribution of health resources) vs. respect for autonomy (i.e., the right to choose or refuse treatment) and non-maleficience (i.e., to do no harm).¹⁷

Utilitarianism is one moral and ethical framework that seeks to resolve this dilemma. Utilitarians believe “we choose the course of action that will benefit most people to the greatest degree.”¹⁸ In the context of COVID-19 vaccine mandates, instituting vaccine mandates would reduce morbidity and mortality, as well as healthcare costs for individuals and society. Indeed, strong evidence exists that high rates of vaccinations reduce the mortality of COVID-19 and that these COVID-19 vaccines have a safety profile comparable to other vaccines.¹⁹

Utilitarianism is not without its critics, though. Individual liberty may not be prioritized in the same way, and the concept of a universally acceptable unit of utility is controversial.¹⁸ Several medical and religious-based exemptions undercut the idea of a universal utility that can be weighed equally among individuals for the benefit of society. At minimum, this means that even with vaccine mandates, clear specifications must exist for what constitutes an exemption and what degree of proof is needed to justify such an exemption.²⁰

Similarly, questions remain about what constitutes the society for which such utility is being considered. Each community is unique in its public health needs, and it may very well be that, in areas in which there is low transmission, a vaccine mandate is not necessary. Conversely, in areas where spread is unchecked, a vaccine mandate may be needed.

On a larger, global scale, it is unclear whether vaccine mandates improve the greater good. As of Dec 16, 2021, the World Health Organization does not support mandates for COVID-19 vaccination and has expressed concern that mandates may hinder worldwide availability of vaccines, particularly in underdeveloped countries.²¹

Lastly, adoption of a vaccine mandate implies a threat to, or a force to be used against, those who are noncompliant. Ethically, it is important to balance the greater good that comes with stopping the transmission of disease with the bad of creating an atmosphere in which individuals feel coerced. Alternatives to vaccine mandates, such as mass education campaigns to convince hesitant individuals, tax breaks or enhanced benefits packages, may be more beneficial.²²

Conclusions

With the continuing spread of COVID-19, vaccine mandates are becoming more common. Although the legal basis of vaccine mandates appears firm, the ethical justifications are steeped in our own perceptions of the dangers of COVID-19 infections, the safety and efficacy of COVID-19 vaccines, trust in governmental and healthcare organizations, and the role of individuals in society as a whole. As with most ethical dilemmas, prompt resolution that leads to universal acclaim is unlikely, but the ability to recognize core legal and ethical principles can help us talk about this topic in a way to help build consensus.

The Committee on Ethics & Conflict of Interest reviews and makes recommendations regarding the ethics and professionalism of the College, its officers, directors and members; and addresses and responds to questions of conflict of interest. It also develops information to educate members on the Code of Ethics and conflict-of-interest issues.

References

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20. COVID-19. Workplace vaccination program. Centers for Disease Control and Prevention. Updated 2021 Mar 25.
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