Vaccine Mandates: Weighing the Common Good vs Personal Conscience and Autonomy

Abstract

COVID-19 is a serious illness with significant morbidity and mortality. Vaccines to immunize against it were developed in record time. Mandates followed. The question to be considered is when mandates are ethical. Mandates can be used to prevent spread of an infection, prevent overwhelming the healthcare system, or protect public safety, thereby protecting the vulnerable and allowing for full flourishing of the common good. At the same time, one must be careful about respecting autonomy by allowing those who consciences do not allow them to be vaccinated to refuse. Because COVID-19 knowledge is rapidly changing as more information is known and the virus mutates, the conditions under which mandates are ethical change as well. At present, since vaccines prevent severe infection and death in high-risk individuals with added benefit for those who are vaccinated and have a history of infection, mandates can be imposed on those individuals. With an estimated 95% of the US population believed to have been infected and prior history of infection shown to be as effective as vaccination, with immunity lasting at least 500 days, and ability to prevent spread unknown at present but limited at best in the past, the vaccines therefore cannot be ethically mandated for those who are low risk for the versions released September 2023 based on information as of October 2023.

Introduction

In December 2019, the World Health Organization (WHO) office in China was informed of several cases of pneumonia of unknown etiology occurring in Wuhan, China. It was identified in January 2020 as a novel coronavirus and given the name Covid Disease 2019 or COVID-19 in February. It spread rapidly. WHO declared it a pandemic on March 11 (David J Sencer CDC Museum 2021).

In the US, community spread was identified by the end of February. In view of the rising numbers of deaths and the fear of overwhelming healthcare systems, state health systems began to circulate criteria for ventilator usage. In Alabama, that initially included those with severe or profound mental retardation and moderate to severe dementia not be considered as candidates. States began shutting down all but what they considered to be essential industries. Initially the shutdown was to be for only 2 weeks but lasted for months. Masks and social distancing were initiated as mitigation measures as well (David J Sencer CDC Museum 2021).

COVID-19 is deadly. In China, initially the death rate was 3.5% (Guo et al. 2020, 5). With more knowledge about the disease and effective treatments, the death rate in the United States is 1.1% (Johns Hopkins 2023) which is ten times greater than influenza (Maragakis 2022). With the advent of COVID-19, life expectancy dropped for two years in a row (Arias et al. 2022, 8). By August 2020, it was the third leading cause of death (David J Sencer CDC Museum 2021). In January and February 2022, it was the number one cause in ages 45–84 (Ortaliza, Amin and Cox 2022). It was the third leading cause of death in 2021 (Ahmad, Cisewski and Anderson 2022, 597), dropping to the fourth in 2022 (Ahmad et al. 2023, 489).

There can be long-term morbidity. Complications include damage to the heart, lungs, kidneys, and brain. There can be immune problems (Mayo Clinic Staff, 2022). Almost one in five who get COVID-19 will have long COVID (Centers for Disease Control and Prevention, 2022d) with persistent fatigue, worsening of symptoms with physical or mental activity, respiratory and heart symptoms, and “brain fog” among other symptoms (Centers for Disease Control and Prevention, 2022c). It increases the risk of being diagnosed with Alzheimer's Disease within a year (Wang et al. 2022, 414).

Risks for various groups of people vary widely. Compared to people 18–29 years of age, people over 65 were 5–15 times more likely to be hospitalized and 25–360 times more likely to die (Centers for Disease Control and Prevention, 2023b). Risk was also increased for certain ethnicities and remains elevated (Ahmad et al. 2023, 490). People with certain medical conditions are at increased risk (Centers for Disease Control and Prevention, 2023a). For children, 70% of those hospitalized had risk factors (David J. Sencer CDC Museum, 2021). Pediatric deaths are rare, less than 0.1% of the total (Centers for Disease Control and Prevention, 2023b) with 86% having pre-existing conditions such as asthma or obesity (McCormick et al. 2021, 6).

During this time, the pharmaceutical industry worked on a vaccine. The first human trials were started by Moderna in mid-March. At the end of April, Operation Warp Speed was begun to help fund the research for and production of a vaccine (Government Accountability Office, 2021). By mid-November, both Pfizer and Moderna had finished their effectiveness trials with emergency use authorization (EAU) in November and December respectively. Initially approved for adults, vaccines are now fully approved down to age 6 months (U.S. Food and Drug Administration, 2023b; U.S. Food and Drug Administration, 2023c).

The biggest predictive determinant for getting vaccinated are feelings of altruism (Allen et al, 2021, 4), fairness, and loyalty. The greatest ones for hesitancy are concerns about purity, physical and spiritual, and fearing contamination because the injection is considered an unnatural substance (Reimer et al. 2022, 745, 755) or the vaccine devalues sacredness (Reimer et al. 2022, 745), possibly because of the belief that aborted fetal tissue was used in the testing or development of the vaccine. These determinants were more predictive than whether one is conservative or liberal (Reimer et al. 2022, 755).

Mandates are by their very definition coercive. Do this or else consequences follow, consequences unrelated to the disease itself. What are the conditions that make a mandate justifiable? What about exemptions and how easy should they be to get?

While others have delineated the conditions for a mandate (Opel, Diekema and Ross 2021, 125–126; Mello, Silverman and Omer 2020, 1296–1299), and have considered the reasons why (Hagan et al. 2022; Mello, Silverman and Omer 2020, 1296–1299), they have not done so from a Catholic understanding.

This paper will first define what is a vaccine and describe the history of vaccination. It will describe Catholic understanding of conscience and the common good and how these need to be weighed when there are differences in opinion when considering a mandate. Finally, it will discuss the conditions that must be present for a mandate to be ethical and whether the present COVID-19 vaccines meet them or not.

History of Vaccination and the COVID-19 Vaccine

A vaccine is a preparation used to stimulate the body's immune response against disease, creating a protective immunity. The process is called vaccination (Centers for Disease Control and Prevention, 2021).

In the Western World, the first vaccine was against smallpox. There was controversy. One of the first uses of the term “conscientious objection” was to describe those who refused being vaccinated against smallpox (Watson, 2019). The US Supreme Court (SCOTUS) ruled in Jacobson v Massachusetts that a man who refused Massachusetts’ mandate for smallpox vaccination had to pay the penalty which was less than $100 in today's money (Mariner, Annas and Glantz 2005, 582). The Court stated:

[T]he 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. (Jacobson, 1905)

Even so, the state had no power to force him to be vaccinated (Mariner, Annas and Glantz 2005, 582). SCOTUS has also determined that freedom from arbitrary physical restraint is a fundamental right subject to strict scrutiny and had to be narrowly tailored to interfere with individual liberty as little as possible (Mariner, Annas and Glantz 2005, 585).

In the past, it could take up to ten years to develop a vaccine, causing concern that the process was rushed, corners were cut, or information hidden for the COVID-19 vaccines (Allen et al. 2021, 2; Nguyen et al. 2021, 2212). It is more accurate to say that that the normal process was accelerated. In early January 2020, the genome of the virus was identified (Anderson et al. 2020, 450). Research on developing vaccines for coronavirus was already in motion (Hasmen Saey 2020). 2 of the usual 3 phases were combined (Gostin, Salmon and Larson 2021). While getting volunteers can take time, in the case the COVID-19 vaccines, it took 4 months to get over 16,000 volunteers (Polack et al. 2020, 5). Thanks to Operation Warp Speed, the production of promising vaccines was paid for while the research was occurring (National Institute of Allergy and Infectious Disease, 2020). While this ran the risk of the government paying for production of a vaccine that did not work, it meant that vaccine was available when Emergency Use Authorization (EUA) was given. EUA is given to a vaccine in the presence of an epidemic with a high mortality rate when there is good scientific evidence that it is safe and effective using short-term data “ to help strengthen the nation's public health protections against…threats including infectious diseases, by facilitating the availability and use of medical countermeasures needed during public health emergencies” (U.S. Food and Drug Administration, 2023a) with continued monitoring for long-term safety (Centers for Disease Control and Prevention, 2022b).

Conscience and Autonomy

Conscience has been defined as an act of the will, an assent to truth to act morally, and a fundamental commitment to act morally (Sulmasy 2008, 142). In Catholic teaching, conscience is one's most secret core and sanctuary where God's voice echoes according to a law not laid down by one's self. It is a law that must be obeyed, calling one to love by doing what is right and avoiding evil (Catechism of the Catholic Church, 2016, #1776). One is bound to follow what one determines to be right and just (Catechism of the Catholic Church, 2016, #1778). One must not be forced to act against one's conscience. (Catechism of the Catholic Church, 2016, #1782)

Conscience is not infallible. It must be informed through prayer and guided by the advice of others including the Holy Spirit and the authoritative voice of the Church (Catechism of the Catholic Church, 2016, #1783–1785). Nevertheless, one is bound to follow one's conscience, even if erroneous (Catechism of the Catholic Church, 2016, #1790). However, even though bound to follow an erroneous conscience, following it does not limit the evil it can cause (Catechism of the Catholic Church, 2016, #1793).

This is different from the secular view of autonomy which is the ability to act freely in accordance with one's self-chosen plan (Beauchamp and Childress 2019, 99). It requires not only understanding, but intentionality and freedom from control (Beauchamp and Childress 2019, 1021). Since a plan is based on one's own interpretation of right and wrong based on one's values, this includes the engaging of one's conscience. Respect for autonomy means allowing others to make decisions based on their conscience.

The Common Good and Vaccination

Caring for the common good with a preferential love for the poor has been a long tradition of the Church as an outward sign of the Church (Jones-Nosacek 2021, 27), a seeking of those things for common profit (Chrysostom, n.d., 1 Corinthians 11:1). By acting for common profit (good), we imitate Christ. It is more than a living wage, ownership of private property, or the responsibilities of workers, employers, and the State to each other (Jones-Nosacek 2021, 27). It is a sacred justice where the most vulnerable who are least able to protect themselves are protected (Leo XIII 1891, #36–37). It is opposed to the utilitarian version of the common good where actions are to achieve the greatest good for the greatest number.

The Catholic idea of the common good goes against the individualism of our culture and its emphasis on autonomy. We are called, both individually and communally, to do what is best for everyone (Jones-Nosacek 2021, 27). We must constantly be on the lookout for the good of others (John Paul II 2005). It can include subordinating one's particular good “if the common good demands it” (John XXIII 1961). We must act in solidarity with others, which Pope Francis (2013) says is a “word that bothers us …[b]ecause it requires you to look at another and give yourself to another with love.” In the end, the common good respects the dignity of the human person, advances prosperity for all, and pursues justice by protecting and defending others, especially those who cannot protect themselves, which in turn promotes peace. Finally, it forms the basis of a civilization of love where life-giving love is present and permeates every social relationship. It makes us more human and more worthy (Pontifical Council for Justice and Peace, 2005).

As part of our social nature, each individual good is “necessarily related” to the common good, which in turn defines our relationship to others (Catechism of the Catholic Church, 2016, #1905). It concerns all our lives (Catechism of the Catholic Church, 2016, #1906). It presupposes respect for the individual (Catechism of the Catholic Church, 2016, #1907), the social well-being and development of the group (Catechism of the Catholic Church, 2016, #1908), and the stability and security of a just order (Catechism of the Catholic Church, 2016, #1909). It is always oriented towards the progress of persons founded in truth, built on justice, and animated by love (Catechism of the Catholic Church, 2016, #1912). As opposed to autonomy, it means that we must both individually and collectively be on the lookout to do what is best for everyone (Jones-Nosacek 2021, 27).

It is concern for the common good seen in the values of altruism, fairness, and loyalty that motivate people to be vaccinated (Allen et al., 2021, 4; Reimer et al. 2022, 750), ranking even higher than self-interest (Jones, Bhogal and Byrne 2022, 93), though one may not exclude higher levels of self-interest among those at risk.

Vaccines have two purposes related to the common good. The first is to reduce the chance of being infected, or at least reduce the risk of complications, by priming the immune system. This allows for individual flourishing. The second is to immunize enough people to significantly reduce spread. This protects those who, for whatever reason, cannot be vaccinated, who were vaccinated but not fully immunized (Goodman 2020) or refuse to be vaccinated. Some vaccines do both, others more one than the other. For example, the measles vaccine gives both immunity to the recipient and prevents spread (World Health Organization, 2017, 3). The rubella vaccine is more for the second reason: to protect the fetuses of unimmunized mothers (Centers for Disease Control and Prevention, 2020).

Healthcare workers (HCW), both professional and nonprofessional, have a special obligation to the common good. By accepting to care for the vulnerable, they have a fiduciary responsibility to promote patient health and avoid harm. They are obligated to follow all reasonable, evidence-based best practices to protect patients from infection (Van Hooste and Bekaert 2019, 2–3) such as hand washing and masking. These duties are both individual and collective, a duty to patients (communitarian altruism), a duty to protect oneself and one's family, a duty to colleagues, and duty to the community (solidarity) (Van Hooste and Bekaert 2019, 8). This includes the possibility of the need to subsume one's individual freedom to protect the vulnerable (Van Hooste and Bekaert 2019, 7). To do so, one needs prudence, an intellectual knowing and wisdom using right reason to act (Austriaco 2021, 318) regarding actions that can be made compatible with human flourishing depending on the circumstances (Austriaco 2021, 317).

Catholic healthcare, as part of Christ's healing ministry, was created out of concern for the common good. Properly performed, it respects the dignity of the human person and the right to life and promotes the good health of everyone (U.S. Conference of Catholic Bishops, 2018, Social Responsibility of Catholic Health Care Services Introduction). This allows for the full flourishing of everyone with whatever condition has been given to them.

If a vaccine is shown to prevent spread from HCW to a vulnerable patient, then the HCW is obligated to receive the vaccine or resign if there is no other reasonable option to reduce the risk of imperiling patients (Austriaco 2021, 318) or an ethically acceptable alternative vaccine. This would extend to others who are not in healthcare but care for vulnerable family members or whose occupation involves dealing with vulnerable populations.

Conditions for Vaccine Mandates

A vaccine mandate is a requirement that ties being vaccinated to access to a benefit, service, or privilege. If the person declines vaccination, there is a penalty such as the inability to access a service or enter a building (Benisek 2022; Johns Hopkins Bloomberg School of Public Health, 2022; William 2021) or even job loss (Mello, Silverman and Omer 2020, 1298). This penalty is unrelated to the disease process itself. The result is that it restricts autonomy and the ability to make an informed refusal. It must be justified (Beauchamp and Childress 2019, 402; Gostin, Salmon and Larson 2021, 533).

Epidemics and pandemics limit or even eliminate the conditions necessary for the flourishing of the common good. It's the role of the state to ensure the common good (Catechism of the Catholic Church, 2016, #1910). In the United States, COVID-19 has disproportionately affected the poor and vulnerable, especially minorities. Minorities are more likely to have risk factors for severe COVID-19. The poor are less likely to have a job where they can work from home, more likely to have comorbidities that put them at risk, and to live in multi-generational households (Raifman and Raifman 2020, 138; Magesh et al. 2021, 9). Third world countries lack adequate resources for medical care. A hospital in Uganda ran out of oxygen and 30 COVID-19 patients died (Abet and Atukunda 2021).

While it is important that a vaccine be effective in reducing risk of morbidity and mortality in an individual, that is not enough reason to interfere with one's autonomy. We do not force people to exercise, stop smoking, or eat healthy diets. People must be allowed to make decisions regarding their own flourishing. Respect for autonomy, in general, means that one is allowed to make mistakes if it does not endanger public health or potentially harm innocents.

To determine the ethical need for a mandate, one must first determine the seriousness of the disease being vaccinated against. This includes its morbidity and mortality. If a large proportion of the population is at low risk for serious illness and death, then the presence of vulnerable groups needs to be considered. Finally, its ability to spread from person to person, affecting vulnerable groups, must be known. For a vaccine mandate to be ethical, it must be for a contagious disease with a high morbidity and/or mortality rate either in the general population or for a vulnerable population. For example, the viruses involved in the common cold, while contagious, rarely cause severe disease or death. If a vaccine for it were ever to be created, it would not be ethical to mandate it.

To justify a general mandate, the vaccine must be shown to prevent spread. It can also be used as a consideration for HCW. If the vaccine does prevent transmission, then not getting vaccinated impacts others who can get infected (Mello, Silverman and Omer 2020, 1297) since no vaccine is 100% effective in preventing infection and there are others who cannot be vaccinated for medical reasons. Preventing transmission allows for the flourishing of society by reducing overall risk of infection. Not all vaccines do that. For example, the injectable polio vaccine (IPV) protects the individual but allows the virus to multiply in the gut and spread to others as opposed to the oral polio vaccine (OPV) (Polio Eradication Initiative 2022).

For the influenza vaccine, its ability to protect against spread is more controversial. Its rate of effectiveness would not be adequate for licensure for most other viral infections (Morens, Taubenberger and Fauci 2023, 146). Studies have not been able to show a decrease in influenza-like or influenza confirmed disease (Ahmed et al. 2014, 54; Carman et al. 2000^; Imai et al. 2018, 7; Potter et al. 1997, 3; Thomas, Jefferson and Lasserson 2016). While they do show decrease in nonspecific all-cause mortality in nursing homes (Ahmed et al. 2014, 53; Carman et al. 2000^; Hayward et al. 2006, 5; Potter et al. 1997, 3), it is at a rate (29%) higher than the official estimate of all influenza deaths (<10%) (Ahmed et al. 2014, 55). There are other major methodological flaws including not controlling for patient frailty or the possible difference in the use of other mitigation measures such as hand washing or masking (Abramson 2012, 3; Thomas, Jefferson and Lasserson 2016, 2). Even the CDC says that it “may” prevent transmission (Centers for Disease Control and Prevention, 2022f).

If the vaccine does not prevent spread, then it should reduce the risk of disease among the unvaccinated overwhelming the healthcare system. This has happened for other infectious diseases. In 2018, a state of emergency was declared in Alabama and elective surgeries were cancelled, and in California, “surge tents” were set up outside emergency rooms to treat patients during an influenza outbreak (MacMillan 2018). If the vaccine can prevent this, like the influenza vaccine (Centers for Disease Control and Prevention, 2022f; Morens, Taubenberger and Fauci 2023, 146), then the vaccine can be mandated for at risk individuals.

A vaccine can be mandated for certain groups if proven to prevent disruptions of vital services. For example, there would be a strain on policing the streets if a significant number of police officers were unable to work. This would also be true of healthcare systems and military preparedness. For the influenza vaccine, it has been shown to reduce absenteeism by 0.13 (Abramson 2012, 2) to 0.5 days (Imai et al. 2018, 10). At the lower end, absenteeism is not statistically different compared to those who were not vaccinated against influenza (Abramson 2012, 2). At the higher end of absenteeism, the benefit to the healthcare institution of influenza vaccination was economical (Imai et al. 2018, 11), rather than avoidance of being overwhelmed.

Therefore, before a mandate can be ethically considered, there must be a contagious disease with a high morbidity and/or mortality rate with a vaccine that prevents spread and/or prevents the healthcare system from being overwhelmed and/or prevents disruption of public safety or health.

There are other criteria that then must be fulfilled. Immunity from previous infection should be compared to that against vaccination alone in its ability to prevent spread or serious illness. One cannot mandate that someone else receive a vaccine if having had the infection provides the same or better protection. Having varicella (chickenpox) prevents you from getting varicella again for decades obviating the need for vaccination (Centers for Disease Control and Prevention, 2012). If vaccination alone without a past history of infection can be shown to be better than previous infection, then a mandate can be considered.

The length of time that the vaccine protects against serious illness and/or spread should be known. Respiratory viruses like influenza (Komaroff 2023; Morens, Taubenberger and Fauci 2023, 147) mutate frequently thus decreasing the protection of previous infection. Vaccines for respiratory infections like influenza do not provide long-term protection (Morens, Taubenberger and Fauci 2023, 148). This results in the need for vaccine boosters. If of short duration, then the mandate must be timed for the vaccine to be effective when the burden of the infection is at its highest.

The side effects of the vaccine should be acceptable (Opel, Diekema and Ross 2021, 126). If there are serious side effects, how do they compare to the disease itself? For example, while the death rate from the initial smallpox vaccine was 1%, this was better than the 30% death rate from the disease itself. Even 1% became unacceptable once cowpox was found to provide similar immunity with less risk (US National Library of Medicine 2013).

The penalty must be reasonable and commensurate with the effect of the disease on public health. There should be the ability for those who may have moral or religious objections to opt out (National Catholic Bioethics Center, 2022). People should not be coerced into acting against their conscience. Excessive coercion does not respect autonomy and the dignity of the human person. At the same time, recognizing the importance of public health by not allowing exempted children to go to school during an outbreak of a serious illness against which they are not vaccinated (Centers for Disease Control and Prevention, 2022e; National Catholic Bioethics Center, 2022) protects the flourishing of vulnerable children by protecting them against infection. This should occur when the risk of morbidity and/or mortality to them is high or the vaccine prevents spread to the vulnerable as in the case of rubella.

Hurdles can be placed if reasonable. For example, Washington state stated that families had to see a physician and get counselling if they wanted to opt-out, then sign a form. This resulted in a 40% drop in requests for non-medical exemptions (Johns Hopkins Bloomberg School of Public Health, 2021). Those who choose not to be vaccinated are still obligated to accept penalties that reduce the risk to the life of others (Congregation for the Doctrine of the Faith, 2020, #5) when the vaccine prevents spread.

There needs to be an priority supply of vaccine not only nationally, but in the presence of a pandemic, internationally as well. Under duty for the common good, one needs to be concerned about not only one's country, but other countries as well. If not, then the priority should be to protect the most vulnerable worldwide. Barriers to accessing the vaccine should be reduced or eliminated as much as possible, including cost. A lack of vaccine access, nationally and internationally, increases inequities (Johns Hopkins Bloomberg School of Public Health, 2021; Mello, Silverman and Omer 2020, 1298).

All efforts should be made to develop the vaccine as ethically as possible. There is a known ethical problem in association with cells derived from aborted fetal tissue line known as HEK293 (Charlotte Lozier 2021, Carney 2020). While the Novavax states that their vaccine did not use HEK293 (Tin 2022), it was used in the testing (Bangaru et al. 2020, 4). In Catholic teaching, human life must be respected and protected “absolutely” from the moment of fertilization, including the inviolable right to innocent life (Catechism of the Catholic Church, 2016, #2270). Abortion is evil since it is done with the willful intention of destroying that life (Catechism of the Catholic Church, 2016, #2271). Using cell lines derived from an abortion, according to Catholic teaching, amounts to cooperation with evil (Congregation for the Doctrine of the Faith, 2008, #34) which must be avoided unless there are proportionate “grave reasons” and no reasonable alternative (Congregation for the Doctrine of the Faith, 2008, #35). If the HEK293 cell line was used, the vaccine that used it the least in its development and manufacture would be the most ethical choice if available.

Since a vaccine mandate impinges upon autonomy, other, less intrusive methods that do not impinge on autonomy should be tried first before considering a mandate. To have a mandate too soon drowns out the voluntary response and does not give enough time to see if the goal can be reached without it (Johns Hopkins Bloomberg School of Public Health, 2021). If a penalty is to be imposed, it should be the least intrusive means necessary to obtain the desired result (National Catholic Bioethics Center, 2022). This could include fines or the inability to enter certain venues.

When the infection is present at high levels in the community, those who decline to be vaccinated could consider other options including being made to mask when others do not at their place of employment, submitting to increase testing or being made to work from home, even if it resulted in a decrease in pay.

Vaccination goals should be clearly defined. At the same time, public health officials should be open to confessing what is not known.

Why not consider a reward as a nudge if it does not interfere too much with autonomy and the ability to make an informed refusal instead of a mandate with its penalty? Heineken found that offering nachos to those who pledged not to drink and drive reduced the amount of drunk driving by 50% (Heineken, 2018). One suggestion for businesses to improve compliance is to turn it into a game (Lowenthal 2014). This could be tried first.

It should have full approval from the FDA (Gostin, Salmon and Larson 2021,532). Some would add that it needs to be recommended by the Advisory Committee on Immunization Practices (ACIP) since ACIP looks at broader issues such as the values and preferences of affected groups, implementation, and health economic analyses (Mello, Silverman and Omer 2020, 1297). While there are those who argue that full approval is not necessary (Hagan et al. 2022), EUA means that, due to an emergency, the FDA had the ability to approve unapproved medical products or unapproved uses of approved medical products when certain criteria are met, including there are no adequate, approved, and available alternatives as determined by the Secretary of Health and Human Services (HHS) (U.S. Food and Drug Administration, 2023a). Problems not seen initially may take time to discover. Mandates should not be done until the vaccine has at least full approval (Gostin, Salmon and Larson 2021, 532). Turning people into involuntary guinea pigs denies their dignity as human persons.

The conditions for determining an ethical mandate are summarized in Table 1 taking into consideration the common good that allows full flourishing.

Table 1.

Criteria for Determining Morality of a Mandate.

Initial
1. The mortality and/or morbidity of the disease should be significant. It should be highly contagious. The effect on vulnerable populations should be considered.
AND at Least ONE of the following:
2. The vaccine should prevent transmission.
3. The vaccine should prevent the disease overwhelming the healthcare system from a large number of admissions and/or healthcare workers being ill.
4. The vaccine should prevent disruption of other essential services such as public safety or military preparedness.
Mandate–Directed Towards Those Who Fulfill the Initial Criteria (all must be satisfied):
1. Immunity induced by the vaccine alone should be similar to or better than that induced by infection alone.
2. The length of effectiveness of the vaccine should be known or at least monitored for. If of short duration, then the mandate must be timed for the vaccine to be effective when the burden of the infection is at its highest.
3. The burdens (side effects) of the vaccine are significantly less than the disease itself.
4. The penalty should be reasonable and use the least intrusive but effective measure to protect public health. There should be philosophical and religious exemptions.
5. There should be an adequate supply of the vaccine nationally in an epidemic and internationally in a pandemic. If not, then the vaccine should be directed to protecting the most vulnerable. Other barriers should be minimized as much as possible.
6. The vaccine should be ethically produced. If that is not possible, then it should be minimized.
7. The mandate should be imposed only after less intrusive means have failed with vaccination goals clearly stated and adequate time has passed.
8. The vaccine should have at least full FDA approval.

COVID-19 and Vaccine Mandates

How does COVID-19 and its vaccines compare with these criteria? COVID-19 is a serious contagious infection with significant morbidity and mortality among at-risk populations. Its vaccines can therefore be considered for a mandate. Both Moderna and Pfizer have received full FDA approval for everyone over the age of 6 months (Food and Drug Administration, 2023b; Food and Drug Administration, 2023c). ACIP recommends one dose bivalent mRNA COVID-19 with boosters for those at high risk (Moulia et al. 2023). Supply is adequate, though initially third world countries initially had trouble (Austriaco 2021, 319). It is readily available in clinics and pharmacies.

Goals were set, though they changed as information changed. As president-elect, Biden set a goal of 100,000,000 doses in arms during his first 100 days in office (Edelman, Gregorian and Shabad 2020). Later, he set a goal of 70% of adults vaccinated by July 4, 2021 (White House Briefing Room, 2021). While that goal was not reached, by September 2021, 79% of people 5 years of age and older had received at least one dose of one of the COVID-19 vaccines with 92% of those over 65 considered fully vaccinated (Centers for Disease Control and Prevention, 2022a).

The vaccines were initially approved as being effective against preventing symptomatic illness and death (Polack et al. 2020, 3; Baden et al. 2021, 6). This would be the most beneficial among those at high risk as well as those who would most likely overwhelm the healthcare system.

Against COVID-19 Alpha, it was 40–50% effective in reducing transmission after at least one dose of vaccine and after 14 days had past (Harris et al. 2021, 759–760). After the second dose, the effectiveness against transmission was close to 90% which was strong enough to reduce the risk of spread (Prunas et al. 2021, 3–4).

The vaccines became less effective with newer variants, and protection is rapidly lost. With Delta, by 12 weeks, depending on the vaccine, protection was either substantially attenuated or the same as the unvaccinated (Eyre et al. 2022, 1). While there was a decrease in spread between 10 and 90 days postvaccination, it was “highly unlikely” to prevent transmission alone (Prunas et al. 2022, 3–4). In a prison population, even with a difference in rate of infection between the vaccinated, 28%, and unvaccinated, 36% (Tan et al. 2023, 259), it was stated that prisoners and staff continue to be a vulnerable population (Tan et al. 2023, 362).

The problem is that the present vaccines, while protecting the individual, do not produce immunity in the nasal mucosa from which the virus is spread (Russell and Mestecky 2022, 1–8). Dr. Fauci agrees that the COVID-19 vaccines as currently formulated cannot provide long term, protective immunity (Morens, Taubenberger and Fauci 2023, 148). The timing of COVID-19 vaccination becomes extremely important. COVID-19 vaccines have a short duration of effectiveness of 90 days with the greatest rate of waning starting at day 65. After day 84, protection continues to be lost at a slower rate over the next 150–200 days (Braeye et al. 2022, 3031, 3036).

A past history of COVID-19 infection is as effective as vaccination to prevent infection and decreases more slowly than vaccination alone. Immunity is even better when the two are combined (Braeye et al. 2022, 3029–3030). Immunity after infection can last a minimum of 40 (COVID-19 Forecasting Team, 2023) to over 70 weeks (Swartz et al. 2023, 197).

The vaccines are safer than the disease. While there are serious side effects such myocarditis (Patone et al. 2022, 743) and postural orthostatic hypotension (POTS) (Kwan et al. 2022, 1118), they are less than being infected with COVID-19. The incidence of myocarditis is six times more likely from the COVID-19 virus itself than from the mRNA vaccine (Patone et al. 2022, 743) in men under the age of 40. POTS is over five times more likely (Kwan et al. 2022, 1119). These findings would not prevent a mandate.

All COVID-19 vaccines use the HEK293 cell line in either production or testing. HEK294 is derived from aborted embryonic tissue (Charlotte Lozier Institute 2021; Runwal 2021). HEK293 is used widely in medications and research (Runwal 2021). Its use is one reason for requesting a religious exemption. While medical and religious exemptions are allowed, in the past, religious ones were hard to get (CBS Pittsburg, 2021; Lieberman and Kaufman 2022), even though the US Equal Employment Opportunity Commission (EEOC) states that the employer should ordinarily accept the request is sincere and should “thoroughly consider” all reasonable accommodations including telework and reassignment (US Equal Employment Opportunity Commission, 2022, K.12).

While there are known problems with staff shortages due a combination of it being present prior to the COVID-19 pandemic and emotional stresses including burnout (Office of the Assistant Secretary of Planning and Evaluation, 2022), there is no evidence that COVID-19 illness itself had a significant impact on staffing. This reason can not be used when considering a mandate with the latest COVID-19 vaccine approved September 2023.

Given the above criteria and what is known about COVID-19 and the vaccines against it, currently the only group where a vaccine can be ethically mandated are those at risk for severe disease who have never had a COVID-19 infection. This needs to be a known, test-positive infection since the symptoms of respiratory illnesses have considerable overlap. This is with the goal of preventing overwhelming the healthcare system. This would be especially true in long-term healthcare facilities with large numbers of frail patients or where at risk people are in prolonged close quarters such as prisons. Vaccination would need to occur shortly before an anticipated high level of COVID-19 in the community. The problem would be finding a penalty that is generally acceptable and reasonable and not discriminatory or violates privacy.

Since the vaccine does not reliably prevent spread, it cannot be mandated for other low-risk populations such as students who are generally young and, if they do not have underlying health risks, are at low risk of serious disease and death. It is especially true if they have a history of COVID-19 infection. Vaccination alone will not prevent community spread. Studies would need to be done to look at the effectiveness of combining vaccination with other mitigation measures such as masking and social distancing versus mitigation alone.

Children under the age of 12 are less likely to get COVID-19 in the first place and are less contagious when they do (Prunas et al. 2022, 3). Since their symptoms tend to be milder (Zimmermann and Curtis 2020) and since immunity from infection is as protective as the vaccine but much longer lasting, it may be more desirable that they not be vaccinated unless they have risk factors.

HCW are a special class. The likelihood of their exposing vulnerable patients varies widely with their duties from the pathologist in the lab to those who are in closer contact such as nursing home employees. The vaccines need to be compared to other mitigation measures such as masking, hand washing, quarantining infected patients, and staying home when ill. Is the harm from inaction greater than from action (Van Hooster and Bekaert 2019, 4)? Studies should be done that are controlled for compliance with mitigation measures and patient frailty.

There is evidence that the vaccines may prevent disruption in care due to HCW illness from COVID-19. Unvaccinated HCW were absent from work 8 days more than their fully vaccinated colleagues (Strum et al. 2022. 2). Considering that there would be a rise in hospital admissions due to an increase rate of serious COVID-19 infection, this increases the risk that the health care system would not be able to provide quality care. However, since previous infection provides similar and longer protection than vaccination alone, this difference should disappear when the majority of the population has already had an infection.

In a nursing home population, there was noted a decrease in all-cause deaths among nursing homes where vaccination rates were in the highest quartile of staff compared to those with rates in the lowest quartile in August 2021 when there were high levels of circulating COVID-19 virus in the community but no difference in the all-cause deaths when viral levels were low (McGarry et al. 2022, 307–308). What is not known is the vaccination rate of the HCW, patients or visitors in those facilities, the COVID-19 infection rate of the patients, or the effect of the 2 middle quartiles. Nor is it known if there was a difference in mitigation practices between the two or what they were. It is known that, in the community, compliance with mitigation practices such as masks is lower among those who refuse the COVID-19 vaccine than those who do (Lam, Kaplan and Saluja 2022, 3). It has been shown that nursing homes with higher rates of influenza vaccination also have lower death rates during outbreaks of other respiratory infections not covered by it (Abramson 2012, 4; De Serres et al. 2017), suggesting that the difference is more than vaccination alone.

With 97% of its active personnel fully vaccinated (Lieberman and Kaufman 2022) and having a generally young and healthy population without risk factors, to justify a mandate, the military needs to show that infections scattered among the remaining 3% would affect their preparedness since their personnel are at low risk of serious illness and death.

The burden is on those who would impose mandate to justify it. Just because it can be done, it does not mean it should be done (Gostin, Salmon and Larson 2021, 533). It must have a clear stated purpose and end if goals are met or found to be impossible to meet. Concerns, even if not considered legitimate by the imposing party, must be at a minimum considered and addressed. Transparency regarding safety and efficacy, even if benefits are more modest than hoped for (Mello, Silverman and Omer 2020, 1296), is essential to build trust.

Contradictory information only validates the suspicion and concerns of those who are hesitant to be vaccinated (Bardosh et al. 2022, 4). Reasons for changing rationale for vaccination or mandates as new data is received must be clearly stated (Bardosh et al. 2022, 10), working with all stakeholders including those who are concerned about vaccine safety (Mello, Silverman and Omer 2020, 1298). If new data shows that the reasons for the mandate are no longer valid, then the mandate should be cancelled. A mandate that is continued even after it is shown to have less effect in reaching goals than originally stated or hoped for gives the idea that it is to punish and stigmatize the unvaccinated and mold public opinion and compliance rather than guided by science (Bardosh et al. 2022, 9). Mandates should not be used just as a punishment for behaviors we do not like.

Conclusion: COVID-19 Vaccination Mandates and the Common Good

In times of “great dangers” to “the safety of the public,” the government and those nongovernmental entities given that authority do have the power to mandate vaccinations if the mandate is not arbitrary or oppressive and has the means of having a “real or substantial relation to the goal” (Mariner, Annas and Glantz 2005, 583). For a mandate to be ethical, it must be for a disease that causes significant morbidity and mortality. The vaccine must prevent spread or stress on the healthcare system or prevent disruption of essential services to protect the public. The mandates must be effective, proportionate, equitable, and legal (Bardosh et al. 2022, 3). There needs to be robust exemptions for those who refuse for religious and philosophical reasons (National Catholic Bioethics Center, 2022).

Vaccination is based not only on the duty to preserve one's own health but a duty to the common good (Congregation for the Doctrine of the Faith, 2020, #5). This follows the Catholic teaching of duty to care for the common good which allows for the full flourishing of all people, not only physically and mentally, but spiritually as well. The operative words are “for all,” not for the greatest number. That would include consideration of the flourishing of those who choose not to be vaccinated for whatever reason, even if one disagrees with their reasoning. There are those who are willing to risk their lives rather than profit from the intentional destruction of a human life, even if they can not avoid it in other areas.

As of November 2022, it is estimated that 95% of the U.S. population has had COVID-19 (Klaassen et al. 2022). 81% of the total population has received the ACIP recommended one dose and 70% are fully vaccinated as of May 2023 (USA Data Tracker, 2023). If infection alone continues to provide the same immunity as the vaccine and lasts longer, then the need for general mandates at present is minimal. The best time when general mandates were ethical was when it was known that the vaccines did reduce transmission, but by March 2022, that was no longer the case (Eyre et al. 2022; Prunas et al. 2022). Because of this, it cannot be used as a reason to mandate that HCW be vaccinated.

For those who choose not to be vaccinated due to conscience, it does not mean that, because one is obligated to follow the demands of conscience, others must allow that to happen without consequence. People who decline vaccination when mandated must accept the penalty if it is reasonable, even if it results in inconvenience. If the vaccine prevents transmission of the virus and they decline on moral grounds to receive it, then they “must do their utmost to avoid, by other prophylactic means and appropriate behavior, becoming vehicles for the transmission of the infectious agent. In particular, they must avoid any risk to the health of those who cannot be vaccinated for medical or other reasons, and who are the most vulnerable” (Congregation for the Doctrine of the Faith, 2020, #5) since refusal does not release them from their duty to care for the common good.

Excessive penalties can be so coercive as to prevent any autonomous decision. This leads to resentment and further lack of trust due to a feeling that one's conscience was violated and autonomy not respected. It provokes resistance (Bardosh et al. 2022, 10). “No jab, no job” for vaccines that do not alone prevent spread is not only unethical, but excessive compared to the small fine for not receiving the smallpox vaccine which did prevent spread and had 30 times the death rate. If restrictions are considered necessary, they should be the least burdensome possible (National Catholic Bioethics Center, 2022) such as strict adherence with mitigation measures.

Virtue cannot be mandated. Using reasons such as healthcare workers not being vaccinated themselves because of fear that they will be a bad example, feed fear of vaccines, or reinforce vaccine hesitancy (Van Hooste and Bekaert 2019, 3; Hagan et al. 2022) are not enough justification. Stigmatizing those who oppose one's position and using it as a justification for discrimination only further polarizes society (Bardosh et al. 2022, 10). It hardens opposition and reduces trust in those who authorized the mandate. It is unlikely to convince those who are not under the mandate to be vaccinated when they see others being forced to choose between vaccination or supporting themselves and their families. It is unlikely that physicians who accepted vaccination under duress will see themselves as role models and enthusiastically promote the vaccines.

Those in authority should be transparent about the reasons for a mandate and what they know or do not know, what a vaccine can or cannot do, why certain penalties were chosen and why lesser means would not be effective, and at what point the mandate may be lifted. It does not build trust when people in authority like President Biden insist that people be vaccinated to prevent spread months after it was shown that it does not (WHIO TV 7, 2021).

Mandates ethically should not be imposed, even if they are legal, if they cannot meet the criteria in Table 1. As a general mandate, the COVID-19 vaccines do not since it was found in August 2021 that the vaccines modestly prevented infection (Harris et al. 2021, 759–760) and later studies showed it to be even less effective (Eyre et al. 2022, 1). At this time, the vaccines alone will not prevent transmission (Prunas et al. 2022, 4; Tan et al. 2023, 362). The COVID-19 vaccine approved in September 2023 claims only to prevent severe infection, hospitalization, and death (Centers for Disease Control and Prevention, 2023c). Only mandates to vaccinate those at high risk of causing strain on healthcare systems can be considered ethical at this time. Consideration of mandates for HCW without risk factors must be shown to prevent significant absenteeism and weighed against the effect that employees quitting will have on the system. One must take into consideration the fact that, like the rest of the US population, the vast majority will have already had COVID-19 infection so that information from previous years may not be valid and needs to be reassessed.

COVID-19 vaccination mandates should not be used as a method to impose the will of those who believe that the vaccines are in other's best interests. Those in favor of vaccines cannot decide for others what are another's best interests or what is necessary for one's own particular version of thriving, even if they understandably want to prevent those opposed from possibly regretting that decision if they become seriously ill. One should not stigmatize someone for not agreeing with one's own vision of human flourishing.

People of goodwill may come to different conclusions. Each individual must use the virtue of prudence to discern the best option (Austrico 2021, 319). A modest reduction in the ability to infect others may be enough for some to justify a mandate depending on the infectious disease, but not others. Some totally reject vaccine mandates because they argue that vaccination should only be voluntary (National Catholic Bioethics Center, 2022). The Catechism of the Catholic Church #2478 instructs us that we should be “careful to interpret insofar as much as possible” what others think, say, or do in the most favorable interpretation possible (2016). Respect for autonomy and conscientious objection means recognizing differing views of flourishing. Both sides should have epistemic humility and be willing to be surprised by information that challenges and possibly changes their preconceived notions, and then be willing to change.

Biographical Note

Dr. Cynthia Jones-Nosacek, MA, MD is a family physician. She retired from full time practice after practicing for more than 35 years the full range of medicine from obstetrics to hospice, as well as inpatient, outpatient, and nursing home care. She received her medical degree from Loyola-Stritch School of Medicine and did her residency at Resurrection Hospital in Chicago. She is now working as a bioethicist, having received her Master of Arts degree from Ohio State University. She splits her time between the US and mission work in Uganda and is past-president of the Milwaukee Guild of the CMA.