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    Mandatory COVID-19 Vaccination for Healthcare Workers: A Medical, Ethical and Legal Overview for Healthcare Systems and Employers

    By M. Hamza Habib, MD, FACP, FAAHPM, MRCP, Rutgers Cancer Institute of New Jersey, New Brunswick, NJ / Rutgers Law School, Newark, NJ and Hayley Penan, JD, MPH, State of California Office of Legislative Counsel, Sacramento, CA

    Introduction

    Recent data has shown significant apprehension in healthcare workers (HCWs) about receiving a COVID-19 vaccination.1 This has led to low initial vaccination rates among HCWs.2 HCW unease about the COVID-19 vaccines primarily includes worries about the vaccine development process and the vaccines’ safety and long-term side effect profiles.3 Many HCWs have also voiced concerns regarding the speed of, and suspected political interference in, the vaccine development process.4 Although the manufacturers of the three currently authorized vaccines have released data on vaccine safety and efficacy, it does not seem to be enough to allay these fears.5

    HCWs are primary caregivers to the most vulnerable patient populations in large healthcare systems, hospitals, nursing homes, and clinics. Their stance on vaccination not only affects their patients, but also affects the general public's perception of these vaccines.6 In addition, it can significantly affect the efficiency of a healthcare system if some part of its workforce is constantly out sick, or if employees continue to infect their coworkers or patients. Not only can this be a financial burden, but it can create ethical and legal issues for these employers. This scenario puts the employers and employees in healthcare in a very precarious situation.7

    This article looks at the current vaccination numbers in HCWs and outlines HCW concerns about getting the COVID-19 vaccine. It then discusses the ethical premises and legal precedents governing these issues. Finally, it provides strategies for healthcare systems and other healthcare employers to effectively manage these issues based on current data and existing law.

    Who is a Healthcare Worker?

    Although the phrase “healthcare worker” is commonly associated with doctors and nurses, the reality is that healthcare delivery relies upon a range of clinical and non-clinical workers performing a variety of roles. According to the federal Centers for Disease Control and Prevention (CDC), there are about 18 million HCWs in the United States.8 The question of who is categorized as a HCW has come to the forefront of discussions around HCW vaccine prioritization, and has important implications for who gets access to the COVID-19 vaccine and when. Per the CDC’s definition, healthcare personnel includes all paid and unpaid persons serving in healthcare settings who have the potential for direct or indirect exposure to patients or infectious materials such as medical specimens or waste products.9 This definition covers acute care facilities, long-term acute care facilities, inpatient rehabilitation facilities, nursing homes and assisted living facilities, home healthcare, mobile clinics, and outpatient facilities, such as dialysis centers and physicians’ offices.10

    In a sprawling U.S. healthcare system, this definition covers all personnel working as on-site patient appointment schedulers, medical assistants, transporters, hospital food delivery workers, pharmacy workers, medical social workers, dietitians, case managers, lab workers, facility management and janitorial staff, mobile clinic workers, home healthcare staff, dialysis center workers, and physical/occupational therapists.11 It also includes medical administrators and any staff working in hospitals, clinics, nursing homes and assisted living facilities, labs, dialysis/infusion centers, and physical therapy units.12 Based on recommendations from the CDC’s Advisory Committee on Immunization Practices, an independent panel of medical and public health experts, the CDC recommends that all of these healthcare personnel be among the first of those offered the first doses of COVID-19 vaccine.13

    Data on COVID-19 Vaccination in Healthcare Workers

    As of March 23, 2021, COVID-19 has caused 540,503 deaths in the United States.14 It has had a significant detrimental effect on the economy and daily social life in this country, and around the world. HCWs have been at the forefront of clinical management and treatment of COVID-19 patients since the first COVID-19 cases were reported in the United States in January 2020.15  From the beginning of the COVID-19 pandemic to March 16, 2021, about 446,110 HCWs have been infected with COVID-19 and 1,450 HCWs have died from the disease.16 With such a high rate of infection, and the risk of further transmitting the infection to the most vulnerable patients, it was logically and scientifically sound to have HCWs be the first-line recipients of the recently authorized COVID-19 vaccines.17 According to federal data, during the first month after approval, almost 11 million vaccines were distributed in the country, but surprisingly, as of January 25, 2021, only two million vaccines had been actually given to HCWs in total.18 This is approximately 12 percent of the U.S. healthcare workforce.19

    This is obviously a very small percentage, so the question arises: what is the hold-up in receiving these vaccines, especially when personal protection and patient safety are the main deliverables in this process? It is correct that the vaccination rollout and execution process has been relatively slower than expected from federal and state agencies, but there is also significant hesitancy to receive the vaccine on the part of some HCWs.20

    Vaccine Efficacy Data

    Uncertainty about vaccine efficacy, both real and perceived, is a major obstacle to HCW vaccination. However, data for the currently approved Pfizer/BioNTech, Moderna, and Janssen vaccines is for the most part reassuring. On December 12, 2020, the CDC published emergency use authorization (EUA) data on the Pfizer mRNA (messenger Ribonucleic Acid) COVID-19 vaccine showing 95.0 percent efficacy in protecting against the first COVID-19 strain (compared to a placebo) with its two-dose vaccine regimen given 21 days apart.21 Data on serious adverse events were balanced between the vaccine and placebo groups (Relative risk ~ 1.14).22 Most side effects ranged from mild to moderate. There were two reports of serious adverse events related to vaccination among over 21,000 vaccinated people.23 Common side effects included fever, chills, tiredness, and headache, all of which were more common after the second dose of the vaccine.24 A small proportion of allergic reactions were also observed, mostly in people with prior history of allergic reactions to medications.25

    About a week later, on December 20, 2020, the CDC published EUA data for the Moderna mRNA COVID-19 vaccine, showing 94.1 percent efficacy in protecting against the first COVID-19 strain (compared to a placebo) with its two-dose vaccine regimen given 28 days apart.26 Similarly, most side effects were mild to moderate. The most commonly reported side effects were pain at the injection site, tiredness, headache, muscle pain, chills, joint pain, and fever, which were likewise more common after the second dose.27 The allergy profile was similar to that for the Pfizer vaccine.28

    On February 27, 2021, the CDC published EUA data on the one-dose Janssen COVID-19 vaccine, an adenovirus-based vaccine (as compared to the Pfizer and Moderna mRNA vaccines).29 The data shows a 66 percent efficacy for symptomatic laboratory-confirmed COVID-19, 74 percent efficacy for asymptomatic seroconversion, 93 percent efficacy against hospitalization as a result of COVID-19, and 75 percent efficacy against all-cause death.30 Similarly, most side effects reported were mild to moderate, including pain at the injection site, redness, swelling, tiredness, headache, muscle pain, chills, fever, and nausea.31

    HCW Perception of Vaccine Data

    Although the vaccine efficacy and safety numbers above are impressive, a sizable percentage of HCWs appear hesitant or unwilling to be vaccinated. A CDC poll from November 2020 revealed that about 37 percent of HCWs surveyed were unsure about getting the COVID-19 vaccine.32 Another poll conducted by the American Nursing Association of 13,000 nurses showed that one-third of them were unsure about whether or not they wanted to receive the vaccine, or would not get the vaccine voluntarily.33 A survey at UCLA Medical Center demonstrated similar results, finding that only 66 percent of its HCWs wanted to get the vaccine.34 Likewise, a New Jersey poll showed that about 66 percent of HCWs were willing to get the vaccine.35

    Typically, most HCWs have better health literacy than the general population and would have a higher likelihood of being informed about, and understanding, this medical data about the COVID-19 vaccines.36 Given the relatively safe profile of the vaccines, their high effectiveness, and the health literacy of the HCW population, why are HCWs so apprehensive about becoming vaccinated? This is especially puzzling when considering the excellent HCW compliance with flu shot vaccinations and Tuberculin testing for tuberculosis performed annually at most healthcare systems.37

    The most commonly stated concerns are addressed below.

    Unusually Rapid Development of the Vaccines

    The COVID-19 vaccines were developed quickly in response to the urgency of the pandemic. Typically, vaccine development takes about 10 years.38 This timeframe includes an exploratory stage between two to four years, where a certain virus’s protein or external capsule structure is studied for its antigenic properties in producing protective human antibodies.39 Then pre-clinical animal trials are conducted to ensure the safety and protective capabilities of the vaccine.40 Successful completion of animal testing is followed by application to the federal Food and Drug Administration (FDA) for Investigational New Drug (IND) approval. After IND approval, the vaccine is subject to three phases of testing in humans.41 Phase 1 involves the evaluation of safety in a relatively small number (about 20 to 80) of human candidates. This is followed by phase 2 that involves evaluating the protective efficacy of the vaccine in a larger group of human candidates (at times several hundred). A successful phase 2 study is followed by a phase 3 study to gather safety and efficacy data in a much larger human group (usually in the thousands). If successful, then following subsequent approval from the FDA, the drug is marketed for commercial human use.42 The comparatively short timeframe of the COVID-19 vaccines has prompted HCW concerns about the vaccines’ safety and efficacy.43

    Lack of Long-Term Safety Data/Special Populations

    A full phase 3 trial usually takes a few years of post-vaccination follow-up to identify any long-term safety issues. This becomes even more important here, since mRNA vaccine technology is relatively new, and there is currently no prior long-term use or safety data in humans for any other disease. But due to the disastrous effects of the COVID-19 pandemic across the country, these vaccines were fast-tracked with the hopes of early public access.

    The absence of this important data has raised questions about the long-term safety of these vaccines, especially in HCWs who are the first in line to receive them.44 In addition, pregnant patients and breastfeeding mothers were not included in the clinical trials for safety reasons. This has created further concern among HCWs who are pregnant, planning to become pregnant, or who recently gave birth.45

    Political Interference in the Vaccine Development Process

    The divisive political landscape of 2020 left its mark across the fabric of American society, and shaped public perceptions of the vaccine approval process. In particular, rapid vaccine development was linked in the media and political/social discourse to expected voting gains for the governing administration.46 Such information has been discredited by the vaccine manufacturers and federal agencies.47 However, fear about political interference in the development and proliferation of COVID-19 vaccines has caused further skepticism in HCWs regarding the safety and efficacy of these vaccines, and led to lower vaccination rates among this population.48

    New Technology Concerns: First mRNA Vaccine to be Developed for Public Use

    Although mRNA vaccines have been researched since the 1990s, they have rarely been used clinically.49 Pfizer/BioNTech and Moderna are the first mRNA vaccines for public use.50 Because of this novelty, the public perception of mRNA vaccines has been influenced by the spread of false rumors and misconceptions.51 For example, one rumor (from Facebook and other forums) suggests that RNA vaccines can lead to genetic mutations and a significant increase in the risk of passing these faulty and mutated genes to one’s offspring.52 Although this concern is conceptually dubious and unsubstantiated by any evidence, it has nonetheless caused significant concern in HCWs who are first in line to receive these vaccines.53

    Changing Guidelines/Non-Uniform Strategies from Federal and State Agencies

    The lack of reliable guidelines for the prevention and care of COVID-19 has also prompted HCW doubts about vaccination. Since the beginning of the pandemic, federal and state government guidelines regarding masks, social distancing, and stay-at-home orders have been inconsistent and at times conflicting.54 Likewise, hasty reports hailing the efficacy of drugs such as Hydroxychloroquine have been followed by reports of unproven effectiveness or even inferior outcomes. These shifting medical recommendations and their consequential failures have primed HCWs to regard vaccine guidelines with similar skepticism.55

    Prior Research Exploiting Black People and Other Ethnic Minorities

    Black and Latinx individuals constitute about 13 percent and 20 percent of the U.S. population, respectively.56 In clinical trials for the Pfizer and BioNTech vaccine, 10 percent of study participants were Black. In the Moderna vaccine trials, 20 percent of participants were Latinx and 10 percent were Black.57 This participant make-up is ethnically much closer to the U.S. ethnic demographic ratio than most other vaccines in current use.58

    However, the United States has continued to grapple with the ramifications of centuries of systemic racism and inequality, including ongoing exploitation of Black, Indigenous, and other People of Color (BIPOC). In particular, the trauma of the Tuskegee Syphilis experiments (1932-1972) continues to impair trust in the medical field among Black people.59 In those experiments, the government researchers recruited hundreds of Black men already afflicted with Syphilis without informing them of the purpose of the study and with no intention of providing treatment for their Syphilis.60 Even when Penicillin became the drug of choice to cure Syphilis 10 years into the trial, the subjects were still not told they had Syphilis nor provided with Penicillin.61 The lack of treatment eventually led to the deaths of 128 Black study participants and uncounted infections of family members and others (reports of at least 59 have been confirmed).62 Revelations about the Tuskegee experiments in 1972 resulted in public outcry and a class action lawsuit, and eventually led to the development of modern institutional review boards.63

    BIPOC individuals continue to experience racism and disparate treatment in the healthcare system to this day.64 It is thus understandable that many BIPOC individuals have a deep mistrust of the healthcare system. This mistrust is a big deterrent to HCWs of color being early recipients of the COVID-19 vaccines.65

    Conspiracy Theories on Social Media

    As a readily accessible source of information, social media has also facilitated the spread of disinformation and rumor. The typical American spends an average of two hours and eight minutes connected to social media every day.66 Social media has come to play an important role in how people connect with each other, consume news and other media, and stay up to date on social events and cultural phenomena. Although Facebook, Twitter, and Instagram have actively been stemming out false links about the safety and efficacy of vaccines, new conspiracy theories crop up faster than these platforms can moderate them.67 Exposure to such false and misleading information may cause concern in prospective vaccine recipients, including HCWs.68

    Waiting for Herd Immunity

    Many HCWs are refusing to get vaccinated because they would prefer to instead wait for herd immunity to develop.69 Herd immunity is a form of indirect protection from infectious disease that occurs when a sufficient percentage of a population has become immune to infection.70 Herd immunity works in preventing the spread of the disease, and it can come from either contracting the actual disease or receiving the vaccine. When large enough percentages of a given population become immune to a disease, it indirectly protects others in the population who have not developed this immunity, (i.e., if enough people get vaccinated against COVID-19, it will also protect those who have not been vaccinated against COVID-19 because the disease cannot spread within the population due to the levels herd immunity achieved).71

    However, it is important to note that with limited data on COVID-19-related herd immunity in larger communities, we do not yet have evidence that it will provide much individual protection in the long term. In addition, the newer COVID-19 strains like the UK and South African variants will likely make it harder to achieve herd immunity on a global scale.72 Most importantly, herd immunity does not confer safety on an individual basis.73 Despite the evidence against this strategy, some HCWs have expressed the preference to wait for herd immunity to develop rather than get vaccinated themselves.74

    Allergies and Intolerances

    Food and medication allergies on an individual level are a commonly stated reason by HCWs for not being vaccinated.75 From a clinical standpoint, having had a previous medication allergy has been associated with a slightly higher chance of an allergic reaction after receiving a COVID-19 vaccine.76 Although the absolute risk is low, fear of allergic reaction has been a big deterrent to voluntary vaccination.

    It is important to differentiate between true allergies and temporary intolerances from vaccines. True allergies that can quickly progress to full-blown anaphylaxis, causing immediate life-threatening circulatory and respiratory compromise, are a serious risk in some rare cases.77 But intolerances in the form of side effects like nausea, low grade fevers, and fatigue are more common, usually short lived, less serious, and easily managed with short use of over-the-counter medications.78 Based on the currently available vaccine data and the safety parameters for administration of these vaccines (e.g., clinical monitoring for 15 minutes after vaccine dose administration and the presence of anti-allergic medications at vaccination sites to counter these rare but extreme allergic reactions) should minimize and rapidly correct any harsh allergic reaction issues on site.79 Despite the relatively low risk of experiencing a dangerous allergic reaction and the safety precautions for vaccine administration, it is still a significant concern for many HCWs, and misunderstandings about allergies versus side effects may be further exacerbating these fears.

    Medical Martyrdom and Sacrifice

    It is a common trope that HCWs have been known to be self-sacrificing to cover the needs of others, especially when it comes to their patients. This phenomenon has been well noted in times of war, past pandemics, and other large scale crises.80 In some HCWs, the logical extreme of this sacrifice of self for others has manifested in a view that the best way HCWs can help others is to save the limited doses of the available vaccine for those they perceive to be most in need—their vulnerable patients.81

    HCWs are also overrepresented in the numbers of those who have already had COVID-19, and may believe that prior infection already offers them protection. HCWs represent one in seven reported COVID-19 cases around the globe.82 However, there is a lack of sufficient data from which to draw definitive conclusions about individual immunity following infection.83 HCWs may nonetheless believe that they are still protected, and that the right course of action is to forgo getting an available vaccine so that it can go to someone else who has not already been exposed.

    Medical Ethics and Mandatory Vaccination

    The concerns articulated above provide serious dilemmas for employers and employees in healthcare settings around the country. In addition to the moral and ethical issues arising from  HCW concerns, there are concerns raised by the nature of a mandatory vaccine requirement by a healthcare employer. A vaccine mandate raises both legal questions and ethical questions regarding the duties of employers to protect individual employees while respecting their autonomy. At the same time, healthcare delivery organizations also have a duty to protect patients within their care. In order to fully dive into these issues, it’s important to understand the ethical models that inform them before assessing potential strategies to counter HCW concerns about COVID-19 vaccination.

    Fiduciary Responsibility of HCWs to Patients

    HCWs have a fiduciary responsibility to their patients to take all possible precautions and “follow all reasonable, evidence-based, best practices to ensure patients’ safety.”84 There are two main ethical models that have been used in analyzing the role of vaccines in HCWs’ duties to their patients: the Hippocratic Model, or HCW-patient relationship-focused model, and a public health model.

    Hippocratic Model

    Two widely accepted principles of Hippocratic medicine guide these duties: promoting the wellbeing of one’s patients and doing no harm to one’s patients.85 It is clear that taking an available vaccine for a communicable disease reduces the likelihood of HCWs transmitting that communicable disease to their patients, thereby reducing the likelihood of harming a patient. Under this framework, it can be argued that HCWs have a duty to their patients to take all reasonable steps to protect their patients from harm that could be caused by the HCW, such as by transmitting a communicable disease for which a vaccine exists. However, the Hippocratic Oath is also based on principles of autonomy and is centered on the individual HCW’s duty to the HCW’s patients, so the idea of a mandatory vaccine that elevates this moral imperative to a mandate, irrespective of the individual autonomy of the HCW and the specifics of the environment the HCW works in or the patients the HCW serves, may go beyond the bounds of the Hippocratic Oath framework.86

    It is worth noting that not all HCWs take a Hippocratic Oath—it is primarily a physician-focused oath.87 Nursing and other allied health programs often include an oath of some kind, such as the Nightingale Oath, which includes the same types of ethical obligations to care for and protect patients.88 However, large swaths of individuals who are considered HCWs for vaccination purposes based on the nature of their jobs, such as those cleaning hospital rooms and serving food to patients in cafeterias, take no such oath and are not bound by professional licensure or culture to traditional notions of Hippocratic duties.

    Public Health Models

    Public health ethical models tend to take a more systemic approach rather than focusing on the individual HCW-patient relationship and corresponding duties. Two interesting public health approaches to consider are the “New Ethics” and “Components of Justice” Models.89 The “New Ethics” Model shifts to a more public health perspective than the clinical doctor-patient focused approach of the Hippocratic Model. It promotes “prevention and [] optimizing public health, not [] individual outcomes.”90 This ethical framework appears to favor even more strongly the idea of a mandatory vaccine for HCWs, focusing on the importance to the broader public health of widespread vaccine use rather than on the importance of the individual HCW’s duties to protect the HCW’s patients. On the other hand, some argue that the public health model does not support a vaccine requirement for HCWs because there is no direct evidence that HCWs receiving vaccines prevent disease in patients.91

    The Components of Justice Model builds on the systemic view taken in the New Ethics Model, but starts with the underlying presumption that “we have a duty to protect the vulnerable.”92 This also builds on the general fiduciary duties that HCWs have towards their patients, but adds this extra layer of duty to protect the vulnerable. Under this ethical framework, it is argued that HCWs should take a comprehensive approach to protect their vulnerable patients, including by taking available vaccines to reduce the potential likelihood of transmitting to a patient a disease that could have been prevented by the vaccine.

    Ethical Considerations Regarding the Impact of Mandates on Vaccine Use for Influenza

    While there are individual and systemic ethical concerns for HCWs with respect to whether to take a vaccine, there are also ethical considerations for healthcare employers. These considerations are largely based on the same two model categories discussed above: the responsibility to the individual patients and the responsibility to the broader public health. Employers also have an additional ethical duty to their employees, including the duty to create a safe environment for both the individual employee, and the coworkers of each individual employee, while also respecting the individual autonomy of all of their employees to the extent practicable.

    In thinking about these duties and the broader public health, it’s important to consider the impact that a vaccine mandate would have on the number of employees receiving the vaccine. With respect to the influenza vaccine, studies have shown that if an employer requires the vaccine, 85 percent of employees get vaccinated, compared to 43 percent that get vaccinated in the absence of a vaccine requirement.93

    One hospital system, Midwest-based Essentia Health, is an interesting case study in vaccine requirements. Initially, by using incentives and encouraging employees to get the flu vaccine, Essentia was able to vaccinate 70 percent of its employees without a vaccine requirement.94 Then Essentia Health created a mandatory participation model where every employee had to respond with a yes or no regarding getting the vaccine, which pushed the percentage of employees vaccinated up to 82 percent.95 Now Essentia Health requires the flu vaccine, with exceptions for religious or moral objections and disability objections, as required by law, and has a 99.5 percent “compliance rate” from employees, though the actual percentage of vaccinated employees was not made publicly available.96 It is important to note that this may in significant part be due to the fact that Essentia Health had a strict compliance policy when it instituted the requirement, terminating 50 employees who refused to comply. Based on its clearly stated employment policy, Essentia successfully defended these terminations.

    Legal Framework for Healthcare Employer Vaccine Mandates

    There are a number of legal frameworks that govern these kinds of employer requirements and any potential adverse action taken by an employer against an employee for failure to comply. Courts have long upheld the constitutionality of vaccine mandates, both in the context of a broad state mandate and in the specific cases of healthcare employers requiring the influenza vaccine for their employees. It is important to note, however, that none of the cases addressing these issues have considered a mandatory vaccine requirement with respect to a vaccine that has only received EUA, as compared to approval through the typical full-length approval process for drugs through the FDA cited above.

    In 1905, the Supreme Court decided the seminal mandatory vaccination case of Jacobson v. Commonwealth of Massachusetts, holding that the state’s decision to require that all of its citizens receive vaccinations for smallpox in response to the smallpox pandemic was a constitutional exercise of the state’s police power, which includes the authority to enact reasonable laws to protect public health and safety, and thus was not an unconstitutional infringement of the rights of the citizens of Massachusetts.97 While this case is focused on government, and not private employer mandates, it provides the context for how we think about vaccine requirements in this country: there are some situations where mandatory vaccines are needed to protect the public health, but there is a weighing of the rights of the individual against the government’s duty to protect the public health that is critical to the analysis. This weighing of rights and duties is also a core part of how employee rights and employer duties are conceptualized. 

    OSHA Workplace Standards

    The federal Occupational Safety and Health Act (OSHA) and many state laws require employers to provide a workplace without serious recognized hazards.98 As part of this duty, known as the “general duty clause,” some employers may choose to require vaccines for HCWs. OSHA generally allows employers to require vaccinations if the requirement is job-related and consistent with business necessity, so long as employees are “properly informed of the benefits of vaccinations.”99

    However, U.S. Equal Employment Opportunity Commission (EEOC) guidance provides that while vaccine requirements are allowed, “ADA-covered employers should consider simply encouraging employees to get the influenza vaccine rather than requiring them to take it.”100

    This creates a tricky situation for an employer where a vaccine mandate would further its duty to provide a workplace without hazards, one of its essential duties under OSHA, but at the same time is discouraged by the EEOC from instituting mandatory vaccine requirements for its employees.101 OSHA has established safety standards that employers must comply with, but there is precedent indicating that an employer may be held responsible for violating its general duty clause if the employer knows of an obvious hazard and does not take steps to mitigate the associated risks, even if the employer is complying with all applicable OSHA safety standards.102 It is unclear whether this would extend as far as making a healthcare employer liable for failing to require a vaccination in a healthcare environment where the risks of contracting a communicable disease for which there is an available vaccine are known and substantial, but there is definitely an argument to be made that an employer who “fails to at least encourage and enable at-risk employees to be vaccinated may violate OSHA’s general duty clause.”103

    Disability Protections

    The EEOC offers guidance on how an employer should respond if an employee, including a HCW employee, refuses to get the flu vaccine on the basis that the employee is unable to receive the vaccine because the HCW has a disability. The EEOC, among other duties, is the agency responsible for enforcement of the Americans with Disabilities Act (ADA).104 The ADA protects against discrimination on the basis of disability, and defines an individual with a “disability” to mean an individual with “a physical or mental impairment that substantially limits one or more major life activities of such individual.”105

    Under the ADA, an employer may have a “qualification standard” if it is “a requirement that an individual shall not pose a direct threat to the health or safety of individuals in the workplace.”106 However, if a qualification standard, such as a requirement that an employee take a vaccine, would disqualify someone with a disability, an employer must be able to demonstrate that the failure to comply with the vaccine requirement would cause a “significant risk of substantial harm to the health or safety of the individual or others that cannot be eliminated or reduced by reasonable accommodation.”107 The EEOC concludes that if an employer determines that there is a “direct threat that … an unvaccinated individual will expose others to the virus at the worksite,” the employer may exclude that individual from the workplace only if there is no reasonable accommodation, such as working remotely, that can be made so that the employee may continue working without posing a direct threat to others at the workplace.108 Exclusion from the workplace does not necessarily mean that the employer can terminate the employee for this reason. Some employees may instead be eligible to telework, if possible, or to take leave under the Family Medical Leave Act,109 the Families First Coronavirus Response Act,110 or under any applicable leave policies of the employer, until herd immunity levels are achieved and the risk of transmission by the unvaccinated employee is minimized.111

    Exemption: Religious or Moral Belief Protected under Title VII

    Title VII of the Civil Rights Act of 1964 protects an employee who refuses to receive a vaccine due to a sincerely held religious or moral belief, observance, or practice. This would apply to a HCW employee who refuses to get the COVID-19 vaccine due to a sincerely held religious or moral objection to receiving it. If a HCW employee refuses to be vaccinated due to a religious or moral objection, the employer must provide a “reasonable accommodation” for the religious or moral belief unless it would cause an undue hardship on the employer, which courts have defined as “more than a de minimis cost or burden on the employer.”112 EEOC guidance explains that a religious or moral belief is interpreted broadly and that “the employer should ordinarily assume that an employee’s request for religious accommodation is based on a sincerely held religious belief” unless the employer has an “objective basis” for questioning the belief’s sincerity, in which case the employer may ask for supporting information. Federal regulations based on Supreme Court precedent provide that what qualifies as a religious practice includes “moral or ethical beliefs as to what is right and wrong which are sincerely held with the strength of traditional religious views.”113

    In interpreting this standard, courts have found that what qualifies as a religious belief for these purposes is fairly broad. In Chenzira v. Cincinnati Children's Hospital, a federal court in Ohio denied a hospital employer’s motion to dismiss a case brought by a hospital employee who claimed an exemption on religious grounds from the hospital’s flu vaccine requirement on the basis that the vaccine was made from animal byproducts and the employee was vegan.114 In denying the employer’s motion, the court noted that it was “plausible the [plaintiff employee] could subscribe to veganism with a sincerity equating that of traditional religious views,” and thus the employee’s veganism could qualify as a sincerely held religious belief under Title VII of the Civil Rights Act.115

    If the employee’s refusal to get vaccinated is based on a sincerely held religious or moral belief, the employer must provide a reasonable accommodation, if possible, and may only exclude an employee from the workplace if a reasonable accommodation is not possible. Again, excluding an employee from the workplace does not necessarily mean that the employer can terminate the employee, but in some cases termination may be acceptable. An example of these constraints can be seen in the 2016 decision, Robinson v. Children’s Hospital of Boston, in which a federal district court in Massachusetts granted a hospital employer’s motion for summary judgment on a claim by a former hospital employee who was terminated for failure to obtain the flu vaccine, in violation of the hospital’s mandatory flu vaccination policy for all patient-facing employees.116 The employee was a patient-facing employee working in the hospital’s emergency department who objected to being vaccinated on religious grounds (because of pork byproducts used in creating the vaccine) and then later, objected based on a medical exemption based on a past vaccine reaction.117 The hospital gave the employee time to gather required medical documentation, and offered to provide the employee with an alternative version of the vaccine that did not contain pork byproducts, but the employee did not provide the necessary documentation and still refused to get vaccinated, so the hospital terminated the employee, treating the termination as a voluntary separation so as not to bar the employee from reapplying for another position at the hospital in the future.118 In deciding the summary judgment in favor of the employer, the court discussed that the hospital had gone above and beyond to try to accommodate the employee, but given that the employee was in a patient-facing role, it would be considered an undue hardship on the employer to accommodate the employee’s request to not receive the flu vaccine.119

    Current Employer Stance on Compulsory Vaccination against COVID-19

    Most legal officers in healthcare settings have been active on the issue of mandatory vaccinations over the last few months, and have used the above described ethical and legal frameworks to find a middle ground with their employees. At this point, most healthcare systems believe that mandating the vaccine for all HCWs is not currently necessary.120 They are waiting for more data and also looking at their own infection numbers to evaluate whether compulsory vaccination for all HCWs is necessary.

    As an example, a recent survey of New Jersey and Pennsylvania healthcare systems confirmed this trend. A Temple University spokesperson has stated that Temple’s goal is to educate its employees on the importance of vaccination, rather than pushing for mandatory vaccination.121 Similarly, a Penn Medicine spokesperson stated that Penn will continue to refine its policies on this matter as more data and approvals from the FDA come into the public eye.122 Likewise, Jefferson Health Care System wants to keep vaccination voluntary at present.123 On a statewide level, the New Jersey and Pennsylvania health commissioners have publicly stated that they believe it's too early to mandate vaccinations for HCWs, and that more data is needed to make a determination about the value of a vaccine mandate for HCWs.124

    Strategies for Improved Voluntary Vaccination Rates

    It seems that voluntary vaccination is the approach most hospitals are adopting. At the same time, it is important that healthcare systems and other healthcare employers set aside resources to better understand their employees’ concerns about vaccination and adapt a multifaceted strategy to help alleviate these concerns.

    Improving Education/Incentivizing

    Instead of mandating that employees get vaccinated, many hospital systems are looking at working with HCWs to educate them and convince them to get the vaccine voluntarily.125 The following are some examples of the strategies that have been employed.

    Meetings with HCWs and Leadership

    In many large hospitals and healthcare systems, the health entity’s leadership is taking time to hold regular town halls with its employees to help allay their fears about the vaccines. For instance, in one Minnesota healthcare system, physician and nursing vaccination rates have been above 80 percent, but only in the 40 to 60 percent range with respect to other hospital staff and employees that provide ancillary services. The health system has brought in its leading infectious disease specialist physicians and employee union leaders to talk to employees about the effectiveness and importance of the vaccine, which has been noted to help allay employees’ fears regarding vaccination.126

    Vaccination of Leadership

    In addition to holding regular leadership meetings with staff to answer questions about the vaccine, having hospital leaders themselves getting vaccinated, especially publicly, sends a strong message to the hospital staff. On the national level, seeing the country’s leadership like then President-elect Joe Biden, then Vice President-elect Kamala Harris, and then Vice President Mike Pence be vaccinated on live television has gone a long way in assuaging fears about these vaccines. On an anecdotal note, in the hospital where one of the author’s works, Robert Wood Johnson University Hospital in New Jersey, seeing Dr. Anthony Fauci getting vaccinated helped employees gain confidence and increased vaccination numbers among clinical staff.127

    Open Data Strategy

    Although the CDC data is very helpful in answering most questions that employees may have about the COVID-19 vaccines, an employer may wish to also consider using its own vaccination data to demonstrate the minimal side effects and lower COVID-19 positivity rates in vaccinated staff, as this data becomes available. Sharing data from the employer’s own community that reinforces the benefits and confirms the low risks may help encourage employees to get vaccinated voluntarily.128

    Education and Engagement

    Creating incentives for employees may improve compliance with voluntary vaccination. This could potentially include insurance rate discounts, future savings on healthcare coverage, or pure monetary incentives. Even personalized thank you notes of encouragement and support, coffee gift cards, and cafeteria coupons as a thank you to staff for choosing to get vaccinated may help to incentivize employees.129

    Minimizing Work Disruption

    Employers need to minimize work disruption due to the vaccine. This includes educating management about work disruption issues associated with vaccination. The following points from the CDC guidelines for employers provide some practical tips for managing large scale vaccinations for hospital or healthcare system staff:

    • Vaccinating HCWs on days preceding weekends of their regular days off so that they are not scheduled to come into the facility on the day or days following vaccination, in case they experience any side effects.
    • Staggering vaccine delivery for HCWs in the facility so that not all HCWs in a single department, service, or unit are vaccinated at the same time. Staggering considerations may be more important following the second dose (for the two-dose vaccines) when systemic symptoms after vaccination, such as fever, are more likely to occur.
    • Informing HCWs about the potential for short-term systemic signs and symptoms post-vaccination and potential options for mitigating them if symptoms arise (e.g., nonsteroidal anti-inflammatory medications or acetaminophen, as tolerated based on comorbidities and medical history). Making these available at no cost to HCW employees may also be a good strategy for helping to facilitate a smoother and painless vaccination process.
    • Developing a side effect hotline for employees to provide timely assessment of post-vaccination clinical symptoms.130

    Paid time off

    Vaccination prior to the weekend may help employees get some time off to recuperate from any vaccine side effects without disrupting the regular work schedule at the hospital or health system, but in some cases it will not be practicable or sufficient to rely on existing day off schedules.131 Employers can also make extra paid time off (in addition to what employees are annually entitled to) available for a reasonable amount of time for employees who experience clinical symptoms from vaccine side effects that preclude them from working effectively.132

    Working with ADA/Title VII Protections

    From a liability standpoint, employers need to continue to comply with federal law. This includes not developing any policies or taking any actions that run afoul of the ADA, Title VII, or EEOC or OSHA guidance that would expose the employer to legal liability.133

    Staying Up to Date with CDC and FDA Guidance

    As the vaccine becomes more widely available and more data about efficacy and risks is developed, epidemiological researchers focused on COVID-19 will gain an even better understanding of the important role that the vaccines are playing in combating the spread and the risks of serious complications from COVID-19. Therefore it is imperative for employers to stay up to date on the most current data, as well as on forthcoming CDC and FDA guidance, that may help them develop their own vaccination policies and educational tools for employees.134

    Other Factors for Employer Consideration

    In addition to the legal considerations outlined above, employers need to look at certain other practical factors before deciding whether or not to implement a mandatory vaccine policy.

    Emergency Use Authorization Status

    All current COVID-19 vaccines were approved through EUAs, and have not yet been subjected to the more extensive FDA approval processes that require long-term safety and clinical data. So from a clinical standpoint mandating the vaccine for all HCWs may not be fully supported at this point in the absence of such long-term data. This makes the COVID-19 vaccines significantly distinguishable from other vaccines, such as the influenza vaccine, that have been mandated for employees in many healthcare settings and were approved through the full FDA approval process.135

    State and Local Laws

    States and localities across the United States have taken a wide variety of approaches to combat COVID-19 over the last year, and have different baseline legal infrastructures governing activities conducted in their state or local jurisdiction. Each health facility should stay apprised of the state and local laws governing the entity as it considers taking actions to encourage, or require, vaccinations for its HCW employees.136

    Unionized Employees

    According to the U.S. Bureau of Labor Statistics, about 20 percent of registered nurses and licensed practical nurses are unionized in healthcare settings, and a total of about nine percent of HCWs overall are unionized.137 Healthcare employers need to keep any applicable unions in the loop with the employers’ COVID-19 vaccination policies. Unions may push back if vaccines are mandated by a health employer. The employer should work closely with the employee unions to keep its finger on the pulse of employees’ concerns about vaccination requirements and facilitate a smoother transition to a mandated vaccination process in the future, if the entity deems it to be necessary.138

    Staffing Crunches

    According to data from the U.S. Department of Health and Human Services from late 2020, there is a critical shortage of staff in more than 1,000 hospitals in the nation, with, for example, more than 50 percent of hospitals in North Dakota showing critical staffing shortages.139  Missouri, New Mexico, and Wisconsin have been critically short on staff.140 Before instituting a mandatory vaccine policy that would make it a condition of continued employment, healthcare employers must be cognizant of any staffing shortages and the potential implications on staffing if the policy were to result in any employment terminations or resignations.141

    Continuing Hand Washing, Mandatory Masking, and Social Distancing Policies

    Regardless of employee vaccination status, hospitals should continue to strictly require hand washing, masking, and social distancing for all staff.142 The Director of the CDC has emphasized the importance of these strategies, stating that they may be more efficacious than any other preventive strategy in reducing the spread of COVID-19 at this point in time.143 In addition, vaccination status has not been conclusively related to halting virus transmission from an asymptomatic carrier.144 It is important to consider that the vaccines are still approximately 95 percent effective in protective antibody production at the highest end of the spectrum,145 so although there is not yet data on this issue, there is logically about a five percent chance that a vaccinated person may still become infected with COVID-19. This factor alone emphasizes the critical importance of continuing to emphasize handwashing, masking, and social distancing policies in all health facilities.

    Conclusion

    HCWs have been at the forefront of COVID-19 over the last 15 months since the first documented case of COVID-19 in Asia, but the number of HCWs voluntarily receiving vaccinations has been surprisingly suboptimal. Concerns raised by HCWs about the vaccine include a low level of trust in the existing efficacy and safety data, allergy issues, and concerns about the vaccine’s long-term safety. This creates a problem for the healthcare employers who want to ensure a uniform culture of compliance. Requiring vaccination may expose healthcare employers to legal liability. In addition, with the existing HCW staffing crunch, it may be counterproductive to mandate vaccination for all HCWs.

    In light of this information, currently most large healthcare employers that have been reported in the news media (and the few specific employers reviewed above) agree that voluntary HCW vaccination is the correct approach. They also agree that improving education about vaccine efficacy and safety will help increase employee confidence in the vaccination process. In the absence of a mandate, employers should consider instituting policies that can help with voluntary vaccine uptake. Employers should also consider implementing strategies that can lessen the impact of large-scale vaccination efforts on their staff and on their operations, which may help improve voluntary vaccination numbers and minimize workforce disruption. It is also important that healthcare employers continue to stay up to date with federal healthcare guidelines and any changes to state law to ensure regulatory compliance, and work closely with employee unions to ensure they are tuned in to the evolving needs and concerns of their employees in this rapidly changing environment.

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    94. Id.
    95. Id.
    96. Id.
    97. Jacobson v. Commonwealth of Massachusetts, 197 U.S. 11 (1905).
    98. 29 U.S.C. § 654(a)(1) (1970).
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    101. This analysis is from EEOC guidance addressing “Pandemic Preparedness in the Workplace and the Americans with Disabilities Act,” which was originally issued in 2009 to focus on the H1N1 influenza virus. The document was updated on March 21, 2020 to also include information related to COVID-19. With respect to the content on vaccinations, there was not yet a COVID-19 vaccine when the guidance was updated on March 21, 2020, and the guidance has not yet been updated since the approval and availability of the COVID-19 vaccine.
    102.  Baxter, T.B., Employer-Mandated Vaccination Policies: Different Employers, New Vaccines, and Hidden Risks, 2017 Utah L. Rev. 885, 897-98 (2017) (citing Safeway, Inc. v. Occupational Safety & Health Review Commission, 382 F.3d 1189 (10th Cir. 2004); Duriron Co., Inc. v. Secretary of Labor: U.S. Occupational Safety & Health Review Commission, 750 F.2d 28 (6th Cir. 1984)).
    103.  Baxter, supra n. 102, at p. 899.
    104.  The ADA: Your Responsibilities as an Employer, U.S. Equal Emp. Opportunity Comm’n (last visited Mar. 23, 2021, 3:16PM), https://www.eeoc.gov/publications/ada-your-responsibilities-employer.
    105.  42 U.S.C. § 12102.
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    108.  What You Should Know About COVID-19 and the ADA, the Rehabilitation Act, and Other EEO Laws, supra n. 106.
    109.  29 U.S.C. § 2601 et seq.
    110. P.L. 116-127 (Mar. 18, 2020).
    111. What You Should Know About COVID-19 and the ADA, the Rehabilitation Act, and Other EEO Laws, supra n. 106.
    112. Id.,
    113. 29 C.F.R. § 1605.1 (citing U.S. v. Seegar, 380 U.S. 163 (1965); Welsh v. U.S., 398 U.S. 333 (1970)).
    114. Chenzira v. Cincinnati Children’s Hospital Medical Center, No. 1:11-CV-00917 (S.D. Ohio 2012).
    115. Id.
    116. Robinson v. Children’s Hosp. Boston, Civil Action No. 14-10263-DJC (D. Mass. Apr. 5, 2016).
    117. Id.
    118. Id.
    119. Id.
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    121. Id.
    122.  Id.
    123.  Id.
    124.  Id.
    125.  Id.
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    About the Authors

    M. Hamza Habib, MD, FACP, FAAHPM, MRCP (London) is an Assistant Professor of Medicine at Rutgers University, Robert Wood Johnson School of Medicine In the Department of Medicine/Division of Medical Oncology. Dr. Habib serves as Director of Outpatient Palliative Medicine, and Director of Outpatient Cancer Pain Service at the Cancer Institute of NJ. He is an Interventional Pain Management and Palliative Medicine Specialist with a focus on Minimally Invasive/Surgical procedures for Cancer Pain management. He is also a Law Student at Rutgers Law School in Newark, NJ, with an interest in Health Policy relating to Medical Malpractice, the Opioid epidemic in the United States, and Legalities at End of Life. For any questions/future correspondence regarding this article, Dr. Habib can be contacted at [email protected] and @M_HamzaHabibMD.

    Hayley Penan     is a Deputy Legislative Counsel with the Office of Legislative Counsel for the State of California, where she primarily focuses on healthcare law issues. Prior to joining the Office of Legislative Counsel, Ms. Penan worked as an attorney at the National Health Law Program (NHeLP), where she focused on a wide range of state and federal health law and policy issues impacting low-income and otherwise underserved populations. Before joining NHeLP, she served as a Health Policy Fellow at the U.S. House of Representatives Ways and Means Health Subcommittee. Ms. Penan serves as the Chair of the American Bar Association Health Law Section's (ABA HLS) COVID-19 Task Force and as a Vice Chair for the ABA HLS Public Health and Policy Interest Group. Ms. Penan received her J.D. with honors from the University of California, Irvine School of Law, and a Master’s in Public Health with a concentration in Health Policy from the Harvard T.H. Chan School of Public Health. She earned her undergraduate degree in Media Studies from the University of California, Berkeley. She may be reached at [email protected].