Ethical Considerations for a COVID-19 Vaccine Mandate

Vaccination Mandates for HCW

Federal and State Regulations

Since the advent of vaccines, mandates have been used to achieve herd immunity both in the general population and amongst HCW.^1,2 Current federal regulations do not include any mandatory vaccination programs; rather, vaccine mandates are generally within the purview of state and local governments. State vaccine requirements for HCW vary widely. Some states have laws requiring HCW to be vaccinated against diseases such as measles, mumps, and rubella, with opt-out provisions for when the vaccine is medically contraindicated or against the person’s religious or philosophical beliefs.³ Mandatory requirements for influenza vaccination among HCW exist only in three states: Alabama, Colorado, and New Hampshire.⁴ At present, no state has mandated COVID-19 vaccination for HCW. 
 

Healthcare Organizations

Many professional organizations endorse the proposition that HCW have a professional and ethical responsibility to help prevent the spread of infectious pathogens. The Society for Healthcare Epidemiology of America recommends annual influenza vaccination as a condition of employment and professional privileges for HCW.⁵ The American College of Physicians policy suggests that influenza vaccination be mandated for all HCW, unless there is a medical or religious objection.⁶
 
In 2004, Virginia Mason Medical Center in Seattle, Washington, became the first healthcare system in the United States to make influenza vaccination a condition of employment. Within three years, the hospital reported 98% staff coverage. The remaining 2% of the staff who refused for medical or religious reasons were required to wear surgical masks when in the hospital during the flu season.⁷ This influenza vaccine mandate is now followed by more than 400 healthcare organizations.⁸
 

COVID-19 Vaccines

Currently, all COVID-19 vaccines are being used under Emergency Use Authorization (EUA) granted by the U.S. Food and Drug Administration (FDA). An EUA requires fewer safety and efficacy data than full Biologics License Application (BLA) approval, which may result in less trust in the vaccines because administration could be considered “ongoing medical research.”⁹ Under an EUA, vaccine recipients must be informed of “the option to accept or refuse administration of the product.”^10,11 It is unclear whether COVID-19 vaccines can be legally mandated while operating under an EUA prior to official FDA approval, as courts have not yet ruled on this issue. Once COVID-19 vaccines receive BLA approval, healthcare facilities may implement mandates for COVID-19 vaccination more broadly (as with influenza vaccination).
 
The U.S. Equal Employment Opportunity Commission (EEOC) states that employers should follow COVID-19 vaccine guidelines specified by the Centers for Disease Control and Prevention (CDC) and state or local public health authorities. Employees may also be subject to certain legally protected exceptions for disabilities under the Americans with Disabilities Act and for sincerely held religious beliefs under Title VII of the Civil Rights Act.¹²
 
According to CDC recommendations, COVID-19 vaccines are not mandated under EUAs; however, they allow for local mandates: “whether a state, local government or employer may require or mandate COVID-19 vaccination is a matter of state or other applicable law.”¹³
 
As of May 2021, Italy is the only country that has required HCW to be vaccinated against COVID-19.¹⁴ Most healthcare organizations in the United States have not yet broadly mandated COVID-19 vaccination.  Exceptions include Indiana University Health, the New York-Presbyterian healthcare system and Houston Methodist Hospital. The latter hospital was sued over this mandate, but the lawsuit was subsequently dismissed by a US District judge.¹⁵
 
The risk for transmission of infections is high among vulnerable persons in healthcare settings: patients, HCW, and third parties with whom they may come in contact. The goal of a vaccine mandate would be community protection or ‘herd immunity.’
 

Ethical Analysis

The root of the ethical dilemma behind a vaccine mandate is the conflict between public health ethics and the right to individual liberty and autonomy. Utilitarian arguments for vaccine mandates claim that higher immunization rates result in greater good for all (lives saved, morbidity avoided). According to this view, mandating universal vaccination is morally justified because of the consequences: community protection and reduction in virus transmission, resulting in lower rates of infections, hospitalizations, and deaths. Critics of utilitarianism contend that it is limited to “value monism” or that utility is the only fundamental “super-value” and that other values (eg, individual liberty) do not have the same moral value.¹⁶ Conversely, appealing to self-interest and individual liberty via lotteries and offering payment for vaccination¹⁷ (inducement) could erode the sense of solidarity with public health and the willingness to take risks for the common good.
 

Advantages of a Mandate

• Beneficence, nonmaleficence: Healthcare institutions have a legal and ethical obligation to ensure a safe environment for patients, HCW, and visitors. Vaccination would reduce viral transmission and thereby promote health, enhance patient safety, and provide a sense of security. HCW have an ethical/moral obligation to provide care for patients and to do no harm; vaccination would limit the spread of COVID-19 infection.
• Justice: Vaccines prevent hospitalizations and may reduce HCW shortages and protect health system capacity. This would enhance distributive justice and enable healthcare organizations to fulfill their obligations to the sick and vulnerable.

Disadvantages of a Mandate

• Administration of a vaccine requires verbal, informed consent. Mandates eliminate the right to informed consent or refusal of treatment.  A mandate with no exemptions would infringe upon personal autonomy and likely has implications for privacy and confidentiality. 
• If basic requirements for HCW, such as personal protective equipment, are not met, a vaccine mandate may be counterproductive, negatively affecting staff morale and violating trust when stress levels among HCW are already high.  

Issues to Consider

• Availability of vaccines: A vaccine mandate requires unrestricted access to vaccines; therefore, considerations for a mandate would apply only to areas where COVID-19 vaccines are freely available and supply is unlimited. Of note, the World Health Organization (WHO) does not presently support mandates for COVID-19 vaccination, instead favoring a focus on educational campaigns and universal availability of vaccines.¹⁸
• “Dynamic justification”: The relative weightiness of reasons for mandating vaccines varies under different circumstances and epidemiological conditions (eg, background vaccination rate, infectivity rate, and rate of hospitalizations).¹⁶ Evidence for reduced viral transmission following COVID-19 vaccination is emerging. The incidence of new infections and hospitalizations in the United States has been steadily decreasing as more adults, adolescents, and now children have been vaccinated.¹⁹
• Availability of other options: If the use of personal protective equipment, physical distancing, and physical barriers prevent the spread of COVID-19 and these options are available to HCW, mandating vaccinations may not be ethically warranted. Additionally, imposing a mandate may not be necessary for those who do not interact physically with patients or can work from home.  When other alternatives exist, coercion²⁰ in the form of a mandate, specified threats, or significant negative consequences for refusal may not be justified.

 

"Mandatory" Vaccines and Exemptions

Contemporary forms of “mandatory” vaccination compel vaccination by direct or indirect threats of restrictions in cases of noncompliance.²¹ Adverse action or termination of employment as a result of vaccine refusal could be considered coercion,²⁰ and the employer could be subject to legal action. 
 
According to the U.S. EEOC and CDC guidance documents, vaccine mandates are subject to medical and religious-based exemptions.^12,13 Providing exemptions would reduce HCW concerns and help them feel more empowered in their vaccination decision.

Facilities that opt for strict vaccine mandates should specify exemptions and offer alternatives to employment termination (ie, teleworking when feasible, staying home without pay).
 

Alternatives to Implementing a Mandate

Alternatives include education campaigns, inducement in the form of incentives and “nudge strategies.” Some states have offered huge monetary incentives to encourage people to get vaccinated.¹⁷ No EEOC guidance specifies which vaccination incentives can be offered by employers. Thus, these kinds of inducement may be legally problematic, given the potential for “undue inducement” and the different effects they have on persons who may see increased benefit from monetary compensation.²²
 
Nudges change behavior by means of ‘choice architecture’ by organizing the context in which people make decisions.²³ Tax breaks or enhanced benefits packages and health insurance premiums for HCW who get vaccinated are nudge strategies that can be considered by healthcare systems.²³
 

Conclusions

Most people would agree that healthcare organizations are obligated to routinely offer COVID-19 vaccines to all HCW. Considerations for a mandate (even under EUA) would depend upon the local context, and the decision-making process should ideally involve discussions with state and local public health authorities. Deliberations and ethical analyses by institutional policy makers (including organizational ethics experts) should be transparent. Given existing information about COVID-19 vaccines and current EEOC/CDC guidelines, the question faced by healthcare organizations once the vaccines receive full FDA approval is not so much whether vaccination can be mandated legally, rather whether it is ethically justifiable to do so. 

References

1. McClure CC, Cataldi JR, O’Leary ST. Vaccine hesitancy: where we are and where we are going. Clin Ther. 2017;39(8):1550-1562. 
2. Haviari S, Bénet T, Saadatian-Elahi M, et al. Vaccination of healthcare workers: a review. Hum Vaccin Immunother. 2015;11(11):2522-2537. 
3. Lindley MC, Horlick GA, Shefer AM, Shaw FE, Gorji M.  Assessing state immunization requirements for healthcare workers and patients. Am J Prev Med. 2007;32(6):459-465.
4. Centers for Disease Control and Prevention. State immunization laws for healthcare workers and patients. Accessed 5/28/2021  https://www2a.cdc.gov/vaccines/statevaccsApp/AdministrationbyVaccine.asp?Vaccinetmp=Influenza#221
5. Talbot TR, Babcock H, Caplan AL, et al. Revised SHEA position paper: influenza vaccination of health care personnel. Infect Control Hosp Epidemiol. 2010;31(10):987-995.
6. American College of Physicians. Patient safety and health care provider immunization. Accessed 5/28/2021  https://www.acponline.org/acp_policy/policies/healthcare_provider_immunization_2013.pdf
7. Rakita RM, Hagar BA, Crome P, Lammert JK. Mandatory influenza vaccination of health care workers: a 5-year study. Infect Control Hosp Epidemiol. 2010;31(9):881-888.
8. Dubov A, Pjung C. Nudges or mandates? The ethics of mandatory flu vaccination. Vaccine. 2015;33:2530-2535
9. Gostin LO, Salmon DA, Larson HJ. Mandating COVID-19 vaccines. JAMA. 2021;325(6):532-539.
10. Centers for Disease Control and Prevention. COVID-19 vaccine Emergency Use Authorization fact sheets for recipients and caregivers. Accessed 5/28/2021 https://www.cdc.gov/vaccines/covid-19/eua/index.html#:~:text=For%20each%20COVID%2D19%20vaccine,an%20informed%20decision%20about%20vaccination.
11. U.S. Food and Drug Administration. Emergency Use Authorization for vaccines explained. Accessed 5/28/2021  https://www.fda.gov/vaccines-blood-biologics/vaccines/emergency-use-authorization-vaccines-explained
12. U.S. Equal Employment Opportunity Commission. Pandemic preparedness in the workplace and the Americans with Disabilities Act. Accessed 5/28/2021 https://www.eeoc.gov/laws/guidance/pandemic-preparedness-workplace-and-americans-disabilities-act
13. Centers for Disease Control and Prevention. Workplace vaccination program. Last updated March 25, 2021. Accessed 5/28/2021 https://www.cdc.gov
14. Paterlini M. Covid-19: Italy makes vaccination mandatory for healthcare workers. BMJ. 2021;373:n905. doi:10.1136/bmj.n905
15. ‘Mandatory Vaccination Policy Lawsuit Update: Nurses Take a Shot Against Hospital, But Judge Jabs Back.’ The National Law Review Vol XI, Number 167 .  June 16, 2021.  Accessed 6/16/2021. https://www.natlawreview.com/article/mandatory-vaccination-policy-lawsuit-update-nurses-take-shot-against-hospital-judge
16. Navin MC, Attwell K. Vaccine mandates, value pluralism, and policy diversity. Bioethics. 2019;33:1042-1049.
17. Groppe M. Federal government gives OK for states to offer lotteries, cash incentives for vaccinations. USA TODAY. May 25, 2021. Updated May 26, 2021. Accessed 5/28/2021 https://www.usatoday.com/story/news/politics/2021/05/25/covid-vaccine-feds-ok-lotteries-ca. sh-incentives-vaccinations/7436394002/
18. World Health Organization. COVID-19 and mandatory vaccination: ethical considerations and caveats. Published April 13, 2021. Accessed 5/28/2021 https://www.who.int/publications/i/item/WHO-2019-nCoV-Policy-brief-Mandatory-vaccination-2021.1
19. Moghadas SM, Vilches TN, Zhang K, et al. The impact of vaccination on COVID-19 outbreaks in the United States. Clin Infect Dis. 2021. Jan 30:ciab079. Published online ahead of print. doi: 10.1093/cid/ciab079.
20. Department of Health, Education, and Welfare; National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. The Belmont Report. Ethical principles and guidelines for the protection of human subjects of research. J Am Coll Dent. 2014 Summer;81(3):4-13.
21. Gravagna K, Becker A, Valeris-Chacin R, et al. Global assessment of national mandatory vaccination policies and consequences of non-compliance. Vaccine. 2020;38:7865–7873.
22. Emanuel EJ. Undue inducements: nonsense on stilts? Am J Bioeth. 2005;5(5):9-13. Published correction appears in: Am J Bioeth. 2006;6(1):54.
23. Dubov A, Phung C. Nudges or mandates? The ethics of mandatory flu vaccination. Vaccine. 2015;33:2530-2535.

This educational activity was funded in part by a cooperative agreement with the Centers for Disease Control and Prevention (grant number 1 NU50CK000566-01-00). The Centers for Disease Control and Prevention is an agency within the Department of Health and Human Services (HHS). Its contents do not necessarily represent the policy of CDC or HHS, and should not be considered an endorsement by the Federal Government.