More than a year into the declaration of a pandemic and national emergency, healthcare employers across the country are asking whether they should implement a mandatory COVID-19 vaccination policy for employees, making proof of vaccination a condition of employment. Certain immunization requirements are common in healthcare settings, as healthcare workers may have a higher risk of exposure than the general public due to direct patient contact or the handling of infectious materials. Healthcare employers also implement vaccination requirements in part to demonstrate to patients that they provide an environment safe from certain infectious diseases.1 The U.S. Centers for Disease Control and Prevention (CDC) recommends vaccines – such as influenza or hepatitis B vaccines – for healthcare workers depending on environment and level of exposure.2
The vaccines against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2 or COVID), available as of the date of this writing, have all been issued on an emergency use basis, rather than with a full Biologics License Application (BLA) approval from the U.S. Food and Drug Administration (FDA).3 That fact, combined with early vaccine shortages and significant vaccine hesitancy among some populations, has led healthcare employers to move slowly in mandating vaccination.4 A Texas-based hospital just became the first known, large hospital in the United States to mandate the vaccine for its employees.5
This article explores legal and practical considerations related to healthcare employer decisions about whether to mandate the COVID vaccine for workers, including the implications of emergency use authorizations (EUAs) for the vaccines, the permissibility of a vaccine mandate under federal employment law, and the impact of unionization. It concludes with a discussion of resources available to employers seeking to increase vaccine acceptance rates in their organizations, including the CDC’s Employer COVID-19 toolkit.
Emergency Use Authorizations and “Voluntary Acceptance”
The FDA’s EUA authority allows the FDA to authorize unapproved medical products or unapproved uses of medical products in an emergency to diagnose, treat, or prevent serious or life-threatening diseases or conditions.6 The FDA issued an EUA for the Pfizer-BioNTech COVID-19 vaccine on December 11, 2020.7 A few days later, on December 18, 2020, the FDA issued an EUA for the Moderna vaccine.8 On February 27, 2021, the FDA issued an EUA for a third vaccine that prevents COVID-19, the Janssen COVID-19 vaccine issued by Janssen Biotech Inc., a pharmaceutical company of Johnson & Johnson.9 When issuing these EUAs, the FDA noted limitations as to the amount of data to support the overall effectiveness against asymptomatic infection and the transmission of COVID-19.10
The Federal Food, Drug, and Cosmetic Act, which is the authority under which the FDA issues EUAs, requires that individuals be informed they may refuse the vaccine and the consequences for refusal.11 Specifically, EUAs must always have conditions to ensure that individuals are informed of the “option to accept or refuse administration of the product, of the consequences, if any, of refusing administration of the product, and of the alternatives to the product that are available and of their benefits and risks.”12 However, the fact that the FDA is required to inform those to whom the product is administered (through EUAs and EUA fact sheets) that acceptance is voluntary, does not necessarily extend to an obligation upon private employers.13 Some have interpreted the law in that way,14 but the FDA has not weighed in and federal guidance is not conclusive. The CDC says that the FDA “does not mandate vaccination….Whether an employer may require or mandate COVID-19 vaccination is a matter of state or other applicable law.”15 Some have hypothesized that employees terminated for failure to comply with a mandatory vaccination policy might file a wrongful termination lawsuit in state court on a theory that the vaccine mandate was against public policy or seek an injunction against an employer.16
Throughout the pandemic, the Equal Employment Opportunity Commission (EEOC) has updated guidance related to COVID-19, the Americans with Disabilities Act (ADA), and other equal employment opportunity laws.17 The EEOC has concluded that an employer may exclude those with COVID-19, or symptoms associated with COVID-19, from the workplace if their presence would pose a direct threat to the health or safety of others, therefore constituting a “direct threat.” The EEOC’s “direct threat” analysis can be used by employers to determine whether a significant risk of harm would be posed by having a person with COVID-19 or any symptoms thereof present in the workplace.18
The EEOC has not explicitly endorsed mandatory vaccination policies but has suggested that employers can mandate vaccination, with the appropriate exceptions for individuals with disabilities or sincerely held religious beliefs.19 Sincerely held religious beliefs may exempt employees from mandated vaccination requirements.20 While its position is not specific to COVID-19, the EEOC has previously stated that “once an employer is on notice that an employee’s sincerely held religious belief, practice, or observance prevents the employee from receiving the vaccination, the employer must provide a reasonable accommodation for the religious belief, practice, or observance unless it would pose an undue hardship under Title VII of the Civil Rights Act.”21 Therefore, an employer-mandated vaccination policy would have to allow for religious exemptions.22
The ADA also poses a potential legal hurdle to mandatory vaccination requirements.23 Under the ADA, employers may not require employees to get a medical exam or make certain disability-related inquiries.24 The EEOC in its guidance does mention that the administration of a vaccine does not constitute a medical examination, and that asking for proof is not a disability-related inquiry.25 However, if an employer chooses to administer the vaccine itself, the employer must be able to establish that the pre-screening questions are job related and consistent with a business necessity.26 The standard is satisfied if an employer has a reasonable belief (based upon objective evidence) that an employee who does not answer pre-screening questions and does not receive a vaccination will pose a direct threat to the health and safety of employees.27 EEOC guidance further states that “if an employee cannot get vaccinated for COVID-19 because of a disability…and there is no reasonable accommodation possible, then it would be lawful for the employer to exclude the employee from the workplace.”28
Considerations in a Unionized Environment
Unions are also beginning to enter the debate over the legalities of requiring COVID-19 vaccines. Companies may have to negotiate with unions before making the vaccine mandatory for a unionized workforce.29 This is because having a mandatory vaccination policy would likely be considered by unions to be a change of a “condition of employment and subject to mandatory bargaining.”30
Pending Legal Challenges
Lawsuits have already begun over whether employers can mandate vaccines for employees.31 On January 29, 2021, Las Cruces, New Mexico issued a mandate directing all first responders to receive the COVID-19 vaccination as a condition of ongoing employment, unless the employee had an exception that was granted by the county human resources office.32 The plaintiff, an employee at the Dona Ana County Detention Center, alleges that the directive is a violation of 21 U.S.C. § 360bbb-3.33 The lawsuit asks for a court order confirming that his employer cannot coerce him or other employees to get vaccinated, an injunction blocking the detention center from firing him, and if he gets terminated prior to the court’s ruling, then an order forcing the county to rehire him.34 Some have opined that it is unclear whether the EEOC’s guidance on COVID-19 vaccines applies equally to private sector employers and public employers like a municipality. The position of the plaintiff’s employer seems consistent with EEOC guidance, and “the key question in this case appears to be whether the EEOC’s guidance is as fully applicable to public employers....”35
Another complaint has been filed, in the United State District Court for the Central District of California, by teachers against the Los Angeles Unified School District alleging that in the absence of full FDA approval of a vaccine, a mandatory vaccination would constitute impermissible medical experimentation without consent in violation of federal and state law.36 The plaintiffs seek declaratory and injunctive relief against an employer-mandated vaccine requirement, arguing, among other things, that administration of the vaccine “on pain of termination from employment, would deprive Plaintiffs of their substantive due process rights….”37
There has also been at least one lawsuit filed preemptively against mandatory vaccinations by a concerned citizen. A constitutional scholar and former political candidate filed suit pro se in the District Court for the District of New Hampshire seeking injunctive relief against a hypothetical federal mandate for COVID vaccination.38 Her objections were to the lack of data and research surrounding the vaccines, that there are “cures” for COVID and therefore a mandatory vaccine is unnecessary, that there is a “little-understood connection between vaccination and DNA.”39 The US District Court of New Hampshire denied the plaintiff’s request for a temporary restraining order and dismissed the plaintiff’s case on grounds of lack of subject matter jurisdiction, noting that the plaintiff did not comply with her notice obligations and did not allege that she faced imminent mandatory vaccination in the absence of an injunction, since there is no federal mandate.40 The plaintiff has appealed.41
While the EUAs are still in effect and until a BLA is issued, mandating COVID-19 vaccines may still be deemed too risky for many employers. If an employer does wish to eventually mandate the COVID-19 vaccine, then the employer needs to prepare accordingly for vaccine hesitancy and accommodation requests. Significant numbers of people nationally still say they do not wish to receive the vaccine and would consider leaving their job if required to receive it, raising potential employee morale and retention concerns.42 Steps that employers should consider include: reviewing religious and medical accommodation policies with management and supervisory personnel; training managers and supervisors on how to spot, respond to, and forward an accommodation request to the necessary human resources personnel; appoint an accommodations coordinator or liaison; and remember to participate in the interactive process.43 The interactive process is typically a discussion between an employer and employee about whether the employee needs an accommodation to fulfill the employee’s job duties and about which accommodations would be appropriate and reasonable.44
Employers will also have to consider the ADA’s requirements when obtaining information from employees regarding vaccines. As noted above, the EEOC has stated that administration of the vaccine is not a medical examination; however pre-screening vaccination questions might violate the ADA’s limitations on disability-related inquiries. EEOC guidance suggests that employers might use third parties to ask pre-screening questions without violating the ADA and to administer the vaccine.45 It is also likely that employers that track compliance or ask about vaccine proof will need to treat that information as confidential medical records under the ADA and maintain it in separate medical files.46 Further, the EEOC’s guidance is sub-regulatory, meaning that it is unclear what deference, if any, courts will afford to it.47
Another situation to consider is how to handle adverse reactions to the vaccine when an employer requires mandated vaccination, and whether such reaction would be covered by workers’ compensation.48 If an employer only encourages its employees to get vaccinated, then no liability attaches and an employee will likely not be able to recover under a workers’ compensation policy.49 If any employer mandates vaccinations, then workers’ compensation liability might attach.
Tools to Address Vaccine Hesitancy
The CDC has issued guidance to help employers navigate workplace vaccination and provide information to employees who have any questions or concerns about the vaccine. Specifically, the CDC developed a toolkit designed for employers of essential workers.50 The purpose of the toolkit is to help an organization have clear and accurate information to educate employees about COVID-19 vaccines, raise awareness about the benefits of the vaccination, and address common questions or concerns.51 It contains templates for introductory letters, newsletter content, COVID-19 basics slide decks, and other messages to provide to employees.52 This toolkit also offers guidance on a workplace vaccination program.53 It details the various factors to consider on the best methods for the employer to distribute the vaccine to workers on site or off site in the community.54
The toolkit discusses the potential benefits to employers and employees of a workplace vaccination program.55 Benefits to the employer include keeping the workforce healthy, reducing time missed from the workplace, improving productivity, creating a safer work environment, and improving morale.56 The benefits to the employees include preventing the risk of COVID-19 for themselves and other employees, reducing the hassle of trying to schedule appointments by offering a convenient means at work of receiving them, and helping improve morale.57
Other resources available for employers include messaging recommendations issued by the Ad Council and COVID Collaborative, which contain recommendations for general and specific populations.58 Employers trying to encourage voluntary vaccine participation are encouraged to maintain an open dialogue with employees, rely on trusted messengers to communicate to employees, and allow employees time and space to ask questions. Trusted messengers are often those who look like or are from the same demographic group as the audience the messenger is trying to reach.59 The trusted messenger is typically someone who might also be from or worship in the same community, such as a Hasidic singer who grew up in Brooklyn, and despite not having public health expertise, is viewed as a trusted messenger in parts of the Hasidic community.60
Until a vaccine is approved by the FDA as a licensed product and not simply authorized under an EUA, mandating the vaccine for employees in healthcare settings poses some risk.61 Employers can prepare for mandatory vaccination programs by beginning to work on or amend accommodation policies and address any union concerns the employer might have.62 Short of mandating the vaccine, legal counsel can be beneficial in helping facilities and other providers consider incentives that might encourage workers to get the vaccine. Healthcare employers should continue to properly educate and encourage their employees to get vaccines and host workplace vaccination programs to make vaccinations more easily available and efficient for employees.63 Whether through a mandatory or voluntary vaccination program, healthcare employers should encourage high vaccination levels in the workforce in order to ensure the safest possible environment for patients and staff.
- Yasmin, S., Mandatory Shots: Should Hospitals Force Health Care Workers to Get the Flu Vaccine?, yahoo (Dec. 23, 2013), https://news.yahoo.com/mandatory-shots-hospitals-force-health-care-workers-flu-165200216.html.
- Vaccine Information for Adults, Centers for Disease Control and Prevention (last visited Apr. 6, 2021), https://www.cdc.gov/vaccines/adults/rec-vac/hcw.html.
- Gostin, L., Salmon, D., & Larson, H., Mandating COVID-19 Vaccines, jama (Dec. 29, 2020), https://jamanetwork.com/journals/jama/fullarticle/2774712. A BLA “is a request for permission to introduce, or deliver for introduction, a biologic product into interstate commerce (21 CFR 601.2). The BLA is regulated under 21 CFR 600 – 680. A BLA is submitted by any legal person or entity who is engaged in manufacture or an applicant for a license who takes responsibility for compliance with product and establishment standards.” Biologics License Applications (BLA) Process (CBER), Food and Drug Administration (Jan. 27, 2021), https://www.fda.gov/vaccines-blood-biologics/development-approval-process-cber/biologics-license-applications-bla-process-cber.
- Johnson, S., Hospitals Mixed on Imposing Staff COVID-19 Vaccination Mandates, modern health care (Dec. 1, 2020), https://www.modernhealthcare.com/hospitals/hospitals-mixed-imposing-staff-covid-19-vaccination-mandates; Quig, A.D., Why We Don't Know How Many Medical Workers Haven't Been Vaccinated, and Why It Matters, Chicago business (Mar. 19, 2021), https://www.chicagobusiness.com/health-care/why-we-dont-know-how-many-medical-workers-havent-been-vaccinated-and-why-it-matters.
- Dean, G., A Hospital in Houston Said It Could Fire Staff if They Refuse to Get the COVID-19 Vaccine, Making It Potentially the First Large US Hospital to Take Such Action, business insider (Apr. 1, 2021), https://www.businessinsider.com/houston-hospital-covid-19-vaccine-fire-staff-employees-refuse-texas-2021-4.
- Emergency Use Authorization, Food and Drug Administration (last visited Mar. 31, 2021), https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization#:~:text=The%20Emergency%20Use%20Authorization%20%28EUA%29%20authority%20allows%20FDA,medical%20countermeasures%20%28MCMs%29%20needed%20during%20public%20health%20emergencies.
- FDA Issus Emergency Use Authorization for Third COVID-19 Vaccine, fda (Feb. 27, 2021), https://www.fda.gov/news-events/press-announcements/fda-issues-emergency-use-authorization-third-covid-19-vaccine.
- Section 564(e)(1)(A)(ii) of the Food, Drug, and Cosmetic Act; 21 U.S.C.S. § 360bbb-3 (LexisNexis, Lexis Advance through Public Law 116-344, approved Jan. 13, 2021, with gaps of Public Laws 116-260, 116-283, and 116-315).
- See also id. (detailing the voluntary nature of the EUA).
- See generally Siri, A., Federal Law Prohibits Employers and Others Requiring Vaccinations with COVID-19 Vaccines Distributed under an EUA, Stat News, (Feb. 23, 2021), https://www.statnews.com/2021/02/23/federal-law-prohibits-employers-and-others-from-requiring-vaccination-with-a-covid-19-vaccine-distributed-under-an-eua/.
- Workplace Vaccination Program, Centers for Disease Control and Prevention (last updated Mar. 25, 2021), https://www.cdc.gov/coronavirus/2019-ncov/vaccines/recommendations/essentialworker/workplace-vaccination-program.html (emphasis is in the original source document).
- Mittman, J. & Lowe, S., Mandatory COVID-19 Vaccination Policies Could Carry Risks in Light of FDA Authorization Status, blogmsk (Mar. 18, 2021), https://blogmsk.com/2021/03/18/mandatory-covid-19-vaccination-policies-could-carry-risks-in-light-of-fda-authorization-status/. See generally Wrongful Termination in Violation of Public Policy, Cornell Law School (last visited Apr. 21, 2021), https://www.fda.gov/vaccines-blood-biologics/development-approval-process-cber/biologics-license-applications-bla-process-cber. An employee may have a state law claim for wrongful termination if the employee is fired for taking a legal action, refusing to take an illegal action, or whistleblowing as to illegal conduct. Id.
- What You Should Know About COVID-19 and the ADA, the Rehabilitation Act, and Other EEO Laws, U.S. Equal Employment Opportunity Commission (last updated Dec. 16, 2020), https://www.eeoc.gov/wysk/what-you-should-know-about-covid-19-and-ada-rehabilitation-act-and-other-eeo-laws.
- Legal and Practical Considerations for Employers Weighing COVID-19 Vaccination as a Condition of Continued Employment, Jones Day (December 2020), https://www.jonesday.com/en/insights/2020/12/legal-and-practical-considerations-for-employers-weighing-covid19-vaccination.
- See generally Religious Objections Mandated COVID-19 Vaccines, Fisher Phillips (last visited Mar. 31, 2021), https://www.fisherphillips.com/resources-alerts-religious-objections-mandated-covid19-vaccines.
- See supra n. 17.
- See generally supra n. 18. Title VII contains a workplace religious exemption that requires employers to provide exemptions and accommodations for employees who raise objection to receiving employer-mandated vaccines based on their religious beliefs. Further, the EEOC provides a broad definition of “religion” which extends beyond membership to a church or belief in God, but also focuses on firmly and sincerely held moral or ethical beliefs. Id.
- See supra n. 17.
- See supra n. 20.
- What You Should Know about COVID-19 and the ADA, the Rehabilitation Act, and Other EEO Laws, U.S. Equal Employment Opportunity Commission (Dec. 16, 2020), https://www.eeoc.gov/wysk/what-you-should-know-about-covid-19-and-ada-rehabilitation-act-and-other-eeo-laws#exclude.
- Gangitano, A., Unions Wade Into Debate Over Requiring COVID-19 Vaccine, The Hill, (Jan. 1, 2021), https://thehill.com/business-a-lobbying/business-a-lobbying/535143-unions-wade-into-debate-over-requiring-covid-19; Brown, P. & Volberding, A., Labor Law, Union Implications for Employer-Mandated Covid Vaccines, Bloomberg law, (Jan. 21, 2021), https://news.bloomberglaw.com/daily-labor-report/labor-law-union-implications-for-employer-mandated-covid-vaccines.
- See supra n. 29 (describing how employers might not be able to make the vaccine mandatory in the middle of a contract unless the state or the government required it.)
- See e.g., Maxwell v. United States Sec'y of Def., No. 20-cv-1193-PB, 2021 U.S. Dist. LEXIS 19390 (D.N.H. Jan. 14, 2021); Legaretta v. Macias, No. 21-cv-179 MV/GBW, 2021 U.S. Dist. LEXIS 44474 *1, *1 (D.N.M. Mar. 4, 2021).
- First Lawsuit Challenging Mandatory COVID-19 Vaccine, Fisher Phillips, (Mar. 5, 2021), https://www.fisherphillips.com/news-insights/first-lawsuit-challenging-mandatory-covid-19-vaccine-may-shed-light-on-employer-parameters.html.
- Legaretta, 2021 U.S. Dist. LEXIS 44474, *3 (D.N.M. Mar. 4, 2021). The plaintiff argues that a mandatory vaccine would be in direct violation of 21 U.S.C. § 360bbb-3, which is the provision describing how authorization for medical products for use in emergencies is “optional” in nature. Id. See 21 U.S.C.S. § 360bbb-3(e)(1)(A)(ii)(I-III). “Appropriate conditions designed to ensure that individuals to whom the product is administered are informed—
(I) that the Secretary has authorized the emergency use of the product;
(II) of the significant known and potential benefits and risks of such use, and of the extent to which such benefits and risks are unknown; and
(III) of the option to accept or refuse administration of the product, of the consequences, if any, of refusing administration of the product, and of the alternatives to the product that are available and of their benefits and risks.” Id.
- See id.
- See supra n. 32, para. 10.
- Davis, K., Can Your Employer Require A Vaccination? Probably. So Can a Restaurant or a Hotel, Los Angeles Times (Apr. 8, 2021).
- California Educators for Medical Freedom et al v. Los Angeles Unified School District, Case No.: 21-cv-02388, available at https://secureservercdn.net/184.108.40.206/k7i.767.myftpupload.com/wp-content/uploads/2021/03/LAUSD-Complaint-Conformed.pdf.
- Maxwell v. United States Sec'y of Def., No. 20-cv-1193-PB, 2021 U.S. Dist. LEXIS 19390 (D.N.H. Jan. 14, 2021); See also Mary Maxwell Files as a Republican Candidate in NH Presidential Primary, DC Presswire (Nov. 16, 2019).
- Mary Maxwell Files in US Court for Covid Vaccination Injunction, Gumshoe News, (Dec. 24, 2020).
- Wells, B. & Killham, E., A Workplace Divided: Split Opinions on COVID-19 Vaccine Could Disrupt the Return to Work, perceptyx (January 2021), https://f.hubspotusercontent10.net/hubfs/2759869/AWorkplaceDivided-ResearchReport.pdf.
- See generally supra n. 18.
- Enforcement Guidance on Reasonable Accommodation and Undue Hardship under the ADA, U.S. Equal Employment Opportunity Commission (last visited Apr. 21, 2021), https://www.eeoc.gov/laws/guidance/enforcemaent-guidance-reasonable-accommodation-and-undue-hardship-under-ada.
- See supra n. 24. If the employers are administering the vaccine themselves or through a third party, those employers may be more likely to make disability-related inquiries in connection with screening questions. Requiring employees to receive the vaccine from a third party would likely result in the third party, and not the employer, making any disability-related inquiries, thereby likely avoiding ADA violations by the employer. Id.
- Nagele-Piazza, L., COVID-19 Vaccines and Employer Liability, shrm (Jan. 20, 2021), https://www.shrm.org/resourcesandtools/legal-and-compliance/employment-law/pages/covid-19-vaccines-and-employer-liability.aspx.
- Essential Workers COVID-19 Vaccine Toolkit: Information for Employers and Employees, Centers for Disease Control and Prevention (Mar. 22, 2021), https://www.cdc.gov/coronavirus/2019-ncov/vaccines/toolkits/essential-workers.html.
- Id. at “Vaccine Mandates & Exceptions.”
- Id. at “FAQs for Employers.”
- COVID-19 Vaccine Education Initiative: Messaging Recommendations, ad council, https://adcouncil-covid-vaccine-education-initiative.s3.amazonaws.com/TOOLKIT_MESSAGING+RECOMMENDATIONS.pdf. “The Ad Council and COVID Collaborative are leading massive communication efforts to educate the public, while seeking to build confidence around the vaccine, specifically addressing the disproportionality in communities of color.” COVID-19 Vaccine Education Initiative, Ad Council, (last visited Apr. 22, 2021), https://www.adcouncil.org/covid-vaccine.
- Kritz, F., Trusted Messengers, Trusted Messages: How to Overcome Vaccine Hesitancy, npr (Dec. 24, 2020), https://www.npr.org/sections/health-shots/2020/12/24/948776228/trusted-messengers-trusted-messages-how-to-overcome-vaccine-hesitancy.
- See generally supra n. 18.
- See discussion above.