Affidavit: Healthcare and the Law - COVID-19 Vaccination: Coming to a Workplace Near You?

Contributors: Alison Rosenblum and Erin Duffy
To learn more about Alison and Erin, click here.

 

Nearly a year after the coronavirus pandemic exploded, the beginning of the end may finally be within sight.  Novel vaccines have shown tremendous promise, and the United States Food and Drug Administration (FDA) granted Emergency Use Authorizations (EUAs) to the two COVID-19 vaccines — one developed by a collaboration between Pfizer and BioNTech SE and the other developed by Moderna — in late 2020 and another developed by Johnson & Johnson in February of this year.

While the initial phases of vaccination have begun for certain groups, including essential workers, seniors, and those with underlying health conditions, widespread vaccination may not begin in earnest until spring or early summer. Nonetheless, businesses should start planning now for how to handle critical issues related to COVID-19 vaccination.  Although state and local authorities have been primarily responsible for the early distribution and administration of the COVID-19 vaccines, availability of the COVID-19 vaccine may soon open up to other distribution channels such as the workplace.  As businesses prepare for more widespread distribution, they must consider several key issues, including:

  • Education and messaging
  • Logistics
  • Consents
  • Mandates
  • Liability

EDUCATION AND MESSAGING
While the vast majority of Americans will have to get vaccinated before life returns to some semblance of normal, many say they are unlikely to do so. Recent surveys have shown more than a third of Americans are unlikely to get vaccinated, including many fearful about the safety of vaccines developed so quickly.[1]  The vaccines are both effective and safe, and educating employees about the vaccines will be critical.[2]  Businesses must also consider the significant disparities in vaccine acceptance along demographic lines including age, race and ethnicity, education, political party, and family income, in developing effective messaging for their workforces. 

LOGISTICS
At the most basic level, businesses need to determine how their workforce will receive COVID-19 vaccines, whether through public means or employer-based clinics.  Businesses sponsoring on-site clinics need to plan how to obtain the vaccines; where and how to hold the clinics; how to implement infection control procedures; who will administer the vaccines; and how to ensure everyone receives a second vaccine dose.[3]  Businesses should also plan for side effects by possibly staggering vaccination to avoid staff shortages; preparing for post-vaccination absences; and implementing precautions to ensure that employees experiencing side effects do not have COVID-19, contracted before they gained immunity.  Finally, businesses should maintain precautions even after their workforces have been vaccinated, especially in light of the CDC’s and OSHA’s recommendations that mask wearing and social distancing continue until more is known about whether the vaccines actually prevent asymptomatic infections or silent transmission of COVID-19.

CONSENTS
Before mass vaccination efforts begin, businesses will need to obtain informed consent from their workforces. Signed informed consent forms provide evidence that an individual received information about the potential risks and benefits of vaccination, had the opportunity to ask and obtain answers to any questions they had, and freely chose to receive the vaccine.  While many vaccine providers have created intake and consent forms, businesses should consider developing their own forms as well. They might also consider asking employees who decline vaccination to sign consent forms outlining the risks of that decision and the restrictions on activity and additional precautions they might be required to take.  Employers should add copies of all consent forms to their employees’ health-related records, which by law must be maintained separately from their general employment files.

MANDATES
A major question facing employers is whether to mandate vaccination for workforce members once sufficient vaccine supplies are available.  Mandates raise several employment law issues, many of which were addressed by the Equal Employment Opportunity Commission (EEOC) in its December 16, 2020 COVID-19 guidance.[4]  First, employers administering the vaccine or who have contracted somebody to administer on their behalf should be careful about pre-vaccination screening questions, which might implicate the Americans with Disabilities Act (ADA) and the Genetic Information Nondiscrimination Act of 2008.  Second, companies must prepare to respond to employee requests for medical exemptions under the ADA and religious exemptions under Title VII of the Civil Rights Act.  In addition to following EEOC guidance on handling such issues, companies should be careful to apply any mandates and exemptions fairly, consistently, and in a non-discriminatory manner.  They should also be aware of state anti-discrimination restrictions. Finally, businesses with unionized workforces may need to bargain with unions in accordance with existing collective bargaining agreements.

LIABILITY
Employers requiring or offering vaccines could potentially face litigation related to informed consent, employment discrimination, or even negligence if an employer’s failure to adequately encourage vaccination leads to a COVID-19 outbreak in the workplace.  While proposed state and federal bills providing liability waivers for employers have met with strong resistance, it is possible employers who run vaccination clinics might enjoy limited protection under the federal Public Readiness and Preparedness Act (PREP Act)[5] from state law-based lawsuits related to their vaccination efforts.  Whether and to what extent such employers would be eligible for such immunity in the context of COVID-19 vaccination has yet to be tested.  Finally, employers should keep abreast of the issuance and/or expiration of any state and federal liability waivers and court decisions.

CONCLUSION
Much remains unclear as to precisely how U.S. vaccination efforts will ultimately unfold.  As with all matters pandemic-related, employer stakeholders must continue to follow the constantly changing information, plans, requirements, and recommendations from federal, state, and local authorities.

Contact Alison at:
[email protected] 
312.499.6757

Contact Erin at:
[email protected] or
215.979.1946

Disclaimer: This Article has been prepared and published for informational purposes only and is not offered, nor should be construed, as legal advice. 

References

  1. Pew Research Center, “Intent to Get a COVID-19 Vaccine Rises to 60% as Confidence in Research and Development Process Increases,” Dec. 3, 2020, https://www.pewresearch.org/science/wp-content/uploads/sites/16/2020/12/PS_2020.12.03_covid19-vaccine-intent_REPORT.pdf; National Poll on Healthy Aging, University of Michigan, “Older Adults’ Perspectives on a COVID-19 Vaccine,” Nov. 2020, https://www.healthyagingpoll.org/report/older-adults-perspectives-covid-19-vaccine.
  2. Prior to receiving FDA authorization, the vaccines underwent rigorous testing and clinical trials to demonstrate both efficacy and safety.  Indeed, as the CDC has explained, the new COVID-19 vaccines are “being held to the same safety standards as all vaccines.” CDC COVID-19 Response Vaccine Task Force, “COVID-19 Vaccine Basics: What Healthcare Personnel Need to Know,” Dec. 2020, https://www.cdc.gov/vaccines/covid-19/downloads/What-HCP-NeedToKnow_508.pdf (emphasis in original); see also Mayo Clinic, “COVID-19 vaccines: Get the facts,” Dec. 17, 2020, https://www.mayoclinic.org/diseases-conditions/coronavirus/in-depth/coronavirus-vaccine/art-20484859.
  3. The CDC website offers some guidance for setting up a workplace vaccination site at: https://www.cdc.gov/coronavirus/2019-ncov/vaccines/recommendations/essentialworker/workplace-vaccination-program.html.
  4. EEOC, “What You Should Know About COVID 19 and the ADA, the Rehabilitation Act, and Other EEO Laws,” 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.
  5. 42 U.S.C. 247d-6d; see also HHS, “Declaration Under the Public Readiness and Emergency Preparedness Act for Medical Countermeasures Against COVID-19,” 85 Fed. Reg. 15198 (March 17, 2020); Office of the Assistant Secretary for Preparedness and Response, HHS, “Public Readiness and Emergency Preparedness Act,” last reviewed Feb. 8, 2021, https://www.phe.gov/Preparedness/legal/prepact/Pages/default.aspx (opinion letters and guidance).