COVID-19 vaccination efforts are underway and health care personnel (HCP) vaccination prioritization recommendations by the Centers for Disease Control (CDC) Advisory Committee on Immunization Practices (ACIP) have been widely publicized. Although the vaccine is now available to HCP, a survey conducted by the American Nurses Foundation reveals that only 36% of nurses would voluntary vaccinate themselves if their employer did not require it.¹ Top concerns listed include vaccine development occurring too quickly; not receiving enough information about safety, side effects, and administration; and skepticism regarding the clinical trial process.
Prior to COVID-19 vaccine availability, the best and only method to prevent the spread of SARS-CoV-2 relied on the implementation of pandemic infection prevention and control measures per CDC guidance. From a liability risk mitigation standpoint, recommendations have consistently been aimed at ensuring these best practices are in place and visible to patients and visitors. Additionally, educating patients on the measures taken to keep them safe may decrease the likelihood of the assumption that an infection occurred as a result of their interaction in a specific healthcare practice setting.
With the common knowledge that COVID-19 vaccines are readily available to HCP, will patients now expect or perhaps even inquire about vaccination status prior to care? This webpage will outline the recommended approach to ensure you are prepared to respond to inquiries such as these and provide guidance if you are contemplating mandatory vaccination of your HCP.
Responding to Patient Requests and Inquires Related to HCP Vaccination Status
It is important to understand what the existing messenger RNA (mRNA) vaccines are intended to achieve and their potential limitations. As new vaccines with different mechanisms of action may become available or existing vaccine research evolves, this information will change. Be sure to review and understand the vaccine specific information for any and all of the COVID-19 vaccines your staff may receive.
Interim clinical considerations for the use of mRNA vaccines currently authorized in the United States are outlined well by the CDC, which notes the following in regard to vaccine efficacy and potential limitations:
- Efficacy: Preliminary data suggest high vaccine efficacy in preventing COVID-19 following receipt of two doses of mRNA COVID-19 vaccine (Pfizer-BioNTech: 95.0% [95% CI: 90.3%, 97.6%]; Moderna: 94.1% [95% CI: 89.3%, 96.8%]). Limited data are currently available regarding the efficacy of a single dose.
- Public health recommendations for vaccinated persons: Given the currently limited information on how much the mRNA COVID-19 vaccines may reduce transmission in the general population and how long protection lasts, vaccinated persons should continue to follow all current guidance to protect themselves and others. This includes wearing a mask, staying at least 6 feet away from others, avoiding crowds, washing hands often, following CDC travel guidance, following quarantine guidance after an exposure to someone with COVID-19, and following any applicable workplace or school guidance, including guidance related to personal protective equipment use or SARS-CoV-2 testing.
Providing education to patients about preliminary efficacy data and possible limitations of the vaccine is an important liability risk mitigation strategy. The primary endpoints in the mRNA vaccine trials were symptomatic disease, not reduction of infection.² Therefore, vaccinated individuals may be capable of becoming infected, remain asymptomatic, and potentially transmit COVID-19. It is important that patients understand additional research is being conducted to study this, and that in the meantime their risk of exposure may not be dependent on an HCP’s vaccination status. Be sure your implementation of and overall compliance with well-established pandemic infection prevention and control measures per CDC guidance are emphasized and visible. From a public health standpoint, your patient education efforts are also important: patients who better understand any applicable vaccine limitations may be less likely to infect others after they become vaccinated.
If a patient inquires whether specific HCP have been vaccinated prior to receiving care, it is important to comply with privacy laws that may prevent you from disclosing which employees have received a COVID-19 vaccination without the employee’s prior consent.³ You may consider alerting the patient of your duties pursuant to applicable laws and also provide a general update about your compliance with state guidance for vaccination prioritization. Employees may choose to share their own vaccination status with patients but should understand that sharing vaccination status of co-workers without their consent violates privacy laws as well.
Mandatory Vaccination Considerations and Guidance
Mandating vaccination for HCP may be legally permissible if the vaccination policy provides exceptions in accordance with discrimination laws. Examples of federal law exceptions include religious accommodations under Title VII of the Civil Rights Act of 1964 and medical accommodations under the Americans with Disabilities Act (ADA). The Equal Employment Opportunity Commission (EEOC) addresses the question regarding how employers should respond to employees who indicates they are unable to receive a required COVID-19 vaccination due to a disability. The EEOC explains that the ADA allows an employer to have a qualification standard for employment requiring that individuals do not pose a health or safety threat to others in the workplace, but that if requiring a vaccination to do so screens out a person with a disability, an individualized risk assessment should be completed to assess if a direct threat to others exists.4 If the unvaccinated individual would pose a direct threat of virus exposure to others, a reasonable accommodation should be provided to reduce the risk so he or she is no longer a direct threat.4 Due to limited information regarding existing mRNA vaccines’ abilities to prevent transmission, and the public health guidance from the CDC that vaccinated persons should continue to follow all current infection prevention guidance to protect themselves and others, it is unclear what conclusion an employer may draw upon conducting the risk assessment. Federal OSHA does not currently have a standard specific to COVID-19 or vaccination requirements. The 22 states with OSHA-approved State Plans may have varying requirements. If you practice in one of these states, be sure you are familiar with the details of your State Plan. Additional state and local laws may impact employee rights and employer responsibilities and are important to understand as well.
Instituting mandatory COVID-19 vaccination for your HCP is complex. It is difficult to predict if mandatory vaccination is an effective liability risk mitigation strategy given the limited data on long-term COVID-19 vaccine effectiveness, specifically how long the protection lasts and whether the vaccine prevents transmission. Further guidance may evolve as additional vaccine candidates are approved for use and as research on existing vaccines continues. A more effective approach in the meantime may be to strongly encourage HCP vaccination based on CDC guidance, bearing in mind that they are at increased risk of exposure to COVID-19 with cases and deaths increasing daily.
- CDC and IDSA COVID-19 Realtime Learning Network: Vaccines FAQ
An overview of existing available vaccines and FAQs
- CDC: Understanding mRNA COVID-19 Vaccines
General information on mRNA COVID-19 vaccine technology
- Moderna: Moderna’s Fully Enrolled Phase 3 COVE Study of mRNA-1273
Moderna mRNA vaccine trial updates, which will be ongoing as trial participants are followed for two years post-vaccination
- EEOC: What You Should Know About COVID-19 and the ADA, the Rehabilitation Act, and Other EEO Laws
FAQs regarding mandatory vaccinations and related ADA and Title VII issues (see, Section K. Vaccinations)
- Ogletree, Deakins, Nash, Smoak & Stewart, PC: Mandatory COVID-19 Vaccination: Is It Legal and Is It Right for Your Workplace?
What to expect and how to prepare your workplace for vaccination
- Powers Pyles Sutter and Verville PC: Can Healthcare Employers Require Employees to Receive the Covid-19 Vaccine?
Overview of federal laws impacting mandatory COVID-19 vaccination of employees
- WebMd: State-by-State Guide to COVID Vaccine Information
Links to state health department webpages outlining vaccine allocation plans
- NORCAL Group: COVID-19 Information, Resources & Tools
Compilation of healthcare operations resources including healthcare workforce infection control resources
- American Nurses Foundation. Pulse on the Nation’s Nurses COVID-19 Survey Series: COVID-19 Vaccine. https://www.nursingworld.org/practice-policy/work-environment/health-safety/disaster-preparedness/coronavirus/what-you-need-to-know/covid-19-vaccine-survey/. Published October 2020. Accessed January 19, 2021.
- COVID-19 Real-Time Learning Network: Vaccines FAQ. https://www.idsociety.org/covid-19-real-time-learning-network/vaccines/vaccines-information--faq/. Updated January 19, 2021. Accessed January 19, 2021.
- Lashay J, Binzak Blumenfeld B, Hu-Rodgers T. The Vaccine Mandate: What Healthcare Employers Need to Know About Mandating the COVID-19 Vaccine. https://www.bipc.com/the-vaccine-mandate-what-healthcare-employers-need-to-know-about-mandating-the-covid-19-vaccine?utm_source=advisory&utm_medium=email&utm_campaign=2020-12-17_Healthcare. Published December 17, 2020. Accessed January 19, 2021.
- What You Should Know About COVID-19 and the ADA, the Rehabilitation Act, and Other EEO Laws. https://www.eeoc.gov/wysk/what-you-should-know-about-covid-19-and-ada-rehabilitation-act-and-other-eeo-laws. (Section K) Updated December 16, 2020. Accessed January 19, 2021.