In the somewhat-near future, US employers actually may be able to replace face coverings, social distancing markers, plexiglass barriers and Zoom calls with face-to-face interaction and handshakes. At least two COVID-19 vaccines are expected to be issued Emergency Use Authorizations (EUA) by the FDA before the end of 2020, following closely behind the footsteps of the UK, which began vaccinations on December 8, 2020.

While this is good news for the country, the change won’t be felt immediately for most US employers. On December 1, a Centers for Disease Control and Prevention (CDC) panel advised that the first vaccine doses should go to health-care workers and long-term care facility residents. The next group up is reportedly other “high risk” groups: bus drivers, factory workers, teachers, older people and people with underlying conditions. At this point, widespread availability of COVID-19 vaccines is not expected until spring or summer of 2021. So, what should US employers whose workforce may not be eligible for vaccinations until later in the year be doing now to prepare?

Here are our Top Ten considerations for US employers right now:

1. Can employers make a COVID-19 vaccine mandatory for their employees?

Employers can legally make a COVID-19 vaccine mandatory for employees, with two exceptions:

• First, employers may have to provide an exemption from a mandatory vaccination requirement as a “reasonable accommodation” when employees have an ADA-covered disability that prevents them from taking the vaccine, unless providing the accommodation would constitute an undue hardship (in this context, significant difficulty or expense) for the employer’s business.  Examples of medical disabilities might include those similar to health-related reasons employees seek exemptions of an otherwise mandatory flu vaccine, such as an allergy to the vaccine or any ingredient in the vaccine, or a history of Guillain-Barre syndrome.
• Under Title VII, employers must also provide reasonable accommodations to employees whose sincerely held religious beliefs or practices prohibit them from the taking the vaccine, unless doing so would constitute an undue burden (in this context, more than de minimis cost or burden) for the business.

In addition, state and local statutes prohibiting religious or disability discrimination may apply. And requiring employees to be vaccinated for COVID-19 will require employers to review several other considerations, some of which are discussed below.

2. How can employers tell if employees have legitimate medical and religious objections–as opposed to fraudulent ones?

For employees requesting a medical exemption under the ADA, employers may request medical certification of the disability limiting vaccination (if the disability and need for accommodation aren’t obvious). Specifically, employers can require an employee seeking an accommodation to provide a health care provider certification confirming that the employee is disabled and describing the restrictions imposed by the disability on the employee’s ability to perform the job (or here, to be inoculated with an employer-required vaccine).

If an employee is requesting an exemption based on a sincerely held religious belief, the employer may inquire into the sincerity of the employee’s religious belief, including requesting third-party verification that the employee sincerely holds the asserted religious belief (from a religious official, fellow church member, or others who are aware of the employee’s religious belief).

3. Can employers be required to pay for vaccines and for employee time taken being vaccinated?

Many states and municipalities require employers pay or reimburse employees for “business-related expenses.” This will likely apply for employers requiring employees to take a COVID-19 vaccine.

In addition, although far from certain, waiting for a vaccination and submitting to a vaccination could be argued to be “hours worked” under the Fair Labor Standards Act (FLSA). Though only tenuously related, the Department of Labor (DOL) opined in a FLSA opinion letter regarding employer-mandated drug tests that “attendance by an employee at a meeting during or outside of working hours for the purpose of submitting to a mandatory drug test imposed by the employer would constitute hours worked for FLSA purposes . .[.]” The DOL also takes the position that, besides the time actually spent undergoing the test, time spent traveling to and from the test and waiting for the test would also likely be deemed hours worked. Though an employer-mandated vaccine is not a drug test, they are both required by the employer in order for the employee to continue employment. Between state and local business-related expenses reimbursement requirements and the FLSA, employers may want to be on the safe side and compensate employees for the time spent traveling to receive and receiving COVID-19 vaccinations.

4. Should employers have on-site administration of COVID-19 vaccines once they’re available? What should employers consider if going this route?

Employers may wish to make vaccines available to employees, much the way they do for annual flu shots. However, there may be some practical obstacles to this. For instance, some vaccines must be stored in extremely cold temperatures (colder than winter in Antarctica), which could pose problems if an employer does not have appropriate on-site equipment to keep the vaccine at the required temperature. However, other vaccines can be maintained at higher temperatures, such as in a regular freezer. If on-site administration becomes possible, employers should retain medical professionals qualified and licensed to administer vaccines, and should generally make onsite administration voluntary for employees.  Employers should also consider coverage for the vaccines under their healthcare plans.

5. If vaccines aren’t administered on-site, how can an employer be sure that employees received the vaccine? Can employers require their employees to show proof they have been vaccinated?

Generally, yes. Employers can require their employees to provide proof of vaccination unless federal, state or local privacy laws prohibit it.

However, employers providing coverage for the vaccine under their health care plans may wish to consider how the Health Insurance Portability and Accountability Act of 1996 (HIPAA) impacts the process. HIPAA applies only to certain types of “covered entities.” Though most employers would not be considered a covered entity under HIPAA, if the employer has a group health plan, that health plan would be a HIPAA covered entity. HIPAA-covered entities are restricted in what individually identifiable information they can use and disclose without authorization from the individual. Therefore, without individual employee authorization, a group health plan could not send health plan records regarding COVID-19 vaccinations (such as claims information for the vaccinations or records that an employee was vaccinated) to the employer. Employers who have group health plans hoping to have the vaccination covered under the group health plan will want to be certain to have documentation ready to obtain employee consent so that the HIPAA-covered entity can share the requested information with the employer.

Also, remember that medical information obtained from a medical examination or inquiry by or for the employer during employment is covered by the ADA’s confidentiality provisions. Under the ADA, if employers keep medical information-including vaccination records-the information must be kept in a confidential medical file separate from the employee’s personnel file. In addition, employers should check state and local laws, which may require employers keep any vaccination records confidential in a certain manner or method, or hold onto records for a certain period of time.

6. Can an employee who works from home full time (and does not come into physical contact with any other employees, clients, or customers) refuse to be vaccinated?

Most likely. The ADA restricts when and how much medical information an employer may obtain from any employee (or job applicant). Any medical inquiries or examinations-including vaccines, based on the medical inquiry necessary to obtain the employee’s status of vaccination-must be “job related and consistent with business necessity.” In its COVID-19 Q&A guidance, the EEOC applied this standard and said employers could take screening steps (including requiring COVID-19 tests for the presence of the virus) to determine if employees entering the workplace have COVID-19, because an individual with the virus poses a “direct threat” to the health of others. However, if an employee who works from home (and who doesn’t visit the worksite, or meet with other employees, contractors, clients, or customers as part of their job), there is no “direct threat” to the health of others in the workplace. In this situation, requiring a vaccine would not likely meet the standard of “job related and consistent with business necessity.”

7. Though mild for most COVID-19 vaccine trial participants, there are reported side effects from the COVID-19 vaccine. What should employers consider with regard to side effects if they want to make vaccinations mandatory for their workforce?

Reported side effects from trials of COVID-19 vaccines are mild-but existent. If possible and economical, employers may want to avoid vaccinating a whole department on the same schedule to avoid the risk of having several individuals from the same department out ill-even if only for a day-from side-effects at the same time.

In addition, side effects might be considered “work related illness” under OSHA guidance if a vaccine is mandatory, and could be required to be recorded on an OSHA Form 300 (Log of Work-Related Injuries and Illnesses) and OSHA Form 301 (Injury and Illness Incident Report), and maintained at the worksite for five years. For establishments covered by OSHA, a “recordable illness or injury” includes any work-related illness that results in days away from work or requiring medical treatment beyond first aid. Depending on the individual and how they react to the vaccine, certain side effects could be work-related and recordable if they are reactions to an employer-required COVID-19 vaccine.

8. If employers mandate a COVID-19 vaccine for the workforce, what liability issues should the employer be concerned about?

As explained above, there have been reported side effects from those receiving the vaccine in trials (including side effects of headache, fever, fatigue, and joint and muscle pain). Though the majority of the symptoms reported were minor, it remains to be seen whether other-worse-adverse reactions occur. If employers require vaccines, they should brace themselves for claims if employees have severe adverse reactions from taking a required COVID-19 vaccine. Possible claims include claims based in negligence, violation of workplace safety compliance standards, workplace injury/wrongful death claims, claims related to requested (but denied) sick leave, and workers’ compensation claims.

Employers could also see claims for violation of workplace privacy standards (if, for instance, confidential employee medical information regarding vaccination is breached), and disability / religious accommodation claims. Employers should check with insurance carriers to find out how carriers would handle claims, such as workers’ compensation claims, related to a vaccine.

9. Are there any immunity provisions employers should know about?

There may be state and local laws in place that provide a certain level of immunity for employers.

In addition, employers may have immunity under the Public Readiness and Emergency Preparedness Act (the PREP Act) once vaccination guidance is provided by federal, state and local authorities. Under the PREP Act, employers who administer vaccines in accordance with the public health and medical response and emergency declarations of federal, state, or local authorities may have immunity to certain claims. The PREP Act authorizes the Secretary of Health and Human Services (the Secretary) to issue a declaration to provide liability immunity to certain individuals and entities (“covered persons”) against any claim of loss caused by, arising out of, relating to, or resulting from the manufacture, distribution, administration, or use of medical countermeasures (including vaccines issued an EUA). A PREP Act declaration was issued by HHS relating to COVID-19 on March 17, 2020.

Under the PREP Act, private employers are “program planners,” and thus “covered persons”-making them eligible for immunity-if they supervise or administer a program regarding the administration, dispensing, distribution, provision, or use of a covered countermeasure (i.e., vaccine)-including if they provide a facility to administer or use a covered countermeasure. “Administration” of a vaccine extends to physical provision of a vaccine to a recipient (i.e. injecting the individual with a vaccine), and also to activities related to the management and operation of programs and locations for the physical providing of vaccines to recipients.

Therefore, if an employer sets up a program onsite (i.e., “provides a facility to administer or use” a vaccine), or sets up or supervises a program at the worksite or elsewhere for employees to receive vaccinations (i.e., engages in activities related to the management and operation of programs and locations for providing the vaccine to employees), the employer will be covered under the PREP Act.

Liability immunity under the PREP Act includes claims related to side effects from taking the vaccine, and claims relating to the management and operation of a countermeasure distribution program or site, such as a slip-and-fall injury or vehicle collision by a recipient receiving a vaccine at a site serving as an administration or dispensing location that alleges, for example, lax security or chaotic crowd control. Liability immunity under the PREP Act begins on the date of an applicable authority’s emergency declaration and lasts through the final day the emergency declaration is in effect, or October 1, 2024, whichever occurs first.

10. Are there any additional considerations for employers with unionized workforces?

If an employer has a unionized workforce, whether or not to require a vaccine could be a mandatory subject of bargaining by the union, depending on the terms of the collective bargaining agreement (CBA). Many CBAs include a “zipper clause,” providing that the parties agree that all matters that are appropriate subjects for bargaining are already specified in the agreement-and that during the term of the CBA, no other matters are subject to additional bargaining. If the CBA does not address vaccines and does not include a zipper clause or other language reserving the topic for the employer’s unilateral decision, whether an employer can require mandatory vaccinations for employees in the union may be a mandatory subject of bargaining.

So . . . what should employers do now?

• Get a lay of the land when it comes to vaccines in the workforce in the jurisdictions where the company operates.
• Be thoughtful about company policies. Consider instituting policies that include religious and disability-related exemptions. Employers should also keep in mind that there are many people who don’t want to take a COVID-19 vaccine. According to a September 2020 Pew Research Center report, almost half of US adults surveyed said they would definitely or probably not get vaccinated. And in a recent survey on race and health, almost half of Black adults said they were not planning on taking a COVID-19 vaccine-even if scientists declare it safe and the vaccine is available for free. Reasons cited include the historical treatment of Black populations in medical trials, as well as the current political climate.
• Consider alternatives to mandatory vaccines, such as requiring employees who do not get vaccinated to wear face masks in the workplace. This practice is common in medical settings when employees refuse annual flu shots. Considerations for employers include addressing required remote work or PPE use for employees who are not vaccinated, making a vaccination mandatory for admission to the workforce, and addressing contractor employees and visitor vaccination rules.
• Finally, employers should continue to monitor any new relevant federal, state and local guidance, and be certain to modify policies and protocols as applicable guidance is issued.

For assistance navigating the maze of considerations relating to vaccinating your workforce, contact your Baker McKenzie employment attorney.