Who Needs to Know
All employers.

Why It Matters
Businesses should begin to address these issues now so that when COVID-19 vaccines are ready for distribution, they will be too.

On December 11, the Food and Drug Administration announced that it would be issuing emergency use authorizations for two COVID-19 vaccines and that distribution may begin as early as December 14. While initial doses of the vaccine will be allocated to health care workers and long-term care residents, all businesses should be preparing for broader availability of the vaccine in early 2021. The COVID-19 pandemic and new vaccines present unique circumstances in which employers must balance employee rights with the overall safety and health of its workforce, customers, or clients when developing a vaccine strategy. This FAQ is intended to help employers across all industries understand the legal framework that regulates mandatory and voluntary employer vaccination programs.

We have only started to scratch the surface of the myriad questions employers will face about a new COVID-19 vaccine. The Troutman Pepper Vaccine Task Force will maintain our COVID-19 Vaccine Frequently Asked Questions site to help our clients as they think through these issues.

This information is based on available guidance, as of December 11, 2020.

1. General Questions

a. Generally, what laws should employers consider when evaluating a vaccination program?

Employers must comply with the Americans with Disabilities Act (ADA), Title VII of the Civil Rights Act of 1964 (Title VII), the Occupational Safety and Health Administration (OSHA) requirements, the Public Readiness and Emergency Preparedness (PREP) Act, and federal and state privacy laws governing individual identifiable information.

b. What should employers do now to prepare for the vaccine’s availability?

Below find a few suggestions on what employers can do now to prepare for the availability of a COVID-19 vaccine:

• Review all vaccine-related policies and procedures with legal counsel and consider whether updates are needed. To the best extent, clarify any ambiguity and ensure consistent treatment for similarly situated employees.
• Consider whether to mandate vaccination, encourage or incentivize vaccination, or remain silent on the issue and the ramifications of each decision.
• Communicate internal policies to your workforce in advance and educate them on the benefits and risks of getting the vaccine. Focus internal communication on maintaining a safe environment for employees, customers, and others.
• Assess prior internal processes for reviewing, granting, and monitoring medical or religious exception requests. Anticipate and prepare for an influx of questions and accommodation requests.
• Review vaccine alternatives offered to employees in the past and consider if they constitute viable alternatives in the context of COVID-19. Ask if the business should consider additional alternatives and work with leadership to evaluate these additional options, if any.
• Evaluate your collective bargaining agreements and determine whether the agreements speak to mandatory vaccines. If so, begin conversations with the union(s) early.
• Since the COVID-19 landscape is changing rapidly, stay current with advice and guidance issued by the Centers for Disease Control (CDC) and your state/local public health authorities.

c. Can the state government mandate COVID-19 vaccination for individuals?

Based on prior precedent, it appears that a state government may mandate that individuals get vaccinated. A 1905 Supreme Court case, Jacobson v. Massachusetts, 197 U.S. 11 (1905), considered whether a state could impose a compulsory vaccination law and found that it could. The Court held that the law was squarely within the police power of the state. It is unclear whether facts and circumstances surrounding the COVID-19 vaccine that distinguish it from the vaccine considered in Jacobson v. Massachusetts, including its EUA status, would result in a different outcome.

2. Emergency Use Authorizations

a. What is an Emergency Use Authorization (EUA)?

An Emergency Use Authorization (EUA) is an expedited process that allows the U.S. Food and Drug Administration (FDA) to authorize the use of otherwise unapproved medical products in an emergency to diagnose, treat, or prevent serious or life-threatening diseases when no adequate, approved, and available alternatives exists. The FDA acknowledges that a request for a COVID-19 vaccine EUA can allow for the vaccine’s rapid and widespread deployment. The issuance of an EUA would require a determination by the FDA that the vaccine’s benefits outweigh its risks based on data from at least one well-designed Phase 3 clinical trial demonstrating the vaccine’s safety and efficacy in a clear and compelling manner.

b. How long do EUAs last?

EUAs are temporary. They are only effective for the duration of the declared emergency under which authorization was originally granted. Generally, the secretary of the Department of Health and Human Services’ (HHS) emergency declaration will terminate the earlier of: (1) a determination by the HHS secretary that the circumstances precipitating the declaration have ceased, or (2) a change in the product’s approval status such that the authorized use of the product is no longer unapproved. For example, an EUA issued to allow an unapproved use of an approved product may no longer be needed if the FDA later approves that product for the use permitted by the EUA. Before an EUA declaration terminates, the HHS secretary must provide advance notice sufficient to allow for the disposition of an unapproved product.

c. Do EUAs constitute FDA clearance or approval?

The granting of an EUA does not constitute FDA clearance or approval. Rather, products are “authorized” for use pursuant to an EUA. EUA candidates wishing to commercialize their products beyond the timeframe set by the EUA declaration must seek FDA approval through traditional clearance or approval pathways, for example, NDAs, BLAs, 510(k)s, and PMAs. Furthermore, the FDA requires that products commercialized under an EUA (with the exception of certain personal protective equipment, or PPE) prominently display disclaimers including:

• This product has not been FDA cleared or approved;
• This product has been authorized by the FDA under an EUA;
• This product is only authorized for the duration of the declaration under circumstances justifying the authorization of emergency use, unless the authorization is terminated or revoked sooner.

d. What happens when an EUA is no longer effective?

The FDA explains that, for any products that are not approved, cleared, or licensed, manufacturers may submit the appropriate premarket submission to legally market their product after the EUA declaration is terminated, or the EUA is otherwise revised or revoked. Manufacturers are encouraged to pursue premarket submissions through the appropriate regulatory pathway during the emergency so that products can remain on the market after the emergency.

e. What are the requirements for obtaining an EUA?

Medical products that may be considered for an EUA are those that “may be effective” to prevent, diagnose, or treat serious or life-threatening diseases or conditions identified in the HHS secretary’s declaration of emergency or threat of emergency under section 564(b). The “may be effective” standard for EUAs provides for a lower level of evidence than the “effectiveness” standard that the FDA uses for product approvals. The FDA intends to assess the potential effectiveness of a possible EUA product on a case-by-case basis using a risk-benefit analysis. A product may be considered for an EUA if the commissioner determines that the known and potential benefits of the product, when used to diagnose, prevent, or treat the identified disease or condition, outweigh the known and potential risks of the product. For the FDA to issue an EUA, there must be no adequate, approved, and available alternative to the candidate product for diagnosing, preventing, or treating the disease or condition. A potential alternative product may be considered “unavailable” if there are insufficient supplies of the approved alternative to fully meet the emergency need.

3. Employer Vaccine Mandates and Incentives

a. Can an employer mandate that employees receive a vaccine as a condition of employment?

Yes. Generally, employers can require employees to be vaccinated provided that the employer permits employees to request a reasonable accommodation if they have an ADA disability or a sincerely held religious belief, practice, or observance under Title VII that prevents the employee from taking the vaccine.

When an employee raises a disability-related or religious objection to the vaccine, employers must interact with these employees and implement reasonable accommodations, barring undue hardship. Under the ADA, an accommodation results in an undue hardship for the employer if it requires significant difficulty or expense. Under Title VII, an accommodation results in an undue hardship if it requires more than a de minimis cost.

While the EEOC opined that neither the ADA nor Title VII prohibit employers from requiring employee vaccination, employers should review other considerations before implementing such a requirement. Practically speaking, vaccination will be more critical in some workplaces and workforces than others (retail or restaurant environments, call centers, or other close-quartered workplaces versus a largely remote or teleworking group of employees, for example). The employer should consider whether a requirement is appropriate for its workplace or workforce once a vaccine becomes publicly available and distributed. Further, if the vaccine is difficult to obtain or if supplies are limited, an employer should consider the impact of requiring employees to obtain it before it is readily available.

Earlier this year, the EEOC updated its previous pandemic guidance that responded to the 2009 H1N1 pandemic flu outbreak. This guidance indicates that the EEOC prefers employers to encourage employees to get the COVID-19 vaccine rather than issuing a mandate. We expect that the EEOC will issue new and updated guidance related to the COVID-19 vaccine once a safe and effective vaccine becomes available for widespread distribution.

b. Will the vaccine’s EUA impact an employer’s ability to mandate a COVID-19 vaccination?

While the FDA has announced that it will be issuing EUAs for two COVID-19 vaccines, the text of the EUAs has not yet been released. Until the formal EUAs are issued, it is unknown whether they will impact an employer’s ability to mandate that employees get vaccinated. An EUA may include conditions requiring individuals receiving the vaccine to be informed of the option to accept/refuse administration; of the consequences, if any, for refusing administration; and of any alternative products available and their benefits/risks. Some believe these conditions could further prohibit employers from mandating vaccinations, while others believe they only require employers to notify employees of the consequences of refusing vaccination when they are not entitled to an exemption for disability or sincerely held religious beliefs. Once the EUAs are made publicly available, the specific language will need to be evaluated to determine its impact on mandatory vaccination programs.

c. Can employers base a return-to-office policy on whether the employee has been vaccinated? Can an employer require a vaccine to return to the office?

Yes, an employer may require employees to receive the COVID-19 vaccine in order to return to the office (subject to any EUA restrictions and the exceptions noted above for disabilities and sincerely held religious beliefs). Telework or mask-wearing may constitute an appropriate and effective accommodation for appropriate positions in this instance. Regardless of whether a vaccine is required, as the EEOC recently confirmed, employers should avoid selecting individuals for return to work in the office (or telework) based on protected categories (e.g., refusing to allow individuals over age 65 or pregnant individuals to return to the workplace).

d. Can employers include a vaccine requirement for employees who travel for business? What about employees who travel in their personal time? How would such a requirement interact with state laws limiting employers’ ability to regulate off-hours activity?

As noted above, employers can generally require employee vaccination as a condition of employment, which would cover any instance of business travel. If vaccine quantities are limited, requiring only employees who travel for work as an essential function receive the vaccine may be one effective way to implement a vaccine requirement among a limited group of employees, so long as the employer considers requests for reasonable accommodations due to disability or sincerely held religious beliefs and any restrictions in the EUA.

Employers should also be aware that the EEOC confirmed that questions about why an employee was absent from work and/or where an employee traveled would not be a prohibited disability-related inquiry. Further, if the CDC or state/local public health officials recommend that people who visit specified locations remain at home for a certain period of time, an employer may ask whether employees plan to return from these locations, even if the travel was personal.

e. Do employers who mandate the vaccine need to pay for the cost for employees to receive the vaccine? And how would this interact with existing benefit plans and programs?

As of now, it appears that employers cannot purchase or obtain batches of the vaccine on their own, at least initially. However, employers could consider reimbursing employees for the cost of receiving a vaccine, even if they cannot run an employer-sponsored clinic, just as many do for the flu vaccine, so long as they do so consistently across the employee population. Covering the cost may be one effective way to ensure that employees comply with a mandate and, depending on the workforce (and the out-of-pocket cost of the vaccine), may be necessary as a practical matter for certain classes of employees. Employers should consult their particular benefit plans and providers to determine whether the cost of a COVID-19 vaccine will be covered under the terms of those plans.

f. Instead of covering the cost of the vaccine, can employers offer a bonus to employees who receive it? What if the vaccine isn’t available to all employees because of limited distribution? Does the size of the bonus matter? And, if people receive a payment for getting the vaccine, is it coercive?

Yes, employers can likely provide a one-time gratuitous bonus or even another benefit, such as additional “paid time off” or a “dress-down” day or similar perk, to employees to encourage them to get vaccinated. If what is offered is truly a gratuitous benefit (and not unreasonably large, such that it could be considered coercive), the employer can offer enticements to encourage employees to get vaccinated even if the employer does not require it as a matter of course.

g. Do employers need to include a vaccine requirement in an Illness and Injury Prevention Program (IIPP)?

For the reasons noted above, an employer may require vaccination as a condition of employment, but OSHA has not yet opined as to whether vaccination is an appropriate or advisable component of an IIPP. Each employer should review its workforce and working environment to determine whether vaccination might reduce a substantial risk of infection, considering availability of any vaccine, in making this determination for its individual workplace(s).

4. Exemptions and Accommodations

a. How should employers address accommodation requests for those who refuse a vaccine based on a sincerely held religious belief and/or disability?

Regardless of whether an employer chooses to mandate the COVID-19 vaccination, employers should ensure that there are procedures and policies in place for employees to request reasonable accommodations, including for religious beliefs and disabilities. After receiving a request for reasonable accommodation (whether based on religion or disability), employers should engage in an interactive dialogue with the employee to discuss the requested accommodation. As part of the interactive process, employers may request that the employee provide supporting information or documentation to substantiate the need for the requested accommodation. If the employee establishes a sincerely held religious belief or disability, the employee must be afforded a reasonable accommodation unless the accommodation presents an undue hardship to the employer. The interactive process, including assessment of an employee’s religious belief and/or disability and any resulting undue hardship on the employer, is fact sensitive and will vary by the individual and corresponding circumstances. For example, the resulting undue hardship for a vaccination exemption may vary by an employee’s position or essential job duties, such as whether the employee’s duties require regular interaction with members of the general public or whether the employee can perform his/her duties remotely.

b. What constitutes a “sincerely held religious belief” to support an employee’s religious accommodation request to refuse vaccination?

In order to warrant protection under Title VII, an employee must have a “sincerely held religious belief” that opposes or conflicts with receiving the vaccination for an employer to provide an accommodation or exemption. The EEOC’s guidance broadly defines religion to include organized religions and religious beliefs, but does not include social, political, or economic philosophies or personal preferences.

While an employee may have a sincere belief against or in opposition to the vaccination, the key inquiry is whether the employee’s belief is rooted in religion or a religious belief. A nonreligious opposition is not covered under Title VII. The employee must establish that the objection is based on a legitimate, sincerely held religious belief in order to warrant an exemption as an accommodation.

Courts differ on what constitutes “religion” to warrant protections under Title VII. For example, the U.S. Court of Appeals for the Third Circuit recently affirmed dismissal of a Title VII religious discrimination claim for a hospital employee terminated for refusing a flu vaccination based on her holistic health lifestyle and personal belief that the vaccine was unnecessary. While the employee may have had a sincere opposition, the Court of Appeals noted that the employee must establish that “opposition to vaccination is a religious belief.” Citing Fallon v. Mercy Catholic Med. Ctr. of Se. Pa., 877 F.3d 487, 490 (3d Cir. 2017) and Brown v. Children’s Hosp. of Phila., 794 Fed. Appx. 226 (3d Cir. 2020).

On the other hand, the U.S. District Court for the Southern District of Ohio refused to dismiss a religious discrimination case where the employer terminated an employee for refusing to submit to a mandatory flu vaccination based on veganism. The employee claimed that the vaccination contained animal products that went against her religious and philosophical views as a vegan. The court found “it plausible that [p]laintiff could subscribe to veganism with a sincerity equating that of traditional religious views.” See Chenzira v. Cincinnati Children’s Hospital Medical Center, Case No. 1:11-cv-00917.

Based on the contrasting case law and fact-sensitive analysis, employers should consult with legal counsel before denying an accommodation request based on an employee’s proffered religious belief.

c. May an employer validate an employee’s proffered disability for refusing the vaccine?

Yes, employers may request clarifying information or documentation as part of the interactive dialogue to assess an employee’s accommodation request based on disability. For example, an employer may require the employee to provide a doctor’s note that describes a substantially limiting impairment and the reasonable accommodation needed as a result (e.g., recommendation against receiving the vaccine). However, employers should be mindful of the balance between requesting information to sufficiently verify the validity of the employee’s proffered disability and corresponding accommodation (such as a generic doctor’s note stating the recommendation for the vaccination exemption), as opposed to scrutinizing why or how the proffered medical reason or disability may exempt the employee from the vaccination (such as requesting additional information about specific diagnoses or reasons why the exemption is recommended). Once the employer obtains sufficient information to describe a substantially limited impairment and any resulting need for accommodation, the employer cannot ask for additional information. Assuming the employee establishes that he/she has a disability within the meaning of the ADA, employers should focus on how the requested accommodation (e.g., not receiving a vaccine) will impact the employee’s ability to perform his/her essential job duties, and whether the exemption will result in an undue hardship to the employer. Employers must also be mindful of their obligation to maintain strict confidentiality of any medical information received as part of the interactive process.

d. What constitutes an “undue hardship” that would justify an employer’s refusal of an employee’s vaccine exemption request based on religion or disability?

Unfortunately, there is no bright line answer to what constitutes an “undue hardship” to justify an employer’s refusal of an employee’s request for accommodation. As noted above, the interactive process, including the determination as to whether a requested accommodation presents an “undue hardship,” is an individualized assessment that employers must conduct on a case-by-case basis.

“Undue hardship” may also depend on the reason for the accommodation request. For example, in the context of a religious accommodation under Title VII, “undue hardship” is a lower standard that requires “more than de minimis” cost or burden to the employer. The EEOC identifies factors of what may constitute “undue hardship” in the context of religious discrimination under Title VII, including if the accommodation is “costly, compromises workplace safety, decreases workplace efficiency, infringes on the rights of other employees, or requires other employees to do more than their share of potentially hazardous or burdensome work.” See EEOC Guidance on Religious Discrimination.

Under the ADA, “undue hardship” is a higher threshold that requires “significant difficulty or expense” based on the employer’s resources and circumstances, or that the employee poses a “direct threat” to the health and safety of others. See EEOC Guidance on Undue Hardship.

Regardless of the context, employers should assess several factors when determining whether the accommodation results in “undue hardship,” ranging from financial costs to the type of operations. Employers should also be mindful of state anti-discrimination laws, which may impose even higher burdens of “undue hardship.”

Accommodation determinations are regularly questioned and scrutinized through litigation — even without involving the controversial topic of a mandated vaccine. “Undue hardship” in the context of the COVID-19 vaccination in particular presents a unique twist to the traditional analysis because all employers have had to make at least some changes to their operations in response to the pandemic. Specifically, many employers have already implemented the alternative accommodations that a vaccination exemption would offer, such as minimizing employee interactions requiring PPE, telework arrangements, and social distancing — all of which would arguably constitute reasonable alternatives to vaccination.

e. Can an employee refuse to be vaccinated if they don’t believe the vaccines are safe?

Typically, a generalized fear that COVID-19 vaccines are not safe is insufficient to warrant an exemption under the law. However, employers must consider any underlying basis for the refusal in order to assess any available protections under the law. As discussed above, an employee’s refusal may stem from a religious belief or a disability, which may require accommodation. An employee who refuses vaccination due to a reasonable belief that it may result in serious injury or death (such as a serious reaction) may be protected by Section 11(c)’s whistleblower provision under the Occupational Safety and Health Act. Likewise, an employee or group of employees who refuse or protest a mandatory vaccination could claim to be engaged in concerted activity, which is protected under Section 7 of the National Labor Relations Act. Some states also protect an employee’s political views, which could potentially implicate political speech based on an employee’s views on the COVID-19 vaccine in light of the political climate.

f. Can employers give an exemption to the same employees who obtained a flu shot exemption?

Not necessarily. An employee who received an exemption for a flu vaccine may receive, but is not necessarily entitled to, a COVID-19 vaccine exemption. Employers are encouraged to conduct individualized assessments in response to each accommodation request.

5. Vaccine Program Design

a. Companies with flu vaccine policies may wonder how to apply those to COVID-19 vaccine. Should they establish voluntary programs like they do for flu vaccines (hosting clinics at their workplace, for example)? How does the distribution plan for any vaccine impact this, and what about smaller employers who cannot host this type of initiative?

According to the CDC COVID-19 Vaccination Program Interim Playbook for Jurisdiction Operations (last updated October 29, 2020), “routine immunization and pandemic influenza program activities can serve as a foundation for COVID-19 vaccination planning.” This includes implementing COVID-19 voluntary immunization programs, such as hosting vaccination clinics at the workplace, leaving open the possibility of establishing a vaccine mandate. Employers that cannot offer on-site vaccination clinics should encourage employees to seek vaccination in alternative sites in the community (e.g., hospitals, pharmacies, state and local public health departments, and potentially government-run mass vaccination sites). Note that the effectiveness of these voluntary programs will depend on further guidance on the allocation, ordering, distribution, and inventory management of the COVID-19 vaccine.

b. What documentation will employers require to demonstrate that an employee received the vaccine? How will they maintain it?

There is currently little guidance on what documentation employers may require and keep to show that an employee received the vaccine. Generally, subject to additional guidance, employers should ask the employee to provide documentation from an immunization service validating the date on which the vaccine was administered.

c. What are the privacy implications involved in collecting and maintaining this type of employee medical information? How will it implicate confidentiality and recordkeeping requirements under federal and state-specific laws?

The ADA and similar state-specific laws generally require employers to keep an employee’s vaccination status confidential and to keep employee medical information separate from employee personnel files. Therefore, employers should maintain COVID-19, vaccine-related medical information in existing medical files.

d. How should employers allocate the vaccine if there is a limited amount (at least initially)? If employers don’t receive the vaccine for distribution, who should they encourage/mandate to get the vaccine? And how can they ensure they do not make this type of allocation decision in a manner that does not involve any characteristic protected by law (g., not just requiring those over age 65 to receive the vaccine)?

The COVID-19 vaccine supply is expected to be limited during the initial implementation of vaccine-response activities. Thus, at least in the initial stages, employers should focus their vaccine distribution efforts on workers with increased risk for severe illness from COVID-19 (e.g., those 65 years of age and older and those with preexisting conditions) and other essential workers. To ensure that the distribution is not administered in a discriminatory manner, employers should prioritize access to the vaccine on medical needs and public health grounds. In the event employers do not receive the vaccine for distribution, they should strongly encourage their workers to seek vaccination in alternative sites in the community again, based on medical needs and public health grounds.

e. Can employees’ time spent receiving a required vaccine count as compensable work time?

Generally, yes. Under the Fair Labor Standards Act (FLSA), employers must reimburse expenses an employee incurs on its behalf or that an employee must expend primarily for the employer’s convenience. State or local wage and hour laws may have similar, if not more restrictive, requirements. If the employee is required to receive a vaccine that is job related and consistent with business necessity, an employer will likely need to compensate the employee for the time spent and expense of receiving the vaccine.

f. How will vaccination policies be impacted if they include vaccines with two-dose regimens?

Currently, most COVID-19 vaccine products will require two doses for immunization, with the second dose given several weeks after the first. The different COVID-19 vaccine products also are not interchangeable. Thus, employers using vaccines with two-dose regimens should carefully track the doses and storage requirements, and they should follow up with each individual receiving the vaccine to ensure they receive the same vaccine with the second dose given at the proper time. Employers likely may not rely on existing vaccination policies since this two-dose schedule was not required for other mass-distributed vaccines, such as seasonal influenza or during the 2009 H1N1 pandemic influenza. The CDC and local jurisdictions are currently in the process of providing additional guidance on how to monitor COVID-19 vaccine administration through a vaccine tracking system, including issuing second-dose reminders.

6. Liability Questions

a. If employers mandate the vaccine and it results in an injury, is the employer liable?

Employers who mandate or administer a COVID-19 vaccine before employees return to work should be afforded liability protection under the PREP Act, assuming the employer acts in accordance with the PREP Act and other appropriate guidance. The PREP Act authorizes the HHS secretary to provide certain individuals and entities (referred to as “covered persons”) with immunity from liability arising out of, relating to, or resulting from the manufacture, distribution, administration, or use of medical countermeasures (referred to as “covered countermeasures”) except for claims of willful misconduct.

A COVID-19 vaccine would be considered a “covered countermeasure” and thus covered by the PREP Act, so long as the FDA issues the vaccine an EUA. The secretary’s March 17 declaration under the PREP Act includes private sector employers who “supervise or administer” the dispensing, distribution, or use of a covered vaccine, including those who “establish requirements, provide policy guidance,” or “provide a facility to administer” a covered vaccine as “covered persons.” Therefore, employers who engage in these activities should be considered “covered persons” and afforded protection under the PREP Act. Furthermore, per the secretary’s fourth amendment to the March 17 declaration, the PREP act also offers immunity from liability to any entity that administratively supervises the allocation, dispensing, distribution, or use of covered countermeasures even if said countermeasure is ultimately not administered.

To obtain immunity under the PREP Act, however, an employer would need to perform those activities “in accordance” with the secretary’s declaration. Such declaration may include directions to vaccinate only certain groups or only under specific conditions, such as with a health agency’s approval. An employer would not have immunity if it mandates or administers a vaccine for those excluded groups or if not in compliance with the agency’s specific conditions. It is therefore critical for employers to ensure that any mandate or administration of the vaccine adheres closely to the secretary’s declaration and any health agency’s directions.

It is also important to note that PREP Act immunity is retroactive from February 4, 2020, and it extends only through October 1, 2024 or when the secretary announces the end of the COVID-19 public health emergency, whichever occurs first. Thus, any claims based on vaccines administered after such date would not receive immunity under the PREP Act.

Although the PREP Act is broadly drafted by including the terms “arising out of” or “relating to” or “resulting from,” time will tell how courts define those terms and others, such as “willful misconduct” and “in accordance with.” The definition of these terms is critical in determining the scope of PREP Act immunity, but courts have not yet interpreted them.

The PREP Act FAQs state that any compensability for injury will be paid from the Countermeasures Injury Compensation Program (CICP). The CICP is only available for “serious physical injury,” including those that “warranted hospitalization” or “led to a significant loss of function or disability.” However, even if applicable, the “CICP is payer of last resort, so benefits are reduced by the amounts payable by all other public private third-party payers (such as health insurance and workers’ compensation).” These FAQs suggest that any illness or injury caused by an employer-mandated vaccine may result in liability under any applicable workers’ compensation system. Depending on the state, workers who get sick from taking a required vaccine would need to prove their employer was reckless or grossly negligent to get around the workers’ compensation system.

b. What if the CDC begins strongly recommending employers require employees to get vaccinated before returning to work? Do employers face liability concerns if they do not require a vaccine in that instance?

Typically, employers are prudent to follow CDC guidance on COVID-19 updates. However, the CDC’s guidance has changed since the emergence of the pandemic, and it will likely continue to evolve. If the CDC issues guidance that recommends the vaccine, an employer’s refusal to follow such guidance will not necessarily result in liability. In addition to CDC guidance, employers should monitor and comply with federal, state, and local legislation or orders regarding the COVID-19 vaccine, along with any other COVID-19 preventive efforts. Typically, state and local agencies and health departments have authority to enforce more or less restrictive requirements within their jurisdiction, which can result in conflicts between federal, state, local, and city requirements. For example, while the CDC may recommend the vaccine, certain states or localities may prohibit vaccination mandates or limit such mandates to certain industries. Employers should also monitor guidance from relevant government agencies like the EEOC and OSHA — neither of which has yet issued guidance on COVID-19 vaccines.

c. How should employers requiring or recommending vaccines (or hosting employer-sponsored optional vaccine clinics) prepare for possible liability associated with these activities?

Injury or illness attributed to an employer-mandated COVID-19 vaccine will likely receive compensation under any applicable workers’ compensation scheme. Some states and jurisdictions do not allow COVID-19-related liability waivers in the employment context. In states allowing liability waivers, employers should consider using waivers for both those employees who are vaccinated, as well as those who are granted an exemption or choose to forego vaccination.

If an employer wanted to mitigate any potential liability associated with vaccine injury, the employer could consider making any vaccinations entirely optional and voluntary. To further minimize any connection to the employer, employers may consider providing information on where employees can obtain vaccinations instead of hosting or sponsoring a vaccination clinic during work hours.

d. Can vaccine manufacturers be held liable for injuries related to the COVID-19 Vaccine?

Manufacturers of vaccines for COVID-19 can be protected from liability under the PREP Act, so long as they comply with the terms of their FDA authorization or clearance, as well as any other applicable regulations. As previously mentioned, a vaccine would be considered a covered countermeasure under the PREP Act, as it is a drug used to “treat, diagnose, cure, prevent, or mitigate COVID-19, or the transmission of SARS-CoV-2 or a virus mutating therefrom, or any device used in the administration of any such product, and all components and constituent materials of any such product.” Generally, covered countermeasures are FDA or NIOSH cleared or approved products, or, at minimum, are product for which the FDA grants an EUA. An entity will be protected as a manufacturer or distributor of covered countermeasures “regardless of who receives the countermeasure or where it is administered or used.” Furthermore, per the most recent amendment to the PREP Act declaration, manufacturers will be protected from liability for the administrative prioritization or purposeful allocation of a covered countermeasure, even if this results in the non-administration of said countermeasure.

e. What exceptions are there to vaccine manufacturers’ liability immunity under the PREP Act?

Liability immunity granted under the PREP Act is not absolute. Vaccine manufacturers will not be immune from suits for willful misconduct. The PREP Act defines willful misconduct as an act or failure to act that is taken intentionally to achieve a wrongful purpose; knowingly without legal or factual justification; and in disregard of a known or obvious risk that is so great as to make it highly probable that the harm will outweigh the benefit. All three conditions must be unequivocally proved for liability to exist.

Furthermore, the only exception to liability immunity under the PREP Act is an “exclusive federal cause of action” against the manufacturer for death or willful misconduct. Therefore, willful misconduct cannot be found against a vaccine manufacturer for HHS-regulated actions if neither the attorney general nor the HHS secretary initiates an enforcement action. The only remedies available without this federal cause of action are administrative remedies, pursuant to 319F-4 of the PHS Act.

f. What remedies or compensation are available for people injured as a result of a COVID-19 vaccine?

The PREP Act establishes that, without a federal cause of action for death or willful misconduct, the only remedies available for injury claims are administrative remedies.

Any person claiming injury as a result of a COVID-19 vaccine (or any other covered countermeasure) can seek compensation through the HHS CICP. CICP is an administrative process, which can directly ascertain coverage and compensation by the HHS, including compensation for serious physical injury or death. To establish a covered injury, the CICP must determine that the injury sustained direct resulted from the administration or use of a covered countermeasure. Under the PREP Act, the CICP may only make such determinations “based on compelling, reliable, valid, medical, and scientific evidence.”

7. Health Care

a. Can a health care provider require its staff be vaccinated?

Yes, provided that the health care provider makes an exception for those with a bona fide ADA medical condition or Title VII religious belief. In a 2016 case, a Massachusetts federal district court considered a hospital’s mandatory vaccine policy and an employee’s request for a religious exemption. The employee worked in the emergency room and came into direct contact with patients during registration. In response to the employee’s claim for a religious exemption, the hospital offered several accommodations, including an alternative vaccine. The employee refused and was ultimately deemed to have voluntarily resigned based on her refusal to get the influenza vaccine. The court upheld the hospital’s action, in part, because allowing the employee to continue working in her current role without getting the vaccine would constitute an undue hardship.

“…[I]t would have increased the risk of transmitting influenza to its already vulnerable patient population. Health care employees are at high risk for influenza exposure and can be a source of the fatal disease because of their job. Numerous medical organizations support mandatory influenza vaccination for health care workers…. Had the [h]ospital permitted her to forgo the vaccine but keep her patient-care job, the [h]ospital could have put the health of vulnerable patients at risk.” See Robinson v. Children’s Hosp. Boston, Civil Action No. 14-10263-DJC (D. Mass. Apr. 5, 2016).

b. Can a health care provider adopt different vaccination requirements for different types of employees (g., patient care/patient-facing employees vs. nonpatient care/patient-facing employees)?

Yes, health care providers can elect to implement different vaccine requirements for employees who engage in work that places them at a higher (or lower) risk. Consideration can be given if the employee provides direct patient care and/or has access to patient care or other vulnerable areas. Put a different way, if a health care provider elects to impose a mandatory immunization policy for the COVID-19 vaccine, such provider should consider the appropriate scope of the mandate. At least initially when the vaccine is in limited supply, it may be more advantageous to impose a mandatory policy on only those in direct patient care or vulnerable settings.

If a health care provider considered this approach, it should (1) articulate a clear and reasonable justification for using this approach based on patient and employee safety, and (2) implement the policy in a fair and nondiscriminatory manner, allowing for medical and religious exceptions as discussed in more detail elsewhere in this FAQ .

c. Can a nursing home participating in Medicare or Medicaid require its residents to get vaccinated?

The Centers for Medicare & Medicaid Services (CMS) require participating nursing homes to offer influenza and pneumococcal vaccines to residents. However, residents or their legal representatives may refuse immunization. Unless or until CMS provides guidance to nursing homes on the COVID-19 vaccines, these facilities should adapt their influenza and pneumococcal vaccines policies for the COVID-19 vaccines. This means that facilities should offer residents education on the benefits and potential side effects of immunizations, offer the immunization unless the immunization is medically contraindicated, provide the resident or resident’s legal representative with an opportunity to refuse immunization, and document the education and immunization or refusal in the resident’s medical record.

d. Can a private long-term care facility require its residents to get vaccinated?

A private long-term care facility that does not participate in Medicare or Medicaid may be able to require residents to receive the COVID-19 vaccine, depending on how the issue is addressed in the resident’s agreement with the long-term care facility and other governing documents, as well as state law. Facilities in this situation should review their resident agreements, current policies and procedures, other documents that may address immunizations, and state licensure laws and amend any such policies or procedures in advance of the COVID-19 vaccine being released. They also should work with residents and family members to communicate such changes in advance of implementation.

In any mandatory immunization policy, the facility should make exceptions for those residents where the vaccine is medically contraindicated or who have a sincerely held religious belief prohibiting them from being vaccinated. Facilities should have processes in place to evaluate these requests and employees trained to handle them appropriately.

e. How should a long-term care facility prepare to handle residents who refuse the vaccination?

Facilities should have a plan for how best to care for residents who elect not to be vaccinated. For example, will the facility require that these residents and/or their assigned health care workers wear enhanced personal protective equipment (PPE)? Should they be moved to a particular area of the facility? Will the facility require them to sign a waiver form documenting their decision not to be vaccinated and the reasons therefor? At a minimum, the facility should require staff to document its (1) discussion with the resident and/or family of the benefits and risks, and (2) the patient’s and/or family member’s refusal of the vaccine. This documentation should be made part of the resident’s medical record.

f. Can a long-term care facility discharge a resident who refuses to be vaccinated?

If a facility wants to consider “discharge” as a result of a resident’s refusal to be vaccinated, especially in the absence of a sincerely held religious belief or medical condition, it should carefully review its admission agreement, policies on transfers and discharges, and applicable state and federal law, including the Medicare conditions of participation (if applicable), and consult with legal counsel to ensure this step is appropriate under the circumstances.

8. Education

a. Can colleges and universities mandate that students receive the COVID-19 vaccine?

Generally, yes. Colleges and universities may mandate that students receive the COVID-19 vaccine. The same exceptions discussed above based on a bona fide medical condition or religious belief would generally apply. It is important that schools consult their local state laws since many states have specific rules about vaccinations exemptions, which schools should follow if they choose to mandate a COVID-19 vaccine. See the CDC’s summary information about state exemption laws.

However, before adopting any policy requiring vaccinations, schools should consider some of the same factors identified above, including whether the vaccination will be in sufficient supply, and how they will administer and enforce compliance with the mandate. Schools should also closely follow guidance from the federal, state, and local government as it evolves on this issue.

b. Can schools release information about whether particular students were vaccinated?

Generally, no. The Family Educational Rights and Privacy Act (FERPA) would preclude release of information absent written consent. FERPA, rather than HIPAA rules, would generally apply to colleges’ and universities’ release of such information. Schools should consult the FERPA regulations for any specific exemptions that might apply.

c. Should colleges and universities offer the vaccine to students at no cost?

Colleges and universities may consider covering the cost, or subsidizing part of the cost, of the COVID-19 vaccine to all students, but they are not required to do so.

d. Can colleges and universities mandate that employees (professors, administrators, coaches, etc.) receive the COVID-19 vaccine?

Yes, see above for the discussion on mandatory vaccinations of employees. Schools, however, should ensure that they follow their internal policies.