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Frequently Asked Questions on Workplace Vaccine Policies

Posted: December 23, 2020

On December 11, 2020, the Food and Drug Administration issued emergency use authorization (EUA) for a COVID vaccine developed by Pfizer.  On December 18, 2020, the FDA granted similar approval to a vaccine developed by Moderna.  Despite various manufacturing, distribution and logistics issues, over 20 million doses have been administered, and approximately 100 million more doses are expected to be distributed by the end of April, providing significant protection to 60 million people in the U.S.  A third vaccine from Johnson & Johnson may be added in the coming months.  Wider distribution will occur over the following months based upon manufacturing capacity and distribution efforts, but it could be sometime in the fall before everyone who wants the vaccine can receive it.

The availability of these vaccines raises questions about whether employers can require their employees to receive the vaccine.  On December 16, the Equal Employment Opportunity Commission amended its technical assistance, “What You Should Know About COVID-19 and the ADA, the Rehabilitation Act, and Other EEO Laws,” to address common employer questions regarding the vaccine.  

We have seen an increase in questions from employers about vaccines.  Before he took office President Biden indicated that there would be no federal mandate.  We anticipate that state legislatures and governors may start looking at the issues of mandatory vs. voluntary vaccinations in public and private workplaces, schools, public accommodations, and other settings.  Employers need to watch for new developments.

Below, are the most common questions we have been hearing from employers, and our guidance.  We will be periodically updating and revising these FAQ’s.

Can an employer mandate that all of its employees get a vaccine when it is available to them?

There are currently no federal or state laws that prohibit employers from requiring vaccinations as a condition of employment, though there are laws that may place conditions on such requirements.  There may be existing rules or contracts that prevent a particular employer from doing so unilaterally.  Public employers will be subject to state and local personnel rules or laws.  When employees are covered by a collective bargaining agreement, the employer will need to determine if this is a mandatory subject of bargaining.

Subject to any new or existing laws applicable in the employer’s industry, an employer may require employees to get the vaccine as a condition of continued employment.  However, at the current time, the more prudent approach is to encourage employees to get the vaccine, but not mandate it.

Why shouldn’t employers mandate the vaccine at this time?

The vaccines are still experimental, having been approved on an emergency basis.  It could be a year or more before the FDA gives final approval.  In the past, courts have been reluctant to uphold a mandate that individuals receive an experimental drug or vaccine.

There is still a lot we do not know, and will not know for many months until there is more data.  The Pfizer and Moderna vaccines were highly effective during clinical trials in providing a robust protective immune response that will protect the vaccinated person.  It is unclear whether a vaccinated person, though not ill, can still carry and spread the COVID virus.  That is why the CDC is recommending that those who are vaccinated still wear masks and practice social distancing.

We do not know how long any immunity will last.  The evidence is that the vaccines will last longer than the immunity from having COVID-19, but we do not know how frequently boosters will be needed.

As new vaccines are approved, they may have different levels of effectiveness, but be easier to manufacture and distribute.  At some point, there may be choices, and the employer would have to decide whether to mandate a particular vaccine, or leave that to the employee and their physician.

Polls show there is a significant percentage of adults who are cautious about a new vaccine, in addition to those who are anti-vaccine. 

What is EUA status?

An EUA is a mechanism to facilitate the availability and use of medical countermeasures, including vaccines, during public health emergencies, such as the current COVID-19 pandemic.  The FDA has not yet compiled all the information needed to fully approve the vaccines under its usual processes, and so it approved the first two developed vaccines pursuant to EUAs.  The FDA has used the EUA for other drugs and products, but had only done so for one prior vaccine (Anthrax), and said it might do so in an emergency for one smallpox vaccine.  So there is little past guidance. 

The FDA has found that the vaccines have met its “rigorous, scientific standards for safety, effectiveness, and manufacturing quality needed to support emergency use authorization” and that “[their] known and potential benefits clearly outweigh [their] known and potential risks.”  The FDA will conduct additional monitoring before granting full approval for the vaccines, and that could take several months, and possibly more than a year.  The same will be true for any further COVID-19 vaccines approved under an EUA.  Until final approval, these vaccines are legally considered unproven and experimental. 

Can a vaccine in EUA status be subject to a private employer mandate?

Without further clarification from the FDA, the answer is unclear.  Under the Federal Food, Drug & Cosmetic Act, the FDA has statutory authority to set the conditions for the use of EUA vaccines.  In its conditions for the EUAs for the Pfizer-BioNTech and Moderna vaccines, the FDA has not addressed whether a recipient has the right to refuse the vaccine without suffering adverse action at work or school.  However, in the mandatory Fact Sheet that must be given to all recipients, one of the required disclosures states:  “It is your choice to receive or not receive the [vaccine].  Should you decide not to receive it, it will not change your standard medical care.”  See Section IV (A).  In contrast, for at least one prior vaccine, the Anthrax vaccine, the EUA contained language that shielded individuals who exercise vaccine right of refusal from adverse action.  This raises a legal question of whether such specific language must be clearly stated in the conditions of use – which it is not for the EUA-approved COVID-vaccines. 

There are good arguments that the Fact Sheet language is nothing more than a statement of informed consent for the person administering the vaccine, and it has no impact on whether failure or refusal to get vaccinated may have other consequences at work, school or in commerce.  Because of the statutory ambiguity, and the silence of the FDA, employers could have a good faith, reasonable basis to conclude that under the EUA does not prevent mandatory COVID-19 vaccine programs by employers.  This relatively novel issue of law poses an additional level of risk and uncertainty to any mandatory vaccination requirements.  

What if an employee refuses to get the vaccine due to a disability?

At this time, employees with certain medical conditions may be recommended to not get the vaccine. Some experts have suggested caution about women who are pregnant or breastfeeding until there is more data.  The list may change as more information is obtained.  While most of the side effects reported are normal for any type of vaccine, there could be some medical conditions where there is a higher risk that may justify a person with a disability waiting.  The EEOC has confirmed that these must be considered as possible reasonable accommodations under the ADA.  In determining whether to waive a vaccine requirement, employers should follow their ADA accommodation process, including requiring documentation and questioning that documentation if it is incomplete or unclear.  Most state and local laws that prohibit disability discrimination will be interpreted consistently with the EEOC guidance. 

If an employee refuses to get a vaccine for a disability-related reason, the EEOC says that the employee cannot be excluded from the workplace unless the unvaccinated employee would pose a direct threat due to a “significant risk of substantial harm to the health or safety of the individual or others that cannot be eliminated or reduced by reasonable accommodation.”  29 C.F.R. § 1630.2(r).

It is not easy to establish a “direct threat.”  In making this determination, an employer should consider (1) the duration of the risk posed; (2) the nature and severity of the potential harm; (3) the likelihood that the potential harm will occur; and (4) the imminence of the potential harm.  If an employer determines that an unvaccinated employee will pose a direct threat in the workplace, the employer must then engage in the interactive process:  is there a reasonable accommodation that the employer could provide that would eliminate or reduce the risk posed by the unvaccinated employee?

The challenge for many employers is that millions of workers have been at their jobs this year without being vaccinated.  CDC and OSHA have had best practices for operating a safe workplace without vaccines, including masks, social distancing, and good ventilation.  The employer would have to demonstrate that despite all of these precautions, or others, having this employee at work would be a direct threat to themselves or others.

If there is no reasonable accommodation that would reduce the risk, the employer can exclude the employee from the workplace.  In some industries, exclusion from the workplace will, necessarily, lead to termination of the employee’s employment.  However, there are industries in which the employee can perform work remotely.

If an employee must be excluded from the workplace and cannot perform work remotely, the employee may be eligible for leave under the Family Medical Leave Act (FMLA) or the Families First Coronavirus Response Act (FFCRA).

What if an employee refuses to get the vaccine based on a sincerely held religious practice or belief?

Employees of private employers may raise religious objections under Title VII and state laws.  Employees of public employers may raise First Amendment objections as well.  This may include request for a waiver of a vaccination mandate as a reasonable accommodation of their religious beliefs.  The EEOC has confirmed that these objections must be considered on a case-by-case basis.  There may be situations in which the burden of waiving the requirement for a vaccine (e.g., the risk to others) is more than de minimis, which is the standard under Title VII.  Most state and local laws that prohibit religious discrimination will be interpreted consistently with the EEOC guidance

An employer must provide employees with reasonable accommodations for the employee’s sincerely held religious belief, practice, or observance where it would prevent the employee from receiving the vaccine.  The reasonable accommodation cannot impose an undue hardship, which is defined as an accommodation having more than a de minimis cost or burden on the employer.

Religion is interpreted broadly and includes beliefs, practices and observances with which an employer may not be familiar.  Ordinarily, an employer should assume that an employee’s request for a religious accommodation is based on a sincerely held religious belief.  However, where an employer has an objective basis for questioning the religious nature or sincerity of a belief, practice or observance, the employer may request additional supporting information.

The analysis will be similar to that under the ADA, but there is a lower level of what is considered an undue hardship.  However, the Supreme Courts and other federal courts have been far more sympathetic in recent years to religious objections.

If an employer is unable to provide a reasonable accommodation that allows the employee to remain in the workplace, the employee may be excluded from the workplace.  In some industries, exclusion from the workplace will, necessarily, lead to termination of the employee’s employment.  However, there are industries in which the employee can perform work remotely.

Can or should an employer offer vaccines in the workplace as they become more widely available?

Yes, but they should do so with caution.  The vaccines currently available are experimental and have been approved for use on an emergency basis.  An employer considering providing the vaccine at the workplace should consider all of the risks.

The EEOC also notes that the pre-vaccination screening questions for the current vaccines are disability-related inquiries, and may involve disclosure of confidential genetic information, and are subject to the ADA and GINA.  The employer would have to defend these inquiries as job-related and consistent with business necessity, and keep the information as confidential medical information.  These issues can be avoided if the vaccine is administered outside the workplace by a third party (e.g., pharmacy or doctor).

Are there any OSHA issues?

In 2009, OSHA gave guidance to healthcare providers regarding H1N1 vaccines that “employees need to be properly informed of the benefits of the vaccinations.  However, although OSHA does not specifically require employees to take the vaccines, an employer may do so.  In that case, an employee who refuses vaccination because of a reasonable belief that he or she has a medical condition that creates a real danger of serious illness or death (such as serious reaction to the vaccine) may be protected under Section 11(c) of the Occupational Safety and Health Act of 1970 pertaining to whistle blower rights.”  More recently, in its FAQs on COVID-19, OSHA discussed potential claims for retaliation, noting that “Section 11(c) of the Occupational Safety and Health Act of 1970 (29 USC 660(c)) prohibits employers from retaliating against workers for exercising a variety of rights guaranteed under the law, such as filing a safety or health complaint with OSHA, raising a health and safety concern with their employers, participating in an OSHA inspection, or reporting a work-related injury or illness.  . . .”  So in addition to ADA and other considerations, an employee who raises safety or medical concerns about mandatory vaccinations may be engaging in protected activity under OSHA.

Can an employer incentivize employees to get vaccinated?

Yes, but it should be framed appropriately.  For example, instead of rewarding employees for getting the vaccine, an employer might choose to provide a stipend to reduce the burden of the vaccine.  If, for example, the vaccine is provided at a charge, the stipend could cover some or all of the cost.  If the vaccine is free, an employer could offer a small stipend to employees who receive the vaccine to compensate them for the cost or burden of receiving the vaccine, such as traveling to the vaccination location, waiting in line, and experiencing any of the normal mild side effects the vaccine may cause.

Because employees may decline to get the vaccine for any number of reasons, only some of which relate to their membership in a protected class, legal risks arising out of unequal treatment are reduced.

Can an employer ask employees if they’ve received the vaccine?

Yes, an employer can ask an employee if they’ve received a vaccine.  Additionally, an employer may ask an employee to provide proof that the employee has received a vaccine.

The EEOC has clarified that such inquiries are not disability-related because the employee’s answer does not necessarily reveal the employee’s medical condition.  By way of example, if an employee answers that they have not received the vaccine, there are multiple reasons why they may not have received it, not just medical reasons.

We recommend that if an employer requires employees to provide documentation showing that they have received the COVID vaccine, that they instruct employees to provide only information regarding the vaccine, to the exclusion of the employee’s other medical information.

There are also legitimate business reasons to keep track of the number of employees who are vaccinated as part of the employer’s overall safety program.  This data, together with information about the risk of transmission by people who are vaccinated, can inform the employer’s decisions about re-opening or expanding the number of individuals at work.

Can or should an employer require employees who are vaccinated to return to work, or require those not to stay home?

Our advice is the same as mandates.  In many situations employers could take these steps, but we recommend against them.  In the short term, other than first responders, the priority for vaccination is those who are most vulnerable based upon age or medical conditions (i.e., disabilities).  Requiring older employees and those with disabilities to come into the office or workplace, while permitting younger and healthier employees to continue to work remotely, invites legal claims.

Employers who are asking this are also making the erroneous assumption that those who are vaccinated are at no risk to themselves or others.  The latter is still unknown.

The ability to bring employees back to work safely is something essential industries have been addressing all year.  It is a balance of what is permitted under local executive orders, the ability to enforces mask mandates and social distancing, customer contact, ventilation, safe public transportation, and many other factors.  The number of employees vaccinated is going to be an important factor, but should not be decisive.