Mandating a Novel Vaccine is a Novel Legal Issue

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Mandating a Novel Vaccine is a Novel Legal Issue

June 8th, 2021

Awake Goy

Mandating a Novel Vaccine is a Novel Legal Issue
by Carolyn Hendler, JD
Published June 7, 2021
The emergency use authorization (EUA) granted to vaccine manufacturers by the U.S. Food and Drug Administration (FDA) to allow experimental COVID-19 vaccines to be distributed to the U.S. population states that the product is “an investigational vaccine not licensed for any indication” and requires that all “promotional material relating to the COVID-19 Vaccine clearly and conspicuously… state that this product has not been approved or licensed by the FDA, but has been authorized for emergency use by FDA.”¹
Because the experimental COVID-19 vaccines have been authorized by the federal government for emergency use only, the Secretary of Health and Human Services must, “ensure that individuals to whom the product is administered are informed… of the option to accept or refuse administration of the product.”² Since the government requires that individuals be given a voluntary choice about whether or not to take the vaccine, how then can an employer mandate that employees receive an experimental vaccine authorized under an EUA, which denies the individual the legal right to “accept or refuse administration” of the vaccine?

Unprecedented Distribution of Experimental COVID-19 Vaccines to Millions of Americans Under EUA

Can employers legally mandate the experimental COVID-19 vaccine? According to some proponents of mandatory vaccination policies:

This is new ground. The FDA has never before granted an EUA for a vaccine for the entire population, so there is no perfect precedent here.³

Historically, an experimental vaccine is in development for approximately 10-15 years before the FDA licenses it for use by the general public,⁴ allowing the public to gain confidence in its safety and effectiveness. By contrast, the COVID-19 vaccines were rushed to the market in response to the declaration of a public health emergency by the U.S. government in April 2020,⁵ and the many questions and concerns about the origin of the virus and safety and efficacy of the novel vaccine have not yet been answered.⁶⁷ ⁸ ⁹ ¹⁰
In response to a question about whether the COVID-19 vaccines can be mandated, Amanda Cohn, MD, executive secretary of the CDC’s Advisory Committee on Immunization Practices (ACIP) said that under EUA rules, “Vaccines are not allowed to be mandatory. So, early in this vaccination phase, individuals will have to be consented [sic] and they won’t be able to be mandatory.¹¹
While employer vaccine mandates have been previously upheld by the courts and government agencies, they involved FDA approved vaccines that had undergone years of testing.
The EUA granted to manufacturers to distribute experimental COVID-19 vaccines provides that recipients are required to be informed “of the option to accept or refuse administration of the product, of the consequences, if any, of refusing administration of the product, and of the alternatives to the product that are available and of their benefits and risks.”¹²
At issue with an employer mandating an EUA vaccine is the interpretation of the phrase, “of the consequences, if any, of refusing administration of the product.” We do not know the intent of the drafters when they referred to the consequences of refusing the product. It could be interpreted to mean the consequence, if any, could be the risk of contracting the disease the vaccine was designed to prevent or it could be interpreted to mean any and all consequence from anyone or anything including but not limited to losing one’s job.
A limited reading of the term consequences seems the stronger legal and moral argument as the EUA guidance makes clear that the experimental medical intervention is intended to be voluntary, allowing all potential recipients the option of refusing use of the product. The decision to submit to use of an experimental medical product under the threat of losing one’s job and ability to earn a living is not a voluntary decision.
One thing is clear, when an employer institutes a vaccine mandate for employees, whether it is for an FDA approved vaccine or the COVID-19 experimental vaccines, regulations and guidelines set by government agencies must be followed.

OSHA Safety Guidelines Will Not Being Enforced

The U.S. Occupational Safety and Health Administration (OSHA) Apr. 20 guidance may have given employers pause to reconsider before mandating the experimental COVID-19 vaccine. This initial guidance by OSHA required that employers mandating the COVD-19 vaccine record adverse reactions as a work-related injury and stipulated that employers with more than ten employees must have a safety record on file of serious work-related injuries. Those injuries would have included adverse reactions to the experimental COVID-19 vaccine. Employers who merely recommend the vaccine rather than requiring it were not required to report vaccine injuries as part of their safety record keeping.¹³
Corporations and other businesses aggressively lobbied the government to change the OSHA guidance and, by the beginning of May, it was revised.¹⁴ The OSHA guidance to employer regarding COVID-19 vaccine mandates now states:

DOL and OSHA, as well as other federal agencies, are working diligently to encourage COVID-19 vaccinations. OSHA does not wish to have any appearance of discouraging workers from receiving COVID-19 vaccination, and also does not wish to disincentivize employers’ vaccination efforts. As a result, OSHA will not enforce 29 CFR 1904’s recording requirements to require any employers to record worker side effects from COVID-19 vaccination through May 2022. We will reevaluate the agency’s position at that time to determine the best course of action moving forward.¹⁵

As a result, OSHA’s guidelines remain unclear because the original guidance does not align with the revised guidance. This gives the appearance of the agency having been pressured by employers to not enforce traditional safety guidelines governing injuries related to employment. No new guidance has been issued by OSHA since May 2021.

EEOC Guidelines on Workplace Discrimination Related to COVID-19 Vaccine Mandates UnClear

The Equal Employment Commission (EEOC) enforces anti-discrimination laws including but not limited to the American with Disabilities Act, the Rehabilitation Act, Title VII of the Civil rights Act, the Age Discrimination in Employment Act, the Genetic Information Nondiscrimination Act.¹⁶
The EEOC’s guidance may allow employers to recommend or require that employees receive the COVID-19 vaccine, but when the vaccine is required in the workplace, certain restrictions and requirements under ADA and Title VII are triggered. The ADA protects employees with disabilities and Title VII protects employees with sincerely held religious beliefs from discrimination in the workplace.¹⁷
Under the ADA, employers must be careful about pe-screening questions asked prior to vaccination if the vaccine is given by the employer or a company contracting with the employer, as it may trigger information about a disability. In that case, employers may only continue the inquiry when the questions are “job related and consistent with business necessity.” The ADA does not consider requiring or requesting proof of vaccination a disability related question and, therefore, employers can ask for proof of vaccination that was performed by another provider.¹⁸
While not binding, the EEOC’s guidance may play a role in the court’s decision when employer mandates are litigated in the court system.¹⁹ EEOC guidance allows for employers to mandate vaccines as long as reasonable accommodations are made for those whose disability or religious beliefs prevent them being vaccinated unless the accommodation would cause the employer undue hardship. What constitutes a reasonable accommodation and an undue hardship are made on a case by case basis.
For employees with disabilities, an undue hardship is defined by the ADA as a “significant difficulty or expense.” With employees whose religious beliefs prevent them from accepting a vaccine, an employer need only show that the accommodation is anything more than a de minimis cost or burden to be considered an undue hardship.²⁰

EUA COVID-19 Vaccines Were Not Proven to Eliminate Infection, Transmission of SARS-CoV-2

One scientific issue employers would need to overcome if they face litigation for discrimination over COVID-19 vaccine mandates for employees is that in clinical trials used by the FDA to grant an EUA to manufacturers, experimental COVID-19 vaccines were not proven to eliminate infection with and transmission of the SARS-CoV-2 virus, only that use of the vaccines could prevent mild to severe symptoms of COVID-19 disease, hospitalization and death.²¹ ²² ²³ This fact hinders the argument that a mandatory COVID-19 vaccine policy is necessary in order to keep the work place safe.
Professor of Law Ann Hodges wrote an analysis about employer COVID-19 vaccine mandates for the American Constitution Society and stated:

At present, it is not clear that vaccination eliminates the risk of transmission so if that is the concern, personal protective equipment may well be deemed equally protective. If scientific knowledge were to change, however, the accommodation requirement will change with it.²⁴

Employers who incentivize getting the experimental vaccine also may also trigger legal implications. Questions could be raised about whether the vaccine is effectively required if the incentive is large enough. When a vaccine incentive program is considered a wellness program by the ADA, then it must be voluntary if it requires the release of disability-related information, which would be the case when asking pre-vaccination questions.²⁵

EEOC Guidance Being Interpreted Differently Among Employment Experts

Whether the EUA vaccine can be mandated under the EEOC is subject to interpretation. Some experts argue that the EEOC’s guidance allows for employer mandates while other experts contend that EEOC’s guidance does not permit mandating an EUA vaccine.²⁶
The EEOC’s guidance issued in March permits employers to mandate COVID-19 screening tests. The logic behind that determination may extend to mandating vaccination as well. The American with Disabilities Act requires that employer’s medical inquiries and medical tests are “job related and consistent with business necessity,” and an argument could be made that a mandatory vaccination program is job related and consistent with business necessity.”²⁷
EEOC urges caution when employers consider mandating vaccinations as a condition of employment. Whether or not the COVID-19 vaccine may be mandated in the workplace, the EEOC makes it clear that an employee’s disability status and religious beliefs must be taken into consideration and reasonable accommodations made with any vaccination program in the workplace.²⁸

The National Labor Relations Act Protects Employees Right to Protest

The National Labor Relations Act (NLRA) is a federal law that protects the legal rights of employers and employees through the creation and management of labor unions and the prevention of unfair labor practices. The NLRA applies to private companies exclusive of airlines, railroads, agriculture and government agencies.²⁹
In unionized workplaces, a mandatory vaccination policy may be considered a mandatory subject of bargaining that requires a duty to bargain before implementation. Employers should be familiar with the language in their existing labor contracts as the language in the contract could prevent them from mandating a vaccine altogether.³⁰
Section 7 of the NLRA applies in non-union workplaces protecting workers who engage in “concerted activities” with the purpose of “mutual aid and protection.” Should an employer implement a mandatory COVID-19 vaccine program, Section 7 would protect employees who gather together to complain about the program, which could hurt morale and prove bad for business.³¹
A law analyst writing in Forbes warns:

Employers who are considering mandating vaccinations should be certain that the cost-benefit analysis works out in favor of mandating. Employers should also consider that many employees will not be keen on the idea of mandatory vaccination, and they will have the right to get together and complain about it—even publicly—due to the protections offered by Section 7 of the National Labor Relations Act. So in addition to the threat of litigation, employers should factor in the likelihood of workplace disruption and potential PR problems.³³

Adverse Vaccine Reactions Could Fall Under Workers’ Compensation

Adverse vaccine reactions are another hurdle to mandatory vaccination programs in the workplace. An adverse reaction to a COVID-19 vaccine, whether it is FDA approved with an EUA status or when it is approved by the FDA in the future, would likely fall under workers’ compensation.

Even in cases where immunization was voluntary, such vaccination would have arguably been encouraged by the employer, benefited the employer, and served a business purpose. Furthermore, if the vaccination occurred at work or was paid for by the employer, these factors also would support a finding that workers’ compensation applies. [33]

The Prep Act May Protect Employers from Liability

The Public Readiness and Emergency Preparedness Act (PREP Act) limits legal liability for adverse outcomes to countermeasures such as the COVID-19 vaccines administered during a declared pandemic. The Prep Act protects certain “covered persons” from being sued for damages related to adverse reactions to countermeasures such as the COVID-19 vaccines, except in cases of “willful misconduct.”³⁴
The PREP Act may preempt other federal and state laws, including state tort laws. Therefore, an employer may not be liable to an employee for injuries and adverse reactions to the COVID-19 vaccine even if it was mandated in the workplace outside of the employers “willful misconduct.”³⁵
On Dec. 3, 2020, the PREP Act was amended for the fourth time to expand the civil immunity “from tort claims related to the manufacture, distribution, administration, and non administration of COVID-19 countermeasures, which would include COVID-19 vaccines.”³⁶

Employees Would be Willing to Lose Their Job Over A COVID-19 Vaccine Mandate

The only thing clear with COVID-19 mandates in the workplace is that there is no consensus on the legality of employers requiring this novel vaccine as a condition of employment, whether it is an experimental vaccine being distributed under an EUA or when it is eventually licensed by the FDA. However, with that uncertainty comes the certainty that mandating the vaccine in the workplace is likely to lead to controversy.
A recent poll by The Economist/Yougov showed that 18 percent of the people polled would not get the COVID-19 vaccine and of that 18 percent, 79 percent said that “nothing would change my mind.”³⁷ With almost 18 percent of the population stalwart in their position and unwilling to change their mind under any circumstance, employer mandates are not likely to be met with passive acceptance.
Further evidence that a mandatory vaccination program could negatively impact the workplace comes from the Society for Human Resources management which found that 28 percent of employees would be willing to lose their job if the vaccine was mandated by their employer.³⁸
There are many negatives to forcing employees to act against their own judgment and conscience when it comes to their health. Attorneys have cautioned:

Forcing workers to decide between getting a vaccine or losing their job could hurt morale at a time anxiety is already high and disrupt business operations if enough people refuse.³⁹

Jay Rosenlieb, an employment lawyer warns:

Mandating the vaccine is a hot potato. I do not believe that employers should be required to have mandatory vaccination programs. See how much trouble we are having with requiring face masks? It would be the same thing, only 10 times larger. A mandatory vaccine program opens the employer to bad media relations, negative social media comments and disruptions in the workplace.⁴⁰

For all of the above reasons, most employment experts warn than employers should exercise caution when considering a mandatory COVID-19 vaccination policy as a condition of employment.

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Click here to view References:
ACIP, ADA, Advisory Committee on Immunization Practices, American with Disabilities Act, Carolyn Hendler, COVID-19, EEOC, Emergency Use Authorization, Equal Employment Commission, EUA, FDA, Food and Drug Administration, Forbes, Jay Rosenlieb, National Labor Relations Act, National Vaccine Information Center, NLRA, NVIC, Occupational Safety and Health Administration, OSHA, PREP Act, Public Readiness and Emergency Preparedness Act, The Economist, The Vaccine Reaction, YouGov