Health Care Employers Should Be Able to Mandate Inoculation Once FDA Approves Vaccine

Once a COVID-19 vaccine receives full licensure from the U.S. Food and Drug Administration (FDA), there is little doubt that a health care employer in the current pandemic can require employees to receive the FDA-approved COVID-19 vaccine as a condition of employment. However, until the vaccine receives full approval, there are good reasons to wait.

At this time, however, the COVID-19 vaccine has not been approved (or licensed) by the FDA.  Even though no COVID-19 vaccine has been approved by the FDA, two vaccine candidates are presently being considered by the FDA for “Emergency Use Authorization” (EUA). The FDA will consider Pfizer’s EUA request on December 10 and Moderna’s EUA request on December 17.  An EUA is not the same as FDA licensure.  The FDA may issue an EUA, when, among other things, the agency determines that based on all of the available scientific evidence, the known and potential benefits of the vaccine outweigh the known and potential risks.  The FDA also has the authority revoke or revise an EUA at any time.

Even if the FDA grants an EUA for Pfizer’s vaccine on December 10 and Moderna’s vaccine on December 17, there are legal and practical reasons for employers to wait before making the receipt of either COVID-19 vaccine a condition of employment.

FDA Approval is Needed

The FD&C Act expressly provides that, in setting forth the conditions for EUA, the Secretary of HHS will “establish such conditions on an authorization under this section as the Secretary finds necessary or appropriate to protect the public health, including . . . 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.”

The Minnesota Department of Health (MDH) has similarly opined that, if the COVID-19 is authorized for EUA only, the vaccine cannot be mandated.

When it comes to employer-mandates, there is an important distinction to make: in making a vaccine mandatory, an employer is not forcing an employee to become vaccinated against their will; an employer is simply requiring the employee to be vaccinated in order to keep working.  Obviously, however, without further guidance from the Secretary of HHS, the FDA, or the MDH, whether the EAU applies only to government mandates or whether it applies more broadly to any mandate for the vaccine is uncertain.

Accommodation Concerns Await

Under the assumption that an employer may be able to mandate a COVID vaccine once it’s FDA approved, there are two significant employment considerations to keep in mind moving forward.  Even if an employer has a mandatory vaccination requirement, employees are able to seek an exemption from the mandate as a reasonable accommodation for a disability. Employers will have an obligation to consider whether an employee can be exempted from being required to get the vaccination. An employer’s obligation to provide a reasonable accommodation, however, is not unlimited; an employer does not need to provide an accommodation if doing so creates an undue hardship on the employer (i.e. creates a significant difficulty or expense), or if the accommodation poses a “direct threat” to the health and safety of others.

For traditional vaccination requirements, potential accommodations typically take the form of telework (assuming the employee’s job can be performed remotely), masking in the workplace, or altering the employee’s duties, if possible, to lower the risk of contact with patients or their coworkers. Of course, it is unclear whether these accommodations will be feasible in the context of COVID-19. For example, if the employee wearing a mask in the workplace still creates a direct threat to the health and safety of others (given the fact that masks are not 100% effective in reducing COVID-19 transmission), such an accommodation may not be reasonable. Ultimately, employers are still required to engage in a case by case analysis of the employee’s accommodation request to determine if there are any reasonable alternatives available which allow the employee to safely perform the functions of their position.

In addition to accommodation of disabilities, an employer will have to consider whether to grant employees a religious exemption from a mandatory COVID vaccine. Under Title VII of the Civil Rights Act, employers have an obligation to grant a religious accommodation from a vaccination requirement based upon an employee’s sincerely held religious practice or beliefs. Title VII requires employers to grant accommodations from complying with an employment policy which conflicts with an employee’s sincerely held religious belief. In the context of vaccines, courts have held that a simple non-religious opposition to vaccination (for example, thinking vaccines are generally “unhealthy”) is not protected.

Moreover, an employer is not obligated to accommodate an employee’s religious beliefs if doing so imposes an undue hardship. In the religious accommodation context the undue hardship standard is a lower bar for employers to meet than an undue hardship under the ADA. For the purposes of religious accommodation, an undue hardship is defined as an accommodation imposing “more than a minimal burden on [the] operation of the business.” As it relates to religious accommodations to other mandatory vaccinations in the healthcare field, courts have noted that an increased risk of transmitting a disease to vulnerable patients poses an undue hardship for the employer and therefore does not require an accommodation for a religious belief. It is likely that a COVID-19 vaccination would be analyzed similarly.

Don’t forget that if you have any unionized employees, employers will likely need to bargain with the union over the implementation of a mandatory vaccine.

Bottom Line

This is a critical juncture in the battle against COVID-19 and there are many legal issues to be resolved.  Nevertheless, it is exciting to think about how these vaccines will help get us back to a more normal workplace.