As the first COVID-19 vaccines are authorized for emergency use, FCA Legal Counsel prepared a memorandum with information on vaccine approval and mandates. 

Employer Vaccine Mandates Likely Must Await Final FDA Approval and Sufficient Vaccine Supply

Employers that are considering whether to implement a policy requiring employees to receive the FDA-approved COVID-19 vaccine as a condition of employment likely must await two conditions: (1) The COVID-19 vaccine must receive full licensure (or approval) from the U.S. Food and Drug Administration (FDA); and (2) There must be sufficient COVID-19 vaccine available for the employee to receive the vaccine.

COVID-19 Vaccines Await Full FDA Approval

As of the date of this writing, no COVID-19 vaccine has been approved (or licensed) by the FDA. In fact, referring to a singular “COVID-19 vaccine” is misleading because there are actually several vaccines that have completed Stage 3 clinical trials.

Each vaccine was manufactured by a different company and each utilizes different vaccine technologies. For example, Moderna’s vaccine and Pfizer/BioNTech’s vaccine utilize mRNA technology, while AstraZeneca’s vaccine uses more traditional viral vector technology.

While no COVID-19 vaccine has been approved by the FDA, the agency issued an “Emergency Use Authorization”(EUA) for Pfizer’s COVID-19 vaccine on Dec. 11. It’s important to note that an EUA is not the same as full FDA approval or licensure.

The FDA may issue an EUA when, based on all of the available scientific evidence, the agency determines the known and potential benefits of the vaccine outweigh the known and potential risks. The FDA also has the authority to revoke or revise an EUA at any time, and it is considering an EUA for Moderna’s COVID-19 vaccine on Dec. 17.

The authority for the FDA to issue an EUA is set forth in the Food, Drug, and Cosmetic Act (FD&C Act). 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.” 21 U.S.C. § 360bbb–3(e)(1)(A)(ii)(III).

According to the FDA’s “Fact Sheet for Recipients and Caregivers” receiving Pfizer’s COVID-19 vaccine, all patients are advised prior to receiving the vaccine:

WHAT IF I DECIDE NOT TO GET THE PFIZER-BIONTECH COVID-19 VACCINE?

It is your choice to receive or not receive the Pfizer-BioNTech COVID-19 Vaccine. Should you decide not to receive it, it will not change your standard medical care.

It is safe to assume that, if Moderna’s vaccine receives an EUA later this week, a similar advisory will be issued to those receiving that vaccine pursuant to the EUA.

While it is not entirely clear whether the “option to accept or refuse” would apply to an employer-mandate (as opposed to a government-issued mandate), it would certainly be problematic for an employer to mandate a vaccination that the FDA insists to be optional. Thus, waiting for final FDA approval is prudent.

COVID-19 Vaccine Will Remain Scarce for Most Industries

Access to COVID-19 vaccination may not be possible for a large segment of workers for many, many months. Current planning anticipates that essential employees (e.g., those in public safety, utilities, education) may be next in line, followed by persons considered high risk due to age and/or underlying medical issues. Only then will other people be eligible for vaccination and as such, as a very practical matter, employers really cannot require their workforce to be vaccinated until vaccination is available to their employees.

Other Considerations

  • Bargaining Employees – For employers with a unionized workforce, the imposition of a required vaccination policy is likely a mandatory subject of bargaining under the National Labor Relations Act. Therefore, employers may need to give the union representing any affected employees notice and an opportunity to bargain over the implementation of any newly implemented vaccination policy, unless, of course, the existing labor contract provides that management may implement such a policy unilaterally.
  • Workers’ Compensation – If a vaccination is made mandatory and carries side effects which result in injury or illness to the employee, the injury could be considered a work-related injury covered by workers’ compensation. However, if the vaccine was simply suggested, but not required as a condition of employment, any injury resulting from the vaccine would likely not be covered by workers’ compensation.
  • Employee Relations – From an employee relations standpoint, it may be prudent to consider whether there are any effective solutions other than a flat mandate. For example, a strong recommendation of vaccination combined with other safety precautions, such as requiring masks/other social distancing measures, could result in a high compliance rate.

    With respect to the influenza vaccine, policies requiring employees to “opt-out” by affirmatively explaining why they do not wish to receive the vaccine have been shown to have high participation rates, despite not being mandatory.
  • Mandating – Not mandating the vaccine may especially be prudent given the novel nature of the virus and the public’s general lack of trust for the safety/efficacy of the COVID-19 vaccine (due in part to its unprecedented development speed).

    In a Gallup poll conducted from Oct. 19, 2020 through Nov. 1, 2020, only 58 percent of those surveyed said they would receive a COVID-19 vaccination (although it is likely that this percentage will increase if a vaccine eventually receives full FDA approval). In fact, as more people receive the vaccine and show little or no side-effects, voluntary vaccination may increase, thereby minimizing the need for a policy mandating it.

Bottom Line

Employers will likely have the ability to mandate vaccination of their workforce once the FDA issues a final approval or licensure for one or more of the COVID-19 vaccines. However, the need to do so may be relatively distant given the current predictions of when the vaccines will be available to the general population.