Since the Food and Drug Administration issued final approval of the Pfizer-BioNTech coronavirus vaccine for individuals age 16 and older in late August, a number of well-known companies have publicly announced that they will be requiring employees to be vaccinated.
Further, on Sept. 9 the Biden administration said that the Occupational Safety and Health Administration (OSHA) will be issuing emergency rules to require all employers with 100 or more employees to ensure that their employees are vaccinated or submit to regular testing.
These developments have left many smaller employers questioning whether they should require vaccines or adopt a hybrid vaccine-testing approach, as well as what the recent changes really mean for them.
The magnitude of the change triggered by the Pfizer approval is a matter of perspective. From a strictly legal point of view, there is really nothing that employers can do now that they couldn’t lawfully do before the FDA approval. From the practical or risk mitigation perspectives, however, the FDA’s action is a game changer, clearing the way for employers to more smoothly and easily implement vaccine requirements.
The Path to Final Approval
Before the Pfizer approval, each of the Covid-19 vaccines was being administered under the FDA’s emergency use authorization (EUA) status. From the outset, this raised questions about whether employers could legally require employees to receive a vaccine that had only been approved for emergency use.
At the end of May, the Equal Employment Opportunity Commission updated its Covid-19 related guidance to make it clear that, subject to reasonable accommodation obligations, employers could require employees who would be “physically entering the workplace” to receive one of the EUA Covid-19 vaccines without running afoul of the Americans with Disabilities Act or any of the other federal equal employment laws.
Then, in early July, the Department of Justice also weighed in to opine that the Food, Drug and Cosmetic Act (which vests the FDA with its authority) does not restrict employers from mandating Covid vaccines that only have EUA status. The same conclusion was reached by a federal district court in Texas in a case challenging a local hospital’s vaccine mandate.
Thus, even before the final Pfizer approval, employers who chose to institute a vaccine mandate had strong support for their lawful right to do so. Still, concerns lingered about the yet unexplored legal issues that might arise from mandating a vaccine on EUA status—for example, if an employee experienced a severe side effect from the vaccine.
For this and other reasons, many employers decided to hold off on making a decision about requiring Covid-19 vaccines until one or more had received final approval. Alternatively, other employers, the federal government being the largest example, adopted policies that allowed employees to be vaccinated or submit to regular testing, thus coming short of mandating the vaccine.
FDA Approval Ushered in Greater Legal Certainty
The FDA’s announcement actually did not change the answer of whether employers can require the vaccine. But it has ushered in an environment of greater of legal certainty and fewer open questions for employers that choose to do so.
The precedent surrounding an employer’s ability to mandate an FDA-approved vaccine as a condition of employment is relatively well developed and predates the current crisis (required flu shots being an example). Additionally, not long before the FDA’s announcement, OSHA confirmed that employers will not be required to report any side effects from mandatory Covid-19 vaccines as workplace injuries at least through May 2022.
The observable increase in employer vaccine requirements since the Pfizer approval suggests that these factors have played a significant role in helping employers feel they are on firmer ground, both legally and practically, to require vaccines. For its part, the Biden administration also announced on Sept. 9 that the federal government will be doing away with its hybrid approach and will be implementing a strict vaccine mandate for federal employees and contractors.
Of course, FDA approval does not eliminate all of the potential issues facing employers. They will still have an obligation to reasonably accommodate an employee who cannot receive the vaccine because of a disability, or who won’t receive the vaccine because of a sincerely held religious belief, unless the employer can demonstrate an undue hardship (as defined by law) in doing so.
Additionally, some employers will have to contend with state laws that limit or prohibit certain employers from mandating vaccines, Montana being the most restrictive example.
There will also be a number of logistical issues for employers to consider—such as the timeline for rolling out a vaccine requirement, whether employees will be offered paid leave or any other incentives to encourage compliance, and how employees who refuse to comply will be handled.
In short, implementing a vaccine mandate will still require careful thought and policy development. What the FDA approval does is give employers one less area to worry about in taking this step.
With the threat of the delta variant and increased pressures and demands from customers, employees, and the public, that alone may be enough to tip the scales for employers to decide that implementing a vaccine requirement to protect employee and public health and promote recovery is worth the effort.
This column does not necessarily reflect the opinion of The Bureau of National Affairs, Inc. or its owners.
Jessica Summers is a principal in the Employment Law, Employee Benefits, and Litigation practices at Paley Rothman in Bethesda, Md., where she works with companies and organizations on implementing effective employment policies, maintaining employee benefit plans, and handling administrative claims and litigation.