What the FDA’s Regular Approval of the COVID-19 Vaccine Means for Employers


On August 23, 2021, Pfizer-BioNTech COVID-19 vaccine received regular approval from the Food and Drug Administration. Moderna has submitted its application for regular approval, and it is expected that such approval is forthcoming shortly. With these developments, certain legal hesitation regarding vaccine mandates – including by employers – has fallen away.

Putting political and philosophical arguments to the side, vaccine mandates were initially subject to some concerns from a legal perspective. In particular, the fact that the vaccines were approved under Emergency Use Authorization (EUA) was an issue. The EUA statute specifically provides that individuals must be informed of their right to refuse the vaccine, which gave rise to an argument that any employee who was terminated because they exercised their right to refuse the vaccine could then assert a claim of wrongful or abusive discharge in violation of public policy, i.e. the policy articulated in the EUA statute.

Notably, this argument did not find much traction. In July 2021, the U.S. Department of Justice (DOJ) released an opinion definitively stating that the Emergency Use Authorization (EUA) statute, under which current COVID-19 vaccines were approved by the Food and Drug Administration (FDA), “does not prohibit entities from imposing vaccination requirements” including “to return to work or be hired into a new job.” Additionally, the argument was also rejected by several federal courts, including Bridges v. Houston Methodist Hospital, in which a hospital’s vaccine mandate for its employees was upheld. Yet, until this point, there existed the possibility that other courts might not agree with the DOJ or their fellow courts. However, with regular approval, the EUA issue has become moot.

Concerns about whether such mandates are permissible under other federal workplace laws have been previously addressed by the relevant federal agencies. From a workplace safety standpoint, the Occupational Safety and Health Administration expressly encourages employers to impose such mandates. In its recently revised Protecting Workers: Guidance on Mitigating and Preventing the Spread of COVID-19 in the Workplace, OSHA pointedly suggests “that employers consider adopting policies that require employees to get vaccinated or to undergo regular COVID-19 testing – in addition to mask wearing and physical distancing – if they remain unvaccinated.”

As for federal discrimination laws, the Equal Employment Opportunity Commission (EEOC) has updated its What You Should Know About COVID-19 and the ADA, the Rehabilitation Act, and Other EEO Laws resource to address the impact of federal non-discrimination laws on an employer’s vaccine requirements, most recently on May 28, 2021. Notably, the guidance specifically asserts that employers may mandate vaccines under certain circumstances, but employees may be entitled to an exemption under the Americans with Disabilities Act due to a medical condition or under Title VII due to a religious belief, and pregnant employees should be extended the same accommodations provided to others. Additionally, in its 2009 Guidance, Pandemic Preparedness in the Workplace and the Americans with Disabilities Act, the EEOC recognized that an employer can impose a vaccine mandate in the context of a pandemic, subject to religious or disability accommodations.

However, many states have enacted or are considering restrictions on a company’s right to require proof of vaccination (e.g. bans on so-called “vaccine passports”), which could prevent enforcement or imposition of a vaccine mandate. These bans come in many different forms. Some are limited to governmental or public entities. Others (including Alabama, Florida, North Dakota, and Texas) prohibit private entities from requiring vaccine passports in providing goods, services, or access to the public, but do not govern employers’ ability to impose a vaccine mandate on their employees. Montana prohibits employers from requiring proof of vaccination, and many other states have similar legislation pending before their state legislatures.

Thus, although employers may freely impose vaccine mandates under federal law, it is critically important for them to stay on top of any changes in state law on this issue.