This week the Food and Drug Administration (“FDA”) announced its full approval of the Pfizer-BioNTech vaccine for use among people age 16 and older. Within just hours of that announcement, a string of employers private and public alike began declaring their intentions to put mandatory vaccination policies in place. Among the most notable early actors were the Pentagon, Goldman Sachs, CVS, the unions at Disney, the New York City School System, and the New York State Court System, all of which declared that mandates are now in place, or soon will be.
Back in December 2020, the FDA permitted use of the vaccine pursuant to an emergency use authorization (“EUA”), which the FDA defines as a “mechanism to facilitate the availability and use of medical countermeasures, including vaccines, during public health emergencies.” Pfizer and BioNTech applied for full approval in May and now have the FDA’s official seal of approval, just like other more familiar vaccines.
While a string of new vaccine mandates have come into effect in the short time since the FDA’s announcement, not much has really changed from a legal perspective. According to guidance from Equal Opportunity Employment Commission (“EEOC”), employers have technically been able to implement mandates since December, provided they did so in alignment with state and local laws, and with certain medical and religious exemptions.
Why then all the hubbub around FDA licensure? The answer seems largely to do with perception – that of the general public and, more specifically, the employees to be directly affected by these mandates. EEOC guidance notwithstanding, the implementation of vaccine mandates has not been without its backlash. Some employers have faced lawsuits challenging the legality of the policies themselves. Others have had employees quit. All have faced the difficult question of how to implement a mandate when vaccination itself has become an emotionally and politically charged subject shrouded in misinformation and misunderstanding. The hope is that the FDA’s seal of approval may give the vaccine campaign the image boost it still desperately needs among those who doubt its efficacy.
On the legal front, vaccine mandates have seen success in Texas, Florida, North Carolina, and California, among other places, where court decisions have all come down in favor of mandates. Also, in July, the US Department of Justice issued an opinion concluding that the Food, Drug and Cosmetic Act does not prohibit public or private entities from mandating Covid-19 vaccination, even if the vaccines only have emergency-use authorization. Moreover, on August 12th, the U.S. Supreme Court, the nation’s highest court itself, held that Indiana University could require its students to be vaccinated against Covid-19.
In other words, from a legal standpoint, vaccine mandates are proper as long as employers abide by state and local law and applicable guidelines, including those by the EEOC specifying necessary accommodations. Yet the question of whether to issue a mandate remains complex. Employers should consider, among other things, whether they have a firm grasp of the applicable guidelines; whether they are prepared to face lawsuits, even if unsuccessful; whether they are prepared to answer employees’ questions and concerns as to ethics, autonomy and safety; whether they have in place the mechanisms necessary to ensure that private information remains private; whether they are prepared to deal with potential workers’ compensation claims; whether the nature of the work is such that employees work in close proximity to each other; whether they have the resources to combat misinformation; and whether they are prepared to suffer a loss of workforce, should at-will employees ultimately decline to be vaccinated.
For further information as to whether a policy requiring vaccinations is right for your workplace, please contact Jessica M. Baquet at firstname.lastname@example.org.