The Pfizer/BioNTech COVID-19 Vaccine Recently Received Full FDA Approval, What Changes Now?

Carissa Davis

Since the introduction of COVID-19 vaccinations, employers have considered whether vaccine mandates are right for their workplaces. One hurdle has been several lawsuits claiming that because the COVID vaccinations did not have full Food and Drug Administration (“FDA”) approval, employers could not implement vaccine mandates. In making this argument, many plaintiffs pointed towards the federal law permitting the issuance of emergency use authorizations (“EUA”), which provides that recipients should be advised of “the option to accept or refuse administration of the product.”  While several of these claims against government employers are still pending, a federal court dismissed an identical claim, explaining that the quoted language does not affect private employers’ rights. Additionally, the U.S. Justice Department issued a nonbinding advisory memorandum explaining that the EUA in no way prohibited employers from mandating vaccines.

While the weight of authority indicated that the EUA could not serve as a basis for employees to resist vaccine mandates, plaintiffs continued to file claims. This trend reinforces the lesson that many employers have learned: with COVID-19, it’s not always about what a company can do legally but is about the practical risk of expensive litigation and the prospect of losing workers during a labor crisis.

Last week, the FDA issued full approval to the Pfizer vaccine. Now, after a rocky start with divergent opinions, the general consensus is that an employer may impose a mandatory vaccine policy so long as it engages in the interactive process to determine if a reasonable accommodation is available for employees with sincerely held religious beliefs or medical conditions preventing them from receiving the vaccine.

With the FDA’s announcement, employers received a boost in implementing effective mandatory vaccine policies. Vaccine holdouts have one less legal theory to advance, and risk-averse employers may feel more comfortable moving forward with mandatory policies. Of course, when considering vaccination policies, employers should consult counsel, as many states have explored legislation with respect to these issues.