With distribution of COVID-19 vaccines moving ahead full-steam, an end to the pandemic may be in sight in the coming months. However, what is collectively known as the “new normal” still comes with a minefield of unanswered questions, particularly for employers, and the vaccine issue is no different.
Contending with the polarization of vaccine skepticism and the country’s desire to return to “normal” in the wake of a global pandemic, many are wondering: Can employers require employees to get vaccinated against COVID-19?
Guidance from the federal Equal Employment Opportunity Commission (EEOC) may suggest that the answer is yes, but the current legal context for COVID-19 vaccines is different from ordinary, time-tested vaccines. Employers should therefore carefully consider their potential legal liability if they impose such a requirement prior to full approval of any such vaccines from the Food and Drug Administration (FDA).
Ordinary Vaccine Considerations. Employers generally can mandate “ordinary” vaccines, subject to business considerations, taking into account accommodations that may be required under the American with Disabilities Act, or due to certain medical conditions (such as pregnancy or strong allergies to vaccine components), or for religious reasons. Requests for religious accommodation may be based on objections to the concept of vaccines generally, or specific to a particular vaccine (e.g., gene-based vaccines). This analysis applies in the context of vaccines approved by the FDA through its formal process under which, after consideration of evidence from human studies, the agency determines that vaccines are safe and effective. For example, the FDA has formally approved many influenza vaccines, which in turn have been mandated by some employers (such as health care providers) in accordance with EEOC guidance.
EEOC Guidance regarding COVID-19 Vaccines. In December 2020, the EEOC issued guidance (“Guidance”) in which it implied that employers can mandate COVID-19 vaccines. However, unlike influenza and similar vaccines, COVID-19 vaccines are currently being made available not through the FDA’s formal approval process, but rather through a more streamlined “emergency use authorization” (EUA) process. In its Guidance, the EEOC carefully sidestepped the issue of whether employers may mandate vaccines authorized under an EUA, versus those approved pursuant to the FDA’s formal approval process. (See Guidance, Question K.4, including links to the FDA’s website regarding EUAs.) The statutory provisions governing the FDA’s emergency process, however, include language that raises concern about the potential legality of employers mandating vaccines authorized under an EUA. Specifically, the language appears to provide individuals with a federal statutory right to refuse administration of vaccines authorized under an EUA.
The FDA’s Formal Approval Process. The FDA’s normal process for authorizing the development and marketing of a vaccine has two general stages. In the first stage, the agency approves an “investigational new drug” application (IND), which authorizes the company involved to conduct studies in humans of the effects of the vaccine (clinical studies). Phase 1 clinical studies focus on determining the safety of the vaccine; Phase 2 clinical studies provide further evidence of safety, as well as initial evidence of effectiveness; and Phase 3 clinical studies are typically large-scale studies of safety and effectiveness. In the second stage of development and marketing, the company submits an application to the FDA for formal approval to market the vaccine (a biologics license application, or BLA). The FDA considers all of the clinical evidence from the IND studies and makes a risk-benefit analysis of whether to approve the BLA. Existing guidance and case law regarding employer-mandated vaccines all appear to have involved vaccines with approved BLAs.
The FDA’s Streamlined EUA Process. In the aftermath of the Sept. 11, 2001, terrorist attacks, Congress decided that, in emergency situations, the FDA should be permitted to authorize the market entry of drugs (including vaccines) that have not been approved through the FDA’s full formal process. Specifically, Congress created Section 564 of the Federal Food, Drug, and Cosmetic Act (FDCA), which gives the FDA authority to allow the marketing of unapproved drugs if the Department of Health and Human Services (HHS), through the secretary of HHS, has issued a declaration that there is a public health emergency. (See 21 U.S.C. § 360bbb-3.) The premise presumably is that, in an emergency situation, the FDA will allow a greater degree of risk, in part by not requiring the full range of clinical studies that would be necessary for formal approval. In the case of an emergency vaccine, a company is not required to submit an IND, nor is it required to submit a BLA; instead, under Section 564, it submits an application for an EUA.
An EUA, therefore, is very different from a formal approval by the FDA. Due to the 9-11 attacks, Congress had a strong sense of what it means to be in an emergency situation. The first response of Congress to those attacks was the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (enacted in June 2002 as PL 107-188), but its FDA-related provisions provided only a modest variation on the agency’s formal drug-approval process. Then Section 564 was added to the FDCA by the National Defense Authorization Act for Fiscal Year 2004 (enacted in November 2003 as PL 108-136). Subsequently, Section 564 was reenacted with technical changes as part of the Project Bioshield Act of 2004 (enacted in July 2004 as PL 108-276). The section thereafter was amended several times.
Recognizing the potential for adverse reactions to medical countermeasures, Congress also passed the Public Readiness and Emergency Preparedness Act (enacted in December 2005 as PL 109-148), known as the “PREP Act,” to establish liability protection for the administration or use of medical countermeasures, including products marketed under EUAs, and to create a fund to compensate those injured by such countermeasures. (The PREP Act does not provide protection in cases of willful misconduct.)
There was strong bipartisan consensus on these laws as responses to the 9-11 attacks. As part of this process, Congress anticipated that a pandemic would likely occur at some point and made an effort to think through the issues that could arise in that regard.
EUA Requirements. From its inception, Section 564 has imposed conditions upon the emergency use of FDA-regulated products, including vaccines. Importantly, these have always included the requirements that recipients be informed, to the extent practicable, that they have “the option to accept or refuse administration of the [EUA] product [and] of the consequences, if any, of refusing administration of the product.” (Section 564(e)(1)(A)(ii)(III).) This is a logical requirement, given the increased level of potential risk involved in taking an EUA drug as compared to a drug approved through the formal FDA process.
As evidence of the regulatory scope of Section 564, consider that Congress has created only one exception to the notification and right of refusal requirements, which concerns the armed forces. Specifically, these requirements may be waived for the armed forces if the U.S. president determines, in writing, that complying with such requirements is not in the interests of national security. (See 10 U.S.C. § 1107a.) The clear implication is that, in the absence of such a written waiver by the president, each member of the armed forces has the right of refusal and must be informed of such right. No such presidential determination for EUA COVID-19 vaccines has been made, and approximately one-third of the armed forces has declined to accept the vaccine, according to Pentagon officials. Given that Congress has not enacted any other exceptions, it stands to reason that the general rule is that each individual in the United States has these same rights.
COVID-19 Vaccines under EUAs. On Feb. 4, 2020, HHS declared a public health emergency for purposes of Section 564. On March 27, 2020, an HHS declaration became effective for the FDA to issue EUAs for drugs, including vaccines. As of this writing, three COVID-19 vaccines have received EUAs from the FDA, the Pfizer-BioNTech, authorized on Dec. 11, 2020, the Moderna vaccine, authorized on Dec. 18, 2020, and the Janssen (Johnson & Johnson) vaccine, authorized on Feb. 27, 2021. (See “Drugs and Biological Products” approval letters and fact sheets here.)
The letters granting the EUAs state, among other things, that the FDA has concluded that the vaccines “may be effective” (emphasis added). The letters also state that the manufacturers are required to give a “fact sheet” to health care providers who administer the vaccines that instruct them to inform vaccine recipients of the right to refuse the vaccine. Notably, upon termination of the current HHS declaration of a public health emergency under Section 564, the further marketing and administration of an EUA vaccine will become illegal (unless and until the vaccine is formally approved by FDA).
Preemption and State Laws. The FDCA is a federal regulatory statute that preempts conflicting state laws. This preemptive force should include the individual’s right of refusal under Section 564. Many states are currently considering legislation concerning vaccinations, with some seeking to prohibit mandatory vaccines, and others contemplating imposing vaccine mandates under certain circumstances. It remains to be seen whether laws mandating vaccines will pass, and if so, whether they would survive a legal challenge asserting that the right to refuse the vaccine in the FDCA preempts conflicting state law.
Employer Vaccine Mandates and EUAs. Given these facts, can an employer mandate employees to get vaccinated under threat of termination or other employment action? In other words, is an employer that mandates EUA vaccinations subject to—and in violation of—Section 564(e)(1)(A)(ii)(III) by becoming a “person who carries out any activity for which the [EUA] is issued”? The law regarding EUAs is unclear and as yet untested.
Under FDCA section 510(a) (and Pom Wonderful, LLC v. Coca-Cola Company, 573 US 102, 109 (2014)), there is no general private right of action under the FDCA, but the question of whether Congress intended to create such a right under Section 564(e)(1)(A)(ii)(III) apparently has not been addressed. However, such a scenario could give rise to a claim for wrongful termination in violation of public policy under state law, given the clear right of refusal under Section 564. The FDCA does not address this issue, but it would be difficult to argue that the required disclosure of the “consequences” of refusing administration of the vaccine contemplates things like termination of employment (as opposed to health-related consequences). Moreover, as noted above, once the current HHS declaration of a public emergency under Section 564 is terminated, an employer mandating that employees receive an EUA vaccine will do so knowing (or presumed to know) that such a mandate is unlawful.
Notably, just before this client alert went to press, a case was filed in federal district court in New Mexico on exactly the bases outlined above. (Legaretta v. Fernando Macias, et al., Case 2:21-cv-00179, filed Feb. 28, 2021.) Specifically, the plaintiff, an employee of the Dona Ana Detention Center, asserts that his employment has been threatened with employment termination due to his exercise of his federal right to refuse the EUA vaccine in the face of his employer’s vaccine mandate. The plaintiff seeks declaratory and injunctive relief to, among other things, prevent the employer from coercing the vaccine and from retaliating against him for exercising a federal right. It appears to be the first case of this kind, but it doubtless will not be the last.
Takeaways. Even if employers can mandate the vaccine, the real question is whether they should. That question is currently premature for many employers, given that the vaccines are not expected to be widely available until this summer. The legal issues surrounding mandatory COVID-19 vaccines are currently unsettled, but are likely to be fleshed out in the coming months. Moreover, mandating the vaccine raises a host of issues (see our prior client alert on this topic here). Among other things, it is unclear whether the PREP Act would protect an employer that requires employees to receive an EUA COVID-19 vaccine.
At this juncture, given the uncertainty surrounding the legality of mandating EUA-status vaccines, plus the other issues raised by mandatory vaccines, the safer course of action is to encourage employees to get the vaccine rather than mandating it, providing facts about the vaccine and legally permissible incentives to do so, and accommodating those who are unable to get the vaccine for religious, medical or disability-related reasons. The EEOC recommends this course of action, and the CDC has created toolkits to assist employers in encouraging vaccinations.
Employers should continue to monitor this evolving situation, consider these issues, as well as the additional considerations that doubtless will arise, and work with legal counsel in developing their vaccine strategy.