Assessing The Legality of Mandates for Vaccines Authorized via an Emergency Use Authorization
Efthimios Parasidis & Aaron S. Kesselheim
The Food and Drug Administration (FDA) recently issued two Emergency Use Authorizations (EUAs) for Covid-19 vaccines, and may soon issue a third. Public health officials have begun vaccine administration via state-based priority access plans. Discussion of vaccine mandates is plentiful, including the potential for state-issued orders and private directives from employers and other non-governmental entities. What remains unclear is the legality of mandates for EUA vaccines.
The issue of whether EUA vaccine mandates are permissible is particularly urgent given the woefully inadequate Covid-19 immunization roll-out. By December 31, 2020 fewer than 3 million doses were administered, far short of the goal to inoculate 20 million Americans by year’s end. The number of inoculated Americans has increased—as of February 12, over 34.7 million Americans had received at least one shot—and hopes for accelerating vaccine rollout under the new government remain high, though there has been wide disparity in immunization rates across states. Among the early groups of people receiving vaccines, reports have emerged of far too many physicians, nurses, nursing home staff, and firefighters declining vaccination.
In part the shortcomings are due to early lack of federal leadership, as well as funding and complex administrative hurdles faced by state and local public health agencies. Another factor is widespread vaccine hesitancy, driven in part by concerns about undue political influence over vaccine development and regulatory review under the prior presidential administration. These concerns are particularly prevalent among the poor and people of color, groups that have suffered disproportionally from the pandemic and who already experience a wide array of health inequities.
To address vaccine hesitancy and encourage vaccine uptake, public health officials have considered a variety of strategies. These include creation of working groups focused on minority health, messaging campaigns, enlisting the support of faith leaders and other trusted sources to help encourage immunization, and train-the-trainer programs for local officials involved in vaccine administration. Another option that has been widely discussed, but not yet implemented, is vaccine mandates. One recent study found that 72 percent of major company CEOs would consider vaccine mandates. Other groups have floated the idea of “vaccine passports,” in which a person can gain access to travel, education, work, etc. only if they have proof of immunization. As a practical matter, vaccine passports are functionally equivalent to mandates.
Should vaccine uptake continue to lag, mandating Covid-19 vaccines might be viewed as a necessary component of the public health response to the pandemic. But are mandates legally permitted for vaccines only granted emergency authorization by the FDA?
Interpreting The EUA Statute
The EUA provision was added to the federal Food, Drug, and Cosmetic Act (FDCA) in 2004 to give the government increased flexibility to respond to a chemical, biologic, nuclear, or radiation threat. When the pathway was created, special language was included for informational disclosures for individuals offered a medical product under an EUA. Specifically, under 21 U.S.C. § 360bbb-3(e)(1)(A)(ii)(III), each individual must be informed “of the option to accept or refuse administration of the product, of the consequences, if any, of refusing administration of the product, and of the alternatives to the product that are available and of their benefits and risks.”
Although no court has interpreted this provision, the first segment of the subclause suggests that mandates are categorically prohibited, since each person must have “the option to accept or refuse.” But another plausible interpretation is to view segment two as a qualifier to segment one. According to this interpretation, the provision as a whole could be interpreted to dictate that, although a person has the option to refuse an EUA product, refusal can come with “consequences.” Under this interpretation, the legality of a mandate is likely to hinge on how the term “consequences” is defined. Since the term is not defined in the statute, statutory interpretation principles dictate that the word should be defined in ordinary terms within the context of the statute.
First Potential Meaning Of ‘Consequences’: Health Consequences Only
The entire subsection of 21 U.S.C. §360bbb-3(e) details conditions of authorization for EUA medical products, including the need to assess and disclose known risks and benefits and the need to monitor and report adverse events. There is no reference to mandates or consent waivers. Rather, the subsection focuses on health-related measures that are conditions of administration. As such, in the context of a Covid-19 vaccine EUA, disclosure of “consequences” from opting to refuse a vaccine could be interpreted solely to include potential health consequences of refusal, such as an increased risk of acquiring or transmitting SARS-CoV-2 or an increased risk of disease burden from Covid-19.
Second Potential Meaning Of ‘Consequences’: Any Adverse Action
As an alternative to a health-centered interpretation, one could argue that the word “consequences” should be defined broadly to encompass any adverse action that may be taken should a person decline vaccination. Under this interpretation, “consequences” could include health risks and adverse consequences related to work, access to education, use of public transportation, ability to shop in a store, board an airplane, and more. As a practical matter, such a broad interpretation would open the possibility that public and private entities could institute mandates.
If this interpretation is adopted, the FDCA would require that individuals be informed, prior to their decision on whether to accept an EUA medical product, of all possible health and non-health related consequences. It seems unlikely that Congress would set this broad disclosure requirement on health care providers who are administering products available under an EUA.
Furthermore, if segment two of Section 360bbb-3(e)(1)(A)(ii)(III) opens the door to mandates, it would render meaningless the option stated in segment one. Under canons of statutory interpretation, one segment of statute should not be interpreted to obstruct another. Rather, provisions should be interpreted in a way that makes them compatible, not contradictory.
In sum, it is most plausible that the mandatory disclosures of Section 360bbb-3(e)(1)(A)(ii)(III) are limited to health risks of refusing an EUA product during a public health emergency. This interpretation is supported by the legislative history of the bill that created the EUA pathway. A review of the Congressional Record reveals no mention of allowing the government or private entities the ability to mandate administration of EUA products. Rather, EUAs consistently are characterized as a vehicle for providing access to promising, but unproven, medical products. As one example, Rep. Billy Tauzin (R-Louisiana) stated that the statute was intended to assure that “if there is some vaccine, some treatment under study that has a lot of promise but has not yet been approved, that we are not forbidden to use it.”
Anthrax Vaccine EUA As A Guide
The context in which the EUA pathway was created and first used also supports an interpretation that mandates are not part of the law. The EUA protocol was enacted amid a challenge to the Department of Defense (DoD) anthrax vaccine immunization program (AVIP). The vaccine was FDA-approved as prophylaxis for cutaneous anthrax, but DoD sought to mandate the vaccine among service members to protect against inhalation anthrax. This qualified as off-label use, and service members filed a lawsuit seeking to halt AVIP.
Since AVIP involved off-label use of a vaccine for military personnel, the law required informed consent from each individual or a Presidential waiver of informed consent. From AVIP’s commencement in 1997 to the time of the lawsuit in 2003, neither President Clinton nor President Bush had issued a waiver. On December 22, 2003, a federal court halted AVIP due to DoD’s failure to abide by informed consent requirements. Eight days later, FDA expanded the label to encompass inhalation anthrax. Service members challenged FDA’s decision on procedural grounds, arguing that the agency failed to follow its own regulations regarding label amendments.
As it seemed that the court would likely rule against FDA, the Project BioShield Act was created. In October 2004, a district court actually did side with the service members and vacated FDA’s decision, but the bill had already passed and President Bush signed it three months earlier. In December 2004, DoD filed an EUA for the anthrax vaccine, and within weeks FDA issued the EUA, which encompassed inhalation anthrax.
Subsequently, DoD restarted anthrax vaccinations but only on a voluntary basis. Immunizations remained voluntary until December 19, 2005, when FDA approved a label expansion for the anthrax vaccine, and thereafter DoD resumed mandatory inoculations for certain military personnel. This series of events lends credence to the position that mandates were not intended for EUA products.
Additional Policy Reasons To Preclude Mandates
Ethical and public policy rationales also support the notion that government or private mandates should not be permitted for EUA vaccines. The EUA standard of review is lower than the standard for vaccine approval; for example, rather than provide substantial evidence of effectiveness a sponsor need only offer evidence that the product may be effective. Along these lines, one recent article stated that mandates for Covid-19 vaccines are “legally and ethically problematic” under EUAs, and should only be considered if a vaccine earns full Biologics License Application (BLA) approval.
More specific to Covid-19 vaccines is the issue that the hyper-politicization of public health and persistent undue influence from the Trump White House has resulted in record numbers of vaccine-hesitant Americans, particularly among the poor and people of color. In such an environment, a vaccine mandate is likely to exacerbate public concerns, particularly as questions remain about any Covid-19 vaccine-injury compensation programs for unexpected adverse effects.
Although EUAs for Covid-19 vaccines may help society overcome the wrath of the pandemic, mandates for such vaccines are unlikely to pass legal muster.
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