Preparing Health Care Providers for a COVID-19 Vaccine

• June 01, 2020

• Brian Dean Abramson

Introduction

Even as the COVID-19 pandemic places intense stress on both American health care providers and legal institutions, one area of law is uniquely poised to chart the way out of this crisis: vaccine law. The single most effective thing that can be done to bring an end to the sicknesses and deaths that mark the occurrence of a pandemic is the development and deployment of an effective vaccine. Although it will be many months before a COVID-19 vaccine is ready for distribution to the public, when available, such a vaccine will have an immediate impact on the practice of medicine and the legal liabilities of both individual and institutional health care providers. Attorneys advising such individuals and entities should take time now to prepare for the legal issues that will ultimately arise once a vaccine is available.

Background

The COVID-19 pandemic is the most serious public health crisis the United States has faced in decades, causing hospitals, clinics, private medical offices, and other health care institutions to adopt substantial new measures to protect both employees and patients. Rules intended to stem the spread of the disease have been promulgated by many states and cities pursuant to various sources of emergency authority, and many private institutions have instituted internal policies even more stringent than those imposed by governmental authorities. Among the numerous actions that have been taken at the federal level, Secretary of Health and Human Services (HHS), Alex Azar issued a declaration on February 4, 2020 invoking the Public Readiness and Emergency Response Act,¹ or PREP Act, with respect to COVID-19, covering any countermeasures to the pandemic that are developed in response to it, specifically including any vaccines.

As of May 2020, over one-hundred potential COVID-19 vaccines are in development, with substantial regulatory leeway being given to researchers to proceed through clinical trials and other regulatory requirements at a speed heretofore inconceivable for development of a vaccine. Normally, the clinical trial process alone can take many years, and in some cases efforts to develop an effective vaccine for a disease have gone on for decades without success. With COVID-19, however, the relative familiarity of the virus (being closely related to others for which vaccine research has previously been undertaken) and the vastness of resources being directed to the effort have led to hopes that a vaccine will be developed within 18 to 24 months. Due to the public health emergency, the Food and Drug Administration (FDA) has issued Emergency Use Authorizations for a number of prospective and/or experimental COVID-19 treatments to date, and we can expect to see more of that once a COVID-19 vaccine becomes available, potentially allowing vaccines to go to market even prior to receiving full approval from the FDA.

If a vaccine does become available, the two critical issues facing health care providers and public health authorities will be whether (and when) to mandate vaccination for health care workers, and the scope of immunity from liability that may be applicable for vaccine injuries that may ensue.

Preparing for COVID-19 Vaccination Mandates

Vaccination mandates for health care workers, pursuant to both state law and private initiatives of individual institutions, are widespread but generally sporadic and inconsistent in their actual application. The specific vaccines required, bases for exemption from vaccination, and other details vary widely. However, it can reasonably be anticipated that the development of a COVID-19 vaccine will be followed by robust vaccine mandates requiring its administration to health care workers. Court decisions have generally upheld the right of states and employers to mandate vaccination in the health care field, and given the substantially higher threat that COVID-19 presents to an unvaccinated population, it is exceedingly likely that the rationale supporting this decision would be extended to any COVID-19 vaccine mandate.

It is conceivable that COVID-19 could lead to the first federal vaccination mandate for individuals beyond military personnel and persons seeking to immigrate to the United States. It is also specifically highly likely that COVID-19 vaccination will be mandated, either at the state or the federal level, for health care workers and others likely to come into contact with patients in the health care environment. A federal mandate would likely be the most effective way to ensure uniformity in this area, but it would undoubtedly face stiff resistance on both political and legal fronts from those opposed to vaccination and supporters of state’s rights. The primary question to be resolved in such a challenge would be whether COVID-19 has a sufficient impact on interstate commerce to invoke the power of Congress to legislate in this area. During the measles epidemic of 2019, the Congressional Research Service issued a memorandum analyzing federal authority over childhood vaccinations, finding:

Congress has “granted broad, flexible powers to federal health authorities who must use their judgment in attempting to protect the public against the spread of communicable disease” under the Public Health Service Act (PHSA). This authority to make and enforce regulations necessary “to prevent the introduction, transmission, or spread of communicable diseases from foreign countries into the States or possessions, or from one State or possession into any other State or possession” could conceivably be used to mandate vaccinations, provided that the authority is not exercised in a way that otherwise violates the Constitution or fails to comply with other statutory requirements, such as the Administrative Procedure Act.²

The memorandum concluded, however, that the most likely route for the exercise of congressional power in this realm would be through the Spending Clause, conditioning funding to the state on the adoption of vaccination requirements with respect to the specified population. More directly, Congress could amend the conditions for participation in Medicare and Medicaid services to require hospitals to limit patient exposure to unvaccinated personnel.

Hospitals and other medical institutions will also have strong incentives and be in a position to privately mandate COVID-19 vaccinations for their employees. With respect to employees, courts have typically held that imposition of such a step constitutes a material change to the conditions of employment, so one early step that can be taken to smooth progress in this direction is to obtain agreement on the framework of such a mandate from unions and other groups subject to collective bargaining agreements.

The most significant impediment to robust COVID-19 vaccination is likely to be vaccine hesitancy. Already, some polls have shown in the general population that roughly one fifth of people would be inclined to refuse to ever receive a COVID-19 vaccine.³ Furthermore, in anti-vaccination circles, false information is already circulating regarding characteristics of such a vaccine, even though none yet exists.⁴ One prominent rumor spreading via social media, for example, is that vaccines for which Bill Gates is providing funding will contain “an injected microchip or quantum-dot spy software.”⁵ Although vaccine hesitancy may be lower among health care workers who have had to deal with the effects of the disease itself on the front line, such hesitancy and misinformation bolstering this phenomenon may still manifest in objections to the implementation of vaccination mandates, and in efforts to obtain exemptions from vaccinations once such mandates are implemented.

Cases Impacting Employer Rights

An important case delineating employer rights in this area was decided shortly before the pandemic broke out, in January 2020. The case, Horvath v. City of Leander,⁶ involved a firefighter who refused to receive vaccinations mandated by the department, asserting an objection based on his religious beliefs. The department offered him two alternatives as an accommodation. The first was transfer to a position with equal pay, but without contact with potentially vulnerable civilians; the second was a requirement that he wear a respirator at all times while on the job, and receive regular testing for the presence of vaccine preventable diseases. Horvath objected to this set of options, noting that transfer to the other position would have required a change in his hours which would prevent him from maintaining a second job, and offered as an alternative to wear a mask any time when he would be interacting with vulnerable persons, but only on those occasions.
The department rejected Horvath’s alternative proposal, and after he refused to choose between the two accommodations that were offered, terminated his employment.

The Fifth Circuit found that the accommodations offered were reasonable, and that a reasonable accommodation need not be one that is ideal for the person seeking to be accommodated. The case is significant for several reasons in this area, not the least of which is the court found it reasonable for the department to require an employee in Horvath’s position to adhere to both a stringent masking policy and a disease testing policy or protocol. The court also inherently found that it was permissible as an accommodation to offer an alternative wherein Horvath would be transferred to a position with different duties that, although having the same pay, was less preferable to Horvath for the materially significant reason of offering a less convenient work schedule.

Although Horvath did not examine the sincerity of the claimant’s religious objection, another 2020 case did, this being Brown v. Children’s Hospital of Philadelphia.⁷ In Brown, the Third Circuit reaffirmed the well-established principle that in order to state a claim for religious discrimination under Title VII of the Civil Rights Act of 1964,⁸ the plaintiff must demonstrate a sincerely held religious belief on the discriminated point. Here, the plaintiff asserted a religious objection to vaccination, but the Third Circuit noted that their stated reasons for objecting were that they believed there were medical risks and felt that washing their hands was sufficient to prevent infection. These were assertions supporting a medical objection, not a religious objection. Pursuant to the decision in Phillips v. City of New York,⁹ it is even permissible to distinguish between claims of persons professing adherence to the same religious denomination if one provides a clearly religious basis for opposing vaccination, and another provides a basis derived from health concerns or a more philosophical viewpoint that is merely couched in religious language.

Also of note is the district court decision in Jenkins v. Mercy Hospital Rogers.1⁰ In that case, the Western District of Arkansas found that even where an employee clearly demonstrated religious discrimination in his or her termination for refusal to receive a flu vaccination, the employer health care facility was not liable because, like many hospitals, it was itself a religious institution. 42 U.S.C. § 2000e-1(a) exempts from liability for religious discrimination “a religious corporation, association, educational institution, or society
with respect to the employment of individuals of a particular religion to perform work connected with the carrying on by such corporation, association, educational institution, or society of its activities.” In this case, the court found the facility fell under the protection of that clause even where it had an internal written non-discrimination policy.

With respect to medical exemptions, employers should carefully examine any contraindications that researchers document with respect to any deployed COVID-19 vaccines. Given the large number of vaccine candidates, and the diversity of methods being used to develop them, multiple COVID-19 vaccines may be successfully deployed having different components and different contraindications. It is likely, in fact, that specific COVID-19 vaccine candidates will be found to be preferable for recipients with specific allergies, sensitivities, or other conditions. Some of these therefore may not fall within the parameters of medical exemptions sought by claimants. In the 2019 case of Chmura v. Monongalia Health Systems,¹¹ the termination of an employee who refused to receive a flu vaccination on medical grounds was upheld where it was determined that the examining physician had found the employee to have a latex allergy, but where latex-free flu vaccines were available. If an employee seeks medical exemption from vaccinations, the employer may first require the employee to state with specificity what aspect of the vaccine requires such an exemption and should determine whether an alternative vaccine has been developed that does not suffer from these deficiencies.

Alternatives to Vaccination

In addition to masking accommodations of the type approved in Horvath, other alternatives to vaccination may become available as we learn more about the disease and the potential immunity recovered individuals may have from reinfection. If further research supports it, one potential alternative to vaccination may be serological testing to determine if an employee is already generating the antibodies to COVID-19. Since the aim of vaccination is to stimulate this outcome, the presence of antibodies can indicate that vaccination is not needed. While serological tests are already becoming available, concerns remain as to the accuracy of tests developed so far, as well as the significance of positive results. Further, the degree to which the presence of COVID-19 antibodies prevents a second occurrence of the infection remains unknown—as does the duration
of protection that will be offered by any vaccine.

As noted in Horvath, employers may also consider reassigning employees to positions that do not involve patient contact, in lieu of vaccination. Although Horvath allows employers to offer alternative positions that are less than ideal for the employee, care should still be taken to avoid changes in conditions of employment that could cause the reassignment to be interpreted as a demotion.

Legal Status of Asserted COVID-19 Vaccine Injuries

Secretary Azar’s invocation of the PREP Act has a number of significant implications for the medical community, most prominently that persons who administer countermeasures covered by the Act, including any COVID-19 vaccine that may be developed, will be immune from liability for any injury caused by that administration, so long as the injury was not caused by willful misconduct. What, then, for persons—including, potentially, health care workers themselves—asserting a vaccine injury traceable to a COVID-19 vaccination? The invocation of the PREP Act also provides a route for injury compensation, the Countermeasures Injury Compensation Program (CICP).

Unlike the better-known National Vaccine Injury Compensation Program (NVICP), the CICP limits compensation to injuries that are “serious,” and also provides a much narrower statute of limitations for filing of claims, one year from the date of administration of the vaccine, irrespective of the time when the injury becomes apparent. For health care providers, this dulls both edges of what would otherwise be a quite sharp double-edged sword. Doctors, hospitals, and other institutions can administer any COVID-19 vaccine that may be developed without fear of liability for an injury associated with the vaccination. By some measures, the coverage afforded is actually quite a bit broader than the immunity from liability provided under the NVICP. As one court noted with respect to the interpretation of the statute promulgated by HHS, “the language used clarifies that immunity is extended to slip and fall injuries and vehicle accidents that are connected to the vaccination process, be it at a retail store or some other facility.”¹² The case in question analyzed a health care provider’s liability for failing to administer a vaccine, finding this decision to fall outside of the protection of the PREP Act because no vaccine was administered; the full breadth of immunity asserted under the act has yet to be tested in litigation. Again, the only exception is for willful misconduct.

Employers should be aware that the current invocation of the PREP Act is set to expire in October of 2024. While this is fairly far in the future, institutions should still be prepared for the fact that limitations on liability for injury resulting from a COVID-19 vaccination are scheduled to cease at that point. Beyond that, it is possible that the vaccine will be added to the NVCIP table, or other action will be taken to extend the deadline, such as an extension of the PREP Act coverage period, or Congressional legislation to that effect.

Pursuant to 42 U.S. Code § 300aa-14(e)(2), the Secretary of HHS must add any new vaccine recommended by the CDC for routine administration to children to the Vaccine Injury Table (VIT) within two years of this recommendation. However, nothing in the rules governing the NVICP prohibits the addition of a vaccine that does not yet actually exist. It is possible that steps will be taken towards this in anticipation of the development of a vaccine. For example, the rulemaking process might be initiated at some point when it becomes reasonably clear that a vaccine will be developed and available to place on the market on a timeline roughly coincident with the usual timeline for enactment of such an amendment. Historically, the process for inclusion of vaccines in the VIT more commonly follows a determination by the CDC’s Advisory Committee on Immunization Practices (ACIP). While it is highly likely that ACIP will ultimately make such a recommendation for an effective COVID-19 vaccine, it is less likely that such a recommendation will be made for a vaccine that has not yet been licensed for use by the FDA, and for which long-term efficacy remains in question.

It is possible for the same vaccine to be covered under both the NVICP and the CIPC. For example, the PREP Act was invoked in 2009 during the H1N1 influenza epidemic. Because influenza vaccines are listed on the NVICP’s VIT, persons who received a vaccination for that specific strain were able to elect to seek compensation under either program. However, both the CIPC and the NVICP offset awards made elsewhere, and NVICP settlement agreements in cases where CIPC remedies are also available typically include a waiver of the claimant’s right to pursue any remedy under the CIPC. As of May 2020, no COVID-19 vaccine is listed on the VIT, first and foremost because such a vaccine does not yet exist, and secondly, because the Secretary of Health and Human Services has not gone through the process of listing such a vaccine on the table, which requires the usual notice-and-comment rulemaking procedures governing all amendments to regulatory codifications.

If such an addition were to be made swiftly, it would enable vaccine recipients to recover compensation for injuries alleged to originate from this vaccination through the well-established processes of the NVICP, belaying the need to employ a process parallel to it for COVID-19 vaccination injuries. Such a listing would also likely expand the set of injuries for which compensation could be recovered, the timetable for such recovery, and the kinds of associated costs and expenses that could be compensated. This would be particularly efficient if it were determined that mutations of the virus or limitations on the duration of immunity make it likely that COVID-19 will become a seasonal illness. If that eventuality arises, an annual ritual of vaccination comparable to flu vaccination will become routine and will continue beyond the expiration of coverage under the PREP Act in October 2024.

Conclusion

By the time a COVID-19 vaccine is developed, a much more mature understanding of the utility of alternatives such as mask-wearing and antibody testing should exist, along with greater knowledge of the most effective therapies and treatment options for the disease. However, the vaccine will itself be something of an unknown. It will take time and experience, some good and some bad, to determine optimal COVID-19 vaccination practices, and therefore to determine optimal rules governing vaccination mandates. Both vaccination policies and alternative allowances such as masking policies and antibody testing policies should reflect the most current knowledge with respect to these practices, and they should allow for the policy to be updated without additional negotiation based on further refinement of knowledge in these areas and on new recommendations by the Centers for Disease Control and Prevention, National Institutes of Health, and other agencies responsible for promulgating such information.

That said, however, employers should take care to give clearly and explicitly stated notification to employees of changes to vaccination requirements and should afford a reasonable time for employees to adjust to any changes. Lastly, in light of the evolving knowledge base, it is important for institutions to be aware of COVID-19 vaccination and exemption policies being adopted by other institutions. COVID-19 vaccination of employees will affect the risks passed on to patients, and to the extent policies affect patient welfare, these will collectively establish the standard of care in this area.

Author Profile

Brian Dean Abramson is the primary author of Vaccine, Vaccination, and Immunization Law, which is the most comprehensive treatise written with respect to this field of law, published by Bloomberg Law in cooperation with the American Health Law Association in November 2018. Brian previously worked for Bloomberg Law, for whom he authored the vaccine injury claims chapter of Court of Federal Claims: Jurisdiction, Practice, and Procedure, and for whom he wrote extensively in the fields of health and international privacy law. Brian was a law clerk for the Honorable Pauline Newman of the U.S. Court of Appeals for the Federal Circuit, where he took an exceptional interest in the court’s vaccine injury docket. He interned with the Honorable Susan G. Braden of the U.S. Court of Federal Claims and practiced intellectual property law with the firm of Lott & Friedland in Coral Gables, Florida. He received an MA in Comparative Sociology from Florida International University, followed by his JD, summa cum laude, from the Florida International University College of Law, and an LLM in intellectual property law with highest honors from the George Washington University Law School. Contact him via email at [email protected].

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