Most colleges and universities won’t be in a position to require all members of their communities to be vaccinated against COVID-19 until at least summer or fall of 2021. As of December 2020, vaccines are being made available under FDA Emergency Use Authorizations (EUAs), and federal law requires that recipients of products permitted under EUAs must be allowed the opportunity to decline the immunization. In addition, supply is an impediment: institutions can’t require their students to be immunized when vaccine isn’t yet available to most of that age group. However, given authorization of the Johnson & Johnson vaccine in February 2021 and forecasts of increased production generally, institutions should begin to plan now for whether they will mandate vaccination and, if so, how they will manage such programs.
Voluntary vs. Mandatory Immunization
The first question involves consideration of whether state law will allow the institution to mandate COVID-19 vaccination — either expressly, by amending current laws or regulations to provide that COVID-19 is one of the conditions for which immunization is required under state law; or indirectly, by delegating to educational institutions the choice of what immunizations to require of their students and staff. Assuming that state law, in some manner, allows mandated vaccination, universities will need to calibrate institutional comfort level with imposing a requirement on students that involves inroads into personal privacy and autonomy. Many institutions will choose instead to rely upon voluntary immunization programs, using the carrot of persuasion rather than the stick of decree. Others will conclude that the potential reputational and financial costs to the institution of large clusters of infection among its constituents will make it impracticable not to require COVID-19 immunization as a condition of enrollment. If, after balancing individual interests with institutional responsibilities to safeguard the entire community, the institution concludes that requiring COVID-19 immunization is necessary and appropriate, the institution will need to review and update its policies and procedures to encompass COVID-19 vaccination and potential issues specific to COVID-19.
Challenges of Mandating the COVID-19 Vaccine
Managing a COVID-19 mandate will likely present particular challenges. We are already seeing reports that current vaccines provide different levels of immunity to some emerging COVID-19 strains, and in future years it is not unlikely that preventing COVID-19 will involve annual vaccines or boosters, as with influenza. All states require immunization against at least some childhood diseases as a condition of enrollment in schools and institutions of higher education, so educational institutions have been screening for required immunization programs for decades. While not a simple task, this screening, part of the admission process, generally involves processing standardized attestations on which health care providers verify the immunizations the applicant has received. Clinical health care educational programs will generally operate a more robust process to also verify that students in clinical rotations have had a recent influenza vaccination before starting their rotations. Thus, though pockets within colleges and universities may be well versed in verifying annual immunizations and tracking ongoing compliance, institutions will likely encounter significant challenges in mustering the expertise and staffing resources to stand up and manage ongoing institution–wide immunization mandates covering both new and returning students.
Processing Legal Requests for Exemption
Regardless of context, administering any mandatory vaccine program will require reviewing and processing requests for exemption. All states allow students to request exemption for medical reasons, which is almost always granted upon physician verification of the disease condition occasioning the need for exemption. Often the reason for the medical exemption will be transitory, and waiver of the vaccination requirement will be issued for a time–limited period, generally not exceeding 12 months.
In many states, students whose sincerely held religious beliefs prohibit vaccination are also exempt from vaccination requirements. Other states allow exemption where vaccination is contrary to philosophical beliefs of the student or the student’s parents, and in operation this exemption generally encompasses religious objections even where state law doesn’t expressly say so. (A few states don’t provide for exemptions on either ground.)
Anecdotal evidence suggests that where an institution does grant religious waivers, the process for obtaining the waiver typically involves very little review. Institutional officials are loathe to delve into the sincerity of a student’s stated religious beliefs, and rejecting a requested waiver can lead to burdensome, expensive and unpopular disputes with students who believe they are the victims of religious discrimination. Thus, often the form used to request a religious exemption will require only that the student attest to something like the following statement: “I request an exemption from this requirement on the grounds that such immunization conflicts with my religious beliefs and practices.” More rarely, an institution will require the student to describe the religious beliefs that render vaccination unacceptable for the student.
Notwithstanding the potential blowback, in the age of COVID-19, institutions should consider imposing more rigorous review procedures for religious exemption requests for three primary reasons: to deter claims without a valid basis, to avoid costly litigation, and to circumvent reputational damage.
First, the manufacturers have developed, secured approval and scaled up production of these products in what is probably a record–breaking amount of time. And, as of March 2021, the only vaccines available are permitted under Emergency Use Authorizations, not a full FDA license, which must await generation of additional data concerning efficacy and safety. Opposition to vaccines within a small but significant (and vocal) segment of the population was already a factor in decision–making, but numerous media accounts have explored the further negative effect that the speedy development and approval of these particular vaccines have had on public confidence. Moreover, COVID-19, its prevalence, treatment and prevention all became highly politicized topics in 2020. As a result, institutions may well encounter students who are reluctant to take the COVID-19 vaccine and, lacking a valid medical basis to avoid it, have –”discovered” a religious objection.
If institutions have decided that requiring immunization is the best approach to safeguarding their communities, they will want to ensure that students are not finding loopholes to compliance. Implementing a centralized program that reviews and processes waiver requests according to well–defined, legally solid criteria and creates a readily auditable record will help institutions to avoid such loopholes as well as inconsistent and arbitrary decisions.
Second, though there has been some legislative activity around conferring immunity from lawsuits on employers and institutions as a result of infections traced to their premises, we can expect litigation in the coming months regarding institutional liability for damages incurred by people who are infected during such an outbreak. In the event that such litigation occurs, institutions will encounter a great deal of scrutiny of how they managed reopening their doors and ensuring that their students observed public health protocols. It is far easier to rely on a student’s having been vaccinated to assure that the student is not a risk to others than it is to hope that the student will comply with the accommodations allowed as an alternative to vaccination, and wear masks and socially distance in both learning and social situations. While there are tricky causation issues in such suits, these situations are not free of legal risk for the institution — and demonstrating that the institution proceeded prudently and that exemptions were not approved with a rubber stamp may help reduce that risk.
Finally, institutions should consider the significant potential financial and reputational risk inherent in a campus outbreak that could have been avoided had a sufficient number of students been vaccinated or otherwise developed immunity. We have already seen the consequences of having to shut down days or weeks into a semester. Losing the confidence of students and their families by failing to provide a safe learning environment can be a setback from which even the strongest institution would struggle to recover.
Legal Reasons for a Waiver Allowance
Institutions routinely require that a student seeking a medical waiver name or describe the condition making vaccination contraindicated, often with physician verification also required. Many will argue that religious freedom, a significant platform on which our nation was founded, is a more compelling and sensitive topic than medical conditions — and it is certainly the case that verifying a medical condition is much simpler than establishing the sincerity of a student’s religious beliefs. But providing a substantive and meaningful review of requests for religious exemption need not lead to overly intrusive examination of a student’s beliefs. It should be sufficient — and it is entirely reasonable — to have the student describe and explain the religious tenet that renders vaccination unacceptable, with citations, where feasible, to sacred texts or teachings that validate the student’s belief. That said, institutions must always work closely with legal counsel to ensure that the questions asked and review provided do not cross the line into religious discrimination.
Vaccine and Waiver Mandate Tips for Institutes of Higher Education
Faced with these complexities, many administrators will be tempted to throw up their hands and take the easy route: if a student cares enough to request an exemption, check it off and move on. And the complexities of managing and monitoring such requests efficiently and in compliance with applicable data privacy and security laws can be challenging. But as seen above, the less troubling route may lead to more trouble in the long run. In this environment, institutions should consider the following practice tips:
- Assure that immunization policies and procedures comply with applicable federal, state and local laws and regulations, understanding that any and all of these may be rapidly evolving in response to the pandemic.
- Verify that mechanisms used to process, review, and adjudicate exemption requests are fair and straightforward, and include a limited but effective right to appeal from an initial decision to deny an exemption.
- Build in periodic review of medical exemptions to verify that the condition underlying the exemption continues to apply. Assuring an adequate audit trail is key to this requirement, while also protecting the institution in the event of legal or regulatory challenges and reviews.
- Train all staff involved to assure that exemption procedures are applied in a consistent manner across campus, but also recognize and accommodate segments of the institution — notably health sciences programs — where different criteria, additional levels of review, and coordination with external entities such as the hospital site of a clinical practicum may be necessary.
- Consider IT demands of implementing a meaningful immunization exemption process, and budget accordingly.