Medical-Legal Experts Examine the Legal, Clinical, and Ethical Complexities of 'Vaccine Passports'

Reflecting on an issue that has roared to the top of the list of the set of public debates around a variety of aspects of the COVID-19 pandemic, a team of healthcare policy researchers has examined the question of whether COVID-19 vaccination passports make sense. Their conclusions are complex and nuanced.

In an article published in the JAMA Network online on April 7 under the headline, “Digital Health Passes in the Age of COVID-19: Are ‘Vaccine Passports’ Lawful and Ethical?” Lawrence O. Gostin, J.D., Glenn Cohen, J.D., and Jana Shaw, M.D., M.P.H. look at various aspects of the issue. The three authors of the article are affiliated, respectively, with the O ’Neill Institute for National and Global Health Law, Georgetown University (Washington, D.C.); the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics, Harvard Law School (Boston, Mass.); and the Division of Infectious Diseases, Department of Pediatrics, SUNY Upstate Medical University (Syracuse, N.Y.).

As the authors write, “As COVID-19 vaccination rates in high-income countries increase, governments are proposing or implementing digital health passes (DHPs) (vaccine ‘passports’ or ‘certificates’). Israel uses a ‘green pass’ smartphone application permitting vaccinated individuals’ access to public venues (e.g., gyms, hotels, entertainment). The European Union plans a ‘Digital Green Certificate’ enabling free travel within the bloc. New York is piloting an IBM ‘Excelsior Pass,’ confirming vaccination or negative SARS-CoV-2 test status through confidential data transfers to fast-track business reopenings. This Viewpoint examines the benefits of DHPs, scientific challenges, and whether they are lawful and ethical.”

As the authors write, “Digital health passes offer health and economic benefits until herd immunity is achieved. By allowing a safe return to more normal life, DHPs encourage people to be vaccinated. Digital health passes also allow a gradual reopening of the economy in key sectors such as food, retail, entertainment, and travel. Consumers are likely to rejoin recreational and commercial activities if they are confident doing so is safe. Digital health passes offer a less restrictive means to relax COVID-19 preventive measures such as quarantines, business closures, and stay-at-home orders.”

The authors write that “Digital health passes involve considerable scientific and technical challenges, including variable effectiveness by vaccine type, effectiveness in preventing transmission, durability of immunity, and emergence of variant strains. Currently, the overall efficacy of 6 SARS-CoV-2 vaccines, mRNA-1273 (Moderna/NIAID), BNT162b2 (Pfizer-BioNTech), Ad26.COV2.S (Janssen/Johnson & Johnson), ChAdOx1 nCoV-19 (University of Oxford/AstraZeneca), Gam-COVID-Vac/Sputnik V (Gamaleya Research Institute of Epidemiology and Microbiology), and BBIBP-CorV (Sinopharm/Beijing Institute of Biological Products), authorized for use in select countries, ranges from 65.5 percent to 94.6 percent in preventing symptomatic COVID-19 based on published clinical trial data.”

One of the challenges, the authors write, is that “The duration of protection afforded by SARS-CoV-2 vaccines is uncertain. Coronavirus infections, such as from the 2002-2004 SARS-CoV-1 outbreak, generally afford limited protection for 1 to 2 years. Reinfection with SARS-CoV-2 has occurred, albeit rarely. Yet there is limited evidence of vaccine-induced immunity beyond limited follow-up of clinical trial participants. Waning vaccine immunity will be better understood with follow-up of clinical trial participants, along with observational studies. Digital health passes should include dates of series completion to determine expiration once longevity of vaccine protection is better defined.”

They also caution that “scientific uncertainty” exists around “the extent to which vaccines prevent acquisition and transmission of SARS-CoV-2. Emerging evidence suggests that vaccines significantly reduce asymptomatic infection and spread.”

They additionally caution that “The president has broad power to require vaccination for entry to airports and federal buildings and land, just as President Biden did for masks. However, a federal DHP system would likely require congressional action, and clear necessity to prevent the interstate spread of infectious diseases. Congress could also allocate funding for state DHPs, even conditioning further COVID-19 relief spending on state adoption of DHPs.”

Things are more legally secure in the private sector, as the authors note that “The Equal Employment Opportunity Commission (EEOC) issued guidance on SARS-CoV-2 vaccinations, which applies to any vaccine ‘approved or authorized by the Food and Drug Administration,’ suggesting that employers could require vaccinations even under an Emergency Use Authorization. The EEOC,” they note, “allows employers to require SARS-CoV-2 vaccination to return to the workplace, thus ensuring employees do “not pose a direct threat to health or safety.”5 Employers also can use DHPs for proof of vaccination. Businesses can require employees to “provide proof they have received a COVID-19 vaccination.” Requiring proof of vaccination, moreover, does not violate the Americans With Disabilities Act or the Genetic Information Nondiscrimination Act. However, employers should caution employees ‘not to provide any medical information as part of the proof.’”

Looking at the ethical dimension of this issue, the authors write that, “As long as there is supply scarcity, DHPs would unfairly exclude individuals who cannot access vaccines. Yet once everyone can gain access to vaccines, there is a strong ethical justification for DHPs designed to create safer environments to work, shop, recreate, and travel, as they represent a less restrictive alternative to current public health measures.6 Unvaccinated individuals have no right to impose risks on others, thus impeding a return to normal activities. Digital health passes therefore must be fully and equally available to all members of society, including the most disadvantaged people. Individuals who cannot be vaccinated for medical reasons also should not be excluded from DHP privileges. Consideration should also be given to granting exemptions for genuine religious or conscientious objections.”