Passport in suitcase.

Ethical, Legal, and Scientific Challenges for COVID-19 Vaccine Passports

By Chloe Reichel

As COVID-19 vaccines become more widespread, passports that certify immunization status may facilitate a return to normalcy, write Lawrence O. Gostin, I. Glenn Cohen, and Jana Shaw in a viewpoint published today in JAMA.

But these vaccine passports, or digital health passes, are not without scientific, legal, and ethical challenges.

I asked Gostin, Faculty Director of the O’Neill Institute for National and Global Health Law at Georgetown University Law Center, Cohen, Faculty Director of the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School, and Shaw, a professor of pediatrics at Upstate Medical University, about the key areas of concern and promise for vaccine passports. Our conversation, which has been edited and condensed, follows.

Chloe Reichel: What is a digital health pass?

I. Glenn Cohen: A digital health pass, sometimes referred to as a vaccine passport, is essentially a way of digitally recording that someone has had a vaccination, and then details about the date of vaccination, and potentially the kind of vaccine they were given, to the extent relevant. It might be something created by a governmental authority, or might be something created in the private sector.

CR: How can these digital health passes help us get to a new normal?

Jana Shaw: Vaccine passports, or digital health passes, let others know that you are safe and that you are keeping others safe by getting vaccinated. Places that require digital health passes are making sure everyone there is safe.

Lawrence O. Gostin: Essentially, the goal is to try to return to as normal as possible, as safely as we can, and as soon as we can.

And so the idea of a digital health pass is to make sure that everyone in a given space is protected, and also has a diminished potential for spreading the infection to others.

CR: Can you describe some of the scientific challenges associated with implementing digital health passes?

JS: There are numerous challenges to creating digital health passes.

Length of protection is one of them. However, that can be easily addressed by including the date of vaccination. As we get more information on length of protection from vaccination, vaccine passports can be then used accordingly.

Another limitation is that the efficacy of various COVID-19 vaccines differs. However, we recognize that the efficacy differs against developing symptomatic disease, and all authorized vaccines are very effective against serious illness.

In addition, as we monitor the emergence of variants of concern, there have been reports of decreased vaccine efficacy among certain vaccines. However, that currently is being addressed by vaccine manufacturers. They are developing vaccines that target the emergent variants to ensure that their vaccines will continue to be effective as variants evade vaccine-induced immunity.

We could not really talk about challenges and not talk about access to vaccination. Universal access to vaccines has to be ensured before digital health passes are rolled out, to mitigate the risk of transmission and the risk of creating an equity divide for those who are not vaccinated.

CR: Is that at odds, though, with the fact that some countries and states are already starting to roll out these digital health passes?

IGC: An important point we make is that we don’t want to leave people behind.

And it’s really important that any move to adopt digital health passes, especially as a condition of interstate or international travel, follow meeting our commitments to provide vaccines and support the places where there’s not enough vaccination.

Otherwise, we’re just creating inequities in the name of public health. So, I do think that there is a tension between rolling these out before you get to that place. And our hope is that we can push the idea that they should be going hand in hand, as part of what an ethical framework would look like.

CR: How would you respond to individual concerns about digital health passes?

IGC: The launch of a brand new vaccine, a new vaccine platform, for a virus that itself people are fearful of and don’t understand — I completely understand why some people may have trepidation.

That doesn’t change, unfortunately, the reality of infection rates and the idea that in public health law, sometimes we’re called upon if we want the privileges of being able to interact with other people, and enjoy schools and movie theaters, and the like.

And even if you are someone with libertarian leanings, and you believe in maximal freedom, it’s really important to realize that the alternative to these kinds of systems are essentially more robust restrictions on people’s behavior. If we can’t identify who’s still at risk of transmission or infection and who’s not, then you’re forced to kind of homogenously apply the same rules to everyone.

With digital health passes, we’re really trying to restrict people as little as possible.

CR: What legal challenges might digital health passes encounter?

LOG: Essentially, digital health passes can be implemented by any of three different kinds of actors, but it’s not mutually exclusive.

One is from the federal government. The other is through states or localities. And then a third is through the private sector. Each raise different kinds of legal questions, and sometimes different ethical questions.

The federal government has limited public health powers, and must show that its actions are necessary to prevent the interstate or international spread of a dangerous infectious disease. The president probably would need Congress to effectively and lawfully implement a digital health pass. And Congress would have to demonstrate clearly that such passes were necessary to prevent interstate spread of SARS COV-2. The White House has already said it has no plans for a vaccine mandate. The CDC, however, could provide technical assistance and funding to states or the private sector to support digital health passes.

Primary public health powers reside in the states. States do have the power to issue digital health passes, and perhaps some might. In our article, we describe the pilot in New York State to develop the Excelsior Pass system. But states are unlikely to implement such passes in any wide-scale or systematic way. States, however, could form partnerships with the private sector to support digital health passes.

And then there’s the private sector, such as employers, airlines, and operators of movie theaters or large sporting events. Some large businesses have already said they plan to implement some kind of requirement to have vaccines as a condition of returning to the workplace. Businesses have a strong economic interest in creating a safe environment for their employees and customers. The private sector, moreover, has few legal obstacles to requiring proof of vaccination for employees, and possibly customers, just as many currently require face coverings.

IGC: There are really, I think, two separate questions. One is, who should build these passes and administer the system? And then, who may use them as a condition of denying access to something?

And I think most of the legal questions that are interesting are actually in that latter bucket, in terms of who may use it and how they may use it.

There is important law here, in particular, anti-discrimination law.

While the Equal Employment Opportunity Commission is taking the position that employers may require proof of vaccination, if lack thereof would pose a direct threat to the self, or to other employees, it has also said you have to be careful in a couple of ways.

One way you have to be careful is if you have an employee who has a medical contraindication to a vaccine such that it is a disability, you’re required to offer some accommodations.

They’ve also said if someone has a bona fide religious objection, you may be required to offer some kind of accommodation to that individual.

And then, importantly, in soliciting information about whether they’ve been vaccinated or not, you have to be careful not to try to get at other medical information.

But there are going to be lots of interesting questions about how far you have to go in accommodation, and what it looks like.

It will be interesting to see whether individual states try to get in the way of the private decisions of employers. So, if states try to prohibit an employer in that state from requiring vaccination; whether that happens, and how that will be handled. We haven’t seen that quite yet. But it’s possible, especially in the political conversation of vaccination policy, that we might see that in the future. [After this interview was conducted, the governor of Florida indicated his intention to try to prevent private businesses from requiring vaccination.]

CR: And what are your expectations in terms implementation and acceptance of digital health passes in the U.S., specifically?

IGC: I guess I’m cautiously optimistic, in that I think that necessity will push us in this direction.

If anything, my fear is that too many people excited about it in an uncoordinated way, such that we get fragmentation, overlap, duplication, and the like. I would have been more excited to see that the Biden administration had said, this is a great idea. We’re not going to impose it, but we’re going to organize the platform. It doesn’t particularly look, today, like there’s that kind of enthusiasm. But it may be that as we keep talking about this, and as we see what other countries do, that changes.

LOG: I think, most likely, this is going to be a private sector initiative.

These things aren’t easy to do, because we’ve got, as Jana has said, so many different vaccines, some with one dose, some with two doses, we don’t know the durability of the immunity and the extent to which vaccines prevent SARS-CoV-2 transmissions. It will be vital to ensure that we can authenticate vaccine status and prevent abuse or forgeries.

We’ve seen this story before in the COVID pandemic, where the federal government has left the COVID-19 response to states and businesses. Unless the federal government provides funding, guidance, and technical assistance, you get an uncoordinated and chaotic rollout.

So, it would be nice to see some CDC guidance, particularly on data systems and authentication, so that we can have some consistency, as well as CDC guidance on the critical science issues.

JS: I would like to add here that the digital health passes also address the current problem, which is, we have not yet reached herd immunity. In order to stop the pandemic, we need at least 80% of people to be immune to SARS-CoV-2 — we need high levels of vaccination coverage so our lives can return to normal.

Currently, a small proportion of the U.S. population is fully vaccinated, a large proportion is hesitant or refusing vaccines, and children under 16 years of age are not eligible to be vaccinated. In addition, people who are hesitant about vaccination are socially and geographically clustered, which increases the risk of an outbreak.

But even if all adults who are eligible got vaccinated, we would not reach herd immunity in near future. Digital health passes will allow vaccinated individuals to return to their pre-COVID lives, and do so safely. This also should create an incentive for people to get vaccinated.

Chloe Reichel

Chloe Reichel is the Petrie-Flom Center’s Communications Manager. She serves as Editor-in-Chief of the Bill of Health blog and leads the Center's broader communications efforts.

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