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New viral strains continue to spread across the country, which has added to the urgency of getting as many people vaccinated as possible. With supplies of the two vaccines currently available in the U.S. falling well short of demand, mandating vaccination is likely not a realistic scenario now. But it could be in the coming months.
Is it legal for states, private employers, and even airlines, to mandate a vaccine that has only been approved for emergency use? Who could be held responsible if something goes wrong after getting the shot?
Carmel Shachar, MD, executive director of The Petrie-Flom Center for Health Law Policy at Harvard Law School, joins us to explore those legal questions, and more.
The following is a transcript of her interview with “Track the Vax” host Marshall:
Marshall: Carmel, thanks for joining us. One of the big questions and I think is on everyone’s minds right now that we’re seeing these vaccines roll out: Will I be required to take one? What does the law say when it comes to this issue?
Shachar: We can deconstruct this into several buckets. A vaccine mandate that requires that every man, woman, and child in America get a certain vaccine would be relatively unprecedented. Usually, when we think of vaccine mandates we limit them to if you want to send your child to school; or if you want to work for a certain type of employer, like a hospital.
It’s unlikely that we would see a completely broad mandate. That being said, the limited case law that we have, which largely goes back to this one case from 1905, Jacobson v. Massachusetts, does say that states and municipalities have very broad powers to compel vaccination for the benefit of public health.
Marshall: I mean, we are in a completely different world today than when those case laws were created and especially given a pandemic.
Shachar: Jacobson would be supportive of having a very broad mandate requiring everybody to get the COVID vaccine. But I think you’re right. In 1905 the world looked very, very different, right? People were just getting used to the idea of cars, let alone no internet.
But I also want to bring up, 1905 was before a lot of modern, constitutional law came to be. So Jacobson is still good law, but it doesn’t use a lot of the balancing tests and concepts that we think about today.
When we think about the rights of the individual versus what the government can make you do; it’s possible that there would be a challenge to a vaccine mandate that would go all the way up to the Supreme court, who would say: “Yes, states have a really broad reason to require vaccination, but they need to do so in ways that are potentially the least restrictive means possible, for example.” And they can’t just say, okay, everybody has to get this vaccine.
Marshall: Well, what about with an emergency use authorization. When it comes to these vaccines they haven’t received full authorization. Is it legal to require something that hasn’t been fully authorized?
Shachar: That is a really great question that my colleagues and I like to debate. Emergency use authorizations are not meant to take the place of full, proper authorizations. It’s much more narrow. So requiring people to get a vaccine that has only been approved through an emergency use authorization is a little bit unprecedented.
There’s really good public health arguments. The data suggests that these vaccines are very safe. The public health data certainly suggests that COVID-19 is a huge health risk and that people should be vaccinating to protect themselves. But will it stand up to a challenge of somebody saying: “Hey, if you want to compel me to take something; you have to make sure that it is actually safe and actually effective through the proper channels.” That’s going to be an interesting question that will play out in the next year or so.
Marshall: Will we see vaccine mandates for an emergency use authorization or is that something that even those states and municipalities might say: “No, let’s wait until that does have that full authorization.”
Shachar: I think states will go forward, whether or not it’s under an emergency use authorization or under the full license that it will get. I think, frankly, it’s a race against time. On one hand, Pfizer and Moderna can only apply for the fuller license once they have a certain amount of data and it just takes a while to collect that data.
So it’s going to take them a while to fully assemble everything to go for the full package.
On the other hand, vaccine mandates are really useful when we have more vaccines than people willing to take them. They’re less useful in the situation that’s happening right now in the United States, which is that we have more people who want to take the vaccine than we have vaccine doses. So, I don’t think we’ll start to see mandates in place until we start to hit that tipping point where we have enough vaccines for everybody to take and we’re starting to really hit that wall if people who are vaccine hesitant or are anti-vaccine.
Marshall: That’s an interesting point. So when it comes to going back to normal and going back to work, employers requiring vaccination. That wouldn’t even really be plausible until we hit that tipping point of there being enough vaccines?
Shachar: I think it raises real equity issues. If my employer says, “Okay, you can only keep your job if you get vaccinated against COVID.” I, as somebody who would be delighted to get the vaccine, would be like: “Sure, great, sign me up.”
But right now I have no way to get that vaccine. And the same would be true if the state said: “Okay, we are going to put people in jail or levy severe fines against them if they don’t get the vaccine.” The state needs to make sure that there’s a way for people to comply with the mandate before they create the mandate.
Marshall: Let’s jump forward in time and pretend that there’s plenty of vaccine to go around. We’ve reached that tipping point where if you want it, you can get it. So what does a world with vaccine mandates look like in that point in time? Can an employer say you are not allowed to come back into this office until you get a vaccine?
Shachar: Employers likely can as long as they’re not applying it in a discriminatory fashion. So, if they say everybody who has this type of job, let’s say grocery store, checkout clerk, the grocery store says, “Okay, we want everybody working at our store to be vaccinated.”
As long as employers are thinking about how do I apply this fairly across similar categories of employees and how do I create reasonable accommodations for those who have a legitimate medical reason as to why they can’t get the vaccine, that employer would be able to require people to be vaccinated.
Marshall: What about a situation when an employer says, “Okay, we’re not going to require everyone here to get the vaccine. It’s your personal choice.” But I personally feel at risk and haven’t had an opportunity to get it yet. Can they force me to come into work if a coworker refuses the vaccine?
Shachar: You’re asking, can they bring you into a situation in which you might risk COVID exposure. I would say that’s not different than what some employers are requiring right now. A lot of employers have moved to work from home. But there are some employers who say no, for whatever reason, we don’t think working from home works for us. So you’re going to have to come in even though that puts you at risk of COVID.
In this case, it’s not much different. It’s just more frustrating because you’re like, look, employer, just wait a little bit longer and I’ll be vaccinated and eliminate the risk.
Marshall: So, would all of this apply to schools? Specifically, let’s talk about universities first, before we go to lower grade levels, since that’s an approved age group at this point in time.
Shachar: I think universities likely will require that students who come to campus are vaccinated against COVID. You’ll probably see some big university drives the way that now they do flu vaccinations on campus. A lot of schools have a history of requiring certain immunizations if you want to come to campus. And it’s a good idea because, frankly, dorms are very crowded. It’s communal living. It’s a great way to spread viruses.
Marshall: What would it look like for elementary and middle school students?
Shachar: As soon as these vaccines are approved for the younger age groups, they’re going to be added to the list of vaccines that you need in order to attend school. With school vaccinations, the trends kind of function like a pendulum. So things get stricter with fewer and fewer exceptions saying it needs to be only a documented medical reason that you can’t get the vaccine.
And then parents push back on it and states or school systems will relax the requirements to say, okay, if you have a religious exemption, if you have a philosophical exemption. And then, as we saw in the last several years, oftentimes if you have too many exemptions, the herd immunity effect actually goes away, the way that it did with some measles outbreaks on the West Coast and then states tightened up their requirements again.
I think that as long as the pandemic is going to be a recent memory, you’ll see states be really strict with requiring the COVID-19 vaccine.
Marshall: So we’ve seen exemptions previously, like you said, for things like measles and the flu. Even the Equal Employment Opportunity Commission had a settlement with a hospital employee who refused to get the flu shot based on a religious exemption.
Shachar: I think that it will probably vary by state and their approach to balancing public health with the rights and interests of the individual. I think certain states are going to put a very high premium on public health and say a religious exemption, just a religious objection, is just not sufficient.
I think other states that maybe have more of a tradition of emphasizing individual personal religious objections may have those exceptions baked into it. So I don’t think it will be consistent across the country.
Marshall: It sounds, Carmel, like a lot of these exemptions for vaccinations and the mandates that we’ll likely see come down the road aren’t going to give individuals a whole lot of wiggle room or those individualistic liberties that many Americans pride themselves culturally on. How is that going to play out in the courts?
Shachar: I think that we will see a lot of pushback from individuals, from religious organizations, from patient advocacy groups. Because, as you said, America puts a really high premium on the rights of the individual and we don’t want to infringe upon those rights unless there’s a really good reason. At the same time, what is a better reason than ending the COVID-19 pandemic, both in terms of saving lives, but also in terms of saving our economy, saving the way of life?
So I think that courts are going to give states a lot of leeway and a lot of understanding to say okay, in order to end the pandemic, which is absolutely a legitimate state interest, there’s going to have to be these really broad vaccine requirements with very small narrowly tailored exceptions. And I think by and large, the states are going to win these cases over the objections of people who would prefer not to be vaccinated.
Marshall: What about travel? Would you be able to be kicked off a flight if you don’t have a vaccine certificate or would you still have the right to get on that plane? As individual companies, would they have the right to mandate what vaccines you have to travel with them?
Shachar: So that’s a great question. And it’s fun to think about also, because getting on a plane now for travel feels like complete sci-fi for most of us.
Marshall: It’s been awhile.
Shachar: It has been awhile. I think, first of all, with international travel, a lot of countries are going to require that you demonstrate that you’ve been vaccinated in order to enter the countries. And this is not new. There have always been medical checks, immunization requirements for certain types of travel. So international carriers are going to be very sensitive to those requirements. I think that you will see a lot of airplanes and also, you know, concert halls, or restaurants that will want to require some sort of certificate of vaccination because what they don’t want is to have an outbreak in their plane, in the concert hall, in the sports arena. And then be held liable because they should have been checking.
It’s going to be an interesting question, how we prove that. Right now, people who get vaccinated, get that little CDC card that reminds them when to get the next vaccination. That’s not really a certificate or anything that could be used as proof because frankly, a twelve-year-old with Photoshop could probably create it in the space of under an hour.
I have heard of tech solutions. Where people are building apps that it would take some verification and then you’d be able to use that app and get it scanned and that the airline or restaurant or concert venue or store could trust, okay, this person has actually been vaccinated. Whether it’s a good idea for the tech industry to step into this or whether this is something that the government should be providing because it would be a lot of personal information to provide to these apps, I think that’s going to be, also, an interesting question for the next year or so.
Marshall: You mentioned it’d be so easy to forge those certificates as they currently exist. So if we don’t have that high tech solution, if it is lower tech, even perhaps if it is high tech and somehow someone figures out how to forge it, who becomes liable? I mean, under criminal law, a person with HIV is criminally liable for prosecution if they intentionally transmitted the virus to their partner or somebody else without informing them of their status. So much with COVID is really honor system driven. We have problems with contact tracing. So how do you ensure accountability or oversight within that space?
Shachar: So I think some of this rests on what level of forgery are we talking about? I think anybody who has had contact with a 16-year-old who might be borrowing their big brother’s driver’s license to try to buy alcohol knows that there’s fakes and then there’s fakes. Right?
So if somebody is taking a Sharpie and trying to recreate that CDC card and then submits it to an airline to travel, and the airline accepts what’s an obvious forgery, then they could be potentially liable because you could argue they should have known. They were negligent for relying on what was obviously a fake document.
If we’re talking about something that is much more credible, like somebody fakes medical records and submits it to this app and the app uses those medical records to verify that they’ve been COVID vaccinated, even if they haven’t, then that airline relies on that fake attestation, they’re probably going to have a lot more defense to say we tried our best. We had reasonable protections, but this was a very, very good fake document. So I think it’s really going to depend on the level of forgery that we see.
Marshall: Could the rest of the passengers on the plane sue them for doing this intentionally if they got COVID?
Shachar: I think that we may see some litigation along those lines. I think the example of HIV criminalization that you brought up is a really good one. With HIV criminalization, there’s often specific statutes criminalizing the behavior of knowingly transmitting HIV or knowingly exposing people to HIV. We don’t yet have that for COVID.
But you could see a fact pattern where somebody knows that they’re COVID positive and goes to the lengths to fake documentation and then gets on that plane because they feel like, “I have to get to my cousin’s wedding.” So you could start to see civil suits. Strangers in public places don’t owe each other that much though.
So it would have to be a very high bar. You’d have to try to be aggressively infecting people and using yourself almost as a biological weapon before I think those cases would go anywhere.
Marshall: So how did you ensure accountability then or oversight? Is that a job for the government?
Shachar: I think that the government would be well suited to enforcing accountability and oversight. To say, here’s how we are going to verify that you are vaccinated. Here is what states can rely upon to let people on the subway, to let kids back in school, to say okay you are safe to go to concert halls.
Marshall: How does HIPAA play into all of this?
Shachar: So that is a really interesting question. So HIPAA is famously the United States data, privacy and security act. And HIPAA is really interesting because it is meant for your medical information. So HIPAA is going to prevent a doctor from calling the school and saying: “Hey, my patient Jane Smith tested positive for COVID and told me, ‘Oh, I don’t care. I’m still going to go into school.’ You need to stop her.” Her doctors are not going to do that. That’s going to violate patient confidentiality.
HIPAA doesn’t apply if there aren’t any medical providers involved. So in the case of apps that just rely on people self attesting that they’ve had the vaccine, HIPAA doesn’t necessarily come into play because it doesn’t necessarily involve a physician.
Marshall: I want to ask really quickly about vaccine makers and liability. There’s a lot of questions over whether or not they are shielded from liability. There’s case law that is precedent for this. So can you explain for us what that case law says and how it would relate to COVID, specifically? And the vaccine courts — COVID vaccine is not included in that list of cases that can be brought there. So where would we see things go when it comes to vaccine courts?
Shachar: So I think we’ll pretty rapidly see the COVID vaccine added to the list of vaccines that are governed by vaccine courts. Right now, the COVID-19 vaccines are not part of that system because they are approved under emergency use authorizations, which again are not part of that framework. In order to be in that framework too, it needs to be a routine vaccine that the CDC recommends for either children or pregnant women.
So it’s going to take a little bit for the law to catch up and say, this is now a standard vaccine and here are the injuries that we might expect to see out of it that move you into vaccine courts. I think we are going to see a lot of pharma protection from liability. In part, because that’s good public policy.
We really want to incentivize the creation and the very rapid creation of these vaccines to treat COVID-19. What we didn’t want was a chilling effect where Pfizer said: “Okay, I think I have a vaccine, but I need to test it for three more years to make sure that I’m not going to have just an outrageous amount of liability.”
Marshall: There’s just so much you’ve given us to think about. Looking forward, what’s your biggest legal concern regarding vaccine mandates?
Shachar: I think for now, it really is that push and pull between there are more people who want the vaccine than we have doses. But I do think that in the next year we are going to hit that tipping point where all the people who are really excited to get the vaccine have gotten the vaccine. And then we need to figure out: how do we reach this population of people who are reluctant or are actively against the vaccine? And I think mandates will be part of that arsenal. To say, okay, if you want to be employed, if you want their kids to go to school, you’ve got to get vaccinated.
But I think that they only tell one part of the story and it’s important to really understand people’s reluctance to get vaccinated. Is it because they don’t trust vaccines at all? Is it because they’re worried that this vaccine is so new that there might be issues? Is it because they come from a community that has been historically neglected or harmed by the medical community and they have a distress there? We’ve seen among healthcare workers, who we would expect to have really high rates of vaccine adoption, there’s even amongst them a significant number of people who have said no to the vaccine.
If we don’t have targeted education and outreach, along with the mandate, we’re not going to achieve our goals of getting vaccines in the arms of virtually every person in our community, because there’s going to be so much pushback that it’s going to undermine the whole vaccination campaign.
Marshall: Really incredible insights. I really appreciate your time. And joining us here at Track the Vax, Carmel.
Shachar: My pleasure and fingers crossed that everybody who wants the vaccine will get it very soon.
Marshall: It’ll be interesting to see how this plays out in the courts and across the country in the coming months and years.
Source: MedicalNewsToday.com
