New viral strains continue to spread across the country, adding urgency to the task of vaccinating as many people as possible. With only two vaccines currently available in the United States, a vaccine mandate is likely not a realistic move now, but it could be in the coming months. Is it legal for states, private employers, or even airlines to require a vaccine that has been approved only for emergency use? Who could be held responsible if something goes wrong after people get the shot? Carmel Shachar, MPH, and doctor of law and the executive director of the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School in Boston, joins us to explore those legal questions and more. Listen and subscribe on Apple, Stitcher, Spotify, or Google so you don’t miss the next episode. And if you like what you hear, a five-star rating goes a long way in helping us Track the Vax! Serena Marshall: One of the big questions on everyone’s minds now that we’re seeing these vaccines roll out is, “Will I be required to take one?” What does the law say when it comes to this issue? Carmel Shachar: We can deconstruct this into several buckets. A vaccine mandate that requires every man, woman, and child in America to 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. Serena Marshall: What about emergency use authorization? These vaccines haven’t received full authorization. Is it legal to require something that hasn’t been fully authorized? Carmel Shachar: 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 are 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. Serena Marshall: Will we see vaccine mandates for an emergency use authorization or is that something where even those states and municipalities might say, no, let’s wait until it does have full authorization? Carmel 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 of people who are vaccine hesitant or are anti-vaccine. Serena 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 then? Can an employer say you are not allowed to come back into the office until you get a vaccine? Carmel 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 to apply this fairly across similar categories of employees and how to create reasonable accommodations for those who have a legitimate medical reason why they can’t get the vaccine. Serena Marshall: Would all 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. Carmel 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. Serena Marshall: What would it look like for elementary and middle school students? Carmel 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 [for you to refuse] 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 [objection], if you have a philosophical [objection] [you can refuse].” 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. Serena 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 [objection]. Carmel 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 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. Serena Marshall: What about travel? Carmel Shachar: 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 country. 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 12-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 the airline or restaurant or concert venue or store could trust [that]. 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 an interesting question for the next year or so. Serena Marshall: Looking forward, what’s your biggest legal concern regarding vaccine mandates? Carmel Shachar: I think for now, it really is that push and pull, [because] 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 your 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 distrust there? 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.