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Vaccination Mandates Following the Supreme Court's OSHA and CMS Decisions

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Vaccination Mandates Following the Supreme Court's OSHA and CMS Decisions

In January 2022, the Supreme Court issued two highly-anticipated opinions about the Occupational Safety and Health Administration’s Emergency Temporary Standard on vaccination and testing (“OSHA ETS”) and the CMS Medicare and Medicaid Programs Omnibus COVID-19 Health Care Staff Vaccination Interim Final Rule (“CMS Vaccine Mandate”), related to the COVID-19 vaccination. In this program, we will speak with vaccine law expert Brian Dean Abramson to review the relevant precedent and procedural history surrounding these two cases. We will use these decisions as a starting point for a broader discussion about the legal history and future of vaccination mandates in the United States.

Presenters

Brian Dean Abramson
Vaccine Law Expert and Adjunct Professor of Vaccine Law
Florida International University College of Law

Transcript

Kara Wenzel - Hello and welcome. My name is Kara Wenzel and I'm a Program Attorney here at Quimbee. Today I am speaking with professor Brian Dean Abramson, who is a vaccine law expert. Welcome Brian.

Brian Dean Abramson - It is a pleasure to be here.

Kara Wenzel - Thank you for joining us. Professor Abramson teaches vaccine law as an adjunct professor of law at the Florida International University College of Law. He is a primary author of Vaccine Vaccination and Immunization Law. The most comprehensive treatise written with respect to the field of law, which was published by Bloomberg law and cooperation with the American Health Law Association back in November, 2018. And it's been regularly updated thereafter. A second print edition will be forthcoming in early 2022 later this year.

Brian Dean Abramson - In fact, my second print edition just came out a few weeks ago.

Kara Wenzel - Oh, wonderful, wonderful. We'll have to look out for it. Brian previously worked for Bloomberg Law for whom he authored the vaccine injury claims chapter of Matthew H Solomon's Court of Federal Claims Jurisdiction, Practice and Procedure. And for whom he wrote extensively in the fields of health and international privacy law. Brian was a law clerk for the Honorable Pauline Newman of the U S Court of Appeals for the Federal Circuit, where he took an exceptional interest in the court's vaccine injury docket. Prior to this, he interned with the Honorable Susan G. Braden of the U S Court of Federal Claims. He also practiced intellectual property law with the law firm Lott and Friedland in Coral Gables, Florida. Brian received an MA in Comparative Sociology from Florida International University followed by his JD, summa cum laude from Florida International University College of Law and an LLM in intellectual property law with highest honors from George Washington University Law School. So thank you again, Brian, for taking this time with us today, I know I'm excited to learn more about vaccine launch and specifically vaccine mandates.

Brian Dean Abramson - It is absolutely a pleasure to be here and we are in a remarkable time. There has been more development in the law governing vaccine mandates just in the past few months than there has been in decades before.

Kara Wenzel - Exactly, yeah that's why we wanted to invite you to speak about this. There's been a lot of talk in the news about whether the Federal Government can or can't require citizens certain circumstances to receive a vaccine for some reason or not. And of course, back in January, 2022, the Supreme Court spoke on this in two separate cases. So to get started, if you wouldn't mind, I'd love you to provide some background on that first set of cases, which we'll refer to as the OSHA case. Can you tell us how that came about in a little bit of the procedural history?

Brian Dean Abramson - Yes, to give the full background. Of course, all of this happens in the context of the COVID 19 pandemic. A vaccine was developed in record time. And when it was initially made available to the public, we had long lines of people waiting to receive the vaccine, but there was a point at which that dwindled and in fact dropped off very sharply when all the people who really wanted to be vaccinated were, we still had a large unvaccinated population. And the government was very concerned that we get to health immunity, get to the point where enough of the population was vaccinated to prevent the spread of the disease, which is what would stem the pandemic. So we started seeing mandates.

The first mandates came from private businesses and then from state governments, but the numbers were still not what the experts wanted to see in order to get us out of the pandemic. So the Federal Government stepped in. And really, if you look at the timing of it, the federal government waited until at least one of these vaccines went from being an emergency use authorization to being a fully licensed vaccine to step in and say, we're going to have federal vaccination mandates. Now, historically this is a very novel thing. The only areas where you have had federal vaccination mandates have been on areas that are specifically under the authority of the federal government, for example, for military personnel or for immigrants coming into the country. But here the government tried to do something much broader. So they took a couple of steps. One of which was to say that the Occupational Safety and Health Administration would require for workplace safety, that all workplaces over a certain size, over a hundred people have a vaccinated workforce with the alternative that unvaccinated personnel could be tested for the disease on a weekly basis, which would be fairly so obviously be much easier for everyone to be vaccinated with the vaccines being free and so forth.

A second measure that the government took was to require that all recipients of Medicare and Medicaid funds also have their employees fully vaccinated in order to continue receiving those funds. So the difference between these two regimes is that the imposition on workers generally in large companies was through the Occupational Safety and Health Administration or OSHA, and is backed up by a fine literally if you don't conform with that requirement, you would be subject to a fine of about $1,400 per instance, with potentially much larger fines for willful misconduct or repeated misconduct. And immediately there were lawsuits that were filed by companies that said for various reasons, either were not able to comply with this as written, or we just don't believe that the federal government has the legal authority. And there was something of a race to forum shop for the forum that was going to be most conducive to these arguments. So you saw filings made in Texas, in Louisiana and Georgia, Missouri, Florida states that had large numbers of judges that had been appointed by presidents of a certain political affiliation, which people thought would make them more likely to stay these mandates. And in fact, they were largely successful. So we ended up with some very interesting circumstances. With the OSHA mandate we very quickly got to several courts that were willing to stay the mandate nationwide and say, this is for various reasons beyond the power of OSHA, statutorily, some courts question the constitutionality of it. OSHA had acted under a particular emergency temporary standard authority. And there were a lot of challenges to the question of whether these enactments had particularly conformed with specific requirements of those authorities. And ultimately we saw the OSHA mandate blocked in a number of courts. And then something very interesting happened.

The federal court system has something in place to prevent people from doing this kind of forum shopping, which is that the cases get consolidated in a circuit that is chosen by lottery, it's chosen at random. And in this case, the Sixth Circuit was chosen for the consolidation of cases. Now this was after the Fifth Circuit had upheld a nationwide stay of the OSHA mandate. This went over to the Sixth Circuit. The Sixth Circuit basically overturned the Fifth Circuit. And it was really interesting just in terms of the judges, because the Fifth Circuit, you had a three judge panel that found that it should be stayed. When you got to the Sixth Circuit, you had two out of three judges who thought the state should be overturn. So you had these two judges in this panel on the Sixth Circuit, ultimately making this decision for the country and, it's also really a matter of chance because there are a dozen or so judges on that circuit. And three of them got picked at random for this panel on this court that got picked at random, that decided that it was in fact within OSHA's power to mandate vaccines for employers to require their employees across the country. And then this was appealed to the Supreme Court.

At the same time, a much different, and in some ways more unusual proceeding happened within some other circuits with respect to the CMS mandates. CMS, Centers for Medicaid Medicare Services is the entity that oversees the requirements that Medicare and Medicaid recipients have to meet in order to receive those funds. And they have a lot of very detailed specifications for example, how often hospital bed pens have to be empty and how far apart hospital beds need to be and how often patients need to be seen and so forth. So there has for a very long time been a rigorous set of requirements imposed by CMS on the receipt of those funds. And this was kind of one more addition to those requirements and not even a terribly novel one, because CMS has for a very long time required hospitals to have infection control measures, which have included vaccinations for things like influenza. Although not mandated generally, certainly very heavily promoted. The CMS mandate was again, challenged in a number of courts around the country. Some courts found it permissible, some courts did not. And we ended up with a situation where about half the country, the states had enjoined or had for them and joined the CMS mandate. And in half the country requests to enjoin the CMS mandate were denied. So we had literally half the country where the courts had found that this CMS mandate was statutorily or constitutionally improper, and the other half where they found that it was proper. And of course that's an untenable circumstance. You can't have something where the federal statute is being improperly implied in half the country, but the other half of the country it is being properly implied. So that also was appealed to the Supreme Court.

Now, these were not cases that were heard by the Supreme Court in arguments in chief. That's a process that is still technically ongoing. These went to the Supreme Court specifically and solely for the question of should these be stayed pending further proceedings. And that was the question that the court was faced in its hearing in early January. And that it answered quite definitively in its decisions on January 13th. And those decisions went to very interesting directions. And that has set up kind of a future where vaccine law will be handled very differently by the federal government going forward.

Kara Wenzel - That's fascinating so if the OSHA case, for instance, had been heard in the Ninth Circuit or the First Circuit, I'm making this up, maybe it wouldn't have even gone to the Supreme Court. Is that what you're saying?

Brian Dean Abramson - Well, I think it was destined to go to the Supreme Court no matter what, because either outcome, determination by a circuit that it was permissible or a determination that was impermissible would have been appealed by the party that wanted to go in the other direction. But the fact that it went to the Supreme Court in the posture that it did makes for a very interesting story, at least. And yes, it could have gone differently in a different circuit, but the litigants who wanted to stop the mandates chose their circuits, they chose the courts that they wanted to file in, and they did a fairly effective job of that in that they were able to get stays in most of those courts very successfully.

Kara Wenzel - Okay. So this may be skipping ahead a little bit, but I think all of us are interested in vaccine mandates and precedent. So do you think the Supreme Court's decision in the OSHA and CMS cases, or out of step with precedent that we do have.

Brian Dean Abramson - There's actually very little in the way of precedent on question of whether the federal government can mandate vaccination for any part of the population that's not under its direct authority. For example, as I noted, it's well understood that the federal government can mandate vaccination for military personnel and for immigrants coming into the United States. And it's also well established that state governments can broadly mandate vaccination of their citizens in response to a public health emergency, which the Supreme Court addressed a century ago and its landmark cases of Jacobson V Massachusetts in 1905 and Zutch V. King in 1922. And of course the federal government can offer a state funding that is contingent on the state, having policies in place that encourage vaccination or that meet some targets with respective vaccination levels.

So it's difficult to say whether there is an assignment of precedent here. The precedents that apply are ones that enable states to impose vaccination mandates, whether the federal government can do this was new ground. So the Supreme Court was in a sense, in step with precedent in terms of saying, well, these are our commerce clause or spending clause issues, and its a question of what can the federal government do constitutionally, but it was a little bit outta step with this general idea that authorities at different levels can act to protect the population from the spread of contagious disease.

Kara Wenzel - Okay. So can you tell us a bit more about what surprised you about the outcomes of these cases?

Brian Dean Abramson - Huh, okay. So we had these two cases that came out of the Supreme Court on January 13th. One of them was NFIB versus OSHA, and the other was Biden versus Missouri. And the Biden versus Missouri was the CMS case because Missouri had enjoined half the country and the Biden administration was appealing that. I was more surprised with a composition of the majority opinions than with their actual outcomes. I felt fairly early on that the OSHA mandate, the way that it was written was going to have some struggles. There were issues that were brought up at the trial court level and the circuit court levels about the fact that they applied to all companies with over a hundred employees, irrespective of the stance of those companies of how those employees were configured, whether they were working from home or huddled together in a factory. It didn't apply to companies with only a few less employees than that threshold. Even if those employees were all physically close together, compared to a company that's slightly larger, but everyone's working remotely.

But in terms of the outcome I had thought that it was going to be a six three decision in the CMS case and it ended up being a five, four decision. I thought that it would be Justice Barrett rather than Justice Kavanaugh, who sided with the authority of the government to use CMS funds as a means to mandate vaccination. And I thought this largely based on Justice Barrett's own precedent and her questioning in the oral argument on that. But I wasn't surprised at the outcome. There were some details with him that I had expected the court to go a certain way. One thing I thought was that with the CMS mandate, the court might say that some of the entities that CMS was governing were under its authority for this purpose, or were able to have this mandate imposed on them. And others might not due to differences in the nuances of the way that the statutes are worded. But the court basically said every recipient of CMS dollars can be subject to CMS vaccination mandate. I also thought that the OSHA mandate might be allowed to go forward with respect to certain entities, but rather than doing that, the court basically spelled out the kinds of entities to which it might be allowed to go forward to employers who have employees in cramped and crowded working conditions to employers who have employees who are working directly with a virus and the mandate was struck down entirely, but that left this window for OSHA to kind of go in and craft something new that addresses those specific kinds of employers.

Kara Wenzel - And I think you touched on this, but some of the arguments that businesses brought up in the OSHA case, things like impracticability, or it was impractical to be able to monitor their employees or the conditions didn't warrant this type, because people either worked from their home or remotely. Were there other things that you thought or other arguments that were brought up in the case, or the cases that you thought were novel or unique?

Brian Dean Abramson - In the courts below a large amount of the argument and discussion both by litigants and the judges was over the sort of either with respect to OSHA, the fact that it was a temporary emergency standard or with CMS, it was similarly issued under emergency authority. And there was a lot of discussion about whether the specific parameters of those statutes were made to qualify as an emergency that would be subject to this kind of imposition. And that was something that it was not discussed as much in the Supreme Court. And it really wasn't addressed in the opinion at all. The opinions basically went ahead and presumed that these were appropriate exercises of emergency authority. And the question went to whether the entities, even under that emergency authority had the ability to impose these vaccination mandates.

So it was a little bit surprising to me that the courts did not address that, that the Supreme Court rather did not address that. But at the same time, the court is looking at a longer picture, of course, where you have a situation where a temporary emergency authority is applied, but that agency also has the power to engage in regular rule making that is not under the constraints of that emergency requirement. They could go ahead and pose these mandates under that regular rule making in a bit more time. So I think the court was looking to the question of even if we assume that this is going to be under regular rule making, how do we vote on whether this is something that is within the power of these agencies to do it all? So I think that's why they can kind of didn't address those nuances of it. And it would've been interesting to see what the court would've said about all those little details, but they will probably come up in future litigation if there are more temporary emergency standards that are imposed.

Kara Wenzel - Yeah, I'm curious. So now that we know, or the way that the Supreme Court made this decision in the OSHA case. It seems to provide some leeway for the agency to produce a more narrowly tailored rule or vaccination mandate. Do you think that OSHA is likely to take advantage of that and try again?

Brian Dean Abramson - Well, I have said before that the implementation of the OSHA mandate is the first step in a . And its a where we've seen dance before, there's a sort of very common interplay between agencies, executive branch agencies and the court sort of the agencies will promulgate something. An aspect of it will be challenged. The courts will rule on that and perhaps strike down the ability of the agency to do things the way they did. And then the agency will come back and say, well, here's a new rule that we have formulated that corresponds to the limitations that the court has set with respect to it. So OSHA has been given kind of a guideline by the Supreme Court. The Supreme Court in its opinions it doesn't put things in there by accident. So the court was very specific in saying that OSHA does have the power to regulate.

Now it didn't specify to mandate vaccination, but they did say to regulate and they left to kind of open what that means in cases where people are working directly with a virus or are in crowded and cramped conditions. And there are probably some other situations that can be extrapolated from that certainly medical personnel who are working with, or likely to be working with COVID infected patients or in circumstances where the disease is likely to spread. So it would be in keeping with OSHA's past practices for it to take another go and imposing a vaccination mandate, and to conform it specifically to those parameters. Another point of interest here is that the OSHA mandate did more than just require vaccination of employees. It also imposed reporting requirements for when an employer becomes aware of employees becoming sick with COVID or being hospitalized for it or dying from COVID that they were exposed to through their employment because the entire regulation was stayed. That aspect of it was as well, but the Supreme Court didn't really directly address that. It also didn't address other measures that employers have to take, like having a written vaccination policy. So those are things that I think OSHA could come back and say, well, we're still going to have this requirement, and we're still going to impose this on all large employers or all employers. And that would probably be an aspect of any future action that OSHA takes with respect to this, to impose something like that.

Kara Wenzel - So you kind of touched on this but short of rule making in the wake of these two cases. What else do you think federal agencies or the government at large could do to mandate vaccination?

Brian Dean Abramson - Well, there are a couple of things. First of all, the CMS decision did say that that agency could mandate vaccination for CMS fund recipients for Medicare Medicaid recipients. So that is a fairly substantial outcome because it is the first instance where the Supreme Court has held that a federal agency can mandate vaccination and can basically premise the receipt of federal funds that have previously been designated towards certain recipients on having that vaccination policy. And there are other agencies that are doing things like that. There are other outlets that are doing things like that. One very comparable circumstances, a federal contractor mandate the federal government has imposed, or the Biden administration imposed by executive order. A requirement that all federal contractors working for the government be vaccinated for COVID 19. It was a fairly aggressive mandate. It covered people who were working entirely from home. It covered support staff, HR personnel in companies that have federal employees or federal contractors.

So that is one that has also been stayed by the courts. And it was stayed by the courts before we got to the OSHA and CMS decisions. That is a route by which if CMS is to be taken as a guide, we may see a determination that the CMS decision by the Supreme Court supports a determination that in fact, federal contractors can be mandated to be vaccinated. There are certain other, somewhat smaller impositions that have been put in place headstart teachers who are recipients of headstart funds, for example, have been subject to a vaccination mandate. There are challenges to the military vaccination mandate. Another thing that the federal government can do is it can use its authority to regulate interstate travel and particularly air travel and impose some kind of requirement that people who are traveling on airplanes have to be vaccinated. And also importantly, what the Supreme Court decided in both the OSHA and the CMS cases was that the statutes had to be interpreted in a certain way relative to what congressional intent was. Did Congress intend to give these agencies this broad of a power with respect to OSHA, the court found that they did not, with respect to CMS, the court found that they did.

But that leaves it open for Congress to enact new legislation that specifically gives OSHA that authority or specifically gives some other agency that authority. The court has not said that it's unconstitutional, that it's beyond the authority of the United States Congress to pass a law that would enable a vaccination mandate imposed on the general population. And that is something that was questioned in some of the circuit court decisions. There was at least one judge who in a concurring opinion had said that they didn't believe that the federal government had any authority, even if Congress attempted to pass law to do so. But the fact that the CMS mandate has been allowed to go forward makes it clear that Congress does have the authority to enact some kinds of laws or schemes. And they're likely going to be more successful if they're done with respect to the taxing and spending power than with interstate commerce, but they do have the authority to take measures that mandate vaccination for certain populations.

Kara Wenzel - So can you tell us about exemptions to vaccination mandates? I know that people have medical reasons for not wanting or being able to receive a vaccine but what do those look like if someone is not eligible for medical reasons or some other reason to get a vaccine that's would otherwise be mandated?

Brian Dean Abramson - Well, historically, for as long as there have been vaccination mandates, there have been some kinds of exemptions. Now, the very first case that was decided by the Supreme Court Jacobson V Massachusetts was a case where there were not exemptions for adults who were required to receive the smallpox vaccination. There was an exemption for children, and that was a medical exemption. But as more vaccines were developed over the course of the 20th century, there were communities that agitated specifically for states to enact religious exemptions. And it's important to understand that historically vaccination mandates have almost entirely come from state governments and in some cases, municipal governments, very often, they have been initiated in response to a specific threat, a plague and outbreak. But typically mandates have had exemptions for people who are medically unable to receive a vaccine or have been deemed to be in a condition where receiving the vaccine would be more dangerous to them than the disease itself.

Around the middle of the century, we started seeing a movement to have religious exemptions added to a lot of these statutes. And proponents of that position were very successful. Virtually every state in the country has at some point enacted fairly broad religious exemptions, but both medical and religious exemptions being a state by state matter operate very differently from one state to the next. Typically a medical exemption will require a medical examination and the opinion of a medical professional, usually a doctor in some states a nurse or an RN or a medical assistant or something like that, or a pharmacist even. That receiving the vaccine would be medically and advisable for the person the standards differ. In some cases, it requires contraindications. In other cases, it just requires that there's any family history of a bad reaction of the vaccine and religious exemptions are in fact, even more diverse in how they operate. In some states, all that a person needs to do is basically put on a piece of paper, I have a religious objection to vaccination and sign their name, and they will be presumed to be telling the truth about that and be entitled to that exemption. In other states, a more searching review is required where questions may be asked of the person to describe the basis of their religious exemption or their religious doctrine that requires them to be exempt. And then there are about a half dozen states that do not have religious exemptions. There's one state, West Virginia that never imposed or allowed a religious exemption in the first place. There are other states where the way that it was worded, got it struck down the courts or where it was revoked by the legislature. In one case the State of Maine, it was actually removed by a popular vote in a referendum. So there's a very great diversity there. But as the courts pointed out in examining the OSHA and CMS mandates.

The federal government did provide for religious and medical exemptions to both of these regimes that were imposed. And they used the, they referred to the language of the EEOC the Equal Employment Opportunity Commission, which goes by first of all, the Americans with Disabilities Act. And under the Americans with Disabilities Act, the ADA, it is considered a disability if you have an inability to be vaccinated for a medical reason, you can't be discriminated against on that basis. So someone who can demonstrate that they have that physical inability falls under the protections of the ADA, and then under Title VII of the Civil Rights Act of 1964 people's religious beliefs are protected. So if you can demonstrate pursuant to that regime, that you have a valid religious objection to vaccination, then you can be exempt from vaccination on religious grounds. And that in fact was something that proponents of the OSHA and CMS mandates brought up before the various courts, that there were ways for people who had either medical or religious objections to get out of these vaccinations. Although, in both cases you have to make some kind of showing.

There certainly are people who seek an exemption and have that exemption denied. The Supreme court didn't really address that. So it is something that is actually likely to be a point of contention going forward. The question of whether there are people who specifically assert that they have a religious objection to vaccination, where this is denied, and they feel like the denying employer or government authority has overstepped its bounds in making that determination. And we do have a very broad set of precedents that have examined these exemptions in the past, or these accommodations, as they're framed with respect to employers who are required to do this for employees. And the court did not, was not really called on to address that in the OSHA and CMS cases and did not address that. But it's something that is going to be an interesting issue that percolates going forward.

Kara Wenzel - Thank you, yeah, that's fascinating. I had no idea that different states or municipalities even might have different views of how to apply those exemptions.

Brian Dean Abramson - Oh yes, I always say the states are all over the map. It's my best joke on it.

Kara Wenzel - So on that note, in a more global sense exemptions aside, or even in addition, do you think that these two COVID vaccine cases impact what individual states can or will do with respect to the vaccination mandates?

Brian Dean Abramson - These cases were very much restricted to what the federal government has the power to do. And they gave recognition to the fact that the states do have the authority to impose vaccination mandates. So the cases aren't going to impact what the states can do, although they may impact what the states choose to do. We have seen in the course of this pandemic, a number of states that have actually taken an historically a very unusual position of prohibiting vaccine mandates, and saying that employers or state agencies within those states are not permitted to mandate vaccination. And that has been in response to a really politicized response to the outcome to the pandemic itself. It's something that we've never really seen before.

Historically there has been strong support among all political views that vaccination should be mandated. It should be mandated for children with respect to the childhood diseases. It should be mandated or was mandated for the smallpox when that was a disease that was endemic in the population. So we have this very big change in the way that vaccination is being approached. And it's really a matter of the organization of anti-vaccine rhetoric and politicians kind of being drawn into responding to that. And that is in fact, the reason why the federal government stepped into it all. But I think we are going to continue to see this being a very contentious issue at the state level now that it has developed this kind of new political dimension.

Kara Wenzel - So would you say that the emergency use status of the COVID 19 vaccines affected the way that these cases were considered or discussed?

Brian Dean Abramson - There were a number of cases in mid 2021 following the introduction of the vaccines under the emergency use authorization power in which plaintiffs asserted that because they had not been fully licensed because they had only been allowed under that authority. They could not be mandated and people cited things like the Nuremberg Code, which is an old code of scientific ethics developed in the wake of some rather horrific human experimentation that occurred in concentration camps in World War II, as well as some statutory regimes in the United States that control experimentation and how clinical trials are to be carried out. Notably the Nuremberg Code itself has actually been superseded by new codes of ethics, which are even more robust in protecting individual rights in the course of clinical trials and protecting people from forced experimentation. And the fact that the vaccines were the COVID 19 vaccines were developed very quickly and at historically of speed, and the fact that they were still in this status when mandates began to be implemented did provide a lot of fuel to concerns about the vaccines and to the sort of anti-vaccine movement that swept up the issue into the political process.

However, the courts that heard these challenges uniformly held that the vaccination mandates were permissible despite this EUA status. And they noted in particular that there were appropriate medical and religious exemptions in every case provided for these vaccine mandates. And that the consequence of refusing vaccination was merely that the individual would not be able to continue working for that particular employer or attending that particular school that had it imposed the mandate, which is inconvenience, but it's nothing compared with being experimented on against your will while being held in a prison camp with no option to avoid it. No one has been kind of physically restrained and forced to receive the vaccination against her will at this point. And it's also worth noting. I think the courts pointed out in some of these cases that the FDA in issuing its emergency youth authorization went far beyond the bounds of what the EUA statute itself requires and required a much more robust showing of the safety and efficacy of these vaccines then would be required for it to issue an emergency use authorization for another product.

Kara Wenzel - It seemed like one of the biggest arguments that some anti-vaccine parties brought up was that the vaccine was developed so much more quickly than any others. And I know you're not a scientist, but you have reviewed many, many, many vaccine rules cases and processes in practice in the past. What would you say about that? Do you think this vaccine, the process that was undertaken to reach emergency use status was too quick?

Brian Dean Abramson - Well, I will say this, there's a lot of misinformation and misunderstanding about the technology out there. We now have well over 200 years of experience with vaccines as part of medical treatment in the human population. And we have, I think about the last 50 or 60 years, I would say of really robust experience in developing vaccines for some fairly novel diseases. So the fact that we were able to take what information we had about this virus kind of off the shelf and use that to quickly turn something around, particularly where there were so much of an effort to do this as quickly as possible. It's not all that surprising to me. It's also important to note COVID 19 is a coronavirus it's in the family Coronaviridae . It's the same family that the SARS virus is in and some other viruses that we've experienced in our society. And when SARS occurred more than 15 years ago, we had a response where there were efforts to develop a vaccine. And those efforts were not abandoned entirely. They were kind of shelved, but we did develop some technologies at that time for dealing with a potential virus in the Coronaviridae family. And those were kind of very quickly pulled out. So there was extensive of work that had been done in that area. The other thing that is of concern to a lot of people that is very novel about this is the introduction of mRNA vaccines.

Now, historically, typically what a vaccine, what we would do in developing vaccine is isolate a sample of the virus and then actually breathe that virus to a point where it's no longer harmful to humans or use some kind of chemical or other technique to kill the virus or graft some part of that virus more recently onto a different virus that's not harmful. And any of these could be means by which we introduce it to the system so that our immune system is exposed to the molecular structure of that virus and develops a response that is key to that molecular structure. So our body physically produces some chemical that will stick to that virus and tell our white blood cells, which are the defenders in our immune system to go after and eat it wherever they find it. The mRNA vaccine does things differently. It actually more closely replicates exactly what the virus does. It forces the cells to create themselves some of those molecules that the body will then respond to. And this is the first time mRNA technology has been used in this way, but the technology has been under investigation for more than 20 years.

So again, we came into a situation where we had this virus that was novel to the human experience, but we had some, there were aspects of it, the fact that it is Coronaviridae, the fact that it does had this protein spike that connects to the lung tissues. That is what makes it so effective as a virus makes it so deadly. These were things that we were able to take and work with very effectively in using these technologies that had been around for a number of years and very quickly bringing them together to develop something that would be effective against this virus. So it was really just an application of theory that had been out there for a very long time. And this was the first opportunity to say, okay, we have these technologies, we can employ them now. And it's also worth noting that clinical trials normally have a few dozen people in the first stage, in a stage one clinical trial, and then a few hundred in the second and a few thousand in the third stage. And we observed those people for many years, but with the COVID trials in order to make up for the fact that they were moving very quickly, we had hundreds of people rather than dozens in the first phase, thousands of people in the second phase, tens of thousand, maybe 40 or 50,000 people in these phase three clinical trials.

So we had very large populations being tested and being observed. And that is one of the reasons why the FDA was able to have very quickly confidence that these COVID vaccines were generally safe and were clearly effective in reducing the risk of infection and the duration of infection and the risk of hospitalization and death. So there are certainly good reasons for FDA to do a very searching and thorough review, which they did. But they did conduct that review and they did it under the microscope and with all of the precautions that they take in authorizing any pharmaceutical product for introduction to the market. So people who understand the professionalism of the FDA can have confidence that they've done a good and thorough job in vetting these vaccines.

Kara Wenzel - That's great. I did not know that about the size of the trials and how much larger the populations were in this case, that's new. So shifting gears a little bit throughout the COVID 19 pandemic, we saw large numbers, record numbers, actually, falsification of vaccine cards and other methods of showing that you were vaccinated. So what can we expect related to this concern following these Supreme Court decisions?

Brian Dean Abramson - Historically, the falsification of vaccination records was almost unheard of. It's just a very rare thing. During the age of smallpox, the way that you prove that you were vaccinated is show that you had a vaccination mark. The process of vaccination that was used for smallpox it wasn't injection of something into the arm. It was actually the use of a little, two pronged fork, and they cut a little mark in your skin and they put the smallpox virus, a treated version of the smallpox virus there. And you would develop a scar from that, which you would have for the rest of your life. So there was no kind of falsification of that. Once childhood vaccination became widespread, really, there wasn't opposition to vaccination except in smallpox and there were religious and medical exemptions generally available which did accommodate those issues. So we have seen very little not a zero amount, but very little in the way of attempts to falsify childhood vaccination records. Of course, it's also difficult to do that because the record is generated by a medical professional.

 With COVID we've had a very different circumstance. First of all, because of the widespread implementation of requirements that people show proof of vaccination to enter restaurants and things like that. People who are trying to prove that generally show a card saying, here is my vaccination card. It shows when I was vaccinated. And if you can get a hold of a blank card and you know what the information on it's supposed to say, you can just sort of fill it in yourself and pretend that you've been vaccinated. So there are circumstances like that where it's very easy to fake vaccination. That's not going to work with employers who have to check it against some kind of a record or something like that.

So there have been people who have been caught attempting to fake their vaccination records and have been subject to criminal penalties, because it is forgery of a document containing a federal seal. There's actually a federal crime involved with that. We have also seen instances which are again novel. It's not something we've ever seen before where some medical professionals have been willing for fairly large sums of money to falsify vaccination records and say, well, I vaccinated this person and put that information in the system where that information is held. And that, again, it's a criminal activity. People who have been caught doing that have been subject to prison sentences, and it's not something that's really sustainable. You can't really get away with a scheme like that, where you're offering that for pay. You're going to be found out because it's something that everyone's watching for now. But this has been a radical change in the way vaccination mandates have been approached. And it's something that in particular employers and entities that are imposing vaccination mandates will have to address.

So employers who have a vaccination policy need to make it clear in their policy if it's determined that you're falsifying your proof of vaccination, that determination offense, that's the same as if you know, you're lying about some other credential. You're lying about having a college degree to get the job or lying about having worked a certain number of hours. You say, I worked 40 hours this week. I put that on my time card. When in fact you only work 10. Employers can't have employees who are being dishonest about things like that. So generally I would say to people who don't wanna be vaccinated. If you don't wanna be vaccinated, you don't have to be vaccinated. You might not be able to continue with your current employment. You might not be able to use certain venues that you'd like to use or attend a certain school, but be honest about it. Don't try and fake a vaccination record.

Kara Wenzel - Yes, yes. That makes sense. But how do you think the situation or, sorry, the fact that these cases have been decided. Some states are now banning vaccination mandates. Will this affect existing vaccine mandates for other things like flu measles, like those are wrong established, right?

Brian Dean Abramson - They are. And there has always been kind of a small, but vocal anti-vaccination movement that has opposed any kind of vaccination mandate. And generally that movement has been brief with misinformation about the safety and effectiveness of vaccines and has been very restricted to kind of an outlier fringe segment of the population. The opposition to COVID 19 vaccine mandates has given a lot of oxygen to those groups and has led to some efforts from members of state legislatures primarily, which is where the vaccine mandates generally emanate from the first place to reduce vaccination mandates in other areas.

For example, in the state of Iowa, there is legislation that has been proposed that is pending that with one very simple change of a word in the statute would remove the ability of schools to exclude students who are unvaccinated for particular disease during an outbreak of that disease. Right now the statute says that schools may exclude students who are unvaccinated. And they're trying to say, students may not exclude students who are, the schools may not exclude students who are unvaccinated during those circumstances. And that would be a fairly remarkable change to say that even if you have a measles outbreak in the school, we're going to allow students who are unvaccinated from measles to attend the school.

Legislation has been proposed in the state of Georgia by a fairly large block of members of the state Senate to eliminate all childhood vaccination mandate. So these are very much in contravention to the previous trend. The trend we had seen in the decades leading up to this has been one of states being more concerned with the effectiveness of vaccination mandates, having stricter and more aggressive vaccination mandates ratcheting down on circumstances where for example, physicians have given inappropriate medical exemptions or where people have made inappropriate claims for religious exemptions that has been the trend for many years. And now we're seeing a big push in the opposite direction where we have not only efforts like in Iowa, Georgia, which would very much reduce the effectiveness of vaccination mandates, but also efforts to expand exemptions, make it much easier for people to assert a medical exemption from vaccination or to assert a religious exemption from vaccination. And that's something that is going to have direct public health consequences in the future as those take hold.

Kara Wenzel - Of course, of course. So expanding from the state level a little bit, how would you say that the situation with vaccination mandates in the U S compares with what other countries are currently experiencing.

Brian Dean Abramson - As diverse as the states themselves are within the United States. The approaches taken by other countries are vastly more diverse. And there are countries that have under their own constitutional regimes under their governance. The authority to go much further than would be permitted under the United States law. So there are some countries that have very aggressively mandated vaccinations, such as Austria, which basically says everyone in the country who's over a certain age, has to receive the COVID 19 vaccine or face a fine. In Australia, receipt of government benefits such as welfare and Social Security has been conditioned on receipt of COVID-19 vaccines. In France, access to restaurants and theaters and things like that is conditioned on COVID 19 vaccination. Argentina actually has long had a very strict and aggressive and robust vaccination mandate program. In Argentina, unless you are fully vaccinated for all the childhood vaccine for example, you can't progress from one grade to another in school, you can't get a driver's license or a marriage license or a passport. So they have for a long time now been very aggressive with vaccination and they just basically added COVID 19 vaccination to the list of vaccines that are required for this purpose. On the other hand, you have some countries like Japan, China, and several Scandian countries that have not imposed any vaccination requirements. But have still achieved fairly high vaccination rates. And in some cases that is primarily due to cultural predilection towards vaccination.

In the case of China, it's probably very much that there's no mandate on the books, but everyone knows that they're expected to have to be vaccinated and they're conforming to what they believe the government expects of them. And then at the other end of this, that spectrum, again, you have countries, particularly third world countries where you have vaccination rates that are just in the single digits and that's due more to logistical issues than to legal or cultural concerns. But there are and have been for some time countries for example, in some parts of Eastern Europe, where there have been vaccination mandates for other vaccines on the books for a long time, but they're just not enforced. And because of that, when it comes to COVID 19 vaccination, even though they have access to the vaccines, they're not enforcing it very well.

 There's also a very interesting circumstance in Russia. You know, Russia and Ukraine are in the news right now. They're both hovering a little bit under a 50% vaccination rate. There has been a lot of propaganda that has come out of Russia that has anti-vaccine propaganda that has been put out on social media. And there's been at least one report that a lot of that has circled back to Russia. So there are a lot of Russian people who have received the misinformation that was initially put out from this country and have believed it and declined to be vaccinated because of that. So that's kind of an interesting circumstance of how that is developed, where the anti-vaccine has been put out for political circumstance, that has been put out for political purposes has had a kind of direct impact circling back to its origination.

Kara Wenzel - Yeah, it seems like a lot of cultural and just, I don't know, miscellaneous factors play to either what the mandates are or what they involve, whether people fall on them. That's fascinating. I'm curious, so switching gears just a little bit about the vaccine itself. In order to increase manufacturing speed and production numbers, there have been calls for patents for the COVID 19 vaccine to be just disregarded so that additional vaccine could be manufactured more quickly for other countries primarily. What's happening with that.

Brian Dean Abramson - Well, it's the Biden administration and some international agencies have taken the position that countries should be allowed to waive intellectual property rights, covering COVID 19 vaccines in order to manufacture sufficient doses to has in the end of the pandemic to get the vaccines distributed around the world. International intellectual property law is covered by a treaty called the trips agreement the treaty on rights and intellectual properties. And that does have a provision in it that allows for the waiver of certain intellectual property rights by countries, in response to an emergency situation.

It has not really been carried out and there hasn't been anything done with respect to that thus far with the COVID 19 vaccines. It's something that arguments have been made for and against. And the probably the strongest argument against it is that manufacturing of a vaccine is actually a very intricate process and even if you were to say, we're going to waive the patent rights and even require companies to turn over certain unpatented know-how, what is typically covered by trade secrets. That would not be enough to enable another typical pharmaceutical manufacturer to make this vaccine. And it would actually be more efficient to just say, well, whoever owns the patent, we're gonna give them additional resources to manufacture the vaccine themselves because they've gone to quite a length to figure out how to develop an effective vaccine in the first place. To me, one of the most interesting aspects of this is that there actually is one pending patent infringement lawsuit related to the COVID 19 vaccines.

But it isn't one that has been filed by one of the vaccine manufacturers. It's one filed by the inventor of a technology that party claims or that company claims was infringed by Moderna in the process of inventing its COVID vaccine. So it is interesting to me that if you're saying that vaccine patents should be waived as the administration, some agencies are, then you would think it would make sense to kind of give Moderna a break in this case and say, well, then you should also waive Moderna's infringement of this other technology that was needed in order to invent this remarkable COVID 19 vaccine that has proven so effective. So that is where things stand with that. And it's still an open question, whether we'll see any waiver of patent rights, but it seems unlikely at this point that that would be effective actually in speeding up any vaccine production, because it would take a good length of time from the point at which that waiver was established for any manufacturer to actually get up and running and have a vaccine that they were manufacturing that was effective and was doing the job.

Kara Wenzel - Okay, well, even all that said, it seems like we're still kind of in the brink of a lot of new and rapid development on this front. Sadly, we are almost out of time, but I wanted to give you an opportunity to tell people how they might connect with you if they want to follow your work, read your articles or your books, ask you a question, how can they find you?

Brian Dean Abramson - I am available at [email protected] Generally email me. I'm on Twitter once in a while @brian_abramson. And I have Facebook and LinkedIn, the usual social media outlets. My book is available on the LexisNexis website and on the HLA website, I think Lexis is actually the publisher of the print edition for the second edition. So now those are the routes by which that can be obtained. And I am actually in the fairly middle stages now of putting together a vaccine law conference. A national vaccine law conference that will be held September 8th and ninth at the George Mason University Law School. And it will bring together experts in all these different areas of vaccination, the regulation, the mandates, injury compensation, patent issues. And it'll be the first time that we've ever brought together people from all these different fields to discuss all the different aspects of vaccination law and kind of meet and be in the same room and get the energy of exchanging ideas and an understanding of the broad public policy implications by which many laws and regimes bend towards the idea that we should have a population as fully vaccinated against infectious disease as possible.

Kara Wenzel - Wonderful, wonderful, we will post a link to your bio and all of that info on the page for this course as well. And last but not least, thank you so, so much for joining us and sharing your knowledge. It's really invaluable. I've learned a lot.

Brian Dean Abramson - Kara, thank you for interviewing me. It has been an absolute pleasure and I look forward to the next opportunity.

Kara Wenzel - Wonderful, thanks again.

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