AHLA's Speaking of Health Law

Top Ten 2021: Vaccination Law in the Age of COVID-19

AHLA Podcasts

Based on AHLA’s annual Health Law Connections article, this special series brings together thought leaders from across the health law field to discuss the top ten issues of 2021. In the seventh episode, Valerie Rock, PYA, speaks to Brian Dean Abramson, author of Vaccine, Vaccination, and Immunization Law, about how COVID-19 has impacted the laws and regulations related to vaccine development and distribution and considerations that organizations should consider when crafting vaccine policies. They discuss recent litigation and legal activity; issues related to rollout and distribution, mandates and exemptions, and vaccine injuries; and staying abreast of the myriad laws and regulations from government agencies. Sponsored by PYA.

To learn more about AHLA and the educational resources available to the health law community, visit americanhealthlaw.org.

Speaker 1:

The American Health Law Association is pleased to present this special series highlighting the top 10 issues of 2021, where we bring together thought leaders from across the health law field to discuss the major trends and developments of the year. Support for A H L A in this series is provided by P Y A, which helps clients find value in the complex challenges related to mergers and acquisitions, clinical integrations, regulatory compliance, business valuations, and fair market value assessments, and tax and assurance. For more information, visit PYA pc.com.

Speaker 2:

Welcome to today's podcast, which is part of the series, covering the top 10 issues in health law for 2021. Today's topic is Vaccination Law and the Age of Covid 19. My name is Valerie Rock. I'm a principal at p y a and I'm out of the Atlanta area. I'm joined by Brian Dean Abramson. Brian is the author of the book, vaccine Vaccination and Immunization Law, and he is in Arlington, Virginia. Thank you Brian for joining us on today's podcast.

Speaker 3:

It is absolutely my pleasure to be here.

Speaker 2:

Thank you. So, Brian, I have to say that these days we cannot make it through a conversation without discussing the Covid vaccine. I actually think it ranks higher than the weather is now on the list of conversation starters. So while it's top of mind, I've learned through reading your articles that the nuances of the laws impacting employers, employees, organizations, and individuals are complex and numerous and may actually conflict in some cases. So it is important for attorneys to have an understanding of the laws impacting their clients and for organizations to consider these laws as they create policies and react to employee concerns and situations. So let's dive a little bit deeper into some of the subjects you highlighted in the top 10 article. First, we have seen three vaccines receive regulatory approval to be distributed in the us and two more in phase three clinical trials with the dramatic increase in the use of the vaccine. In the past few months, have you seen any litigation or other legal activity?

Speaker 3:

The first, uh, actual litigation filed by an employee against an employer seeking to mandate code vaccination, uh, was filed New Mexico. Mm-hmm.<affirmative> by a prison system employee. Mm-hmm.<affirmative>. And that is focusing on language, uh, associated with the emergency use authorization, saying that people who receive the vaccine have to be informed of their right to refuse the vaccine. And that's being kind of stretched into this, well, if I have this right to refuse it, then I can't be mandated to receive the vaccine. Mm-hmm.<affirmative>, in a way, it's kind of like, uh, really, it's kind of like saying you don't actually have to wear a seatbelt if you don't really wanna wear a seatbelt. Mm-hmm.<affirmative>, you can just not drive your car. Right. Um, but the fact that you have, uh, this right of refusal doesn't mean you have the right to be employed in certain circumstances. Um, if you're not receiving the vaccine and your employer wants you to do that, um, a lot has been made of the fact that, uh, these vaccines have been issued under an emergency use authorization. Um, and it is, uh, actually very rare or has historically been for vaccines to be, uh, approved in that way, generally because the health crises that we've had that required, the use of that power have passed faster than a vaccine could be developed. Um, there's one precedent where an anthrax vaccine was released under an emergency use authorization was in fact one of the very first, uh, EUAs ever issued, and the military tried to require, uh, all of its officers to receive the vaccine in the Air Force specifically, and some officers blocked at that and filed a lawsuit and ultimately received the relief that, um, because they were in the military and there was, uh, law going back to when, uh, people were being used as Guinea pigs to test the effects of the atomic bomb. You can't test things on, uh, soldiers. You can't use soldiers as human test subjects without their consent. So that use was enjoined, uh, and that was about 16 years ago. Uh, but it's important to, to know in this modern context, um, first of all, that is only a very specific, uh, statute that applies to people in the military. So there's no analog for that in other professions. Um, and also, you know, I think it's very important to stress that not all EUAs are created equal. So the standard for issuing an emergency use authorization is a very low standard of, there just has to be, uh, basically a preponderance of evidence that the, the pharmaceutical product, in this case, a vaccine is more beneficial than it is harmful. And there have been, um, substances that have been released under EUAs under that standard in the past, but the FDA has and has exercised the ability to kind of self-impose a much higher standard. So the standard of testing that they required for these vaccines before they were willing to issue an emergency use authorization, um, was much closer to the standard. They would generally apply for actual licensure of the, of medication. Mm-hmm.<affirmative>, and it's also important for anyone who's considering a vaccine policy to be aware that all of these vaccine manufacturers, uh, the, the ones for the three vaccines that have been, uh, approved at this time, uh, are planning to file for full licensure by the end of this year. Um, president Trump set up a process, uh, when he was in office for anything covid related to be immediately put to the top of the stack for review by the d a, that the Biden administration is continuing that mm-hmm.<affirmative>, which means that the licensure process, uh, should go very quickly. So, um, it would not be at all surprising if we have licensed vaccines by the end of the year, and that's gonna come around before people know it. Um, so you have to already have planned in your vaccine policies, the fact that there're going to be vaccines that aren't even under an e u a anymore, uh, which ones those are, and how that, uh, comes about. Those are the developments that we have yet to see. But as it stands, there is no law that says that you cannot mandate that your employees receive a vaccine just because the vaccine has been issued under an e U A. And, you know, as I said, this, e u a was issued under much more stringent, uh, requirements for showing safety and efficacy than EUAs typically have been in the past.

Speaker 2:

Okay. So in line with that, we've been able to shrink the development time of the vaccine to less than a year instead of the five plus years it's taken historically on the other side of distribution, we have the impact to the population, and that could potentially be negative. So how long does it normally take a manufacturer of a vaccine to determine if it is negatively impacting the population at large? And will that timeframe be impacted by the equally reduced distribution time?

Speaker 3:

That's a very interesting question. Um, historically, if you look back, there was a rotovirus vaccine that was released in 1999, um, and it had gone through all of the typical phases of clinical trials. Normally you have, uh, three clinical trial phases, and they each take about a year and a half to complete. Um, and they study ever-increasing numbers of test subjects and, uh, look more and more searchingly at, you know, first is this safe? Um, and secondly, is it effective? Does it actually work on the, on the condition that is being tested? And then third, really is it effective for everyone? And there are there particular populations or situations, um, where there are likely to be contraindications? Um, and that is something, uh, one of the reasons why that lasts for a year and a half is because you wanna observe people over a long period of time to see how long is this vaccine effective, and are there any long-term effects, uh, to be aware of. Mm-hmm.<affirmative>. Now, generally speaking, if there are negative effects to a vaccine, if it someone has, uh, some portion of population is likely to have an allergic reaction or something like that, you discover that very quickly. Um, most reactions to vaccines happen almost immediately after administration, and that is something that the manufacturers have been testing throughout this process. Um, and in fact, it's, it's, uh, kind of important to note that, to make up for the fact that these vaccines have been developed very quickly. Uh, in order to get kind of more robust testing information, they've used very, very large samples of people who are, they're doing, uh, the phase three clinical trials on. So instead of having four or 5,000 people in that sample, they've had 50,000 people, um, in a phase three clinical trial sample. And now of course, you know, we have the, uh, the real, you know, rollout to millions and millions of people. So if there were a lot of, uh, really negative consequences to the vaccine, uh, that would become apparent very quickly. And it seems that at least for the, for the Pfizer and Ative vaccines, which were the first ones to roll out, um, there have not been, there have been a very, uh, low, uh, number of adverse effects. Um, but I had mentioned at the beginning there was a rotavirus vaccine that was released in 1999 that went through all three phases of clinical trials and was put into use with the population. And it was only after it was put into use that it was discovered that in about one in 10,000 cases, it caused interception in infants, which is, um, a very dangerous intestinal blockage. And so it was pulled from the market because that would be considered an unacceptable risk, um, for the vaccine based on the circumstances of rotavirus and how, um, dangerous that is by comparison. Mm-hmm.<affirmative>, um, I am not anticipating, uh, that kind of problem with any of the covid 19 vaccines that have already been issued under, uh, an e u a. Uh, there have been some questions reported about the AstraZeneca vaccine, uh, which does seem to have, uh, fairly good effectiveness. It's also, uh, very interesting that the Pfizer vaccine and the Moderna vaccine are a very new technology in vaccines that are, were called mRNA vaccines. Right. Uh, rather than using a piece of the virus itself, which vaccines typically use, or a dead version of the virus, they're just inserting a little strand of mRNA into, uh, some of the, the cells of the body and doing exactly what the virus does, taking over the cellular mechanism for reproducing itself and producing something. And in this case, they're just producing that protein hook that the virus itself would produce to cause your body to develop a reaction against that. Um, they don't contain, uh, adjuvants, which are these substances, they're sometimes added to vaccines, to, to provoke the immune system, uh, that have been, uh, kind of, uh, deemed responsible for some of the allergic reactions that people have. Mm-hmm.<affirmative>, and they don't contain a lot of other components that vaccines typically have. They're very kind of simplified and stripped down because they really only need to convey this mRNA strand. Um, so we're actually likely to see fewer, um, bad reactions to those. And, you know, it's going to be very interesting how that develops as a technology. You know, there's talk of, well, if this works for a Covid 19, can we use the same technology for anti-cancer vaccines that are in development?

Speaker 2:

Right.

Speaker 3:

A number of other purposes.

Speaker 2:

Right. You mentioned the rollout and also the, um, the litigation related to the prisoner. Um, but since the number of doses available is high and the concerns regarding the rollout of the distribution and prioritization appear to be, be nearly a non-issue, so if a, the phased in approach and rapids expection of the phased, um, the phases decreased late litigation, or have you seen any related actions? So the way things have rolled out quickly, has that actually decreased the possibility of litigation?

Speaker 3:

Uh, well, I will say the rollout, uh, has accelerated very quickly, and, you know, it ne very, right now it seems like things are going amazingly smoothly. Um, that is, that was not the case. You know, if you look back, uh, a couple weeks or a month ago, you had cases where, uh, there were people trying to steal the vaccine or jump the line, uh, to a great deal. There, there still are people who wanna jump the line, but I think, um, the ones who are really dedicated to that have managed to do it already, but mm-hmm.<affirmative>. Yeah. There was a case in Florida where there were these, uh, two relatively young women who tried to disguise themselves as grandmothers, um, so they could receive the vaccine early. Interesting. Um, you know, and, and ethically that's very, uh, problematic. Mm-hmm.<affirmative>, uh, legally there aren't really consequences for jumping the line if you're, if you're able to, uh, do that and misrepresent yourself either in terms of your age group or your medical condition, um, or your affiliation with, uh, some profession that is able to get the vaccine earlier mm-hmm.<affirmative>, Um, there was an entire class of students at I think Georgetown Medical School, um, where the third year students were eligible to get the vaccine because they're actually out there helping to get the shots. Mm-hmm.<affirmative> and some second year students went and sort of, you know, pretended to be third year students and got the shot. And, uh, they did suffer some consequences for that within the school, but there aren't, um, broader legal consequences. Um, but the fact that there now appears to be a, a real, uh, a really effective ramping up of vaccine distribution, um, that has kind of leveled out the, the desire of a lot of people to try and do line jumping. And now we've gotten to the phase where, um, we're no longer really concerned, will we be able to get everyone the vaccine, uh, within the next two months and into the phase will be concerned about are there a lot of people who aren't going to want to receive the vaccine, and is that going to affect our ability to, um, get to a point of herd immunity mm-hmm.<affirmative> And really to get out of the pandemic itself. Right. Um, and there's, there's, uh, you know, an, uh, a factor in that equation that, um, hasn't been very much considered, which is that we don't actually know how many people in the population have had covid and have natural immunity to it. Right. Um, so we may get to a point where, you know, we get 55% of the population vaccinated, and there's another 20% that we don't know about that has had covid, or we know very small percentage of them had it because they got very sick. But there are a lot of people who had asymptomatic mm-hmm.<affirmative>, uh, covid. Um, and that taken together is enough for us to reach herd immunity. Um, and that's, you know, sort of the ultimate goal towards getting the economy rolling again and having people able to, uh, live as they did before this entire pandemic started. Right. Um, and that's a calculation that, you know, we'll, we'll kind of, we'll kind of see as it goes long. Um, there'll be a sharp drop off in the number of cases reported because there are no longer vectors through which large numbers of cases can be transmitted. Right. Um, but, you know, in the interim, uh, a lot of employers wanna set up systems to have their employees vaccinated, and, and we're going to talk about the, the different things that can be done mm-hmm.<affirmative>, uh, in that regard. Uh, and, you know, the systems that get set up aren't just, well, we're going to do this to get out of this pandemic now. Uh, the fact of the matter is covid is going to be a long-term concern for our population. It's, it's entered the human experience and it's not leaving, um, by itself. Right. It's going to be around for, uh, the rest of our lives probably. Mm-hmm. And it's going to be one of the leading causes of death for the rest of our lives among the population. You know, it's going to kind of supplant the place of the flu, um, in taking that role as a, as a disease that's particularly afflicted of the elderly. Right. Um, and it's something that when we plan for vaccination policies, we're going to have to think about, um, this as being likely an annual vaccination, like, like the flu shot mm-hmm.<affirmative>, um, but something that, you know, in a lot of fields is going to be, uh, considered, uh, more imminent, uh, that it, that it's needed than the flu shot has been up to this point

Speaker 2:

In line with that. Um, what have you seen in the way of mandates and exemptions over the past few months, and what do you anticipate through the end of the year because of that?

Speaker 3:

Um, there have actually been very few mandates implemented at this point. Um, the, the employee in the, in the New Mexico prison system is kind of, um, an exception to what the practice really has been. And that has been a lot of, uh, employers developing policies to encourage and incentivize and facilitate vaccination and falling short of mandating it. Um, where if they do mandate it, uh, mandating it, uh, for a very small segment of their employee population, you know, the, the employees who are most likely to physically come in contact with other people based on their job description mm-hmm.<affirmative>, um, and to be very, uh, open to accommodations, um, and liberal in distributing, uh, you know, if someone says, I have a physical concern, or, um, I have a concern because, uh, I'm, I'm pregnant or trying to get pregnant, um, or if they have a religious or belief based objection, uh, employers have been very leery of saying, um, well, we're going to require this nonetheless. And if you have that sort of objection, um, we're either gonna change the conditions of your employment, uh, and assign you to some other task or, or something like that, uh, or we're going to separate you from employment. And that, that's what happened in the, the New Mexico Prison employee case. Um, the employer said, we need you to be vaccinated, and if you're not going to be vaccinated, uh, we're going to terminate you. Um, that is something that, you know, I think employers do want to avoid. Uh, there are inevitably going to be some number of people who have, uh, an allergy or some other condition that would be considered a contraindication to vaccination. Mm-hmm.<affirmative>. Um, and the a d A requires that you make a, make a reasonable effort to accommodate those people if it doesn't ha impose an undue burden on the employer. Um, there are going to be some people who assert a religious objection to vaccination. Um, and for religious objections, it's, it's very interesting. The standard is a lot lower. Um, but there are also a couple of cases where you have employees working for, uh, what are, uh, effectively religious institutions. And a lot of hospitals, of course, are affiliated with religious organizations that are religious hospitals, and they do have more of an ability, um, to deny religious exemptions. They have, um, a little carve out in, uh, the E E O C statutes, um, that basically say, if you're a religious entity, you can, you can impose your interpretation of religious doctrine on people who are employed. Uh, so there are cases where entities in that, in that realm have been able to terminate, uh, employees or say, tell employees you're either going to be vaccinated or you're, you're going to be terminated and, and not have to grant a religious exemption. And, you know, it, it's a really substantial portion of the health, uh, of the healthcare field, actually, if you look at hospitals that have that kind of affiliation. Right. Um, you know, so that is a consideration, uh, to keep in mind. Um, but even outside of that, uh, the, uh, E E O C has said that COVID 19 presents what is called a direct threat, uh, that raises this direct threat standard, which lowers, again, the threshold, uh, for employees, for employers to be able to mandate this for employees, um, because they're really protecting the lives of their fellow employees, um, ostensibly by being vaccinated. Mm-hmm.<affirmative>. Um, one other, uh, important factor is that not all the vaccines work the same. Um, the Pfizer and Moderna vaccines work by the same mechanism. Uh, Johnson and Johnson and AstraZeneca vaccines are both, uh, kind of a different mechanism where they're using the actual a portion of the actual COVID 19 virus. Uh, in both cases, I think they're what called an adenovirus vector or adenovirus vector, a vaccine mm-hmm.<affirmative>. So they're using an adenovirus as kind of the body to carry this piece of the covid virus that has been grafted onto the adenovirus. It's very interesting technology. Yeah. Um, but if you have an employee who has an allergy or a contraindication to one of the vaccines, um, they may be able to receive one of the other vaccines, um, or one of the vaccines that is still in development and, and may, uh, come to be released in the United States in the next couple months. Um, and you should have that reflected in your policies that, you know, employees are encouraged to determine whether, if they, if they have an allergy to one of the vaccines, determine whether there's another vaccine that they can receive, um, and be very, uh, aware of that and, and circumspect that. Um, so what, what we really are seeing are incentivization programs, um, some efforts at facilitation, um, a lot of efforts at providing information to employees, directing them to the CDC c website or directing them to other resources of information where they can find out, uh, what has been determined about the safety and efficacy of these vaccines. And one of the most effective things that employers have done is, uh, they have asked employees who have received the vaccines and have had a positive experience with that to convey that experience to their coworkers. Mm-hmm.<affirmative>. So that is the, been one of the best ways to really instill confidence in the vaccine among others to say, look, I received it, and, um, it was fine for me, you know, I was a little bit sick after the second shot, but then, uh, I felt better after a day, and now I feel wonderful and, and I'm not concerned about getting covid cuz I've been vaccinated.

Speaker 2:

Right. So you mentioned E E O C, and I know you've said that, um, that the laws have been kind of shifting and changing over time as each kind of situation has come about, you know, because we've gone through this so quickly, um, and the E E O C and OSHA may have laws that perhaps even conflict. So how do we, um, make sure that we're on top of those laws and, and making sure that we're not in a situation where we, you know, get, get I guess a go against any of those calls?

Speaker 3:

Yeah, that is, that is also a conundrum. Um, we are very much, uh, awaiting further guidance from these agencies. Um, and, uh, quite frankly, some greater semblance of coordination between them. Um, for example, the ada, or sorry, the F D A has recently released, uh, guidance for employers. Uh, among the things that they've recommended is that employers have, uh, onsite vaccination clinics, uh, once the vaccine becomes widespread enough for them to do that. And that's, that's a wonderful idea. It's a very effective way of getting your employee population vaccinated. Um, the only problem with that is that a lot of attorneys are advising their clients that, well, if you do have an on-site vaccination clinic, um, under the current readings of various statutes, that's going to implicate, uh, HIPAA issues and ERISA issues, um, you know, does that constitute an element of a wellness program? And by doing that, you have to also offer other components, uh, of a wellness program that you may not be, uh, doing now. Um, also, you know, the E E O C has said that you have to be very careful about the questions that you as an employer ask your employee. Um, it's prohibited to ask employees about their disabilities and so forth, um, and, and to make work-related decisions, uh, based on that. Uh, however, in the act of administering the vaccine, there is a, an element to that by which, uh, the person doing the administering the vaccine has to ask you some questions about, you know, your potential reactions to the vaccine. And that can implicate, uh, the ada a so if you as, uh, a company HR person, hire a pharmacist or hire a pharmacy to come to your work site and administer the vaccine, well now they're a contractor, they're working for you. So if that pharmacist who's giving the shots is asking people these questions, um, that is attributed to you asking the questions as to the employer, and you could be in violation of the ADA for that. Um, so, you know, the E E O C uh, guidance that has been promulgated, and this is guidance that was propagated in December of last year. Mm-hmm.<affirmative> is, uh, pushing people towards saying, you know, we don't want to have onsite vaccination. Uh, and that's kind of contradicting, uh, guidance being given by the fda. Um, and that's, you know, that's, that's kind of problematic. That's something that needs to be resolved. Um, and also the E E O C has, uh, they gave guidance on incentives, which was, uh, it's been talked about a great deal that it shouldn't be anything more valuable than a water bottle, because if you give too big, I an incentive, uh, only to those who have been vaccinated. It's kind of like you're discriminating against those who can't be vaccinated. Um, and that is not going to be helpful really to, uh, incentivize vaccination. Um, that guidance was withdrawn, um, because it was, uh, released, uh, under the Trump administration, uh, when it was, you know, kind of a proposal and, and not fully implemented. And it was part of a large number of, uh, items of guidance that were withdrawn immediately by the incoming Biden administration for review. But right now, we're in limbo. You know, we don't know what the position is in terms of incentivization. Um, um, and quite frankly, you know, if, if it were up to me, I would say that, um, Congress or the administration or, you know, somebody needs to act and say that, well, we're in a pandemic and we wanna get out of it. So employers should be allowed to incentivize as much as they want and not, um, fear negative consequences from doing that. And, uh, likewise, employers should be allowed to have onsite, uh, vaccination programs without implicating other concerns. Uh, there's some other things they should be allowed to do. They should be allowed to ask, um, about your antibody status. Right now, the, a ADA said that it's, uh, that is prohibited as an inquiry. Um, that has in, in some other areas been used as a, a substitute for vaccination mandates. If you have the antibodies you already have in your system, what the vaccine is supposed to develop. Um, so there are some things that are, that are out there that are problematic for employers right now. Um, and those may change, they may change very rapidly. That's just something for council in the field to pay close attention to. And, you know, hopefully something will be done about that. Um, uh, ideally something that will maximize the ability of employers to incentivize and encourage, facilitate vaccination, but if not, at least something that very much clarifies, um, what employers can and can't do without potentially getting into litigation for them.

Speaker 2:

Right. So as we, um, wrap up, I have one more quick question. Um, we talked through what we have to consider related to vaccine injuries, for example, when a hospital is providing vaccines for its employees. In other words, how, what laws are implicated by being both the employer and the distributor?

Speaker 3:

Hmm. Well, that is also a very interesting question. Um, and I would preface by saying that so far vaccine injuries have been, um, very low with respect to the vaccines that have been approved. Uh, but there will inevitably always be some, some very small portion of the population that has a negative reaction to vaccination. Um, and there are, you know, there are injuries beyond just whether the vaccine is, is effective or not, or whether the vaccine is safe or not. Um, you can have, uh, a shoulder injury as a result of someone using the wrong technique to administer the vaccine. And that's just, you know, the needle goes into a, the wrong spot. Um, and you can have some negative consequences from that. Yeah. Um, right now all injuries that are in any way related to the vaccine are covered by the prep Act, which was invoked the very beginning of the pandemic. And that immunizes, uh, administrators, distributors, manufacturers of the vaccine from any liability from any tort liability, uh, for any injury caused in the course of, uh, administering the vaccine, um, unless there's actual willful misconduct involved, which is of course a very high standard, and it's not something that we are seeing in, in any of the, um, administrations that have gone on so far, there hasn't been anything that would kind of invoke that. Um, an element of the prep Act is a thing called the C I C P, the Countermeasures Injury Compensation Program. Uh, most vaccines, the childhood vaccines are covered under a thing called the National Vaccine Injury Compensation Program, the N V I C P, um, which provides a certain amount of compensation for people who are injured by, uh, the routine childhood vaccinations. Uh, the COVID 19 vaccines aren't covered under that program. Uh, there would have to be a notice and comment, um, promulgation by the Secretary of HH s for that to happen. And it's, it's really not likely to happen because they're already covered under this other program set up under the Prep Act. Um, the C I C P provides for compensation for serious injuries, um, and that's not really, uh, a phrase that has been tested a great deal, um, but it does provide compensation where that is the case, uh, for anyone who experiences an injury relating to the vaccine. And that injury manifested within one year of receiving the vaccination. And, um, I do know that there are C I C P claims that have been filed at this point. Um, people have contacted me asking, you know, are you an attorney who filed C I C P claims? Mm-hmm.<affirmative>, uh, which I'm not<laugh>, but, um, you know, the, the C I C P is a program that is available, uh, it is administrative unlike, um, certain other compensation programs. So it's almost like asking for a social security adjustment or something like that. You fill out some paperwork, you provide some documentation, you send it to a functionary, and they make the decision. And there isn't really a process of appeal. You know, if you don't like their answer, you can, you can ask their supervisor to look at it. Um, that in, in our experience, isn't likely to change things. So, you know, it's a very sort of one shot, one stop process. Um, and it isn't one that has played out to a degree where we have litigation where we can look at it and say, okay, this is, um, what the standards for, uh, overturning a denial of a C I C P claim or, or something like that. That inevitably will happen now because there will be some number of people who, you know, they received the vaccination and they say, oh, I, I, I had this long-term, um, negative repercussion from that or something that I, I believe is associated with that. Um, and they'll go through that process and, and perhaps not be satisfied with what they get from the C I C P and seek to overturn that in the courts. Um, and that's, you know, very much something that we'll develop in the future and that we'll watch, uh, with great interest to see, uh, how that applies. Because the C I C P is going to be the method for seeking compensation for serious injuries related to the COVID vaccination probably for the next couple years. The Prep Act invocation, um, when it was declared in February of 2020, uh, asserts that the Prep Act is in enforce until October of 2024. Now, that can change. The administration can at some point say, well, now we feel that the pandemic has passed and we're going to withdraw it. But, you know, they're really not legally required to do that. So that may be the case, uh, for several years. And, you know, we will just have to see how that develops as well. Right.

Speaker 2:

So I guess the, the whole theme here is that we'll have to take every scenario as a unique scenario and as employ, you know, healthcare employers and healthcare employees, um, every scenario will be different. And we'll have to look at what's going on at the time in regards to the law and, um, and the specific scenario to address

Speaker 3:

Yes. And, and very much keep track of things as new developments arise and Right. You

Speaker 2:

Know. Well, thank you Brian, for sharing your insights on Vaccine Law today. It's a topic front and center for all of our clients, so it's very helpful for those listening. So thank you all for listening today, and we hope you will check out the other Top 10 podcasts in this series. Have a great day.