Allison Luke, Chief Compliance Officer, Pinnacle Healthcare Consulting, speaks with Brian Dean Abramson, Treatise Author, Bloomberg Law, and Jerry Williamson M.D., Healthcare Consultant, EBG Advisors, Inc., about how providers can prepare for a forthcoming COVID-19 vaccine. The podcast discusses the possible timing of a vaccine, the PREP Act, impact of a vaccine on the pediatric population, whether a vaccine will be mandated for either children or in the workforce, and the clinical trial and approval process. The speakers also recently participated in a more in-depth webinar on the topic. Sponsored by Pinnacle Healthcare Consulting.
To learn more about AHLA and the educational resources available to the health law community, visit americanhealthlaw.org.
Allison Luke, Chief Compliance Officer, Pinnacle Healthcare Consulting, speaks with Brian Dean Abramson, Treatise Author, Bloomberg Law, and Jerry Williamson M.D., Healthcare Consultant, EBG Advisors, Inc., about how providers can prepare for a forthcoming COVID-19 vaccine. The podcast discusses the possible timing of a vaccine, the PREP Act, impact of a vaccine on the pediatric population, whether a vaccine will be mandated for either children or in the workforce, and the clinical trial and approval process. The speakers also recently participated in a more in-depth webinar on the topic. Sponsored by Pinnacle Healthcare Consulting.
To learn more about AHLA and the educational resources available to the health law community, visit americanhealthlaw.org.
Support for A H L A comes from Pinnacle Healthcare Consulting. Pinnacle works with hospitals, health systems, ambulatory surgery centers, physician groups, law firms, and other healthcare organizations. Their team consists of experts in the area of compliance, audit and risk mitigation, medical coding, compensation and business valuation strategy and operations consulting and transaction support. Learn more about pinnacle@www.askphc.com.
Speaker 2:Welcome to today's podcast. This is a podcast for a H L A and the title is Preparing Providers for a Covid 19 Vaccine. I am your moderator. My name is Alison Luke, and I am the Chief Compliance Officer for Pinnacle Healthcare and an executive consultant with Pinnacle Enterprise Risk Consulting. My background is that I am an attorney. I have been practicing healthcare compliance law since 1993, and I'm also certified in healthcare, uh, compliance. And our two speakers today are Brian Dean Abramson and Dr. Jerry Williamson. And Brian, would you like to introduce yourself?
Speaker 3:Uh, yes. Um, my name is Brian Dean Abramson. I am the author of the Legal Treaties Vaccine Vaccination and Immunization Law, uh, published by Bloomberg Law in Cooperation with the A H L A in 2018. And since, uh, updated a couple times. Um, previously I worked for Bloomberg, uh, BNA on their health and privacy desk, and I was a law clerk to Judge Pauline Newman of the United States Court of Appeals for the Federal Circuit. And the federal Circuit has a very interesting vaccine law docket. We be get both vaccine injury cases and, uh, patent claims are relating to vaccine development. And, um, if anybody listening, uh, does happen to buy my treaties, please email me and I'll be able to send you a PDF of the most recent annual update, uh, at no charge.
Speaker 4:Hello everyone. Uh, my name is Jerry Witson. I am a board certified pediatrician and I have a master's degree in health law from Lo Oli University Law in Chicago, where I currently serve as a adjunct professor of law. I'm a clinical assistant professor of medicine at the Florida State University College of Medicine, a national speaker and an independent healthcare consultant in the areas of risk management, patient safety and compliance. And I would like to take this opportunity to thank Alison and the A H L A for inviting me to participate in this podcast. Thank you, Alison.
Speaker 2:You're welcome. Um, how about let's get started. Brian, do you wanna talk a little bit about how we prepare providers for a vaccine?
Speaker 3:Uh, well, what providers need to know about a forthcoming COVID 19 vaccine? The, the first thing that you need to know is that, uh, a law called the Prep Act has been invoked with respect to it. Um, and that basically says that manufacturers, uh, distributors and administrators of the vaccine, uh, are immune from liability for any harm alleged to be caused by the vaccine. Um, if someone does believe they've been harmed by it and they've been seriously injured, there is a program, um, that they can, it's called the Countermeasures Injury Compensation Program. They can, uh, file to seek compensation from. Um, the more, uh, kind of ambitious and interesting topic that's going to come out of this is whether we have a lot of vaccine mandates. Um, and of course, the, the providers of the vaccine, um, will largely be entities in the healthcare sphere, and they will be sort of on the leading edge of entities that will likely have vaccine mandates for their own employees. This kind of creates an interesting, um, situation where as the provider of the vaccine, they're immune from liability when they're actually responsible for administering the vaccine, but their employees. Um, but they may also have, uh, liabilities through workers' compensation, um, for injuries to the employees if it's, if the injury is asserted received in the course of employment. Um, so there are a lot of issues that are going come up that way. Um, there are questions I think we'll be discussing today about, uh, how a vaccine comes about, how it is approved, and how it first becomes, um, part of our experience. And then, you know, what's going to, uh, proceed from there, uh, in terms of mandates and in terms of, you know, our understanding of the effectiveness and safety of any vaccine that comes out.
Speaker 2:And, um, Dr. Williamson, I know that your focus is really on the, um, impact of a potential vaccine on pediatric population. Do you have any thoughts on mandates relating to, um, the pediatric population?
Speaker 4:Uh, yes, I do Alison, and it's a little bit of a different perspective than Brian just described in terms of the, uh, the prep Act. Uh, and it's more about the impact of the, uh, forthcoming COVID 19 vaccine or vaccines, depending upon how many are made available and their approval for the pediatric population. And, and one of the questions that I think parents need to be thinking about and, and, and, and any healthcare physician or other clinician is that will there be school requirements to be vaccinated with a Covid 19 vaccine as a prerequisite to attend school as there are other vaccines that children need to have, uh, when, when, uh, beginning school or resuming school, and what will that approval look like? Will that vaccine be licensed or is there a possibility? Although I think it's less likely that there may be FDA approval by way of an emergency use authorization and e uua. Uh, and in that case, the question becomes did it meet the proper vetting if in fact, it was by way of an e u a? And this is not something that is typical, uh, typically done by the fda. I think there was one, one previous vaccine, uh, that was approved by the, uh, by way of an EEO a and that was for anthrax. And that was very, very different because it was principally administered, uh, to high-risk soldiers and civilians in war zones. But approving a Covid 19 vaccine on the limited evidence through an e uua, what I believe mark or rather serious departure from FDA policy. And you know, under that e uua, which is section 5 64, the Federal Food Drug and Cosmetic Act, uh, the FDA commission can, uh, allow unapproved medical products or unapproved uses of an approved medical product to be used in an emergency to diagnose, treat, or prevent serious life-threatening diseases or other conditions, uh, caused by chemical, biological, uh, I believe radiological and nuclear threats, uh, threat agents that, uh, uh, when there's really no adequate approved and available alternatives. And of course now we have the, uh, the, uh, pandemic that is facing the, the world. So we are in that type of a situation. So the question here is, if the Covid 19 vaccine, also, if that rate is low in the United States, the question needs to be answered. Will, uh, the federal or more likely state government step in and mandate that vaccine? Particularly, um, now my focus is, uh, with children, and as many of you who are attending, know that the US Supreme Court has ruled that the state's general police power to promote public health and safety encompasses the authority to require these mandatory vaccinations. And the states have all exercised that authority for children, uh, with some exceptions. And we may, uh, address some of the exceptions, but the exceptions have gone down in, in number and in, uh, in types in terms of how they're, uh, characterized, uh, which in many ways is good. And I just want to convey before I hand it off to you, uh, again, Alison, is that I am a major advocate as a pediatrician and four children being immunized, but it's the approach here that causes me a little bit of concern in terms of what will be the level of safety and efficacy before we go ahead and begin immunizing these children.
Speaker 2:Those are excellent points. Brian. Um, you had mentioned, uh, with regard to employment, whether or not there may be employee, um, excuse me, employer mandates. Can you talk a little bit more about that?
Speaker 3:Uh, well, first of all, I, I think it's a very interesting point that, uh, Dr. Williamson raised with respect to EUAs. The standard for a proof for approving, uh, a drug or for allowing a drug to be used under an emergency use authorization is just that there is some evidence that it works. And that based on the evidence that has been gathered to date, the, uh, potential benefits appear to outweigh the potential risks. And there have been cases, and I think like most recently with hydroxychloroquine, where an e u a was issued and then further experience with the, with the drug, um, demonstrated that it was not in fact, uh, effective, uh, or healthy for recipients. Uh, so the e u a was withdrawn. So that that is something that can happen, um, in theory with a vaccine. Um, uh, I would also mention that there is a body called the advisory Committee on immunization practices, which generally makes recommendations for what vaccines should be administered to school children. Um, and a lot of states actually have their statutes, uh, keyed to the recommendations of the, that body of asap. Um, and, and so their statutes say that the vaccine schedule will be, will be whatever ASIP recommends. Uh, but ASIP only recommends vaccines that are licensed that has no authority to even recommend a vaccine that has been issued under an emergency use, uh, authorization. So I think it's generally unlikely that there will be any mandates to receive a vaccine that has been issued solely under an e U A. Um, the only actual case that I know of did involve the anthrax, uh, vaccine in 2004, where the Air Force was, uh, trying to require all of its officers to receive this vaccine, uh, that had been, uh, authorized under an emergency use authorization. And the court held that, because there's a statute that says you, you can't conduct human experimentation on military personnel, uh, going all the way back to, uh, the atomic bomb tests when we would send platoons of troops and to the area after a bomb had been detonated to see what happened. Um, that because that statute had been, uh, passed in response to that you couldn't require them to receive a vaccine that hadn't been licensed. Um, and I think the same thing will generally apply. I mean, it, it applies confidentially now to the military. The same thing will generally apply to people in civilian life. So I don't think that there will be mandates for, uh, a vaccine that has been released under an e U a. Um, there will be availability. So, you know, people who are kind of frontline workers or healthcare workers or in the most vulnerable populations and who want to receive a vaccine, uh, will certainly have the opportunity to receive one once one has been released under that kind of, uh, regime. Um, but I think that, um, the release of a vaccine under an e uua will only be, uh, a couple months short of the, the licensing of a vaccine. You know, there's still some additional period that the FDA will need to use to determine that a a vaccine meets all the, the safety and efficacy requirements, uh, for full licensure. And I think they're, you know, doing everything they can to hasten that process as much as possible. Um, the people I've talked to in the industry, in the, uh, pharmaceutical industry, all kind of, uh, are looking at, uh, April to May of next year as when they think a vaccine will, um, have demonstrated that, uh, level of, uh, reliability. So, you know, we're not that far off from looking at the question of, well, when there is a licensed vaccine, can it then be mandated, um, the, uh, E E O C, which determines whether people can be exempted from vaccination due to a disability such as, you know, a contraindication of the vaccine or, or a potential bad reaction of the vaccine has ruled that, uh, COVID 19 falls under what is called the direct threat standard. And the direct threat standard basically means that the disease represents such a threat that you don't necessarily have to accommodate people, um, who have a disability and can't receive a vaccine for the disease. Employers will, in fact, um, be able to do things with respect to that, that they can't do or that has been held that they can't do with respect to other vaccines like a flu vaccine, for example. Um, and that includes terminating employees who can't or won't receive the vaccine or reassigning them to, uh, less preferable positions, uh, masking requirements, which of course are now already ubiquitous, uh, in our response to pandemic itself. Um, and then, you know, making inquiries into people's medical history that are generally, or medical condition that are generally prohibited, um, under the Americans with Disabilities Act. And, you know, I do think that of all the, uh, epidemics and pandemics that we've dealt with, you know, in our kind of recent historical memory, this one will be the one that will test the ability of employers to mandate vaccination, uh, the most strongly because it's something that is going to really put a lot of pressure on people and, um, not just in the, in the healthcare field, but in a lot of different fields where you have employees who come into contact with customers or other people in the course of their employment, um, to really require vaccination of, uh, as much of the, the employee population as can be vaccinated.
Speaker 2:Those are important points. And when you're talking about the vaccination testing, my understanding is that only adults, um, are having the testing, the, the vaccine testing. Dr. Williamson, do you see that there may be potential concerns with regard to children cause of this?
Speaker 4:I, I do, I do Alison, and in, in terms of what Brian just said, and Brian, I, for the most part, I agree with everything you've said, but I still have a little bit of a concern regarding, uh, the states having the power to regulate public health, and they have in the past, uh, mandated vaccines. And I, my my concern would be, depending on a particular state's state, whether they may contin con consider doing that even prior to licensure. And I realize, I understand in terms of the, the laws that are available now, the courts have consistently as, as we both know, rejected legal challenges and given not a considerable deference to the state's police power requiring, you know, immunizations to protect public health. So that, that's my concern. But to Allison's point, in terms of, um, clinical trials, clinical trials, just, they don't necessarily test children as part of the study that they're, that they're doing. Uh, and we, we cannot assume that there won't be any side effects, even if adults don't experience any side effects. Uh, as I've said many times, uh, adult children are not little adults. And there's also this dilemma that we have in terms of including children in studies. And very few, if any, uh, companies, pharmaceutical companies that are testing vaccines have in fact included children in their, in their trials. Uh, there was a, uh, I believe recently a Chinese company, Syk Biotech, which, uh, in their forthcoming trials said they would include children ages three to 17. Uh, but by, but by and large, most vaccine developers have not launched similar trials with participants that were younger than age 18. And it's, it's somewhat difficult to have parents agree to have very, very young children or children, uh, involved in these clinical trials. Cause there's the potential risks that the trials, uh, uh, contain, uh, in the united still in, in the United States adult clinical trials, uh, that have moved quickly into phase three, children have not been enrolled, uh, in these, in these trials. Uh, there are initial pediatric, uh, studies that, that I believe, uh, uh, need to be conducted in parallel with adult trials to determine efficacy rather than delaying them at this point and just doing the adult trials without including the pediatric trials, keeping in mind that there are difficulties getting this done. And for a trial to participate in a tri, in a trial, as, as many of us on the call know, uh, the legal guardian needs to get consent on their behalf. And there are some that suggest that children that are seven and older must themselves also agree to participate after receiving a thorough explanation of the study's requirements and risks. And I, I, I, as a pediatrician, have difficulties with that concept. Um, but even with, uh, this, uh, type of an involved enrollment process, uh, what we saw during the 2009 H one N one pandemic in our country, uh, there was an, the US accelerated the clinical trial process from the Dsla children and down to different age groups, which is not taking place now, typically after trials and 12 to 17 year olds. Their vaccine trials then come down to looking more to the five to 12 year olds, and if the children younger than the age of five, but as an adult trials vaccine developers was quickly identified both the short and the long-term side effects that may or may not emerge during the vaccination process for children. So my, my bottom line here is I believe that the vaccine, whether it is on an EEO a or it's a licensed vaccine, if it's not been used in clinical trials for children, uh, it may or may not be safe, uh, and have an acceptable level of risk, whatever that acceptable level may be.
Speaker 3:Yeah. I just wanna follow onto that very quickly and say that I completely agree with, with Jerry on the, uh, the fact that states aren't bound by, uh, the determinations of ASIP or any federal body, um, to the extent that if a, if a vaccine is authorized under an emergency use authorization, a state government can say, okay, we're, we are now going to mandate this vaccine. Um, they have that power. It's something I would certainly tend to recommend against. Um, and you know, also with respect to the, the clinical trial process, you know, that's something that even with a vaccine that gets fully licensed, it's going to be a vaccine that went through clinical trials, uh, at a much faster pace. And in a, in a kind of an unusual process relative to what's been done before. Um, you know, typically it takes five years or five to seven years to develop a new vaccine because each phase of the clinical trial involves, um, a year to a year and a half of observation of the test subjects in that phase. And, you know, it's only when you get to the end of that period that you sit down and review your data and say, okay, this is how we're going to design the next phase of the clinical trial, um, to reflect what we learned in the first phase. You know, and now what we're doing is we're starting phase two, a couple months into phase one, um, and kind of overlapping them and adjusting what we do in the phase two trial, uh, on the fly, uh, as we ga more, gain more data from the phase one trial. And, you know, we're doing the same thing with the phase three trial. And, you know, there is, there's an example in that in 2000, a rotovirus vaccine was licensed by the FDA that had gone through all three phases of clinical trials and had been cleared as safe and effective. And some number of months after it, uh, was released for use in the general population and began to be used, it was discovered that it caused in about one in 10,000 cases, um, potentially fatal into subception in infants, which is a kind of intestinal block. It's a very bad thing, and it was pulled from the market. So, you know, it is possible for a vaccine to go through all these, um, phases of clinical trials and be approved and still turn out to have issues that weren't discovered in the course of that. So, you know, there, there are certainly concerns that as quickly as we are going and trying to develop, uh, COVID 19 vaccine, um, there could be a situation like that. Uh, we're fortunate at least to the extent that, uh, there has been efforts to develop a SARS vaccine and SARS is a coronavirus. Um, and we're able to build on some of those sort of previous e efforts. And we do have some knowledge of, um, how coronaviruses work so that, you know, we have, we start with a leg up, but we're still proceeding at, at a record breaking pace. And, you know, I think it's legitimate to be, um, wary of the, the product of that, uh, particularly in terms of making a determination that you're going to mandate that people, uh, receive a vaccine, you know, and that's not necessarily, uh, something that should prevent mandates for a licensed vaccine, uh, if there are really good test results that we can look at. But, you know, it's, it's something for legislators and policy makers to keep in mind as we go forward in the process.
Speaker 4:And, and Brian, in, in the, in the face of that, uh, I, I agree completely. There was a recently, a fairly large study in, in India, uh, suggesting that children may be spreading covid 19 at much higher rates than previously assumed. Uh, and this was published just last month, uh, in science. And the study found that, um, that, uh, that children are also more likely to be asymptomatic carriers of the disease and frequently pass it on to both other children and adults. And they had a fairly large population of individuals that they studied. It was nearly 85,000 confirmed cases. Um, and so, and of course the research on this is, is changing and it's changing daily, so that, that, that information may change, uh, uh, very soon. But I think, you know, to your point, uh, uh, the, it was very clear for me at least, that the, a recent c d C publication has said 10 great public health at achievements to the United States in the 20th century. They put vaccination was as being number one. But e even in spite of that, I think there needs to be confidence in the general public that the vaccines are safe, that they're effective, and that, uh, they're, and that they will assist in creating herd immunity. Um, and a mandate may be the only way to achieve the herd immunity threshold that's needed, uh, to provide the wide community protection. Uh, and as I'm sure many of you know, that herd immunity is established when, uh, and for this particular vaccine, I suspect it will be between 60 and 80%, uh, of the population, uh, having developed immunity, uh, either by vaccination or, or have you been infected and recovered. But it is, you know, it's, it's, the concern is, uh, parents are concerned, and I think the general population is concerned in terms of the safety and efficacy. And, uh, there's just a, uh, uh, a dis somewhat of a distrust in the scientific community, uh, that has led, you know, many parents, uh, to be concerned about this. And I'm talking here about parents that don't fall into the vaccine hesitant parents, but are parents that have their children completely immunized, but are concerned about this particular vaccine when it becomes available.
Speaker 3:I do think that, um, you know, there's been a lot of politicization of vaccination as an issue. Um, and, you know, I think that the question of, of, uh, hesitance or, uh, faith in a Covid 19 vaccine, it does come out, uh, we'll be cleared up a lot in a couple of weeks. You know, we're in an election season where there's, um, a lot of talk one way or the other about, uh, what's going on with respect to policy, with respect to Covid 19, you know, after the election passes, I think there'll be more clarity, um, and, uh, really more, uh, of a tendency to, to trust what is coming out of the FDA and other, uh, bodies that are involved in, uh, examining and improving vaccines. Um, but you know, there's, there's also, as you're well aware, a, a significant dropoff in vaccination rates for the regular childhood vaccines because, um, parents trying to avoid, uh, exposure to covid 19 aren't taking their children, uh, necessarily to see their pediatrician for the regular visits and to get their regular vaccinations. Um, in fact, the federal government has, uh, just released an addendum to the prep Act, which lists all of the regular, uh, asip approved childhood vaccines as covered countermeasures to the pandemic because of the anticipation that there will be an upwelling in all of these other diseases, uh, because of this dropping vaccination rates for them.
Speaker 2:Speaking of, yeah, the vaccinations that children get typically once in their life. What can we expect from this vaccination? Will this be something in that order, or is this something that we're going to have more frequently, have to have more frequently?
Speaker 3:All of the, uh, data that we have to this point indicates that immunity to covid 19 is temporary. Um, there are, uh, primarily anecdotal, but still, uh, reports at this point of people who, uh, were sick with covid 19 earlier in the year, and have since become reinfected with it, uh, five or six or seven months later. Uh, it is quite likely. And all the, all the manufacturers, uh, tend to, uh, agree that this is how it looks, that this will be an annual vaccine like the flu. Uh, in fact, there are some efforts to make a combined vaccine. You know, a lot of vaccines come combined. We have measles, mumps, and rubella. You get one vaccine for all three of them. Um, there will, uh, likely be a combined covid and flu vaccine. And, you know, I've been discussing this a lot with people, and I think it's important to impress upon people the fact that Covid 19 is never going away. It is not something like, you know, when you think about the Spanish flu or the swine flu, it lasted for, um, a season or two, and then it kind of disappeared from the population. Those were just manifestations of, of kind of existing, of the flu of existing diseases. Um, COVID 19 is something that has newly crossed over to the human population. It's part of the human experience now. Um, and even with, uh, an effective vaccine, you know, that has the level of effectiveness that we typically see with, with good vaccines against 90 or 95% effectiveness, um, there will be a substantial proportion of a population that chooses not to be vaccinated, um, or in a given year, chooses not to be vaccinated. Um, and covid 19 will always be, um, as a disease, something that is deadlier than the flu, uh, where someone who gets a vaccine and the vaccine proves to be ineffective for them, will have a worse outcome than someone who got a flu vaccine that turned out to be ineffective for them. Um, where in the unvaccinated population, it will have, uh, a much higher death rate. Uh, and that's something that we need to be prepared for as a society, the fact that, um, we, we are likely to have a vaccine and we are likely to substantially reduce instances of covid 19 and substantially, um, reduce vectors for it spread in that way. Uh, but it's something that's going to be here to the same extent that the flu is here or worse, um, and, you know, will be, uh, a significant cause of death, um, going forward for, you know, the rest of our lives, unless some remarkable new technology is developed that is able to do away with viruses altogether.
Speaker 4:Brian, you touched on something that I think is, uh, is very important. And I guess the question really becomes, you know, why are there less childhood vaccinations being administered during the course of the pandemic? And even in the pre, pre pandemic time, there have been a rather growing, uh, vaccine hesitancy movement that you're, that in the United States, and I'm sure that you're aware of. And I, again, in part, it's, I think, uh, a distrust in the scientific community, uh, has, uh, caused many parents, uh, choosing to forego VA vaccines completely. But as I said earlier, during this pandemic, uh, I think the individuals that are not, uh, that are concerned about this covid vaccine are not individuals that are, uh, vaccine hesitant parents, but are parents that, uh, have completely immunized their children as best as they could up to this point in time. Now, uh, this, this whole idea of children not getting their routine immunizations during this covid period is very troubling because, uh, in the United States in recent years has been multiple outbreaks of measles, uh, and, uh, fortus costs. And in March of this year, when President Trump declared a national emergency in response to the, uh, pandemic, the ability to continue providing routine, preventive and other non-emergency care was and continues to be some in to some extent impacted. And on, on the 24th of March, the CDC c uh, posted guidance emphasizing the importance of routine well childcare and, and immunizations, uh, particularly for children that were two and younger, when many childhood vaccines are actually given, uh, the majority of the vaccines. And there were two data sources that were examined to, uh, assess the impact of the pandemic on pediatric vaccination in the us. And one of them was the, uh, vaccines for Children program, the vfc, and the other was the vsc. And the vaccine tracking system data from both sources indicated a notable decrease in orders for V F C funded a C I P recommended, uh, non-influenza childhood vaccines. Uh, and the, the client actually began, interestingly enough, the week after the National Emergency Declaration. And I think in part, for the most part, parents are concerned that bringing their children to their pediatrician or their family physician or their physician that takes care of their children may present a risk for getting the Covid virus. So parents are, in many ways, avoiding going to the doctor's office and to any other healthcare facility for fear of catching the virus. And I, I believe purely that physicians need to use, uh, analytics to assist in stratifying their pediatric patient population. And if they do this, this will allow them to then outreach to their patient families using, uh, email or texting or whatever, whatever source they would like to use, send directly to the parents and, and, uh, letting them know what the status of this, the, of the children's immunization is, and reminding parents, the parents to contact their, uh, physician's office to update their children's vaccines and, and making them aware of the, uh, security measures that the offices should have put in place, including the changing of office workflows, for example, to, to, to minimize contact between patients and other patients, and to help patients feel safe enough so that they can return to the office and have the children immunizations updated. Because if we don't do this, we're going to start seeing further epidemics and breakouts of some of the other trials of diseases that are not, that are not being provided.
Speaker 2:Well, one last question that I have for both of you, and not to put you on the spot, but do you have any idea of when we can expect a fully approved vaccine? Same.
Speaker 3:My thinking on that, and you know, this is from my conversations with people in the pharmaceutical industry who are working on the development of the vaccine, um, is that we are looking at April or May of next year. Um, that's kind of the, the timeframe that, uh, a lot of different manufacturers are coalescing on. Um, you know, there may be something that gets put out earlier than that, uh, you know, but it's not gonna be very much earlier. And there may again be something that is, uh, in sufficient, uh, shape and has sufficient evidence to be, uh, subject to approval and emergency use authorization sometime before that. Um, it would be remarkable if that were to happen before the end of this year. I think the FDA has said that they're not going to issue any e u a for any vaccine, um, for which they don't have, uh, I think at least two months of, uh, post, uh, phase three clinical trial data. Uh, and that's not something that any, uh, manufacturer in any of the trials has, uh, gotten to a point where they can provide yet. So, you know, I, I think that's the timeframe that we're looking at. Um, but realistically it may be, uh, three or four months beyond that. It may be, uh, into the fall of next year, even before we have sort of widespread confidence in a Covid 19 vaccine.
Speaker 4:Uh, I, I agree with, uh, I agree with Brian regarding the timeline. Sometime I'm thinking next spring, perhaps at the earliest, and I think there's another consideration here, and the other consideration is we can have a vaccine that may be shown to be, uh, effective and relatively safe. The question then becomes, at what point will we have enough vaccine so that we can immunize, uh, uh, vaccinate, uh, the entire population. And it's not just of this country, but I think it has to be a worldwide effort in order to go ahead and reduce this, uh, uh, this virus. So it's not just a com question of when the vaccine will be available. Well, when will we have enough vaccine to be able to accomplish what needs to be accomplished?
Speaker 2:Well, I would like to thank both of you today for this excellent podcast, this excellent discussion. Um, uh, today you have heard once again, Dr. Jerry Williamson and Brian Dean Abramson, thank you again. Thank
Speaker 4:You. Thank you, Alison.