Episode 27

April 15, 2020


Everything You Need to Know About Vaccines and COVID-19

Hosted by

Richard Miles James Di Virgilio
Everything You Need to Know About Vaccines and COVID-19
The Inventivity Pod
Everything You Need to Know About Vaccines and COVID-19

Apr 15 2020 | 00:41:26


Show Notes

What is a vaccine? How long will it take to get one for COVID-19? Are there are other alternatives? What about herd immunity? 

Our guest is Dr. Peter Khoury, the President and CEO of Ology Bioservices Inc.  He is an expert on vaccines and biologics and during his 30-year career, he has worked for the Bill & Melinda Gates Foundation, Merck, and Baxter International. Dr. Khoury has involved in international forums on vaccines, pandemic planning, and biodefense preparation.  




Intro: 0:01

Inventors and their inventions. Welcome to Radio Cade the podcast from the Cade Museum for Creativity and Invention in Gainesville, Florida. The museum is named after James Robert Cade, who invented Gatorade in 1965. My name is Richard Miles. We'll introduce you to inventors and the things that motivate them, we'll learn about their personal stories, how their inventions work and how their ideas get from the laboratory to the marketplace.

James Di Virgilio: 0:37

Welcome to another special edition of radio Cade. I'm your host James Di Virgilio. Today we'll be discussing vaccinations and COVID-19, there's a lot of information, misinformation questions that you have that we have. And with us today, we have an expert in the subject of not only vaccinations, but also manufacturing them. Dr. Peter Khoury. He is the president and CEO of Ology Bioservices Inc and that is located in Alachua, Florida. He's been involved with vaccines and biologics for a majority of the 30 year career employed by organizations, such as the Bill and Melinda Gates foundation, Merck and Company and Baxter international. Dr. Khoury has been an invited speaker for many international forums concerning vaccines. Pandemic planning, biodefense preparation, and has worked on global threat programs against biologics with many ministries of health and oversight committees for large events, such as the Olympic committee. Dr. Khoury, thank you so much for joining us today.

Dr. Peter Khoury: 1:34

Thank you for inviting me.

James Di Virgilio: 1:35

So the role now that you and Ology are playing in the COVID-19 crisis is essentially to manufacture vaccinations amongst other things which are going to unpack, but it seems prudent to start with asking a simple question, but one that is now talked about a lot. What is a vaccine?

Dr. Peter Khoury: 1:54

Probably the simplest answer is a vaccine is a protein that stimulates your immune system to induce immunity or induce antibodies. It's exactly as if you were exposed to the disease. So when a healthcare worker gives a vaccination, they're exposing your immune system to something that looks very similar to a particular virus or bacteria, which helps your immune system then react quickly when you're exposed to the real infection, it has, what's called immune memory and it remembers, ah , I've seen this before and it starts immediately in a sense, producing these antibodies to fight that infection.

James Di Virgilio: 2:46

Now , these viruses, I'm a big fan of game theory are essentially alive in a sense, right? They're adapting, they're changing and your body's doing the same. So if you get a good vaccine and it produces the proper, it's possible that the virus then counters that with a different response of sorts, right? Depending on what we're looking at,

Dr. Peter Khoury: 3:06

It's amazing that a virus can be that smart, that it quickly can adapt, or it's in a sense survivor of the fittest. It's just like an antibiotic. When you have antibiotic resistant organisms, let's say you have a hundred bacteria and you put an antibiotic on it. It kills 99 of them, but there's one that has a genetic sequence that makes that a little more difficult to kill. And if you don't take the full 10 days of the antibiotics, that one tends to still live a little bit and start rowing . And all of a sudden you've got a big colony of this that is intermediately resistant. And then you take another dose of antibiotics for another 10 days, but only take five days of it. And you think it's gone away out of those hundred. There's one that's now resistant. So it's surprising how bacteria or virus can quickly adapt. It's a numbers game is really what it is. There's genetic mutations that will cause one of those virus to have mutated enough that it's getting around your immune system in there for it's called drifting and shifting when it does that. And you see that with influenza in a sense every year. And it's a big guessing game on which strains of flu are included in the flu vaccine every year. If you're lucky, you end up targeting a protein in the vaccine that does not mutate, and then you're golden , you don't have to worry about.

James Di Virgilio: 4:42

And that's a lot of what's going on right now with COVID-19. So on one hand, you read articles, we've found the sequencing, we know what's going on. And then on the other hand you read yet, but that's really a small portion of the battle. We don't know how it's going to react when it's put into live testing with human patients and subjects. When we're talking about vaccinations, how successful against a novel virus like this one, which I believe shares a genome with SARS one to a large extent, but how successful are we? Once we identify step one, this is what it looks like and is at getting it to actually work in people.

Dr. Peter Khoury: 5:17

That's a great question. We are very fortunate as it seems that this Corona viruses not doing any real shifting or drifting at all, and you are correct. So the SARS and mirrors virus, so the sudden acute respiratory syndrome in the Mideast respiratory system viruses were also Corona viruses, which are a, I think it's a genus or a species of virus themselves. And this is just another one. Now this one, for some reason, the human to human transmission has really taken off. And that's why we've now see this pandemic. And they watch this pandemic cascade around the world. If there were this shifting or drifting, they'd be able to take samples from different areas and find out when they run a DNA gels, that there has been some changes in the sequences, but they're not seeing that at all. So that's very fortunate that we don't see up that allows them vaccine R and D personnel to try many different approaches to developing a vaccine. And the most common youth approaches in the past were what they called an inactivated vaccine or killed vaccine, which they take it and they either irradiated or they chemically treat it till it's killed. And then they inject it into you and your body will develop antibodies against that, or what's called a live attenuated vaccine, which they select specifically for a strain of that virus that when you're infected with it, you get what's called a subclinical infection. You develop antibodies, but for some reason you don't end up getting the fever and the respiratory problems and all of that. Instead, you just sorta produce the antibodies for it. And so those are widely used, but there are now some very complicated ways of addressing tough issues with vaccines. HIV for example, that's been around since early eighties and still, there's not a vaccine available for that. I always look at that as the big mystery for developing a vaccine, we were awarded a contract for what's called a DNA vaccine, and this was with a company called Anovo. And this is one of those very complex approaches, which we feel very confident will work, where they take a piece of DNA that codes for what's called a spike protein. They put it in a plasmid in, this is then put in a syringe and injected using a special type of what's called electroporation, where it opens up your cell to take in this little piece of DNA in this circle called a plasmid and it uses your own cellular system to make the protein. So your body starts producing this protein, some of your cells do. And then your other cells that normally produce antibody will see this protein being made and start producing antibody against it. So it's a unique approach. It can be done very quickly and low cost, and that seem important thing. And one of the reasons why this approach is being looked at.

James Di Virgilio: 8:41

Now, how often would this type of approach be used and things people are familiar with vaccinations for like an influenza. And , and if you don't know anything about vaccines and you're more like me, like you mentioned, there's like seven or eight or nine or 10 different types. There's different ways you can create a vaccine. This is one of them. How often has this been used successfully in other.

Dr. Peter Khoury: 9:02

So it's very novel. I don't know of a DNA vaccine yet that has been put on the market because it's such a new approach. And in fact, if you look at all the vaccines that have been available for the last 30 years, all of them basically fit into five different approaches. The two that I had mentioned, and then there's conjugation. There's, polysaccharide, there's another one that is escaping me just basically four or five different ways that vaccines are currently manufactured. So some of the ones that people are talking about now are these very novel biotech approaches that appear to be safer, faster, lower cost, ways of vaccinating. So I'm excited that this innovations finally being used and may produce a vaccine that is both affordable, can be produced in large quantity and available may be sooner than some of the older methods used.

James Di Virgilio: 10:04

And let's unpack some of that because if we were to find using a traditional method, the actual vaccine that works, we have to go through these different phases. So step one, we're going to start with maybe animal testing or something similar. I know chicken eggs tends to be a big one with a lot of things, but you can't do that with coronavirus. So that's a problem that doesn't work. And then I know that in only 16% of the cases, do you make it from phase one to phase three, with a working vaccine? And then how often does your vaccine work? It might only work 50% of the time. And is that good enough? Right? So you have all these hurdles to overcome. That's why it takes a long time. 18 months tends to be the soonest. People think it can happen. How different is that with your solution potentially.

Dr. Peter Khoury: 10:44

So ours also about 18 months, just the clinical study. So not talking about the preclinical animal studies, but when you actually get to the point where you're starting to inject it in humans, it's usually between six and eight years to get through the phase one, two and three. So phase one normally is just a very small study with a few adults to make sure that it's safe. And they do some where they look at the effectiveness on those few people. And if no one kills over in a sense, or they're getting some kind of immune response and there's at least something that they can measure, they'll go into phase two, which is larger, maybe a couple hundred people in some of those are age appropriate. Then. So if they're trying to go down to infants, they'll then throw in a few infants into that study and they'll do, what's called a dose ranging study and look at what's the optimal dose that you would use for them. And they really start looking at the side effects and other things cause they have a larger pool to draw from once that's through and they get the go ahead to go on to phase three, they go into this much larger trial than some of these, especially with infants can be tens of thousands because they're trained to pick up the background noise, a very small number of crucial side effects that potentially could happen. And they're taking very detailed measurements of how safe and effective it could be. Once it gets to that, it goes in front of the FDA. It gets approval for use or rejected, but usually by then, they've spent hundreds of millions of dollars. Hopefully it gets approved, but even then many companies commit to what's called a phase four study, which is a post-marketing commitment to follow up with people that have been vaccinated and also submit to the FDA. Anytime there's adverse events, send them information. So they keep track of it also. So it's very useful. I've got to say for every vaccine that goes through, there's probably 50 that don't make it to the market. So there's a lot of money spent on R and D. Our government's been very good at funding, quite a bit of novel R and D, which has been great. Healthcare is expensive. There's no doubt. We're one of the few countries that really support innovative research and development. And I hope that people still continue to do that. I think that any shorter than a year and a half to do those studies, you would have to do it on what's called a patient name basis where people would have to sign a form and say, I understand it hasn't been fully tested, but I'm willing to take it untested because the risk benefit ratio to me is such that I'm willing to take on that risk.

James Di Virgilio: 13:39

And that's something like Ebola, right? When Ebola came out, people were saying, well, we can't even have a control study because nobody wants to placebo. Just give me a chance with this vaccine versus letting this run its course, which creates difficulty in developing a vaccine. How often are these vaccine side effects worse than what we're dealing with? Is that something that's frequent or is it pretty unlikely that even a testing vaccine is worse than what someone would already have?

Dr. Peter Khoury: 14:04

That's a great question too. The only one that I can think of that they had some problems with. And if you go back and look at the data in hindsight, they had overreacted. Some was with the original Rotavirus vaccine, which is a terrible issue. It's a diarrheal disease that infants get. And when they first did the studies, the studies looked fine, but it wasn't picking up these incidents of what's called intussusception, which is when the intestines fold in on themselves. And once they started using it widely around the United States, within the first two or three months, I had all these infants die of this intussusception they immediately pulled the vaccine from the market. People were in an uproar, but more children died of Rotavirus. And another great example is when you look at polio vaccine, so polio, which still hasn't been eradicated, there's still a few places around the world that have polio. They were using oral polio vaccine for years, but in one, in a million cases, when a child gets oral polio vaccine, it converts back into wild type polio. And the child actually ends up getting polio. So one in a million children end up getting polio from the vaccine, but the other 999,999 children are all protected and fine, but they were so upset about that one child that a lot of money has been spent to develop alternate vaccines for polio.

James Di Virgilio: 15:41

Yeah. I find that to be interesting. And I'm really glad we're talking about this now, because to me, everything in life is a risk reward continuum. It's very rare that you get a very pure two. Plus two is four here all the time. This is the obvious decision. Most often, it's that sort of decision. Well, if we do nothing, we have this. And if we do something it's possible that we have this side effect, we don't know, but what is better than starting with our baseline. And that's a really good contextual answer. So it sounds like the majority of vaccines are not generally super risky, worse than what we're trying to fix, but maybe they're not as effective as others. So if I'm a company, big pharma or otherwise, and I want to manufacture this, right, we have the lab that discovers the vaccine. They come to me and they say, James, we want you to manufacture this. How likely am I to take this on? Because the numbers seem very low. It seems likely I'm going to lose a lot of money and not all of these outbreaks we're dealing with. Come back again. So maybe I develop a vaccine and now it's sort of just gone. How likely is it for companies to want to fund these initiatives?

Dr. Peter Khoury: 16:39

That also was a great question because all we know right now is that we're having a pandemic and we're not clear whether it's flattened out or not personally, I don't think it has yet. And I think still may be the worst is yet to come. And I hope it doesn't act like a influenza, a pandemic where you get a small wave. And then a few months later, maybe this fall or a little later, you get a much larger wave that travels around the world and will kill hundreds of millions instead of a million or two. So I'm just hoping this does not happen or that it takes on the route that influenza does where it's North hemisphere for half the year, then goes down to the Southern hemisphere, then swings back up to the North. They're not quite sure because we haven't had the experience yet with this Corona virus. What they do now is it's not like SARS. It's not like MERS where it was here for a few months and then suddenly just sort of disappeared. This just seems to be staying. So with that, the question is, will it become a yearly vaccine for people. Will there eventually be some drifting of it. So they'll have to be a new vaccine every year. How profitable will it be for companies? Will companies start looking at other emerging infectious diseases and start the research and development earlier, or will the government fund that early research and development? Because there are emerging infectious diseases around the world that we don't have in the United States, but make some background noises in other areas that could easily be the next coronavirus . So when do you start investing in that? So you're a year ahead of where you are now.

James Di Virgilio: 18:32

And that's a great topical point to discuss. You mentioned something earlier about research being done, and I'm not sure how many people know this, but the medical research done in the US and innovative work like you're mentioning is a hundred times or whatever the number is. It's so significantly more than anywhere else in the world. If you look at that graph, it's the US and everyone else is tiny. I think Germany is second on that. And their infinitesimal compared to what's done here. There's a lot of negative emotions around what big pharma and other stuff does. And we're not going to get into that. Other than to say that it is a fact that so many dollars in this country go towards trying to solve these problems. And then here we are with things that are unpredictable to a certain end. Now you worked for what maybe now has become the most famous right kind of foundation. There is with the Bill and Melinda Gates foundation, looking at trying to solve this problem. Bill Gates has been beating this drum for a long time. This is the biggest threat to humanity. What you just mentioned was sort of getting ahead of this. Is there a way for us, was there a way for us, will there be a way for us to sort of prescriptively try to get ahead of some of these things you just mentioned, things that are bubbling up elsewhere, we know kind of exist. How do we do that?

Dr. Peter Khoury: 19:34

So there actually is a list that is kept by the government. The CDC has one, the world health organization has one . If you go on their websites, they talk about emerging infectious diseases. And in fact, the Gates foundation has an area that focuses on these emerging infectious diseases also. And so people do keep tabs on those large pharma, looks at them and says, there's no value to us because we lose money, investing on things that we think are going to be valuable, but it's just hard to solve the problem. You think of the billions of dollars that have been spent on HIV vaccine instill of course one is not available. So they think about that, but then they look at something that's just emerging, especially if it's in the developing world, they say, it's just not worth that someone else should fund it. Gates foundation, fortunately does, which is great. The welcome trust is another, that does. So there are some that do that funding. The US government will fund some of them. If they feel that there may be a threat of it, either coming to the US especially some of the vector diseases that are transmitted through ticks or through mosquitoes, or could be used in biodefense, which is another area that people don't pay that much attention to. We remember the anthrax scare and what happened. Then that's another area that I think probably needs more focus from all governments. So both pandemic planning for other things than just influenza in also good preparation for biodefense.

James Di Virgilio: 21:17

And there's this interesting thing. When you think about humanity, that always strikes me. I'm an investor professionally, and with investing, nothing is black and white. It's a lot of study of people and behavior and things that we know to be true. And one thing that is definitely true is we're not very good at predicting anything as humans. In fact, we're the most accurate at predicting the weather and we can go about 48 hours before that falls off a cliff of actually being significant statistically. So when it comes to these really complicated problems, I often think of the three body problem. You can know A, and you can know B and you can know everything about factor A and factor B, but you can't know C you just can't know where it is. And I think people sometimes pale to understand how complicated and chaotic these systems are. And just because we know A, and B does not mean that we can ever predict C, it's not easy. It's not simple. It's not a one week or one month process. And even with our best foresight efforts, we may never get the prediction. Correct. And then there goes a lot of money into something that may yield nothing, right? And you're kind of always doing this where, like you mentioned, do I put my dollar? So now that we're facing COVID-19 and actively, we know we need to solve this problem. The engines are running, the creativity is going, innovation is happening. You are mentioning something that's brand new right now with regards to trying to save this. And then there are also some other techniques out there. Tell me about using plasma from recovering patients to protect the most seriously ill what's going on with that.

Dr. Peter Khoury: 22:41

Yea I know that that has been on the news and it is an effective way of treating. So what they do is they take convalescent plasma from patients that have recovered, because it has antibodies in it. And those include antibodies that protect against COVID-19. And it's a fast way of developing. What's referred to as hyper immune state, where you have more antibodies than normally your body would produce. So they take the most ill people in, they'll put in this convalescent plasma, which they know contains these antibodies while they contain a lot of antibodies and other things. But for sure it contains the antibodies that help that person recover from COVID-19 and it boosts their immune system of the target patient. That downside is the possibility of their body in a sense rejecting it, it can cause a negative immune response due to something in that plasma or in this has happened in the past a yet to be identified foreign item, which could cause issues to recipients later on. And that's with anything that's blood related. I mean, we saw it with HIV at the very beginning where people were getting blood transfusions, you saw with it mad cow disease at times where prions were transmitted through blood transfusions, but there is another solution. And actually we're working on it. We were given a grant to work with the Vanderbilt University medical center to produce what's called a monoclonal antibody. So what they do is they take the antibodies from a convalescent patient, and they're able to find out which specific antibody is the one that works the best. And they clone only select for the cell or the piece of DNA that produces that protein, that codes for that antibody. And they're able to replicate that in produce just that one antibody, and you can do it in big fermentors or bio-reactors. And you produce these monoclonal antibodies, which are all exactly the same and mass produced . Those had a fairly low cost that can be much faster than vaccines. Now you may see monoclonals before the end of the year, and those most likely will go to healthcare professionals, those immediately on the frontline for protection, and also those that are most critically ill would get these monoclonal antibodies. Those will definitely be lifesavers. And I suspect that the first will be out quite a bit before the vaccine will be,

James Di Virgilio: 25:30

That's like a triage solution, but not the best longterm. Is that a three ?

Dr. Peter Khoury: 25:35

Yeah. It's not long term because eventually your body will remove those antibodies. So you're talking a few weeks protection when you're talking a vaccine, you're talking usually a much longer term protection of years, if not the rest of your life, sometimes vaccines. If they elicit a longterm immune response, you only get them once. And that's that you're protected the rest of your life.

James Di Virgilio: 25:59

So the way out of this is seemingly to have a vaccine. That's what people are saying.

Dr. Peter Khoury: 26:03

It is.

James Di Virgilio: 26:03

The world's not going to truly relax into, we have a vaccine or this just maybe mysteriously disappears, which seems very unlikely at this point.

Dr. Peter Khoury: 26:10

Right? And even if it disappeared, there's always the chance of it coming back. The same with SARS , the same with MERS. I mean, all of those could somehow reappear.

James Di Virgilio: 26:23

So we need to get a vaccine. We know that it takes a long time to actually manufacture a vaccine because it's not that simple. It's not like we have all the supply available in the world to produce a vaccine. We can't just in a day, produce enough to give to the whole world. Right. So even when we get it right, it takes a while to actually produce enough to give out to all the people that need these vaccines. Here we are in the US in a country that has all of these resources. What if we're not in the U S what if we're in a developing country? What does it look like for them?

Dr. Peter Khoury: 26:49

Yeah. So in the US yeah, we're fortunate. We have a lot of vaccine manufacturers, large manufacturers here, and in the time of pandemic borders closed down. And so if you don't have vaccine manufacturing on your soil, it can be a real issue. That's times where the, WHO, UNICEF the large manufacturers get together and say, we need to do something for the developing world. And they actually will donate vaccines that are used in those areas. I know of some manufacturing processes, and we actually in our building bring in some of these new types of manufacturing, just on a trial basis. And some of them are small enough that they literally could be put in a shipping container and take into areas where vaccine needs to be produced immediately. But then you run into problems with clean water and power and other things. But someone has taken the first step to develop a concept of manufacturing that now whether you can get a turn on solar power and you ship in water, where that, or you make the manufacturing process somehow different, I think eventually they'll have something that is a vaccine in a box that you could ship to these countries that will produce low cost vaccine very quickly. The smartest thing right now is to stockpile vaccine. If you can, if you're a country and you have the wealth to do it, and you don't have vaccine manufacturing, if there's a chance for like the release of smallpox , for something as a bio threat, you may want to stock pile some of that vaccine, because if it ever happened, you're going to wish you had.

James Di Virgilio: 28:44

Right. I have something there. So herd immunity is talked about a lot, right? I've seen that we need maybe 50 to 60% of the population to have herd immunity. And it seems like there's a lot of misconceptions starting with the UK, which that was their original strategy. Then they kind of shifted away from it. Now, maybe going to go back to selective release, to build herd immunity, assuming that this goes more of the route of HIV for a little bit, it takes longer than 18 months to get a vaccine, or are we able to build herd immunity without a vaccine? Or is this something where we would just continually have recurring outbreaks of the same significant level year after year?

Dr. Peter Khoury: 29:21

It depends on what the virus does. If the virus goes away, you'll never develop herd immunity. Just the people that happened to come down with it . The same with SARS. I'm curious if someone had SARS, are they immune to this Corona virus? That'd be interesting. I'm sure someone's looked at it because there may be some cross reactivity, the two, but eventually enough people would be infected and recovered that you'd reach that 50 or 60% mark. And then it's again, a game of numbers where the virus no longer is transmitted rampantly through the population. And so exposure risk goes down dramatically. When you reach that. The other approach, when you do have vaccines or monoclonal antibodies, is you do ring vaccination, where you find an area where people are infected and around it, you vaccinate everyone in the area. And so it's contained. And that actually has been shown to work very, very well. Now, if in Wu Han, they had identified and raise their hand very early and put something in place where they either stop the movement of people within that area, which is probably all they could do. Then it probably could have been restricted much, much more, or if there was a vaccine available, vaccinating everyone around the city and making sure people didn't move out until they were over it.

James Di Virgilio: 30:49

Right. And that's the key is stopping the transmission. If we have five people that are immune, got a vaccine there, then all of a sudden you have the one sick person, the virus can't get passed on, which is obviously the goal. So let's spend just a few minutes talking about something that maybe is been confused or is confusing. Are we flattening the curve, therefore reducing the total number of people that will get this, or are we just shifting the total number of people to get this to a lower monthly average? So basically same total are going to get it regardless, but we're just spreading it out.

Dr. Peter Khoury: 31:19

See we never know again, because we don't know if the virus will just dissipate and disappear. If it doesn't then as you lower the curve, you're maybe spreading it out. But when you spread it out like that, the vaccine comes out a year and a half later, then there's a lot of people that still can be vaccinated that haven't had it. And so there's a much lower risk that they're going to get it and then die, or have significant morbidity in mortality from the actual disease itself. So flattening the curve helps in two ways. One is if the virus stops circulating, more people were suffered the consequences of having the disease. The other is if it continues to circulate, you're buying yourself time to get something that could, in a sense, truncate people getting sick, which would be the vaccine in this case,

James Di Virgilio: 32:14

Is there a consideration to extreme flattening of the curve, which we know will potentially lead to more people, not getting it in the short term, but with the other side, which is how much damage do you do to society. And there seems to be two effects. We have Spanish influenza where most cities did nothing, and they took the full brunt of that peak, heavy hits, 50 million die. And then you have what we're doing now, which is the first world's response to really do exactly what you just said. Is there a balance and consideration as a medical person, do you think of what do we do over here economically, if everyone loses their job for a year, or is there just, this is the way we have to do it in order to reduce these cases?

Dr. Peter Khoury: 32:51

That's a real difficult one because as I look around me and I see the unemployment rates skyrocket 10%, 10% last night, I was listening to the news and I just couldn't believe that it's gone up so much and that's just in the US let alone other countries. And I think it's going to definitely cause a global bump, how quickly we recover from that. I think we're pretty wrestling and the whole world will recover, but all of the ships are going down at the same time. So the question is, how much impact does it really have on the economy? If the whole globe is shrinking, if everyone's economies being hit by the same thing. And that's the part I don't understand is it could be a lot worse if it were just the US and everyone else was still thriving. That probably would be even worse for us. But when everyone's going through the same hurt, it's still bad. There's no doubt about it because production's down. People just don't feel like they're productive, which is also a mindset thing. It's, it's not good for anyone. That's a real tough question to ask, but there is a trade off there. There's no doubt about it. And if there were a way to protect everyone and they could go to work, and we knew that they stopped shaking hands and everyone stayed exactly six feet away from each other, eventually the virus would go away.

James Di Virgilio: 34:20

And I think that's, what's interesting is we tend to look at these things in static environments, but the reality is every day we're learning more. And , and even though we know that maybe there could be, like you said, a rebound in the fall, everything we're learning every day helps to apply how we might return to normalcy. And I think one thing I've really learned is that we respond very well as humans. We're not good predictors. We're excellent responders. We're very creative. We're great problem solvers, but we have to have the problem in front of us, which we now have. And like you mentioned, I think the doomsday scenarios of us flattening the curve and no one doing anything for months is probably unrealistic because there will be some tactical solutions to get people back. Bill Gates, himself, I saw just said, I think a day or two ago that the global economic reaction to this will not be immediate recovery. This will take time, which I think he's totally correct. And there's also something else that I think has gotten lost in this, whether the government should have reacted faster or slower or whatever the case may be. Some things in life are beyond our grasp to understand right away, could China to something earlier. Absolutely, will that hopefully be a model for the world later? Yes, but we don't have a clear solution forward. Like you mentioned, we hope that we're thinking of the trade offs. If I choose this course of action, hopefully I won't bankrupt the whole world, but if I don't choose that course of action, how many more people get it right now? Can we handle every, all these questions? They're very difficult to answer. And so I think day by day is the course to say, what's the new data say, what are we doing? And ultimately, when it comes to a vaccination, is it helpful to have more testing at all? Or do we already have all that we need on the vaccination front to get all that research done? Testing is irrelevant to actually developing a vaccine.

Dr. Peter Khoury: 35:51

I think testing is very important. There's no doubt about it, but how much of it can be done concomitantly with administering it to people that are at high risk, let's say so that's when you get into that whole risk benefit again. So the very first people in the phase one and two, should they be the emergency room workers cause you now, Hey, if it works, that's great for them. If it doesn't work, maybe a few will have some issues, but there's a chance that it's going to work because some of these are pretty tried and true methods. It's a real trade off. And it all comes down to that risk and benefit. People tend to like pointing their fingers at the FDA, but the FDA has a job of keeping people safe. And when you're administering in our country, over 300 million doses of this, they give a vaccine to every person in the country. That's a lot of people, that's a lot of lives that you're taking responsibility for, but there is an urgency to , so again, there it's that whole risk benefit.

James Di Virgilio: 36:55

Right? And I tend to be someone who thinks central governing organizations are slow and inefficient in general. Because again, it's hard for us to prescriptively know what's going on, but in times like these there's things that I think are being done well, which the FDA has greatly relaxed the hurdles that exist to create a vaccine. So no matter how you feel about the FDA, if you're more like me, the things I'd like to see it be a little more expedited in times it's happening now. And in fact, I think it's safe to say, if we just got rid of the FDA right now, it sounds like the vaccination time wouldn't be any faster than 18 months at this point in time. Or if it was, it wouldn't be significantly more, right ? So we can take that off the table. The FDA is not going to materially affect the speed with which we're creating a vaccine for COVID-19, which is a good thing to get out there. All right . This has been a wonderful wide ranging expert discussion on vaccinations. Certainly we applaud Ology for doing something that's brand new, which is really neat, right? This DNA vaccination. We look forward to hearing more about this as we go on to conclude the podcast. Is there anything that we haven't talked about yet that you feel is something you'd like to discuss?

Dr. Peter Khoury: 37:57

I feel like I'm the most fortunate CEO in the world. I lead a company that is still privately held and with a large majority of our shareholders that are current or past employees. So many of them are really dedicated individuals. It really see the value that we bring to the market, not just bottom line profits. It allows us to truly support programs where we can combine the measurement of profitability and potential life saved to what Gates foundation does when we decide I'm bringing in new work. So I mentioned that we do work with the government and we do a lot of commercial work with everything from small laboratories to large multinationals. But we also do work for NGLs is like the Gates foundation and others. That really is not all that profitable. And I know that these doses are going to developing world countries and whatever, but my team who, as I said, are everyone that joined their company is given options for shares. The first day they joined, because I believe that if they're invested in the company, that they will always do the right thing, they'll always raise their hand when there's an issue. And they'll make sure that we have the best quality and we're the safest. And they're the ones that agreed that they don't mind taking a little less money if we're helping to save lives in doing so. So I'm still proud of them in taking that mindset on it. It's a lot of the younger, what I'd call millennials, the younger crowd that really likes that. And when we bring in new programs, we have to sit everyone down and explain to them exactly what it is and how it's used and what the diseases and how many people died , because they want to understand exactly how they're helping the world and God bless them for doing it.

James Di Virgilio: 39:58

Yeah. Love your neighbor as yourself. Right. And there's a lot of that going on now, there's one silver lining to something like COVID-19, it does bring the world together and makes you recognize there's really no such thing as race or gender difference or things like that. Because at the end of the day, we're a human race and we're all people and this virus doesn't care. It doesn't at all about the fact that you're a different color from someone else that does care that you are human. And like you mentioned, we can care for our neighbors. We can care for those that have less resources than we have. And we should use that if we have the ability to assist. And the culture at your company obviously is doing that from day one, which will I'm sure leads you to better results in the long run. Anyway.

Dr. Peter Khoury: 40:34

It, will I'm sure. Thank you.

James Di Virgilio: 40:36

Dr. Peter Khoury. Thank you so much for joining us. This has been absolutely fantastic. We've certainly enjoyed visiting with you and for Radio Cade. I'm James Di Virgilio.

Outro: 40:45

Radio Cade is produced by the Cade Museum for Creativity and Invention located in Gainesville, Florida. This podcast episodes host was James Di Virgilio and Ellie Thom coordinates, inventor interviews, podcasts are recorded at Heartwood Soundstage, and edited and mixed by Bob McPeak. The Radio Cade theme song was produced and performed by Tracy Collins and features violinist, Jacob Lawson.

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