Welcome to Inland Marine Underwriters' Association's webinar, COVID-19 Vaccines, Medical Insights, Logistic Issues, and Claim Scenarios. I'm Lillian Colson, and I'm happy to introduce this timely and relevant topic today. I'd like to thank everyone who's joined us. We have over 130 attendees today, and we look forward to sharing. Please note IMUA is using a new platform to deliver the webinar today called GoToWebinar. So before we get started, we'll go over a couple of quick housekeeping items. To help reduce strain on your local network, we suggest you close all unnecessary browsers and internet-reliant programs. That's unnecessary, not necessary. You'll find your attendee control panel on your screen, and it minimizes by default. So when you'd like to expand that, you click on the orange arrow and uncheck the auto-hide option. If you have questions for our presenters today, you have two ways to ask questions. First, you may use the Q&A box to type and submit your question, and then we'll share them with the presenters. After the first presentation, Dr. Mueller will open up the Q&A, so then we'll ask your questions then. And then after the remaining three sessions, we'll open up the Q&A again. We also, you also may ask questions by opening up your microphone, raising your hand and opening up your microphone. And then we'll, once we select you to ask your question, we'll let you know. And after you ask your question, you'll close your microphone. Most of us learn better in an interactive environment. So to encourage your participation today, at the end of the webinar, we'll award a 25 Amazon gift card to two attendees who are the most engaged or have the best questions. Please be aware of the IMUA statement. Today's webinar is hosted by the Northeast Regional Advisory Committee and the Transportation Committee. So they brought together many insurance disciplines on this one important topic. A special thanks to the ad hoc group listed here who directed the content today, and also to Eileen and Ali Monreale who worked close with today's presenters to coordinate this webinar. Our presenters today will cover Medical Insights by Dr. J, Transportation Logistics by Andrew Boyle, Risk Management by Barry Tarnas, Claim Perspectives by Jean Gardner, and then we'll have a moderated Q&A session. So please be sure to join us for that. And we'll also have a Q&A session with Dr. J and Dr. Monreale. And we'll also have a Q&A session and we'll have a moderated Q&A session. So let's begin with the bio of our first presenter, Dr. Jorma Mueller, also known as Dr. J. Dr. J grew up in Massachusetts and attended medical school at Mount Sinai School of Medicine in New York City. Graduating in 2004, he completed his emergency medicine residency at NYU and Bellevue Hospitals in 2008. Dr. J practiced for 10 years at Leahy Hospital and Medical Center as a senior staff physician. He currently lives in Australia and is the co-director of the emergency department at Mount East Bay Hospital in remote Queensland. Dr. J sits on the Queensland State COVID Working Group. Next, we have Andrew Boyle. Andrew Boyle is the co-president of Boyle Transportation, a specialized trucking firm that provides exceptional quality, safety, and security to select clients in government and defense and life sciences. Prior to returning to the company in 2003, Andrew was an investment banker with J.P. Morgan. He earned an MBA from Northwestern University's Kellogg School of Management and a bachelor's degree from Bowdoin College. Andrew is the vice president of the American Trucking Association and a board member of the American Transportation Research Institute. He serves on boards and committees of several nonprofit organizations, including House of Hope. He's also a spectacular youth basketball coach. Barry Tarnas is senior marine risk management specialist and vice president at CHUBB. He is a certified marine surveyor and a certified packaging professional. Barry is the chair of IMUA's Lost Control and Claims Committee and a member of Technical Services Committee of the American Institute of Marine Underwriters. He's also on the advisory board for the Pharma Security Coalition. Dean Gardner Esquire is the chief executive officer at Central Analysis Bureau, also known as CAB. For more than 30 years, she was an active litigation and coverage attorney in private practice. Her national practice focused primarily on transportation and logistics, including inland marine property and commercial auto insurance coverages, where she represented varied insurance carriers on both coverage and defense issues, as well as the representation of trucking companies, warehousemen, and other logistics providers, assisting them in operations and in risk management. At CAB, Dean is involved in analyzing data and determining the trends in the transportation and related insurance industries to allow these industries to understand exposures, know they're insured, and complement a particular appetite for risk. She also writes the monthly bits and pieces report, which the industry relies on. IMUA is incredibly fortunate to have had Jean, Barry, and Andrew as past IMUA presenters on a wide range of transportation-related topics. And I'm excited for all of us to have access to this esteemed panel of presenters in this virtual room today. We'll start with our first presenter, Dr. Jay. Welcome. Hello, and thanks for having me. And greetings from Australia. Let's just see if the slides are moving. So here we go, we'll talk a little bit about COVID-19 vaccines, where we are, how we got here and kind of what's next. And it's not all doom and gloom, hopefully things start to sound hopeful. Just a little bit about where I'm calling from, I work in a remote emergency department in a city called Mount Isa, which you can see is kind of in the northwest of Queensland. So we're about a thousand miles from just about anything and we cover a geographic area the size of Texas. It's a mining community and an aboriginal community. And I sit on the state COVID committee. I have a background in lab science, including working with RNA, and then I switched to sort of meat and potatoes medicine. So I understand the science of it, but my interest is probably the same as yours. What's going to keep my patients safe, what's going to keep my family safe, and what's going to keep me safe, actually. So we'll talk a little bit about this pandemic. So this is the virus that we're probably all familiar with now, probably everybody's become a little bit of an expert, it has RNA as its genetic material inside it. The important thing to think about is that there's a spike protein on it, and the way that this virus gets into your cells is by attaching itself to a receptor called the ACE receptor. And you can think of that as a lock and key type thing. So the spike protein is the key, the ACE receptor is the keyhole, and when they fit together, it enters the cell, like the same way you'd gain access to a room by using a key. If you learn any bit of science today, we try not to make things too nerdy, but if you learn any bit of science, remember DNA makes RNA, and RNA makes protein. It is almost impossible to go from RNA back to DNA, except in very special circumstances, and you can't go from protein back to RNA any more than you can go from baking a cake and turning it back into eggs and flour, you just can't separate things out that way. So there's a lot of misinformation about which way things move, and we'll talk about that in a bit. So COVID-19, SARS-CoV-2 is the virus, COVID-19 is the disease it causes. It causes infections by droplets, droplets are little drops of fluid that you can sneeze out, move around, and they fall to the ground within seconds, so you're probably protected with a surgical mask from those, at least moderately efficiently, and you certainly don't spray them on people. It's also transmitted by aerosol or airborne, that's accepted now, and if you're in a dense airborne area, you probably need a mask with a little bit better filtration, so we're all familiar with the N95 standard now, and potentially transmitted by surfaces too, which I've essentially stopped worrying about, because it's such a minor form of transmission, unless you're working on an active COVID ward where everyone's coughing out COVID, and you just don't need to worry too much about surfaces. The incubation period is two to 14 days, a bit longer with some of the new variants we're seeing, so we're seeing some people in Australia who are going positive when they come back from other countries at 17, 18 days, which is a problem, and the challenges continue to be testing, access to testing. With PCR testing, the problem is false negatives. There are essentially no false positives. With the rapid antigen testing, which you'll be able to buy in a drugstore, it just hasn't lived up to its promise yet as being accurate, and a very variable clinical picture, so that's the hard part for people to understand, is that this can be the sniffles, but it also can be the intensive care unit. On the left is a normal chest X-ray. You can see clear lung fields adjacent to the heart, and on the right, you can see a chest X-ray filled with COVID. Just waiting for the slide to catch up here. So how does COVID kill you? It kills you by a combination of a viral pneumonia and blood clots, which get into your lungs, and you can see, again, this is a CAT scan. The black areas here are normal, healthy lung tissue, and over on the right, we go through a couple of CT scans. You can see in these black areas that had normal, healthy lung tissue, they're kind of getting patchy, but it doesn't look that bad. That's early COVID, and then after another 10 days, it gets really socked down and dense, and then that part of the lung isn't exchanging oxygen anymore. It also causes kidney failure and some cardiac effects with arrhythmias and heart attacks and an inflamed part. The clinical course can wax and wane, and with the best care, it's somewhere between 0.2% and 0.6% mortality, which doesn't sound that bad until you extrapolate that to a population. It's your age and your illnesses that determine how well you're likely to do. Up until about age 50 or 55, it's what illnesses you have, so whether you have diabetes, whether you're overweight or some high blood pressure or other illnesses, and then after age 55, it simply becomes related to age. There are issues to think about with long COVID, which are persistent symptoms that last for a while after the disease, and we're learning about that, and then questions of whether or not people can get reinfected. With the original form of COVID, that's fairly unlikely, but we'll talk a little bit about variants where that's starting to become a true possibility. So what is this pandemic about? That's a speedometer over there. This pandemic is about speed, capacity, human resources, and fatigue. You can see this is a graph that shows how many inpatient beds different countries have, and it's very, very variable. So speed, how fast is the virus moving? How fast can we vaccinate to stay ahead of it? Capacity, do we have room to take care of patients? That's determined by how fast the virus is moving, and then human resources, because you can have all the hospital beds in the world, but if you don't have the doctors and nursing staff to staff them, it's not useful, and that's why so many patients died in Wuhan. They were connected to ventilators, but there were no doctors to take care of them, and fatigue. You can't run people 24 hours a day the way you can run a computer 24 hours a day, and those are really the issues that we're dealing with. Just wait for this slide to move. So a little bit about vaccines. Now historically, vaccines take a long time to develop, and most of the time we fail. So if you look at polio, it took the better part of a century to get a vaccine for it, and all of these other vaccines, typhoid, yellow fever, chickenpox, they took on the order of decades. You can see with swine flu, which you probably remember from a few years ago, we got pretty fast at putting together a vaccine for it, and down at the bottom, we have coronavirus or SARS-CoV-2, and it was 11 months from sequence to having someone roll up their sleeve and get a shot. So there's a lot of doom and gloom with all of this, but this is an incredible human achievement to have active vaccines that are saving lives right now that were initiated within a calendar year of having a genetic sequence for a virus. Oh good, the GIF worked. So this is a coin toss and this is to say that the original bar for vaccine approval was that it had to reduce your chance of getting COVID disease to 50-50 and hopefully a 50% reduction in severe disease. Now when vaccine research started that sounded like an incredibly high bar and what happened instead is that all of the vaccines that are available by that standard are a huge home run. This is Manny Ramirez having just hit a home run and all of these vaccines are a big big home run and just so you know Manny Ramirez is actually coming over here to Australia and he's going to play cricket so like all good things they eventually come down. It just takes a while. So I'm going to put up an unapologetically busy and hideous slide that I stole from a woman named Hilda Bastion who works down in Melbourne and she collates data and we'll start going through these vaccines. So up at the top you see numbers and on the side at the side you'll see the vaccines and it lists the trials and it tells how many people they have in them and how strong the evidence is that they work. So the good players are over here 1, 2, 3, and 7. These are your really highly effective vaccines that's Moderna and Pfizer. So Pfizer is number one actually. Moderna is number two and those are the ones that are available to you in the states which is fantastic. Number three is actually the Russian vaccine Sputnik 5 which is two different viral vector vaccines given a few weeks apart and seven is Novavax and there are some less effective vaccines but they're still quite good. Eight is Johnson and Johnson a viral vector vaccine and four over here is AstraZeneca and we'll talk a little bit about those as viral vector vaccines. I'm not going to discuss the Chinese vaccines which I actually think are quite good and promising because I just think it's very unlikely that those are going to be the way the United States goes. So the Pfizer vaccine and the Moderna vaccine you can essentially consider them in the way they work exactly the same. These are the first trialed mRNA vaccines. Both are 95% effective at preventing COVID-19 disease. Really no severe cases seen in patients in their trials treated with it. A pretty modest side effect profile so 44% will have a reactogenicity reaction so that's a sore arm feeling a little bit lousy and about 14% of people will have a true systemic reaction especially after the second dose where they get a fever and feel quite ill for a day or two. So remember that if you're getting your second dose to maybe miss a day of work or have some Tylenol ready. How do they work? I tried to label it in a way that makes sense. You get the vaccine. The vaccine is just RNA, just genetic material in little globules of fat. So if you shake up your salad dressing before you put it on your salad and you see the oil mixed with the vinegar and you see those tiny little lobules of oil that's the same way that the mRNA is covered and then it can get into the cell because it bonds with the fat that makes the membrane of the cell and then the RNA is inside the cell naked free to do whatever it wants and then it can get into the cell and then it travels to the basically the cell's kitchen and it becomes the cookbook for the cell to make this spike protein. The spike protein then gets spat out of the cell and then it bonds to the outside of a bunch of different cells to provoke an immune response and the one that we think about most is generating antibodies. Antibodies will stick to that spike SARS-CoV-2 tries to come in and it also marks it for death. So that's how it gets rid of the virus. Let me just go through. I think I went back a slide. Oh, sorry. So comparing these head to head, Pfizer requires really cold storage temperatures, essentially dry ice, minus 94 Fahrenheit. Moderna, not quite as bad. You can just put it in your freezer. The shelf life of Pfizer is quite short afterwards. So you got to use it within a few days. Moderna, you got up to 30 days. Age approval, 16 and up for Pfizer, 18 and up for Moderna. This sounds like a trivial difference, but in fact, teenagers start to transmit virus as effectively as adults right in the middle teenage years. So approving it for 16-year-olds as opposed to 18-year-olds is probably really important in limiting transmission. And the dosing interval, a little bit different. Pfizer quite effective for the older age group and Moderna, probably their trial wasn't powered well enough to say, and they're actually both probably pretty good against the South African variant. Pfizer's maybe a little bit better. In terms of side effects, people just have more experience with Pfizer. So data is probably incoming on Moderna. The seven-day itch, so when some of you may have been vaccinated already, and it's pretty normal to have a sore arm for a day. And some people are noticing at seven to 10 days return of that arm pain, actually in the entire arm. And what that is, is those are follicles and what that is, is those are follicles of immune cells reproducing and causing a big ache. So it's actually a good sign of the seven-day itch. A lot of people getting a fever after shot number two. I can tell you anecdotally that every one of my friends under age 55 has had a fever and felt awful for 36 hours. Both of them causing anaphylaxis. Pfizer maybe just a little bit more. To me, this is a non-starter because every day in the emergency room, I give medications that will not save as many lives as these two vaccines will, and have much higher rates of anaphylaxis. And I do it with impunity. And I deal with the consequences, which is an allergic reaction. If you have a history of anaphylaxis though, you still have to be careful. So bring your EpiPen with you. Talk with your doctor about the vaccine. If you have a true allergy to polyethylene glycol, you need to discuss whether the vaccine may or may not be for you. If you just have a history of anaphylaxis to peanuts or something like that, talk with your doc, be prepared for an allergic reaction. Don't leave the vaccination center for half an hour. So if someone offered me both of these vaccines, I haven't been vaccinated. We haven't started any vaccinations in Australia. Decisions, decisions, which would I take? I would take whichever one I can get into my arm. These are essentially equivalent to me. And then the US may be in the position due to the vaccine rollout to mix and match. I'd already been heard about that a little bit this morning from one of the other panelists who was asking about it. And there's no data to support it. But we may find out whether or not that's a sound strategy. So is it working? There is data. Israel made a deal with Pfizer that they would supply all of their data to them. And they put out broad vaccination. I was up to over 10% of their population was vaccinated as I made these slides. And then I worked for a few days. So I don't know exactly where they are now. But the proof is actually in the pudding. So these are very busy graphs. And what you see is the dotted blue line in each of them over to the left is when they started vaccinating. There is a little lockdown there, but the Israelis are horrible about locking down right now. Their mobility data shows they're just not doing it. And what you see is the blue lines dropping down below the yellow lines. The blue lines are the older patients who've been vaccinated. And you can see that their new cases are falling off faster than an unvaccinated people. Their hospitalizations are tumbling way down, and they're just not getting severe cases. And in fact, they're not dying. And this is after their first dose. So when they're fully immune, it's just going to be fantastic. So help is on the way, which is a hopeful thing. So back to this busy, busy slide, we're going to migrate down and talk about some of these other vaccines, which are the viral vector vaccines. So that's Sputnik, AstraZeneca over here, a little less effective, and Johnson & Johnson over here. And just so you know, the purple color means they've been tested against some of the new players in town, which are the variants, which we'll get into. The original trials for Pfizer, Moderna, and Sputnik only tested it against what we would call the wild type or the first version of this virus to show up. So that means we have sort of more current data on those ones in purple. So AstraZeneca is probably the one that's worth talking about, because it's been approved anywhere, everywhere in the UK and in Europe, not in the US yet, because the trial is forthcoming. And it was in patients in South Africa. So broad vaccination has already started with this. This is what we call a viral vector vaccine. In other words, they put a monkey virus right into you. It's an adenovirus. Human adenoviruses, you've probably all had when you get pink eye and a runny nose. Chimpanzee adenoviruses don't do anything. They don't cause disease. They just get into you and they bring this DNA into your cells. And then, as we said before, DNA makes RNA, RNA makes protein. And in this case, it's the spike protein that we want to make antibodies for. And there are some big advantages to a viral vector vaccine. RNA is inherently unstable, likes to break down, but this can be stored at fridge temperatures because it's DNA inside a virus. So it's a little more stable. This is cheap as chips. As we say over here in Australia, it's inexpensive compared to the mRNA vaccines. And I wrote it can be made anywhere. That's not true. It can be made in many, many more places than the mRNA vaccines. And there's data for AstraZeneca that does not exist for other vaccines, that it limits spread by about 70%. And that is how you get out of a pandemic, not by limiting disease just in the person who receives the vaccine, but by limiting it in the next person they encounter who may not be vaccinated yet. So that's incredible data. We don't have it for the other vaccines yet, but we will. And if that is the way that all of these vaccines work, then we're cooking with gas and things will start to wind down. But there are some big disadvantages. AstraZeneca and the other viral vector vaccine, Johnson and Johnson, are about 66% effective. Sputnik, which you saw up at the top, is actually quite a bit better. Now that sounds terrible compared to Pfizer and Moderna, but that's way over the initial bar that was set. If this was the only vaccine that was approved, we would all be hailing it as a human achievement. And it is. Their trials were poorly conducted and they were not forthcoming about their data. So they've had to go back to the drawing board and conduct a new trial to get approval in the United States. And the immune response in South Africa that they saw really started to drop from about 70% coverage, which is not too far off from the 66% from their trials, to about 22% with the new South African variant. So actually a day or two ago, it was pulled from South Africa and they won't be using it anymore. For a country that is really desperate for any answer in this pandemic, to stop using a vaccine is a huge decision. So that's concerning. And lack of data for older, I should say, not percent, but 65 year old patients. So in Europe, they're not approving it for elderly patients. I do think for this platform, the future is actually very, very bright though, because AstraZeneca is two doses of the same virus in your arm. And the reason it might not be effective is because you actually make some antibodies to the vaccine itself before the second dose. Sputnik is really smart. It's two different monkey viruses. So you're not immune to the second vaccine when you get it. It provokes the immune response twice. So the math we may be looking at is whether or not one dose of a Johnson and Johnson viral vector vaccine plus one dose of an AstraZeneca viral vector vaccine equals the efficacy of a Sputnik, which is around 90%. And if that's the case, it's inexpensive, easy to store, easy to distribute. And I think it's probably our national pride that would keep us from using the Sputnik vaccine and we wouldn't have to overcome that hurdle of political relationships. We could just use a viral vector vaccine and get it out to people fast. Now, this is my sweetheart, the one that I'm really hopeful for. And it's number seven, lucky number seven in purple, meaning it's very highly effective up at the top, about 90%. And it's in purple, meaning it's been tested against some of the new players in town, which are the new variants. And that is Novavax. So Novavax is a protein subunit vaccine. This is tried and true technology. It's not newer stuff like viral vector or mRNA. It's very similar to the Hep B vaccine, which most of you have probably had. Overall, about 90% effective against the original version of the virus. It's as good as Pfizer and Moderna and against the B.1.17 variant in the UK variant, still real effective, about 85%. And some weak data that it still provides 60% coverage against this bad South African variant and is keeping people out of the hospital with it. If you look at the charts, the number of antibodies you make in response to this vaccine is massive. So there may be what we call sterilizing immunity, which is that this virus doesn't even get into the cells. It just gets told to pack its bags and go home, and if that's the case, it's fantastic. It's stored in the fridge. You can truly make this wherever you make other protein subunit vaccines, which is all over the world, and they have already committed to making a polyvalent vaccine, which will cover sort of these new variants, which is just awesome. So where are we now? Now we are dealing with variants, and it sounds scary to say this, but the way that you can think about this is really sort of as pandemic 2.0, and that sounds scary until you realize that we've just gone through all of the tools we're going to need to crush pandemic 2.0, and it's the vaccines that we've talked about, but if you look at these curves, these are from Israel, the UK, and Ireland, you can see that they had their waves sort of under control, especially in, you know, the UK and Ireland. You can see as soon as they released restrictions, the curve gets really, really, really steep, steeper than most virologists have ever seen a curve, and that is due to this UK variant. It's probably about 50 to 70 percent increased rates of transmission and maybe 30 percent more lethal, but it's tough to know whether that lethality is just that it started to stress the hospital systems in the countries where it progressed. If you had to choose between a virus being more lethal or being more transmissible, you would take more lethal every day because when it starts to affect more people, it stresses the system, and it'll kill more people that way, and unfortunately this virus, this variant seems to do both, and it means that the things that you have to do to control it are more severe, including lockdowns, the amount of PPE you have to use, so it's quite concerning. The other variants I'm sure you've heard about are the South African variant, which I've talked about a little, and the P1 variant in Brazil. They actually carry the same mutation, and you don't need to worry too much about the molecular part of it, just keep 484 the number in mind if you like to follow these types of things, and if we said before that the way viruses get into cells is a lock-in key mechanism, you can think of the 484 mutation turning that spike protein into a master key that can get into rooms by a lot of different keyholes, and it causes what we call immune escape, meaning if you've had the original version of COVID, you can likely be reinfected with the virus, and that's been confirmed in South Africa now, and likely vaccine escape, which is what we saw when AstraZeneca's efficacy dropped. That being said, it still seems that all of the vaccines that we have discussed will keep you out of the hospital and keep you from getting really sick. You still just may end up with a sort of mild form of COVID, but that data will be forthcoming. So what happens when all of these mutations get together? You end up with a situation like Manaus, Brazil. Manaus is the capital of the region of Amazonas. It was very supportive of their president, Jair Bolsonaro, and had a group of people that didn't take the disease quite as seriously, so they ended up with a lot of COVID their first time around, and it seems like they had antibodies in about 72% of their people, so this is from their first round of COVID, and that Brazilian variant went ripping back through Brazil and overwhelmed the hospital system, and it will take a little bit of time, but this is probably true reinfection, and it puts to bed the idea that this town had herd immunity based on prior infections, so a little bit scary, and it means that we need to get vaccines into people, because the vaccines will at least keep people out of the hospital. So what's next? What's next is what we've described, and that is that it's going to be a race between vaccines versus variants probably for the next 18 months, and I'm actually pretty confident that if people, if we roll out broad, broad vaccination, people will stay out of the hospital, and we'll find which variants we have to deal with, and then we'll be able to ring-fence those with the mRNA vaccines, so it's going to take a while to get this under control, but eventually we'll probably get there, but really what we need is a global strategy, because if we get on top of this in the developed world, you know, the United States and Europe, and we don't control uneven vaccination in the rest of the world, then somebody in, you know, in Africa or a less vaccinated place is going to be developing the next variant that comes ripping back through, so everybody needs a vaccine, and we need to come up with a global strategy for that, and in all of this, we've forgotten that therapeutics will be on the way. I can tell you that if we were having this discussion two months from now, you would all be asking me not about just about vaccines, but also about monoclonal antibodies and immune-modifying drugs, and I think by the end of this year, we'll have really effective treatments, and not just repurposed drugs where we keep trying to get every medication that's been used for something else to work for COVID, but drugs that work specifically for COVID, and finally, this last slide, this is actually probably really important. I don't want to tell people where to invest their money, but you could do worse than investing in companies that retrofit and alter building ventilation. We're going to have to change the way we live, because this will not be our last respiratory pandemic, and ventilation and clean air in buildings, in transportation, in schools, and in cars is going to be something that we think about a lot in dealing with airborne viruses, so that's my last slide. I'll say thank you to all of you for having me, and I can open up for some questions now. Dr. Jay, thank you so much for this very informative presentation, and for really setting the table on this important topic. We have a question from Maria Alonzo, and her question is, have trials for combining vaccines been done, and the second part of that is, does this mean that the same person can get two shots of different vaccines and have a positive effect with no additional side effects? The answer is that those trials are being done. I know they're being done for viral vector vaccines, so for AstraZeneca and Johnson & Johnson, and they may be trying to combine that with one of the Chinese viral vector vaccines. I don't know that they're going to trial the mRNA vaccines so that you can mix and match them. Yeah, so I've dug around. I just haven't seen that as a trial yet. I think probably that the manufacturers are not super keen because they're already cranking it out to necessarily have this happen, at least Pfizer and Moderna, because they don't need to prove any increase in efficacy. The reason to do it with the viral vector vaccines is because you may get a much more effective result, and so that would boost the sales of the companies that are trying to compete with Pfizer and Moderna, whereas Pfizer and Moderna already have such effective vaccines that having you take another dose from another manufacturer doesn't necessarily benefit their bottom line, so I haven't seen any trials for the mRNA vaccines. Thank you. Maria also asked, when will we know how long the vaccines last once the ideal temperature has been disrupted and the interval of temperature at which the vaccine stays active? So the manufacturers give guidelines once they're thawed, and actually it's probably somewhat one of the other panelists may have an answer for that. I mean, Pfizer says that you can thaw it and use it after five days in the fridge, and Moderna up to 30 days. I don't think anyone has pushed the envelope to see how stable it is, and it might just be a question of dose, because Moderna just actually uses a lot more genetic material than Pfizer does, and the reason it lasts longer once it's thawed might be that it just takes more time for all of that RNA to degrade, so one of the ways Pfizer might relieve that is, depending on their manufacturing cost, just adding a little more per dose and proving that you don't increase side effects so that you have more thaw time, because five days is not very long. You know, in a remote location like mine, you thaw it, you have to get the people there to get it. It's problematic. All right, thank you. We also have a question from Steve Silverman. He actually also raised his hand, too, so I'm going to open up his mic and so he can ask a question, and so, Steve, you can open up your line. Steve Silverman. Yep, I didn't really mean to raise my hand, so sorry about that. I was curious about if the vaccine is administered after the recommended period of time after it's been thawed, are there health implications to someone getting that vaccine, or is it really just the efficacy of the drug that people are concerned with? I think it's more related to efficacy. RNA is inherently unstable compared to DNA, so when you work with it in the lab, which I spent a couple years doing, you know, you're dealing with the same cold chain that you're dealing with with the vaccine. It degrades really fast, and it's an efficacy issue. That's why the viral vector vaccines that have DNA, which is sort of kept in a much nicer package, they're able to just be refrigerated. I can't offhand think of any health implication that would arise as a result of having it, except that the RNA has degraded, and you might not get a good immune response. Thank you. Okay, we also have a question from Nathan Earhart. If you've already had COVID-19, is there an advantage to getting one vaccine over another, or just whatever first becomes available you should get? No, I think whatever becomes available is what you should get. You know, we're in the position right now, maybe with the exception of the Chinese live attenuated vaccine, that it's kind of like choosing between which model of BMW you want. They're all really, really good by the bar that was initially set, and all of them will keep you from getting really sick. So, if you've had COVID, we don't know what the natural immune response is and duration is from a natural disease, maybe six months, but it needs to be studied as to how long you continue to have that robust immune response, and you should still get the vaccine, and I think I would take whichever one's available to me. Thank you, and I know we have to be mindful of the time that we have. Have there been, one more question from Frank, have there been any studies which show that people who have gotten the regular flu vaccine are less prone to getting COVID? No, the only vaccine that has shown to have sort of maybe some cross-reactivity with COVID is the BCG vaccine, which is given actually most, a lot in Southeast Asia, but in countries where tuberculosis is endemic, it's not specifically a vaccine for tuberculosis. It just boosts immunity across the board, and we think that probably countries that use that as part of their childhood vaccination program have a less lethal course of COVID. It's not a COVID-specific vaccine, though, it's to prevent tuberculosis. I haven't seen any data that there's any cross-reactivity or benefit from influenza vaccine. All right, thank you, and then this is the last question from Tori Gift, is there a waiting period to get the vaccine if you've already had COVID? I don't know. I don't think so, actually. I think what you're going to find is that with the new administration, you just need to get the vaccine when it's available to you. You don't need to sprint to get it if you've immediately had COVID. In other words, you do have some protective immunity unless this 484 mutation really picks up in the United States, in which case it's concerning, and so I have a few colleagues in the States who've sort of held off for a little bit so that other colleagues can get vaccinated, which is really benevolent of them, but I don't think there's necessarily a waiting period that you need to have after you've had COVID. Okay, all right. Well, thank you very much, Dr. Jay. All right, so I guess I'll take the helm here. Yes, absolutely. Well, Jay, I can just tell you my facility, my headquarters is about five miles from Lahey Clinic. So as a fellow son of greater Boston, we wanna thank you for the admirable work you're doing to venture to an area of the world that desperately needs your expertise. It's commendable and thank you. And I'm always happy to be with this group. I am UA, who gets to be an underwriter? Only the sexy people. So it's a great privilege to be with you guys, share a little bit about what's going on in the transportation world and particularly as it pertains to vaccine shipments. So my company is involved about 70 or 80% of the business that we do is in life sciences. And typically what we do is kept at a very low profile between our work, both in life sciences and government and defense. However, about six weeks ago or six to eight weeks ago when the Pfizer vaccine was the first one approved in that big launch, we were part of a huge media presence that occurred at the plant in Michigan. So you can see here we were featured on all the national news networks and then in fact, internationally of friends and relatives into different countries. So that was very unusual for us, but it's a great honor to participate in this very important logistical effort that spans the globe. But I'm gonna speak mostly to what's going on domestically here in the US. And to do our follow-up with our engagement of our viewers, if you could take this poll, you know, Lillian, I believe the poll is made available to folks. In the- I'm going to bring it up right now. Okay. Thanks, Eileen. So there we go. The poll question is, will you get the vaccine when it's made available to you? Great. We'll give it a few seconds to respond and then I'll share the results. Okay. So trying to get to what the take rate is gonna be, and it'll be kind of an interesting little sample size that we have here. So there we go. And how many answering? We have 84% said yes, 6% said no, 10% said not sure. 84% voted. So we have about 100 people that voted. Okay. Yeah, so that's interesting. That's higher than the general population, I believe. But we'll move back to the presentation here. Yeah, so the take rate is interesting, right? So in my opinion, the best resource for all things COVID is Scott Gottlieb, who served the first two years in the Trump administration as the FDA commissioner. So he's a physician and also sits on the board of Pfizer and some other biotech. So he has a great kind of perspective coming from medicine, public health, regulatory bodies, and then the private sector. And as he points out, sometime later this spring, we're gonna get to a saturation point where we may actually have greater supply than demand. That's not the current concern, but in a couple months, that may be the concern. It might require a lot more education and encouragement, maybe even financial incentives to help people take the vaccine. But that's quite a high rate that we just saw from this group. So let's think about shipping and transportation in the macro sense before we get into vaccines in particular. So as you can imagine, in the past year, as people have been able to do less in the way of say, travel and entertainment, a higher proportion of the consumer's spend has been going towards stuff or goods, right? So goods need to be shipped. So there has been actually an increase despite the kind of slowdown we witnessed in manufacturing and consumption in the second quarter of 2020. Since then, things have ramped back up and we had quite a bit of demand for our market in 2020 as a whole. And our chief economist at the American Trucking Association estimates that we do project five plus percent GDP growth in 2021, but it's likely that a greater proportion of that growth will come from services. So again, travel, entertainment, particularly in the second half. There's probably a lot of kind of pent up demand for services, but it will continue to generate a lot of freight demand. And then inventory to sales. So basically how many widgets do you have on the shelf in order to sell one widget? And this, as the last data available from November, that was the lowest number in about six years. So meaning, when you have lean inventories, you're more reliant on transportation and just-in-time transportation in particular. When inventories are fat, well then you don't require as much just-in-time transportation. So as many of you guys know, there are about what I think 30 to 40 ships off the coast of LA and Long Beach right now trying to come in and deliver containers. So there's a lot of inventory restocking that's being attempted and not a lot of it's being achieved quite yet. So lean, so we have more demand in terms of the volume of goods. And then furthermore, we have a drawdown of inventory, which means more reliant on premium just-in-time transportation. And on the supply side, it's very, very tight. Tightest capacity environment in my career. And many fleets did suffer bankruptcy last year when there was a massive slowdown. And then a big factor for us, as you guys know, premiums in the auto and general liability space for motor carriers have accelerated dramatically. And much of that's attributable to these nuclear verdicts of the past five to eight years. We as an industry are undertaking tort reform as a big initiative in partnership with many of our insurance company partners. And we've tried to change the language from tort reform, which let's face it, Joe Sixpack doesn't know what the hell tort reform means. So we're changing more toward lawsuit abuse. Lawsuit abuse, you can educate consumers as needed if you get referenda or other means of getting it across the goal line. And unfortunately, as you know, interstate commerce, you'd like to think we could federalize some of the tort reform efforts, but the reality is we have to get down to every state and it's a patchwork. And we're taking it on state by state, but it's a huge undertaking. If you're a qualified professional truck driver right now, you're like a lefty starting pitcher. You're very, very desired. And it's a great time because pay, compensation benefits for drivers have risen substantially and that's valid and they should. Part of the scarcity is attributable to this drug and alcohol clearing house. So a year ago, it went into effect. So I used to be able to say, go apply to Barry's company. And if I failed the pre-employment drug test, I could just wait a week or two and I'd go to apply at Jay's company. And there was a box to check to say, have you ever failed a drug test? And I'm trying to get a job, so I would say no. And there was that gap and I'd likely get that job and move on, no one's the wiser. Now, if I fail a drug or alcohol test, it goes into a central federal database. And then when I go to Jay's company, he has to query that database. So as of just yesterday, the updated data were that in excess of 50,000 truck drivers failed during 2020 and about 85% of them haven't even attempted to return to duty. So 40 to 45,000 truck drivers have been removed from the pool in the tightest capacity environment of my career. Furthermore, truck drivers are people too, and they may have family members they have to take care of or they may have kids who can't be in school right now. And truck drivers are not very effective working from home. So that's an additional consequence that causes tightening of capacity. Because so we have fewer drivers from drug and alcohol and a lot fewer from the virus as well. So if you're a shipper, I'd tell you, your pricing will continue to rise. And you can just see it here, the number of units, so number of power units, which means tractors of a tractor trailer has dropped for truckload carriers quite substantially in the five to, or four to 5% range over the past year, which is a lot at the same time that demand has increased. So we've done a lot in our company and many had to adapt. One thing we do really well in transportation is adapting to lousy situations. So some certain simple things like contactless delivery, so last March, I had this epiphany, hey, we should come up with a term so that there's no touching at destination when you're dealing with the consignee. So I came up with this term contactless delivery. And I thought I was the one who came up with that. And then that night I'm watching TV and apparently Pizza Hut had somebody who came up with it at the same time. So I could not retire on the trademarking of that concept, unfortunately. We also, my brother and I, who's my partner, we decided last March and announced to our staff members that we would give up six months of our salary. And we paid that out to about 150 of our, all of our blue collar employees, which numbers about 150. So that was pretty substantial. And then we went to great lengths to procure PPE. And we have about 80% of our operations staff on site now, but we did have to invest heavily, as Jay mentioned, in ventilation, bipolar ionization systems in our HVAC system. And then, you know, I'm very long on plexiglass. So 20 grand worth of plexiglass, 25 grand worth of ventilation, air purifiers, et cetera. And then quite simply, whenever we get up from a workstation, we mask. And I don't know if I mentioned, but when we're transporting medicine, one thing that we provide is a digital chain of custody. So our clients can see at all times that shipment in transit, all the particulars of it, but then they also get a, have visibility on the temperature and basically the product integrity. So ironically, the Pfizer product, which we transport, because it's public knowledge, now I can share that, although the product has to be at about minus 90 or minus 80 C, we actually transport it in controlled room temperature of about 70 degrees because the packaging was configured and designed for ambient room temperature, controlled room temperature. Had we gone down to say minus 20 C, which I thought was gonna be the plan to shrink the difference between the trailer and the package, that actually was not what they wanted because that would have damaged the packaging. We did also announce to our customers last April, we took the step in consultation with our attorney to inform our clients that we were invoking the force majeure clause in our contracts. So as a practical matter, it's probably not likely that we'll incur something like that, but when we do have large scale sick outs, and particularly at that time, we were staring into the abyss, we didn't really know what we were dealing with, and we have had a lot of sick outs. So people who either contract the virus among our professional drivers, or they come in close contact with a family member when they're home and off, or they have some sort of symptoms, regardless, we have to get them off the road immediately. Furthermore, when you're transporting tens of millions of dollars worth of pharmaceuticals, you're in a temp control trailer and temp control vehicle, if you suffer a mechanical failure, and say all your service providers were short staffed due to the virus, that is something that we, again, we wouldn't be in position to resolve in some circumstances. So we just wanted to communicate that with our clients. We haven't had any instance where this came up, but we did wanna inform them accordingly, and it's still in effect. So any of you insuring motor truck cargo, you may just wanna be aware of that. And Jay mentioned kind of the timeline, and if we look at it from the supply chain and the logistics perspective, on the left we see, whoops, what a typical vaccine timeline looks like. You're talking 10 to 12 years. And why that's meaningful for us is the supply chain folks are able to very slowly and gradually progress and establish a supply chain in the manufacturing process, and then the distribution strategy. And we would come into play in that latter, whoops, we keep going ahead here, in that latter program. And what was happening here is basically it was all combined into a parallel process where the preclinical through the supply chain in manufacturing to distribution all took place within 12 months, which is an enormous feat of ingenuity and the leverage, the stroke of genius that the government made was leveraging the capabilities of the private sector, but it did make for a lot of short notice decisions, should we say, in a tight capacity environment. With respect to the business models, look at, boy, I'm having trouble with the presentation here. I hope someone else isn't trying to click ahead. But on the left, we see company A, which is basically Pfizer. They chose to be vertically integrated. They're experts in this whole process. They developed their own manufacturing in supply chain. Whereas on the right, you can see company B, which is Moderna and several others who were engaged in the Operation Warp Speed plan. And they use third-party contractors to help develop and manufacture the drug. I'm sorry, Andrew. Are you up to the next poll? No, I'm not. I'm sorry. I tried to stabilize the slides for you. See if you can move them now and hopefully nobody else is touching them. Okay, I apologize for that. All right. All right, let's see. Okay. So again, on the left, Pfizer, vertically integrated. They said no thanks to Warp Speed funding. They took money from the government to conduct, you know, for orders, but they didn't do it for development. In contrast, Moderna and the other candidates did accept the Warp Speed funding. Andrew, are they moving again? Is that? Yeah, I have it as of as of right now. Okay. All right. So. Okay. Hopefully they're not moving for you. Right. All right. So the again, Pfizer owns all that vertical integration, vertically integrated process. Then they leverage the FedEx and UPS for outbound direct shipping to the administration state sites at different governments in health care providers. Excuse me. Whereas Moderna is using the warp speed model. So that they leverage the the distributors like McKesson. Those guys are already experts at specialty distribute. Unfortunately, most of the bottlenecks are not happening. Instead, they're happening at the government sites. Right. So everybody's aware now that the product is getting to destination. But then the state and local entities who are basically overwhelmed and didn't have mature systems set up to track and manage the product once it gets to them. That's where the problem has been. And, you know, the prior administration did a great great job of leveraging the private sector in terms of development. But now we really get to get to administration and downstream logistics. And that's what the greater emphasis is for the Biden administration. So it is timely. All right. So after those little pickups, our new poll. Hold on one second. I will launch the poll. There we go. Has the vaccine been made available to you yet? And have you received. Have you either received or scheduled to receive at least one dose? So if you just quickly answer, we will share those results. I will. We've got, again, the same percentage, about 100 people responded. So I will close and share the results. There we go. All right. Interesting. Yeah. Yeah. Well, let's I'm optimistic that here in the coming weeks, that that percentage will begin to swing. But we do have a little ways to go. So with this. Are they jumping again? Are you moving those slides? That one I just moved. Oh, good. Okay. We'll see here. We might need it up. They're moving again. We might need a an exorcism. I think. Yeah, we might need an exorcism. We might need an exorcism. I think Father Barry is qualified. Damian Karras. So let's let's just jump to right here. In my opinion, it's the most complicated logistical challenge in our lifetimes. So clearly downstream at the administration sites, those guys are overwhelmed and it's getting better, though. We're starting to leverage the pharmacy networks when we consider Walgreens and CVS of the world already do about 150 million doses of vaccines a year. You know, it's smart to try to use those guys to a greater extent. And unfortunately, let's face it, there's a lot of disparity. And Jay spoke to it a little bit earlier. Globally, they have the disparity between the haves and have nots will become more pronounced. Some of the products like the AstraZeneca one are a better fit for the less developed world with less infrastructure in refrigeration capability than the products that require less refrigeration or better suit better suited to that market. And we do have a little bit of nationalism in play here. We mentioned the Chinese products, the Russian one. I don't know any volunteers for the Russian developed product that was approved by the Russian government. I'm not sure how many of my peers or friends would be willing to volunteer for that one. But in kind of simplest terms, crude terms, say we have seven billion, roughly, you know, seven to eight billion global citizens. And if most of these products require two doses, we're talking 14 billion doses. In order to get to that, we'd have to get up to 20 million doses a day for two years. We're not even close to that now. So that just scales the problem for us a little bit. And then lastly, let's face it, the pandemic has exposed a lot of supply chain vulnerability. You know, we've been harping for 20, 30 years, and let's be lean, let's be global in our supply chain. But what we have failed to do in many cases is become resilient. So my thesis is that, whether it's by government edict or corporate strategy, there will have to be some reshoring or nearshoring. So to either the US or North America, to, you know, to withstand these types of shocks, it doesn't have to necessarily be a pandemic. If there are geopolitical events that cause us to have shortages of essential products, whether they're, you know, API or ingredients for drugs, or even PPE, we suffered a lot from those shortages this year, and we can't let that happen again. So I'll conclude at this point and yield. I know we're a little tight on time. So I apologize, guys, for the abnormal slide transitions there. But it's a great pleasure to be with you. I'll stick around until the end. My great friend, Barry, will take over to talk about the 1983 Philadelphia 76ers. Thank you, Andrew. Yes, hearing Dr. J got me excited. I didn't know what Julia Serving knew about vaccines, but it did my heart warm here. So thanks, everybody, for participating this afternoon. There's not much else going on in the US. I mean, certainly there's nothing on TV or cable news to distract us. So glad to have you here. I'm going to spend a little bit of time specifically addressing COVID-19, but also pharma or life science shipments in general. Let's hope my slides work here. So this is our focus, you know, our quest, our holy grail, our arc, or the source, whatever your age and movie genre preference is. Oh, too fast. Okay, first poll question. Eileen, you want to take this? I'm going to warn you now, this is a bit of a trick question. Okay, here we go. Let me just bring down the... Hold on a second. Okay, so the question is, from what city were the first Pfizer COVID-19 vaccines shipped? So we'll give you a few seconds to read that and make a selection. There's some interesting places here, Barry. They're all Pfizer manufacturing sites. Okay, well, we've got 70% voted. We'll give a few more seconds. Might as well just take a guess. Okay, well, I will close the poll and share the results. Okay, so there you go. I'm blocked out a little bit here with my slide here. Okay, I will read. If you don't see it, it's Endeavor got 19%, Kalamazoo, 47%, McPherson, 7%, Portage, 16%, and Franklin, 11%. Okay, I just... For some reason, I'm... Okay, I'm back. Actually, I'm not exactly sure. Maybe Andrew knows. But technically, everything's at Kalamazoo. But the Pfizer facility in Michigan is so large that it actually spans both Kalamazoo and Portage. So I guess either of those would have been a good answer. Excellent. So you can move your slides again. Okay, I got it. Yes. Okay, so here's the life science. I'm going to use life science, pharma, interchangeably, but it's the risk profile or the risk reward profile. Some of the things that is typical on a insurance of this type of company is high policy limits. Insurance of this type of company is high policy limits. You know, $10 million, no problem at all. High per conveyance amounts. Again, big numbers. In some cases, companies have to limit the number of pallets they can put on a trailer. Otherwise, they're going to exceed their policy limits. So it could be massive numbers. High perishability. Almost all of the life science and most of the pharmaceutical products and even testing reagents are temperature sensitive, and thus the potential for damage, either high temperature or freezing. High theft attractiveness. I don't think it's not so much on the COVID-19 just because there's going to be a lot of eyes on those shipments and the use issues that Dr. J mentioned. So I'm not so sure outright theft is going to be a concern, although there's always a possibility of shipments being, and I'll put in quotes, air quotes, lost, especially in the small package and last mile delivery sector. High regulatory oversight. Pharmaceutical life science companies have a lot of people looking over their shoulder. You have the FDA, and a lot of those rules are in Title 21 Code of Federal Regulation. You also have the DEA for any controlled substance. And then you have the industry best practices that are covered by U.S. Pharmacopeia. And they develop best practice standards for the storage, transit, refrigeration, and temperature management of products. And then high total loss potential. Put this another way, there's very rarely a partial loss in a life science or pharmaceutical shipment, either because of policy terms, you might be aware of the control of damaged goods, but also because they have very strict acceptance requirements. And within those organizations, the quality assurance or quality control people have a lot of leverage. So now, how's your appetite for underwriting something like that? Okay, there is a difference between pharmaceuticals and biologics, and vaccines clearly are in the biologics. So again, just basically, pharmaceuticals use chemical components to make up the finished drugs. The biologics use living organisms, enzymes, bacteria. Pharmaceuticals can be temperature sensitive. Biologics are more susceptible as they can significantly affect their efficacy. Again, there is an issue with humidity in a lot of pharmaceuticals, certainly powders or tablets, but not so much, not so in vaccines because they are liquid formulations. So humidity is not a concern either in storage or transit for vaccines. Let me go back just one here. Just a little bit on temperature. There's a lot of terms that people use when they're talking about the temperature ranges of products. You'll hear the term ambient, which in my opinion is not a correct life science or pharmaceutical temperature term. It's essentially ambient, generically is the temperature, whatever temperature the product is exposed to. It's like saying somebody is interesting. So it covers a wide swath of possibilities. So I would suggest not to consider that a temperature control term. The real more established terms are control room temperature, which is from plus 20 to plus 25 Celsius. But they allow excursions to from 15 to 30. So there is some leeway on those particular products. Cold chain is plus two to plus eight degrees Celsius. But again, those products, and again, that's like AstraZeneca, J&J, and the Novavax, they're going to have a little more ability to withstand higher temperatures, but you don't want to go below freezing on those. Then you have frozen, which I believe is the Moderna, so minus 10 to minus 20 C. And then you have the defrozen, the pharma, which is out of Pfizer, the vaccine out of Pfizer, which is really a cryogenic product. So it's, you know, and that range is from minus 20 C to minus 80 C. And here are the three, I call the three-legged stool of the drug quality or safety criteria. It's potency, efficacy, and that word is really in now everybody's vocabulary, and stability. We're going to talk a little bit more about stability later on in the presentation. This is my graphics, poor graphics effort, the supply chain. So we got from the manufacturing sites, either by plane or truck, or actually air would be truck and air, to the warehouse or distribution centers, and then the short, small vans, or the small package, or courier service. So what possibly could go wrong? Now don't, please do not look at any of the names that might be visible or noticeable in this slide, but this gives you an idea. This, this is not a major hub for, for one of the transportation companies that deal in small package parcel shipments. This is kind of probably a normal day at a smaller hub. So if you've ever been to some of the bigger hubs that might be in Louisville, Columbus, or Memphis, Tennessee, you can get an idea of what kind of scope we might be looking at with the vaccines being, being commingled with other, other shipments going to different or same destinations. And then this is a real picture of a, of a delivery during the Christmas holidays. This is when one of the parcel companies ran out of capacity or bandwidth from, from a driver standpoint. So they subcontract to individual, individuals that were able to deliver products to them. So not, not the best risk management scenario here. You have a, you have a SUV with the trunk open and who knows who has access to that particular cargo space, if you will. Certainly we're anticipating that the supply chain, certainly in the last mile sector is going to be really taxed as we ramp up production and the supply chain on the vaccine. So this is something to watch out for. So these are typical transit, typical transit pearls. And I listed these in ascending order as it relates to the vaccine and life science and pharma shipments in general. Water damage, certainly that's a major exposure in the ocean transport. And don't forget that in air cargo, water damage can occur too. If you've ever been at the airport during a rainy day, you'll, you'll likely see a cargo staged plain side, either waiting for loading or after unloading, waiting to go back into, into the cargo terminal. So that's a concern. Contamination. This generally comes into play when the integrity of the primary packaging, which is the, the packaging that actually contains the contents. So in this case, it would be the glass vial, if you will, for a vaccine. When the integrity is, is breached, then you're going to have a contamination, potential contamination issue. Physical damage here, generally when we're talking about glass breakage, you could have other issues. You could have drums being punctured, but they're, that's something that's very typical in normal handling. Theft, pilferage, and tampering. Again, in my opinion, theft and pilferage is not a major concern with the COVID-19. Tampering is, is, is an issue certainly with any pharmaceuticals. And again, going back to the very stringent quality assurance and quality control requirements that are, that are in place there. So anytime there's any, even a hint that something's been tampered with, even if, if it's just the you know, the tertiary or secondary packaging. So it's the inner box or the outer carton. If that's been, if that's been damaged, there, there might be a concern with, with the integrity of the product. Where, where you see theft and pilferage much more likely in the life sciences arena would be, oh, very popular drugs like statins, lifestyle drugs, controlled substances. Those things are, are much more prone and much more theft attractive. Spoilage, then, you know, the normal temperature excursions or deviations. And I have here, we mentioned earlier stability. Let me talk a little bit about stability data. When a drug is manufactured, generally the manufacturer will do studies with our temperature stability data studies. So what they're designed to do is each of the, the drugs, and if you go into your medicine cabinet at home, look at the back of your prescription, they'll generally give you some idea of that, you know, be held in room temperature in, you know, in a dark, cool space or whatever. But they'll also, but the drug manufacturer will also have data that indicate that not only is it supposed to be maintained in a certain temperature range, but it can go outside that temperature range for a certain period of time. So this really, this can really come into play in, in a claim, in a claim scenario, but it really just is designed to tell you that, okay, here's the optimal temperature, but it goes outside this, within this range, it's still, it will not lose efficacy. And then the acquisition method, how is the temperature, you know, monitored or recorded so you can, you can show that what the temperature was during the entire transit period. So these are the, the three general types of indicators or recorders. On the top, you've got a, what's called a chemical or a time temperature integrator. It will just, it will have a red dye or some other physical characteristic that will show that a certain temperature has been reached. And these are essentially a go, no go, yes or no, good or no good, really binary situation. To the left, you've got the strip recorder, the chart that provides a paper trail with a stylus that indicates the temperature during transit. And then on the lower right is really the industry standard. It's the temperature data logger that gives you a continuous temperature and the data is downloaded via USB port. So these are the most, I think the most effective ones for, and it really is the gold standard for pharmaceutical and life sciences. The issue you have with the indicator, the top center is that they're not validated. They're very cost-effective and they're likely going to be used on the last mile in a small package delivery for the vaccines. It's just not cost-effective to use either of the other options. So I just want to let you know there are some inherent disadvantages of using the chemical indicator. One is that they're not validated or calibrated to NIST standards. So that's the National Institute of Standards and Technology. And secondly, and this is more important, is that it will not show you the exact extent of the temperature excursion. So the last reading is the ranges are pretty significant. So if it's in that box, you can see that there's a big difference between the temperature range there. So you don't know exactly how high or how low it went. And also importantly, you don't know for what duration. So again, that goes back to the stability data. If you're able to use a strip recorder or a data logger, you can actually interpret the information. And maybe there were excursions, but they're still within acceptable limits. What I call critical control points, here we have logistics. So we have the three major modes. Ocean is not going to be, I don't think it's going to be a factor on vaccines, but it is another pharmaceutical and life sciences. So with air, the advantage is speed, obviously. Ocean, it's cost-effective. And truck is the most direct to the consignee. So that's routing, that's important as well. Is something door-to-door or is there transshipment? Transshipment, you have a lot of transfer of the goods. You have extra handling, you have more times at rest. And that really fits into our supply chain model in the U.S. with all the small carriers, small package carriers, and all the less-than-truckload trucking companies. Everything is hub-and-spoke. So it's going to be handled a lot, it's going to be at rest at times, waiting to be transferred. Carrier vetting is very important. In fact, I think it's the most important decision a shipper can make. If they do a good job selecting a carrier, then that's going to take care of a lot of any other deficiencies that might be in play. So really, what's the basis? Are you choosing or selecting a carrier based on cost or competence? Packaging. Andrew did have a slide with active versus passive. Active is refrigerated, mechanical refrigerated units, reefer containers, reefer trailers, and the air cargo containers that are designed either to provide with mechanical refrigeration or through dry ice. Qualified versus validate. In the industry, I think that those terms are interchangeable. And I don't think there's – for the sake of this presentation, it doesn't make sense to go into a lot of details, but essentially, you want packaging that is at least qualified or validated. So that means it's been tested to be able to show that the packaging, as designed, and that's going to be – it's going to be including insulation, some phase-change material. So whether that's a gel pack or dry ice – I see that mine's going, too. And then an outer shipping carton. So you want to make – you want to have it validated. And these come off the shelf, so it will be – you'll get – be able to get an off-the-shelf product that will maintain temperatures between plus 2 and plus 8 C for 72 hours. So pretty straightforward. So what a shipper should do is to get a good feel for how long the transit time – total transit time. So that starts from the time that the drug product or active pharmaceutical ingredient is taken out of – taken out of refrigeration, packed, and then until it's delivered at the final destination. You take that number of hours, and you multiply it by 1.5. That's a good safety factor. So that would give you a good indication that that product's going to be able to withstand any delays that happen in transit. Labels. There's a lot of labels. Keep frozen, do not freeze, all those other things. If you're using dry ice and Moderna and the Pfizer vaccines, you want to be using a lot of dry ice, you need the class 9 miscellaneous, dangerous goods, or hazardous material label. One thing you want to keep in mind is – and shippers sometimes over-label. They put so many labels that they confuse or overwhelm, and people just – cargo handlers and transportation personnel just ignore them. In fact, it's probably safe for shippers just to assume that all the labels and cautionary marks that they put on the exterior of the packaging will be ignored and packaged accordingly. Handling. This is – this is kind of an interesting one. Just in case you didn't know, there's a difference between Celsius and Fahrenheit scale for temperatures. There's a big difference. If I say plus two, and you read it as plus two Celsius, so that's 36 degrees Fahrenheit, which is a big difference between a plus two Fahrenheit. Two C is like New York City, two F is like Chicago. There have been claims and losses because somebody has used F, and you know that C is the international life science and pharma community always use Celsius. So they don't use Fahrenheit. So that's the problem. When it comes in the U.S., you know, automatically we're thinking Fahrenheit. Again, visibility, and Andrew – Andrew's company does a great job. They're able to locate the asset, the shipment. They can have the Internet of things, sensors, temperatures, light, shock, all those good things. And then – but those two components are very good, but the third – the linchpin is to have a response plan, not a contingency plan, a plan B. What happens if something goes wrong? What do you do then? You have to have something in place. And then transportation providers, again, specialists like Foyle Transportation, you know, that's the one – that's the type of companies that you want to be dealing with that, you know, they have the proper equipment. They have trained personnel. They have the added – they have added value. There's a lot of – there's not a lot, but there's probably a handful of freight forwarders that really do a great job in this – the cold chain niche. They will actually monitor shipments from door-to-door. They have access to the airports. They can actually re-ice or put something in cold storage if there's any delays. So those are the kind of companies you want to deal with. And this is my second – my last question. Okay. Yeah, we're going to – Barry, in the interest of time, we're going to move past this polling question on this very fascinating topic. Okay. Great. Okay. I just add that one thing, final thoughts, just you can read those on your own time, but thanks for listening, and have a good day and stay safe. Thank you, Barry. And Jean, yeah, we're just going to try to condense it a little bit. I am actually – How do you talk fast? You know, I can talk as fast as possible. I am not even going to go through the slides because nobody ever wants to talk about claims. But Andrew and Barry really talked about the two main components that are important for claims. One is total loss. Barry is correct. Every time there's going to be a claim, it's going to be a total loss for the vaccine. But remember that we're not only talking about vaccines here. There's a whole lot of pieces to the vaccine being injected into someone's arm. There are needles. There are gloves. There are Band-Aids. There are alcohol wipes. There are all of these items that may or may not be included within the classification of drugs or medical devices. So broaden your horizon when you think about the potential exposure here. What Andrew talked about is the most critical piece of this, and that's the contract. Most of these products are not moving under a standard old common carriage. If it was, it's going to be subject to the Carmack Amendment. Warehousing is going to be subject to the UCC, reasonable standard of care. But that's not the case. These products are moving under contracts. It is critical as an underwriter that you look at the contract and you see what that contract says. You'll go through my slides. I talk about a bunch of the things that are going to be in the contract. But understand that they are accepting greater liability. They're giving up control of damaged goods. And this is on the liability side, but even on the first party property type coverage, you're going to have these same exposures where everything's going to be a total loss. You're not going to be able to salvage it. Whether or not you want to argue it, whether or not you want to argue there's some stability issues there, the reality is that under the federal regulations, if in doubt, throw it out. So I'm going to end it because I'm going to keep us right where we are with just a couple of minutes. And just remember that claims are going to happen. We're not going to have that many claims on the COVID vaccine because they really are moving so well. Everyone's doing what they need to do to get them there, but it's the rest of the product that comes along with it that is where we're going to see those losses. We're going to see the pilferage. We're going to see the tampering, the thefts. There's not a lot of inspections going on while we were having this conversation. I asked my office to run a check to see just on McKeeson because that was one of the names that Andrew brought up. And in the course of an entire year, there were only about 375 inspections of goods being transported on behalf of that company. So they're moving, they're getting where they have to go. But read the contract. Underwriters, please read the contract because claims has to read the contract afterwards and we take on greater liability and we can't get rid of the claims. And so that's as fast as I could possibly go, Eileen. I'm sorry, I did it as best as I could, but we're still seven minutes old. That was perfect, Dean. Perfect. Thank you so much. And thank you to Dr. J and Andrew and Barry for a very interesting presentation today. We'll take questions now, but for those who need to log off right now, we'll send you the recording and we'll take a few questions now. So if you have a question, you can go ahead and type it in into the Q&A box and submit your question or you can raise your hand. And we have a question from Christina Gose and she says, there have been a few skeptics saying that the use of mRNA vaccines actually changes patients' DNA. Is this correct? No. So if you look at, you know, we talked DNA makes RNA and RNA makes protein. There are very special circumstances where RNA can get made back into DNA and that requires that the virus has an enzyme called a reverse transcriptase. And so the classic virus to do that is HIV, but this virus is not showing up with the reverse transcriptase that allows it to make DNA from RNA. So unless it magically decides to come up with a new tool to make that, it's just not likely to, you know, there's no way for that to happen. The mRNA can't be integrated without that enzyme. The virus isn't infecting and showing up with it. So there's just no way to get it back into the DNA. Thank you. And this one is for Maria again. She read that there are some places in Africa where the distribution of COVID vaccines is being done via drones. Has the U.S. considered this solution for the most remote areas? Well, I can say that the U.S. military will be participating in, you know, using airlift assets to get to some less developed countries. So that's as we build up supply in particularly the products, as we mentioned, that are more appropriate for those markets. So military assets will be used. DHL, you know, in the U.S. basically FedEx and UPS are split in the country for the small package delivery. And then, but globally, DHL is obviously a big player in many other logistics firms in, let's face it, you know, if you go onesies by drone, we're not going to get to critical mass very quickly, but there are some applications. It's kind of a sexy story and there will be applications for that. But in the large scale, I don't think that's going to be the means of distribution. Thank you, Andrew. This one's from Steve. Barry mentioned a technical difference with pharmaceuticals and biologics. Should this be reflected in policy language referencing pharma from a coverage exclusion perspective? I'll just put my two cents in, but Jean's probably a better person to address it. But I would say that the biologics, as I said, are going to be much more temperature sensitive, generally speaking. So if that is something of concern, I would think it would be because temperature excursions are probably the major cause of loss or a major cause of loss, you know, within the life science segment. Steve, I would say that there's probably two different ways of looking at this. One is that if you, the more details you get, the more you actually leave open, because then if you've covered everything, you better cover everything, otherwise you're going to get stuck. I think that there's a reasonable argument that it's still a pharmaceutical, even if it falls within a different classification and it would be covered. But again, you know, you've all been around for a long time and we all know that if anybody can make an argument, they will. And if someone thinks that they're not going to get coverage because there's a pharmaceutical exclusion in the policy and this is not a pharmaceutical, they will file suit. I don't know that I'd want to go into that much great detail in an exclusion. I think I'd stick with what we have, but we're always going to wind up with some lawyer that'll take the case. With respect to motor truck cargo, that's an issue that's near and dear to my heart. So I'm not an attorney, but I can tell you, we see a lot of instances where big mature drug companies try to cram unrealistic terms onto motor carriers. So for example, they might have asked for full liability of the value of the product. So in many cases, we're hauling tens of millions of dollars of product and I'll just ask, hey, what do you want? And we'll seek that in the financial markets and we'll come back to you with a price. In 99.9% of the cases, the owner of the cargo already has a policy with some of you all. So it doesn't make sense for them to double pay or double insure. So we afford them typically coverage up to say a hundred, cargo liability up to a hundred thousand or 250,000, something like that, but it has to be defined. There's no value to the insurer, but the shipper cramming those terms onto most motor carriers aren't even worth $40 million. So congratulations, you got somebody to sign a bad piece of paper. And Jean referenced Carmack earlier. I don't know why people keep wanting to waive Carmack rights. Neither the shipper nor the carrier should be waiving Carmack rights. These are remedies that benefit both parties and they're organized. So I think there were a few attorneys who are counseling drug companies for some period of time to have all these Carmack waivers in there. I think we're turning the corner a little bit on them, but those are bad terms and they existed that the same boiler plate was being used by so many different shippers. It caused me to walk away from business for five to 10 years from a lot of these big companies. And fortunately that pendulum has come back to the middle because they've realized it's not really worth much. And I think Andrew's right. And if you're lucky enough to get Andrew as the motor carrier, you've got somebody that's actually looking at the contract. Unfortunately, there are so many of these small guys who have no idea what they're signing and they are literally giving away their life and they've got a hundred thousand dollar policy limit and a $5 million liability or greater. It doesn't help anybody. It just keeps the litigation going on much longer than it should be. So it's important for you to understand that as an underwriter what you're signing on for. Thank you. And we have a question from Clayton Eubank, understanding that this will not be the last pandemic that we'll face, how is this information changing the landscape for insurance underwriting practices, claims and packaging trucking systems? What are the most important things that we should be learning from this current climate? In my opinion on the supply chain, right, we mentioned the risk of supply chain. So something like, was it 80% of API, the active pharmaceutical ingredients come from China and almost all antibiotics are made in China. So just forget about a pandemic. What about our, we have quite an adversarial relationship now. Is that good? Probably not. So the Defense Production Act and BARDA and other, you know, government vehicles are likely to be used to force some sort of nearshoring or reshoring of production of those essential goods. And we've supplied or serviced the Strategic National Stockpile for CDC and Health and Human Services for some period of time. And it's a little discouraging to see that the Strategic National Stockpile was neither strategic nor stockpiled. And so that's going to change TAC quite a bit, in my opinion, in terms of our preparedness. Almost like what happened with Katrina, Hurricane Katrina, you know, changed our approach to preparedness. This is going to be a much larger scale. I think there'll be, hopefully there'll be some lessons learned from this that will help us going forward. I saw a statistic and I don't know where, I don't have the background data on it, but it indicated that 30% of vaccines are lost either because of damage or theft. That's a bit scary. Again, I don't know where that statistic came from, but hopefully we'll do a lot better going forward. All right. Thank you so much. This was an excellent presentation. And I'd also like to thank all of our attendees for your interesting questions and participation today. The winners of the $25 Amazon gift card are Maria Fernanda Alonzo and Clayton Eubank. Thank you both for your questions and thank you for all the questions that we had. We actually still had a few more questions, but we're at our maximum time now. Thank you also to all of the attendees who participated today. You'll receive a link to an electronic survey. Please take time to provide your feedback to INUA. And we look forward to seeing you for the next IMUA event. Thanks, everyone.

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Inland Marine Underwriters' Association

COVID-19

vaccine distribution

transportation industry

vaccine effectiveness

Pfizer

Moderna

AstraZeneca

Johnson & Johnson

shipping challenges

vaccine demand saturation

supply chain complexities