WEBVTT - COVID-19 Chapter 5: Vaccines 0:00:01.240 --> 0:00:03.640 My husband was exposed to a person who was later 0:00:03.720 --> 0:00:08.280 positively diagnosed with COVID nineteen, although that person has remained asymptomatic. 0:00:08.800 --> 0:00:10.879 My husband and I have been self quarantined in our 0:00:10.920 --> 0:00:13.560 home since we found out that person had tested positive. 0:00:14.040 --> 0:00:16.400 We are in our early thirties and are not worried 0:00:16.440 --> 0:00:18.680 for ourselves, but do not want to risk preading this 0:00:18.760 --> 0:00:22.560 disease to anyone else. My husband began developing mild symptoms 0:00:22.560 --> 0:00:25.480 two days ago and I began developing mild symptoms last night. 0:00:25.920 --> 0:00:29.560 We are both experiencing shortness of breath, chess congestion, cough, 0:00:29.680 --> 0:00:33.159 mild fever, and general body ache. Our case manager with 0:00:33.159 --> 0:00:36.080 the public Health Department spent most of the afternoon fighting 0:00:36.200 --> 0:00:39.120 to get test ordered for us. When we called urgent 0:00:39.159 --> 0:00:41.360 care to say we were coming, they told us to 0:00:41.400 --> 0:00:44.360 stay home. They agreed to see us when we explained 0:00:44.400 --> 0:00:46.599 that the Health department told us to get tested at 0:00:46.600 --> 0:00:50.159 our nearest urgent care. The Washington Post is reporting that 0:00:50.200 --> 0:00:53.720 sick people across the country are being denied coronavirus testing. 0:00:54.280 --> 0:00:56.920 If my husband had not been exposed to a confirmed case, 0:00:57.200 --> 0:01:00.279 I believe we also would have been denied. How will 0:01:00.280 --> 0:01:02.400 we know who has the sickness if testing is not 0:01:02.520 --> 0:01:07.760 widely available. Our urgent care appointment was incredibly frustrating. The 0:01:07.880 --> 0:01:10.119 nurse met us at a side door with masks. We 0:01:10.120 --> 0:01:13.240 were there for nearly two hours, and no one seemed 0:01:13.240 --> 0:01:15.520 to know how to treat us, what protective gear they 0:01:15.520 --> 0:01:18.679 were supposed to wear, what questions to ask us. The 0:01:18.760 --> 0:01:20.760 nurse took off her face shield while in the room 0:01:20.800 --> 0:01:23.120 with us to make it easier to see the computer. 0:01:23.920 --> 0:01:27.280 We overheard her say she has pneumonia. Why was a 0:01:27.360 --> 0:01:30.560 nurse with pneumonia assigned to us? We were there for 0:01:30.640 --> 0:01:33.600 nearly two hours, and the whole time could hear people 0:01:33.640 --> 0:01:36.119 outside of our room asking one another what to do. 0:01:36.680 --> 0:01:38.440 Someone was on the phone with what seemed to be 0:01:38.480 --> 0:01:42.440 the CDC. Their guidance appeared to change while we were there. 0:01:42.680 --> 0:01:46.759 The healthcare system is not prepared for a pandemic. We 0:01:46.760 --> 0:01:50.440 were first tested for flu. My results came back positive, 0:01:50.520 --> 0:01:54.120 my husband's negative. We were both written prescriptions for TAMA flu. 0:01:54.600 --> 0:01:58.040 We were also tested for COVID nineteen, but will not 0:01:58.160 --> 0:02:00.920 hear back until Monday or Tuesday, and maybe even Wednesday 0:02:01.000 --> 0:02:04.840 because labs are not staying open over the weekend. When 0:02:04.840 --> 0:02:07.400 you get tested for COVID nineteen. You have to sign 0:02:07.440 --> 0:02:10.280 a form saying that, among other things, you will self 0:02:10.320 --> 0:02:13.799 quarantine until you get your results back. Our doctor sent 0:02:13.840 --> 0:02:17.040 our tamiflu prescriptions to a pharmacy inside of a target. 0:02:17.680 --> 0:02:19.600 We had to point out to her that this would 0:02:19.600 --> 0:02:22.360 break our quarantine and maybe it would be a better 0:02:22.400 --> 0:02:24.960 idea to send it to the pharmacy that was literally 0:02:25.000 --> 0:02:28.240 next door and offer a drive through pickup. It still 0:02:28.280 --> 0:02:31.480 took over two more hours to fill our prescriptions there, 0:02:31.919 --> 0:02:34.440 as the one sent to target was not canceled properly. 0:02:35.400 --> 0:02:39.280 So now we wait under mandatory quarantine. We have enough 0:02:39.280 --> 0:02:42.040 food and other supplies, but worry for others who do not. 0:02:42.760 --> 0:02:45.320 I hope the government and healthcare system figure out what 0:02:45.480 --> 0:02:46.760 to do and quickly. 0:03:31.800 --> 0:03:34.000 Aaron, what date did we get that email? 0:03:34.639 --> 0:03:38.640 So we got that email on March thirteenth, oh Man. 0:03:40.560 --> 0:03:44.200 So this was an email that we received from someone 0:03:44.240 --> 0:03:46.960 who wanted to share their story, and we asked whether 0:03:46.960 --> 0:03:49.080 we could share this anonymously. They did not want their 0:03:49.160 --> 0:03:53.360 name to be shared. And we really appreciate you sending 0:03:53.440 --> 0:03:56.800 us this email because I think it's hugely important because 0:03:56.800 --> 0:03:59.040 it illustrates with a lot of people in the us 0:03:59.120 --> 0:04:01.760 are facing right now these challenges in getting tested. 0:04:02.840 --> 0:04:03.480 Absolutely. 0:04:05.040 --> 0:04:09.000 Hi, I'm erin Welsh, I'm erin Alman Updike and this 0:04:09.080 --> 0:04:12.720 is this podcast will kill you. Welcome to Chapter five 0:04:12.920 --> 0:04:16.080 of Anatomy of a Pandemic. This is our series on 0:04:16.200 --> 0:04:17.120 COVID nineteen. 0:04:17.760 --> 0:04:20.279 So far, what have we talked about. We have talked 0:04:20.279 --> 0:04:25.920 about SARS COVID two, the virus itself. We've discussed COVID nineteen, 0:04:26.240 --> 0:04:31.760 the clinical disease picture. We chatted about control strategies and 0:04:32.000 --> 0:04:34.640 also what we might expect from this epidemic curve and 0:04:34.640 --> 0:04:38.440 what we've seen so far. So in this episode we 0:04:38.560 --> 0:04:41.960 asked an expert all of your questions about vaccines and 0:04:42.000 --> 0:04:45.800 the development of a vaccine against SARS covy two. But 0:04:45.839 --> 0:04:46.880 we'll get to that in a minute. 0:04:47.440 --> 0:04:53.880 First, first things first, it's quarantine anytime, of course it is. 0:04:54.160 --> 0:04:56.479 How are we still managing to sound bubbly for that part? 0:04:56.600 --> 0:04:57.080 I don't know? 0:04:57.440 --> 0:04:57.800 Are we? 0:04:58.320 --> 0:04:59.280 Do we sound bubbly? 0:05:00.080 --> 0:05:00.479 I don't know? 0:05:00.680 --> 0:05:03.520 Do we? Okay, I don't know what are we drinking? 0:05:03.839 --> 0:05:06.800 In any case, I'm drinking water. But if you want 0:05:06.800 --> 0:05:12.080 a quarantine, you could make quarantini number five, which is 0:05:12.200 --> 0:05:14.240 essentially a tequila sunrise. 0:05:14.839 --> 0:05:19.920 Yeah, so tequila, orange juice, cherry, a little bit of 0:05:20.040 --> 0:05:22.000 cherry splash, juice grenadine. 0:05:22.440 --> 0:05:24.840 We'll post the recipe for this quarantini as well as 0:05:24.839 --> 0:05:27.640 our non alcoholic Placebrita on all of our social medias 0:05:27.720 --> 0:05:29.320 and our website. 0:05:29.279 --> 0:05:34.839 Every time, every time, every time. Okay, so a couple 0:05:34.880 --> 0:05:37.760 pieces that might be helpful to know before we jump 0:05:37.800 --> 0:05:39.880 into this interview, just so that we're all in the 0:05:39.880 --> 0:05:43.200 same page when it comes to vaccines. If you want 0:05:43.200 --> 0:05:46.120 a primer on how vaccines work and all the various 0:05:46.120 --> 0:05:50.360 types of vaccines, we have this in enormous detail in 0:05:50.440 --> 0:05:53.719 our two vaccines episodes, the first of which has a 0:05:53.760 --> 0:05:56.120 lot of detail on the types of vaccines and how 0:05:56.240 --> 0:06:00.200 your immune system responds to vaccines. So if you haven't 0:06:00.240 --> 0:06:03.480 heard it, or if you've forgotten entirely, which you know, 0:06:03.640 --> 0:06:07.920 I'm among those, it exists online for you. But for 0:06:07.960 --> 0:06:10.080 this interview, let's quickly go over some of the different 0:06:10.120 --> 0:06:13.839 types of vaccines. There are whole vaccines, so this is 0:06:13.839 --> 0:06:16.520 a vaccine that's made of an entire virus or bacteria, 0:06:17.040 --> 0:06:20.120 and those can either be killed or what we call attenuated, 0:06:20.360 --> 0:06:23.320 which means that they are less virulent and they can't 0:06:23.360 --> 0:06:27.880 really cause disease. There are component vaccines, which means the 0:06:27.960 --> 0:06:30.840 vaccine is made of pieces of the virus or bacteria, 0:06:31.320 --> 0:06:34.839 usually components of their surface, so that our body can 0:06:34.839 --> 0:06:38.440 make antibodies against these surface proteins that can help then 0:06:38.760 --> 0:06:41.400 fight off the virus if we ever get exposed to it. 0:06:41.880 --> 0:06:45.040 And finally, the newest kinds of vaccines, which I think 0:06:45.080 --> 0:06:49.920 are fascinating are DNA or RNA vaccines, and so that 0:06:49.960 --> 0:06:53.359 means injecting the DNA or RNA sequence or part of it, 0:06:53.720 --> 0:06:56.240 of the virus or bacteria into your muscle, and then 0:06:56.320 --> 0:06:59.360 your body has to use that sequence to make the proteins, 0:06:59.760 --> 0:07:03.520 and then your body makes animodies to those proteins, thus 0:07:04.360 --> 0:07:05.159 immunizing you. 0:07:06.080 --> 0:07:08.760 It's it's very cool, aren't it. It's beautiful, y awesome. 0:07:09.440 --> 0:07:12.680 And so having these different types of vaccines means that 0:07:12.720 --> 0:07:16.280 we have a number of different ways to target infectious diseases, 0:07:16.360 --> 0:07:21.600 including novel pathogens like SARS covy two. In the past, 0:07:22.160 --> 0:07:27.320 vaccine development relied heavily on creating attenuated versions of pathogens, 0:07:27.360 --> 0:07:31.000 so live strains of bacteria or viruses that don't cause 0:07:31.040 --> 0:07:35.640 disease but otherwise act a lot like real pathogens, or 0:07:35.760 --> 0:07:39.880 in other cases, we made vaccines out of whole killed cells. 0:07:41.040 --> 0:07:43.920 But both of these types of vaccines take a long 0:07:44.000 --> 0:07:48.840 time to produce, largely because they require first isolation and 0:07:48.920 --> 0:07:53.080 then culture of the pathogen in question, and then you 0:07:53.200 --> 0:07:56.720 have to grow that pathogen in large enough quantities to 0:07:56.760 --> 0:08:00.000 be able to produce a vaccine, So that whole process 0:08:00.240 --> 0:08:04.840 takes a long time and a lot of money too. 0:08:05.720 --> 0:08:10.800 So much money. Today, with the advent of molecular techniques, 0:08:10.800 --> 0:08:14.920 including gene sequencing, we can much more rapidly determine a 0:08:14.960 --> 0:08:17.520 protein or a gene sequence that could be used as 0:08:17.520 --> 0:08:20.720 a target for vaccine development. And we've seen this time 0:08:20.800 --> 0:08:23.520 and time again with every new pathogen that has emerged 0:08:23.520 --> 0:08:28.560 in recent years, from SARS to mers ebola zica. Groups 0:08:28.720 --> 0:08:31.680 rapidly try to identify potential targets that we can use 0:08:31.720 --> 0:08:34.719 to create a vaccine. But even though we can do 0:08:34.760 --> 0:08:37.400 this more rapidly than in the past, and even though 0:08:37.440 --> 0:08:39.680 genetic tools give us a kind of a head start 0:08:39.720 --> 0:08:42.640 on this, as you'll hear our guests explain, there are 0:08:42.760 --> 0:08:46.280 still very many steps to the development of an effective 0:08:46.320 --> 0:08:48.640 vaccine and they can't be skipped. 0:08:49.679 --> 0:08:53.840 So our guest today is doctor Maria Elena Botazzi. She's 0:08:53.880 --> 0:08:56.520 been working for years with her group in Texas on 0:08:56.559 --> 0:08:59.800 a vaccine against coronaviruses since the days of SARS, and 0:09:00.960 --> 0:09:02.800 so we brought her on to talk about her work 0:09:02.840 --> 0:09:05.800 on the development of a vaccine for SARS COVID two, 0:09:06.120 --> 0:09:09.400 the virus causing COVID nineteen. She'll answer all of your 0:09:09.440 --> 0:09:13.200 questions about what the steps are in vaccine development, looking 0:09:13.280 --> 0:09:16.480 at that timeline to development and whether we can hasten 0:09:16.520 --> 0:09:20.719 that process along while still maintaining safety standards. So the 0:09:20.840 --> 0:09:24.040 vaccine that her group is working on is a component vaccine, 0:09:24.280 --> 0:09:27.560 so it's made of that spike protein that you've probably 0:09:27.600 --> 0:09:31.680 heard a lot about in the news and if you've 0:09:31.720 --> 0:09:34.760 listened to the other episodes in this series. But we'll 0:09:34.840 --> 0:09:37.440 let her introduce herself and tell you all the details 0:09:37.480 --> 0:09:51.559 about the vaccine that she's working on right after this break. 0:10:04.480 --> 0:10:08.400 So I'm Marie Lena botazi and currently I co direct 0:10:08.559 --> 0:10:13.400 together with doctor Peter Hotis Center for Vaccine Development, which 0:10:13.480 --> 0:10:19.200 is based in Houston, and it's embedded with Baylor College 0:10:19.240 --> 0:10:23.000 of Medicine and Texas Children's Hospital. So it's a very 0:10:23.120 --> 0:10:30.080 unique vaccine center because we not only apply certainly business practices, 0:10:30.520 --> 0:10:34.920 you know, regulatory practices like any other big biotech or pharma, 0:10:35.000 --> 0:10:39.160 but we do it embedded in academic health centers because 0:10:39.160 --> 0:10:43.840 we have a lot of support through you know, collaborations 0:10:43.880 --> 0:10:46.959 with other I guess researchers. But at the same time, 0:10:47.559 --> 0:10:52.520 in the nonprofit sector, try to build these vaccine technologies 0:10:52.920 --> 0:10:57.520 with the ultimate mission that they can be affordable, reachable, 0:10:57.960 --> 0:11:01.360 and certainly be deployed to popular relations who really need them, 0:11:01.400 --> 0:11:02.560 you know, for the public good. 0:11:03.960 --> 0:11:08.520 Excellent talking now about stars COVID two, which is the 0:11:08.600 --> 0:11:12.560 virus that causes COVID nineteen. What about this virus makes 0:11:12.600 --> 0:11:15.400 it a good candidate for vaccine? 0:11:16.080 --> 0:11:20.240 So COVID nineteen as a coronavirus, and you know by 0:11:20.280 --> 0:11:26.480 that also any virus, you know, usually developing interventions to 0:11:26.600 --> 0:11:29.280 prevent them, you know, are not easy to do. So 0:11:30.000 --> 0:11:34.600 there's nothing particular about this virus that would make it 0:11:34.720 --> 0:11:40.200 easier or less easier to develop a vaccine against it. 0:11:40.240 --> 0:11:45.600 And you know, still with all the science advancements and 0:11:45.720 --> 0:11:50.200 technology advancements that we can't really predict when we would 0:11:50.280 --> 0:11:55.520 be successful at developing vaccines. And certainly now you even 0:11:55.600 --> 0:11:59.719 hear that most of vaccines are being developed in this 0:12:00.080 --> 0:12:04.960 new I guess era compared to maybe the old generation 0:12:05.080 --> 0:12:08.319 vaccines like you know, the measles, mumps, rubella. Is that 0:12:08.640 --> 0:12:12.280 new vaccines tend to becoming more and more that are 0:12:12.320 --> 0:12:15.760 not considered fully protective type of vaccines, but they are 0:12:16.320 --> 0:12:22.520 vaccines that are geared to reduce the severity of illness, 0:12:22.640 --> 0:12:28.000 maybe reduce the certain intensity of infections by different pathogens. 0:12:28.520 --> 0:12:31.600 And it's getting harder and harder to develop vaccines that 0:12:31.679 --> 0:12:35.280 are going to one hundred percent protect an individual. But 0:12:35.360 --> 0:12:38.240 that's still okay, right, I mean that you know that 0:12:38.240 --> 0:12:40.560 that's better than nothing. You know. Again, you know, I 0:12:40.559 --> 0:12:45.120 think the value of vaccines, whether they're fully protective or 0:12:45.120 --> 0:12:50.120 they are partially protected, ultimately is to try to again 0:12:50.240 --> 0:12:56.480 reduce deaths, reduce severity, hence reducing people to having to 0:12:56.559 --> 0:13:01.240 engage the healthcare systems by being hospital eyes or of 0:13:01.280 --> 0:13:04.440 course even going all the way to being put into 0:13:04.480 --> 0:13:09.480 intensive care units, and change the way that we therefore 0:13:09.520 --> 0:13:14.080 can manage these diseases by you know, being able to 0:13:14.160 --> 0:13:16.320 treat them like if you were getting a common call 0:13:16.360 --> 0:13:21.960 with you can basically maintain them through some simple at 0:13:21.960 --> 0:13:27.760 home type of containment or even just clinical management. 0:13:29.400 --> 0:13:33.720 So is the reason that it's becoming more difficult to 0:13:33.800 --> 0:13:36.840 create these completely protective vaccines? Is that Does that have 0:13:36.880 --> 0:13:40.160 something to do with the timeline of vaccine development or 0:13:40.240 --> 0:13:42.040 is it just sort of in the pathogens that we're 0:13:42.080 --> 0:13:44.280 talking about today, where we've kind of tackled all of 0:13:44.320 --> 0:13:46.920 the low hanging fruit of the infectious disease world. 0:13:47.640 --> 0:13:50.680 Well, maybe it's actually a little combination of both. Right, 0:13:50.760 --> 0:13:53.880 So again, if you think of how the old vaccines 0:13:53.920 --> 0:13:57.520 were originally generated, you know, we used to do them 0:13:57.960 --> 0:14:02.360 quite rudimentary, right, you know, use the entire pathogen and 0:14:02.400 --> 0:14:06.160 then you either kill the pathogen or inactivate the pathogen. 0:14:06.679 --> 0:14:11.280 And even though those vaccines are certainly still an approach 0:14:11.360 --> 0:14:15.840 that people occasionally evaluate more and more, now they're becoming 0:14:16.440 --> 0:14:20.120 much more sophisticated in the sense that we do them synthetically. 0:14:20.280 --> 0:14:24.680 Therefore we avoid also putting in any components of the 0:14:24.720 --> 0:14:29.600 pathogen that is really not necessary for us to confer 0:14:29.720 --> 0:14:33.640 protection in the human host, you know. So, yes, I 0:14:33.640 --> 0:14:37.239 mean the procedures, the ways that we produce vaccines, test vaccines, 0:14:38.160 --> 0:14:41.880 you know, have some level of impact of how quickly 0:14:41.920 --> 0:14:45.480 we can move them. But I think the second, which 0:14:45.520 --> 0:14:49.720 is the fact that pathogens, the ones that we consider 0:14:50.880 --> 0:14:53.520 the easy pathogen that we knew we could develop vaccines 0:14:53.600 --> 0:14:56.520 very rapidly, most likely we already did them. But now 0:14:56.520 --> 0:15:00.840 we're dealing with very complex pathogen is that even have 0:15:01.120 --> 0:15:08.320 very multiple transmission modes or that their cycle of survival 0:15:08.440 --> 0:15:13.720 is you know, inclusive and an intermediary vector or reservoir. Right. 0:15:13.760 --> 0:15:16.240 So you know, I just can give you an example, 0:15:16.280 --> 0:15:19.200 you know, the malaria vaccine, right, Why has it been 0:15:19.240 --> 0:15:22.720 so hard? Because what do you develop a vaccine against? 0:15:22.960 --> 0:15:25.440 Which stage of the parasite? You know, do you do 0:15:25.520 --> 0:15:28.400 it from the parasite that is in the blood stage 0:15:28.520 --> 0:15:30.840 or in the or or not do you look at 0:15:30.960 --> 0:15:35.479 you know, the parasite when it's inside the mosquito. These viruses, 0:15:35.600 --> 0:15:40.400 more and more are also quite intelligent in themselves, so 0:15:40.440 --> 0:15:43.560 they're very complex in the nature of how they not 0:15:43.640 --> 0:15:47.840 only find ways to infect but also where they come from. 0:15:48.400 --> 0:15:52.000 And therefore it makes it a little bit more challenging 0:15:52.080 --> 0:15:55.880 for us to find how we can tackle them and 0:15:56.680 --> 0:16:01.120 prevent them to not only infect us, but certainly cause disease. 0:16:01.680 --> 0:16:05.400 Excellent, So, in the case of SARS CoV two, this 0:16:05.520 --> 0:16:09.720 new coronavirus. How is the vaccine that your group is 0:16:09.760 --> 0:16:14.200 working on being made, what is it targeting, and how 0:16:14.320 --> 0:16:17.920 is it going to work against this new virus. 0:16:18.440 --> 0:16:21.920 So if we look at the vaccine that we currently 0:16:21.960 --> 0:16:24.960 are developing, as I mentioned, since our mission is really 0:16:25.000 --> 0:16:29.600 to always find ways that would lead to a technology 0:16:29.640 --> 0:16:34.600 that is already using a proven platform, so that's always 0:16:34.640 --> 0:16:38.520 been our case. So like proven platform, I mean in 0:16:38.560 --> 0:16:42.320 our case it is a recombinant protein based vaccine. And 0:16:42.360 --> 0:16:44.880 the reason we select that is because we know there 0:16:44.920 --> 0:16:48.800 are already many vaccines that are license and being used 0:16:48.840 --> 0:16:53.120 that use that same technology. So the backbone therefore of 0:16:53.160 --> 0:16:56.200 the way that we want to make the vaccine, it's 0:16:56.360 --> 0:17:00.080 proven and already has a lot of safety and as 0:17:00.080 --> 0:17:04.800 well as data on how you can rapidly produce it 0:17:04.840 --> 0:17:09.320 and how good are they by scaling them, and certainly 0:17:09.400 --> 0:17:12.400 even the amount of costs. You know that these types 0:17:12.440 --> 0:17:16.240 of platforms costs. So recombin and protein based vaccines are 0:17:16.600 --> 0:17:20.680 in general quite affordable and more importantly, they don't need 0:17:20.680 --> 0:17:25.880 to have very sophisticated manufacturing plants, and even in low 0:17:25.920 --> 0:17:29.679 middle income countries that do have capacity to develop their 0:17:29.720 --> 0:17:33.920 own vaccines could rapidly adopt them. That is certainly one 0:17:33.960 --> 0:17:37.280 consideration that we want is that you know, we don't 0:17:37.320 --> 0:17:40.240 develop something that is too much of a high cost 0:17:40.400 --> 0:17:43.080 or it has too much complexity in the technology that 0:17:43.119 --> 0:17:45.639 then we can only make it in the US and 0:17:45.680 --> 0:17:49.200 then nobody else is able to adopt it because it's 0:17:49.240 --> 0:17:54.160 just too expensive or too labor intensive. So that's one aspect. 0:17:54.560 --> 0:17:59.000 The second aspect, specifically for COVID nineteen is that everybody 0:17:59.040 --> 0:18:02.000 is trying to attend and to develop a vaccine targeting 0:18:02.800 --> 0:18:05.560 what they call the spike protein, which is the protein 0:18:05.600 --> 0:18:10.800 the virus uses to infect the human cells. But even 0:18:10.880 --> 0:18:15.000 within the spike protein, there are a lot of components 0:18:15.000 --> 0:18:19.400 that maybe it's they're not necessarily useful in the induction 0:18:19.520 --> 0:18:23.560 of this protective response. So we with a group of 0:18:23.720 --> 0:18:27.840 partners from the New York Blood Center as well as 0:18:27.880 --> 0:18:32.240 the University of Texas Medical Branch here in Galveston, we 0:18:32.960 --> 0:18:36.639 were kind of like picked apart the spike protein and 0:18:36.680 --> 0:18:41.720 we narrow down what we think it's the most essential 0:18:41.760 --> 0:18:43.960 piece that we need for us to be able to 0:18:44.040 --> 0:18:47.800 induce our response in humans that is protected but at 0:18:47.840 --> 0:18:52.160 the same time evaluates the safety of using it. So 0:18:52.240 --> 0:18:54.560 it's it's actually a small piece that it's called the 0:18:54.640 --> 0:19:00.199 receptor binding domain. So amongst the spike protein, the like 0:19:00.359 --> 0:19:05.080 uses this domain to specifically target this component in our 0:19:05.160 --> 0:19:08.120 human cells that needs to be bound on and therefore 0:19:08.240 --> 0:19:12.840 used to be to infect the cells. So we therefore 0:19:13.000 --> 0:19:18.520 engineered in our lab a recombinant protein that specifically just 0:19:18.680 --> 0:19:23.680 expresses this receptor domain, and when you put it in 0:19:23.720 --> 0:19:27.600 the right formulation, we know that in animal models it 0:19:27.640 --> 0:19:32.639 does induce a strong and certainly efficacious response and protects 0:19:32.640 --> 0:19:38.680 against a challenge of the SARS virus. Now there's a 0:19:38.720 --> 0:19:42.400 disclaimer here that you know, our vaccine was developed back 0:19:42.440 --> 0:19:47.439 in twenty eleven, so the engineering of this vaccine was 0:19:47.480 --> 0:19:51.680 really based on the SARS virus that was circulating at 0:19:51.680 --> 0:19:56.120 that time and not COVID nineteen virus. But there are 0:19:57.000 --> 0:20:01.440 several evidence and strong scientific evidence that the two viruses 0:20:01.480 --> 0:20:05.000 are very similar to each other. So we believe that 0:20:05.480 --> 0:20:08.720 we should evaluate it to see whether there may be 0:20:09.119 --> 0:20:10.760 a potential of cross protection. 0:20:12.080 --> 0:20:14.800 That's wonderful kind of giving you a jump start on 0:20:14.880 --> 0:20:18.280 the SARSKOV two vaccine potentially. 0:20:17.960 --> 0:20:20.240 Right, And you know, we will not know if it's 0:20:20.280 --> 0:20:23.760 a perfect fit. It may not be a perfect fit. 0:20:24.240 --> 0:20:28.480 But you know, I think, if anything, at this point, 0:20:28.560 --> 0:20:32.000 I know there are many efforts trying to develop very 0:20:32.040 --> 0:20:36.639 specific COVID nineteen vaccines, and they certainly all use different 0:20:36.640 --> 0:20:41.359 strategies and even different platforms. Some may be more favorable 0:20:41.400 --> 0:20:45.760 than others. Again, we probably are the only ones focusing 0:20:45.800 --> 0:20:50.240 on this small domain. We also are, in parallel trying 0:20:50.280 --> 0:20:55.360 to engineer a brand new vaccine that is against specifically 0:20:55.400 --> 0:20:59.160 the RBD of this new virus. But in the meantime, 0:20:59.320 --> 0:21:02.119 you know, since we are already so advanced with the 0:21:02.160 --> 0:21:05.840 prior vaccine, because we already even have it in our freezers, 0:21:06.400 --> 0:21:10.480 manufactured with a grade that can be used in the clinic, 0:21:11.080 --> 0:21:13.800 we think that we should not just wait for us 0:21:13.840 --> 0:21:16.400 to develop a new one. We should, you know, in parallel, 0:21:16.480 --> 0:21:19.160 start evaluating the one that we already have designed. 0:21:20.000 --> 0:21:23.400 Do you mind walking us through that timeline for vaccine 0:21:23.400 --> 0:21:26.480 development and then testing and then deployment, and then maybe 0:21:26.560 --> 0:21:29.399 how soon you think we could expect to see an 0:21:29.400 --> 0:21:32.440 effective vaccine for SARSKOV two. 0:21:33.560 --> 0:21:39.280 Certainly so developing vaccines, and be quite honest, any biologic 0:21:40.920 --> 0:21:44.840 it's a long process. So if you start from scratch, 0:21:44.960 --> 0:21:47.479 like for example, we're starting from, you know, looking at 0:21:47.480 --> 0:21:51.320 the genetic code of the virus, identifying what we want 0:21:51.359 --> 0:21:53.800 to target. I mean, at least for this, we already 0:21:53.800 --> 0:21:57.200 have a heads up because we already had an idea 0:21:57.200 --> 0:21:59.680 of what to target. So let's let's take the example. 0:22:00.040 --> 0:22:03.000 We know we want to target the receptor binding domain 0:22:03.040 --> 0:22:06.760 of the spike, so rapidly we clone that. We have 0:22:06.920 --> 0:22:11.880 to look for the process for making it at laboratory scales. 0:22:11.960 --> 0:22:15.160 But then that laboratory scale has to be scaled up 0:22:15.440 --> 0:22:18.880 to the point where it becomes not only a pilot 0:22:18.960 --> 0:22:24.320 scale in manufacturing agencies, but eventually even what we call 0:22:24.440 --> 0:22:31.480 industrial scales. That's just that sole process of from the cloning, engineering, 0:22:31.600 --> 0:22:37.880 to scaling and producing usually can take from six months 0:22:38.560 --> 0:22:42.760 all the way to maybe eighteen months to even twenty 0:22:42.760 --> 0:22:45.000 four months. And of course it depends on is it 0:22:45.119 --> 0:22:47.639 easy to make it? Is it not easy to make it? 0:22:47.920 --> 0:22:52.080 Are the processes very complicated? Since we already know four 0:22:52.160 --> 0:22:56.440 stars that we already had developed was a very simple approach, 0:22:56.480 --> 0:23:00.479 and it ended up being quite an easy process. Instance, 0:23:00.600 --> 0:23:03.440 think that, you know, we could have a new process 0:23:03.480 --> 0:23:07.000 for the stars to RBD or the COVID nineteen RBD 0:23:07.680 --> 0:23:12.360 in probably the next six months, so that's one piece. However, 0:23:12.480 --> 0:23:16.720 after that, of course, you know, producing something doesn't tell 0:23:16.760 --> 0:23:20.240 you whether it's usable, or if it's going to be safe, 0:23:20.560 --> 0:23:23.719 or if it's going to be protected. So we before 0:23:23.800 --> 0:23:26.240 going to humans, you have to start a whole pre 0:23:26.400 --> 0:23:31.280 clinical plan where you have to have an animal model 0:23:31.320 --> 0:23:35.040 of course, that has to be suitable for the pathogen 0:23:35.119 --> 0:23:39.240 that you want to test your vaccine against. We know 0:23:39.440 --> 0:23:42.760 that there are currently several groups that have been developing 0:23:42.840 --> 0:23:47.960 these COVID nineteen animal models. They probably are not ready 0:23:48.040 --> 0:23:50.000 one hundred percent, but you know there are already a 0:23:50.040 --> 0:23:53.560 few that people are using to be able to evaluate 0:23:54.359 --> 0:23:58.280 any kind of vaccine or even even drugs for example. 0:23:58.720 --> 0:24:05.880 So that process of evaluating your produced vaccine candidate usually 0:24:05.920 --> 0:24:09.720 can take again another six maybe to another nine months, 0:24:09.800 --> 0:24:12.960 So there goes a year, right, and that's just only 0:24:13.040 --> 0:24:16.320 pre clinical. After that, when you decide that yes you 0:24:16.359 --> 0:24:19.479 can make it, yes you have indication in some model, 0:24:20.200 --> 0:24:25.000 then is the critical activity start. And by critical activities 0:24:25.040 --> 0:24:29.080 mean what we call the regulated the activities that then 0:24:29.160 --> 0:24:33.840 you can provide as evidence to a regulatory body, in 0:24:33.880 --> 0:24:37.320 our case the United States Food and Drug Administration. So 0:24:37.320 --> 0:24:42.680 that they can evaluate that information, and those include three 0:24:42.760 --> 0:24:49.560 main components, so a formal manufacturing campaign, a formal toxicology studying, 0:24:49.640 --> 0:24:53.159 an animal model, and then of course a plan of 0:24:53.200 --> 0:24:57.200 how you're going to do the first in human safety evaluation. 0:24:57.960 --> 0:25:03.760 And those three activities generally take another year or a 0:25:03.840 --> 0:25:06.160 year and a half, so you already have one year 0:25:06.280 --> 0:25:10.000 for that what we call research and development, one year 0:25:10.520 --> 0:25:15.840 maybe two years for the initial critical path activities, and 0:25:15.920 --> 0:25:19.760 after you finish that first, then you design a long 0:25:19.840 --> 0:25:24.879 term plan where eventually you evaluate in larger populations, you 0:25:24.920 --> 0:25:28.880 look at efficacy, you look at safety, and so as 0:25:28.920 --> 0:25:31.440 you can see, it can be a two to three 0:25:31.520 --> 0:25:34.639 year program, or it can become a ten year, twenty year, 0:25:34.760 --> 0:25:39.359 thirty year. As you have seen for many other vaccine programs, 0:25:39.840 --> 0:25:42.359 there is never an assurance that we will find one. 0:25:42.800 --> 0:25:45.080 But of course you have to do the studies to 0:25:45.119 --> 0:25:48.760 be able to evaluate if there's even the feasibility of doing. 0:25:48.560 --> 0:25:53.000 So in a situation like this where there's increasing need 0:25:53.240 --> 0:25:56.439 for the development and deployment of a vaccine. You know, 0:25:56.520 --> 0:25:59.320 I've seen a lot of news articles talking about shortening 0:25:59.359 --> 0:26:02.439 those steps, and so which of those steps would be 0:26:02.520 --> 0:26:05.560 shortened to them? Maybe you know, get an early release 0:26:05.840 --> 0:26:08.520 of a vaccine. 0:26:08.800 --> 0:26:13.280 So I think that it's not really a shortening of 0:26:13.359 --> 0:26:17.320 the steps as much as trying to instead of doing 0:26:17.359 --> 0:26:20.840 them linearly and one after the other. That there's been 0:26:20.920 --> 0:26:25.280 some I guess and consultation with the regulatory bodies that 0:26:25.320 --> 0:26:30.320 you can stagger and maybe do things in parallel. So, 0:26:30.480 --> 0:26:36.000