From the university of maryland. We will look at the threat with harvard Professor Joseph allen. If you live in the eastern or tral time zones, host time zones, 202 7488000. In the mountain or western, 202 7488001. If you are a nurse or doctor, we would like to hear u. S. We would like to hear you at 202 7488002. Lastw york city, over the 36 hours, over a thousand deaths. U. S. 13,500 deaths in the across the world, now 1. 5 million cases of coronavirus and approaching 89,000 deaths. Joining us from bethesda, maryland, dr. Wilber chen, a disease expert at the university of Maryland School of global medicine and health. Let me begin with the vaccine. There are three phases to incorporate a vaccine. Where are we with covid19 . Respect touest with vaccines, we are just at the beginning. About two weeks ago, we started the first of hopefully many vaccine trials that will be initiated this year. This first vaccine trial is what we call a phase one trial. Have to govaccines through three different phases before licensure. That means each of those phases has to be successful. There is a phase one study that requires a small sample size and the primary intent was to measure the safety and whether there was reactions to vaccinations. There is the second stage where sample sizen the population. You still look at safety but start focusing more on the immune response. You go to phase three. You continue to measure the ongoing safety, but the immune responses also and that is when you get a first look at the efficacy of the vaccine. Perhaps have a vaccine that is licensed. Faucidr. Anthony indicating this is on a fast track but you have been dealing with this for much of your life. What is the best Case Scenario for approval of this type of vaccine . The vaccine has to be successful at all stages. Isuming that the vaccine completely safe, and the immune response is as good as we desire that we mightope be, at around this time of year, finishing out phase three, which means that we might have a licensable vaccine perhaps in about another six months or a year, 18 months. Trialsbeen doing vaccine for many years. Failedse, vaccines have at any of these stages. The goal for me is to try to see as many vaccines evaluated as possible. Anyone singlet on vaccine. Host at the same time, there is a search for therapeutics. Is this in sync or separate . Guest these are all studies being done in parallel. The treatment trials are done in sick patients, patients who have covid. Those who were involved with our inpatient trials, hospitalized patients, who tend to be sick and ill people. But there are outpatient trials, that means that mild cases can be treated and still evaluate certain therapeutics or drugs. This is going on right now. These vaccine trials, the early phases are tested in healthy adults. In healthyt them adults and see good responses, we start expanding to the rest of the population. Young children, older adults, perhaps even the immune compromised. Those with diabetes and such. These are the target populations we want to get the vaccine rolled out to we have to evaluate the vaccine and how it performs in all segments of the population. Host once we get to that point in we have a vaccine, how quickly can it be manufactured and how does that process work . Guest that is a great question. A lot of people just ask how long it will take the license but then they dont realize what ginormor mess what a ous effort it takes to deploy a vaccine to a population. Licensed, the is manufacturer will have to start making large amounts of the vaccine. I cannot imagine that one single manufacturer can make 7 billion doses for the entire world. But even if you assume they are making a vaccine for small population, one billion doses, that is still a lot for one manufacturer. If they are able to do what is called tech transfer and have that Vaccine Technology licensed out to other manufacturers, then we might assume you might have 10 facilities trying to make that vaccine. Still, it is something that has to be made in large amounts. Thenyou have the vaccine, you have to deploy it down to the people. Chainis a huge logistics from the manufacturer out to federal or National Distribution sites and down to the state or local level, then down to even smaller minas of all levels and local populations. People thatf is not my expertise, but a Large Services that might have to be performed poorly vaccine can be delivered to a person. If this was not a pandemic, a virus you wanted to study, traditionally how long would that take . Guest it would take a decade on average. That is because, as we do the phase one, phase two, and phase three testing, normally there are critical stage gates or milestones you have to meet. When you do a phase one trial, after you completed the trial, you do the data analysis. Then, you think, is there justification for us to move forward and to the phase two. Then, you do the phase two study and you decide, next we can do the next phase two or phase three. Usually it is a series of phase two and phase three studies. It is usually a phase one, a series of phase twos, and a series of phase three studies. It might be different Clinical Trials being performed on one single vaccine and at every point during each of those atdies, you are taking looks how the vaccine is performing. Manufacturers, they are making a business or economic case for how the vaccine is performing, looking at Market Analysis and other things to see if this is a vaccine that will recoup our r d. S for rnd for host there are different studies going on now. One through the nih, a project between the chinese and american government, and another through oxford in england. Are these entities communicating with each other . How does that work . Situation, pandemic i hope there is great communication across. This is a global problem. , datak, at this time sharing and knowledge sharing will be critical. To move these vaccines and therapeutics forward. I am not involved in all of these different vaccine studies. Arehe national stage, there a lot of discussions that are being had that they are talking about sharing this type of data. Host you have been involved in past Vaccine Development, correct . Chin, withdr. Wilbur the university of Maryland Center. Mark in chula vista, california. Good evening. Caller a couple of questions. Orber one, with the cdc whoever basically creates the guidelines, would they be standard tout the get a vaccine much quicker . When will we be able to open the economy to restaurants . Was, i think the question theas asked as if cdc was one controlling the licensure. It is actually the fda. The food and Drug Administration is the federal authority that drugs and vaccines. Regulatory guideline be fast illhem to in a pandemic situation. Truncate these Clinical Trial so they can be done in shorter fashion. It is not to say we are cutting safety and not evaluating the relaxing some are of the requirements so we can enter into these Clinical Trials early on and so we could have early triggers to proceed with phase two testing. This is not just in the u. S. , but also what we call other regulatory authorities across the globe allowing for aunt watching allowing for and watching these therapeutics get evaluated. Host are you able to use the data, the type of vaccine used in previous pandemics . Vaccines beingse evaluated now are based on platform technologies that have been used to evaluate other types of vaccines. Versions for sar caller four example, havefor been used with these technologies. There are other Biotech Companies who have technologies that can be used, that they have used for other vaccines, and adapting it for this coronavirus. Done of studies have been using the broad platform. The fda and other regulatory authorities have some information already based on those prior vaccines using the same platform. There is not a lot of difference. Influenza forin coronavirus, you are using a broad platform for the Expression Technology or something else. These are things that a lot of these Drug Companies are axing companies are doing. They do have the Drug Companies or vaccine companies. They do have the data. , this may noten be your area of expertise. I have been following the infection rates and death rates in a lot of countries. Some of the western European CountriesMegumi Yokota a lot of the western European Countries. A lot of them seem to have higher death rates and their capitan terms of per population seems to be much higher. When i think of western europe, i think of countries that are in my mind the same in terms of health care and the ability to treat people. I wonder if you have any thoughts on that. I have not seen a lot of commentary on that. Guest that is a good question. A lot of scientists are wondering about that as well. Some of it is that in western haspe, the population is a lot of older folks. We know that older adults are at higher risk for more severe disease. There may be more smoking. So, with smoking, there might be more underlying pulmonary disease or lung disease. That can also contribute to seeing more cases. There could be other reasons as well. Some people might think that might be a genetic predisposition to having more disease. Perhaps that contributes as well. Ultimately, we do not know the answers. Things are moving very quickly but may be by this time next year, we will have more data and be able to analyze it so we can understand why there seems to be disparities between some countries such as europe versus the u. S. Or other places. Host based on your expertise, if you are one of the 1. 5 Million People around the world who have had covid19, are you then immune from it . Guest we sure hope so. We have not proven it yet. Of us are really banking on it. Getally hope that once you covid, at least you will have a much lower risk of having reinfection. We have not really tested that hypothesis formally. These hoping that vaccines we are developing will do what natural infection would do. I think that is something to be answered. Was just what does the vaccine do . How does it fight off the disease . Guest it mimics parts of the virus that we think are very important for its survival and for the immune response to mount against the virus so it can kill the virus. One of the important o proteinnts is a glyc on the surface of the virus. Corona means crown. There are these proteins that come out from the surface, they are called spike proteins. Host bristol, tennessee. Guest caller i would like to know when the vaccine is coming out. Would it be this year . Covid19, can they get like a pharmacy or prescription from the doctor . Guest i think the question is basically, how would i get it when the vaccine is available . We hope it will be Something Like pandemic influenza 2009, that these vaccines would be rapidly delivered to local Public Health authorities so you can get these at Vaccine Centers or maybe large Academic Centers or even Doctors Office visits. It would probably be initially at larger Doctors Offices. More and more vaccines become available, it would be at the smaller, private clinics. Logistically, it would be most feasible to have the rollout from the local Public Health authorities. Something that will be hopefully set up within the local communities, so there might be one or two locations within a particular county. Host we welcome our audience herein d. C. And coasttocoast on serious xm. Our guest is dr. Wilbur chan. Chen. Wilbur caller thank you for taking my call. , ianted to ask dr. Chen this rush for a vaccine is more like a money grab. I think there is an insanity involved in trying to make a vaccine for a disease that you cannot even define or identify with a test. Thecan explain a lot of discrepancies with vitamin d. You can get the same group of people. Childrene, blacks, and would not have a problem with lack of vitamin d, because they take milk. I wonder why we are looking at a vaccine as opposed to other protocols . Guest i dont know what the evidence is for the vitamin d. Argumenthere is a huge causings virus is overwhelmingss, medical systems. Huge losses because of the direct effects of this virus. There are ill people all throughout the globe. I dont know what the evidence is for this vitamin d that you are talking about. There is no evidence i have seen about vitamin d having any significant effect on morbidity and mortality. I think there is a huge argument for developing therapeutics against this virus. Im not sure exactly where those assumptions for that question came from. Bet could there potentially various vaccines, one for younger people, one for the elderly . Guest that is a good question. For influenza, there are vaccines that are specifically designed so they can work better for older adults. The standard vaccines perform a little bit more broadly for older adults. The same is true for children. Versions foriatric some vaccines. We had one, even if vaccine available for covid19, we might have different doses. Or there might be a different dosing scheme. Children may get two doses whereas adults may need to only have one dose. Those studies would need to be performed to understand. Caller dr. Chen, i would just like to i am not sure how you will answer this. I appreciate you taking my call. I have noticed that President Trump has been making in his statements, he seems to be making things very political. Worldced that today the Health Organization made some comments about things being very political as well. It seemed to me they were talking about donald trump. I am not sure 100 that they were but i believe that they were. I believe that we would do a lot f donald trump a lot better if donald trump did not make it a political issue, but made it a people who are sick issue and left politics and drama out of it. Not a politician, i am a scientist. But i think at this point in the pandemic, there is not really a lot of time to point fingers and not a lot of time to criticize what other countries are doing. I think we all need to move forward. Teamwork and for all of us to be trying to push forward with progressing alsopeutics or vaccines, sharing best practices how to treat patients ultimately who are hospitalized. Again, sharing of best practices among countries is going to be helpful as well. Petersburg,t. Florida. Bruce, good evening. Caller i have a twopart question for dr. Chen. An are you treating the ards d cytokine storm . And to ace inhibitors have any effect . Guest great question. Sounds like a person who is a scientist or has read some things about the science. Inflammation, generalized, of the lungs in the body. Basically there is what is called the cytokine storm. Withis what we are seeing this infection. Some of the therapeutics that people are trying to evaluate are these particular therapeutics that actually block certain specific cytokines. For of them are used Rheumatoid Arthritis and other rheumatologic diseases, inflammatory diseases. There are some people who want to test to see if these are efficacious. There are some reports from china that some of these might be efficacious. A small still a small scale study, mostly also not randomized and blinded. Se are the we are seeing more severe disease among people who have hypertension. Drugs for most common hypertension, Blood Pressure agents, is something called an a ce inhibitor. Is the name of a receptor that the vice that the virus also binds to. So there is potential commonality of this virus attaching to a certain receptor, and we have a medication that acts in a similar pathway. People are not sure that there is evidence that these ace inhibitors are either partly responsible or in the pathway of why we are seeing more severe infections of people who have hypertension. We are not sure yet. Some of the early looks at the data are proving that ace inhibitors are not involved with more severe infection. But more study needs to be done, which means we need to continue to see and understand how the ace inhibitors use is associated or not associated with covid illness. Host we will hear from vicki from mesa, arizona. Caller i guess i want to know, when will this virus be over with . It is driving me crazy . I cant go to my neighbors, cant go out and play. It is so boring. When is it over with . Guest i think it is probably very frustrating for a lot of individuals, especially as the weather is getting nice outside and people want to go outside. We are trying to cut down transmission as much as possible because that is the only means we have right now in the absence of a vaccine to be able to stop the virus from moving through a population and our communities. If we had a magic way of stopping time and keeping people apart, then we might actually be able to get rid of the virus. What we are asking people to do is to stay in place in their homes, try not to congregate in social gatherings, to really limit your time outside in public to being able to perform the essential things you need to do. Going to get your medications from the pharmacy, buying their groceries, the sorts of things. Essential personnel and First Responders performing their occupations that are critical for the infrastructure to survive. Keepalth care, people who our electricity on, phones going, garbage collection, the supply chain for grocery stores, restaurants. The food supply chain. All of these things are essential but we have to remember that the bottom line is we have to stop transition. Transmission is when we get close to one another and the virus can jump from one person to another. Host our guest is with the university of Maryland Center for Vaccine Development and global health. Dr. Wilbur chen, thank you for being with us on cspan, we appreciate it. Keep in mind, nearly 3000 people 911. In in new york city alone, more than 6000 have died f