Is quite complex. The fda ensures that any vaccine going into clinical studies is. Afe ultimately it goes through the approval process. This is why we have such a reduction in childhood illness, we can count on the safety of the vaccines. And even after they are approved , they can be monitored for safety. To specific scientists work directly with these medical companies throughout the process . Is it a team effort . There is a particular center, the center for biologics and the office of vaccines research. Those are experts on the whole range of issues around vaccines, from their chemistry to manufacturing and clinical trials. They have review teams with these different scientific disciplines. They interact a lot with manufacturers during the process. When it comes to, you are on the board of glaxosmithkline as head of the Science Committee. Can you talk about what that entails. Guest on the Science Committee we work at opportunities to. Evelop new products host are you personally involved in the development . Guest not at present. There are two candidates fda isudy, the , a lot of the u. S. The developments are being funded directly by the government through operation warp speed. That includes two of the three current candidates in the late phase clinical trial. Thats out of the early trials dose,ety, establishing a and having these large trials with 30,000 individuals each, which are clerical critical for vaccine safety. Does itop of that, work . Is it effective . Are the numbers are coronavirus reduced and the people who get the vaccine . By how much . These studies are critical. We have the studies in humans. What data do they need to . Ook at guest they look at the data to see if it was effective, are the calculations and this is very , the entire process of manufacturing can be quite complex, they need to make sure that they can make a vaccine that is consistent with high quality and safety. At, makingot to look sure people are safe and highquality. Host dr. Goodman will be with us until 9 00. You can call us at 202 7488000 for eastern and central time zones, 202 7488001for mountain and pacific time zones. You can submit questions via at 202 7488002 202 7488002 host at 202 7488003. We have a question on twitter, does it help . Guest its working in two ways with substantial funding in biotech technologies with it ising candidates helping to manage the process that it creates so that he can speed along. It will be able to speed up the manufacturing so that there will not be a long period before it is available. This is what we call the investing risk. Essentially, funding is going into being ready to manufacture s. Ccine this is being done on a large scale. We are taking steps to make sure the vaccine can be made more. Uickly host so is there a difference between what was done with h1n1 and coronavirus . Guest its a very different situation. We know less about the withavirus, we are also the challenge and the fact that that are new technologies have been in development over many years, like rna vaccines and vaccine where a coronavirus back coronavirus protein is put into the backbone of the virus. Another reason why the fdas evaluation realistic is a timeline for vaccine normally . Whats realistic when it comes to the coronavirus . Aret typically, vaccines developed in nonemergency settings over several years. Pandemicavirus, or the , or ebola, there were tremendous efforts to accelerate the development. These new technologies let us go to aa virus gene sequence potential vaccine candidate that inld be studied in animals weeks as opposed to months and years. That has really helped accelerate the process. Coming behind that, we have those traditional technologies with a long history of use. Host should be mandatory for people to have . As a child i recall having a polio shot and i dont think i had a choice. Guest is a controversial containing childhood diseases, particularly measles, most states mandate vaccination except under certain conditions, medical and sometimes religious exemptions. Its really up to the American People, i think what is important is that people have confidence in any vaccine that comes along. They know the fda has reviewed it free of pressure. Host we are now taking some callers, rick, go ahead. Caller dr. Goodman, a question. I know for over 20 years or more, scientists around the world and in this country specially have been working on an hiv vaccination. Im wondering, if taken well over 20 years for that vaccine. Whats making it possible to study this virus and come up with a vaccine now in such a short period of time visavis the hiv vaccine . Question. Ts a great , we have thet know cine that has been work the jury still out on if we have a vaccine that is working and safe. Its very difficult to take care of because our immune system does not know how to handle hiv. If you get hiv your immune system, the t cells in your body do not get rid of it. Theres a rare case here and a couple of people out of and a couple that do not get sick. That virus attacks the immune system itself. But many other vaccines that are have aful are able to body that does affect a good immune response. Bill is joining us from syracuse, new york. Good morning. Caller good morning. I have a couple of comments if im going to die anyway, i would be willing to take a chance on a that was somewhat approved but not fully approved. And how will he be distributed . On a random basis, people paying for it. Guest on the distribution point, there are two groups of , some with public input that are looking at particularly when a vaccine becomes available earlier. There may not be enough for everyone and not everyone will get it at once. We have groups of the National Academy of sciences and a Public Advisory Committee with the cdc. These groups have been looking whohis on the basis of needs the vaccine most immediately and who will have the most potential benefit. This really comes down to protecting Frontline Health care workers and other workers at high risk from exposure. And also individuals with underlying medical conditions that make it more like that hospitalization is needed. Older individuals in particular may be at higher risk. So we need a very transparent priority setting system that gets the first dose to those necessary individuals. And there are people who say im take the risk on a therapy or vaccine that is not yet approved. There may be circumstances where the fda has certain provision to expand access before they are approved. Those discussions are under. Onsideration jim, at lake gadsden, wants to have you explain the stages of development when it comes to those trials. Guest sure. Manufacturersans, which could be part of the University System in the u. S. , need to apply to the fda for permission to do a clinical trial. We need to look at if this if the safetyund, data and manufacturing data looks good, so we can advance. Sequence hrough sequence of phase one, phase two, and phase three trials through the phase one trial is typically a small number of individuals phase three trials. The phase one trial is typically a small number of individuals. It checks as the product is safe , is your body making the kind this is an 100 or thatpatience patients it is safe to proceed to larger studies. Question the next phase two studies. Thats typically a few hundred to maybe a thousand individuals. This is for safety data and also looks at the dose in response to the vaccine or drug. We usually set does from this which you then use in the larger studies. ,hen it gets moved to phase 3 wills when the company take a look at thousands of individuals with a placebo, looking also at safety and unexpected serious risks, and is it effective in reducing incidents of the disease . And there are two ongoing studies in 30,000 individuals , is theg the vaccine. Accine effective, host lets go to california, justin is next. Caller can your guest discussed challenge studies . Where they inoculate people with the vaccine, wait a period of time, and intentionally subject get to the virus, you quicker results rather than having to wait many months to see how many people catch the virus and how well the vaccine works. Guest you explained that really well. Essentially he can use a vaccine vaccine toople people. E we need to know how to administer the virus to mimic , we alsoal disease want to do this in a way that is safe, we dont want so much of the dose that your challenge injected buts were then wound up in the hospital with serious illness. So you need to have worked out a system of what is the actual virus and how we can be administered. This has worked out for inluenza, and even studies several areas. Monitoring toly see more accurate test. Dwrusing sensitive mo left hook already tests. You can monitor this and see the time it takes to work this out. You can also monitor for safety data with a relatively small. Umber of people you dont get the safety data that for example we are getting now. There is a side effect that has put one vaccine on hold just now. Host lets talk to jim, in missouri. Who,r starting with the this administration has cast expertsn our suppose it. Defunding the who, the fda fast tracked testing. Andot tests that were worse so inaccurate that you are better off not taking a test. The cdc should have been running and shouldesponse have been pointing it from the getgo. We did not like pyeongchang fauchi, so we will find someone else. Done, whyis said and would anybody trust a vaccine coming out of this administration . , we gon it is available back to the people who are antivaccine to begin with. Thank you. Guest the caller raises a number of important points. There has been a lot of conflicting messages throughout the pandemic. Theres a lot of concerns about the response, many which i share. I think some of the things that have concerned me quite a bit have been pressure on the fda and other scientific agencies. Been announcements about getting a vaccine quickly. We all want that and thats correct. That the fda, for those with confidence, they need to be able to trust the toentific experts at the fda act independently and make those decisions based on the science. Thats important and any pressure on the fda from outside needs to stop if people want to trust the vaccines. I am very sympathetic to getting it quickly, everybody wants that. But as polling has shown, the ableity people want to be to have that process be done in that ensures that vaccines are is this as safed and effective as safe and effective as could be. If we want to vaccine, which we all want to help and the pandemic, people need to be able. O trust the recommendations the fda has said it will stick to the science. When theres pressure people become skeptical. This is important to address in the upcoming month. The fda need to be really transparent about the data it and it any approvals and aergency authorizations to Public Advisory Committee. That will help. But i think some damage has been done to the public trust. Host once a vaccine is available, will it be cost prohibitive for some people . I think thats an important thing, there would be tremendous injustice for people that some people can afford to be protected and others do not. Is vaccine will be it believed that any vaccine will be free to the American People due to the funding through operation warp speed, but there may be administration costs, whether its pharmacies, physicians, Public Health to , many people are hurting right now and have to choose between health care and food. Its going to be critical that it could be administered and received by anyone who wants it in that administration. Thats really important. Taking this to another level, what about the rest of the world . India, brazil, we are seeing a horrible toll that this virus takes. It really needs to be beyond the u. S. , a concerted Global Global effort to again get access to the vaccine for those people who are worse off than we are in the u. S. Host with us is dr. Jesse goodman joining us for a conversation on vaccines. I want to show a Senate Hearing on the topic of vaccines, featuring dr. Collins, and they talked about the pause reported from a vaccine trial at astrazeneca. [video clip] the reason we are investing in six different vaccines is because of the expectation that they will not all work, although it would be lovely if they did. The pause is not unprecedented. This happens in any largescale trial where you have tens of thousands of people invested in taking part in, some of them may get ill, and you try to figure out if it is because of the vaccine or were they going to get that illness anyway. So you investigate carefully to see if anybody else he received ae vaccine might have had similar finding of a spinal cord problem. This ought to be reassuring when we say we will focus first on safety and make no compromises, this is exhibit a about how that is happening. If it is a real consequence of this vaccine and can be shown to because and effect, all low doses for that will be thrown away, because we do not want to issue something not safe. Host that was the statement from yesterday from dr. Collins. What is your take . Guest we do not yet know enough details. And in fact, the company developing the vaccine may not know it all yet because event isg what this believed to be, transfer some be, aghters to spinal cord inflammation, we do not have enough information to say if it was related to the vaccine or not, but it is concerning. It is good to hear that the individual is recovering. , that isis an illness some people can lead to neurological deficits. So it is serious. We need to wait and see what the results of the investigation are. I have also seen reporting that there was an earlier patient in the study who may have had similar side effects, again, we do not know if it is a side effect of the vaccine, but may have had a similar event, but in that case it was believed that person had multiple sclerosis. We need more data to assess this. And even with more data it is complex. In a way,at this is, the system working. We are detecting these things because, whether they are related to a vaccine or coincidental, we have the opportunity to work carefully at this because these are larger trials done with thousands of individuals. That is critical. That is why the process must be allowed to go forward. Why the fda needs to play a critical role. And why nobody should assume we have a vaccine until these studies are done. Host we saw a host of companies, including the one that you are associated with, sign a safety pledge for the vaccine. Is the unusual that unusual . Itst it is unusual, but shows, i think, that there is a concern that people have confidence in a vaccine that is produced. And confidence around covid orcines, if it is lost, confidence and the fda or even manufacturers, could affect peoples confidence in vaccines more generally. We do not want to have a country where we have measles outbreaks because people do not trust vaccines. I think it is a good thing that they have pledged to follow normal processes. It is unusual. And i think it shows they were sensitized to some of the same things that one of the callers was, the concern that if people feel like a process is rushed, not a fair umpire in terms of the fda, and if people have questions about those things it could jeopardize our response to the pandemic. Host glenn in california. Caller god bless our president , donald trump, for working hard for american citizens. Working on a vaccine with so many different medical providers and that. Disease, whereod i have the third case in california. It was valley fever and he gave me arthritis through my whole body and i almost lost one of my lungs. I had it at 18 months. I went down to 42 pounds. I was at the ucla medical center. And i went all through the kaiser facilities. All this all these other things, we have no representation at they were house of representatives with it,democrats pushing past to see what is in it and all this other stuff, but here is the thing the president is working so hard. And he has got no help from the Democratic Party or the never trumpers. Throughrking so hard our medical systems, but what about all of the side effects on every drug that we take . Host lets let our guest tae ake that up. It soundsst of all, take careactually did of many patients at the ucla. And i am glad you recovered from that terrible disease. It is still a disease that is ravaging many parts of our country. I do appreciate the efforts of operation warp speed and the funding going into vaccines. Know, i think we need to support that. I think what we are hearing is we also need to be sure, because vaccines are given to healthy people, that people have confidence in them. But i appreciate the efforts of has,overnment in that he as well as countless people in medical schools, the patients who are contributing under the trials to develop these vaccines. As you said, treatments, everything has risks and benefits. Nothing will ever be completely riskfree. But even if you had a side effect that was serious, and only one and 100,000 people, that sounds like nothing. Thatf you suddenly amplify to a population of millions, you could have hundreds of people with serious side effects. We need a balance. And we need to make sure that we tonot do damage in trying protect people from the coronavirus. Host tina in virginia. Caller as a mother, i want to know questions from a childhood point of view, are the children included in the clinical studies . Are they able to because of their age . They cannot sign and estate, and say, i can do this. If not, how do they know vaccines will not have children develop that rare inflammatory disease, like they do as a result of having the virus . How are they going to test that part of safety . Guest that is a great question, because as you said, even though a group that do not commonly get the biblical adult the typical adult coronavirus able toen, um, they are spread the disease. Them,ey do good, some of this extremely challenging, systemicvere inflammatory syndrome that we do not understand very much about. So it will be really important to have a vaccine to also protect children. What is usually done, what is song done in this case, more in this case given the unusual disease in children, is to get the data in adults first. And when we see the vaccine is safe and adults, then in adults, then begin studies in children. I im not aware of the status of all the pediatrics. They may not have to wait until everything is complete, but unleased at least until the fda has a sense it is safe to proceed with studies in children. Children are often neglected in these processes. Our wish to protect them. But in this case, we want to make sure they can get the potential benefit and that we have a safe vaccine. We do not want to have to wait years for children to be protected from it. Thats an excellent question and i and others have been advocating that the childhood studies, that the vaccine trials and children be