Chief scientist of the food and Drug Administration serving from 20092014. Oodman, good morning. As you talk about your work chief scientist and how it relates to the fdas role with finding a vaccine . The science of vaccines is very complex. They are complex the study. On thentry relies experts at the fda to ensure that any vaccine that goes into clinical studies and oversees the Development Process and ultimately the approval process. Have such ane amazing reduction in childhood illness. Approved, itey are is monitoring their safety. To particular scientists work directly with the companies or is it a team effort . How does that work . There is an office called the office of Vaccine Research and there are experts on a whole range of issues from their chemistry, their manufacturing, their trials. There are different scientific disciplines that interacted the process, but at the end, it is completely independent. Host when it comes to you personally, just to care five to out just to clarify to our viewers, you are the head of the sides committee. Can you talk about that and what that entails . Company oneh of the manufacturers of vaccines. We look at opportunities to develop the products, which includes vaccines. Host are you involved in any Vaccine Research or development . Guest not at present, no. Host what has to happen or at least what stage is the fda at now . 200t globally, there are or so candidates for coronavirus vaccines under study. The u. S. ,ocused in and the fdas role is approving vaccines for the u. S. A lot ofvaccines their development is being funded directly by the government through operation warp speed. That includes the recurring candidates that are in the late stage of trials. The early trials showing safety, now there areand these large trials of 30,000 individuals each, which are critical to determine if the vaccine will work in a larger group of patients. On top of that, does it really work . Is it effective . Are the numbers of coronavirus cases reduced, and if so, by how much . These studies are ongoing are absolutely critical. We can talk about animal studies, but the proof in the pudding is in the studies. Host when the studies get to the fda, what other data to they need to look at to know that the vaccine is a safe product . It looks at not just a summary of the results, like you might see in a scientific paper, but at the actual data. Make sure the data is highquality, its true, it has integrity, and so it looks at that data on was the vaccine safe. Look at the data to see if it was effective, are the calculations and this is very important guest it looks at the entire 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. 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 done as soon as it is safe. Highly text, im allergic to eggs. Are all the vaccine for covid19 also made with eggs . Guest none of the ones i am aware of, none that are being studied in large numbers of patients are made with eggs. Taht is that is kind of ancient. It has been used in most influenza vaccines, but it is not being used for these. Youru should certainly ask physician, have them know about think it iswill not a problem for the Covid Vaccine. Re some influenza vaccines that are made in cells, not eggs, that are just fine. So you should be able to access those. I would ask your provider about them. Amt another viewer, i wondering what the definition is of an effective vaccine. I have heard it is 57 protection. Like his is kind of 50 protection. Guest this is kind of like a subjective thing. But when the fda provided guidance, it said for it to approve a Covid Vaccine they would want to see at least 50 reduction. That is the standard that they have put out. We would all like to see something much higher than that. The flu vaccine is over 90 effective, so is the polio vaccine. But from what we know about coronavirus, and thinking about the earliest vaccines we were developing in a time when people did not fully understand the disease, we do not know how the host is protected. Is it the antibodies, the t cells, etcetera. Earlypossible that an vaccine may not be hardly effective. The fda set the bar at 50 . We would like to see more. And we are just going to have to see what the studies show us. Host new jersey, we are hearing from maria. You are on with dr. Jesse goodman. Caller i have three points to discuss. First, the sourcing of the carrier material and other materials for the manufacturing of the vaccine. I understand that the vast majority comes from india or china, where inspectors get to inspect may be every 10 or 12 years, and use interpreters that are hired by the companys. And if somebody wanted to move every nine years, they do not get inspected, so what is the sourcing for the tests for the vaccines and what did they resort to if that is approved . The second thing i wanted to get into was the safety pledge. On to it ironic that this be basic ethics. Could you have dr. Harvey rich from the school of Public Health on . He has reviewed all the studies on hydroxychloroquine and zinc. And it is amazing how effective that is in the first stages of the disease. Getrather than hurrying to something 50 effective, why dont we explore honestly what is available now . Host give me the name again. Caller dr. Harvey rich. He has been on the Laura Ingraham show and the joe banks show. It is the yale school of Public Health. He has done studies on hydroxychloroquine. Host thank you for the suggestion. We will go back to the doctor. Guest i am trying to remember some of those points, but one of them was the pledge. I agree with you that that is more expected behavior, something we should expect from companies, governments and the scientists. I think that people were emphasizing that they are following normal procedures here. I think it is very important that the public and the fda are there to make sure that happens and to make sure that political pressures do not affect thi ngs. That is my main comment. Host she asked about the sourcing material. Guest yeah. I do not personally know the details about the sourcing material of these candidate vaccines, but i believe most of them will not be sourced in china or india because of the nature of them, but these are questions that can be asked and discussed, and should be able to for example, at the Public Advisory Committee. Host you talked about the fda being a fair umpire. Talk about the reason that the current administrator has, his oversight for his oversight of this. Guest it is a mixed assessment. Im fairly pleased and impressed, because he seems to be a decent person. Stated, to be has clearly, that he intends for the fda to follow the science on any vaccine. And he and the other scientists at the agency have said that they will bring the decisions to an advisory committee. However, i think it is really important that he clearly stands andor the career scientists normal processes of the fda, to reassure the public that the agency will not be pressured. , for was so much pressure example, around hydrochloric and hydroxychloroquine that it raised questions about the authorization of those drugs. Pressure may continue, and more from the white house on vaccines. So i think it is important that dr. Hahn reassure the public and take the steps and make it clear that there will not be political interference in the fda. That the head of the division saidreviews these vaccines he would resign if he was forced to do something he thought was wrong. In addition, the director has said that too. I hope we do not come to that. The process needs to be respected. Not just the process, but the limbions and the bases for should be transparently explained to the public when they are made. Host since the viewer brought it up, what is your personal take on the efficacy of hydroxychloroquine or blood plasmas as treatment . Guest i think on hydroxychloroquine i have a different view of science. Work but i have not seen any convincing signs that it works. Just as we saw with the recent trial detecting an adverse event, we need data from the control studies and control ntrol trials. Those for hydroxychloroquine have not supported efficacy. Is room forere scientific debate, but i think that the evidence is pretty clear and i would not want people to think that taking that drug would be able to prevent them from getting the virus. There are studies going on, but it does not look promising. On convalescent plasma, you know, there are hints of efficacy and a large, uncontrolled use of the product. Its what we call biologically plausible. If you give people antibodies that react against the virus, give it early enough, there is reason to think it might be helpful, but even from a study that was used to support the emergency authorization, the benefits seem fairly small. So we need control trials. I think it is unconscionable, in the case of hydroxychloroquine and in convalescent plasma, that we have all this uncontrolled use, which in the case of hydroxychloroquine did raise safety questions. The we started months ago control trials we needed to settle the question. If something works well, we need to know and we can offer it to everyone. At when they are used in nonscientific way, we do not and up with an answer. Host we will go to tennessee. Hello. Caller how are you doing . Be puttion is what will into place to make sure there is tosecrecy as it relates africanamericans being part of the faxing process. People are of the vaccine process. People are hesitant because of the issue that came out, that we do not end up and we know mostanamericans and minorities have conditions that lend themselves to not having a positive outcome. Guest an important question and issue. Of some a history striking episodes of abuse of africanamerican populations in medicine and in clinical trials. Thats very important. And there is a trust gap. To addressiety needs that. Aen we talk about covid, for variety of reasons this disease has a disproportionately affected nonwhite communities, both in terms of the incidents, how often they are getting infected and their risk of getting infected, and in terms of outcomes being more severe. So there is disproportionate factors. So it is important that whether it is a treatment or a vaccine, that we address that population. One of the things that is going on that the nih and others have said, is that they want to try to enroll substantial diverse populations, including africanamericans, in the clinical studies. Wantnow, it takes trust to to be in a study, but it is important to reach out and have those patients, so that the thatnts patients know the candidate vaccine has been tested in those populations and appears to perform well there, as with others. Knowing that could possibly help build trust and the product. But i think that this is also a much bigger project. It is a project that does not just pertain to vaccines or medical products, it pertains to trust in the Health Care System and we have a lot of work to do to earn and rebuild that. Host a few more minutes with dr. Jesse goodman, the former chief scientist at the food and Drug Administration, from 20092014. Philip in kentucky. Caller kudos for dr. Goodman. He seems like a straight shooter. And 100,000 Adverse Reactions was good. Lets talk about death. Gardasil killed thousands of little girls. Aimed andmed and mi made barren 10,000. Yet they say it is a safe drug. How many people are allowed to die with this vaccine for the coronavirus . There are a saying not that many dead at the 200,000 mark, that it is 20,000, less than because i know somebody who got killed on a motorcycle who had covid. So this guy seems like a straight shooter. Guest let me be share i was not misunderstanding. I do not think that one in 100,000 is a serious adverse event, something that could be lifethreatening or lead to permanent disability is something that we want. That is not in my mind acceptable. Obviously, it depends on the disease you are trying to prevent and how effective the vaccine is, balancing that with the side effects. But in general, that is something that could be concerning. In 1976, there was a swine flu virus break at fort dix. Neurologiced a syndrome that was not detected in the early trials in about 1000 individuals, and several million were inoculated. In fact, the upright has and it wass passed, clear that that risk was not outweighing the benefit of the vaccine, so it was stopped. Even 30,000 people, we need a system to monitor safety after the vaccine is rolled out. Make sure that there are not side effects commit to change how we do the safety of that vaccine. So i will restrict my comments thatvid, but i will say with gardasil, i believe all these issues with safety have been raised and most have supported the study of the human papilloma vaccine and that has prevented thousands of cases of cervical cancer. So i appreciate your concern. Its important that those be publicly discussed. Host brad is in minnesota. Caller good morning. I have a comment, then a question. Vaccinated, 40 million to 60 Million People get vaccinated every year for the flu, and we still get tens of thousands dying. My, question is my question is, if we start taking these vaccines, is it because for why we are seeing such an autoimmune disease with all these people that we are filling up with all these antibodies, because we all know that the best to fighting is your own virus immune system. Ok, the immune system is the one that that we have to, there is no explanation for why or how. We understand how it works, but why it works the way it does, so wire we going down this path when we should be protecting the elderly and the people with underlying issues . And we are causing something that is going to, in a longterm effect, that we are having more autoimmune systems falling because of the vaccinations, the vaccinations that are given today to people. That is my question. Host thank you. Guest thank you for that question. It gives me an opportunity to say that lots of scientists have had that question, and about longterm side effects, and the issue of autoimmune disease. Theres not evidence and that vaccines have a role in increasing incidents of autoimmune disease. What i would like to stress is point, whichortant is in the immunity to a natural infection, if you survive, is what is effective. The vaccine is a controlled attempt at the same thing. For example, for coronavirus it takes what is believed to be the most important protein of the immuneand it trains your system to recognize it and find it. So it is simpler, less likely to more all kinds of things, so than the normal infection. If you look at pneumonia and meningitis, yes, you could say if you survive, you are fine, but you would have been better off not getting meningitis to begin with. But it all goes to the riskbenefit calculation. Id to one of your comments, agree that the First Priority fora safe vaccine will be the people with the highest risk. But essentially what you vaccine ends up doing is helping to make us all immune to the actual infection. And then stopping the outbreak. I would like to add, as you commented, flu vaccines are one of our less effective vaccines. In a good year it might be 70 effective at reducing infection, other times it is much lower, sometimes only 30 or 20 , if it is a bad match for the flu. Of thealso prevents some bad outcomes, even in those who get infected. If we have a first coronavirus vaccine, we do not have that yet, but if there is one, it may not be 100 effective. And we will need to keep doing it. We cannot just declare victory unless we have a 100 effective vaccine. And if it is not 100 effective, then we will keep needing to Pay Attention to these things like social distancing and the Public Health things that can reduce the spread of infection. As more people get vaccinated, if we have a safe vaccine, we can change our behavior and help our economy. Host dr. Jesse goodman is formally of the fda and currently with the Georgetown University medical center. Cspans washington rnal, every watch washington journal live seven 00 a. M. Eastern. Yourre to join with facebook comments, Text Messages and tweets. Follow the federal response to the coronavirus outbreak at. Org coronavirus. Watch congress, white house fromings, and updates governors. Track the spread throughout the u. S. And the world with interactive maps. Watch ondemand any time, unfiltered at cspan. Org coronavirus. Before a thursday vote on a gop Coronavirus Relief bill, Senate Majority leader mitch and minority leader Chuck Schumer talked about what was at stake with this legislation. Heres the majority leader. Senator mcconnell 19 years ago tomorrow, thousands of our fellow americans were murdered by terrori