Dr. Jesse goodman is joining us. Guest good morning. Host could you talk about, in a broad sense, your work at the fda . ,articularly as chief scientist particularly when it comes to vaccines. The science of vaccines 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. 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 tarting 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. After all is said