Need for a safe and effective vaccin vaccine. And how the vaccine trial process works. This is a 50 minute conversation hosted by the Aspen Institute. Student i am delighted to meet shoot for the 2020 event. While this coed pandemic has kept us from being in person we host inspiring artists, scientists innovators and policymakers. We cannot be more excited about our program today an inside look at the Vaccine Development process through the lens of the food and Drug Administration for the fda. With the urgency to have a safe and effective covid 19 vaccine available, the third vaccines being developed at socalled warp speed interest in understanding the vaccine developed processes never been greater. And we have got just the expert both and of the fda inside and out to help us do just that. So let me briefly introduce our incredible speaker today. Doctor stephen hahns the 24th commissioner of the food and Drug Administration. He is also a clinician having trained in medical oncology and radiation oncology. Part of it during the fda doctor hahn served as a chief in medical of the university of texas and the Anderson Cancer Center but before that insured the department of radiation oncology at the university of Pennsylvania School of medicine, my alma mater. Doctor Peggy Hamberg was the 21t commission of the fda. Before that she was Vice PresidentSenior Scientist at the Nuclear Threat initiative a foundation dedicated too reducing Nuclear Chemical and biological threats. More recently doctor hamberger was born secretary for the National Academy of medicine and president board chair with the advancement of science. Joes reason the completed. Service with both organizations. They will be in touch with editorinchief of fortune. Shes been a guest editor for the New York Times office, and is held senior positions at the smart money magazine. Chris is also the author of the book, the truth in small doses. While losing the war on cancer and how to win it. Which is named as newsweek for the best books about canterbury that downing cochair which is when numerous awards for his journalism and leadership in the anticancer effort. Ive terrific, terrific line if you should all agree. A quick item before turn the program over to cliff. As always a welcome question summer audience. Going too submit a question the q a feature of your screen. Please feel free too submit your questions throughout the conversation, that we will have the mall, queue them up and have them ready to go. But that thank you for taking time through incredibly busy schedule to be here with us today for what will be an interesting discussion. Thanks to all of you and our audience are being here with this part the 40 senior soon for the next Aspen Institute health event. And with that the aspen stage is all yours. Thank you. Its so exciting to steering the bios again. Such a pleasure too speak with both of my esteemed panelists. Thank you doctor hanna doctor doctor hamberger spent some time with us today. Doctor let me begin with a question for you. This question could not be more timely. But the meeting of the vaccine and Product Advisory Committee better known as meeting as we speak right now. Listen in this morning which was an hour or so introductions. I got some of the presentation. The meeting is designed too discuss the process of developing, authorizing and eventually licensing a cam while vaccine candidate for covid19. This meeting brings together a whos who of vaccine experts, bios strata stations and others. I think its very fundamental which is the credibility of the process. Doctor just talk a little bit to open up this process to everybody. See skepticism and this country that preceded the pandemic. That should concern all of us. Has been the widespread administration and the of the pandemic number people who are dying and of course who have had is of significant importance. That is one way will put this pandemic behind us. We really do have to be concerned that we do need to make sure we have confidence because when we do and hopefully it is when we have an effective for covid19 Royalty Administration will of course be depend upon people willing to build to take that vaccine. So transparency run the process, transparency run the criteria for either authorization or approval. Very important. Dwight issued guidance of june of this year that we would use up so the criteria for hate the orionids the ineffectiveness. We want people to know how to see and how to design the trial trials. Around the emergency authorization. We want to be clear about that. That transparency about the criteria that also the transparency on the process we felt was very important too enhance. Thank you very much for that comprehensive answer. If i could drill down a little bit more into this. So it is plain shocking. Only half of american surveys actually got a coat would vaccine. Roughly the same numbers the Kaiser Family foundation. 70 of americans in a recent stat that the covered 19 processes driven more by politics and science. We are seeing across the board gallup has a similar pole. Its not a new thing. Theres been more talk about it as of late. This has been for around for a while. It is a fundamental concern about how we communicate to the public and healthcare workers import new products. We always want them to have trust and confidence in the process we always want them too understand what the product is, how it works, and who should take it. Because especially when youre talk about a vaccine when theres a need for an individual to take the vaccine too protect themselves or limit. [inaudible] it also is a public good it is a Public Health measure thats needed for control of that on going pandemic now is been very disturbing in recent years seeing the movement which in my view with vaccine safety and result in preventable outbreaks of disease measles in particula particular. Which many people dont recognize can be a deadly disease and can have other life long as well. In the measles vaccine is almost 95 perfective seeing another phenomenon confidence in the trust of the Public Health agency responsive for the Regulatory Oversight is being questioned because of the intrusion of politics. And concern that reflect also the process as being so accelerated. And we are you even using terminology Like Operation warp speed they get something unnatural, manufacturing at risk it is a financial risk of investing. Before we know whether it will actually be authorized for use. They conveyed some sense of our corners being cut. Any her politician saying on this vaccine by such and such a day, whatever. And understandably people start to be concerned. But i think events like the one today, discussion about the process, laying out what is being done, how it is being done and why every outside scientific experts to confidence and trust the only vaccines that have met rigorous be authorized for broader use. Submit the release information war here, its not a fair fight. Theyve got statements by fda and by the government. And sometimes by the Scientific Community at large. Thats against his overwhelming force of misinformation. Impartial information on social media and out there. How do you can bet that . We all have to stand together, not just about covid19. All the right now that is the urgent situation. This is really about as a country, do we stand behind science . Do we stand behind the performance of Clinical Trials . Do we stand behind with the most Public Health public measures we have which is fox nation for it we have to band together communicate this. Think about the context here. I daresay the American Public never had heard of what it do state monitoring board was before the last several months. Or the difference of being a phase one or phase three Clinical Trial. Im willing to bet a lot of medical communities dont completely understand what it does. And yet doctor hamburg pointed out the real issue here. Its data coming from his Clinical Trials. These late stage trials. They have to hit prespecified endpoints. They have to trigger something that independent board of science and statisticians we call eight monitoring board than a lookout. Only after that is dependent review is that information then released and then decide whether to apply to the fda for authorization or approval. And our process we have amazing scientists, doctors, nurses, pharmacists will look at this data. Make an initial determination. Im sure the American People do not owe the fda looks at the raw data from the Clinical Trial. We dont look at a scientific paper alone, dont look at summarize. We look at the data make her own conclusion. In the colonies outside experts that are meeting today. Our name will help us look at this application. They will give us their advice for that transparent, that will be open. That release be emphasized to the American People. This is so important. And want to get to the covered vaccine specifically just a Second Period but for no now, doctor hamburg mentioned measles. Weve seen many outbreaks in the united states. This is an incredibly infectious disease. Ive also seen things like childhood and foot diseases like whooping cough, pertussis. Again, vaccine control we can put behind us and yet we are seeing these outbreaks. We are seeing this problem that really needs to control itself. Im sure this question about it. No one should be done from a disease that can be controlled by vaccine that can be prevented by vaccine. We must have the medical Community Get together in this trade we must have the importance that each issue settled. This is settled science. We need vaccines that event approved with biologic are safe and effective. Doctor hamburg meant to the measles vaccine. We must get this message out over and over again. What has to be a concerted effort and we have to file the medicine. Its interesting in some ways is destroyed Public Health the victim of its own success. Public health is about prevention. Public health is working well disease dont happen. I think dennis or Public Health prevented me from being at risk for this disease prayed they taken for for granted. In this country vaccines have been so successful. These to be devastating to individuals and families. Have been prevented that they are not taken as seriously anymore. And people think theres any risk to a vaccine, why would i want my child to have it . When they are never going too get the disease anyway. The sad truth is, if we start relaxing our fox nation standards from the virus still exists in the world, then those individuals, those kids are in fact at risk. And we know that from experienc experience. You look at other countries were some of these diseases are much more endemic and really take a toll every day. In those populations are much more eager too get access to a vaccine. There is a challenge is really making sure that underserved populations can get the vaccine that they need. Lets talk for a few minutes about the Covid Vaccine that we have now the candidates. Seeing a lot of novel approaches here. Doctor hahn, maybe if you could talk a little bit about this sort of guidance for vaccine advocacy. I know the fda has up that threshold is 60 . Making sure its even more effective than the original guidance suggested might be necessary. So i think you highlighted one important fact here. It is a good news story. Also doctor hamburg has mentioned the wording around it sometimes suggests that corners have been cut when they have not been. But we have no use a sports metaphor. A shotgun goal for approaches but a couple different platforms are being tested. That is good news of some novel vaccines and some that are tried, true and tested over the years for many, many years. So this is a good news story because of a lot of different approaches to a very novel virus that we are still learning about every day. Our guidance outlined in june was for efficacy. The liturgy 5050 efficacy for that vaccine. The reason we wanted stay implants are flying about that is it was the time that th the late age Clinical Trials are being designed. And as they were being designed they had to be whats called powered prayed they have to have enough people in them to actually look for mess up a 50 or higher. Of course we all when a highly effective vaccine. If we could get to 97 , that will be great. But we wanted to establish rapport which allows these trials to be put so that can be protected. As you probably know from Public Information, and i cannot speak about individual confirmation uncheck confidential information. We probably nobody Public Information they have unrolled even more its necessary to test that level of effectiveness. Thats a good story. I not only gives us a database it received vaccine placebo for effectiveness but also for safety. In our most recent guidance for emergency use authorization. That is an authority that allows us to look at a medical product and assessment based on the risk and benefit ratio during a Public Health emergency. But its important too remember unlike therapeutics book goes to someone who is sick with covid19, a vaccine is going into someone who is not sick with covid19. And therefore changes the riskbenefit profile. These are healthy individuals for the most part. That has to factor into the decision. The scientist spent a lot of time thinking about how we assess what the same time doing everything in the same process is as expedited as possible understanding of course we did not went to cut corners. When i look back at the last summer vaccines over the last ten to 15 years, but we found with the sweet spot for that was too much. You could follow a subject in a trial for two months. You could get the vast majority of side effects associated with the vaccine. If you couple that with a very vigorous followup program once a vaccine is authorized, you could be very confident about the safety of that vaccine. Our scientist thoughts this was a sweet spot and put into our guidance. It generated a fair amount of controversy as you can imagine. I thought this is a great place to be. That something the vaccine advisor will be discussing today, that criteria for the scientist a very about that and i totally support them in the information they put their. Doctor honda mentioned the fact youre giving these vaccine are we will be given these vaccines to healthy people, that is the point. Its a challenge still because you have to get populations giving that vaccine to to be representative of the population at large. There is some challenge in that. He had the factors much Older Americans that quite often do not get into trials, pregnant women and only one of the vaccines is being tested now, the fisa vaccine is being tested in children up to the age of 12 or over the age of 12. How do we make that transition for that Traditional Group of people to go the Clinical Trial to recruiting a much Larger Population . Is a very fundamental and important question. We certainly do want to be able too understand the risks and benefits of these various vaccines and different subpopulations. Theres a lot of reasons to think certain of the vaccines in Development Elderly which frequently have a more demented immune to spots. We want to have that informatio information. We went to ultimately have a vaccine that can be available across all ages. An available that have different co morbidities are different medical problems as well. And we certainly what one that pregnant women can take. It is being approached in a somewhat staged away. You cannot do everything you might want to do at once. You may not want to be able too learn everything you might want to know from the very beginning. These trials, the phase three trials actually are larger than many vaccines. Although they will be shorter. But, that has enabled a broader spectrum of ages to be included. With other disease conditions as well. Important to go down to the Lower Age Group as a set that will be done in a stepwise way. And as we have more experience with vaccine and the immune response to vaccine in our study of Natural History of infections, we will learn a lot more about what we call the corliss of the new protection. What should the antibody response look like in terms of achieving its level of protection. That will help us to better bridge between different studie studies. And to better understand some of these vaccines as well. Weird the beginning of a process which has been a normal silly rapid in terms of the normal length of vaccine studies dealing with a virus we did not even know about as the year began. It is lot more we need to learn. And she had the nail on the head here. He looked back to the past several years, the number of people who participated all three phases of development from 5000 to 65000 with an average of 21750. If you look at the trials this doctor hamburg said, sometimes 40 or 45. Very robust data in terms of the terms of trials for the covid19 vaccine. Absolutely and it has been a remarkable achievement. One of the challenges of the speed though is it doesnt make people wonder are there any corners being cut