Covid19 vaccine available and with those vaccines developed at socalled warp speed interest in understanding the process has never been greater. The fda inside and out, they have to do that. Let me briefly introduce our incredible speakers today. Dr. Stephen hahn is the 20 fourth administer of the fda, having trained in medical oncology and radiation oncology, prior to joining the fda served as chief medical executive at the university of texas cancer center. Before that he chaired the permit of radiation oncology at the university, and the alma mater. And the commission of the fda, before that was founding Vice President and Senior Scientist at the Nuclear Threat initiative, foundation dedicated to biological threats. Recently dr. Margaret hamburg was foreign secretary, at the American Association for advancement of science. She completed her services at the organization. Commissioners dr. Margaret hamburg and dr. Stephen hahn will be talking to clifton leaf who was guest editor of the oped page and held senior positions at the wall street journal magazine. And author of the book, losing the war on cancer and how to win it, listed as one of the best books about cancer. The cochair won numerous awards for journalism and leadership in the anticancer effort. A terrific terrific lineup i think you would all agree. A quick housekeeping item before i turn the program over to cliff, we welcome questions from the audience. If you would like to submit a question use the q and a feature and feel free to submit questions throughout the conversation, no need to wait until the end. We will have them all ready to go. With that, dr. Stephen hahn, dr. Margaret hamburg, thank you for taking time from your busy schedule on what promises to be a very interesting discussion. Thanks to all of you for being with us. We look forward to seeing you for our next health event. So exciting, what we have in store for today. Thank you, dr. Stephen hahn and dr. Margaret hamburg for spending time with us today. Let me begin with a question for you. This conversation could not be more timely, the vaccines and related biological products advisory committee, actually meeting as we speak, it was a narrow introduction but some of the presentation, the meeting is designed to discuss the process of authorizing licensing the vaccine candidate to prevent candidates to prevent chloroquine to. And this is fundamental to what i hope we will talk about today which is the credibility of the process. Talk a little bit about why it is essential to open up this process to everybody. Weve seen vaccine skepticism in this country that preceded the covid19 pandemic and that should concern us because one of the most significant advances we had in Public Health over the years has been the widespread administration of vaccine. With covid19 and the urgency around this pandemic the number of people who are dying, who have had covid19 around the world, the quest for a safe and effective vaccine is of significant importance because that is one way we will put this pandemic behind us. We have to be concerned and make sure we have confidence, because when we do and hopefully when we do have a safe and effective vaccine for covid19 the rollout of the vaccine will be dependent on people willing to take that vaccine. Transparency around the process and the criteria for authorization and approval is important, why the fda issued its guidance for vaccines in june 30th of this year, we wanted to be clear about criteria we use for looking at Clinical Trials and the criteria for safety and effectiveness, let people know what we wanted to see and in the most recent guidance around emergency use authorization process after 9 11, we wanted to be clear about that. That transparency about the criteria and the process we felt was important to enhance that. Thank you for that good and comprehensive answer. Some of the polling data is shocking. In may, only half would get a covid19 vaccine of offered and the Kaiser Family foundation. 78 of americans in recent staff and harris poll read that the covid19 vaccine process would be driven more by politics than science. We are seeing this across the board. There is a similar poll, wondering how deep this is. I want to come to you on the same issue because this is not a new thing. Theres been more talk of it overweight, the prevalence of vaccines in our consciousness. This is been around for a while. It is a fundamental concern about how we communicate to the public and healthcare workers more broadly about the important new products. We always want them to have trust and confidence in the process and understand what the product is, how it works and who should take it. Especially when you talk about a vaccine where there is a need for an individual to take the vaccine to protect themselves and limit risk of disease but also is a public good. Of Public Health measure needed for control of the ongoing pandemic now and to limit spread of other serious Infectious Diseases so it is disturbing in recent years to see the antivaccination movement which has been in my view deliberately putting out misinformation about vaccines safely the tragically resulted in underimmunization of populations in certain communities and resulted in preventable outbreaks of disease, measles in particular, many people dont recognize can be a deadly disease with a lifelong the measles vaccine is 90 effective. We are seeing that in the background and now we are seeing another phenomenon which is equally worry somewhere the actual trust and confidence in the process, Public HealthAgency Responsible for the Regulatory Oversight is being questioned because of the intrusion of politics and concerns that reflect the fact the process is so accelerated and things Like Operation warp speed that suggest something unnatural, manufacturing at risk, financial risk to make vaccines before we know whether it will be authorized for use but all of that conveys some sense of corners being cut and politicians saying i will make sure we have this vaccine by such and such a date and 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 and identifying ways in which there are inputs from scientific experts all should add to confidence and trust that only vaccines that met rigorous scientific criteria will be authorized for broader use. And information war here, not a fair fight, things like the birdbath meeting today and statements by fda, the government and the Scientific Community but that is against this overwhelming misinformation and partial information on social media. How do you combat that . We have to stand together on this. It is not just about covid19 the right now that is the situation. It is about a country, do we stand behind science and Clinical Trials and one of the most important Public Health measures, vaccination, we have to band together to communicate this and think about the context. I daresay the American Public never learned what a monitoring board was for the last several months, phase i and phase 3 Clinical Trials. Im willing to bet a lot of the medical community doesnt completely understand what it does. An important issue, one is data coming from Clinical Trials, they have to hit influence to trigger something an independent board, data safety monitoring board will look at and only after the review is it released to a manufacturer who can then decide to apply an authorization for approval and our process, we have amazing doctors, nurses and pharmacists who will make an initial determination and the American People do not know fda is one of the few regulatory authorities who look at the raw data from Clinical Trials. We dont look at a scientific paper, we dont look at collated or summarized data. We look at the data and make our conclusions and they are meeting today and will help us with this application and give their advice. That will be transparent and open and that needs to be emphasized to the American People because it is so important. We will get to the covid19 vaccine specifically in a moment but dr. Margaret hamburg mentioned measles where weve seen many outbreaks in the united states, this is an incredibly infectious disease, 7 times as infectious as covid19. We have seen childhood or infant diseases like whooping cough. Vaccine controlled something put behind us and we are seeing this outbreak. It seems as if this is a problem that needs to be controlled. No question people should not, no one should be dying of these diseases that are controlled by vaccines, can be prevented by vaccines, we must get together on this and emphasize the importance, these issues are settled, this is settled science and these vaccines that have been approved by the approval process are safe and effective. We must get this message out. And we must support the science. In some ways it is the story of Public Health, a victim of its own success. Public health is about prevention but when Public Health is working well and diseases dont happen nobody wakes up in the morning and says thank goodness for Public Health that prevented me from being at risk for this disease. It for granted and then because they have been so successful in many of these it used to be devastating to the individuals and families. They havent taken it as seriously anymore and any risk to the vaccine why would i want my child to have it when they are never going to get the disease anyway but the the sad truth is, if we start relaxing our vaccination standards and the virus still tt in the world, then those individuals, those kids are, n fact, at risk and we know that from experience. You look at other countries where some of these diseases are much more endemic and really take a toll every day, and those populations are much more eager to get access to vaccines and their bear the child is really making sure that underserved populations can get the vaccines they need and there the challenge is. Lets talk about the construct you now, the candidates. We are seeing lot of novel approaches, and dr. Hahn, maybe if youou could talk a little bit about what the sort of guidance is for vaccine efficacy. I know fda has ups that threshold to 60 making sure its even more effective than the original guidance suggested might be necessary. So i think you have highlighted one important factor here and it is a good news story although his dr. Hamburg or mention the wording around it sometimes suggest corners have been cut when they havent been. I will use sports metaphor, a lot of shots on goal from the right of different approaches come different platforms are being tested. Thats good news, some novel like him and are a vaccine and some have been tried and true and tested over the years for many, many years. This is a good news story because we have a lot of different approaches for a very novel virus that were still learning about every day. Our guidance outlined in june was for efficacy. 50 efficacy for the vaccine. The reasonth we wanted to plant our flag about that is that was the time these late stage Clinical Trials were being designed. As the Clinical Trials were being designed, they have to be whats called powered, enough people in them to look for and effectiveness the 50 or even higher. And, of course, we all want highly effective vaccine. If we could get the 97 , that would be great but we wanted to establish rapport which allowed these style to be put together so they could be detected. From Public Information and i cant speak about individual confirmation confidential information but as you probably know from the Public Information a lot of these trails have enrolled in the more that is necessary to detect that level of effectiveness and thats a good news story because it not only gives us a database of people have received the vaccine or placebo for effectiveness and also for safety. In our most recent guidance for emergency news authorization, if the element of time is such i can point out that is an authority that allows us to look at a medical product and assess it based upon the risk benefit ratio during a health emergency, but its important remember unlike a therapeutic which goes to someone who is sick with covid19, vaccine going into someone who is not sick with Covid Vaccine and, therefore, changes the riskbenefit profile because these are healthy individuals for the most part. That has to factor in the decision. Our scientists spend a lot of time thinking about how do we assess safety while at the same time doing everything we can to make sure this process is as expedited as possible. Understanding of course we did not want to cut corners. When we looked back at the last number of vaccine of the last 15 years what we found was this sweet spot for that was two months. If you follow a subject in in a trial for two months, you could get the vast majority of side effects associated with the vaccine and ifff you couple that with a very vigorous we call it vigilance, a followup program once vaccine is authorized, you could be very confident about the safety of that vaccine. Our scientists thought this was the sweet spot. We put into our guidance. Generate a fair controversy because we did put our stake in the ground without this was a great place to be so that something the vaccine advisor will be discussed in today, those criteria. Our scientists feel very confident and i totally support them in their information they put there. Dr. Hamburg, dr. Hahn mention the fact youre giving these vaccines or we will be giving these vaccines to healthy people, thats the whole point. But its a challenge is still because you have to get populations that youre giving that vaccine to, to be representative of a population at large. Theres some challenge in that, particularly in fact, you have to recruit a lot of much Older Americans which often dont get into Clinical Trials. We will need ultimately pregnant women. We won the children and only one of the vaccines thats being tested now, the Pfizer Vaccine is being testedac in children up to the age of 12, over the age of 12. How do we make that transition from this sort of traditional route of people that go into Clinical Trials to recruiting a much Larger Population to test these new vaccine trials . Its a very fundamental, important question, and we certainly do want to be able to understand the risks and benefits of these serious vaccines in different subpopulations, and theres a lot of reasons to think that certain of the vaccines that are in development mayrt work better at eliciting immune response in certain subpopulations like the elderly whiches frequently havea more diminished immune response. We really do want to have that information, and would really do want ultimately to have a vaccine that can be available across all ages. And those that have different comorbidities and other problems as well that you can do everything that you might want to do for everything you might want to know. The phase three trials actually are larger than many vaccine studies although they probably will be shorter. That has enabled i think it is important we start to go down to the Lower Age Group but as i said that would bes done in that way and even with more experience with vaccines and that response to National History we will learn a lot more with the antibody response would look like in terms of the levels of protection to help us to better bridge between different studies to better understand these vaccines with the normal length of the vaccine studies dealing with the virus not even knowing about as the year began. Looking back the last several years number of people who participated in all three stages of development of vaccine trails on trials 5000 to 65000 and with an average of 21750. Are very robust data where people in the trials with the covid19 vaccine. But it does wonder of the corners to help to make these trials. And with that participation in the Clinical Trial saying is tracking 192. And 160 are in phase two and with the real population to reach out to people with black and latino americans. What is the fda doing . We have an office and doctor marx and i have spent a lot of time talking to groups with the dominantly and where we are transparent about the process so he will continue that effort and to spend time on this also. And with that Clinical Trial structure to compare that to things that have been done abroad and to have a relative approach for the trial and Many Americans so if you have Cancer Patients at the really good number. And with that situation we have had and then to take a look back on. And then to get answered as quickly as possible may be that they are paying for those Clinical Trials as soon as possible. I was going to comment the public has learned a lot about how Clinical Trials are done and vaccine research. They are also probably learning to think about whether they want to participate in Clinical Trials. We havent done is good of a job and now to understand how important it is but the way we have that answer is doing a controlled trial and then report back and how it works for them as part of that can one informed consent. It has been an interesting process also that the Clinical Research and why that matters. And with