Oall the urgency to have a safe and effective vaccine available and with those being developed with socalled warp speed interest and understanding the E Development process has never been greater. Weve got the experts both inside and out to help us do that. Let me briefly introduce our speakers today. The 24th commissioner of the food and Drug Administration and clinician having trained in both medical oncology and radiation oncology. Prior to joining he served as the chief medical executive is the university of texas and the anderson cancer center. Before that he chaired the department oncology at the university of Pennsylvania School of medicine. Twentyfirst commissioner of the fda before that founding Vice President and Senior Scientist at the Nuclear Threats initiative, a foundation dedicated to reducing Nuclear Chemical and biological threats. More recently the foreign secretary for the president and board chair of the association for the advancement of science. For the oped at the smart money magazine also the author of the truth in small doses and the anticancer effort. A quick housekeeping item before return the question over we welcome questions from the audience if you would like to submit a question you can do so by using the qanda feature at the bottom of the screen and please feel free to submit questions no need to wait. With that, thank you both for taking time from your incredibly busy schedule and of course thanks to all of you and the audience for being here with us we look forward to seeing you soon for the next event and with that the stage is all yours. That is so exciting. Good afternoon everyone. Its a pleasure talking with both of my esteemed panelists this afternoon. Thank you for spending time with us today. Let me begin with a question for you. This conversation couldnt be more timely. Today is the meeting of the vaccines and related biologic project Advisory Committee meeting as we speak right now. It was about an hour or so of introductions but the meeting is designed to discuss the process of developing, authorizing and eventually licensing a vaccine candidate to prevent candidates to prevent covid19. This meeting brings together a whos who of experts and i think this is fundamental to what 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. A. We have seen a great deal of the vaccine skepticism in the country. And that should concern all of us because one of the most significant advancements we have had over the years has been the widespread administration of vaccines and of course with the urgency around this pandemic the number of people who are dying and who have had covid19 around the world, the kids advancement around the state is so significant because thats one way we will put this pandemic behind us. So we do have to be concerned and make sure we have confidence because when we do have a safe and effective vaccine the rollout will be dependent upon people willing to take that vaccine. So the transparency around the process and around the criteria either authorization or approval is why they issued the guidance for the vaccines in june the 30th of this year because we wanted to be clear about the criteria we would use for both looking at Clinical Trials and the criteria used for the safety and effectiveness. We wanted to let people know how they should design the trials. We wanted to be clear about that because that transparency around the process was very important to enhance. Thank you very much for that good and comprehensive answer. Some of the polling data that we have seen is shocking. It offered the same number of the Kaiser Family foundation. 78 of americans were worried that it would be driven by more politics than science and so we are seeing this across the board and gallup has a similar poll. Im just wondering how deep this is. And i want to come to you on this same issue. Theres been more talk about it of late given the presence of the vaccines in our consciousness but this has been around for a while. It is a fundamental concern about how we communicate to the public and healthcare workers more broadly about important new products. We always want them to have trust and confidence in the process and understand what the product is and how it works and who should take it because when we talk about a vaccine where there is a need for an individual to take the vaccine to protect themselves or limit a public good is a Public Health measure needed for control of this ongoing pandemic now and to limit the spread of other serious infectious diseases. So its been disturbing to see the antivaccination movement which has been deliberately putting out misinformation about the vaccine safety and its tragically resulted in populations and certain communities and resulted in preventable outbreaks of disease which many people dont recognize can be a deadly disease and can have other lifelong so we are seeing that in the background and now we are seeing another phenomenon which is equally worrisome where the actual trust and confidence in the process and the Public HealthAgency Responsible for this oversight is being questioned because of the intrusion of politics and concerns that reflect also the fact that the process is being so accelerated and we are even using terminology that could be confusing Like Operation warp speed that suggests something unnatural and manufacturing at risk that means financial risk investing before we know whether it will actually be authorized to be used. But all of that conveys some sense of the corners being cut and then you hear the politicians say im going to make sure that we have this vaccine by such and such a date and understandably, people start to be concerned. But i think that events like the one today, the discussion about the process. All should add to confidence and trust that only vaccines that have met the rigorous criteria will actually be authorized for the broader use. Its not really a fair fight. Youve got things like statements by the fda and the government and sometimes by the Scientific Community at large. I think that he is right well have to stand together on this because this isnt just about covid19 although right now that is the situation. Do we stand behind the most important Public Health measures so we have to band together and do our best and think about the context here. I daresay the American Public never has heard of what the monitoring board was before the last several months or the difference between phase one and phase three Clinical Trial. Data coming from these Clinical Trials, they have to hit the prespecified so they have to trigger something that is independent what we call the data safety monitoring board will look at and only after that review is that information then released to a manufacturer who can then decide whether to apply the authorization and then our process amazing doctors, nurses, pharmacists that will look at the data and make the determination we dont look at a scientific paper alone, we dont look at the summarized data. We make our own conclusion and then we call on the outside experts meeting today and they help us look at this application. This confidence is so important. I want to get to the vaccine specifically in just a second. But for now we have seen mentioned measles and many outbreaks in the united states. This is an incredibly infectious disease. Seven times perhaps as infectious as covid19. We also see things like whooping cough. It seems this is a problem that really needs to be controlled. Theres no question about it no one should be controlled by vaccines that can be prevented and we must get together on this and emphasize the importance. Its settled science and theyve been approved. We must get this message out over and over again. It has to be a concerted effort and we must support the science and medicine. In some ways if the story of Public Health is victims 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 god for Public Health that prevented me from being at risk for this disease. They take 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 truth is if we start relaxing our vaccination standards and the virus still exists in the world, then those individuals, those kids are at risk and we know that from experience. You look at other countries where they are much more and there the challenge is making sure that underserved populations can get the vaccines they need. You are seeing a lot of approaches here. Maybe if you talk a little bit about the sort of guidance it is a good story although as mentioned, the wording around it sometimes suggests the corners that we cut when they havent been. Its been tried and true and tested over the years. It was the floor for efficacy and you eluded to 50 efficacy for that vaccine so the reason we wanted to. They have to have enough people to actually look for the effectiveness of the 50 or higher to allow the trials to be put together so that that can be detected. As you probably know from the Public Information and i can speak about the individual confidential information but as you know, a lot of the trials have enrolled even more to detect that level of effectiveness. So thinking about how we access things and understanding that when we look back at the vaccines over the last ten or 15 years what we found was a trial for two months you could get the vast majority of side effects from the vaccine for those follow programs you can be confident about the safety of the vaccine. That is the sweet spot put into the guidance generating controversy because we did. Stake in the ground about this was a great place to be so we will be discussing today and i support that. Then that so good point. And then have to get the populations and then to be representative that we dont get into Clinical Trials and only one of the vaccine it has been tested the Pfizer Vaccine up to the age of 12 so hardly make the transition and then to recruiting on a much larger population. There is a fundamental important question. And then to understand the risks and benefits of the subpopulation. And certain of the vaccines may look better to elicit the immune response for certain subpopulations like the elderly so we really want to have that information 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 the bunch of questions that we want to get to. But the virus keeps evolving if they test positive for the symptoms of the vaccine protect us from various strains as it evolves . Thats a good question. We thought a lot about this at the agency and it is an intersection and it is an intersection where still learning about this virus as we go forward how long will that last . Were still learning about tha that, we have seen so far where the viruses and the variation variations, were confident the current approaches will provide protection if the data and Clinical Trial shows that. We havent seen anything to raise alarm bells. So doctor alluded to the fact thE Development of antibodies is something to look at in the credit in the clinical tria trial. We made clear from our guidance would have the clinical and point with the prevention of the covid19 disease. In those trials look at the immune and then how persistent it is. We look at the virus on how that affects and with that question is completed to. With all other coronavirus is and in those cases the duration of those antibodies is mixed. Were not sure how that response last. The virus that causes covid19 help protect it is we need to collect the data to answer the question and then looking at this from ecological studies. And then it would raise bad infection memphis overtime. That is a completely uncommon its a critical question we dont know the answer yet. And to the vigilant of the possibility. And its dangerous there are some people that believe wednesday have been infected and recover and to do whatever they want. And is bad practice. So with five oh the vaccines as we participate through the nia, nia, some require two doses of course sends a challenge not just with manufacturing but also in the interim. To make sure you are protecting someone and giving them dad neutralizing antibody response. If we do receive an application with emergency use authorization with the approval process, this is something we will require. It is a mechanism through that process whereby we are able to keep track of receives the first vaccine and then to ensure the second of the series is absolutely critical we keep track of that. And with those who received the vaccine. Going back to one thing that so important this virus is still with us and we actually have to take those precautions we are been talking about social distancing even in the situation have been protected at some point we stay diligent and protect the most formidable so far messengers could get that message we cannot be nonchalant about this and what is going on. I just want to follow up. And is problems and that and the vaccine. But it is so important to track these products in the entire lifespan and that vaccine there are several different packages which add to the database and getting access to Important Information about the products and their use. There is reporting back of individuals and healthcare workers and companies to adverse events occurring in that is jointly between the cdc and the fda. There are systems for using databases to collect information with the sentinel Surveillance System that allows you to identify potential emergency concerns to clear the system if you have a problem. But there have been some reports in some instances the enforcement of that has not been as complete as we would like but also it is enormously important and it goes back to the issues of Public Education as well because the public does need to understand what all of these systems are it is the responsibility that the companies have for the ongoing oversight. So several fda officials with the postmark surveillance realworld data so will you talk about some of those initiatives to help us identify the safety issues . Particularly people with comorbidity which has been a challenge with the longerterm effects from the response from the virus and with other drugs. There is at critically important that we have learned a lot during covid19 with the collection of data from a variety of different sources. So the centerpiece for monetary safety is called that sentinel system and that is part of the data that we collect. Not just integral but the engine for methodological innovation and a platform and that is a pretty rich environment that allows us to look at insurance claims are medicare claims. And with Electronic Medical records around the country to gather data to complement the system. We think realworld data and then to actually make sure that our system is very robust. And then remember coming in with the emergency use authorization that is not the same. So we are expecting a somebody would come in and we expect the application and then there is the requirement for us is the continuing ongoing effort limits our job to stay on top of this. Those as and the chairs before the current and past fda commissioner, talk for a minute of the scope of what the fda has to do. We know to regulate vaccines with the critical safety protocols but also prescription drugs and brandname generics and overthecounter drugs. And pacemakers and surgical implants. Bottled water, formula, laser products, Mercury Vapor lamp . Color additives. Nail polish, pet food, this is insane. Because your budget is only a few Million Dollars per year or so. About half of what we gave to the census its one quarter of what the irs spends each year. This is a very large portfolio and a major challenge that to somehow make sense of all of that. Actually in your litany left out food safety and nutrition. [laughter] and also when i was commissioner the fda took on the historic and important responsibility to regulate tobacco products. It is a huge agency but a remarkable portfolio of responsibilities and what matters to people every day sometimes in lifesaving ways. The work of the fda matters to the Healthcare System and the health of our economy and to our security as a nation and beyond. Fda truly is quote truly a unique agency and chronically been underfunded it may be slightly higher than what you said but i didnt follow that closely since i was commissioner but has been chronically underfunded. It needs more staff topnotch scientist and other professionals and then to be enabled to do this job without unnecessary interference from a whole gamut of potential pressures whether political or commercial or other idea logic and then to be enabled to do its job. 20 percent of an American Consumer spend money on gdp and covers a wide gamut of products the fda workload has doubled, double during the covid19 pandemic. In addition to responding the 17000 have been doing their regular jobs to improve new drugs and continue to work on sh is the deadline and then had been criticized for that is significant applications and working on those employment statutory responsibilities. We mentioned hiring. This year net hiring of 1000 employees at the fda it was 153 fy 1954 percent of those are under cures which allows us to go after those with remarkable scientific expertise. That is a shameless plug for what we have done these are remarkable people and we can always use more resources. I and incredibly proud. While he was selling those in sheets i was selling tank posters to ukraine nobody has been tougher on russia than donald trump. Everything thats going on about russia to make sure i dont get elected the next president of the united states