Transcripts For CSPAN Discussion On The Development Of A Coronavirus Vaccine 20240712

As of this morning, there were over 27 million confirmed cases covid19, and over 800,000 deaths. Have 6. 3 million confirmed cases and we are approaching 190,000 deaths. We have seen significant economic disruption to businesses and families and normal daytoday activities have been vastly altered. Leading experts have said we need a vaccine to return to normal. Which is why the topic of todays discussion is so critical. We will also discuss the lessons we are learning and developing a learning now in developing a covid19 vaccine, and the implications for future Vaccine Development. We have a short amount of time and a number of really terrific speakers. So why dont we go ahead and get started . Mark, why dont we begin with you. We have all heard about vaccines under development from pfizer, astrazeneca and the university of oxford, all of which are phasing phase three Clinical Trials. You have been working to develop a process to fasttrack safe and effective vaccines. Can you tell us what that process looks like and where things stand for now . Mark thank you. Thanks for bringing together a great group. A very timely topic, and a reminder of why Research Americas mission is important, this is it. It really has been impressive to see the amount of research and Development Progress happening on covid19, particularly in the area of vaccines. We have been working on this topic for a while. If you go to the website and look for accelerating therapeutics or topics like that, a lot of the information that we put together on what has happened this time that is so different because of the very large health and economic consequences of this pandemic. Essentially, we are moving a lot faster, and with multiple vaccines at the same time. There are backed by the u. S. Seven government. More in development in china, europe and other parts of the world because of the high burden of the pandemic. Not because we are necessarily cutting corners. What has changed is moving from a long and linear, uncertain, and questionablyfunded process ,o one that is hyper parallel with clarity and everything we need to get us to a safe and effective vaccine. That includes clear guidance on what needs to be done from a regulatory standpoint. Fda and other regulatory agencies came together early on around specific guidance for vaccine,expected for a free clinical testing getting it into humans. Detailed guidance which i would recommend people , inrested to look at it june, on the develop and process. Some clarity about what is needed to be demonstrated in terms of an impact on reducing the severity of infections, or reducing the number of infections. [inaudible] Clinical Trials of a substantial size and the potential safety effects in a bigger population too. At the same time, the nih and other groups have come together to develop a Clinical Trial network. It is enrolling a large number of people in these trials. So, for the early trials to get started at largescale for moderna, for pfizer coming soon. Astrazeneca has already started to enroll more next month. Expecting 30,000 or more enrollees. Many of these trials that just started recently are already up to that number. Pfizer is already in the second round of vaccination for this twodose vaccine that they are developing. So the Clinical Trials are happening at an unprecedented pace. At the same time, there is a lot of early investment in manufacturing of vaccine at scale before we even know it works. The Government Agency that oversees these countermeasure and Public Health emergency activities is going in jointly with many of the manufacturers to build manufacturing capacity here and elsewhere, to have literally tens if not hundreds of millions of doses promising the vaccine will be available by the time the Clinical Trials are completed. And there has been a lot of discussion recently about cornersthe speed means are being cut. From what i have seen so far, the answer is now. It is really just a very substantial planning process. You have all these critical steps done at the same time. Looking ahead, there are some very important decisions coming based on the evidence that is being developed in the Clinical Trials. The fda has made it clear that a vaccine is not going to be approved, even for emergency use unless there is a clear , clinical signal that meets the standard of effectiveness. Also, no clear data in these tens of thousands of patients who have been tested clear a safety problem. Drug safety Data Collection is asng to continue for years, it often does with vaccines to make sure there are any issues. So, how fast this could be done beenn the subject has the subject of a lot of debate among experts and it seems unlikely we are going to have any of these trials completed to the point where that level of evidence is available before the election. But people should have a clear understanding that the fda and other groups involved in these efforts have a very transparent process Going Forward. So, before the fda approves the vaccine, it has made clear that it will have an Advisory Committee. For the Advisory Committee meeting, there will be data reported from the company that they put in their application there will beuse, a review from the fda staff about what they think of the data, and there will be public discussion about what it all means as a basis for further decision. Let me just emphasize that emergency use for a vaccine would be very different than emergency use for treatment like , say convalescent plasma. Are treatment where we have seen it used in many other conditions, thousands of patients with serious covid infections. It is intended for people who are hospitalized or seriously ill, not for a broad, healthy population. Because there are many safety concerns, it has a different standard than what i have been talking about for vaccines. So, some very important developments over the coming weeks. We will see how fast the trials can actually go in terms of not just enrolling patients but declining rates of covid in the country, it is a good thing for Public Health. But it may take longer for trials to complete. We will see how effective the vaccines really are in reducing the number and severity of covid infections, and the people who are running the trials, their data safety monitoring board will be looking along the way to see when there is a single that that meets theal fda standards. As long as we are following fda standards and a clearlydefined approach that the fda experts and their biologic center has laid out to get us to this point and move forward, we have a very promising outlook for vaccines. That said, i think we are still weeks to months away from having that moredefinitive evidence. It is going to be sometime before the vaccine gets out to everyone. It may be starting with some very highrisk or highpriority groups like military personnel and medical responders. And going out from that, as the evidence accumulates, and we have more supplies of vaccines available. We are at a critical time now but i think were going to be in this phase of uncertainty and continuing to learn for a number of weeks to come. That is a terrific overview. We will pick up on a lot of the things you talked about. Paul, i want to get you into this conversation. The topic of the timeline. Since the early part of the year, we have heard 1218 months. We are approaching some part of that, and this expectation that we will have some kind of vaccine or vaccine candidates available as early as november or december, can you help us understand what this timeline means for Traditional Vaccine Development . What can we expect toward the end of this year and what can we ofect in q1 or the middle next year, and is all of this realistic . Paul yes, i am happy to make any prediction you would like as long as you dont hold me to it. [laughs] mark covered a lot of this. The average length of time that it takes to make a vaccine is 1520 years. You go from preClinical Trials to phase one to phase two phase three. Through small dose trials to larger dose trials, then you get the big definitive phase three trial, the placebocontrolled 30,000person trial which is the only way you will determine efficacy for a large number of people. What has happened now is the government has taken the risk out of the pharmaceutical companies. We have been able to coalesce timelines because the government has said we will take the risk. , we will pay for this and , in some cases, we will massproduce the vaccine. We are willing to throw away doses, if it is shown not to be effective. Obviously, no company would ever do that. That is why it is so much faster. I think on the one hand i am not worried about these coalesced timelines. We are doing big phase three trials. If we are doing what we say were going to do which is eight trial, that is fine. There is also two other thing standing in the way of releasing a vaccine that would less than safe or effective and that is the data safety monitoring board who are charged with overlooking these vaccines as they would any other vaccine. Then, if dr. Hahn is true to his word when he wrote the oped in Washington Post or in the journal of american medical association, he will seek the advice of an Advisory Committee, another group of independent researchers who are not with the government, not associated with the pharmaceutical industry. I think they will give you an honest opinion. None of that worries me. One,ever has to be however, has to be concerned about a few things. This is not standard procedure. It is likely to go through emergency use authorization. Language that surrounds emergency use authorization according to the fda guidelines includes phrases like may be effective. Second thing you worry about if you look at what happened with hydroxychloroquine or convalescent plasma, mark is right, they were given to people who are already sick. Different, they are being given to millions of people who are generally going to be healthy young people who are not likely to die, so you certainly want to hold them to a higher standard of safety. First two that in the cases, you clearly saw influence by the administration on the fda to do something that shouldnt have been done. I think it neither of those should have been approved for use. If people are worried about whether the vaccine is going to be approved for use under a much looser standard. That the pharmaceutical industry got together, Major Players and wrote a letter saying dont worry, these vaccines are going to be held to , they shouldnt have to write the letter. Thats what the fda does. It stands between the American Public and the pharmaceutical industry to make sure that you get a product that is safety. It worries me that they felt the need to do that. What they are doing when they write that letter, they are saying to this country that there is a question about the fdas willingness to stand up to the administration that is going to be under pressure. The pressure is going to come not just from the november 3 election, but the fact that china, russia and the u. K. May well come out with a vaccine before we do. The fdaands, between vaccine Advisory Committee, and dr. Hahn and his commitment on paper to make sure we hold these to a standard, i feel good. But you are a little worried. That is it. Maybe i am a warrio worrier. It does worry me a little bit. I will stop there. Thank you. Just to followup on a couple of points, and i will bring others into the conversation as well, is there a guarantee that we will have a covid19 vaccine, because as many scientists have said, science is hard. You have been involved with science for many decades. Army guaranteed to have a vaccine that is safe and has high efficacy . Paul know, there is no guarantee. This bad coronavirus has already done things you have never predicted. It rages in the summer months. Who would have ever predicted that . The postinfectious phenomenon, i dont know any other virus that has been what this virus does. Influenza also kills older people but fewer than 10 are of those deaths are from nursing homes. Here we had 40 . It causes vasculitis. Not because it reproduces itself in the blood vessels, it appears to be all immunologically stroky disease. That is surprising. We are meeting that challenge with vaccine strategies like , that have basically never been used as commercial products in the United States before. Is there going to be a learning curve . I cannot imagine there would not be. The things we wish we would learn we would know now i guess the short answer is no. That is why you do the phase three trials. We will come back to that discussion about the level of evidence between the emergency use authorization and life insurers. There is a lot of different types of technologies right now that is in development that has never gone all the way through to commercialization. First, what has happened in the past that brought us to this point that we can accelerate the covid19 vaccine with these new technologies and how do you think about that Going Forward . Are we now testing things that you anticipate you will have treasured the vaccine as we go forward . What led us to this point . That is a great question very broad reaching question and very broad reaching. Let me state very clearly that we look upon vaccines in somewhat two different baskets. One are the vaccines that are infants,inely and for safety is very much our area of concern. Our typical infant vaccines are examples. Vaccine, covid19 vaccine is what we call a Public Health emergency of International Concern vaccine. It is a different ballgame. It is a different handbook that we follow. We have thought about and pandemic like a are seeing now because once before, a century ago, we saw it with an influenza vaccine. So we know it can happen. There have been a few signals that stimulated dress rehearsals. 1976 when iback in was a young assistant professor and there was a worry about swine for, a pandemic swine flu, a pandemic. The modern dress rehearsal in my view began seriously with the Ebola Outbreak in west africa, which devastated the health care infrastructure, destroyed the economies and when cases started to appear in europe and north america, it became very clear all the consequences and we began to worry more. 2015 epidemic014, came the birth of the coalition for epidemic preparedness innovation. This is why it was created. For science to make vaccines to quickly grab up, quickly rev up, we have seen a number of milestones put to use. Sequence of ahe ofus, pick out the antigen key interest and use that inuence either expressed sectors or to make purified croteins or to make nuclei acid vaccines all become possibilities. There has been a lot of background work on these platforms. Cepi and other groups have been doing is monitoring and looking at what might be the next dangerous organism. To sars outbreak in 2002 2004, that was a harbinger of what might happen. The mers is a harbinger. Those were beta coronaviruses. Here along comes this beast of a virus beginning in east asia. Very quickly, the sequence of that virus was made public. Very quickly, that was utilized by various vaccine developers. On the way, one of the things that was done was the modification of the sequence so that this is work done at the root the Vaccine Research center of nih. Modification said that the prefusion configuration becomes stabilized, which theoretically enhances the stabilization of the neutralizing antibody. This is mrnas moment. Makeare ways to quickly vaccine. The mrna has the theoretical advantage of going and it has been shown from the sequence to first inoculation in just about two months. Also, the possibility of largescale manufacturing. But, these are not from the , superc perspective perfect vaccines even if they are safe and they are highly protected. They require two doses. They require a special chain. These are not showstoppers. Along. Are so far we are very close potentially to having very good vaccine. Last point i would make is this is truly a global problem. We have to have vaccine not only for u. S. And europe, but we have to have vaccine for the entire world because as long as there is a reservoir of continuing transmission, the homeland, u. S. Homeland, the rest of the industrialized countries are in danger. Ruth, i want to bring you into this as well. Out did a nice job laying the potential for these technologies, how quickly you can develop the vaccine. We have the mrna platform as he described. What that means is we need a robust process for evidence generation. Conducting Clinical Trials in such a way that we can determine which vaccine is the most effective for different populations that may benefit. I know you do a lot of work thinking about these kinds of issues. When we are looking at and rolling different patients into trials, pregnant women, children, the elderly, right now for covid19, this highly impacted patient populations like minority communities. How important is it that these trials are representative if we can get definitive answers we need either for authorization or Life Insurance . I would like to get everybodys thoughts on that. You are on mute before you start to speak. Ruth thanks so much for that reminder. I think you bring up a very important point. I think that all of these considerations are not the same and i think we should start there. And to say that pregnant women, racial and ethnic minorities and of course there are overlaps in those categories, but i do not think it. Hould treat we should lump those together as we think of Clinical Development. In thinking about this panel, i have been thinking about Lessons Learned for the future and how we can think about what we do in this time will inform our future Vaccine Development. What i think is a really critical issue is going to be around inclusion and one of the legacies is going to be around inclusion. This is not a new problem, right . Either the problem is speaking particularly about racial and ethnic minorities, having a disproportionate burden of Infectious Diseases and nonInfectious Diseases is not a new problem. Lack of inclusion in Clinical Trials is not a new problem, but our focus on this and our efforts to make this right both because we need these data and these are Critical Data for us to think about how we deploy vaccines. We do have a number of vaccines. I think by nature i am an optimist. I actually think we will have vaccines and we will have more than one vaccine. Usethink about how to best these vaccines, we really need to know how they work in populations. We really need to be able to build trust. As part doing the trials, which is a bridge to having trust when we deploy vaccines. For all the populations we consider, we want to think about risk, benefit, firm platforms. What we are trying to prevent in terms of vaccination. Are we trying to prevent acute disease or are we trying to prevent severe disease . Are we trying to prevent transmission, which i would remind everybody, we are not looking at in any of our u. S. Trials. That is a bit of a jump in our thinking, although certainly we do have many examples of pediatric vaccines that have prevention transmission to others. I think those are all issues that we will need to think about as we continue with the evaluation of these vaccines. I would also just say that we ,ll as clinical investigators as policymakers, as developers, we really have to walk the talk. Everyoneeryone had has embraced the notion we have to have diversity in trials, but we actually have to continue to monitor and think about if we are not hitting our target, if we are not doing what we want to do, what are the barriers and how do we overcome them . Followup on what you have said, are you comfortable with the level of enrollment you have seen around diverse populations . What do you think still needs to be done . Well, i think the practical issues i think there are the practical issues and i think there are the trust issues, to be honest. I think around the practical issues, we have to remove barriers. One of the things that i think all of my colleagues have highlighted is that this one, this is not business as usual. Two, we have resources for Vaccine Development, the likes of which none of us have ever seen, right . And we need to use those resources for good. So if there are barriers to enrollment that are around access, somebody does not have a car or transportation to get to a vaccine center, by all means, there should be mobile vans that can go to where the people are. If there are populations that havemall and rural and different ways of doing things, one of the things that i think is really important is we need to listen both to the populations and actually to some of the really experienced clinical investigators who have spent their careers in some cases working with disadvantaged populations. What both the populations themselves and the investigators what do these , populations need . Thats a very sort of pragmatic answer. Then on the others there is , building trust. That has to do with both, quite frankly, having members of the study team who are members of racial and ethnic minorities so that people can feel comfortable that there are people on that team that look like them, that are part of their communities. And it also has to do with going to Community Leaders to engage and to support. Yeah, absolutely. I think building that trust in an ongoing way is extremely important with local communities. Will, if i can turn to you as we heard when mark described the landscape, for many of the programs that are well underway, the government has borne the full risk. Thats why were able to accelerate things so quickly. And we know that it takes a tremendous amount of resources to bring any vaccine to the population, always commercialization. We talk about how it takes a billion dollars, 10 to 15 years to develop any one drug. When were in a pandemic, we rally around because of the significant disruption. And then its solved, and then we move on to other issues. You recently coauthored a paper in Science Magazine along with gary and others just around the topic of how do we need to provide the right incentive, not just in the middle of a pandemic, but postpandemic, so that when we are confronted with yet another pathogen, we are better prepared . Do you see those kind of incentives you wrote about happening now . What do you think about them Going Forward . Will well, thank you, and good afternoon, and thank you, or a buddy alice for being involved. Its an honor to be with you. We have authored this paper together to think a little bit about the innovation regime that we have in this country and how its applied to the current efforts to develop and then disseminate a vaccine and the opportunities it provides for future crises. In this country, our innovation regime comes out of the constitution. Section 8, clause 8, provides and copyrights. That covers one part of what we need to develop vaccines, the innovative and sent the innovation incentive. You need to create an incentive for people to develop and to transmit and manufacture all of these different vaccines and therapeutics. But the other part of the problem is that patents create the incentive by giving a 20year monopoly to the owner of the patent. And so while you have received you have conceived of your convention, reduce it to practice, and then given public exposure, which is the tradeoff for the oneyear monopoly, we get to an issue that dr. Karen just raised, inclusion. Once you have received the innovation and exchanged it for a monopoly, there really is no inclusion because you are going to get monopoly crises. And the problem in a crisis like this one, where anybody can get infected, there are huge externalities toward vaccinating anyone whether they can afford to pay or not. We are at a disadvantage if we rely entirely on the patent system. So we talked about what alternatives could we use. In fact, these alternatives should not be unfamiliar to people in pharma because they use it privately everyday. Its essentially a reward system. So where you want to create an , andtive to develop disseminate. It is the government acting individually or ideally, collaboratively to create pools of rewards for phase one completion, phase 3 completion and approval. And then for manufacturing and distribution and administration. What we could have is the best of both worlds. We could have the incentive to innovate as well with pricing as close to marginal costs as possible. In Infectious Disease where you have Huge Positive externalities whenever you treat your marginal additional patient, that is a pricing mechanism superior to the patent pricing mechanism we have now. Something dr. Levine said earlier. He said we can have these reservoirs of continuing transmission. The problem we have internationally is we are right now in the United States that reservoir of continuing transmission. If you look at it, we need to cooperate and collaborate internationally so that we can create such a regime of incentive and then apply it internationally. So you could do it with the wealthiest countries, creating a reward for all of the innovators. And then we need to have international distribution. After you say what are we are doing what are we doing now, i think there are things we are doing that the wrong way to go. Trying to pick winners and losers through government grants to specific manufacturers i do not think is the right way to go. The used to be a time where people with an r next to their name did not pay winners and losers. I still do not think we should be picking winners in lizs. Winners and moses. Winners and losers. Everybody can benefit on an inclusive basis from the innovations the public has funded. I think you raised an important point in terms of, what we need in a Sustainable Way to continue innovation well past the peak of the pandemic . What we have seen, and i will turn to gary, is that we have seen tremendous collaboration. Seeing Companies Come together in new and different ways. Potentially, that will continue Going Forward in the future. We have seen philanthropy in the private sector come to bear in ways we perhaps have not seen before or certainly not at this scale. When you think about the ideal system and will pointed out one part of what an ideal system could look like, when we go forward, what you think is the ideal role of industry, private sector, philanthropy, government in having a cohesive Vaccine Development ecosystem . A really important i haven and one that been involved with since my early days at the nih with tony actually, developing the Vaccine Research center. I think wills comment and the piece we wrote together with thattt highlights the fact we essentially when we approach these outbreaks, we basically have a fire drill when there is an emergency. So we have these boom and bust cycles where we invest in vaccines and Vaccine Research. I think that all of us appreciate that for us to build a sustainable and effective deterrence for Infectious Disease and i would argue for all of human health, we need to have consistent and sustainable funding. You know, in some ways, mike and his comment mentioned the importance to structural biology in the current vaccines that are Going Forward. When you look at the complexity of Vaccine Development, what it enoughi cannot stress how unimaginably complex this process is. I would argue that of all the endeavors to as human beings, from building cars to getting to the moon to developing new medicine, there is probably nothing more complex than developing a vaccine. It starts with things as sophisticated as structural biology that micah mentioned. It goes to that mike mentioned. It goes to human health. It goes to manufacturing technology. It goes to ethics. It goes to the way societies live and except information and accept information. It goes to the diversity of human population. Think about when we were talking about vaccine trials, think about going out in the real world. We are doing trials and we are not doing trials where the control group is identically and genetically matched and camped in the same environment as the control group. We are dealing with populations where people are walking around, some have underlying cancer, some have colds, and you are doing a trial in the real world where all of these people are exposed to normal life. That is why we do the 30,000 30,000 person trial we talked about earlier. From my perspective, the most important thing we can do, and i think what we need to begin to implement in a serious way is really a global, public, private partnership where we find mechanisms by which we can continually support these efforts where we systematically monitor new bio threats, where we systematically develop letter diagnostics so we can better diagnostics so we can catch them early, or we have better measures in place that guard against the most likely threats in the shortest period of time and we can deploy our knowledge about vaccines in a way that leads us to the kind of fruitful and protective countermeasures we need. The only other comment i would make is and several have said this and tony said it in his comments earlier, that it is completely unprecedented that we have been able to develop a vaccine any the period of time we have. A lot of people should be congratulated for this. Both from the industry and from basic science, from the nih to the cdc to the fda. But i think that we should also forget should not forget that one of the reasons we are able to act this quickly is our effort on these Coronavirus Vaccines did start with the first sars in 2004. And it started as on this road of developing effective vaccines for coronaviruses first with the very first sars vaccine. We developed a prototype that could not be tested in 2004. But it then progressed with mers. That station mike was talking about came out of mers research. It shows you the value of consistent, longterm support from the Research Enterprise and across the board in technology and Clinical Development and Public Health. That is i think what we need to focus on for the longterm. I think to that point, we have the potential to bear the fruit of the labor today for the future, many decades from now. Just as you pointed out, what we are experiencing today in acceleration started with sars, but i think again, we need that sustained funding. Nowe are pressures right that we have been talking about, we have been hearing about, and i want us to go back to that, around evidence generation and to go back to the conversation we started with with mark and paul commenting around, what do we need from an evidence perspective that will make the public feel confident with a vaccine if it has been authorized under an emergency authorization. Mark, should we be concerned as paul talked about or you feeling confident . Mark i would feel more confident if there are lots of people with the knowledge and respect paul has in making clear we need to take this vaccine emergency use or broader use really seriously. I think the Good Foundation we have to build on this is that fda and the staff at the biologic center have been clear about what is needed to get their recommendation for approval for emergency use or more broadly for a vaccine. Have ane interested, we event on thursday with the leadership from the center. We are going to talk about this exact topic. If you look at what they said, it is going to be very different in the emergency use authorization standard for Something Like remdesivir or convalescent plasma. This is a reminder that as a standard that in general, does not require definitive evidence of safety and effectiveness. That is why some of the treatments that have been approved so far where there is not any evidence of a substantial safety problem and there could be evidence of benefit, why that has been done for these treatments for seriously ill patients. I personally would feel much better if we had a better Evidence Development system in place for those technologies just like we do it for vaccines because of all of the effort that has gone into support Vaccine Development. We still do not have a good randomized trial completed of convalescent plasma. We would still like to learn more about some of the other treatments that have been approved for emergency use and are in development. Frankly, things are not going as quickly as we would like. I would like to take a lesson out of the playbook for vaccines to set up some simpler, more compelling trend compelling Clinical Trial networks for the other therapeutics. Effective vaccines in particular, i think what will be very helpful is for people like those in this group to make sure they understand what exactly the biologic center at fda is looking for when it comes to a decision or recommendation about emergency use authorization or broader authorization for a vaccine. The more that thoughtful people can take a look at those standards, which theyre trying to be clear about and help make the a public more aware, the public more aware, hopefully we can address the challenges that start coming once this political preelection environment we are living in. I think this is not just an issue between now and november 3. After the election, there will be some time where we are not sir about the results or a transition. There will be the next few months, they are going to be the very important months for vaccines where we will have more of this evidence coming along, where we will have we will be getting into distribution and there will be the next few months where it will be very important for vaccines, where we will have more coming out and where we will potentially be getting into distribution and riskthe reaching of the at populations, people of color and others, that ruth has mentioned, and for that to work, it is not just a matter of working out the Technical Details of this distribution. Its a matter of working out the reasonable basis for Public Confidence in the decisions that are made. And i think all of us here who care about these issues and who are viewed as having some relevant expertise to the issue owe it to the American Public to spend time looking closely at what would be involved in the emergency use authorization, what would be involved in approval and making sure were weomfortable with that, and can talk to the American People about that. We have every other piece of this Vaccine Development effort to proceed at an accelerate pace with intense effort in a hyper parallel way. This other key element, expert understanding and communication , is another key part of that parallel process to actually work. We need to bring the American Public along, and the only way to do that is to have a process that works. So thats why stuff like what industry has done recently to say they want to be behind an effective f. D. A. Regulatory process, what people like me and other former commissioners have said along the same lines. We need more people who are willing to take a close look and willing to get behind an effective approach here for Public Confidence in the vaccines that will be coming and the decisions and the support that affects the decisionmaking about them. Yeah. Yes, i want to thank ruth into this, as well, who has a comment on this question, and then, paul, just to begin something with you. What does the safety monitoring mean in terms of Going Forward with public trust, and, ruth did , you have a comment about this evidencegeneration question . Youre on mute again. Ruth yes. Sorry about that. Yeah, i actually wanted to make a comment about public trust and communication. And this may paul may have two things to address when hes teed up next, because im sure this will play very much into things hes interested in. I think that regardless of the extent of the evidence that we have, whether for eua or for licensure, there have been things that we dont yet know. For example, an obvious example is we will not know much of, if anything, about the durability of protection. And there may be other things we dont know. We will not know even with these there mayson trials, be weird side effects we dont detect in these initial trials. All of these things are true when were licensing vaccines and other contacts, but it will be true here also. I actually think that this is a sort of national, teachable moment about vaccines. In thebsolutely i saw chat box, somebody mentioning the New York Times vaccine tracker. I would really encourage anyone listening who has not gone to that website and who has not looked at that vaccine tracker to look at it, because its an extraordinary peefs education for the general public about the kinds of vaccines that were evaluating. But i think its also really important when we do efficacy trials for the public to begin to understand, and explained in ways that everyone can understand, quite frankly what , did some of the statistical tests that we do . When a lower bounce by 30 , what does that actually mean, and what does the point estimate mean . And if we say something, you 70 , one vaccine is effective, and one is 65 effective against the endpoints, and the confidence overlaps, are those are those vaccines different . I think we really need to think more about how we can educate the public and thinking forward, thinking about the legacy of this after this pandemic is over, if we can use this time to peach the more about vaccines, we will be better off for this problem and for future problems. Public education is going to be absolutely critical and what the public understands , is length of time. Was understand the vaccine under development for a. Of time and now has been made available. Paul, how can you help explain the question around the Timely Development and any concerns about safety or adverse events that typically dont emerge until you get to hundreds of thousands of people who have gotten vaccinated. Paul right. When vaccines were launched, theyre not launched because you know everything. Because you have enough safety data, because you have enough to understand theoretical risks. Certainly, we have 1000 people dying per day of this virus. I think there is a health decline. You are the skiddish American Public. The reason they are skittish is because what is surrounding this process has been scary, work speed, race to a vaccine, who is the finalist . I mean, one gets the feeling that things are being truncated unnecessarily or worse and that guidelines have been skipped. You do have an administration thats been willing to perturb the signs, whether its the Environmental Protection agency, who are sciencebased agencies, the National Weather service, the food and drug administration. It makes people nervous, makes me nervous. I can understand how theyd be nervous. And then also just personally, its like when you see phase one trials being publish in the new england journal of medicine, which about 10 people, 15 people are actually getting the close thats going to be the final dose. And then you hear the companies talking about how they can make tens of millions of doses, its a little nervewracking. You dont feel on some level is the humility that should all be part of this process. I mean, gary, ruth, mike, and i know this well. As you move forward in these processes, i mean, nature gives its secrets up slowly, grudgely, and often with a human price. I mean, i worked on rona viruses. Norovirus. For the 26 years took to us make the vaccine. That virus had been worked on for four decades before i started working on it, both an animals and ultimately with people, and then there was a vaccine introduced in the late 1990s that caused this. No one would have predicted it, and we have been working on that vaccine, either animals or people, for 40 years, and that was a surprise there. We have been on it for about a year. I think you have to be humble here. In terms of explaining people, and ruth said this, i think, once you have the data in hand, then you can try to explain what you know and dont know. Then you can say youve given it to 20,000 people, but thats not 20 Million People, but there are systems in place like the Prison Program by the f. D. A. That can then look for rare adverse events. As ruth said, you have the vaccine is effective for a certain length of time, but you dont know how long. You have to be really honest and transparent about what you know and dont know. If we do not do that its going , to be a slow climb up the hill, but i think we can get there. Yeah, mike, are we going to have an annual Coronavirus Vaccine . Do i need to prepare my children for a flu shot and covid19 shot . Mike we do not know that. Theres been monitoring of the viruses. Different things emerged in china, and that will be one of the things to watch. As paul mentioned earlier, this is an unusual virus, the coronavirus that does not , exhibit striking seasonality. This virus did not read the book. And so it was bothersome. How would you stand, if i may, give us a demand to the last suggestion. And that is, with all of our tents to be opened, key point. One, a portion of the population theyve already said they wont take the vaccine. Theyre subdivided into one group that is antivaccine. They will not be their minds, i do not think, will be changed based on interactions over measles vaccination in past years, and then there are others who are hesitant. They see smoke. They wonder if theres a fire there. But the truth is even with well done trials, and we do everything right, we follow up, there are unexpected things that happen. And we need to look back in the other dress rehearsals. In 1976, about 40 million americans were immunized and rarely, it was a very rare paralysis,ascending what a terrible legacy, but it is part of our legacy. We just need to be very, very careful. We need to be as open as positive. We also need to recognize that there are folks out there who are planning to do their own education of the population. I really like pauls comment about humility in the vaccine. One thing missing is a soothsayer, someone to look into the future, something we cant do. Well, i think that probably saves a lot, which is the uncertainty that we are dealing with right now. Why dont we turn it over to questions that are coming in from the audience, and someone was interested in wills we lead futurew Development Efforts towards pandemics, so interested in your perspective and critique of the da approach, and what you have posed, which are rewards and incentives. The question is, is there a key difference with the patent structure . Governments,ze for the ultimate price is paid to the kind of arrangements that are closer to marginal costs, so i think essentially what your paper outline, how do we really move forward and how do you think about this current approach and how barda has done this . I think it is interesting, and you will have to pardon me. Constitution suggested the patent system, it just delineated it, and this created this issue. The constitution also provided a potential solution. I remember back in the days when people were complaining about the price of hiv and aids medication and the fact that these were patented drugs and should have just been given to patients. There is a solution within the constitution. It is a taking. Essentially, you pay fair market value for this asset, this piece of property held by a private party, and in exchange, you can now own it and can janeiro size genericize it. We are doing it ex ante, in exchange, the public gets to own the intellectual property at marginal cost. It is a merger of some of those concepts. What we would say in this is not with gaming the Pharma Company either. Without gain to the Pharma Company either. In Infectious Disease, h1n1, for as another and my father were quite happy to point out to me people had ramp up and , made investment only for the market to never materialize. They took enormous risk and got nothing for it. Here you know ahead of time there is a lockedin benefit to incentivize you anyway. That is going to be your reward. The publics reward is pricing is distribution cost and marginal cost, as possible. So i think these are the concepts we are playing with. Had asomebody else question. Are these underway . Nobody has actually undertaken this reward system come not transnationally and certainly not in the united notes, reward system, transnationally and certainly not in the United States, but it would be a legacy of the covid19 pandemic to have the systems for specific diseases where the social externality as such that they are called for. Yes. And maybe to continue down that line of thought. The, a question came in in chat in terms of is it possible to realize a viable local partnership in this currently highly competitive fragmented, International Environment . And what would be effective next steps to take us in that direction . We are not nationalizing a vaccine, for example. Gary that is a great question. I would say despite a lot of the heat that we see at least in the media, i do think that collaboration does happen across borders. I think that you know, a good example, and eyesight this only because it involves a company thisi work with i cite because it involves a company i work with, but they partnered with gsk on a covid19. Sanofi is using the proteinbased technology that on virus insect production together with something gsk used and had an agreement with barda for emergency use. That has the net effect of saying heres an opportunity to enhance the potency of the proteinbased vaccine and potentially also reduce the dose that you would have to give to any individuals. You would have more supply and potentially more effective. Now that needs to be , demonstrated. But i think what the example shows is that when there are aligned incentives, and where both parties can stand to gain and do things together they could not do alone then those , kinds of partnerships can happen. And i think there have been fits and starts. I think we need to do better. And if i were to suggest something new to try to address, you know, this kind of a disconnect that we experienced with the current covid outbreak, i would say that we need to have essentially the equivalent of a biological u. N. We need to say, listen, we are going to unite and coordinate. We are going to forget politics. We are going to focus on the science and the epidemiology and gy. Vaccinolo i think that can be done. You need to have some investment there. The the g8 and g20, given Economic Impact that this epidemic has created, investing a few billion dollars a year compared to a trillions of dollars this took out of the worlds economy would be a small price to pay. So i think we need to think about new structures. I think we need to think about funding mechanisms. I think we also need to recognize, and this may be something that has not been said but should be top of mind here. In our lifetime, it has not just been covid. Think back to hiv. Hiv was not a problem when i was a kid. There was no such thing as hiv. Now, over 38 Million People have died of hiv. Weve had avian flu. We have had sars. We have had chikungunya. We have had ebola. They come one after another. This will not be the last show. They will be more. I do think the time is now and i do think not only can we do better, we must. We need to be thinking globally. Ruth, a question came in with regard to the loss of trust in whichment over 40 years, does not bode well for Public Health immunization efforts. You talked about this earlier. How can we communicate the benefits and the risks to a very skeptical public . And then the second part of that question deals with what does this mean for pediatric patients and Adult Patients in terms of building that trust . Will parents feel comfortable vaccinating their Young Children who potentially have not participated in these Clinical Trials . Thank youhink for that question. I think the audience members. I think there really are several parts to that. So i would a little bit take issue with the notion of a very skeptical public. I would go back to something mike said, and certainly something that paul has talked about quite a bit, which is that the number of people who really are antivaccers is a small but very vocal minority. And there are a much larger number of people who, in fact, and who canhesitant be brought along, and i think the way to do it, as we have talked about before, is really to be transparent, to be absolutely clear about what it is that we know, what it is we do not know, why we are advocating vaccination, what the risks are, what the benefits are, and i think we need to think about that population by population, and i think that the conclusions that we come to for elderly adults, for younger adults, for pregnant women, for children that we will weigh all of those things. What i do think is true is we will probably not recommend vaccination before we have some data from Clinical Trials in various populations. We will not recommend widespread vaccination. And so, there are people thinking about how we can do those studies in those various populations, and, certainly, people have been talking, for example, about pregnant women and when and how those studies will come. So i think we need to generate data. It will not be the kind of 30,000 person data weve had from our big efficacy trials. But we need to have that information. And then i think we need to communicate. I would imagine that some of my colleagues might want to weigh in on this, as well. Im going to go in a different direction. But that was very well stated and reassuring as well. Maybe to close out with this q a, we have talked about what gives us pause, maybe some things that are concerning, some reassurances, but as you think about where we are right now what gives you hope . ,where is your greatest optimism coming from despite the challenging news we see every day . Mark, why dont we start with you . What gives you hope . Mark i think we are on a path for an effective vaccine. That is something in the end that will help get us out beyond this pandemic and turn it into a more manageable ongoing Public Health threat, like the flu. Hopefully, things will get better. Weve also had some opportunities to learn about ways to Work Together more effectively outside of the research context. There are some steps of Public Health agencies working with Health Care Organizations to get out in communities, using Community Health workers to identify highrisk individuals. Do testing more effectively. I hope we can build on that. In the area of research, there been very important collaborations. You know, we still have a ways to go. Thatof the Clinical Trials have been undertaken for covid they are not going to yield notsults because they were designed with enough power to begin with or because the out in thetered specific location where they were testing. We have seen with the vaccine what other Trial Networks are trying to do, with nih support and some with private efforts, trying to do very fast trials, more efficient with Data Collection. We can do a lot better from this, and we have heard from others about collaborations on developing distribution capacity, planning so we are not just relying on very thin and fragile supply systems, and the point about planning ahead for creating the right incentives for new technologies, you know, we have to do it in the context of covid vaccines. This time around there is added doing marketentry rewards for antibiotics that can with organisms and others with global support, so i think we can make the most of a Silver Lining here. An incredibly burdensome pandemic, particularly here in the United States, but i do see some good stuff coming out, not the least of which is an effective vaccine. Great. In 30 seconds for everyone, just to close us out, what gives you hope, paul . Paul i mean, scientific advances have allowed us to live did 100 longer than we years ago. I think science has led the way out. I think the dual prong of hygiene and a vaccine, it will lead us out. I think it will be slower than some would like. I dont think vaccines will be a magic bullet. But i think along with hygienic measures, we will be able to climb out of this. Mike . Mike the vaccine is the tool we need. Ofs brings me back to polio the 1950s that was the scourge, and the National Foundation for infantile paralysis, where people, as a kid, would go around with a thing to collect money. People paid for a vaccine that massive the famous Tommy Francis field trial and showing efficacy. , it was everybodys vaccine. Time, ans back to a different era, when everybody pulled together, and it was everybodys vaccine. We are going to have vaccines, and it will work, and we will stop this covid. Ruth . Ruth yes. So i would say the willingness of everyone to roll up their sleeves. I mean that figuratively with respect to vaccine developers, the government, clinical investigators to get trials up and going, and, of course participants that are willing to , come and do this and really everybody committed to the greater good. I also have to say as a pediatrician in the school of Public Health, the new respect for Public Health that people appreciate the importance and i hope that will continue Going Forward. Absolutely. Will and gary, you get the last word. Will . Will this is echoing what everybody else said. The ability in the private sector to respect the Public Interest and collaborate and coordinate in ways we had not seen before. The collaborations, and the letter that was written by pfizer and j j. These are in the name of Public Health, and i think that is a positive outcome to what we have been seeing the last six months or so. Gary . Gary well i will put it simply. ,i think for me, the hope is there is an end in sight. I think the end is months away. Not decades away. Months and possibly a year or so. It will be longer before we get back to normal. But there is an end. And the way we are going to get there is through science. I think that we are going to see the contribution from diagnostics, from therapies, and vaccines, and we will get there. I think we all have to pull together. We all have to support one another, and the final thing i would say is we should be very appreciative of our doctors on the front lines and our health professionals. They have been through an amazing experience. We only hear a fraction of the stories. But to the people on the ground, when it is all over, we owe them a lot. And i think part of what we owe them is to build systems in the future that prevent this from ever happening again. What a fantastic group. Thank you. This is a tremendous conversation. Incredibly thoughtful. Very needed to provide clarity to all of us watching this very closely, and to families who are looking for a ray of hope. You for your efforts and expertise. I give it back to donna. Donna thank you, and let me add my things for what an amazing discussion. It truly was outstanding, so thank you very much. [captions Copyright National cable satellite corp. 2020] [captioning performed by the national captioning institute, which is responsible for its caption content and accuracy. Visit ncicap. Org] atouncer here is a look wednesday. The Surgeon General dr. Jerome adams for a Senate Health Committee Hearing on the development of a Coronavirus Vaccine. Then, at three 00 p. M. , the Senate Intelligence Committee Reviews the policy for declassified government documents and possible changes to the process with a representative from the office of the director of national intelligence. On cspan2, the senate is back at 10 00 a. M. To consider judicial nominations, and on cspan3, a house subcommittee looks at the amtrak response to the coronavirus pandemic with the Company President and ceo. That gets underway at 11 00 a. M. Eastern. Announcer there are several event streaming live wednesday on our website. P. M. Eastern, our camping 2020 coverage continues with joe biden in warren, you are watching cspan, your unfiltered view of government. Created by americas Cable Television company as a Public Service and brought to you today by your television provider