Experts talked about the latest research into the development of a Coronavirus Vaccine, as well as safety concerns and the need for global participation. As of this morning, there were over 27 million global confirmed cases of covid19, and 892,000 deaths. Point 3. S. We have six million confirmed cases and we are approaching 190 thousand deaths. We have seen significant economic disruption to businesses and families, and normal daytoday activities have been vastly altered. Leadingexperts experts have said we need a vaccine, which is why the topic is so critical. We will also discuss the lessons that we are learning now in developing a covid19 vaccine, and the implications for if used future Vaccine Development. We have a short amount of time and a number of really terrific speakers, so why do we not get started . Mark, why dont we begin with you. About vaccines under development from pfizer, astrazeneca, in partnership with the university of oxford, all of which are in phase three Clinical Trials. You have been working on many fronts working to establish a viable process to fasttrack safe and effective vaccines. Can you fill us in on what that looks like and where do things stand. Mark thank you. First off, thanks for bringing us together, this is a great group and a timely topic and a reminder why Research Americas mission is important. It is important to see the amount of research and develop and progress happening on covid19 particularly in the area vaccines. We haves mentioned, been working on this for a while. You look for accelerating therapeutics or a topic like that, and a lot of the information that we have 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 faster, and with multiple vaccines at the same time. Seven are backed by the federal government and more are 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. Fromhas changed is moving a long and linear, and uncertain , and questionably funded process to one that is hyper parallel with clarity, and every channel needs to succeed to get 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 on early on with specific guidance on what was expected for a vaccine and preclinical testing. The fda issued a detailed guidance that would recommend people who are interested in this talk it to take a look at the process. Further Clinical Development process, there is clarity on what is needed to be demonstrated in terms of an impact on reducing the severity of infections, and the number. It needs when nickel trials of a certain sample size to have safety effects and in a bigger population. The nih and others have come together to develop a Clinical Trial network that is enrolling large numbers of people in these trials, so the early trials get moderna, and pfizer, and coming soon astrazeneca. I have already started to enroll several more in the next month 30,000 orpecting more. Many of these are already up to that number. Pfizer is always in the set already in the second round for this two dose vaccine. That is the first vaccine they are developing. Clinical trials are happening at an unprecedented pace. At the same time there is a lot of early investment in manufacturing a vaccine at scale before that we know before we know that it works. The Government Agency that oversees these countermeasure and Public Health emergency activities going in jointly with many of the manufacturers to build capacity here and elsewhere and have literally tens of hundreds of millions of doses of each of these promising Vaccines Available by the time the Clinical Trials are completed. And, theres been a lot of discussion recently about whether this means corners are being cut. Based on what i have seen, the answer is no. A very substantial planning process. You get all of these critical steps done at the same time. Looking ahead, there are important decisions coming based on the evidence that is being developed in the Clinical Trial. The fda has made clear that a vaccine is not going to be approved, even for emergency use, and less there is a clear standardat meets that of effectiveness. Also, no clear data and tens of thousands of patients who have been tested of a clear safety problem. Safetyy that, drug collection will continue for a couple of years as the fda often does with vaccines to make sure that there are not any late issues. So, how fast could this be done is in the subject of a of debate s,ong scientists, political and others. It seems unlikely that we will have any trials complete where that level of a of evidence is available before the election. People should have a clear understanding that the people involved in this effort have a transparent process Going Forward. Before the fda approves the vaccine it will clear that it has a meeting of its independent advisory committing. Before that there will be data or ported from the company that they put in their application for emergency use or otherwise. It will be reviewed for the staff and what they think of the data and that will be a public discussion of what it all means for the basis of any further decisions. Emergencyhasized that use for a vaccine is very different for emergency use for a treatment like cosmo convalescent plasma, that is the treatment where we have seen it used in any other conditions and thousands of patients with serious covid infections. It is intended for people who are hospitalized and seriously ill, not a healthy population. Because they are not many safety concerns, it is a different kind of standard than what we are talking about for a vaccine. Very important developments over the coming weeks and we will see how fast the trials can go in terms of not just enrolling patients, but a declining rate of covid in many parts of the country, a good thing for Public Health. It means it might take longer for trials to complete, and we will see how effective the vaccines are in reducing the number and severity of infections. Running people who are the top the trials, they will be looking along the way to see when there is a signal that meets fda standards. As long as we are following verily very clearly laid out approach and a defined that fda experts and the center have laid out to get us to this point and help us move forward, we do have a very promising outlook for vaccines. That said, we are weeks to months away from having the more definitive evidence and even then, as we may talk about during the panel, it will be sometime before the vaccine gets out to everyone. We might be starting with high risk or highpriority groups like military personnel and medical responders. And, we might go out from that as the evidence accumulates and we have more supplies available. I are at a critical time, but think we will begin this phase of uncertainty and continue to learn for a number of weeks to come. Donna that was a terrific overview, and we will pick up on a lot of the things we talked about. Paul, i wanted to get you into this conversation on the topic of the timeline. Since the early part of the year we have heard 12 to 18 months, and we are approaching some part of that and this expectation that we will have some kind of a vaccine or candidates available as early as even november or december. Can you help us understand what this timeline means for Traditional Vaccine Development . What could we expect towards the end of this year, and what could we expect in q1 or middle of next year . And is this realistic . Paul i am happy to make any prediction even though as long as you dont hold me to it. Mark covered a lot of this. The average length of time it takes to make a vaccine is 15 to 20 years. Because we do it so carefully. You go from preClinical Trials and thenredoes trials you get the big definitive placebo and control and 30,000 person trial which is the only way you will determine if it can be done safely. What has happened now is that government has taken the risk out of the pharmaceutical companies. We have been able to coalesce because the government said we will take the risk. We willpay and massproduce this vaccine without knowing whether it is safe or effective. We are willing to throw away doses if it is not effective. No company would ever do that, which is why i think that on the one hand, i am not worried about this timeline initially. We are doing big recalls. If we are doing what we are going to do which is a 30,000 person trial, that is great. Conjugate pneumococcal vaccine was a 35,000 person trial. There are two other thing standing in the way of releasing a vaccine that would be less than safe and effective, which who are charged with looking over the vaccines. That is good. And then if he was treated this true to his word if during that oped, he will speak the advisoryr the fdas committee and that is another group of independent resources researchers not associated with the government or pharmaceutical injury. He will give you their honest opinion. None of that worries me, i think it is good. One however has to be concerned about a few things. One is that this is not a standard licensure procedure. It is likely to go through emergency authorization and that is looser. The languor the language that surrounds emergency authorization includes phase phrases like maybe. The second thing you worry about is if you look at what happened with hydroxychloroquine or convalescent plasma, which were given to those who were already sick, that is different in that they are being given to billions of people who are generally going to be healthy and young people who are not likely to die. You want to hold them to a High Standard of safety, and i worry in those two cases, that you saw to donce on the fda something that should not have been done. I think neither of those should have been approved for use. So people that are worried about whether the vaccine would be approved for use under a luzern ndard, so much so that looser standard. So much so that the pharma coals the pharmaceutical industries wrote a letter saying that they will be held to a High Standard of safety. They should not have to write that letter, that is what the fda does, stands between the American Public and the pharmaceutical injury history to make sure industry to make the mayor can people feel safe. They say with that letter that the fdas unwillingness to stand up against an administration under pressure. The fact that china, russia, and the United Kingdom might come out with vaccines before we do. I think, as it stands between hiscommittees and commitments on paper to make sure that we hold these to a standard, i feel good. But you are a little worried, that is it. Nobody am a worrier, but else is, but it does worry me a little bit. Donna just a followup and i will bring others into the conversation as well. Is it a guarantee that we will have a covid19 vaccine . Many scientists have said that science are hard and you have been involved in science for many decades. Are we guaranteed to have a vaccine based that has high efficacy. Paul no. There is no guarantee. We have this elusive difficult to characterize virus. This coronavirus that made a statement to the human population and done things you have never predicted. That is an envelope virus rages through us and who wouldve produced predict that. They had it has post infectious phenomenon, i know no other virus that does this. Influenza also kills older people, but 10 deaths are in norse Nursing Homes and here it is 40 . It appears that all of the stuff all organs are at risk to a heart attack, stroke, liver disease, kidney degree kidney disease. Weeder meeting that challenge and vaccines with mrna adenoviruses that have never been used as commercial products in the United States before. Is there going to be a learning curve . I cannot imagine that there would not be. Things that we knew now we will learn. Things that we wish we knew now, we will learn. There is no guarantee, which is why we do the trials. Donna we will go back to the discussion that is needed the amount of evidence needed. I wanted to pick up with the point that paul brought up that is there is a lot of different kinds of technology right now that is in developments that has never gone all the way through to commercialization. The first, what has happened in the past has brought us to this point so we can accelerate the covid19 vaccine with these new technologies, and how do you think about that Going Forward. Are we testing things that you anticipate will have treasures for other vaccines . What led us to that point. That is a great question and very broad reaching. Let me first say very clearly that we look upon vaccines somewhat to different baskets. One are the vaccines that would be used routinely, in particular safety is very much our area of concern. Infant vaccines are typical infant vaccines are examples. Is a public vaccine Health Emergency of International Concern vaccine and it is a different ballgame and handbook. We have thought about and worried about a pandemic like we onceeeing now because before, a century ago we saw it with an influenza vaccine. And so we know that it can happen. There have been a few signals that stimulated dress rehearsals. 1976 when i was a young assistant professor and there was a worry about a swine flu virus pandemic. Rehearsals inss my view began seriously with the Ebola Outbreak in west africa, which devastated the health care infrastructure, destroy the economy, and when cases started to appear in europe and north america, it became very clear that all of the consequences and we began to worry more. , 2014 through 2015 epidemic came the birth of the coalition for epidemic. This innovations. And why its moments was kurt it was created, first science to make vaccines rev up. Ly we have seen a number of milestones put to use. And, technology is we call them plant farms, where one can take the sequence of a virus, key, andthe antigen use that sequence to either express in live virus vectors or to make a purified protein, or vaccines,cleic acid all become possibilities. Each one of those is potential each one of those has potential. There has been a lot of background work on these platforms. Part of what we and other groups have been doing is monitoring and looking at what might be the next dangerous organism. In 20022004reak was a harbinger. The mers is the harbinger. Those are both other beta coronavirus is. And hero comes this and here along comes this beast of the virus in east asia. Very quickly the sequence of that virus was made public, very byckly that was utilized various vaccine developers. On the way, one of the things that was done was a modification of the virus. So, this is work done at the surf center, modification so that the prefusion configuration becomes stabilized, which, theoretically enhances the stimulation of neutralizing antibodies. s moment, because they are ways to quickly make vaccines. The mrna has a theoretical advantage. And it has been shown from the sequence to first inoculation and in just about two months, and also, the possibility of a largescale manufacturer. But, these are not from the , superc perspective perfect vaccines, even if they are faced and highly protected. They require two doses, a special cold chain, these are not showstoppers. Aree are solvable, but we so far along where we are very close to having very good vaccines. Last point i would make is that this is truly a global problem. Vaccine not only for the u. S. And europe, but we have to have vaccines for the entire world, because as long as there is a reservoir of continuing transmission, the homeland, the u. S. Homeland, the rest of the industrialized countries are at risk. Donna yes. Ruth, i want to bring you into job, and mike today nice laying out the potential for these different technologies, how quickly you can develop the vaccine. We have the mrna platform as he described. What this means is that we need a robust profit process for ed evidence generation and Clinical Trials where we can determine wicks vaccine is the most which vaccine is the most effective. I know you think a lot about these kinds of issues. When we are looking at enrolling different patients, pregnant elderly,ildren, the 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 the answers that we need . Either for office authorization and insurance . Ruth, and you are on mute before you start to speak. Ruth thank you for the reminder. I think you bring up a really important point, and i think that all of these considerations are not the same, and i think we should start care and say that pregnant women, children, racial and ethnic minorities, and there are overlaps in those categories. Those are not all the same and i do not think we should treat it and lump those together as we think about Clinical Development. In thinking about this panel, i have been thinking a lot about Lessons Learned for the future and how we can think in this time do will inform our future Vaccine Development, and one one of the Critical Issues will be around inclusion, and one of the legacies is going to be around inclusion. Certainly, this is not a new problem. Speakinge problem particularly about racial and ethnic minorities having a disproportionate burden of Infectious Diseases and nonInfectious Diseases is not a new problem. And lack of inclusion is not a new problem. Are our focus on this, and efforts to make this right and our efforts to make this right because this is Critical Data for us to think about how we deploy vaccines, because we do have a number of vaccines. I think i am by nature an optimist, and i ac