Of the public broadcasting series moderated by journalist, calvin thank you for. Doctor francis collins, director of the National Institute and health. We are pleased to accept questions from our audience, especially journalists tuning in today. To the question, email and letters and the edition of the u. S. Government of health and Human Services is our nations medical Research Agency of the largest Biomedical Research in the 32,000,000. 000000 in hand life and reduce illness and disability. And i present components, each with its own Research Agenda focusing on particular diseases or body systems. About three received funding directly from congress. The office of the director and the policies and financial planning, managing and coordinating the programs and activities of all the nih component. 2009, doctor francis was appointed by president barack obama, serving as the 16th director of nih he was elected by President Trump in that position in the Current Administration will collins is a geneticist, noted for his landmark discoveries of disease, he served as rector of the National HumanGenome Research institute nih 1993 and 2008 when he led the International Genome project. He was awarded the president ial of freedom by president obama in 2005. Doctor collins and this year the coronavirus to develop an effective vaccine, we are honored to welcome you to the National Press club program, the podium is yours. Very much. Your, 2020 word everything is a little different than the home office, in chevy chase, as i looked behind me the and for most of the last eight months is the largest Biomedical Research and support the budget of 42 billion a year, provided to us on behalf of the taxpayers a time for medical research is making remarkable advances across the board in many areas, basic science, Clinical Trials and everything in between whether we are talking about diabetes or Heart Disease or cancer or rare diseases, diseases or infectious diseases, nih is in the middle of all th that. Likely it was founded from nih. Quickly explain how that works. Most of our budget, 82 of it goes out and grants across the country, they send out the best ideas. If they have the resources to support it, we put this in the process, the only still can fund out of five of the applications so that is the cream of the crop with the resources go out and make discoveries that are transforming our understanding of how life works and that is why this is such a remarkable moment, understanding things like how the brain works, what it means about alzheimers disease and figuring out how you can read the instructions and individual cells, gene editing approaches like the one that won the disease like sicklecell, there is a lot going on. Being the worst Global Pandemic more than a century, our focus has turned very intensively to the effort to try to figure out how to get the best science diet stocks is therapeutics from vaccines. Against the virus, coronavirus, this guy, which i show you a model of, circular little double here on the surface, the proteins that enable the virus to get inside herself, it can do so because you inhaled it. Those proteins latch on to the cell in your respiratory system, they find its way in they turn into a factory and make lots of copies of itself. Yes, a virus we didnt know anything about until january and here we are in october a remarkable set of scientific advances that have happened that i want to tell you about briefly and then and looking forward to hearing the questions from the group that has submitted them from the advanced and some of them so many right now. First, we are at a very serious moment in this covid19 pandemic in the United States people may have somehow gotten complacent after we have this terrible experience in march, april and may, particularly in new york, a great deal of people who fell ill and many were in icu and many have died. Efforts remain to do Everything Possible to stamp it down, it looks like things were Getting Better but then we had the outbreak in the southeast, florida and louisiana, alabama, mississippi, georgia and arizona, california. This is a great number of increased cases, hospitalizations and deaths. And it started to get better because people took appropriate measures of Public Health protections for themselves but now we are in the third month, i dont want to call it the third wave, certainly we are still in the first wave because we never really drove the infections down to the base line but now we are in a very serious place. Yesterday, 75000 cases of covid19, that is the second highest recorded in the United States started. Id be willing to bet will sadly have a new record higher than that over the next few days because the curve is going straight up. This time, in the middle of the country. The midwest and stretching over to the rocky mountains, particularly places like montana and iowa and missouri, all those places and its not just in the cities which is what people were kind of getting used to. This is a very infectious virus diabolically infectious in about 40 of the people who get infected with this, they dont have symptoms and dont know they have it and yet, they are spreading it by being in the public areas unless they are doing Something Like wearing a mask havent seen virus quite like this before and thats why this has been so difficult to try to manage all of us, recognizing to take responsibility not to be the super spread of the virus and doesnt know it and viewing it to other vulnerable people. It is a moment for all americans to recognize individually, we want to turn this around. What you talk to you about vaccines but we dont have them yet. Its going to be a tough season people are more indoors with cold weather. The virus is likely to spread this time. Weve got to take action in a very serious way. That means wearing your mask when you said, say 6 feet apart, dont congregate inside you might have the greatest chance of spreading this, please dont do that. By the way, get your flu shot because we dont need a double problem. Now lets talk about the science because where i spend my time. We are working on cytotoxic tests as a whole program. Not when he spent a lot of time on it but weve developed 22 new ways to find out what if somebody is infected with the buyers even if they dont have symptoms. Thats what you call it pointofcare, it can be done in a particular location. For instance, a nursing home when you want the staff to be tested before they start the shift to ensure they do not bring into the place, but there is a lot happening and i for wider and wider asymptomatic care, doing more of that and get people isolated before they infect others. Let me talk about treatment. If no doubt seen cases of the president , the treatments were offered in that case, a drug called remdesivir, they designed and carried out the race in early trial so we knew the drug provide benefits for people who are quite sick with covid19 and just this week, they granted full approval. Its an antiviral, basically gets into the virus and cross up so it cant replicate itself and that is what you want. We know steroids can also be helpful for people with serious lung disease, the president also received that. Theyve shown in several trials it reduces the likelihood of people ending up on a ventilator or dying. Everybody agrees those two are beneficial and there are a lot of things on the way. Once that has gotten a lot of attention antibodies, we know people who have had covid19 and survived, they survived because their immune system made antibodies against the virus could we learn from them turn their antibodies into a product that could cure the people who have not made their own and might be getting sick . That would be a very powerful strategy. There are a couple companies that are far along in developing these antibodies from covid19 survivors turned into products and put into trial. It sounds encouraging but not yet definite fda approved with those kinds of interventions for people who are fairly recently infected will provide some benefits. It may not be so good after a while because wait ten days, you probably started to make your own device so its probably going to turn out that this will be useful early on or maybe even prevention. Thinking about that in a place like a nursing home so thats a coming along. We have 20 pharmaceutical companies, cdc and a bunch of other agencies working about to get in early never happened before, it would normally take about two years to put together. This was put together with that. Talk about vaccines. Thats what Everyone Wants to talk about that and i get that. You have to come up with a way that our population develops immunity, maybe as many as 70 or 80 of us developing unity would be enough for the virus to be able to replicate, it would start to fade away. We are a long ways from that right now, even in places like new york that had a lot of infections, may be 20 have because of recovering from illness, it is not nearly enough. We knew vaccines have been such an incredible to humanity, smallpox was figured out. Weve developed ways to do this over the last few years that are much faster and potentially more safer than previously. January 10 when the chinese released the sequence, the letters of the code of this virus causing covid19, within 48 hours, vaccines being designed at the Vaccine Research center and working with the Company Called maternal within 65 days, that went into phase one trials volunteers were getting injected. Phase one is looking really good. People who got the injection basically had a sore arm but not much else. When you tested them, they developed antibody levels that were very similar to what you see in somebody who has had the real disease and got better. They are scaling that up that trial and another one from pfizer started july 27. Working with other companies, its set up a ways trials can be done in a harmonized protocol so they are all very similar in design, they are very rigorous, very largescale, all involve at least 30,000 participants. There is a standard, about what would be considered safety and what would be considered efficacy. Nobody will get their vaccine approved until that happens. The maternal trials, the one i know most about because they have been a partner in the city, they announced yesterday they have completed their enrollment of 30,000 dissidents. Working with them, weve made sure this is a Diverse Group of participants, 37 are people of color, we want to do that because he hit people of color particularly hard, so we want to know, does it really work . It also has a generous number of individuals who have chronic illnesses, we also need to know that we have people who are over 65. This trial has now reached without will start looking people have been protected by the vaccine how do you know that you have to do this we have learned over the decades, the only way to be sure, if you signed up for the trial and lived through all the process you would get an injection, he would not know whether the act of faxing or a placebo. Theres a 50 50 chance. Then we followed the 30,000 people and looked to see, they are in areas where the buyers is present to see who get sick. The question is, people with the actual vaccine getting a lot less cases of covid19 and also, are they doing okay . Are there any issues . Thats what we are going to be doing, this is one of four vaccines started phase three trial, to have been on a temporary hold because of a concern about patients who had an outcome that was concerning but they have nothing to do with the vaccine. Also present developed a medical problem. Waiting to see whether they get started back up again. The two of them are moving along without that and are in place now where i could get his likely by late november it will be possible to say it looks like one of these is, they had a big meeting about this yesterday to decide whether they met the standard and it should be emergency use alteration. If that happens, it would be safe to administer the vaccine for those who wanted. You dont want to start giving the vaccine to just anybody because there will be a limited number of doses for a while although there will be a lot, operation warp speed that was put in place in may to think about these things, its already paid for the manufacturing of hundreds of millions of doses of these various vaccines in order to have them if the vaccine turns out to be successful. There will probably be 100 million by january or after that, but we dont know if they are going to work. There is a fair chance one or more will fail, we just have to push the doses out but if your trying to end a terrible pandemic, you dont want to say hooray, we have a vaccine that works, oh, it will take another six months before we have doses to get to the people who need it. This is an unprecedented way so that is all happening with nih working with our partners, the industry operation warp speed and i sought the front page of the Washington Post today writing a positive story about what is happening with covid19, see this and its positive because of the signs in the way in which the Vaccine Department has been unprecedented, one of the things you dont expect to see. Somehow the vaccines dont work, at the moment, this is breathtaking in the pace thats been achieved and the promise it carries with it. We are pretty excited about that but weve still got a lot of work to do. That was my opening view of where we are, but now i would like to hear the questions people have. Lets have a. Thank you very much. We do have a number of questions for you. Lets start with, what is currently within the realm of possibility in terms of approving a vaccine . What you think in terms of still before the end of this year . Let me walk you through the steps that happen to get there. I think that is really important, theres been a lot of concern about whether this warp speed means orders are being cut safety is not treated with what it deserves and with politics involved, let me walk you through what has to happen for an approval. Ive already told you about the way in which the trial has to be designed, they have very large, they have to be randomized and controlled so this is the only way you really know it works, that is what we are doing. If one of these vaccines in the next month or so, where it looks as if there is a significant number of people who got the vaccine who are protected, more cases in the Placebo Group in the vaccine group, and if it looks as if over at least half of the people who got the injection at the safety issues are good, want to be sure theres not a slightly delayed piece, if that happens, theres a data safety monitoring board, a group of individuals who dont work for companies, basically scientists and logistical experts, they are the only people who get the unblinded data and they raised their hands and say i think theres something here and they would tell the company okay, we think you want to look at the data and decide if you agree that it is time to go to the fda. The company will look at it and the ceos have all said they wouldnt want to submit something they dont think is really good so they might say lets wait a little longer but well see. If they decide to hit that mark, they go to the fda. The fda looks at it, which will take a couple weeks and decide whether they think they are going into the details, they will hold a Public Meeting of the same group met yesterday, vaccines that have a biologic product, this is a group also of distinguished experts who dont have particular conflict, they just there trying to help decide. Everybody will get to see if the data is compelling or not. Only then the fda consider issuing an emergency use authorization, we are in the middle of the pandemic, the data is convincing, we are going to allow this be distributed but we still want to see more in terms of longterm color. Eventually theres something called bla, and all of those steps have to go where are we now . The first to vaccines that got started and of july, will probably get to where maybe november, will look and say i think theres enough here, the Company Better have a look or they might not because we dont know. Vaccines are not usually one 100 elective, even the very best vaccines like measles, 96 effective, even the flu a lot of times with the flu vaccine is about 50 or even a little less, the fda will not approve a vaccine that has less than 50 effectiveness. So we have no way of knowing until we see the day how theyre going to do. Will they be like the measles or the flu . Until you have the experience, you dont know. Im saying i am cautiously optimistic by the end of 2020, there will be a vaccine thats reached that stage of emergency use authorization but i dont know that for sure. It might not happen, it might take longer. It might be another vaccine in the pipelines that will start next couple months. It is a good thing we have these menus of scientific approaches, which if it was just one vacci vaccine, id be more worried. The Associated Press working with Kaiser Health news has undertaken look at Public Health departments across the country and reports that it currently lacks staff, funding and tools to she would administer and track the doses to some 330 million people. About what kind the logistics that has been mapped out already between the companies and they know that capacity to the distributor and lets be clear this is not the first rodeo the cdc for the influenza vaccine with 80000 doses im sorry 80 million doses in a typical year so the framework for achieving this is something we already had in place i do think they are right to point out it is a stretch and they have been allowed me to Financial Stress because i havent seen like a priority so there needs to be a lot of attention for that backstop for any of those efforts and we are looking at that in