Broadcasting series moderated by marvin kalb. We have dr. Francis collins, director of the National Institute of health. We are pleased to accept questions from our audience, especially our journalists tuning in. I will ask as many as time permits. Headliners p ress. Org. Medicalur Nations Research agency. It is the largest public funder of Biomedical Research in the world, investing more than 32 billion a world to enhance life and reduce illness and disability. Nih comprises different components each with its own Research Agenda often focusing on particular diseases or body systems. Receive their funding directly from congress. The director of the Central Office is responsible for setting policy and planning, managing, and coordinating programs and activities of all the nih components. In 2009, dr. Francis collins was appointed by former president barack obama to serve as the 16th director of nih and he was selected by President Trump to continue in that position in the current administration. Dr. Collins is a physician geneticist known for his landmark discoveries of disease genes. He served as director of the Genome Institute at nih from 1993 through 2008 where he led the International Human genome project. For his efforts, he was awarded the president ial medal of freedom in 2005. Dr. Collins, in this perilous year of pandemic and the historic efforts underway to develop an effective vaccine, we are honored to welcome you to the National Press club and say our virtual podium is yours. Dr. Collins thank you very much. It is a privilege to be able to be your virtual newsmaker today. 2020,a special year, where everything is different than we thought it would be a year ago. I am stationed from my home office. Those are my books behind me and this is where i have been most of the last eight months trying to run the largest supporter of Biomedical Research in the world. We have a budget of 42 billion a year generally provided by congress on behalf of the taxpayers. At a time when medical research is making remarkable advances across the board in many areas, basic science, clinical trials, and everything in between, whether we are talking diabetes or Heart Disease or cancer or Rare Diseases or common diseases or infectious diseases, nih is in the middle. When you hear about a breakthrough in any area it is likely it was nih supported it. To quickly explain how that works most of our budget, 83 of it, goes out in grants that are peerreviewed to those institutions across the country, and some outside the country, who sent their best ideas about what they think they could do. We put them through this very rigorous review process. We are only able to fund one out of five of those applications. That is the cream of the crop, the best there is, we provide them with resources and they make discoveries that are transforming our understanding of how life works and disease happens, and that is why this is such a remarkable moment in history. We are understanding how the brain works and what that means about alzheimers, figuring out how to read the instructions of individual cells, developing themediting and applying to cure diseases like sicklecell. There is a lot going on. This year, being 2020, being the worst Global Pandemic and more than a century, our focus has turned, very intensively, to the effort to try and figure out how we can get the best science to develop diagnostic therapeutic vaccines. Guidy, aoronavirus this circular devil with the spike proteins which enable this virus to get inside your cells because you have inhaled it, and they latch on to a cell in your respiratory system and find their way into that cell, and turn it into a factory to make copies of itself. On the cycle goes. This is a virus we really did not know about until january and here we are in october with a remarkable set of scientific advances that have happened that i want to briefly tell you about. I am looking forward to hearing the questions from the group that submitted them in advance and some that will so that them now. Please do. First let me say we are at a very serious moment in this covid19 pandemic in the United States. People may have somehow gotten complacent after we had this terrible experience in march, april, and may, particularly in new york, of a great deal of people who fell ill and were in icus. Efforts were made to do Everything Possible and it looked like things were Getting Better, but then we had the big outbreak in the southeast, florida, louisiana, alabama, mississippi, georgia, arizona, california and texas. That led to a great number of increased cases, hospitalizations, and deaths. Then that started to get better again because people took appropriate measures of Public Health protection for themselves. But now we are in the third bump. I do not know if i want to call it the third wave. We never really drove the infection down to the baseline. But now we are in a very serious place. 75,064ay, there were new cases. That is the secondhighest recorded in the United States since this started. I would be willing to bet we will have, sadly, a new record in the course of a next few days. This time it is in the middle of the country. The midwest and stretching to the Rocky Mountains and particularly wisconsin and the dakotas and montana, iowa and missouri. It is not just in the cities which is what people were getting used to. It is in little areas. This is a very infectious virus and it is diabolically infectious. In about 40 of the people who get infected, they do not have symptoms and yet, they are spreading it by being in the public area unless they are doing Something Like wearing a mask to prevent that. We have not really seen a virus quite like that before and that is why this has been so difficult to try and manage, and that is why it is critical for all of us recognizing that is how this virus behaves to take responsibility not to be that unwitting super spreader that happens to have the virus, does not know it, and is giving it to vulnerable people. This really does become a moment were all americans have to recognize each of us, individually, has a responsibility if we want to turn this around. Im going to talk about vaccines but we do not have them yet. It is going to be a tough season as people are more indoors. That is the time when virus like this start to spread. All the more reason we have got to take action in a serious way. That means wearing your you go outside, staying six feet apart, that means not congregating inside where you might have the greatest chance of spreading this, especially if you took off the mask. Please do not do that. It also means getting your flu shot. We do not need a double problem this fall of covid and flew at the same time. Now let me talk about the science. That is how i spend my time. We are working on diagnostic tests, i will not spend time on the program, but we have testoped 22 new ways for a to find out if somebody is infected even if they do not have symptoms. Many of those are active care tests where they can be done in a particular location where you want answers right away. For instance, a nursing home where you want the staff to be tested before their shift and they have not brought this into the space. There is a lot happening in the testing arena. More asrt is to have ymptomatic testing. We can get people isolated before they can infect others. Illness, aidents drug called remdesivir, which nih working with gilead designed and carried out a vigorous an early trial so that we knew that drug could provide benefits to people who were quite sick with covid19. Just this week the fda granted full approval of remdesivir. It is an antiviral. Gears so itthe cannot replicate itself and that is what you want. We know that steroids, dexamethasone, can help with those who have serious lung diseases. The president received that. We have shown in several trials that reduces the likelihood of people ending up on a ventilator or dying. Those two are beneficial and then there are other things that are on the way. One that has gotten a lot of attention is this idea of monochrome n antibodies. Immune systems made antibodies against the virus. Could we learn from them and turn their antibodies into a product that could be given to people who have not made their own yet and might be getting sick . That would be very powerful and it has worked for a few other things. It worked for ebola. There are a couple of companies, eli lilly and regeneron, who are developing these antibodies derived from survivors turned into purified pharmaceutical products and put into trial. It does look encouraging, not yet definite and not fda approved. Fore kinds of interventions people who are recently infected will provide benefit. It may not be good after a while. You wait 10 days and you have started to make your own antibodies. Do you need somebody elses at that point . This will be particularly useful early on or for prevention. Give somebody the antibody before they see the virus. We are thinking about that in a nursing home. Therapeutics are coming along. We have this publicprivate cdc,ership with nih, fda, and a bunch of others. We are working in a way that never happened before. A partnership that would normally take two years to put together because i have done some of those. This was put together in two weeks. Vaccines is what everybody wants to talk about and i get that. We want to put covid19 in the rearview mirror. We have to come up with a way our population develops immunity, may be as many as 70 or 80 developing immunity would be enough for this virus to not be able to continue to replicate. It would start to fade away at that point. Even in places like new york that had a lot of infection. Maybe 20 have gotten immunity because of having recovered. That is not nearly enough. If we were going to get to 70 or 80 , it would be a vaccine. We knew that. Vaccines have been such an incredible gift to humanity ever since smallpox was figured out. We have developed ways to do this in the course of the last few years that are much faster than we think, potentially much safer, than previous methods. On january 10 when the chinese released the letters of the code within 48rs virus, hours the vaccine was being designed at the Vaccine Research center at nih. Working with a Company Called moderna within 65 days that went into phase one trials. The first patients volunteered. That was light years ahead of any vaccine effort that has ever been mounted before at that scale. Phase one looked really good. People who got the injection had a sore arm but not much else. When you tested them they developed antibody levels that were very impressive. Very similar to what you would see in somebody who had the real disease and got better. That meant it was time to start upscaling that. The second trial with pfizer started july 22. At nih, working with other companies, set up away these trials can be done and what you call a harmonized master protocol, so that they are all similar in design, very rigorous, they are very largescale, all involve at andt 30,000 participants, they have an agreedupon standard which fda put forward about what would be considered safety and what would be considered efficacy. Nobody is going to get there vaccine approved until that happens. The madrona trial, the one i know most about because they have been a partner from the beginning, announced yesterday they had completed their enrollment of 30,000 patients. Working with them we made sure this was a Diverse Group of participants. 37 are those of color. We want to do that because this disease hit people of color particularly hard. Is the vaccine really going to work in those communities . It also has a generous number of individuals who have chronic illnesses. We have a lot of people who are over 65. We need to know that, too. This trial has reached the point where they will start looking to see, have people actually been protected by the vaccine from getting sick . How do you know that . You have to do this the way we have learned over the decades. This is a randomized controlled trial. That means if you signed up for the trial and went through the process, you would get an injection and you would not know whether it was the active vaccine or a placebo. There was a 5050 chance. Then we follow those 30,000 people, 15,000 got the vaccine and 15,000 did not, and they are in areas with the virus is spreading, particularly southeast, and see who gets sick. The question is are the people who got the actual vaccine getting a whole lot less cases of covid19 . That would tell you it worked. Also, are they doing ok . Are there any issues that pop up . That is what we are going to be doing. Vaccinesne of the four that have started phase three trials. To have them have been on temporary hold because of a single patient that had an outcome that was concerning, but may have nothing to do with the vaccine. With this many people it is not surprising somebody developed a medical problem. It would be surprising if we did not have some of that. We are waiting to see whether they can start that back up again. Two of them are moving along and in a place now where it is reasonably likely by late november it will be possible it looks like one of these is working. Then it will be up to the fda to look at that data. They had a big meeting yesterday to decide whether they have met the standard and should issue emergency use authorization. If that happens, then it would be safe to start administering that vaccine to those who wanted, who are in highrisk. You do not want to start giving the vaccine to just anybody. We will have a limited number for a while. Although there will be a lot. Operation warp speed was generated and put in place in may to try think about these things and has already paid for the manufacturing of hundreds of millions of doses of these various vaccines in order to have them ready if the vaccine turns out to be successful. There will be probably 100 million by january and more after that. We do not know though whether they will work. There is a fair chance one or more of these will fail and we will just have to throw those doses out. But if you are trying to get rid of a pandemic, you do not want to find yourself in december saying, hooray, a vaccine that works. Well, it will take another six months before we have doses. We would not let that happen. His is an unprecedented way nih is working with partners and industry, operation warp speed, and i saw the front page of the Washington Post today writing a very confident story about what is happening. We do not see a lot of those. It was positive because of science and the way in which the Vaccine Development has been unprecedented. One of the commentators said flawless. We are not done yet. Something could still go wrong. We could find these vaccines do not work, but at the moment this is breathtaking and the pace that has been achieved and the promise it carries. We are pretty excited about that. We still have a lot of work to do. That was my opening view of where we are with the disease, therapeutics, vaccines, but now i would like to your questions people have. Michael thank you very much. We have a number of questions for you, dr. Collins. Let us start with, what is currently within the realm of possibility in terms of approving a vaccine . Oft do you think in terms before the end of this year . Dr. Collins let me walk you through the steps that have to be followed. I think that is really important. There has been a lot of concern about whether this warp speed means corners are being cut and safety is being not treated with as much seriousness as it deserves and there is politics involved. Let me walk you through what has to happen for approval to happen. I have already told you about which ways the trials have to be designed. They have to be large and randomized and controlled. This is how you know something works. That is what we are doing. If one of these vaccines comes to the point 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 against the illness, there are more cases than in the placebo group, and it looks like over two months since half of the people got the injection that the safety issues are fine you want to be sure there is not a delay if that happens, there is a data safety monitoring board. A group of individuals who do not work for companies. They are basically scientists and statistical experts. They are the only people who get to see that unblinded data. They would raise their hand and say, i think there is something here. Ok, would tell the company, we think we want to work with this data and decide whether you agree it is time to go to the fda. The company would look at it. All the ceos have said they do not want to submit to the fda something they do not believe is good. They might say, well, wait a little longer, but we will see. If they decide to hit the mark, the go to the fda. The fda looks at it, which is going to take a couple of weeks, and decide if the data is compelling. They will hold a Public Meeting with the same group that met yesterday. This is a group of distinguished experts who do not have any particular conflict. They are trying to decide what to do. Everybody will get to see if the data compelling or not . Only then will the fda consider issuing an emergency use authorization which says that we are in the middle of a pandemic, the data looks convincing, we are going to allow this to start to be distributed. But we still want to see more in terms of longterm followup to be sure there is no other consequence downstream. Bla is what the Companies Get which is full approval. You are asking where are we now . Again, the first two vaccines at the end of july will probably get to the point where they are dsmbs in november. Or they might not because we do not know. Remember, vaccines are not usually 100 effective. Even the very best vaccines like measles is 96 effective. You look at the flu and it varies from year to year. There are some years where it is 50 or less. The fda is not going to approve a vaccine with less than 50 effectiveness. We have no way of knowing until we see the data how these are going to do. Will they be like the measles or like the flu . Until you h