Here now, the president of the United States. Pres. Trump thank you very much. It is good to see you all. Hope you had a great weekend at your convention. And we are going to have a Great Convention coming up, and i look forward to it. But before i discuss a historic breakthrough in our fight against the china virus, i would like to provide an update on the recent wildfires in california, and the storms in the gulf of mexico. Yesterday, i approved a major disaster declaration for california. I spoke to governor newsom. As they battle two of the worst wildfires in the history of their state. That continues. The federal government has already deployed over 26,000 First Responders, and personnel to battle the wildfires. Were working very closely with the governor and very closely with a lot of great state representatives and local representatives. And well take care of the situation. But we have 26,000 First Responders already. Our hearts go out to the thousands of families who have lost their homes. As we grieve for the families of two First Responders, and five residents who have tragically lost their lives. Been a very horrific fire. One of the biggest we have ever seen. My administration is also closely monitoring hurricane marco and Tropical Storm laura, which are coming in rapidly. Hurricane marco is expected to make landfall in louisiana tomorrow, and Tropical Storm laura is expected to hit louisiana two days later. This is somewhat unprecedented. The scope of the storms, and also the fact that they come so quickly after another. All storms have the potential of gathering strength before the make landfall and could cause significant damage across the gulf also in puerto rico. We have everybody stationed and ready to go in puerto rico and the gulf coast. And we have tremendous, tremendous people. We have fema is lined up, and we have the coast guard ready. The coast guard has done a fantastic job. They do so many they do such good work. We want to thank our great coast guard. I am asking all americans in the storms path to follow the instructions of your state and local governments very closely. I have approved emergency declarations for puerto rico as well as louisiana. Fema is mobilized on the ground and is ready to help. They will be in there very quickly. I spoke to Governor John Bel Edwards also of louisiana. And ive informed him, and at his request also, a major disaster declaration is signed and ready to go. We have everybody ready in puerto rico, the gulf coast, louisiana, and also in the forest fires in california. So we have a great team. Unfortunately we have some very, very powerful natural disasters. On the therapeutics front, this is what ive been looking to do for a long time, this is a great thing. Today, i am pleased to make a truly historic announcement in our battle against the china virus that will save countless lives. The fda has issued an emergency use authorization, and thats such a powerful term, emergency use authorization, for a treatment known as convalescent plasma. This is a powerful therapy that transfuse is very, very strong antibodies from the blood of recovered patients to help treat patients battling a current infection. Its had an incredible rate of success. Todays action will dramatically expand access to this treatment. And i want to thank dr. Hahn, and secretary azar. I want to thank the fda, all the people that have been working hard on this. It showed tremendous potential. This is the only possible, and it is only made possible because of operation warp speed. That is, everybody working together. We are years ahead of approvals, we would be, if we went by the speed levels of past administrations. We would be two, three years behind where we are today, and that includes with vaccines that you are going to be hearing about very soon, very shortly. We are removing unnecessary barriers and delays, not by cutting corners, but my marshaling the full power of the federal government. We provided 48 million to fund the mayo clinic study that tested the efficacy of convalescent plasma to patients with the virus. Through this study, over 100,000 americans have already enrolled to receive this treatment, and it is proven to reduce mortality by 35 . Its a tremendous number. The fda, m. I. T. , harvard, and mount sinai hospital have also found convalescent plasma to be a very effective method of fighting this horrible disease. Based on the science and the data, the fda has made the independent determination that the treatment is safe and very effective. Recently, we provided up to 270 million to the American Red Cross and Americas Blood Centers to support the collection of up to 360,000 units of plasma. In late july, we launched a nationwide campaign to ask patients to have who have recovered, and these are patients who have been incredible the way they have donated but these are people recovered from the virus to donate plaza. To donate plasma. Since then, weekly plasma donations have doubled. Today i once again urge all americans who have recovered from the virus to go to coronavirus. Gov, and sign up and donate plasma today, please. Its been really an incredible just incredible people. The country has united so strongly behind us. I will go over the numbers but if you look at what has happened and the success that we have had the people do not talk about, the United States has experienced the lowest case fatality rate of any Major Company in the world. You dont hear that. The European Unions case fatality rate is estimated to be three times higher than that in the United States. Europe has seen 33 more fatalities compared to a typical nonpandemic year than the United States. I just want to ask two of our people who have done such a fantastic job, alex azar and stephen hahn, to say a few words. The fda really stepped up, especially over the last few days in getting these done. The results have been incredible. And i think you will see the results go up substantially. We appreciate it and maybe i will ask alex to go first and then stephen. Sec. Azar thank you very much for the bold leadership that allowed us to deliver this very happy news today. Thanks to your allamerica approach, america has done more than any other country to expand the art of arsenal we have to battle covid19. Thanks to early efforts by your administration, americans have broader access to these treatments, including convalescent plasma, than patients anywhere else in the world. In early april, early in our fight against covid19, the fda barred us, the mayo clinic, and others sprang into action to to set up an expanded access protocol for this Promising Program promising treatment. President trump is the right to try president , and he fought hard to ensure americans can have access to promising covid19 treatments. Convalescent plasma has been a triedandtrue therapeutic method in prior outbreaks. But the president wanted to ensure that we develop the data to support its use, and this fda authorization is one result of that effort. The data we gathered suggested that patients who were treated early in their disease course, within three days of being diagnosed, with plasma containing high levels of antibodies, benefited the most from treatment. We saw about a 35 under survival in the patients who benefited most from the treatment, who were patients under 80 and not on artificial respiration. I just want to emphasize this point, because i do not want you to gloss over this number. We dream in Drug Development of Something Like a 35 mortality reduction. This is a major advance in the treatment of patients. A major advance. Convalescent plasma is one new tool weve added to our arsenal against covid19 alongside remdesivir, steroids, and a number of other promising options currently being studied. Because of the president s operation warp speed, we expect to have other new results and new options reaching patients as soon as this fall. Operation warp speed is supporting experimental therapeutics all the way through to manufacturing so that if they meet fdas Gold Standard for safety and efficacy, they can begin reaching patients without a day wasted. Americans who have tested positive for and recovered from covid19 can go to coronavirus. Gov to find out a quick and convenient way to play a potentially lifesaving role in our fight. Know if you donate plasma, you could save a life. We have also provided guidance, so Healthcare Providers can contact patients who have recovered from covid19 and give them information on how they can donate. So thank you again, mr. President , for supporting this remarkable progress against covid19, and i want to thank dr. Hahn, dr. Marks, and the entire team at the fda for the speed in which they have approached this, the diligence to ensure this meets the standards at fda, and i will turn it over dr. Hahn thank you for your leadership. It is good to be here today to announce the fdas recent decision. From the beginning of this pandemic, the president has asked fda to cutback redtape, to speed products into the hands of patients and american consumers. I want to echo the president s thanks to the more than 17,000 men and women who work at the fda. They work day and night to do that. So, plasma is the liquid portion of the blood. That liquid portion contains the Natural Immunity that someone develops in response to an infection. In this case, covid19. That liquid portion can be extracted. And for many years, its been given to patients with Infectious Diseases for more than 100 years. So there was a really good rationale for why this might work. And as was mentioned, in early april, an expanded Access Program was started at the mayo clinic with the support of the federal government under President Trumps leadership. And that has gone on for the last four months. More than 90,000, close to 100,000 americans have enrolled in this program, and over 70,000 have received treatment. This is one of the largest expanded Access Programs in the history of fda. So, very successful approach to evaluating how convalescent plasma would work. So, in the independent judgment of experts and expert scientists at fda who have reviewed the totality of data, not just the data from this expanded Access Program, but more than a dozen published studies, as well as the historical experience associated with this, those scientists have concluded that covid19 convalescent plasma is safe, ensures promising efficacy, thereby meeting the criteria for an emergency use authorization. In the optimal treatment of the optimal patient as described by secretary azar, treated with there was a 35 improvement in survival, which is a significant clinical benefit. We are waiting for more data. We are going to continue to gather data. But this clearly meets the criteria we have established for emergency use authorization, and we are very pleased with this result. So let me put this in perspective. Many of you know i was a cancer doctor before i became fda commissioner. A 35 improvement in survival is a substantial clinical benefit. What that means is, and if the data continues to pan out, 100 people are cyclical by 19, 35 would have been saved because of the administration of plasma. We have seen a great deal demand for this from doctors around the country. What the emergency use authorization today does is it allows us to continue that and meet the demand. And i want to echo the president s and secretarys ask of the American People if you have recovered from covid19. Please donate. It could save a life. Mr. President , thank you again. Pres. Trump ok. Any questions . I want to ask you about the covid19 drugs that are in phase three. Are they going to be available to the American Population . You and i talked previously about the right to try. Can we assure the American People that if it is in phase three, you have that right . Pres. Trump it is a good question. I am not sure a lot of people have been thinking about right to try. We are all finding waiting for the final answer. Maybe i could ask stephen, but i would say right to try is if someone is virtually terminal, in other words they are not going to make it, and if we have these incredible therapies and drugs that are happening, i think it is a very interesting question. I congratulate you for that question, because i think we are all waiting for that exact final input. What about that . We have all of these seemingly great answers that are ready to come out, but because of the process can we use some of this under right to try . Sec. Azar that is a great question and it all depends on the clinical circumstances and what a doctor and a patient together decide. But if you think about what happened with convalescent plasma and the expanded Access Program, this is exactly what happened. So, we have ongoing Clinical Trials randomized between placebo and the convalescent plasma. While that was going on, we knew there was great demand from patients and doctors. The expanded Access Program is a way of doing that, and it fits perfectly with what the president just said about allowing people to be able to use something we have now determined to be very safe. Pres. Trump it is something we have to consider. I think it is fantastic. You should get credit for that. Thank you. That is very good. Convalescent plasma as a treatment has been around for 100 years. You mentioned operation warp speed, which enables this process to move along a lot faster. What went into the effort to get this approved for covid19, and was that hold up political in nature . Pres. Trump i think there might have been a holdup, but we broke the logjam over the last week, to be honest. I think there are people in the fda, and actually in your Larger Department that can see things being held up, and would not so mind it is my strong opinion. That is for political reasons. This has nothing to do with politics. This has to do with life and death. So we are being very strong and we are being very forthright, and we have got some incredible answers. We are not going to let them be held up, because every day is lives and we are not going to let that happen. Ok . Very good. Thank you. In announcing this today, he said the fda has made the independent termination that the treatment is safe and very effective. Yet dr. Hahn just said it was showing promising efficacy. The two is correct . Pres. Trump i think i will let him answer that question. Dr. Hahn under our Legal Authority for emergency use authorization, this is not the same as an approval, but an authorization that allows us to expand the access to this. Our data, we know we are going to continue to collect data. We know that for all of our emergency use authorizations. So remdesivir, which was authorized on may 1, we are still collecting data and we will continue to do that with plasma as well. It is the nuances of the language around the authorization use. It a promising treatment. You couldnt say its very effective just yet. Dr. Hahn i would say if you are one of those 35 out of 100 people who this data suggests survives because a bit, this is significant for that person and their family. Pres. Trump this is a big day. A day we have been looking forward to. Was there pressure on you to authorize this . You did not answer the question. Monday, Republican Convention delegates meet in North Carolina to nominate President Trump and Vice President prince for a second term in office. Live coverage begins at 9 00 a. M. Eastern on cspan. The president s come available in paperback, hardcover, and ebooks, from public affairs. Ispired by conversations noted historians about the leadership skills that make for successful presidency. In this president ial election year, as americans decide who should lead our country, this collection offers perspectives into the lives and events at forged each president s leadership style. To learn more about all our president s and the books feature thetorians, visit cspan. Org president s come available in paperback, hardcover, and ebook , wherever books are sold. Why have white house chief of staff mark meadows appeared to talk about the federal coronavirus response. Heres a look. The deep state or whoever at the fda is making it difficult for Drug Companies to get people to test the vaccines. Obviously they are hoping to delay the answer until after november. Lets focus on speed and saving lives. What evidence does the president half that the fda is manipulating this process for