James S. Brady Press Briefing Room Washington D.C. August 23 5:32 P.M. EDT
Thank you very much. And it's good to see you all. Hope you had a great weekend at your convention. And we're going to have a great convention coming up, and I look forward to it.
But before I discuss a very historic breakthrough in our fight against the China virus, I'd 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. We're working very closely with the governor and very closely with a lot of great state representatives and local representatives, and we'll 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 in a very horrific fire — one of the biggest we've 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 one another.
Both storms have the potential of gathering strength before they make landfall and could cause significant damage across the Gulf Coast and 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. We have the Coast Guard ready. The Coast Guard has — has done a fantastic job. They do so many — they do such good work, and we want to thank our great Coast Guard.
I'm asking all Americans in the storm's path to follow the instructions of your state and local governments very closely. And I've approved emergency declarations for Puerto Rico and for Louisiana. FEMA is mobilized on the ground and is ready to help. They will be in there very quickly — very, very quickly.
And I spoke to Governor John Bel Edwards also, of Louisiana, and I've 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 on 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 I've been looking to do for a long time. This is a great thing. Today, I'm 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 that's such a powerful term: emergency use authorization — for a treatment known as convalescent plasma. This is a powerful therapy that transfuses very, very strong antibodies from the blood of recovered patients to help treat patients battling a current infection. It's had an incredible rate of success.
Today's 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 of the people that have been working very hard on this. It showed tremendous potential.
This is the only possible — and it's only made possible because of Operation Warp Speed that has everybody working together. We're years ahead of approvals. We would be — if we went by the speed levels of past administration, we'd be two years, three years behind where we are today, and that includes in vaccines that you'll be hearing about very soon, very shortly.
To deliver treatments and vaccine to save lives, we're removing unnecessary barriers and delays not by cutting corners, but by marshaling the full power of the federal government.
We've provided $48 million to fund the Mayo Clinic study that tested the efficacy of convalescent plasma for patients with the virus. Through this study, over 100,000 Americans have already enrolled to receive this treatment, and it has proven to reduce mortality by 35 percent. It's a tremendous number.
The FDA, MIT, 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 America's 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 that have been incredible, the way they've donated — but these are people recovering from the virus — to donate plasma. Since then, weekly plasma donations have doubled.
And 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. It's been really an incredible — just incredible people. The country has united so strongly behind this.
And I'll go over the numbers, but if you look at what's happened and the success that we've had that people don't talk about — the United States has experienced the lowest case-fatality rate of any major country in the world. You don't hear that.
The European Union's case-fatality rate is estimated to be three times higher than that in the United States. Europe has seen 33 percent more fatalities, compared to a typical non-pandemic year than the United States.
And I just want to ask two of our people that have done such a fantastic job, Alex Azar and Stephen Hahn, to say a few words. And, Stephen, I want to thank you because the FDA really stepped up — and especially over the last few days — in getting this done. The results have been incredible, and I think you'll see the results even go up very substantially. So we appreciate it.
And maybe I'll ask Alex to go first, and then Stephen. Thank you very much, Alex.
Well, thank you very much, Mr. President. Thanks for the bold leadership that allowed us to deliver this very happy news today.
Thanks to your all-of-America approach, America has done more than any other country to expand the arsenal that we have to battle COVID-19. And 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 COVID-19, the FDA, BARDA, the Mayo Clinic, and other partners sprang into action to set up an expanded access protocol for this promising treatment.
President Trump is the Right to Try President, and he's fought hard to ensure that Americans can have access to promising COVID-19 treatments. Convalescent plasma has been a tried-and-true 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 suggests 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 percent better survival in the patients who benefited most from the treatment — which were patients under 80 who were not on artificial respiration.
I just want to emphasize this point because I don't want you to gloss over this — this number. We dream, in drug development, of something like a 35 percent mortality reduction. This is a major advance in the treatment of patients. This is a major advance.
Convalescent plasma is one new tool that we've added to our arsenal against COVID-19, 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 FDA's gold standard for safety and efficacy, they can begin reaching patients without a day wasted.
Americans who have tested positive for and recovered from COVID-19 can go to Coronavirus.gov to find out a quick, convenient way to play a potentially lifesaving role in our fight. Know: If you donate plasma, you could save a life.
We've also provided guidance so healthcare providers can contact patients who have recovered from COVID-19 and give them information on how they can donate.
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