As Delivered
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 developed 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 the 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 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.
So thank you again, Mr. President, for supporting this remarkable progress against COVID-19, and I want to thank Dr. Hahn, Dr. Marks, and the entire team at the FDA for the speed with which they've approached this and the diligence to ensure this meets the standards at FDA.
