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Home Australian News Trump' US FDA announces emergency authorisation for convalescent plasma to treat Covid-19

Trump’ US FDA announces emergency authorisation for convalescent plasma to treat Covid-19

President Trump in press Briefing James S. Brady Press Briefing Room: 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.

SECRETARY AZAR:  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.

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, the diligence to ensure that this meets the standards at FDA.

And I’ll turn it over to Dr. Hahn if that’s okay, Mr.  President.

THE PRESIDENT:  Good.  Thank you very much.

Please, Doctor.

DR. HAHN:  Thank you, Mr. President, for your leadership.  It’s good to be here today to announce FDA’s recent decision.  From the beginning of this pandemic, the President has asked FDA to cut back red tape to try to speed medical products into the hands of providers, patients, and American consumers.  And I just want to echo the President’s thanks to the more than 17,000 men and women who work at FDA.  They have worked day and night to, in fact, 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, COVID-19 — and that liquid portion can be extracted.  And for many years, as the President and Secretary Azar said, it’s 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, in fact, 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 Trump’s 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, a 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 — those scientists have concluded that COVID-19 convalescent plasma is safe and shows promising efficacy, thereby meeting the criteria for an emergency use authorization.

In the optimal treatment — the optimal patients, as described by Secretary Azar, treated with convalescent plasma at the highest titers, there was a 35 percent improvement in survival, which is a significant clinical benefit.

Now, we’re waiting for more data.  We’re going to continue to gather data.  But this clearly meets the criteria that we’ve established for emergency use authorization, and we’re very pleased with these results.

So, let me just put this in perspective.  Many of you know I was a cancer doctor before I became FDA commissioner, and a 35 percent improvement in survival is a pretty substantial clinical benefit.  What that means is — and if the data continue to pan out — 100 people who are sick with COVID-19, 35 would have been saved because of the administration of plasma.

We’ve seen a great deal of demand for this from doctors around the country.  And what this EUA does — EUA — emergency use authorization today does: It allows us to continue that and meet the demand.

And again, I want to echo the President’s and the Secretary’s ask of the American people: If you’ve recovered from COVID-19, please donate.  It could save a life.

And, Mr. President, thank you again.

THE PRESIDENT:  Thank you very much, Stephen.  I appreciate it.

Okay, any questions, please?  Please, go ahead.

Q    Thank you, Mr. President.  I want to first ask you about the COVID-19 drugs that are in phase three.  Are they going to be available to the American population on — you and I talked previously about this idea of Right to Try.

THE PRESIDENT:  Right.

Q    Can we assure the American people that if it’s being studied and it’s in phase three, you have that right?

THE PRESIDENT:  You know, it’s a great question.  And I’m not sure a lot of people have been thinking about Right to Try.  We’re all waiting for the final answer.  And maybe I could ask Stephen, but I would say that Right to Try is exactly — if somebody is virtually terminal — in other words, they’re not going to make it — and if we have these incredible therapies and drugs that are happening, Alex, I think it’s a very interesting question.

I congratulate you for that question because I think —

Q    Thank you, Mr. President.

THE PRESIDENT:  — we’re all waiting for that exact final endpoint.

What about that, Stephen?  We have all of these great — seemingly great answers that are ready to come out, but because of the process, it takes — can we use some of this early, under Right to Try?  Please.

DR. HAHN:  So it’s a really good question.  And, of course, it all depends on the clinical circumstances and what a doctor and a patient together decide, with respect to the administration of any agent.

But if you think about what happened with convalescent plasma and the expanded-access program, this is exactly what happened.  This program — so, we have ongoing clinical trials that are randomized between placebo — or an inactive substance — and the convalescent plasma.  While that was going on, we knew that there was great demand from patients and doctors.  The expanded-access program is a way of actually doing that, and fits perfectly with what the President just said about allowing people to be able to use something that we have now determined to be very safe.

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