Transcript: Testimony of NIH official Dr. Anthony Fauci on the U.S. Ebola response in West Africa – Sept. 16, 2014

Partial transcript of testimony of Dr. Anthony Fauci, Director of National Institute of Allergy and Infectious Diseases at NIH, on the U.S. response to the Ebola outbreak in West Africa. The joint hearing before the Senate Committee on Health, Education, Labor and Pensions and the Committee on Appropriations was held on Sept. 16, 2014:

…The involvement of the NIH and NIAID in Ebola has really dates back to the tragic events of 9/11/2001 which was followed closely by the anthrax attacks through the mail to letters to United States Senators as well as to members of the press. Because this led to a broad multi-agency endeavor to develop what we call bio-defense against threats not only of deliberate threats but of unexpected naturally emerging and re-emerging threats.

And as you see on the right hand side of this, there was an agenda – a research agenda involving what we called Category A agents. They’re listed there and they’re familiar to you. They’re anthrax, botulism, plague, small pox…and on the bottom bullet you see a category called the viral hemorrhagic fever viruses, which are Ebola, Marburg, Lassa, and others.

And the reason why these viral hemorrhagic fever viruses was so important and so deadly and so in need of counter measures is that as you mentioned in your introductory remarks as have other Senators they have a high degree of lethality and infectivity.

Unfortunately, the therapy is essentially mostly supportive without specific anti-viral drugs directed against the microbes in question.

And as we know a vaccine for any of these is not available at present.

This is an electron micrograph of the Ebola viral, which is a fever virus given the name because of the filament’s appearance that it has when one looks at it.

The NIH’s Counter Measure Research and Development Program is ongoing and has been for several years.

But before I even mention that, I want to underscore something that Dr. [Beth] Bell said is that right now today the best way to contain this epidemic, this outbreak is by intensifying infection control capabilities.

What we’re seeing now evolve and what we’ve seen for some time, the ability to isolate and identify, contact trace, protect our health care workers with personal protective equipment.

But if we want to be prepared in a durable way, we need counter measures…

What we do is basic and clinical research but we also supply the resources for researches in industry and in academia to get to our end game, which is better diagnostics and of course therapeutics and vaccines.

The product development pipeline is not uni-dimensional.

The NIH is fundamentally responsible for developing the early concepts, doing what we call pre-clinical studies and early clinical studies, which I’ll mention in a moment.

We partner with our colleagues from BARDA, which you’ve mentioned, who are involved in the advanced development to hand the baton over to industry for commercial manufacturing with ultimate regulation and approval by the US FDA among other regulatory agencies…

Let me just spend a moment outlining some of the promising therapeutics.

You mentioned and you’ve heard of ZMapp from Mapp Biopharmaceuticals. This is a combination of three artificially produced antibodies directed against the Ebola virus. It has been shown to be very promising in an animal model.

And as you will hear from the next witnesses…that this was given for the first time in humans.

It is very, very important that we understand whether it truly works, how well it works, what’s the proper dose, and is it safe.

Anecdotal, we have determined that it looks like under circumstances, it could be beneficial but we don’t know that, and it’s our job to prove it so that we could have it readily available for larger numbers of people.

On the slide, there’s another couple among several interventions.

One by the company BioCryst with which we’re collaborating with, which is one of several novel drugs that interfere with the reproductive process of the virus.

And then our Department of Defense is in collaboration with a company called Tekmira to get a drug which is actually a small inhibitory molecule, again, interfering with the replication of the virus.

As I mentioned, ZMapp has been administered to seven individuals.

This is probably when you look at the animal model a very encouraging result that we’ve seen in the animals. And as we know, this has the potential because it can block the virus to do something that we hope we’ll be able to capitalize on again with research ahead.

And then finally, there’s the issue of vaccines. This is something that traditionally an infectious disease has been the stalwart of preventing and protecting people.

We have been working on an Ebola vaccine for several years in an iterative process that we’ve improved upon. We have favorable results in an animal model using one of a few candidates.

And the one I will mention in closing is the NIAID GlaxoSmithKline candidate which was developed at the NIH in collaboration with GlaxoSmithKline and looked very good in an animal study.

But as I have told you, Mr. Chairman and others on the committee many times, the proof is in the pudding to show scientifically that it works. And we have actually started that process.

On Sept. 2 at the NIH Clinical Center in Bethesda, we started the first phase I study of this vaccine aimed at vaccinating 20 normal volunteers.

So far 10 of the 20 volunteers have been vaccinated, and thus far there have been no red flags.

Following this, which will likely end at the end of November, the beginning of December, we will expand these studies to try to prove in fact that we have a safe and effective vaccine.

And so in closing, I’d like to reiterate what I’ve referred to as the dual mandate of NIH and NIAID research when it comes to infectious diseases. It’s our responsibility to maintain a robust basic and applied research portfolio in microbiology and infectious diseases. But also we have the other mandate to have to respond rapidly and efficiently to emerging and re-emerging infectious diseases with the kinds of counter measures that would prevent morbidity and mortality and would have our citizens feel safe both home and abroad.

And clearly Ebola is one of the most daunting of those re-emerging infectious diseases and it’s our aim over the next months to years to make sure that we do have the counter measures to prepare us to address this problem…


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Spotlight: Ebola epidemic


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