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[00:00:00]

This is the Fox News rundown extra. I'm Jessica Rosenthal. This week we spoke with the Health and Human Services Secretary, Alex Azar, about the latest virus treatment to get emergency use authorization from the FDA convalescent plasma. We talk with Azar about the science behind it, how it works and how it might lead to other even more successful treatments. But we also asked him about the president's accusations ahead of the plasma approval that the deep state at the FDA was slow walking treatments until after the election.

[00:00:36]

We often have to cut interviews down for time during the week, but we definitely thought we'd like to hear this full conversation. Thanks for listening. Please subscribe to the weekday rundown podcast if you haven't already. Now here's Secretary Alex Azar on the Fox News rundown extra. Hey, Jessica. Hi, Secretary, thank you so much for your time, appreciate it. Glad to be with you. OK, so let's just dive right in. I know you have limited time to talk to me about your knowledge of convalescent plasma.

[00:01:09]

What do we know about it? Why do we think it might be helpful and effective? So yesterday, the president announced the FDA's emergency authorization for convalescent plasma. This is really a milestone achievement in our efforts to save lives from covid-19. So what is convalescent plasma? When somebody gets covid and then recovers, their body has produced antibodies to the antigens in the virus. Those antibodies are present in your plasma. You can donate plasma in a way similar to donating blood at the American Red Cross or your local blood bank.

[00:01:43]

And that plasma contains your antibodies. And then those antibodies that plasma can be given to somebody who is suffering from covid. And what we have what we have done is made that available under President Trump's right to try initiative to over 70000 patients in the United States. And yesterday, the FDA authorized its emergency use for people who are suffering from covid. So it can it can reduce the severity and reduce the likelihood of mortality for individuals. And we encourage anybody who has had Kobun and recovered to go to coronavirus dot gov to learn more about how they can donate or called the American Red Cross or their local blood bank.

[00:02:31]

Is it kind of like how we give somebody a little bit of the flu to give them a vaccine against the flu?

[00:02:38]

Not quite. So what you're doing with a flu vaccine is you're actually provoking the body to produce the antibodies to the flu because this is more like you're actually giving somebody a head start by literally putting the antibodies in their body right away and and before their body even has to start producing their own antibodies. Now, this is this is a pretty tried and true therapeutic tactic. It's been around for the 1918 flu, was used for SARS, used for murres.

[00:03:15]

And what President Trump has done is actually collected the data and the evidence to support its emergency authorization. So a very important advance. And this makes it available at hospitals throughout the United States. And it's just a it really is part of a continued adding to the to the toolkit that we have to help save lives of people who might suffer from covid.

[00:03:40]

But talk to me about the successes that we've seen so far with those 70000 people, because it's you know, it has been reported, I believe, in The New York Times. They said National Institutes of Health director Dr. Collins and even Dr. Anthony Fauci had tried to intervene in a decision to allow convalescent plasma using the data just wasn't strong enough yet. Obviously, that that's changed because it's now been approved. But talk to me about what we do know about the successes, given the reports that some people like, you know, like Foushee and Collins have said, wait a second, maybe we shouldn't go there just yet.

[00:04:19]

Well, what we did is we had this expanded access program under President Trump's leadership of right to try to make sure that people would have this convalescent plasma available. And we collected data on it. And importantly, what what what having that many people exposed to convalescent plasma did is we had everybody produces different levels of antibodies in their plasma. And so when when they donate, you could have somebody with a very high level of antibodies. We call that a high titer.

[00:04:52]

Or you could have a donation. That was a low titer. And what this enabled us to do was to actually study the impact of higher levels of antibodies in the plasma. And it demonstrated clearly that the higher levels of antibodies administered to people who had not yet been put on any type of mechanical respiration, who were under age 80 and were given this within three days of being admitted to the hospital, also earlier in their disease progression, saw a significant benefit.

[00:05:24]

Now you still are. We're still running the more traditional clinical trials where you test it against a placebo in a randomized controlled clinical trial. And that's the that's the kind of thing that we would do for a normal full on permanent license of the product. But this type of large scale statistical analysis showed that that you have a dose response, we call it the higher titer of antibodies leads to a better response. The earlier someone gets it, the better.

[00:05:58]

We'll want to confirm all of that. As you know, NIH and FDA would like through the the randomized clinical trials, but for an emergency in this unprecedented pandemic, this is a very accepted type of treatment. And now it has. The author is. From the FDA to go forward and all hospitals and doctors who makes more antibodies versus somebody who who doesn't like what's the who's a high titer versus a low titer? Was it somebody who maybe suffered more severely from the disease they produce more antibodies, or is that not how it works?

[00:06:30]

Well, we don't know that yet. That's still those are the those are important scientific questions that I think over the course of this disease. We'll learn more about that. You know, the the interesting thing the important thing that this data shows us is that these antibodies actually can have an effect on disease progression and severity. That's really important as we think about the next generation of therapeutics that we're working on after this, which would be basically the bioengineered version of those antibodies.

[00:07:00]

We call them monoclonal antibodies.

[00:07:02]

Monoclonal antibodies. Yeah, I've heard of those. Yeah.

[00:07:05]

So we have a couple of companies right now that we're working with who are in clinical trials, in patients where you they basically bioengineer those antibodies. And you can that way you can get the same dosage of highly concentrated, purified and you don't need donors and mass production. And those are interesting. The fact that convalescent plasma provokes this kind of response is very positive as we think about monoclonal antibodies. And it's also very positive as we think about our vaccine program, because it says that the antibodies that the body can produce can actually neutralize the virus.

[00:07:45]

So it's also supportive of the underlying scientific hypothesis around up.

[00:07:50]

Interesting Secretary, there have been plenty of headlines about how, you know, the FDA authorized this use of plasma underpressure. You know, the word pressure has been applied. And a lot of these headlines from the Trump administration and the president himself did tweet something about like the deep state at the FDA is making it difficult to get vaccines and therapeutics and that, you know, that the they're hoping to delay everything until after the election, November 3rd. Can you comfortably say there is no pressure to approve plasma as a treatment?

[00:08:26]

So the the we're in an unprecedented pandemic and President Trump is going to ensure that we get rid of any unnecessary bureaucratic red tape that stands in the way of saving lives. This convalescent plasma data came in over the course of the last week, was being analyzed by NIH and FDA and actually, as of Friday, were preparing rollout materials for an authorization on Sunday. So that was already well underway. This was, as we said yesterday, an independent determination by the Center for Biologics at the FDA, the career top official, as well as Commissioner Hahn, the commissioner of food and drugs.

[00:09:11]

And the FDA is not delaying vaccines or therapeutics until after the election, right?

[00:09:17]

No, but what what what the president is insisting on what I insist on is that we move as quickly as we can to meet the FDA's safety, efficacy and regulatory standards, whether it's therapeutics or vaccines. And that's really what's behind operation warp speed is how can we reduce any inefficiency, get rid of any unnecessary bureaucratic red tape to move with speed because people's lives are at risk here.

[00:09:46]

This is a global, unprecedented pandemic and we have got to move as quickly as possible. Our normal timelines just can't hold. We've got to move fast. The president insists on that. But we're also going to insist that products, whether therapeutics or vaccines, meet the FDA standards of data and evidence to meet the regulatory requirements.

[00:10:12]

Can I ask a couple more questions? Sure. OK, I've been fascinated personally by Taiwan, and I was even more fascinated when I heard you were going there, I think it was a few weeks ago now, right after you, I think, came back, I saw someone tweet about how her parents, I believe they were like at a restaurant.

[00:10:33]

And she she was talking about the pictures she saw in Taiwan of people out to dinner having fun. Everyone was touching, kissing. Hello. They hadn't had a death since, I think it was mid-May, she said from from covid. And I'm wondering the stark differences, obviously, in a place like, you know, Taiwan, which was apparently trying to warn everybody that covid was transmissible from human to human before before China admitted it. What did you learn in your trip?

[00:11:00]

What did you take away from from Taiwan, you know, not just as secretary, but, you know, just as a curious person there, seeing how they're all interacting and behaving now?

[00:11:10]

Well, Taiwan has had an exceptional response to covid, and they've really been a model in the world. They've been open, transparent, collaborative, cooperative in the global community, unlike China. And we see the results in terms of what has happened there in Taiwan. Now, it's an it is an island. So there are 23 million people. It's an island. It's easier to to control traffic and movement of peoples. In addition, it's a it is a they were they were burnt quite badly by SARS back in 2003 and by China's concealment and deception during SARS.

[00:11:51]

And so they have been willing to take very aggressive steps. You know, for, for instance, individuals who travel into Taiwan must be tested. They must go into into mandatory legal quarantine for a certain number of days, depending on where they're coming from. That quarantine is enforced by the police. You have information technology apps on your phone that monitor your compliance with that. And if they check in with you and you don't answer your phone right away and the GPS monitoring on that, the police will show up to find out where you are.

[00:12:32]

And they have mandatory contact tracing so that they identify if there's a positive case and there's an individual that was near them, that person will be put under mandatory legal isolation and quarantine with the same types of information technology. Now, these are choices that fit a legal, social, ethical norm in Taiwan that are not necessarily applicable in other societies, for instance. And, you know, in the not in the United States.

[00:13:02]

Secretary, if a new administration takes over in January, what do you imagine the transition process will be like in the midst of this virus in the middle of winter? You know, if Mr. Biden is the incoming president, let's say, and he said things like, you know, let's have a national massed mandate and he'd be willing to shut the country down if it were recommended by scientists, that would be, you know, a market change difference from this administration.

[00:13:27]

It would be an interesting transition. Are you guys talking about that three months ahead of the election?

[00:13:33]

Well, I'm not I'm not going to speculate. It's not appropriate for me to talk about politics. I'm going to I'm just going to focus on what the president's mission is for us, which is to save American lives. We are in such a better place now than we were five, six months ago in terms of personal protective equipment now having authorized therapeutics, having made historic progress on vaccines, having the fact that not a single American has died for lack of a ventilator or an ice or an ICU bed.

[00:14:02]

And we are going to be in the months ahead and even better positions as we bring more therapeutics to the market, as we see these vaccines deliver results we believe is very credible that we will have in the high tens of millions of doses of FDA gold standard vaccine by the end of this year and the many hundreds of millions of doses as we go into the following year, thanks to what the president, what President Trump has done here, which is marshaled, the entire government and the entire American biopharmaceutical enterprise towards the important goals of delivering at warp speed on therapeutics and vaccines.

[00:14:42]

Wow, that's helpful. And we and we can only hope secretary is there. Thank you so much for your time. Thank you. Good to be with you. OK, used to serve you well.

[00:14:55]

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[00:15:29]

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