The following is a transcript of an interview with Regeneron CEO Leonard Schleifer that aired Sunday, October 11, 2020, on "Face the Nation."
MARGARET BRENNAN: Soon after the president was diagnosed with COVID-19, he was given Regeneron's antibody cocktail. That's an experimental treatment that has been received by only 10 other people outside of ongoing clinical trials. We want to go now to the CEO of Regeneron, Dr. Leonard Schleifer, who joins us from Westchester, New York, this morning. Good morning.
REGENERON CEO LEONARD SCHLEIFER: Good morning, MARGARET.
MARGARET BRENNAN: So President Trump was given this cocktail and he has since said that it was both a cure, and that he is now immune. Does your drug cure COVID and does it make you immune?
SCHLEIFER: Right. So the president's case is a case of one, and that's what we call a case report, and it is evidence of what's happening, but it's kind of the weakest evidence that you can get. Although, there are some very interesting aspects of his case, such as he was elderly, he had some risk factors, and that he did not have his own immune system in gear when he was sick and he got treated with our immune system in a vial, if you will. But the real evidence has to come about how good a drug is and what it will do on average has to come from these large clinical trials, these randomized clinical trials, which are the gold standard. And those are ongoing. We've got some preliminary evidence that we've talked with the FDA, and we're going for an emergency use authorization, because we think it's appropriate at this time. But yes, the president's case is a case report, perhaps the most analyzed case report ever,--
MARGARET BRENNAN: Yeah.
SCHLEIFER: --but it's just low down on the evidence scale that we really need.
MARGARET BRENNAN: But your drug, does it create immunity?
SCHLEIFER: Yes, it does. When the virus comes in your system, your immune system is trying to create immunity. It's trying to create these things called antibodies, which are going to glom onto this virus, and provide you immunity from getting sick with the disease.
MARGARET BRENNAN: For how long?
SCHLEIFER: A vaccine- well, it depends on how you acquire this immunity. If you get it in the form of a vaccine, it's hoped that it might last for years. In some cases, vaccines can last for decades. If you get it in the form of natural immunity, that isn't known yet.
MARGARET BRENNAN: Right.
SCHLEIFER: Could be months, could be years. If you get it in our vial, if you will, that's probably going to last you for months.
MARGARET BRENNAN: A few months, OK. The president has also said he wants to make your drug free to anyone who needs it. Have you talked to the president about this idea, and how would it work?
SCHLEIFER: Yeah, well, we've talked to the administration a lot about this, and what they decided to do is take some risk. Back in the spring before we actually had any data from randomized trials. They went ahead and said, listen, you start manufacturing the product, we will commit to buy it from you. Stop manufacturing the other products that you're working on or move them elsewhere. And let us make sure that if it does work, it'll be available. And what the government said--
MARGARET BRENNAN: That was a 450 million dollar contract that the US taxpayer paid for. So--
MARGARET BRENNAN: But how much supply--
SCHLEIFER: And they will get the drugs--
MARGARET BRENNAN: How much supply did taxpayers just buy? Because the president says he's making it free to everyone.
SCHLEIFER: Right, well, they bought from us several hundred thousand, maybe around 300,000 doses, which they are going to make it for free. What I think that the administration has been working recently- I saw an announcement with- with AstraZeneca. Look, we need- Regeneron can't do this alone. We need the entire industry. And I'm so proud the industry has risen. We have companies like Lilly, great companies. We're partners with Roche, one of the best companies in this whole field. Amgen is involved. AstraZeneca is involved. Black-Scholes is involved. We all have to step up--
MARGARET BRENNAN: Right.
SCHLEIFER: — if we're going to provide enough of this.
MARGARET BRENNAN: Well, and exactly that point, providing enough is a key question. There were nearly 60,000 people infected in this country on Friday alone, just on Friday. Regeneron in that FDA emergency use authorization application that you said you made this past week, said there are doses ready for 50,000 patients.
MARGARET BRENNAN: That's not even enough.
SCHLEIFER: It's not enough.
MARGARET BRENNAN: It's not even enough for one day of infection. So who decides who's going to get the supply of your drug?
SCHLEIFER: Right. So I think this is going to be worked out by the government, by- in consultation with the FDA, in consultation with ethical experts. Coming up with a distribution system where we take what's limited, and we try and give it to the people who most need it, who would most benefit from it. The vulnerable people, elderly people, people who are at high risk, household contacts perhaps. We have to figure out ways to ration this. And we have to get the entire--
MARGARET BRENNAN: And the government would do that from your understanding, decide who gets the drug and who doesn't?
SCHLEIFER: I think in consultation with local health authorities, that's what they've been doing with remdesivir, Gilead's drug.
MARGARET BRENNAN: Yeah. Right.
SCHLEIFER: It's a complicated problem.
MARGARET BRENNAN: It is. And there were shortages of that, which is why I ask you. I want to ask you something specific to how your drug was developed. According to your company, the antibodies in it were developed using cells that were derived from fetal tissue, a cell line known as 293T. Those were harvested from the kidney tissue of an aborted fetus. There are also vaccine makers using the cell line. But the Trump administration last year has suspended federal funding for research projects that involve fetal tissue from abortions. Should the president and the administration reconsider it, given that this breakthrough was possible using those kind of cells?
SCHLEIFER: Yeah, well let me be very clear, our drug is not manufactured using fetal cells. That's not in the way you make the product, but--
MARGARET BRENNAN: I understand that, developed, but not--
SCHLEIFER: It's just- so let's not- we shouldn't exaggerate the situation.
MARGARET BRENNAN: I'm not. I'm reading what your company said, which was it was developed using it.
SCHLEIFER: Yeah. I wasn't suggesting you are. I'm just saying we as- as a society. And it's not used to manufacture the product. It was- it's a standard cell line that was derived over 50 years ago. And so it's used as a research tool. Where that research should be done, that's a good debate to have. But it's probably the debate we need to have right now.
MARGARET BRENNAN: OK, who should be getting this drug in terms of how you think it should be used? Is it a prophylactic? Should it be given to diabetics, asthmatics, pregnant people?
SCHLEIFER: Right. Those are great questions, MARGARET. It can be used we think, as a prophylactic. We're doing a trial to see whether or not if you live in the household of somebody who's got it, whether it would stop you from getting it. And that would be very important evidence that we hope to get the not too distant future. Then we might think about if somebody in the nursing home gets it. We- maybe we can treat the other people in the nursing home. If people who are very sick are exposed to people, people who don't have good immune systems.
MARGARET BRENNAN: Yeah
SCHLEIFER: These are all really important questions, which we're trying to- our best--
MARGARET BRENNAN: OK
SCHLEIFER:-- while we're building this plane and flying it at the same time to be ready to answer some of those questions as well.
MARGARET BRENNAN: Understood. Thank you, Doctor, for your time. And we will be back with Dr. Scott Gottlieb. So stay with us.
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