Highlights from Upcoming Interview With FDA Commissioner

[MUSIC PLAYING] You're watching Coronavirus in Context. I'm Dr. John Whyte, chief medical officer at WebMD. Today, I am joined by Dr. Stephen Hahn. He's the commissioner of the US Food and Drug Administration. Dr. Hahn, thanks for joining me.

John, thank you, really appreciate the opportunity. It's great to be part of this webcast.

Well, Dr. Hahn, let's start with the obvious. How is this process going to be transparent, when there is a large number of the public that are more interested in these particular products than they would be in, you know, perhaps a diabetes medicine, or a medicine, you know, for the heart?

As you know, we have experts at, uh, FDA in our vaccine division in the Center for Biologics and Evaluation and Research who do this for a living. They are great scientists, doctors, nurses, pharmacists, statisticians. And they look at the primary information, the raw data that come from clinical trials on vaccines. And they make a decision about a couple of factors.

One is the safety. The other is the effectiveness. And the third is information about the manufacturing. And there's a-- a number of different acronyms we use for that, but that's not really important. What it is is, are we confident that the manufacturing is of high quality, and that every lot-- every vaccine that comes off the-- the manufacturing plant-- actually has a high level of consistency and quality associated with it?

So those are the data that we would look at, regardless of whether it's an emergency use authorization or a biological license application to us. With a vaccine, it's a little different than a therapy. Because this is going to be given to people who are presumably healthy, who don't actually have COVID-19. So that changes the balance somewhat for us. So we-- we've listed a couple of criteria that recently came out in vaccine guidance.

One is we will need to see effectiveness and safety data from at least one well-designed and performed clinical trial that is robust, and that shows data that are clear and compelling. We've already said that we would look at a floor of 50% efficacy. Now remember, that's a floor, not a ceiling. And of course, we want to see high efficacy, um, if possible. But the floor will be 50%.

Give people a reference for that. Is-- is 50% good? Is it consistent with many other vaccines? Maybe compare it to-- to influenza? We know pneumonia-- Pneumovax can be 90% effective. So explain to us that 50%. Because I think people get confused by that.

We felt for this public health emergency that the most appropriate floor-- our scientists did-- was 50%. So that should give you some perspective on that.

OK.

With respect to safety, what we said was from the last dose-- and in some cases, there are two doses of vaccine, in some cases, they're one-- from the last dose of vaccine, we would need to see follow-up data of a minimum of two months after the last dose of the vaccine in at least 50-- well, in the-- in the median, which is, you know, 50% of the volunteers who are on the trial.

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And 15,000 people, is that right?

Right, so that's exactly right. So it's a trial of 30,000, and then 15,000 receive placebo, 15,000 receive the active vaccine. Now we added something else to just make sure that we can ensure safety. And that is we require a very robust program to look at additional safety after, um-- or if-- a vaccine is approved or authorized. So in this case in the EUA, we want to see this minimum amount of safety data. But then we're going to be very close in terms of our observation of any diff-- a-- additional safety events.

So how does that play in the role of safety? Because I-- I'll tell you, on surveying that we've been doing at WebMD, people are very concerned about, you know, getting it in the first three months. Everyone's saying, I'll let you, Dr. Hahn, get it and see how you do. We all can't be doing that.

So a couple of things-- one, is our safety database isn't just from, uh, the randomized clinical trial. Remember, for some of these vaccines, which started in humans, uh, back in the spring, we have safety data from those individuals as well. So we'll look at those totality of data. The other thing that we're going to do, obviously, is this, um, very active post-marketing assessment program. And we're going to do a very aggressive approach to that.

And-- and also, remember, this won't be given to a 100 or 300 million people in the first three, six months. There will be a rollout plan associated with this as the manufacturing runs up. And so what we'll want to do-- and again, I don't want to prejudge that this is going to happen. It all depends upon the data. And remember, the data are going to be looked at by our scientists, but also a vaccine advisory committee. So I think our scientists feel that, given the fact that we do have a-- a-- a robust safety database up till now, plus the size of these trials-- which are-- are larger than many trials for vaccines in the past-- and the surveillance afterward-- that we can have, uh, confidence around the safety.

Now that being said, we really do have to look at the data, and look at it very closely. But if you look at the current situation, anywhere between 800 and 1,000 people are dying per day in the United States, let alone worldwide, from COVID-19. If there is a highly effective vaccine that appears safe in this data set that we're talking about, we will consider-- I'm not saying, we'll do it-- but we would consider authorization, um, in order-- if the data suggest it-- to prevent additional deaths associated with COVID-19.

Now, I-- I will not prejudge. And this is not my saying that we will do it. I'm just saying that this is what FDA does. If we do not feel that the data are, uh, supportive of-- enough of safety, we won't authorize. That is for sure.

And I think that's an important message, you know? And finally, I want to ask you about morale. Tell us about the morale. And you know, let's be honest, eh, I'm sure it can be challenging if-- if one feels there is an attack on science, if one reads that it's a political hit job, in terms of trying to-- to put out good information. How are people feeling?

STEPHEN HAHN: So, um, throughout this pandemic, um, our folks at FDA-- 17,000-plus-- John, you know them yourself personally-- have been absolutely remarkable. They have stepped up to the plate to serve the American public. John, our workload has doubled during this pandemic. So not only are we working on COVID-19, but all of our regular work, cancer drug approvals, cardiac drugs, our-- all of our user fee deadlines.

We're-- we're meeting those-- those-- those parameters and those deadlines. We're doing our regular work. And at the same time, we're responding to the public health crisis. These are remarkable public servants. They have not looked back. They have stepped up to the plate, and they've done tremendous work.

So of course, one's tired. There's a large workload. We're trying to stay focused on the public health, uh, commitment that we all have. And of course, I think, you know, the external-- externalities that we always hear in the press and elsewhere-- it-- it does take a toll. There's no question about it. One thing I can tell you, though, that I am incredibly proud of is the amazing resiliency of our folks. We spent a lot of time-- the leadership, center directors-- focusing on how we can help build resiliency, but al-- also how we can best support our incredible staff at FDA.

I want to tell your listeners, but the entire American public, America's FDA is there for them. They have been there for them. They do nothing except do-- use science and data to make decisions. They've done that up till now. We will continue to do that. I have absolute confidence and faith in them. And I am incredibly proud of them as a work force.

Well, Dr. Hahn, I want to thank you for taking the time. And, you know, I want to clarify to our audience there were no questions that were off-limits in our discussion today. You've been very gracious with your time. And-- and I want to thank you for clarifying, um, and providing answers for what's on people's mind, as well as the dedicated work that-- that you and, you know, the thousands of people that work at FDA, literally all over the globe. Um, so thank you, Dr. Hahn.

John, thank you, and my-- I-- I really appreciate you and your organization, and asking these questions. You know, we talked a little bit about what increases trust. Transparency. It's being able to answer the questions that need to be answered. And I appreciate you're doing that, thank you.

Thank you.

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