The following is a transcript of an interview with former FDA Commissioner Scott Gottlieb that aired Sunday, September 13, 2020, on "Face the Nation."
MARGARET BRENNAN: We're back with former FDA commissioner Dr. Scott Gottlieb, who is in Washington this week. He's a fellow at AEI and he also sits on the board of Pfizer. Good morning to you.
DOCTOR SCOTT GOTTLIEB: Good morning.
MARGARET BRENNAN: You have consistently said on this program that American people shouldn't expect to get that shot in the arm until 2021. Doctor Bourla just seemed pretty optimistic, and he said it's not impossible to get it before that time. What is a realistic timeline?
DR. GOTTLIEB: Well, he was speaking to when Pfizer's likely to have data, and they've done internal modeling about when they could have a result from the clinical trial. And this- this clinical trial is an event-based trial, meaning that they have to wait until enough people in the clinical trial actually develop COVID disease to get a readout from the trial and whether or not the vaccine is actually preventing people from getting signs and symptoms of COVID. The initial market entry of this vaccine, if you will, is not going to be like a traditional approval of a vaccine where it's sort of a binary event and a vaccine gets licensed for a broad community. What it's likely to be is offered under an emergency use authorization to a very narrow population, initially, perhaps front line health care workers and first responders, maybe people above a certain age who were- who are more likely to have a bad outcome from COVID. And then after the FDA gets more experience with the vaccine and after the original data set from these clinical trials continues to mature, then the FDA is going to slowly walk down that approval, meaning let it be available to successively larger groups of people while they collect very rigorous evidence in the post-market. So this is likely to be a very staged market entry. I think that's what people should expect. But for most people, they will not have access to a vaccine until 2021. I think maybe the first quarter of 2021, probably the first half of 2021. And that's assuming that these vaccines are demonstrated to be safe and effective in these large trials. I think the people who will get it this year are going to be people, select populations, who are either at high risk of contracting the virus and perhaps spreading it or at high risk of having a bad outcome to it.
MARGARET BRENNAN: So when the president said last week that we remain on track to deliver a vaccine before the end of the year, maybe even before November 1st, you think he's only referring to that emergency use scenario and a very small part of the population, is that right?
DR. GOTTLIEB: I think that that's right. I think we're going to be using this vaccine, at least initially, almost in a therapeutic sense. We're not going to use it like we use a traditional vaccine where you broadly vaccinate a population to try to prevent the virus from spreading across the population. What we're going to be doing is targeting the vaccine to select- select groups of people who are at very high risk of a bad outcome from COVID to try to reduce their risk. But it's not going to be used to achieve broad-based immunity, at least in 2020, perhaps in 2021. And I think it's likely that if the FDA is able to get topline data from- from the trial that Dr. Bourla is talking about at the end of October, it's going to take them a number of weeks to even turn around an initial authorization. They're going to want to bring that before an advisory committee. They're going to want to scrub that data set very hard. So this isn't something you can just turn around in a couple of days. So, you know, I think hopefully we'll see some availability in 2020. I'm optimistic that we will if these trials are successful, but it'll be very limited availability.
MARGARET BRENNAN: Well, and you need people willing to take it. Kaiser had a study out saying 62% of Americans polled worry political pressure from the administration will cause the government to rush approval before it is actually safe. Why do you think the public is losing faith in these institutions? And does the problem go away after Election Day?
DR. GOTTLIEB: I think perhaps some of it goes away after Election Day. There's a lot of anticipation around the election as an artificial deadline for vaccine news, and I think that that deadline is going to come and go. I don't think we're going to see an authorization before- before the election. So hopefully everyone just takes a deep breath after the election. You know, look, I think that these things have been talked about in a political context, and that's atypical for the approval process for any product. It's not- it's not extraordinary. We've seen it before, but it's atypical and especially with a vaccine--
MARGARET BRENNAN: Yeah.
DR. GOTTLIEB: --that people want to be confident in, you want to try to keep the politics and the science separate.
MARGARET BRENNAN: OK, we're going to take a quick break and come back with more from Dr. Scott Gottlieb in our next half hour. So please stay with us.
MARGARET BRENNAN: Welcome back to FACE THE NATION. We are continuing our conversation now with Dr. Scott Gottlieb. You just heard that sound bite from Bob Woodward. There has been a lot of scrutiny this week of the president's response to COVID-19 given the revelations in Bob Woodward's book. For any president, their very first responsibility is to protect the American public. From your point of view, do you think the critical failing here was one of public messaging or was it operational?
DR. GOTTLIEB: Well, look, the public messaging wasn't clear and consistent in the outset and could have been better at all levels of government. I think if you look back in February, and I think when history looks back, the biggest failing over that month was that we were- we were situationally blind. We had no idea where this virus was and wasn't spreading. And so when it came time to have to shut down cities, rather than focus on the cities that were truly epidemic, like New York City, we went for a simultaneous shutdown order across the whole country when that was unnecessary now, in retrospect, because there were a lot of cities where the virus wasn't spreading at that time and we could have focused on mitigation. But we had no diagnostic test in the field to screen people. And what CDC officials were relying on and telling the coronavirus task force was that there was no spread of coronavirus in the United States in February, they were telling them that because they were looking at what we call the influenza-like illness surveillance network, basically a surveillance network of who's presenting to hospitals with flu-like symptoms. And they said that they're seeing no spike in people presenting with respiratory symptoms, therefore, coronavirus must not be spreading. And they were adamant about that. I was talking to White House officials over this time period. They were adamant about that. And I suspect the president was being told as well that this virus wasn't spreading in the United States. And that may have impacted what he did and didn't say and his willingness to, you know, as he said, talk it down a little bit because he was of the perception that this was not spreading here in the United States. That really was the tragic mistake, not just that we didn't have the information, but we were so confident in drawing conclusions off of what proved to be faulty information and incomplete information.
MARGARET BRENNAN: Are you saying he was failed by health officials? Are you letting him off the hook?
DR. GOTTLIEB: Look, I think in this respect, the White House leadership was failed by health officials. We did not have a diagnostic in the field, so we couldn't screen for it. We should have. We should have started working on that in January. And we over-relied on a surveillance system that was built for flu and not for coronavirus without recognizing that it wasn't going to be as sensitive at detecting coronavirus spread as it was for flu because the two viruses spread very differently. Those were two critical failings. Now, you could say, well, the president put those people in place, he's responsible. You know, you can make second-order arguments around that. But I think ultimately the White House did not have the information they need to make decisions. The key function of agencies and the government is to provide policymakers with accurate, actionable information. The White House didn't have it. And I had a lot of conversations with the White House over this time period because I was concerned it was spreading here, and I was pushing them on that. And they were- they were telling me over and over that they were hearing from top officials from the agencies that they were pretty confident that it wasn't spreading here. I think when history looks back, that's going to be a key moment. That's what was going on over February.
MARGARET BRENNAN: All right, Dr. Gottlieb, always good to have your analysis. Thank you for joining us.
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