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Transcript: Scott Gottlieb on “Face the Nation,” July 11, 2021

Thought Leader: Scott Gottlieb
July 11, 2021
Source: Link

JOHN DICKERSON: And we go now to former FDA commissioner Dr. Scott Gottlieb, who is on the board of Pfizer. He joins us from Bluffton, South Carolina. Good morning, Dr. Gottlieb.

DR. SCOTT GOTTLIEB: Good morning.

JOHN DICKERSON: So let’s start with this booster question. What led Pfizer to request emergency authorization for a boost?

DR. GOTTLIEB: It was data coming out of Israel that suggests that people who were vaccinated a while ago, particularly older individuals, might be more vulnerable to the infection. So we see declining efficacy of the vaccine in Israel against the Delta variant. But that declining efficacy seems to be clustered among people who are older and who are vaccinated. A while ago and remember the United States, we vaccinated some of our oldest and most vulnerable citizens at the beginning of the campaign. So many nursing home residents, for example, were vaccinated last December. Many physicians were also vaccinated last December. With respect to the boosters, what we’re talking about is a third dose of the existing vaccine. And we also need to remember that anyone who gets vaccinated right now will not need a booster. If you go out and get vaccinated right now, that vaccine is going to carry you through the- through the fall in the winter. What we’re really talking about is people who were vaccinated a while ago where there may be some declining efficacy. And because Delta is such a difficult variant, because you get such high viral titers from the Delta variant, what could be happening is that as people’s antibodies start to decline because they’re further out from their vaccine, the Delta variants able to overwhelm their residual antibodies, the antibodies that they have left, and it takes a little bit of time for their memory B cells, the other components of the immune system to kick in and start producing more antibodies. And that’s why they’re more prone to infection. The vaccines still seem very protective against severe disease. What we’re seeing in Israel is people becoming mildly and asymptomatically infected. But there also are some people who are vaccinated who are getting more serious illness, and that’s what’s causing concern and prompting the hard look at boosters.

JOHN DICKERSON: And does Israel have this data because they just decided to study it or because they started the process of distributing the vaccines earlier? And therefore, they have people in their population who are further along than in the states.

DR. GOTTLIEB: Both I mean, Israel did vaccinate their elderly population early, we did as well, but they do a very good job of tracking people who have been vaccinated. So they’re collecting this data very aggressively. So it’s not a surprise that they might be first to spot these trends. We’re a little bit behind here in the United States. The United Kingdom has already made a decision that they’re going to provide boosters to those above the age of 70 as they get into September and then walk it down the continuum. Israel just announced today they’re going to provide boosters to people who are immunocompromised, who have immune disorders that might leave them more vulnerable to the infection. I think we need to start the process here in the United States. And that’s really what Pfizer, the company I’m on the board of, is trying to do. We’re doing these studies. We’re going to be submitting that information to the Food and Drug Administration, asking for authorization to provide a third booster should it be needed. Ultimately, that decision is going to be up to the FDA and then up to the CDC to make a general recommendation. But that’s a multi month process. So if we don’t get started right now, we’re not going to be in a position to have boosters available should we need it come the fall. I think, quite frankly, we’ve probably missed the window in terms of providing boosters for the Delta variant, the Delta variants likely to play out really over the months of August and September and maybe into October. This wave of infection will have passed us. But you still want to consider boosters for people going forward, particularly vulnerable elderly people in nursing homes, people who we know are more vulnerable to the infection. We want to maintain a sufficiently high level of neutralizing antibodies in their blood so that you protect them from any infection, even a mild infection, because in a vulnerable individual, some people will get in trouble with the virus.

JOHN DICKERSON: Let me ask you on that timing question. Dr. Fauci seemed to suggest that there- there wasn’t a timing issue. Educate me here. If it’s just a third shot of what’s already on the shelf, why does there have to be a lot of time? Why can’t somebody make that decision and then it’s available in the doctor’s office?

DR. GOTTLIEB: Well, so Pfizer’s doing the study right now, looking at a third dose, the data looks very good. They put out some top line information about that. You get 5 to 10 times the number of antibodies that you had from the second dose. And so far, from a safety standpoint, it looks clean. Now, that study isn’t done. It’s got to be submitted to FDA, FDA. It’s got to be independently reviewed. Pfizer is going to publish those results for public scrutiny. That’s probably a month or two process, going through the FDA process, trying to get an emergency use authorization to use the vaccine as a third dose. And then ultimately it needs to go to CDC and their advisory body, which makes a recommendation on who would get boosted. I would suspect that if there is a recommendation on providing boosters, it’s going to be for a select portion of the population, perhaps people who are older, who are more than seven or eight months from completing their original vaccination. It’s not going to be a general recommendation for the entire public, because for most people, most people who are younger, who have intact immune systems, they’re probably going to have sufficient protection from their original vaccination that they’re not going to need a booster. We’re really talking about a more vulnerable population who not only have declining protection from a vaccine over time. We know vaccines don’t work quite as well in older individuals, but they’re also more vulnerable to infection. You want to- want to prevent even mild infection from a vulnerable person because, you know, at least some people are going to get in trouble if they do get infected with the virus. So ACIP ultimately needs the issue. That general recommendation. You’re talking about a process that’s probably at least a couple of months long, could take a little bit more time than that. So I think starting right now, frankly, is prudent and that’s what’s happening.

JOHN DICKERSON: You mentioned that anybody getting a vaccine right now doesn’t have to worry about a booster. You were careful to make that distinction. Do you think that’s a public health challenge for the administration, for public officials, as they’re desperate to try to get people vaccinated in the first place? That discussion of a booster kind of complicates things for them.

DR. GOTTLIEB: They clearly have data that shows that when you start having a discussion about boosters, that discourages some people from seeking a vaccination. So I think that has weighed on them as they try to meet the deadline for trying to get a certain percentage of the population vaccinated. The president set out to vaccinate 70% of adults over the age of 18 by July 4th. And they were pushing hard to meet that deadline and they almost did. I mean, they did a good job getting close to the stretch goal that they set out for themselves. So I think they are worried that if you start a conversation around boosters now, it could discourage people who haven’t been vaccinated from going out and seeking vaccination. I quite frankly, think that there’s a way to bifurcate this message. When we talk about boosters, we’re not talking about people go out and get vaccinated now, who, by and large, are younger, healthier people because we vaccinated many of our elderly individuals much earlier. What we’re really talking about is people who were vaccinated last December, last January, people over the age of 65 who now are a significant amount of time out from their original vaccination. Do you really want them going into the 2021, 2202 COVID season this fall and winter with a vaccine that’s more than a year old? Remember, we vaccinated the 1.34 million residents of nursing homes, the most vulnerable people in our country to COVID we vaccinated them last December. We also vaccinated our front line health care workers last December. Our physicians are going to want to go into this fall and winter season with a vaccine that’s more than a year old, particularly if they’re more vulnerable than older individuals as well. Those are the questions we need to start asking. I’m glad we started the process. Tony talked about the meeting that’s going to take place tomorrow with the company. And we’re doing the studies to take a hard look at this

JOHN DICKERSON: As the last question, let me ask you about the- about schools. The CDC gave recommendations, said schools, if you’re vaccinated as a teacher or a student, you don’t have to wear masks. How do you think those schools are going to sort through those who aren’t vaccinated and checking up on whether they’re wearing their masks? How do you think that’ll play out?

DR. GOTTLIEB: Yeah, I don’t think they’re really going to do checking. I think what’s going to happen is some schools are going to implement mask mandates, others won’t, depending on what state you’re in, 8 states have announced already that they’re not going to allow masks in schools; California announced that they will. I don’t think you’re going to create a situation where you can have some students wearing masks and others not. Schools are going to be wearing masks or not, depending on what the prevalence is in different states and what the risk tolerance is. The other components of that guidance the CDC put out was also looking at podding students, improving air filtration and doing testing. This was the first time the CDC recommended testing in schools.

JOHN DICKERSON: All right, Dr. Scott Gottlieb, as always, we’re grateful. Thanks for being with us. FACE THE NATION. We’ll be back in one minute.

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