The following is a transcript of an interview with Dr. Scott Gottlieb that aired on Sunday, April 24, 2022 on “Face the Nation.”
MARGARET BRENNAN: Mark Strassmann in Atlanta. We now turn to Dr. Scott Gottlieb, a former FDA commissioner and Pfizer board member. He accompanies us from Westport, Connecticut. Good morning to you, Doctor.
DR. SCOTT GOTTLIEB: Good morning.
MARGARET BRENNAN: I want to reach the kids in a moment. I have a lot of things I want to ask you there. But let’s start with the masks. Set aside the legal argument. As a medical professional, when you get on a plane, will you still wear a mask?
DR. GOTTLIEB: I wear a mask when I get on a plane while I’m boarding and also while getting off the plane. I think these are the two points where you are in a crowded environment, where there is poor air circulation. These are really the risky places. These are the highlights of your trip. When you’re in the air, when you’re at 10,000 feet, there’s a pretty good air leak in an airplane. So I don’t feel at risk right now. So I take off my mask while we fly. This has been my practice since this term was lifted. That’s probably what I’ll continue to do, as long as the prevalence stays where it is right now.
MARGARET BRENNAN: And to be clear, when you say mask, you mean an N95.
DR. GOTTLIEB: Yes. Look, I’m wearing a high-quality mask. I wear a KN95 mask. I think if you wear a poor quality mask, a fabric mask, or a procedure mask other than a level three procedure mask, you’ll probably get a lot less protection than you perceive. Omicron is an airborne pathogen at this point, it is spreading by airborne transmission. A fabric mask does not provide a measurable degree of protection. So if you want to protect yourself from this pathogen, you really need to wear a well-fitting better quality mask.
MARGARET BRENNAN: Big picture, according to HHS, we’re still in a public health emergency. Are we still in an endemic-endemic phase of this?
DR. GOTTLIEB: No, no, I think this year is really a year of transition. I think this will be the year that this becomes a more endemic disease. It will not be a definite moment when this happens. But what will happen is that this will adapt to a more seasonal pattern. I expect prevalence levels to start declining. We may be at our best right now if you look at the wastewater data, hopefully during the summer, through the summer. We have a fairly low prevalence of this infection and then we will see it resurface in the fall. The question is what comes up again?
MARGARET BRENNAN: Yes.
DR. GOTTLIEB: Is it a new variety of Omicron? And that will drive decisions around the vaccine.
MARGARET BRENNAN: And autumn makes children’s vaccinations even more timely. So stay with us. We take that break and come back and end our conversation with Dr. Gottlieb.
MARGARET BRENNAN: Welcome back to FACE THE NATION. We continue our conversation now with former FDA Commissioner Dr. Scott Gottlieb, who is also on the Pfizer board. So, Dr. Gottlieb, when I heard that the mandate of the mask was being lifted on transportation, I thought to my 1-year-old son that I don’t want to get on a train and I don’t want to get on a plane because I can’t put on a mask and is not vaccinated. What are the parents of younger Americans supposed to do? Not traveling?
DR. GOTTLIEB: Look, this is a really difficult situation because we’re actually saying that people need to be taken into account to protect themselves. We are no longer mandating the entire population, but we are asking people to individually assess their own risk, but we are not giving everyone the tools they need to do so, especially young children who will now become vulnerable in these environments. public. But no vaccine is available for these children. And I know a lot of parents have been waiting for a long time. There are children with health conditions who cannot get the benefit of a vaccine that could provide them with a basic immunity that could protect them from serious illness. And I think we should try to make a vaccine available to these children very soon. As for the current situation, you know, I will take each request in turn. Pfizer, as you know, submitted data on its two-dose vaccine about four months ago. The FDA has had this data for about four months and has had the advantage of reviewing it. They postponed the decision on this vaccine. They did not feel that it reached the level of efficacy they had prescribed, which was a 50% effectiveness threshold for preventing symptomatic disease. Therefore, Pfizer is testing a third dose to see if this will increase the effectiveness of the overall regimen, and data on this should be available very soon. Moderna released frontline data on its vaccine on March 23. Their two-dose vaccine and reports are the public reports they will present this week. My expectation is that the FDA will hold an advisory committee in early June to discuss one or both applications. This gives the agency about six weeks to review the Modern app, which is consistent with the time it has taken the agency to review these applications. It took five weeks to review Pfizer’s application 5 to 11, and I hope Pfizer has all its data in time to be considered on this advisory committee as well. But to top it off, you know, if the Modern app is ready and the Pfizer app isn’t, I think the FDA should consider it separately.
MARGARET BRENNAN: Well, that’s an important point to point out, because this week it was reported, as you know, to Politico, that there were talks within the Biden administration worrying about whether to authorize one vaccine before the others. , which would confuse parents. . But with adults, one vaccine was authorized and made available before the other. So is this thinking flawed? Do you know if there is anything true in this report?
DR. GOTTLIEB: Well, look, no, I don’t agree with the thought, but when I just look at the timeline set here, if you think they’re going to have an advisory committee in early June, that’s been rumored for a long time. . That, that meeting had to be planned to be considered a bivalent vaccine, the specific Omicron vaccine. And consideration of the childhood vaccine will be attached to this meeting. If you consider this deadline, it gives them about six weeks to review them or during the application. And I think Pfizer will have your data long enough to meet that deadline as well. Six weeks is what the agency has been taking. They have been reviewing these apps for four, four or five weeks. Having an AdCom adds extra time. It will add a week or two. The last point I would like to make is the question of why they bring him before the advisory committee? And this raises the broader question here whether or not the agency will consider vaccinations that do not reach the 50% threshold to be approved. The reason they postponed, at least in part, the reason they postponed the Pfizer vaccine earlier is that it did not meet that threshold. So this will be controversial before the advisory committee. That’s why they take it before AdCom. I hope there is a favorable outcome for one or both vaccines, but I hope there is some rejection among these members.
MARGARET BRENNAN: When we talked in January about where Pfizer was with its presentation, you argued that it might be advisable to have only two doses while looking at a third, because a little bit of protection is better than none. Is the FDA thinking so? You mentioned a 50% efficiency rate. If the data does not meet this benchmark, should these vaccines still be approved?
DR. GOTTLIEB: Well, the data won’t get to that benchmark. Moderna’s data is about 40% of the data they published. Pfizer data: The previous data was also around 40%. We’ll see if the third dose provides extra protection on top of that. But we know that these vaccines do not work very well against Omicron to prevent symptomatic diseases. I believe that from a clinical point of view, it is valuable to achieve the initial immunity of children, even if you will not completely protect them from symptomatic diseases, if you can protect them from serious illnesses and hospitalization, this provides a lot of value. , especially children who are vulnerable, who have health conditions. Therefore, I believe that for the FDA to authorize these vaccines, they will also have to come to this view, because these vaccines will not meet their pre-specified goal of providing 50% effectiveness. We know that right now. I mean, it’s possible that the third dose of the data, the third dose of the Pfizer vaccine will reach that benchmark. I don’t think that’s because I don’t think there are enough symptomatic cases in this dataset to evaluate them.
MARGARET BRENNAN: This is an important conversation. We will continue to have it and watch what the FDA does very carefully. Thank you so much.
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