The following is a transcript of an interview with Dr. Scott Gottlieb that aired Sunday, December 19, 2021, on "Face the Nation."
MARGARET BRENNAN: We go now to former FDA commissioner and Pfizer board member Dr. Scott Gottlieb. Good morning to you, doctor.
DOCTOR SCOTT GOTTLIEB: Good morning.
MARGARET BRENNAN: The administration and certainly Dr. Collins really issuing some warnings there to take this seriously. They still, even though Omicron was discovered nearly a month ago, don't seem to have a lot of answers to big questions. Does what you've seen so far indicate that this will cause a more severe illness?
DR. GOTTLIEB: There's no indication that it causes more severe illness, what we've seen in South Africa in particular, is a decoupling between the cases and hospitalizations. So, hospitalizations are down about 30% relative to cases, and we're probably not measuring all the cases in South Africa. We're probably only picking up a small fraction. And more severe cases requiring ICU admissions are down 80% relative to past waves in cases versus ICU admissions, so it does appear to be a less severe illness. Now, a lot of people believe, including myself, that the reason why it's manifesting as a less severe illness is probably because we have baseline immunity in the population. Probably around 80% of Americans and 90% of South Africans have some level of immunity, either from prior infection or through vaccination. So even though we're still getting infected because this is spreading through immune evasion, it's spreading by evading the immune- immunity that we've acquired. We have some baseline immunity that protects us from getting very sick. And that's in fact what you're probably seeing in terms of these hospitalization statistics.
MARGARET BRENNAN: But that takes us to the unvaccinated or ineligible. As we said, you sit on the board of Pfizer, we learned this week that when it comes to their vaccine, for those under the age of five that it's going to take more time. You had been predicting first quarter of 2022 for young children to be vaccinated. Can you level set for parents? How much longer do we have to wait?
DR. GOTTLIEB: It depends on what the circumstances are that- that base case is now getting pushed out to the second quarter of 2022. So, what we've done, what Pfizer did was test a significantly lower dose in young children, in the toddlers. It's a 3-microgram dose compared to a 10-microgram dose that's being used in children 5 to 12, and a 30-microgram dose in teenagers and adults. And the reason to go with a substantially lower dose is you're very focused on tolerability in young children. You don't want to have vaccine related side effects like injection site reactions, pain, fevers. And so, they tested very low doses to try to achieve a very tolerable vaccine. Now, in six months to two years that low dose produced a comparable effect in terms of the immune response when compared to 16 to 25 year olds. And what you're measuring is antibody response. So, the antibody response in the very young children was comparable to the antibody response we see in 16 to 25 year olds, but in two to four, it was less. And so what the company is doing right now is going back and extending the trial and looking at three doses, to see if three full doses- and we know this is going to be a three-dose vaccine regardless whether three doses produces a comparable level of immune response compared to the 16 to 25 year olds. We believe it will. I believe it will. But I also think that if we start to see bad outcomes in kids, hopefully we don't. But if we see kids getting in trouble with Omicron, I do believe FDA will be in a position to make an earlier authorization on the basis of the data we have right now, because even that lower antibody response in the two to four year old's is still providing some baseline immunity that should protect them from more severe outcomes from this disease.
MARGARET BRENNAN: And that could be key because, as Dr. Collins said, he still doesn't have a good answer as to why there were those larger infections among small children in South Africa. Back here, we've been talking for months now, doctor about learning to live with COVID, but now we've got this Delta wave and the overlay of Omicron on top of it. Do we need to put the brakes on the return to normal?
DR. GOTTLIEB: Well, look, I think people are really tired of living diminished lives from COVID generally, and you're seeing that in terms of what people are doing, they're re-engaging activity that we know are going to be conducive to the spread of this virus. Omicron really has thrown a curveball here. I think that this is a temporary incident, I think is going to blow its way through the population, probably very quickly. When you look at what happened in South Africa and even what's happening in the UK right now, where it's moving very fast. But we do face a hard four to six weeks ahead of us, as is most of the population. I think it is prudent, especially for people who are going to be around vulnerable individuals to take added precautions heading into the holidays. Try to use testing, make sure you're boosted, take precautions within your settings in your social settings as well. Use the high-quality masks when you go out. I don't- a lot of people don't want to be a link in a chain of transmission that could get to a vulnerable individual, either a young child or an older individual, even if they themselves know that there is significantly less risk from a bad outcome from this virus. So, we should be prudent over the next four to six weeks.
MARGARET BRENNAN: Being prudent means testing before you go into those family settings, you heard, Dr. Collins say, stay tuned; we'll tell you which tests work. Do you have any indication which ones do?
DR. GOTTLIEB: Well, FDA is testing the use- testing the tests, evaluating them against live virus this week, and so are the manufacturers. So, they've gotten hold of plasma from patients who've been infected with Omicron and live virus, and they'll be doing those evaluations. I think we're going to know much more very early in this week. Every indication is that the mass market tests that people are using should be- should hold up with this new virus. They should be able to detect it. So, I think most of the tests that individuals are using are going to be just fine. It might be some of the smaller market tests that aren't in wide use that might be more suspect, but things like the BinaxNOW, which have been evaluated very carefully, should be fine.
MARGARET BRENNAN: You said weeks ago that the confusing language around the rollout of boosters was one of the most costly mistakes potentially of the pandemic. We just heard from Dr. Collins that when it comes to one of the few tools in terms of monoclonal antibodies that seems to work, that they need to ramp up supply, that America doesn't have the stockpile it needs right now. Why not?
DR. GOTTLIEB: Well, look, I think we haven't looked ahead at the unknown unknowns, tried to predict what could happen and prepare for it. The Vir Biotech antibody we always knew was going to be preserved against a lot of different mutated forms of this virus. We should have crashed the production of that stockpile much more. The government only contracted for that about a month ago. We have 55,000 doses right now that are finally being forward deployed, and we'll have 300,000 in Jan. There's another drug, Lilly has a drug that's clear to phase two studies that could be ready to be deployed as well. There are 300,000 doses sitting on pallets waiting to be forward deployed. It's pending regulatory review by the FDA. That's another one that we should be looking very hard at, trying to move that to the market more quickly. We have to get to a platform where we can update these monoclonal antibodies more quickly as new variants arise. Similar to what we're doing with the vaccines, the vaccine division has moved very quickly to allow new iterations to come to market as the virus has evolved. We need to do the same thing with drugs and not treat each monoclonal antibody against each iteration of this virus as if it's a brand-new drug.
MARGARET BRENNAN: Very quickly, should parents expect to send their kids back to in-person school after Christmas?
DR. GOTTLIEB: I think in most places of the country, the answer is yes, in some hard-hit parts of the country where there is a high prevalence of Delta right now; high flu prevalence like the Northeast, the Great Lakes region and now Omicron later on top of that where health care systems could get pressed. I think that you could see some districts make decisions to extend the breaks.
MARGARET BRENNAN: Dr Gottlieb, thank you very much and we'll be right back with much more FACE THE NATION.
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