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Transcript: Dr. Scott Gottlieb on "Face the Nation," February 13, 2022

Gottlieb: New data prompted FDA to delay decision on vaccine for kids
Gottlieb says new data prompted FDA to delay decision on vaccine for young kids 05:09

The following is a transcript of an interview with Dr. Scott Gottlieb that aired Sunday, February 13, 2022, on "Face the Nation."

MARGARET BRENNAN: We go now to former FDA commissioner and Pfizer board member Dr. Scott Gottlieb. Doctor, I have to say there was a lot of whiplash this week with the FDA and the Pfizer decision to hit the brakes on this vaccine for toddlers, for children ages four and younger. Now we have to wait until April for a decision. What happened?

DR. SCOTT GOTTLIEB: Yeah, there were no new safety issues coming out of the data set, the issue here is the ability for the FDA and for Pfizer to clearly define the level of efficacy that the vaccine is delivering. And what you have is a situation where the data sets continuing to evolve because we're still in the middle of this Omicron wave of infection, there still effect infections accruing on the patients in the clinical trial, both the patients who have been vaccinated and the patients who've been unvaccinated. And so, the data set is changing. And there was additional data that was submitted to the FDA late last week, on Thursday and Friday that changed the FDA's perception of the absolute efficacy of the vaccine. And given the fact that that is changing, that's evolving. New data is accruing. It's hard for the FDA to give its advisers a fixed snapshot of what the absolute efficacy is of this clinical trial, of the data set. And so, if they wait a little longer, if they administer the third dose in that clinical trial, they're not only going to have perhaps a better measure of effectiveness from this trial, but they'll also have a settled data set. They'll have a very firm picture of what- what level of effectiveness the vaccine is delivering, and that's important for patients and pediatricians to be able to make fully informed decisions because it's important to know that the vaccine is safe. But it's also important to know what the level of effectiveness that's delivering as well.

MARGARET BRENNAN: It's whiplash in the meantime, as parents continue to wait. And then we also see, you know, in some areas of the country, like New Jersey, states lifting their mask requirements in schools. So should parents of children under the age of five keep their kids back- keep their kids masks in school?

DR. GOTTLIEB: Look, I think there's portions of the population that are going to be in a very difficult spot right now because they remain vulnerable, one portion of the population are young children, parents who work who are at risk of bringing the infection back into the home with a child who's unvaccinated. Also, people who are older, who have comorbid conditions that put them at risk of COVID will continue to be vulnerable. But we're clearly shifting from a compact where there was a shared sense of sacrifice across the population generally to take certain measures to take certain mitigation, like wearing masks, like protecting congregate settings towards one where policymakers are clearly shifting the burden onto individuals to try to protect themselves based on their own measure of their risk and the risk of their environment. It's incumbent upon policymakers to give people the tools to do that, but there are pockets of society that don't have those tools, like young children don't have vaccines, so parents are in a difficult spot. They're going to continue to have to remain vigilant if they're concerned about the risk of infection, those young children. But this is clearly a trend right now across the country.

MARGARET BRENNAN: Walmart, world's largest retailer, I mean, they set the tone for a lot of corporate America. They have decided to lift the mask mandate for vaccinated employees. You have this wave of Democratic governors, as you predicted lifting mask mandates. But the CDC and the president say it is too early. Is this just another round of the CDC being too slow or is everyone else moving too fast?

DR. GOTTLIEB: Well, the CDC is setting a national standard and there's still parts of the country that have a lot of Omicron infection, not every part of the country is through this wave of the epidemic. Clearly, the Northeast is the mid-Atlantic, where cases are 20 cases per hundred thousand people per day. But when you look at states like Kentucky, West Virginia, Tennessee, Missouri, they're at about 100 cases, or Mississippi, there are about 100 cases per hundred thousand people per day. That's a pretty dense epidemic. So the CDC has a hard time setting a national standard across a very diverse experience with this- this virus. I think what you're going to see the CDC do, though, is come out with guidance that's more specific to communities. That's based on what the local prevalence is, and that's probably where they should have been all along. I think they're going to make that adaptation because there clearly are parts of the country where prevalence is low enough now and heading in a positive direction if they can start lifting this mitigation.

MARGARET BRENNAN: One other question before I let you go, you tweeted this week that it's hard to believe in the middle of the worst public health crisis in modern times. Democrats are letting twist in the wind, their party's nominee for FDA chief. Why, more than a year into the administration do we not have a confirmed FDA commissioner?

DR. GOTTLIEB: Well, look, I'm hoping Rob Califf, Dr. Rob Califf, will be confirmed this week is going to go before the Senate. I think he's an outstanding choice for the agency previously held that job, and I inherited the FDA from his leadership, so a lot of his policies and his team was what I inherited when I took over the agency. You know, there's different political reasons why senators have made an issue of his confirmation. One of them is the issue of opioids, which he's been very strong on advancing policies to help deal with the opioid epidemic.

MARGARET BRENNAN: So well, it sounds like he has your endorsement there. Dr. Gottlieb, I have to leave it there and hit this break. Thank you so much.

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