The following is the transcript of the interview with former FDA commissioner Scott Gottlieb, who now serves on the boards of Pfizer and United Healthcare, that aired on "Face the Nation with Margaret Brennan" on Dec. 7, 2025.

MARGARET BRENNAN: For a look at some recent changes to U.S. public health policy. We're joined now by former FDA commissioner Dr Scott Gottlieb. He also serves on the boards of Pfizer and United Healthcare. Welcome back.

DR. SCOTT GOTTLIEB: Thank you.

MARGARET BRENNAN: You know there was some pretty big news on Friday, and the American Academy of Pediatrics said they are deeply alarmed that the CDC vaccine advisory panel, ACIP voted in this 8-3 decision to change this 30 year long policy regarding Hepatitis B and newborns. They are now recommending delaying the dose until a child is two months old, instead of within 24 hours of birth. What does this decision mean for families of newborns?

DR. SCOTT GOTTLIEB: Yeah. Well, look, I think we first need to understand why we give that birth dose of the vaccine, because the idea of giving a vaccine to a newborn, to a lot of parents, sounds discomforting, that the first thing a child is going to face when they're born is going to be a vaccine within the first 24 hours. For a child over the age of five, if they develop Hepatitis B infection, if they're exposed to it, they're going to have a 95% chance of clearing that infection, and they'll go on to develop lifelong immunity. For children between the ages of one and five, they only have about a 25 to 50% chance of clearing the infection, so about 25 to 50% of kids will develop chronic infection, and about a quarter of them will go on to die from hepatitis B if they're between the ages of one and five. So children are more vulnerable to this virus and can't clear the infection. But when you're talking about a newborn, an infant, 90% of newborns who become infected, and they'll become infected during delivery, will go on to develop chronic infection, they won't be able to clear the hepatitis B, and about 25% of them will die from sequelae of that infection, either from liver disease, cirrhosis or from liver cancer. So we have this unique opportunity by giving this birth dose and the subsequent inoculations to virtually eliminate the chance that a newborn can contract Hepatitis B and go on to develop chronic infection, it's almost 99% effective at preventing that chronic infection. And the refrain is.

MARGARET BRENNAN: And–

DR. SCOTT GOTTLIEB: And one final point, the refrain is, oh, sorry, please.

MARGARET BRENNAN: No, no. And this decision now is to wait two months before giving that dose.

DR. SCOTT GOTTLIEB: Right.

MARGARET BRENNAN: The President of the United States came out and said, this was very good, because Hep B is only transmitted sexually or through dirty needles.

DR. SCOTT GOTTLIEB: Yeah, look, that's the problem. That's simply not true. The fact is, there's a refrain that if you just test the moms during, while they're pregnant, you can detect whether they have hepatitis B, and if they have hepatitis B, you continue to give that birth dose. But the reality is, many moms don't get tested, even though they intend to, many times, those test results aren't checked, and the tests themselves have a false negative rate, meaning they're going to say you don't have hepatitis B, when in fact, you do, of about 2 percent. That may not sound like a lot, but that 2% is going to translate into at least 1000 babies being born and getting infected with hepatitis B. There was one modeling estimate that estimated in the first year of this new guidance, there's going to be 1,400 children, infants contracting hepatitis B, and again, 25% of them will die from that infection.

MARGARET BRENNAN: Well, we look at this because there is this broader scrutiny of vaccines right now by the Trump administration and in this board decision, which the public could listen into. It was publicly broadcast. The board was hand picked by RFK Jr, who is a skeptic here of vaccines, from those who voted against the decision to delay. One of them who you heard at the top of the show said the CDC is doing harm. Another said, "No rational science has been presented, and the committee must accept responsibility when harm is caused." Those are pretty extraordinary statements. If the group making a decision that has such high consequences for the most vulnerable Americans isn't basing it on science, no rational science, what does that indicate about what comes next?

DR. SCOTT GOTTLIEB: Well, look, this is the ACIP by and large, except for a handful of members, are anti-vax activists who were put there to carry out a specific agenda. And look, the Secretary, to his credit, has been very honest about what his intentions are here. He's the most prominent anti-vaxer in the country prior to coming into this position, and he stated that his goal is to eliminate childhood immunization, or many of these childhood immunizations, and I think they're going to take a methodical approach and slowly chip away at this. This is a big unforced error insofar as ACIP was a esteemed body that a lot of states tie their own decision making to, and what we're seeing right now is as a group, it's being degraded, and I don't think it will ever be restored. I don't think you can just flip the switch and restore this where people are going to suddenly respect its decisions again. There's about 600 state laws that were tied to decisions ACIP made. About 17 states have already passed new legislation saying they will no longer respect the decisions of ACIP. The insurers came out and said they're going to tie their own coverage decisions to the professional bodies like the American Academy of Pediatrics and not ACIP. So I think in time, ACIP is going to be fully degraded as a decision making body, and it's going to be more symbolic. There will be certain states that- that adhere to it, but will be more symbolic.

MARGARET BRENNAN: So you this week, we saw a big sell off in biotech stocks following these reports that the FDA, which you used to run the first part of the Trump administration, is now going to require one study to clinch approval of vaccines. You were one of the former commissioners who put out this really extraordinary editorial in the New England Journal of Medicine, arguing that the FDA and top vaccine regulator, Dr. Vinay Prasad, are changing policies in a way that's going to slow down new and better vaccines. What specifically is the problem you see? Because this isn't just hep B, this is the vaccines of the future. You're saying just won't be created?

DR. SCOTT GOTTLIEB: Right. So Vinay Prasad, who is the head of the biologic center. Also oversees the vaccine Division. He also has been appointed the head of biostatistics, the Chief Medical Officer of the agency, and chief scientific officer. So he occupies a lot of positions. Put out a memo saying that they're going to do away with, or move away from, what they call immuno bridging studies. These are studies that allow you for well validated vaccines, like the flu vaccine, to be able to demonstrate each year that the vaccine, the new vaccine, that's formulated against the circulating strain, can elicit antibodies that are effective against that particular strain, and that could be the basis of approval, rather than requiring new outcome studies every year to prove that the vaccine actually reduces the incidence of influenza. For established vaccines, where we know that antibody production is a good correlate for immunity, this has been a long standing practice. It's, we do it for flu vaccine, we do it in covid Certainly, we do it for things like pneumococcal vaccine, the vaccine for pneumococcal disease, where we look at serotypes circulating bacterial serotypes. This allows us to update vaccines as these viral and bacterial strains change, and as the composition of the strains change in time to provide protection for the Fall respiratory season. If they move away from this, which is what he said, they plan to do, we're just not going to be able to update vaccines each season, as we've done historically, to accommodate whatever the circulating strain is.

MARGARET BRENNAN: And 12 former FDA commissioners came out saying they're deeply concerned about what is happening. That memo that made clear the changes that are happening within the FDA from Dr. Prasad was obtained by CBS, and it claimed that career FDA staff are making changes in part because they found at least 10 children have died after and because of receiving the Covid vaccine, referred to it as a profound revelation, and said and asked, Did it kill more healthy kids than it saved? The administration, to date, has not backed up information to back up these claims, but, but, what questions do you have for the FDA commissioner, because they're arguing they're doing this to help people?

DR. SCOTT GOTTLIEB: Yeah, look, well, first of all, one thing doesn't flow from the next. So the idea if, in fact, they found cases where the covid vaccine was linked to tragic deaths, it doesn't then follow that you make these policy changes. In fact, the policy changes wouldn't address what the concerns are related to the covid vaccine itself. These are- every case needs to be carefully adjudicated. It's tragic to see any suspected case that could be linked to a vaccine. And these were looked at previously by the FDA, and I don't believe that the new FDA had access to the case level data analysis of cases, individual cases that get filed with the agency where there is a death in proximity to vaccination, and some of these are filed by the manufacturers themselves are very subjective and require the goodwill the people involved in that. And so I think that they should make that analysis public so it could be scrutinized and people can get comfort in that they've already backed away from the 10 is reporting from endpoints that now they're saying it's eight or nine, so they're already backing away from it.

MARGARET BRENNAN: Okay. And HHS said they will eventually make that data public. We'll look for it when it comes out. Dr Gottlieb, thank you for your analysis today. We'll be back in a moment.

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