The following is a transcript of an interview with former FDA Commissioner Dr. Scott Gottlieb airing on CBSN on Sunday, September 26, 2021.
MARGARET BRENNAN: We go now to former FDA commissioner Dr. Scott Gottlieb, who also sits on the board of Pfizer. He’s the author of a new book, “Uncontrolled Spread: Why COVID 19 Crushed US and How We Can Defeat the Next Pandemic.” Dr. Gottlieb, good to have you. You know, we rolled through examples with the CDC director to try to pin down exactly who should consider going out and getting that third Pfizer dose now that those considered at high risk of exposure are included in the language. How do you think the CDC handled this rollout?
DOCTOR SCOTT GOTTLIEB: Well, look, I think that the criticism has been that it looked messy. The process, though, was designed to create conflict. We need to recognize that we used a process for adjudicating what vaccines should go into pediatric vaccine administration schedule to define who should get an adult vaccine in the setting of a public health emergency. The process that we use intentionally creates conflict between FDA and CDC. Because you want that process to be highly deliberative, you want to be slow. You want it to reflect very careful analysis because decisions about what vaccines should be mandated for pediatric population across the country are very weighty decisions. But a slow, deliberative process that creates conflict that’s visible to the public isn’t optimal in the setting of a public health emergency, where you need to move quickly, and you want to show that public health officials are unified. We should have brought the CDC and FDA together, I believe, from the outset. I think in terms of how they handled it, though, I think they handled it well within the confines of the process that they were using by announcing, you know, about a month ago that they were going to pursue boosters. It gave the administration time to get the logistics in place with the pharmacies to be able to deploy these shots very quickly. Once that decision was ultimately reached, which is what they were able to do within 24 hours. The boosters were available.
MARGARET BRENNAN: Right. And laying that groundwork key to avoiding a repeat of what the Trump administration experienced with like a three-week lag before some of the shots were able to be rolled out. That’s what you’re referring to there.–
DR. GOTTLIEB: Right, it–
MARGARET BRENNAN: But when- when the CDC director said it, it’s not bureaucratic, it’s a scientific debate process. Are you arguing that in a pandemic, there should be different standards?
DR. GOTTLIEB: I’m arguing in a pandemic there should be a different process entirely. We used a peacetime process for a wartime setting. You know, the way it works right now is the FDA renders a judgment about a vaccine and then it goes to a CDC advisory panel. And the CDC oftentimes narrows the scope of the FDA approvals in terms of defining who should be eligible for a vaccine. The- the panel, ACIP, which advises the CDC, which is a panel we’re talking about, is very heavily weighted with pediatricians because most of what they arbitrate are pediatric vaccines that go into the childhood immunization schedule, so that- that’s a process that unfolds over the course of months. You see the visible divide between FDA and CDC, and we want that process to be very deliberative and create conflict between the two agencies. The two agencies are basically being asked to answer the same question but apply different judgment to it because you want a very deliberative, slow, careful process in a setting of a crisis. We needed to move very quickly, and we needed to move with a unified front. People are going to use- people who want to create doubt about these. Vaccines are going to use the optics of a divide between the two agencies to sow doubt when in fact the process is intended to create that divide between the two agencies. What we should have done is realigned FDA and CDC at the outset. This goes back to the Trump administration. If you remember, the CDC used a very Byzantine schedule in terms of defining who should get the initial vaccines last December. And it proved very hard for the states to implement, and many states moved away from it in Florida and Connecticut went with an age-based regime. They were criticized for it at the time, but it proved to be more optimal in getting people vaccinated more quickly.
MARGARET BRENNAN: Well, the CDC director said, “I recognize confusion.” So, she’s acknowledging that there is some confusion on who falls into that frontline worker category of someone who should self-select to go get a booster shot. In your view, should all of us eventually go get a booster?
DR. GOTTLIEB: Well, I think the data is still to be determined on that question. I mean, very clearly- look, they authorize it for anyone 65 and above and in a long-term care facility. I think that you can make an argument that the data suggests that people above the age of 60 and maybe even above the age of 50 should get a booster based on just a- a risk benefit analysis. And that’s where the FDA ultimately was heading in the discussion that they had. But people below the age of 50 who are otherwise healthy, I think it’s an open question right now. The data isn’t strong to support the question either way. But those who have medical risk factors, I think, certainly need to take that- take that into consideration and people who have occupational exposures. And that’s exactly where the CDC came out. They left a lot of flexibility–
MARGARET BRENNAN: Yeah.
DR. GOTTLIEB: to people- for people to make judgments about their risk and for doctors to help guide patients.
MARGARET BRENNAN: Right, but the director didn’t take it off the table that it would open up. In fact, what the president said is that we will eventually open it up. And she did seem to say no, not yet, leaving room to do so. Is that a political judgment?
DR. GOTTLIEB: Look, I think they created a set of criteria, the CDC did, where they ultimately came out that are very sort of accommodating, and it’s going to allow a lot of people to self-select into boosters if they want to and a lot of doctors to make recommendations for patients to get boosters. I think that was intentional, the- the language they ultimately used. I think they want a frictionless process. That’s what I’ve been told by pharmacies who’ve been advised by the CDC. And I think the director’s comments today reflected that, where she didn’t want to really articulate very clear divides on who should and shouldn’t be opted into getting a booster. She left it very general in terms of her own advice and, you know, left it to patients to make judgments with their doctors and with themselves.
MARGARET BRENNAN: Lastly, the CEO of Pfizer, the company you served on the board of affirmed today that that data on vaccinations for 5 to 11 year olds will be going to the FDA within a matter of days. Is that confirming your schedule of vaccines by Halloween?
DR. GOTTLIEB: Yeah, I think that’s still possible. FDA has said that the review is going to be a matter of weeks, not months. I- I interpret that to mean potentially a four-week review, maybe a six-week review. So, I think on the- on- on the low end, it could take four weeks and that could give you a vaccine by Halloween. If it slips a little, it could be mid-November.
MARGARET BRENNAN: All right. Dr. Gottlieb, thank you very much for your analysis.
DR. GOTTLIEB: Thanks a lot.