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Brian Lehrer: Brian Lehrer on WNYC. Are they going to get to yes on the human and physical infrastructure bills today? I think you will hear it first because Congressman Hakeem Jeffries called away into this leadership meeting is going to come on when it's over and that's going to be in 20-25 minutes so hang around for that. Meanwhile, Scott Gottlieb is the rare Trump appointee to have won over critics on the left when he led the food and drug administration for the first two years of that administration and he's now seen as a voice of authority on combating the pandemic.

He's a medical doctor and a medical investor. He's on the board of Pfizer and as a fellow at the American Enterprise Institute, the Free Market Think Tank. His new book is Uncontrolled Spread: Why COVID-19 Crushed Us and How We Can Defeat the Next Pandemic. He joins us now to talk about what went wrong and what we should learn from it. We'll get Scott Gottlieb's thoughts on some of this week's COVID news as well, like how to understand why advisers to the FDA, which he used to lead, and advisors to the CDC disagreed on who should get booster shots.

Dr. Gottlieb, thanks for making this virtual house call today and we really appreciate it. As I was just mentioning to the listeners you bumping up the time from later in the show while Congressman Jeffries is in that leadership meeting. Hi.

Scott Gottlieb: Hi, how are you? Pleasure to join you. Thanks a lot.

Brian Lehrer: You introduced the book with New York city's experience during the early part of the pandemic and your ties here as a medical student at Mount Sinai. I see you did training at Elmhurst Hospital, which of course was one of the hardest hit by early COVID. Looking back, how did New York City end up being the deadly epicenter of the virus at first, the prime example of how COVID-19 crushed us as you put it in your books, title?

Scott Gottlieb: Look the city is always vulnerable to infections like this and we've long known it. When I practiced medicine at Elmhurst, we would see a lot of emerging diseases there. We used to diagnose half a dozen cases of malaria every year, maybe more because of the diverse population, the fact that you have a lot of people coming in and out of the city. The density of the city makes it very vulnerable, particularly to the spread of a novel respiratory pathogen.

I think it was always going to be one of the most vulnerable cities in the country to this virus, as it emerged around the world and it also was a point in time when we didn't understand the virus. We didn't understand how it spread. We didn't understand the social and geographic compartments in which it spread. We didn't know how to treat it. In the early days, we were using drugs like hydroxychloroquine and pepcid that were providing no benefit. Now, in retrospect.

It was a fog of viral war when this virus struck New York City and it almost brought the healthcare system to the point of collapse. I was talking to many physician colleagues over the course of that, those early days, and the healthcare capacity of New York City was effectively breached. It became a COVID-only healthcare system for a period of time.

Brian Lehrer: Could New York have done something different at the start. Many cities have similar underlying conditions, overcrowding, inequality, everything that we've been talking about for a year and a half, but very few cities got hit as hard is as New York. In fact, no other city did.

Scott Gottlieb: Look, New York, I think got heavily seated when you look back at the genetic epidemiology, the work of people like Trevor Bedford and others who trace the lineage of different strains as they course their way into United States, New York got very heavily seated, particularly from travelers from Europe and Italy, not so much from China. We didn't have a diagnostic test we couldn't detect that early spread.

That wasn't just a challenge New York face. That was a challenge everyone faced because of the breakdown at the federal level and making diagnostic testing available. Could the city have shut down a week early or reached for mitigation a week earlier? I think these were tough decisions in the early days because we didn't fully understand the scope of the risk that we faced. It was easier for other cities having seen the experience in New York to take more proactive steps and be more aggressive but New York really was the first, it got heavily seated and was the first city to see explosive growth.

Brian Lehrer: You were no longer at the FDA by January 2020 when COVID burst on the scene, but you still had ties to the Trump administration. How involved were you in their initial response?

Scott Gottlieb: I had a lot of conversations, especially early on. Later on, I stopped having as many conversations with the Trump White House because a different view, began to take hold that continued, uncontrolled spread was inevitable and there weren't things that we were going to really be able to do to mitigate it. I think that what I was preaching at the time was no longer aligned with the policy direction they were heading in but early on, I was having a lot of discussions with them.

My first phone call to a senior White House official was to the head of the domestic policy council on Martin Luther King Day Weekend in January, when I saw the cases from Wuhan reports out of China, going from 50 reported cases of severe pneumonia to 200. That alarmed me on two counts, number one, it's very rare to see a viral pneumonia that only presents as severe pneumonia. The fact that they were reporting 200 cases of severe pneumonia suggested that they may be hundreds, if not thousands of cases behind that. Number two, seeing the case growth overnight go rise that quickly suggested that this was exploding.

I called the White House for the first time and expressed my concern, told the head of domestic policy council they ought to get engaged and try to coordinate the different operating divisions of the department of health and human services, FDA, CDC, NIH, because I knew from experience that in order to have a proper response to something like this, you really needed coordination across those agencies. We ended up not having that and I think that really hurt us in the beginning.

Brian Lehrer: About China and those early days you go through China's unwillingness in the book internally and externally to acknowledge what was happening and share information to help the work of slowing the spread. How much do you think the problem was with China in particular or how much were the pathogen that just doesn't recognize borders in a world with so much global travel?

Scott Gottlieb: Look, this was going to become a global pandemic regardless. For China to contain this virus inside China, and there was a window to do that. I talk about a study in a book that looked at if they had intervened earlier, they might've been able to contain it, but they didn't have enough information on their own to really be able to do that. I think it's unreasonable to think that they could have taken the dramatic step of locking down Wuhan much earlier than they did.

There was suppression of information at every level. First at the provincial level from authorities in Beijing, and I document this, and in Beijing withheld information from the United States. There is the opportunity that we could have known probably certainly by end of December, but maybe by mid-December, that there was a novel Coronavirus that was spreading, that was causing severe pneumonia, that it was spreading through asymptomatic transmission, and that it was infecting people, it was spreading from person to person.

We now know that there were healthcare workers that were infected by mid-December. That's an indication of human-to-human transmission. We know doctors in China believe that there was asymptomatic transmission and we know that dozens of samples, human samples, we sent off for sequencing by mid-December to various labs, including the Chinese Lab BGI, all of which were generating results, that this was a coronavirus.

That information was knowable. Those facts that I just laid out really weren't revealed to the world probably till early to mid-January and those would have been critical facts that could have helped action, a better response.

Brian Lehrer: Listeners we have time for a few phone calls. Anything you've ever wanted to ask a commissioner of the Food and Drug Administration but never had one over to dinner with your food and drugs. 646-435-7280, 646-435-7280 for Dr. Scott Gottlieb. Or you can tweet a question @BrianLehrer. His new book is called Uncontrolled Spread: Why COVID-19 Crushed Us and How We Can Defeat the Next Pandemic. We'll also pivot in a few minutes to some of his takes on the latest COVID news.

To what you were just saying, years ago, I remember reading an account of the Cuban missile crisis that was notable for analyzing it, not as the result of actions taken by people with their individual personalities, as much as we talk about Trump and hydroxychloroquine and shining UV rays inside us and all that wacky stuff, but by people as bureaucratic players.

You seem to be doing some of that with this book. It's not just that Donald Trump had to be handled like former press secretary, Stephanie Grisham's new book is set to detail. It's that the CDC and your agency, the FDA, and also the National Security Council all had roles to play, but they weren't set up to coordinate in the face of this public health threat. Can you go into that a little bit?

Scott Gottlieb: Yes. Look, I think that that's right. Could we have had a different response with different political leadership? Certainly. I think where the administration erred the most was the lack of a consistent approach to the collective action that could have helped mitigate this crisis. They lost focus, they lost resolve. They lost a sense that there were things that the federal government could do with constant action to prevent the spread that we saw. We weren't going to be able to prevent a pandemic, but we could have preserved more life. We could have bought ourselves more time till we got to a vaccine.

I think the bigger failures were at an agency level and they were structural and systematic and that's why I think the book is important because I think if we're not going to point out the more structural features of government that failed, we're not going to be better prepared for the next pandemic. I think this narrative has taken hold that this was just a failure of political leadership, and I think we need to move beyond that and recognize where the shortcomings were below that.

The biggest debacle early was the diagnostic test and I think it illustrates a lot of what went wrong. We wrongly relied on CDC to manufacture and distribute a diagnostic test. This was never CDCs mission. They didn't have the logistical capability to do this. They had never done this before. They manufacture tests, bespoke tests for public health labs, on a very small scale and then they contaminated their lab because they didn't have good processes in place, good infrastructure in place to even accomplish the test that they were asked to do.

Policymakers didn't recognize the limitations of CDC early enough. They didn't recognize that they were asking the agency to do things that they just were incapable of doing. They weren't charged by Congress to do and what really needed to happen was we needed to get all these agencies aligned in helping to mount and all of the above approach to getting diagnostic tests into the market.

We had to get private industry engaged early. Someone needed to make a phone call to the major device manufacturers in January and say, "We need you in this game." We needed to get the academic labs in this game early, but none of that happened because we followed this highly sequential process where CDC went first and we over-relied on them. It was a failure of policy vision, and then it was a failure the agency to actually execute and also raise their hand and say, "Hey, guys, we don't have this. This isn't what we do. This is going to be a bigger crisis and we're going to be equipped to handle."

What happened was we didn't have diagnostic tests early. We didn't have them for months and that created two major problems. Number one, we got heavily seated in this country with virus because we couldn't detect the spread and we couldn't even protect healthcare workers. Number two, not only didn't we know where the virus was, but we didn't know where it wasn't.

If you go back to 2005 pandemic plan, which I was a part of helping to work on when I was in the Bush administration, it envisioned using things like closing schools and closing businesses, the population-wide mitigation to control a pandemic, and at that point, we were prepping for a pandemic involving flu, but it never envisioned using it on a national scale. The reason was because we always assumed we would have a diagnostic test so we would only target the mitigation to places where the spread was occurring.

What happened, in this case, is we closed down Bozeman, Montana. We closed down parts of Texas in the south, where the virus hadn't spread yet. This was a highly regionalized epidemic in the beginning and so when the virus finally spread to those regions, those places said, "Look, we've had it. We already shut down and we're not doing it again and you couldn't muster the political support to do what needed to be done."

Brain Lehrer: Really interesting on so many points. Let's take a phone call. Vic in Manhattan, you're on WNYC with former FDA Commissioner, and he's also on the board of Pfizer, Dr. Scott Gottlieb. Hi, Vic.

Vic: Hi, good morning. Dr. Gottlieb. What do you say to the anti-vaxxers who claim that the FDA is overly influenced, if not captured by Big Pharma, true or not appearances matter?

Dr. Gottlieb: Look, what I would say to people who are skeptical about this vaccine is that there was nothing short about the development process this vaccine went through. I'm on the board of Pfizer. I was close to that process, but I looked, I'm aware of all the processes that these vaccines went through. These were the largest clinical trials ever undertaken in modern times. Pfizer and Moderna combined enrolled about 90,000 patients in the clinical trials.

The only vaccine trial I remember being even close to that large was the Rotavirus vaccine, which was a pediatric vaccine, which enrolled 60,000 patients. These were hard endpoints that we used in these trials, meaning that we required the sponsors to prove that the vaccines actually prevented death and disease, severe disease. We didn't just approve these vaccines on the basis of measuring their ability to generate antibodies, we actually wanted to see hard clinical outcomes.

The only reason the trials went quickly was because people were motivated to enroll so they enrolled fast and tragically, they read out fast because there was so much infection around the country when these trials were going on that you had a lot of people getting sick in the placebo arm, but there was no nothing short about the clinical development. Some people who are skeptical feel that this felt fast and what I tell people is that there wasn't anything fast about the clinical development program. It actually was an exhaustive clinical development program. It just went quickly because of the backdrop in which these trials were being run, a raging pandemic.

Brain Lehrer: Fast, not fast, it just went quickly. You're saying those are different. They sound like the same thing on their face, and the development process was called Operation Warp Speed after all.

Dr. Gottlieb: Let me use more precise lexicon. The clinical trials clearly went quickly. There were no shortcuts taken. It wasn't a typical clinical trial, it was an exhaustive clinical development program in terms of having a lot of patients enrolled in the trial, very large trial, and waiting for hard and hard clinical endpoints as the outcome. There's ways you could make trials go faster by making accommodations in the rigor of the trial that wasn't done here.

Brain Lehrer: We see the results in the real world. So many people who have gotten a vaccine. The disparate rates of people being hospitalized with COVID now nine to one or more among the unvaccinated as opposed to the vaccinated and it's not like people are dropping dead from the vaccine so it seems to be proven in the real world.

Dr. Gottlieb: We're approaching probably 400 million doses of vaccine distributed in the United States 6 billion globally and two years of data at this point, we were approaching two years of data since the start of the clinical development program. That's a pretty big database of information at this point, relative to even any other medical product that we're currently using. We have a tremendous amount of data about not just the short-term safety of these products, and all of them, not just the Pfizer, the Moderna vaccine, the J&J vaccine, the AstraZeneca vaccine but long-term follow up data on a lot of patients now.

Brain Lehrer: We don't, of course, know long-term side effects, which is what so many people who are not ideological anti-vaxxers, but are resistant site, what would you say to them?

Dr. Gottlieb: I would say that look, most vaccine side effects are manifest within the first three months and that's just the regulatory knowledge. That's why the follow-up period, the first three-month follow-up period is so critical with a vaccine. We're approaching more than a year and a half of follow-up data on the first cohort of patients who were vaccinated, that's pretty long-term data, in terms of being able to follow up patients. Also, we're following them very aggressively. These cohorts of patients who are vaccinated are being followed very closely.

We're assembling a data set around this COVID vaccine that's going to exceed anything we've ever done around any medical product and we already have a plethora of data. I think people can feel reassured that if there were things that we were going to learn about these vaccines including the long-term behavior of these vaccines, those things would be emerging. Look how the issues around the long-term efficacy of the vaccines are starting to emerge, particularly in the Israeli data set, we see some indication of declining effectiveness over time. We're seeing that because we're looking so carefully at this vaccine, probably more carefully than any other medical product that we're examining right now.

Brain Lehrer: One more along the anti-vax lines before we move on to another thread. One of the things that I've heard them say, we had a caller to the show the other day, who said it, and I wonder if you could put to rest as a myth or just made up out of whole cloth. They say, more people have died from this vaccine from any other vaccine in human history. Have you heard that as an anti-vax talking point?

Dr. Gottlieb: Look, it's not true and the challenge is that when you vaccinate 150, 200 million people, things happen every day to people and so because someone had a heart attack a week after they got a vaccine, doesn't mean the vaccine caused the heart attack. When you look at this data as a regulator, what you're looking for, is some increased rate of a natural event in proximity to the product.

If you know that if you vaccinate 10 million 80-year-olds, and you know that on any given day, X percent of our population of 80-year-olds are tragically going to die of natural causes, the question becomes when you vaccinate an 80-year old a week later, is there an increase in the natural background rate of bad events relative to the time at which you gave the vaccine? The answer when we look at the data is no.

The things that we're seeing happening to people happen to people and they're not happening at an increased rate relative to what you would normally see even in the setting of the proximity in which they receive the vaccine. When people look at the VAERS database, the Vaccine Safety Database, they say, "Aha, 10 million people were vaccinated and within six months X percent of them died they must have died with a vaccine." No X percent died because people tragically die every day of natural causes, of accidents, of other things.

Brian Lehrer: Very clear, you could teach us a statistics course. My guest is Dr. Scott Gottlieb, former FDA Commissioner, a member of the Pfizer board, an author now of Uncontrolled Spread: Why COVID-19 Crushed Us and How We Can Defeat the Next Pandemic. Angela in Manhattan, you're on WNYC with Dr. Gottlieb. Hello?

Angela: Hello. I'd like to change to a more general subject. I'd like to hear Dr. Gottlieb speak about the broader issue of FDA commissioners transitioning on to the boards of pharmaceutical companies for which they were often involved in making decisions that affect all of our lives. I would just like to hear his views on what seems, to me, an obvious conflict of interest.

Scott Gottlieb: Look, before I came into FDA, I had worked with the industry, I had worked in venture capital for many years investing in startup biotech companies. People knew that, it was obviously a part of my public record. I think it's what helped prepare me, in part, for the role because I had an understanding of how the industry works of how medical products get made. I made sure that when I set up my office, there was clear boundaries in terms of what I would and wouldn't engage in, and I didn't engage in particular matters related to drug companies. I recused myself from those I had been working for prior to coming into the role.

When I left FDA, I re-engaged in similar work. I'm back at the venture capital firm I've long worked at continuing to invest in startup technology, and I've joined this position on the board of Pfizer. I'm glad I'm on that board. I'm proud of what I've been able to do. I feel like I've been able to have an impact from that role during COVID. I watched Pfizer develop that vaccine. I have been a part of that process. I think companies benefit from that insight and expertise, and that, done properly with the proper transparency, this can help companies advance the interests of the public health. I feel like I've been able to do that from that role.

Brian Lehrer: You understand why when there's that revolving door when somebody comes in from being an investor in the pharmaceutical industry, to then regulating the pharmaceutical industry, that people don't trust that. Why shouldn't there be an institutional barrier to that even if you've been honorable as an individual?

Scott Gottlieb: Look, I understand the perception issues. For all the people who distrust that, there are also people on the other side of the ledger who say, actually, that's the kind of expertise we want to attract into these roles but we want to make sure we attract people who have integrity and understand that when they transition from these roles, they have a different set of obligations. My obligation, when I was in the FDA, was to uphold the obligations I made to Congress and to the American people to advance the public health interests of that agency.

I think if we were going to put in place some kind of blanket prohibition on people being able to come out of government and transition into roles where they can apply some of the knowledge that they learned, but more importantly, apply their expertise. My expertise is I worked on developing technology. People knew that before I went into the FDA, people knew that after I left the FDA. If there was some prohibition on that, I think you'd lose some good people.

I think you wouldn't be able to inform industry with the kind of insights and expertise that can help them advance the mission and their goals. They are public health-minded organizations too. Pfizer is a public health organization. You need to make sure that you're putting in place proper constraints on what people can and can't do. I was recused from engaging in certain activities when I went into FDA, and I was recused after I left FDA.

There are rules in place and you need to make sure that people of integrity are in these positions. That's where the public should be holding people accountable if they're not behaving in a way where they are working to advance the interests of the organizations and people that they serve.

Brian Lehrer: Pfizer is a public health organization like you say, but it's also a publicly-traded company. If you watched the coverage on CNBC, let's say, the financial channel of what's happening with COVID, you will also see Pfizer stock went up or down based on some regulatory decision or delay, same with Moderna, all the other companies, so it's both things.

We heard from the doctor in charge of vaccine programs for the World Health Organization in Africa on the show this week, that as much as vaccine donations by rich countries like the United States are good, transferring the technology would be more helpful, in his opinion, to allow local production of the vaccines. I assume that kind of thing would be bad for Pfizer's bottom line, but maybe good for the world and maybe good ultimately for defeating the pandemic if it stopped globally instead of just locally. Is it something that Pfizer could help facilitate?

Scott Gottlieb: Absolutely, and it's something that Pfizer has facilitated. The company has entered into a collaboration with a vaccine manufacturer in South Africa to do local vaccine production in the African continent. I don't think that that's going to necessarily be a profitable enterprise but it's the right thing to do. The reason I say it won't be a profitable enterprise is because the production process of this vaccine is so complex that the only way to do it in the most profitable way is to do it at a tremendous scale.

When you start manufacturing vaccine across many different sites, it can sometimes be more costly, but it's the right thing to do because you want to get local production into markets. It's not just about capacity building in those markets, which is important. We want to make sure that developing regions of the world have their own capacity to make vaccines and have their own expertise, their own skilled personnel. One way to do that is to do these tech transfers too for Pfizer to go in and help stand up a facility to do this because now that facility is going to be there hopefully in perpetuity and there's going to be trained people who live locally who know how to do this and they can move on to other similar endeavors.

The other critical part of this is that my view is we're going to have a lot of vaccine supply over the next 12 months, enough to vaccinate the developing world. I think that we're going to find that it's a challenge to get vaccine to the developing world, in part, because of the austere environments and setting up the logistics and the supply chain, but also there's going to be vaccine hesitancy. Some of that vaccine hesitancy is going to be asking people to take a Western vaccine in other markets, just like you see vaccine hesitancy here, it's going to be vaccine hesitancy in other parts of the world.

If we can actually manufacture the vaccine in South Africa, or at least do the fill finishing there, my hope is that that's going to make people who live there more confident about taking that product because they know it was produced in their market and it's not just an imported product. That's another critical reason why it's important to do these things locally when you can.

Brian Lehrer: We're going to take one more call for Dr. Gottlieb. I'm told that Congressman Hakeem Jeffries is going to be ready to give us an update from the House Democratic Leadership meeting which just took place and see if they came to yes on the infrastructure bills. We'll get that report from Congressman Jeffries in a minute. I do want to get this question from Michelle in Woodcliff Lake on the air for Dr. Gottlieb, former FDA Commissioner.

Hi, Michelle, you're on WNYC.

Michelle: Hi, Brian. Thank you for taking my call. I just want to take the opportunity really quickly to say thank you, thank you. I'm a pediatrician and I have been listening to your show for years, but in the last 18 months, it's just been a critical piece of my information gathering. Your guests like Dr. Gottlieb and Wang and on and on have just been an incredible source of information for me as a physician, so thank you for that.

Brian Lehrer: That's very kind. Thank you.

Michelle: Dr. Gottlieb, you might be the perfect person to answer this question that is on the minds of all pediatricians. My colleagues and I have this running joke like, when will the vaccine be available for younger patients? I don't know. Did you watch the Today Show today because I'm not-- We don't know where we're getting our information from. Clearly, it's a complicated process and I understand all that, but in trying to answer parents' questions and concerns and also logistically plan ahead for opening up our COVID clinics, would love some insider information on that. [chuckles]

Scott Gottlieb: I can try to shed some light on it. As a father of three young children, I appreciate everything that you do. It's been a difficult year and a half with young kids and the pediatricians on the frontlines have made an enormous sacrifice to help take care of families. The vaccine for children ages 5 to 11, which is a 10 microgram vaccine, it's basically the same vaccine that's being offered in adults, but it's 1/3 the dose.

Pfizer actually tested three different doses in 5 to 11, a 30-microgram dose, a 20-microgram dose, and a 10-microgram dose. We chose the 10 microgram dose because it was the best balance between providing a comparable level of immune response based on how many antibodies the children were getting with that dose with the least vaccine-related side effects; fevers, injection site reaction. The company was very focused on getting a vaccine dose that was very tolerable in children recognizing that children are unique and you don't want a vaccine that is going to induce a lot of vaccine-related side effects. The data from that trial was submitted to FDA this week. The portion of the data package that FDA needs to review relates to manufacturing and chemistry and controls the so-called CMC portion of the review. That's also going to be submitted imminently to the agency. It's going to be on FDA to review that data very carefully make an independent assessment, but assuming that they agree that the data supports the market authorization of this vaccine, I think that it's possible they can conduct that review before the end of October.

I think if it slips, it's probably not going to slip by more than a couple of weeks. Mid-November becomes a base case maybe the end of October becomes an optimistic case. My hope is that's the window that we're working within. Assuming again, FDA conducts a thorough review, which they will, and they come to an assessment that the data that Pfizer has submitted supports a market authorization.

Now the vaccine for children ages six months to four years, that's being studied in two separate tranches. There's a data set looking at kids ages two to four, that could be available before the end of this year, perhaps late November. Then there's a dataset looking at six months to two years, that's going to be a little bit later because the trial started a little bit later. We'll read out a little bit later. That could slip to the end of the year, maybe early next year.

Brian Lehrer: There you go. Now, Michelle, there you got pediatrician Dr. Michelle in Woodcliff Lake. At least some timeline to tell your patients and their parents. I hope that helps just before you go, you mentioned the dosing for children compared to adults. Why, just for adults, does the Pfizer vaccine, and again, you're on the board of Pfizer, have a significantly lower dose than Moderna? There's evidence emerging that Moderna's protection lasts longer as a result.

Scott Gottlieb: They're different formulations. The question becomes how many doses of mRNAs? When you say dose, Pfizer's a 30-microgram dose of mRNA, a matured as 100-microgram dose of mRNA. The question is how many mRNA do you need to generate an equivalent amount of spike protein? It's the fact that the mRNA induces the production of spike protein in the human body, that we develop an immune response because we're developing the immune response against the spike protein.

Pfizer made the judgment based on the data that we had, that we could use a 30-microgram dose and generate a sufficient amount of spike protein by using a lower dose of mRNA. The presumption is you'll have less immediate vaccine-related side effects, like, pain in the arm, fevers because it's the marinade itself that is immunogenic. You get the "reactogenicity" from the mRNA. It can stimulate the immune system all on its own, even before it does its work of stimulating the production of spike proteins.

I think the data around-- My view all along what I've said, and there's been studies that came out that said Pfizer slightly better and some that came out that said modern is slightly better. I've said the same thing all along, regardless of the data. These are pretty comparable vaccines. I think they have a comparable profile. I think they're providing comparable benefit, I think any American who's offered one of these vaccines, including the J&J vaccine, which looks very good based on the data that's coming out, the long-term data. I think these are all safe and effective and good vaccines. You should take the vaccine that's offered to you.

Brian Lehrer: All right. 30 seconds for our final question, as Congressman Jeffries is standing by. I saw you say on TV the other day, or I read that you did say on TV the other day, that we're going to move maybe around Thanksgiving, which is soon from the pandemic stage of the Delta variant and COVID in general to an endemic stage. What does that mean?

Scott Gottlieb: Well, there's not going to be a bright line demarking the two stages, but at some point-- I think this Delta wave, maybe the last major surge of infection at some point, this virus just becomes an endemic virus, meaning it's persistent, it's omnipresent, but it's not causing the extreme death and disease and it's not spreading at these extreme levels that we're seeing right now. We still have to worry about it. It's still going to be a threat, but it's going to be something that becomes a more manageable threat. We're going to have to figure out how to reorder society in subtle ways to deal with it.

Brian Lehrer: Last, that you said Delta would probably be the last big deadly wave. People are starting to talk about the mu variant, which reportedly could be more vaccine-resistant than Delta. Are you concerned?

Scott Gottlieb: I'm concerned about all the variants we're seeing. There's conventional wisdom right now among some of the genetic epidemiologists is that if there's going to be a new variant that emerges that partially evades the immune protections that we've acquired either through vaccination or through natural infection, it's likely to be some variant within the Delta lineage and there's actually 20 different variants of Delta.

What it's likely to be is Delta some version of Delta acquire some features to partially evade our immune protections. We might have to reorient vaccines. We might have to move to a vaccine that is based on a Delta backbone for next fall or winter.

Brian Lehrer: Dr. Scott Gottlieb, former FDA commissioner, and now the author of Uncontrolled Spread: Why COVID-19 Crushed Us and How We Can Defeat the Next Pandemic. Thank you so much. Very informative. We really appreciate your time.

Scott Gottlieb: Thanks a lot.

 

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