The Munk Debates Podcast - Munk Dialogue on the bivalent COVID-19 booster: do the benefits outweigh the risks?

Episode Date: October 21, 2022

Health Canada, the FDA, and the CDC have approved COVID bivalent vaccines to anyone over the age of 12. This booster is different from previous COVID shots, targeting multiple strains of the novel cor...onavirus, including Omicron sub variants. And while the vaccine is being widely distributed, some epidemiologists are sounding the alarm. Dr. Paul Offit,  Director of the Vaccine Education Center and attending physician in the Division of Infectious Diseases at Children’s Hospital of Philadelphia, is one of two members on the FDA committee who voted against advising all adults over the age of 12 to get the jab. He joins us to talk about why this booster might not be necessary, and whether its benefits really outweigh the risks.  The host of the Munk Debates is Rudyard Griffiths - @rudyardg.   Tweet your comments about this episode to @munkdebate or comment on our Facebook page https://www.facebook.com/munkdebates/ To sign up for a weekly email reminder for this podcast, send an email to podcast@munkdebates.com.   To support civil and substantive debate on the big questions of the day, consider becoming a Munk Member at https://munkdebates.com/membership Members receive access to our 10+ year library of great debates in HD video, a free Munk Debates book, newsletter and ticketing privileges at our live events. This podcast is a project of the Munk Debates, a Canadian charitable organization dedicated to fostering civil and substantive public dialogue - https://munkdebates.com/ Producer: Ricki Gurwitz Become a Munk Donor ($50 annually) to get 72-hour advanced access to the full length editions of Friday Focus and Munk Dialogues. Go to www.munkdebates.com to sign up. Hosted on Acast. See acast.com/privacy for more information.

Transcript
Discussion (0)
Starting point is 00:00:01 These statues have to come down. It's always been a pandemic of the unvaccinated. The problem now is it's a pandemic of the willfully unvaccinated. Falling birth rates are good. They're good for our planet. They're good for our societies. We're not responsible for the escalation with Russia. We're not the ones who invaded Ukraine.
Starting point is 00:00:21 I don't think it's fair to portray people of color as victims. It is a very dangerous time in American politics. Hello and welcome to this, the latest in our installment. of Monk Dialogues. These are long-form conversations with some of the world's sharpest minds and brightest thinkers. On this edition of the Monk Dialogues, we're going to go deep into the science, the medicine, of the latest round of COVID-19 bi-variant vaccines, so-called boosters. This we know, Health Canada, the FDA, and the CDC have all approved these boosters for anyone over the age of 12.
Starting point is 00:01:04 And these shots are different from previous COVID vaccinations. They target multiple strains of the novel coronavirus, most notably the lineages of the virus that have come out of Omicron. And while these vaccines are currently being widely distributed around the world here in Canada, the United States, and everywhere, some epidemiologists are advising caution about those interested in getting the latest round of jabs. One of those scientists and big thinkers is Dr. Paul Offutt. He's the director of the Vaccine Education Center and an attending physician
Starting point is 00:01:44 in the Division of Infectious Diseases at the Children's Hospital of Philadelphia. For the purposes of our discussion today, he's also one of two members of the FDA, the Federal Food and Drug Administration Committee, who voted against asking companies like Moderna and Pfizer to make the latest round of Omnacron-specific Bivariant boosters. He joins us now to talk about why these boosters might not be necessary for everyone who they could certainly be very helpful for and why in some cases we may want to dig a little bit deeper about the risks versus benefits of getting this latest round. of shots.
Starting point is 00:02:31 Paul, thank you for coming on the monk dialogue. Always a pleasure to connect with you. I want to begin our conversation by having you comment on the news that you made earlier this fall as a member of the Food and Drug Administration's kind of official empaneled committee that approves all vaccines and boosters in the United States. You broke with the majority of your fellow members at the FDA. to not recommend booster shots for all Americans 12 and over. Give us your rationale for that decision.
Starting point is 00:03:12 Why did you take a different view from your colleagues? And what was the thinking behind your dissent on the FDA committee? Right. So in June 28th, the FDA's vaccine advisory committee on which I sit, was asked to consider whether or not we would approve the use of a bivalent vaccine as a booster dose moving forward. And I voted no. I was one of only two people that voted no. There were 19 yes votes. The reason I voted no was I didn't think there were any data that had been shown that made it clear that the bivalent vaccine, which in this case included both the original, the original recipe vaccine, the ancestral strain,
Starting point is 00:03:57 and then the second strain, the data we were shown, was BA1, which is the Omicron strain, the original Omicron. That's not the way this vaccine was going to launch. It was going to launch as the ancestral plus BA4, BA5. But in any case, even the data that we were shown clearly didn't make it clear that this was any better than just boosting with the monovalent vaccine. I would still argue we don't have any data that shows that that's true.
Starting point is 00:04:22 And what the FDA decided to do was, withdraw their emergency use authorization for the monovalent vaccine, thus only allowing for that bivalent vaccine booster. I wasn't saying that boosters weren't a value. I think boosters are a value. I was just saying that I don't see why that bivalent booster was any better than the monovolent boosters that we were getting. Very clear. Thank you, Paul. Let's back up here a little bit. What exactly is a booster? I guess in my mind, when I hear the word booster, I think somehow that it's different from the vaccines that I've had to date and not maybe different just in the composition of what's in it, but what it actually does. So explain to us, what is a booster and is it in any way
Starting point is 00:05:06 significantly different in what it contains and what it does to us vis-a-vis the other inoculations that we've had to date for COVID-19? Yes. And here's why. I think let me, let me explain just by going back to the beginning. So in October, November of 2019, a strain of virus, a bat coronavirus made its debut in the human population. It was called SARS-CoV-2. And a couple months later, in January of 2020, that virus was isolated and its gene was sequenced. So now you could make a vaccine. All the vaccines that are made, Pfizer's MRNA vaccine, Moderna's MRNA vaccine, Johnson & Johnson's Vectored Virus vaccine are all designed to prevent that strain, the original strain, the Wuhan One strain. Now, that's not the strain that left China.
Starting point is 00:05:56 The strain that left China was really the first variant. It didn't have a Greek letter designation. It was just called D614G. And that's the strain that swept across Asia, swept across Europe, swept across the United States, killed a couple hundred thousand people, only to be replaced by the alpha strain because it was more contagious,
Starting point is 00:06:15 only to be replaced by the Delta strain because it was more contagious. So that really was the first year. The first from December 2020, when a vaccine, was available, the MRNA vaccines were available, to December 2021, those were the strains that circulated. So the question was, did the vaccine that we had this Wuhan-1 vaccine protect against these variant viruses? And the answer was yes. This was a study done by the CDC
Starting point is 00:06:39 in December 2021, looking at the one-year experience with that vaccine, a two-dose vaccine. And what they found was looking at 10,000 people in this study, that the vaccine continued to hold up to do what it was supposed to do, which is protect against severe disease, because that's the only reasonable goal for this vaccine. The only attainable goal for this vaccine is protect against severe disease, keep people out of the hospital, keep them out of the intensive care unit, keep them from dying. Two doses was enough to protect through that whole year. Then Omicron hit. That was the end of December 2021 and the Omicron sub-variance, which then take us to the present day. Did the vaccines work as a two-dose vaccine then?
Starting point is 00:07:22 And the answer was not as well for certain groups. So the CDC did study showing that a third dose decrease your risk of hospitalization and that later that a fourth dose to a lesser extent decreased your risk of hospitalization. But who benefited? Was it everybody or was it really just certain high-risk groups? And the answer was, according to the CDC data, only certain high-risk groups, specifically people who are immune compromised, people who have, had the kind of high-risk medical conditions where even a mild illness could land them in the
Starting point is 00:07:53 hospital, like long-term heart disease, kidney disease, lung disease, et cetera. And then the third group were people who were elderly, or as Dr. Walensky, our CDC director, says, thank goodness, the elderly elderly, meaning people over 75, which is good because that lets me out. So then, just within the last few days, there was another study done in the United Kingdom, which included the United Kingdom, Scotland, Northern Ireland, Wales looking at, and this was like a 30 million person study trying to answer the question, who benefited from booster doses? Booster, meaning boost the immune response that you got after those first two doses. Who benefited in terms of protecting against severe disease? And the answer was exactly the same. People who were immune
Starting point is 00:08:36 compromise, people who had high-risk medical conditions. And here, elderly was defined not as people over 75, but people over 80. But again, we're talking about older people. So, When the CDC on September 1st, the United States CDC on September 1st said, we recommend a booster dose, a third dose, for everyone over 12 years of age, I just don't think that the data support that. I think a more targeted approach makes sense. Let's back up here a little bit and just try to understand a few of the insights you shared with us. The first, I guess, that maybe is surprising to some people is you're indicating that the current science does not seem to indicate that
Starting point is 00:09:15 a booster shot today based on the original wild strains versus a booster based on the new variance has much difference in terms of efficacy or outcome. Is that correct? And if so, what does that say about either the boosters themselves or what they're doing to our bodies to, in a sense, elicit protection? Right. I think the best way to understand why is to look at the individual components of the immune response that are associated with protection. If you're trying to protect against mild illness or asymptomatic infection, you need a high level of neutralizing antibodies present at the time of infection, at the time of exposure to the virus. What happened with Omicron and the Omicron subvariants is those variants were immunovasive for protection against mild illness.
Starting point is 00:10:12 Even if you've been vaccinated, even if you've been naturally infected, or both, you could still get a mild illness. But that's really not the critical part of the immune response in terms of protection against severe disease. Protection against severe disease is mediated by something called T cells. And there are two different groups of T cells. There's the so-called T-helper cells, which help B cells make antibodies. And then there's a critical kind of cell, which gets scant attention, unfortunately, called cytotoxic T-cell. Cytocetal toxic, armful. So these are cells that kill virus-infected cells.
Starting point is 00:10:46 Those are the cells that are probably most important in preventing against severe disease. Now, the good news, if there's any good news to be had from this pandemic, is that the part of the virus that's recognized by these T-cells are much more conserved. So whereas, for example, where antibodies are recognizing regions on the SARS-CoV-2 spike protein that drift, which can be dramatically different from the Wuhan-1 strain to, say, the B-A-4-5 strain, that's not true for T-cell recognition. There's still there's about 80% conservation for T-cell recognition between the original Wuhan-1 strain and now BA4, BA5. And that's why people are still protected against severe disease who are otherwise healthy and young, because they're recognized in that part of the virus that's conserved across all of these strains. That's why it's very hard to show a difference, actually, in terms of protection against severe disease if you're going to try and look just at these variants because everything works.
Starting point is 00:11:40 that's super helpful very clear i'm learning something here so thank you um is there a reason there for paul potentially to be optimistic that we're seeing something happen here which could suggest that the future of this pandemic won't be as worse as the past in that if that t-cell response has been elicited through the initial vaccinations that we received maybe we've received one or two boosters many of us, myself included, obviously have had COVID recently. Does that mean, Paul, that potentially, you know, we can now be a half glass full when we look at this pandemic and its future trajectory and course? Well, yes. I mean, I think there is every reason for optimism. When this virus rolled into this country in, say, January, February of 2020, what didn't we have? We didn't have
Starting point is 00:12:37 monoclonal antibodies. We didn't have antivirals. We didn't have vaccines. And we had a completely naive population. We were immunologically a blank slate for that virus. And so you'd have, as we move towards, say, fallen ones, you'd have 3,000 deaths a day, 3,500 deaths a day, 4,000 deaths a day. Then we develop vaccines by the end of December. And the virus continued to sweep through the population. So now, as distinct from early 2020, when we had 0% population immunity, now we probably have 95% population immunity, people who've been vaccinated or naturally infected or both. And natural infection does prevent severe disease. So it's a much, much different story right now. I think the question that's going to need to be answered going forward is going
Starting point is 00:13:20 to be have to be answered by two groups. One is the CDC, CDC epidemiologists in our country and then the equivalent in other countries. And two are academic immunologists. And here's the question they need to answer. Take somebody like me. I had three dose of vaccine. My first dose was in December of 2020, right when the vaccine came out. My second dose was in January of 2021, and my third dose was in November of 2021. And then six months later, in May of this year, I had, I had, or May of this past year, I had a infection. I had a natural infection. So I've had three doses in a natural infection. I suspect I have high titers of T cells, high frequencies of T cells in my body. And so I think I'm protected.
Starting point is 00:14:05 I suspect for a fairly long time against severe disease. I'm not going to be protected against mild disease because my neutralizing antibodies will fade over six months. That has to happen. And that's what did happen. I mean, I got my third dose. And then six months later, I had a mild natural infection, a two-day natural infection. There's no avoiding that.
Starting point is 00:14:22 I think that moving forward, we are going to have to get used to the fact that mild infection and virus circulation is going to be part of this virus, even if the whole world were vaccinated and even if the virus never mutated. We're going to have to get used to that. What we shouldn't have to get used to is having severe disease. And so the question is for someone like me, how long am I protected for? Or for a healthy person, less than 65 years of age, who's received two doses, three doses of the vaccine, for how long are they protected?
Starting point is 00:14:50 And so the CDC can answer that question, and the academic immunologist can look to see, well, you know, what kind of T-cell responses are hanging out over time. And then we'll know, really, who does benefit from a booster dose over time. Okay, you're no slouch as a vaccineologist with some pretty impressive scientific accomplishments of your own. So I'm not going to hold you here, Dan, I think, but what do your instincts tell you? You know, looking at the course of the data and what we're seeing out there, do you think that protection will be long-lasting? I think protection against severe disease will likely be long-lasting for healthy young people. I think what happens when you get older or your immune compromise, especially, is that you aren't very good at making T-cell response.
Starting point is 00:15:32 I think for people who are younger but have comorbidities, like say severe lung disease or severe heart disease, when they get even a mild infection, that could land them in the hospital. So there's sort of two separate groups in that sense. But I think that my sense is that protection probably will be long-lasting. I think what I imagine happening over time is that you're going to see this virus,
Starting point is 00:15:54 continue to circulate, continue to cause mild disease, and continue to cause severe and occasionally fatal disease in some. And so I think our challenge moving forward is that you're going to see this virus, forward is protect those vulnerable groups. And remember, every year in the United States, three and a half to four million children are born who are completely susceptible to this virus. Now, Paul, we're hearing a lot about new variants. It seems almost a week doesn't go by where there's a report. Sometimes they seem a bit sensationalized in the media about a new variant that seems to show incredible capacity to break through in terms of the vaccines that have been
Starting point is 00:16:29 administered, but also the natural immunity that people have been acquired, the so-called reinfection. Are you concerned about these new variants? Are you concerned about the perceived risk? It certainly has discussed a lot of a variant that suddenly emerges that is not only highly transmissible, but has unfortunately increased kind of lethality. I know these are kind of known unknown, so we're speculating here, but I just want to get, again, what your kind of instincts tell you what you feel is happening out there in terms of your conversations with colleagues and what you're just seeing in the science. Right. What this virus has done, which I think surprises people, because I don't think people thought coronaviruses could do this. I think people always understood
Starting point is 00:17:15 influenza viruses could do this, but I don't think people thought coronaviruses could drift in the manner that these viruses are drifting. The good news is the drift still has been, in terms of protection against mild illness. Because it's basically what is evading, the immunovaciveness of these strains has been against, in terms of neutralizing antibodies. So the neutralizing antibodies you've gotten from being vaccinated or naturally infected or both don't work as well to protect you against mild infection with these viruses. But T cells still do. So what I would worry about is should a strain arise and we need to look. We need to have the kind of international surveillance systems that inform us of this, that a strain should arise.
Starting point is 00:17:55 that is completely resistant to protection against even severe disease. Then we're starting all over again. We're not there. We may never be there. That might never happen. And when people sort of talk about, for example, a universal or a pan-sarbecovirus vaccine or universal vaccine, you could argue as long as T-cell immunity holds up, we're still largely protected against these different strains.
Starting point is 00:18:16 And I think that probably the worst communications error we made, and we've made many communication errors with this vaccine, was back in July of 2021 during an outbreak in Provincetown, Massachusetts, when sort of thousands of men got together, celebrate the July 4th holiday. 79% were vaccinated. Nonetheless, there were 346 men who, despite being vaccinated, got infected. Four were hospitalized. The hospitalization rate of 1.2%.
Starting point is 00:18:45 That's great. That's a vaccine that's working well. The rest had mild or asymptomatic infection, which sadly were labeled breakthrough infection. The word breakthrough implies failure. That's not a failure. That was a moment to celebrate that vaccine. It really was. In fact, there was a senator, a Republican senator from South Carolina
Starting point is 00:19:04 that when he got a mild upper respiratory tract infection associated with sinusitis, he said, quote, correctly, this would have been much worse if I hadn't been vaccinated. Right. And that's what we should have, we should have trumpeted how good this was, but we did the opposite of that. We used phrase like waning immunity and breakthrough infections, infections, thus holding this vaccine to a standard it cannot possibly meet.
Starting point is 00:19:27 These are short incubation period, mucosal infections, like influenza, like rotavirus, like pariolense virus, like respiratory syncytrovirus, you are never going to eliminate these viruses. This notion of COVID-Zero is fanciful. So you're going to have to get used to the fact the virus continues to spread, continues to cause mild disease, and just identify those groups who are at highest risk to prevent severe disease in them. That's the only reasonable goal here. And I just think we don't explain that well. Hey, Monk podcast listeners, I wanted to let you know about our other weekly audio program.
Starting point is 00:20:05 It's called Friday Focus. And hey, guess what? It comes out each and every Friday. It's half an hour long. And it provides you with a masterclass on international events, all the big issues and ideas shaping our world. We've got that for you. each and every Friday here at the Monk Debates, simply access via our website, triplew monkdebates.com.
Starting point is 00:20:30 Click on Friday Focus in the top right navigation. You'll get all the details or check out a sample of the program in the same podcast feed as the main Monk Debates podcast. I hope you'll join us for the next edition of the Friday Focus podcast. Now back to our program. Paul, a lot of people have a concern. about long COVID. And there's a perception, maybe accurate or not, that, you know, even mild infections
Starting point is 00:21:00 can lead to the symptoms associated with long COVID. So to what extent should we factor into our thinking about getting boosted and the benefits of, you know, our current level of immunity versus maybe a more vigilant stance of, as you say, artificially increasing our antibodies to keep them high. in a sense, all the time to really reduce the actual risk of infection itself amongst all age groups to, again, address this concern out there about, wow, I really don't want long COVID. That's something I'm going to go to a significant series of extents and lengths to avoid. Great question. And that's probably the question I get asked most frequently.
Starting point is 00:21:48 Here's what I would say. The question is, does vaccination, including repeated booster vaccination, protect against long COVID. How many times do I need to be vaccinated to protect myself against long COVID? So there was one study in Italy that just got published. And long COVID is many things. I think it's hard to define. Its definition is variable,
Starting point is 00:22:08 not only sort of in different parts of this country, but in different countries of the world. But here's the way the Italian study was done. What they looked at was what was the incidence of long COVID in people who got COVID who had not been vaccinated? And the answer was around 42%. 42% of people who continue to experience symptoms more than 12 weeks after their COVID infection. If they'd gotten one dose of vaccine, that 42% number dropped to 30%.
Starting point is 00:22:32 If they got two doses of vaccine, that then got COVID, that 30% number dropped to 17%. If they got three doses of vaccine, that 17% number dropped to 16%. So there really wasn't any difference beyond that second dose. Now, whether that holds up in the United States or holds up under different definitions of COVID, we'll see. But that study did not make a case for booster dosing anywhere beyond the second dose. What would you say, Paul, to someone listening to this thinking, well, you know, 16, 17%, percent, that's still almost one in five. And those are just simply, you know, unacceptable risks to me.
Starting point is 00:23:09 That their perception of that is that it's a significant health risk and therefore, you know, repeated and scheduled boostering every what it would be 90 days. if you really want it to keep your antibodies high consistently is the course of action that they want to take to zero to get like can they zero that risk out in effect through repeated boostering I don't think so unless you want to maybe it's possible if you boost yourself three times a year keep your neutralizing antibodies high decrease your chance of getting mild illness by doing that that's possible but I was was taken by this Italian study because there was no difference between that second dose and that third dose, which is to say you were maximally protected against long COVID to the degree you're going to be protected after two doses. There wasn't an advantage to a third dose, and I think one could assume there's probably not an advantage to a fourth dose. I think when you hear people in public health now talk about how you need to keep getting
Starting point is 00:24:10 boosters to decrease your risk of long COVID, I'm perfectly willing to believe that, but it would be nice to see some data that support that because right now the data don't support that. Fascinating. So basically, if you're going for a fourth and a fifth and a sixth booster, probably you're plateauing there in terms of the efficacy of one to the next in terms of any additional protection against long COVID. Let's talk about younger age groups, because as you say, the FDA has come out and here in Canada, too, recommendations that, you know, children, as young as 12 and up, you know, consider boosting with these bivariants. bi-variant versions. What is your view of the risk reward for younger people? There has been reporting, as you know, about effects, cardiac and otherwise, very small, but nonetheless
Starting point is 00:25:08 still there amongst young populations who have been inoculated with the MNRA vaccines. where do you come down on that kind of risk-reward calculation for younger groups and boosting children and young adults? No, that's a really good question. I would say if you had to ask me, what's the question that upsets me the most? It's when people say, yeah, well, what's a downside? There's always a downside. I think to any medicine or any therapeutic, in this case, any biological, there's always a potential downside. And so if you look at healthy young people, especially people less than, say, 30 and who are male,
Starting point is 00:25:47 clearly this vaccine does in sum, and it's not a trivial percentage. It's roughly 1 in 45 will cause a transient, short-lived, self-resolving immune response against your own heart. It's true. I mean, there was a study just done in Thailand, looking at 300 children between 13 and 18 years of age. And then right before the second dose, they got blood. and then obtained blood, this is after the second dose of Pfizer's vaccine, three doses, three days, seven days, 14 days later, and saw that you had a spillage into your bloodstream of two heart enzymes, so-called troponin, creatine kinase, that those levels came back down again.
Starting point is 00:26:26 But there are studies also showing, and I think there's an article coming out in science, which is going to go through these data, showing that even four months later, six months later, although those heart muscle enzymes have now decreased, you do still see when you do heart MRIs, you know, these magnetic resonance imaging studies, that you still see some evidence of an effect. And be humble here. Realize that there's always a spectrum of illness and that there may be longer-term effects
Starting point is 00:26:52 with regard to heart effects. And so if the benefits are clear and certainly getting vaccinated, I think the benefit is clear because remember the virus itself can cause myocrytitis. But once you get beyond that, talking about a third dose and a fourth dose, and the benefits aren't clear for healthy young people,
Starting point is 00:27:08 than the risks, even if they're theoretically, even if they're apparently small now, are not trivial. And one in 45 is not trivial. You know, just I think what we initially, when our committee considered these vaccines, and we looked at, say, the myocarditis risk in, say, the 16 to 29-year-old, you know, was around 1 in 6,700. But that was clinical myocarditis. There clearly is a, that was the tip of a bigger iceberg. There are also people who are starting having this subclinical myocarditis, which may also have longer,
Starting point is 00:27:38 of effect. So again, benefits have to be clear before you ask people to accept risk. Yeah, and maybe it's just important also to remind listeners, and maybe you can do that for us, the actual relative risk of a younger person in terms of severe illness, hospitalization, and death. Is it correct to assume that that is still very low? And is it right? Because often I know we make these imprecise calculations about the risk of influenza for different. age groups versus COVID, but could you say amongst that younger healthy population, in fact, maybe the risks of influenza in terms of severe illness and death are greater than that of COVID?
Starting point is 00:28:20 So about 1,000 children have died in the United States. A little more than 1,000 children have died since this virus came into the country in 2020. And when they die, only about a third of those children have comorbidages that would have put them at higher risk. So two-thirds of children, i.e. healthy young children, can be high-year. hospitalized and can die from this virus. When we see children, I guess the disease that scares me the most because it occurs in that 5 to 13 year old range kind of peaks at nine years of age, this so-called multi-system inflammatory disease, where a month after basically recovering from a COVID infection,
Starting point is 00:28:53 you make an immune response to your own heart, your own liver, your own lungs, your own kidneys. And those kids are sick, and sometimes they go to the ICU and sometimes they die. I think as of right now there have been about 9,000 such cases in this country, and there have been about 70 deaths or so. So can you be seriously hurt by COVID if you're a young person? Yes. Do, does a young person clearly benefit from getting a vaccine? Yes. Do the risks? Do the benefits of the vaccine in young people clearly outweigh the risks? Yes. I think what what I'm talking about is beyond that, beyond that say first two doses in the case of Pfizer's vaccine for the less than five year old, the first three doses. Do the benefits
Starting point is 00:29:34 of the booster dosing clearly outweigh the risk? And I'm saying I don't see that, right? now. And until the epidemiological studies make that clear, I just didn't agree with that recommendation that everybody over 12 in the United States should receive a booster dose, because I really do think we should focus just on those who are most likely to benefit in terms of protection against severe illness. So yeah, let's talk about the public policy consequences of a recommendation for boosting at 12 and up. What do you see as the drawbacks of that recommendation, either in terms of people's perceptions about the vaccine? We know that uptake is very low at this point. Some people concerned about that. I don't know the extent to which you are concerned.
Starting point is 00:30:13 I think it's less than 5% of Americans have opted at this point for the bivariant booster. So what's your sense of what comes out of the decision that you went against? Well, it's interesting. The people who have decided to get it are interesting, those at highest risk. So in some ways, they know that. I think they figured that. out. Certainly, if you look at the uptake in booster dosing and then stratify it by age, meaning 75 to 85 to 75 and 75 and 75, you'll see that it's certainly the elderly, elderly, I would argue, who have largely chosen to get this additional dose, that's good. I think people who are immune compromised see this as benefiting them. And then people
Starting point is 00:30:59 who have serious, say, heart or lung disease also see that. So, but the general population generally doesn't see that as being critical to them. I think at some level they're right. That's interesting. So what is your recommendation at this point if someone is trying to figure out, in a sense, what they should do? Let's just kind of summarize with different age groups. What would you recommend? First, for young people, let's say 25 and older, and then that age group often seems to be bracketed off 25 to 50 or 60. And then, you know, are there gradations of people's vigilance here that should care?
Starting point is 00:31:38 kick in as we go higher up into different age groups, or is it more important to think about your comorbidities and issues that you might have, you know, regardless of your age that could affect your health? I think number one is age. This virus, unlike flu. I mean, flu accounted for probably 10% of his deaths with flu occurred in nursing homes.
Starting point is 00:32:05 It's 40% for this virus. I mean, this virus is the angel of death for people who are elderly. And so that group should get vaccinated. Over 75 or over 75 already get vaccinated. My mother is 93 years of age. She's now had her fourth dose. I think that's most important.
Starting point is 00:32:21 See, the term immune compromised is a broad term. I mean, some people may be receiving a monoclonal antibody for the rheumatoid arthritis. Other people may be on immune suppressive therapy because they've just gotten a heart transplant. So there's different levels, different grades of immune compromise. I think some people are so,
Starting point is 00:32:38 immune compromise that they're not going to respond to the vaccine, no matter how many doses they get. And for those people, you really need the kind of barrier protection, meaning, you know, masks, distancing, and just be really careful when you're out there. For others who have, who are more, who are to a lesser extent immune compromise, there you clearly benefit from an additional dose to boost what is to some extent an immune response that's not great. And then, and then I think people really do have serious, harder lung conditions, I think, you know, where even a mild illness could hurt them, that that sort of, that sort of, with three to six months of protection they're going to get by getting a booster dose, say,
Starting point is 00:33:12 around the winter time when this virus is more likely to circulate and more likely to cause a problem, because typically these are winter viruses. I think those people benefit. And then for the rest of us, you know, for people, healthy young people who've gotten two doses, or three doses or that plus or minus a natural infection, I really do think epidemiological studies need to answer those questions for us moving forward. I don't agree with the notion of a yearly vaccine for all. you know, which is the flu model.
Starting point is 00:33:39 I don't see that for this virus. Just one gradation here because I'm self-interested here. I'm 51 years of age. There's often 50 seems to be a cutoff, at least here in Canada, for our own health agency and its guidelines. It seems to stress the importance of getting a booster if you're over 50. Any sense of why we're choosing 50 is that important? You maybe seem to be suggesting the number where you might want to start.
Starting point is 00:34:07 or put more emphasis on the public communication around boosters could actually be older than that. So in the U.S., when we first made these recommendations for older people, the number that was used was 65. That's the retirement age. It was a number of people were used to define themselves as older. And then it dropped to 55. And the reason was largely lobbying by groups that felt like, you know, our, although you may, this may be true for, say, a Caucasian, middle-class, or upper-man. middle-class community, that if you look at other groups, the kind of comorbidies like
Starting point is 00:34:42 hypertension, obesity, is a phenomenon of the younger person. So let's cut it off at 55. I would say if you look at the data in terms of who is most likely to get severe disease if they didn't get a third dose, say, or didn't get a fourth dose, it's really the most recent studies by the CDC was 75, and the most recent studies, I'm talking the last two days by out of sort of England, Scotland, Wales, and Northern Ireland. it was 80. So I think it's really what Dr. Walensky refers to as the elderly elderly. So I think you're good, frankly, at 50-51. I don't put you in that older category. Fascinating. You must have
Starting point is 00:35:19 thought a lot about what's happening in China because we've, again, just seen the party Congress, this major event that sets in a sense not only Chairman G's kind of unprecedented third term as the de facto supreme leader, but also reiterated a commitment to a COVID-Zero. policy in China. Paul, what do you think they're trying to do there? Are they stuck in the sense that they don't have the vaccines that could seemingly, you've painted a picture here of a series of steps that could very quickly lead to, you know, widespread, not simply resistance against severe immunity and severe illness and death, but the challenge probably that they're thinking most about in China is the effects on their health care system and the extent to which they can protect
Starting point is 00:36:11 that health care system in the face of a wave of illness. So do you have any clues as to what the thinking is there, maybe what advice you might have for them at this point? So obviously China, it was easy for them to take the lead on developing a vaccine because the virus was there, was isolated, it was sequenced. I mean, you had then the tools to be able to make any kind of vaccine, whether it was an MRNA vaccine or these Johnson Johnson live, these sort of vector virus vaccines, they chose an inactivated vaccine. If you had to ask me at the beginning of all this,
Starting point is 00:36:45 which vaccine that I think would be best, that's the one I thought would be best. Take the virus, grow it up, inactivate it with the chemical, and then give that as the vaccine. That's the way that we make the polio vaccine. It's the way we make the hepatitis A vaccine. So it's a tried and true.
Starting point is 00:36:59 And the advantage of that is it's all four proteins. So the virus, it's a relatively small virus. It's only composed of four proteins. But now you're making a response to all four proteins. There's an advantage to that. I think there are certainly studies showing that in some ways you're better off being naturally infected, assuming you live in terms of your protection than being vaccinated because when you're naturally affected, you're going to make an immune response to all four proteins.
Starting point is 00:37:23 When you're vaccinated, you're making an immune response to one. I thought that would be the best vaccine. I was wrong. It wasn't nearly as good as people had hoped. So that was one. There's no reason China can't use vaccines that are not the inactivated vaccine. Even those were the companies that made it. They can buy that vaccine from the MRNA vaccines of Pfizer-M-Burdone.
Starting point is 00:37:44 I'm sure Pfizer-M-M-Durna would have no problem selling it to them. Or the J&J vaccine, or the AstraZeneca vaccine, which is another vector virus vaccine. So that would be one. The notion of COVID-Zero is just nonsensical. It's not going to happen. Unless what you do is you say everybody has to stay home. So, you know, closed schools, closed businesses, you know, test, test, test, isolate, quarantine, restrict travel. Then you can probably get there because we did get there.
Starting point is 00:38:12 I mean, you know, when we, the FDA Vaccine Advisory Committee, every March picks flu strains for September because it's a six-month production cycle. If you look at the data from like 2020, flu was gone, gone, which tells you how much worse COVID would have been had we not done all the restrictive measures we did. But that's not practical, first of all. And assuming that people are going to be going to work and they are going to be going to school and they are going to be interacting with each other, even if they wear masks, you're still going to see this virus circulating. So I think COVID zero is just a marketing thing. It's not certainly anything that's ever possible. I think where I, you know, the president of China, and I don't see that happening anytime soon, I would say that, you know, I would move in with the MRNA vaccines because they're really effective, much more effective than one would have ever imagined when we were first talking about that. these vaccines. So just finally, Paul, if we look at the future course this pandemic, it sounds like
Starting point is 00:39:05 generally you're optimistic that we're building up, you know, immunity, obviously facilitated by the original vaccines, which were thankfully highly effective. And now we've layered that over with a significant amount of naturally acquired immunity, which it sounds like might be more protective than just the vaccines themselves. Should we, Paul, be, and again, maybe this is to misunderstand what the boosters are. Should we be redeploying these boosters to other countries around the world that aren't as fortunate and affluent as we are? Like, would these boosters protect someone in Senegal to the same extent that my original inoculation began to protect me from severe illness and death? Yes. I think, frankly, the most disappointing thing that's happened
Starting point is 00:39:56 over the last few weeks was when the FDA withdrew its EUA for the use of just the monovalent booster dose. So what happens to those vaccines? I mean, they're excellent as a primary, you know, as they're excellent. And so, you know, what's the, what's the immunization rate in this country? About 70 percent. What's the immunization rate in Africa? About 10 percent.
Starting point is 00:40:16 I mean, does that matter? Yes, of course, it matters to the world because the virus continues to reproduce itself, continues to create variants, which may become more and more resistance. I mean, you know, where did the, you know, the, you know, where did Omicron come from? The period to come from South Africa. So it affects all of us. And I just don't see that sort of international strategy
Starting point is 00:40:36 that really should exist because it is an international problem. You know, people get on planes and travel. And as long as that's true, if you don't believe that, just look at that polio case in Rockland County. That probably, I mean, although this particular man who got paralyzed
Starting point is 00:40:51 by that so-called circulating vaccine-derived type 2 strain, he didn't travel, but he went to a, he was at an event about a week and a half before he got paralyzed where there were people who had come from Israel and other countries where these kind of viruses are circulating. What happens in the world affects all of us, so you're right. And, you know, we've seen another virus emerge that caused a lot of sensation in the media, which was monkeypox. It seems that that threat has waned. I don't know if that is, in fact, a correct assessment of the state of monkeypox. pox today, but what's happening here, Paul, I guess, to end on, like, are these viruses becoming
Starting point is 00:41:31 somehow more prevalent? Do you think the frequency of them is increasing? We, you know, had Ebola in the not-so-distant memory, COVID now, monkey pox. Is something happening here? You know the argument. The argument is one about humanity pushing up against nature in a variety of different ways and stressing nature and nature in turn has a response to to our you know kind of invasion of of its geographies of its species are we right to think that we're in a cycle of history where we might see more and repeated viruses that possibly some of them could be future pandemics right so different reasons i mean if you look at sars co v2 that was a bad coronavirus that made its debut in Wuhan, presumably because of those markets, the Hunan market, where there was
Starting point is 00:42:31 an intimate association, if you will, among civets and raccoon dogs and pangolins and other intermediate species that allowed for that jump to occur. It's not the first time. I mean, SARS-1 was in 2002, MERS was in 2012. These were both pandemic potential coronaviruses because we live in close association with animals. That's true. Roto virus, you know, the vaccine I worked on is, you know, is originally, it's a mammalian virus.
Starting point is 00:42:58 It affects virtually many mammalian, frankly even avian species. Tuberculosis is, you know, is certainly something that affects a variety of mammalian species, good cows. So, you know, this, yes, so there's that. The polio story is really a different story. I mean, the polio story is that that was self-created. I mean, Albert Savin's oral polio vaccine could revert to essentially a paralytic type. And that's what affected that boy, that's.
Starting point is 00:43:22 man, rather, in Rockland County, but that solution's easy. Vaccinate. I mean, he was unvaccinated. He lived in a highly unvaccinated community. And that's why I fear he's not going to be the last case we see in this country as polia, as people choose not to vaccinate themselves against polio, because I think although we found, for example, that particular revertent strain, that vaccine revert and strain in wastewater in Rockland County or Orange County, we should look in every city in this country to see where it is. Because I find it hard to be that's the only place it is. remember, only one of every 2,000 people who's infected with that particular kind of vaccine virus that has reverted will become paralyzed. So he's the tip of a very big iceberg. And my question is, how big is that iceberg in the United States? But again, the solution's easy. Vaccinate,
Starting point is 00:44:06 and we don't. So that's part of it. Unfortunately, we live in a vaccine era. So the monkey pox can be certainly attenuated by giving this genios vaccine. And for someone like me who's born well before 1972 where we stop using the smallpox vaccine in this country, I'm probably protected against serious illness from monkeypox. So just to end on vaccines themselves, you know, maybe it's important for people just to hear this message that, you know, I've heard a formulation that there are, in a sense, two great accomplishments of the modern age, one of which was the invention of the steam engine and the kind of unleashing now for better or worse of hydrocarbons to power an age of prosperity that's lasted over two centuries.
Starting point is 00:44:54 And interesting, I've heard people say number two are competing with that in terms of one of the great accomplishments of the modern age, the modern era, is vaccines. Do you subscribe to that? And if so, why should we look at vaccines? And maybe why should we, frankly, make more of an effort just to understand how utterly transformative they have been of our way of life, of allowing us to have the society that we enjoy today. Because, you know, they've become demonized. There's a lot of, I think, fear and uncertainty often around them. And I think maybe people have lost sight to just how revolutionary
Starting point is 00:45:34 they are in terms of the human condition. Right. I think vaccines are a victim of their own success. I think when you, for example, see somebody like Jenny McCarthy go on Oprah's show and say, you know, that she'll take the measles every time because she feels that measles vaccine caused autism, which isn't true. But when she said that, you know, I'll take measles every time. It tells you that not only have we largely eliminated measles from this country, we've eliminated the memory of measles. Measles can make you sick and measles can make you dead as it did for 500 people, many of whom were children in, you know, before we had a measles vaccine in the early 1960s, then 50,000 people. people would be hospitalized every year with measles. Measles made you sick, and we don't realize that. I think, you know, smallpox probably killed 500 million people in the world's history.
Starting point is 00:46:20 And for those who survived it, many were left blind. It was a terrible disease, eliminated by vaccines. So vaccines, I think, are, if not the single most powerful tool, say, as compared to, say, sanitation, purifying, drinking water. It's certainly in the top three, and I do think we don't appreciate it. Because I think we're living in an era now where people just declare their own truths, including scientific truths, like, you know, vaccines cause autism or the MRNA vaccines change your DNA or whatever. And it's just, it's hard to watch, frankly. Well, Paul, we thank you for being such a clear and concise communicator for sharing your considerable kind of wisdom and expertise for us and just all your public service. prior to the pandemic, your innovation on important vaccines yourself, but also during the pandemic,
Starting point is 00:47:11 you're certainly somebody here at the Monk Debates community that we've really valued talking to over the last 72 months or so. So thanks so much for coming on the Monk Dialogues today. It's my pleasure. Thanks for asking. The Monk debates are a project of the Aurea and Peter and Melanie Monk Charitable Foundations. Rudyard Griffiths and Ricky Gurwitz are the producers. Be sure to download and subscribe wherever you get your podcasts. And if you like us, feel free to give us a five-star rating.
Starting point is 00:47:45 Thank you again for listening.

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