COVID vaccine answers, straight from Dr. Offit (vaccine co-inventor and member of the FDA Vaccine Advisory Committee) 🔥.
– [Zubin] Everybody, P. Diddy, Paul Offit, back on the show. Welcome, Paul.
– [Paul] Thank you. Happy to be here.
– [Zubin] You got dressed up, not for me, but for CNN. And I’m a little jealous, because the tie is hot.
– [Paul] Certainly was not for you. Absolutely not.
– [Zubin] I put a shirt on for you. Normally I’m shirtless. I’m not wearing pants, but that’s standard broadcaster procedure these days. Today, guys, we’re gonna talk with Dr. Offit, who is the vaccine guru of gurus, about all the things, including the third dose for adults. We’re gonna talk about kids 5 to 11. We’re gonna talk about all kinds of stuff. Naturally infected, “naturally” infected people, misinformation, we’re gonna talk about mandates, all kinds of things. Therapeutics, we’ll dig in. So Paul, let’s start with this. Everybody’s right now thinking about their kids ages 5 to 11. Governor Newsom in California just announced that as soon as this thing is approved by FDA for EUA, he’s gonna mandate it for kids. Let’s start with what are your thoughts. Just start spinning out how you think about young kids and the coronavirus vaccine.
– [Paul] When the virus first came into this country, early last year, the mantra, which was correct, was this is a disease of the older person. This is a disease that is more likely to kill the older than younger person, that when children get infected, they get infected less frequently. And when they’re infected, they’re infected less severely. And that’s largely true. I mean the, certainly 93% of the deaths, I think, at this point are in people over 55 years of age. So that holds true. However, things have changed epidemiologically. I mean, whereas children accounted for about 3% of cases when this virus first came into the country, now they account for about 27% of cases. And a lot of that has to do with differences in testing, but a lot of it has to do with they are a susceptible population. This is a highly transmissible variant, the Delta variant, and I think this virus has found a susceptible group. Now, at least the last few weeks, you’d have 200,000 cases in children a week, or 250,000 cases a week, 2,000 hospitalizations a week. And I was just on service at Children’s Hospital Philadelphia last week, and I can tell you, we had our share, representing the national average, of an increased number of children with SARS-CoV-2, some of whom were in the intensive care unit, and one of whom was on ECMO, meaning extracorporeal membrane oxygenator, the heart lung machine, and is fighting for her life. So it is, certainly the answer to the question can children suffer this disease, yes. Can they be hospitalized and go to the intensive care unit? Yes. Can they die? Yes, more than 500 children have died. So if you can prevent this vaccine, I’m sorry. If you can prevent this disease safely and effectively, then prevent it.
– [Zubin] Well, Paul, so let’s dig into what you’re really seeing there at CHOP on the wards. Are these kids having comorbidities? Are they obese? Is there a particular racial predisposition? What are you seeing on the ground with kids?
– [Paul] Right, so I would say often there is a co-morbidity that predisposes to serious infection, most commonly obesity, and then less commonly type 1, type 2 diabetes, chronic heart or chronic lung disease. But certainly I would say about a third of the children who we see don’t have any evident comorbidity to put them at high risk.
– [Zubin] Yeah, so about a third have no comorbidities at all. And in all age groups, or are you seeing like, say, a less-than-one-year-old infant is more represented than say a five-year-old or an eight-year-old?
– [Paul] Well, we certainly see young children. I mean, two year old is one of the children who is severely affected, so sure, we do see young children. There was, yeah, yes. We do see young children is the answer, although certainly the less-than-five-year-old is less commonly affected, but it can affect all age groups. And if it can affect all age groups, then we should try and protect all age groups, assuming we can do that safely. I mean, that’s the number one thing, because this disease is less frequently a problem in children, and often less severe. That safety, safety, safety has to be paramount.
– [Zubin] Yeah, so that benefit and risk ratio with kids is something that we look more carefully at. And you and I were talking about this, even in the early days of the pandemic. I have a 13-year-old and a 10-year-old, girls both. The 13 year old got vaccinated. We had that discussion, risk/benefit. She’s female; myocarditis risk’s a little lower. There’s social pressure in the Bay area, and we’re just kinda pro-vax people. We said, okay, on balance, let’s do this. For our ten-year-old, though, I’d love to hear how you would look at the data and make a decision for a 10-year-old girl. Say for me, like, talk to me about, you know, I’m your patient, she’s your patient. How would you talk to me about that?
– [Paul] Well, first of all, we do have a vaccine for the 12 to 15 year old, and it’s under-utilized. In that age group, about 45% or so of kids who could get the vaccine have gotten it. So while most of the people I know can’t wait for a vaccine for children, once we have a vaccine for children, it would be nice to actually get it. So the 12 to 15 year old is still under-vaccinated. And the 12 to 15 year old gets the same dose of the Pfizer vaccine as does the older adolescent, then, and adult. So 30 micrograms per dose, three weeks apart. The 5 to 11 year old is gonna get one third that dose. So that’s 10 micrograms per dose as a series of two doses. And then the six-month-old to five-year-old or four-year-old is gonna get three micrograms, so one tenth of the adult dose. That’s the way that’s gonna play out. So in terms of how you think about it, I guess I’d look back at that 12 to 15 year old recommendation. When that recommendation was made, I got a lot of angry emails, and the emails went like this. So you just did a study, Pfizer just did a study, of 2,300 people. Half got the vaccine, half didn’t get the vaccine. That’s it, that’s all you want to do, 2,300 children? And now you’re about to recommend it for millions and millions of children? Do you think you know enough at this point, because when you did a study in adults, Moderna did their study, it was 30,000. Pfizer did their study, it was 40,000, and now you’re gonna do 2,300 children and declare this safe and effective, really? And my answer to that is, I get that question. I mean, it’s what’s the most upsetting thing, actually, about being on the FDA Vaccine Advisory Committee, or the most challenging thing, or the most nerve wracking thing, is you are trying to predict what’s going to happen in millions of people after you’re looking at data in just thousands of people at most. You know, there were 18 cases of COVID in that 2,300-person study. So if you did a 23,000 person study, which one could reasonably do, there wouldn’t be 18 cases of COVID. There’d be 180 cases of COVID. All of those 18 cases were in the placebo group. And it may be most, if not all, those cases would be also in the placebo group, which means 180 children get COVID. So this is always the issue. What price knowledge, what is the human price of knowledge? When do you know enough? And just if you’ll allow me one rant, because I am an old person, as you can see on your screen, so I’m a child of the 1950s. I certainly remember polio. I mean, I was in a polio ward for six weeks when I was five years old. I remember polio, and my parents were, not surprisingly, scared to death of polio. Me and my two first cousins had to swim in this little sort of plastic pool in our backyard, because our parents would never let us go to a public swimming pool during summer. So Jonas Salk made his polio vaccine, took polio, grew it up in cells, purified the virus, inactivated it with the chemical formaldehyde, gave it to about 700 children in the Pittsburgh area, and declared it safe. He said, “This is it. It’s safe. I induce great antibody responses. This is it.” He said to his wife, Donna, “Eureka, I’ve got it.” And that was it, as far as he was concerned. He didn’t want to do any more than that, but nonetheless, the March of Dimes insisted on doing a large clinical trial, which broke Jonah Salk’s heart. He didn’t want to do that trial. He didn’t want to give placebo, meaning saltwater, to first and second graders heading into the summer in the United States, knowing polio was gonna cause a problem, as it always did. But nonetheless, that study was done. 420,000 children got vaccine. 200,000 got placebo. When the trial was over, Thomas Francis stood on the podium at Rackham Hall at the University of Michigan. He ran the trial and said those three famous words: safe, potent, effective. And those three words won the headlines of every newspaper in this country. Church bells rang out. Synagogues held special prayer meetings. Departments were stopped while that announcement was made. It was over Voice of America for Europe. Well, how do we know it was effective? We knew it was effective because 16 children died of polio in that study, all in the placebo group. We knew it was effective because 36 children were permanently paralyzed for the rest of their lives, 34 in the placebo group, and those children were my age. I was a first and second grader. I mean, but for the flip of a coin, they could have lived long, fruitful lives but weren’t allowed that. So this is always the issue. What price are you willing to pay for knowledge? And it’s never when do you know everything. You never know everything. There’s always unpleasant surprises. I mean, there is not an innovation that we have ever made that has allowed us to live longer than we did a hundred years, 30 years longer than we did a hundred years ago, that was not associated with tragedy, not one. And you know, that’s always true. Myocarditis, clotting, I mean, the embracing of the consequences, rare, rare consequences of this vaccine are always things that surprise you at some level. But we have to be open to the fact that we learn as we go, and everybody would think, “Okay, great. I’m just gonna wait until the learning curve is over.” It’s never over, is the problem.
– [Zubin] Mm. That rant is heard and acknowledged, Paul. I mean, and this idea of, again, the childhood vaccinations that have made us forget things like polio and smallpox and these diseases. They’re a victim of their own success in the PR Department, ’cause now people just don’t think those diseases are real. Even varicella, chicken pox, used to hospitalize, what, 10,000 kids a year. And now in the post-vaccine era doesn’t do that anymore. So these are a big deal now, but getting into sort of the risk side of this, right? So myocarditis is the big one that’s on everyone’s mind. Looking at the 5 to 11 data, that’s not quite been released yet, right? So Pfizer put out their top-line data, but you guys are still gonna be looking at the details soon.
– [Paul] Yeah, so we, the FDA Vaccine Advisory Committee, will meet on October 26. We usually get the sponsor’s report, meaning the company’s submission, usually about a week beforehand. I mean, I’ve already looked at the Moderna and Johnson & Johnson booster data for Thursday and Friday, so I got that a few days ago. We should get these data for the 5 to 11 year old. And usually, the FDA also reviews all those clinical cases and submits their own report. So these are usually two 100 to 120 page reports that you read before you go to these meetings, and then you’ll make your best estimate as to how you think you can move forward. You know, I think the myocarditis issue was a surprise, certainly. I mean, it’s primarily a male phenomenon, usually after the second dose, usually within four days of the second dose. If you take sort of that highest risk group, which is the young male between 16 and 29 years of age, the risk is about one in 40,000, so it’s rare. And I think people also need to know that SARS-CoV-2 also causes myocarditis. I mean, there was a JAMA Cardiology paper looking at Big Ten athletes. And what they did was they took about 1,600 people who were athletes who had COVID. And then what they did, they did heart MRIs on all of them, 100% percent of them, to answer the question, was there evidence of myocarditis in these people who had COVID? And the answer was yes. And it was in about 2.5%, so roughly one in 45 people, which is a whole lot higher than one in 40,000. So there aren’t, as is always true, there are no risk-free choices, just choices to take different risks. And I think the goal for any parent is to choose the lesser risk, but there is no risk-free choice.
– [Zubin] No risk-free choice, I think, is a key thing. And then you can haggle over what is the exact myocarditis risk number and so on, and there’s Israeli data and this data and that data and age-dependent, second dose. Is there any reason just like to do what the British have been doing and recommending a single dose for kids in that age bracket?
– [Paul] You know, again, what we know about that second dose is that, for mRNA vaccines, is that that second dose is really what induces the memory response, memory B-cell response, which then assures a more durable and long-lasting immunity. I mean, if you look at the cellular immune responses after dose one and two for both the Pfizer and Moderna vaccines, you didn’t really detect much in the way of memory after dose one for memory B and T cells. It was after dose two that you saw that. And after dose two is when you got your higher neutralizing antibody responses. So I don’t like that idea. I think that doesn’t put the child in the best position moving forward to protect them against SARS-CoV-2.
– [Zubin] Right, and this memory response is what’ll lead to the durable immunity, purportedly. And we’ll talk about previously recovered COVID patients a little later in the show, but we can think about how that second dose makes sense or doesn’t make sense in that population, but… So back to the myocarditis thing, ’cause I think it is interesting, what’s the proposed mechanism of this? I know smallpox vaccine has done this as well, historically. Is it an immune response? Is it something about, you know, we were talking, it’s been circulating, this mouse paper, where they injected intravenously, the mRNA, versus intramuscular, and found in the intravenous injection, there was more myocarditis than in the intramuscular. What do you think is going on here?
– [Paul] I think it’s immune mediated. I say that because it is a second-dose phenomenon, primarily, much more so than a first-dose phenomenon. This isn’t virus. I mean, it’s just viral protein. I mean, it’s messenger RNA that’s translated to a viral protein. I suspect as we look more, we’re gonna see that there is a cytokine or chemokine or a panel of cytokines or chemokines that is causing this reaction. The good news about this, and myocarditis never sounds good. There’s the term “mild myocarditis” is, I think, sounds like a contradiction in terms, I’m sure, to most people. Myocarditis is inflammation of the heart muscle. How can that ever be anything other than awful? But it does appear, at least what we’ve seen in our hospital, to be transient, short-lived, and without evident sequelae. So I think that’s good. I really will feel a lot better when we have a handle on the pathogenesis of this phenomenon, so that we can better predict it as we move forward with other vaccines.
– [Zubin] Mm, and so in your clinical practice, when you see myocarditis, it’s generally self-limited and no long-term sequelae, right?
– [Paul] We treat it with anti-inflammatories, don’t treat it with anti-inflammatories, it seems to be win-win. These kids get better.
– [Zubin] They get better, yeah. And one of the related questions to that was this question of aspiration. If this is an immune phenomenon, then it doesn’t seem like if you inject accidentally, intravascularly or intramuscularly, it shouldn’t really make a difference, yeah? ‘Cause you’re still getting an immune response.
– [Paul] Yeah, I mean that paper that you mentioned, it’s, I mean, you really have to mess up to inject something directly into a vein when you give a vaccine, especially when you’re giving intramuscularly. So I just didn’t see that as in any sense helpful, just sort of scared people. Again, I think that the other thing is MIS-C, this multi-system inflammatory disease. There, myocarditis is common. I mean, looking at these reviews, anywhere from 50 to 75% of people, children, who get MIS-C, and this has sort of been a 6 to 14 year old phenomenon, sort of, median nine years of age, that’s commonly myocarditis. I mean, we saw a bunch of kids, children, at our hospital last week, with this multi-system inflammatory disease, and myocarditis is invariant, common.
– [Zubin] Yeah, and one of the questions I would have is does vaccination of that age group actually prevent MIS-C in terms of… because we know that it’s not perfect at preventing infection, but is it better at preventing some of the sequelae of infection, long COVID, MIS-C, what are your thoughts?
– [Paul] So we need more data, but what makes me feel optimistic about that is that it’s not just a childhood phenomenon, this multi-system inflammatory disease. It also occurs in adults, so-called MIS-A, which I think is really underdiagnosed, as a guess. And I think you now have a lot of adults who’ve been vaccinated. Half the country’s adults have been vaccinated. And we haven’t seen this phenomenon of myocarditis following vaccination of someone who had, say, likely MIS-A, but was either undiagnosed or underdiagnosed. So, yeah, so I don’t think it’s gonna be a problem, as a guess.
– [Zubin] Got it. Yeah, yeah, yeah. Okay, so let’s shift from kids, because I think as that data comes out and FDA makes a recommendation, we’ll probably have you back and dig into it more, because I think parents are, again, a lot of parents are like, “When can I get this for my kid?” They’re, it’s like polio-level concern. And then a lot of parents are very concerned, and both you and I get these emails, right, on both sides of this, but Moderna and Sweden, the Nordic countries, stepping back and saying, “We don’t want to give Moderna at a young age, 30 and under people, because of the myocarditis risk being higher.” Can you unpack this? What’s going on there?
– [Paul] Good question. I mean, this is based on Nordic data that I haven’t seen yet. I saw that those two countries, Denmark and Sweden, right? Was it Denmark and Sweden? I think, that paused
– [Zubin] I think so. Yeah.
– [Paul] Yeah, they paused the Moderna vaccine for those people between, less than 30 years of age, right, ’cause those born after 1991, yeah, so 30 years of age, because of obviously this risk of myocarditis, which by definition they would have had to assume was greater than the risk of myocarditis from getting this disease. And I’d really love to see those data, ’cause I don’t understand that. I don’t understand that pause. It didn’t make sense to me, although frankly, when J & J was paused, that didn’t make a lot of sense to me either, when this is a phenomenon, the clotting phenomenon that we’ve seen with J & J, if you look at the US data, it’s about one per 500,000. With AstraZeneca, which is a similar vaccine, it was about one in 250,000. I didn’t get that. I think we’re terrible at communicating risk in this country and in this world. You know, I just think that we take very, very small or even sometimes theoretical risk, and scare the hell out of people by sort of blowing them up into being this major thing. As I’ve said before, there’s kind of no risk-free choices. This virus is common. John Udell, who is the Head of Virus Research at NIH, at the National Institutes of Health, I think said it best about a year ago. He said, “Over the next few years, you’re gonna have two choices, which is getting vaccinated or getting naturally infected, and getting vaccinated is always gonna be the better choice.”
– [Zubin] Okay, what you said about risk is absolutely right, the way it’s been communicated, the way we’ve understood it. And I’ve been ranting and raving about this. You and I had, on one of our early episodes. It’s like, man, we just have no idea how to understand risk here. And this idea is what I tell people is, look, you have a date with Delta at some point. Either you’re gonna have a condom in your purse, or you’re gonna go all out. And honestly I’d vote for having the condom, and that’s the vaccine. So actually this is a very good… This is a good sort of shift into, there was some thought that Moderna may have, in some Israeli series, maybe double the risk of myocarditis, which is still a small risk, but it’s also potentially a little more efficacious against infection and a little longer lasting, yeah?
– [Paul] Yeah, against asymptomatic or mildly symptomatic infection, the Moderna vaccine induces apparently better protection against that. We can talk about the booster dose issue, in terms of what the goal of this vaccine is in terms of preventing severe versus milder infection. But yeah, I mean, and that, again, it makes the argument for why it is that this is an immune-mediated phenomenon.
– [Zubin] Yeah, yeah, yeah. Immune mediated. The second dose means that then you get that re-priming of the immune and pssht, that’s it. Yeah, so okay. This is a perfect segue into boosters. Okay, so you’re on FDA Advisory Committee. The booster thing, talk about communication issues, and also just understanding the science behind this. This is freaking a lot of people out. Hit me, Paul. What’s going on with boosters, man? Or third dose, third dose.
– [Paul] Right, and that’s the critical difference. Is it a booster, or is it a third dose? And that is a different thing. And so we’ll talk about that. So I think the end of August, President Biden stood up at the podium and said on September the 20th, we were gonna make a third dose available for everyone over 16 years of age, which was not the right thing to do, for many reasons. I think, first of all, don’t give a date, ’cause what that does is it marginalizes the FDA and the CDC. There was a process here, and the process is what’s the problem? In theory, the problem is waning immunity. What’s the solution? In theory, the problem is solved by giving another dose. Where are the data that shows that that’s true, and then go to the FDA, which is a regulatory body, that says, “Okay, the company can now distribute that under that guideline of third dose,” and then it goes to the CDC, which then recommends it for certain groups. That’s the process. And that process was sort of skipped, and that made a lot of people upset. It did, and you can see, I don’t know if you’ve… We met on September 17th to discuss the booster dose. I don’t know if you watched that vote, but the original vote, which was, and first I thought I was gonna be the only one to vote no. You know, ’cause while we agree that those over 16 now can get a third dose. And that was the vote was no by a vote of 16 to 2.
– [Zubin] And you were in the no-vote category. Yeah, exactly.
– [Paul] No-vote category. Right. So here’s the way I put this together. So the question is, what is the goal of this vaccine? One could argue that the goal of this vaccine is to prevent serious illness, which is the goal of most vaccines. I mean, the goal of the chickenpox vaccine, the goal of the rotavirus vaccine, the goal of the pertussis or whooping cough vaccine, the goal of flu vaccine is to keep you from being seriously ill, so much so that you have to seek medical attention, or you have to go to the hospital or to the ICU or worse. Does this vaccine do that? And all the evidence is, epidemiologically, yes, which is to say that that all of the data that we’ve generated, study after study after study, either published by the CDC, presented by the CDC, or by the academic community, is that you’re in the sort of 80 to 90% protective efficacy for all age groups, including Delta, up to this current time. So as of now, the epidemiology does not support that this vaccine does anything other than consistently protect against serious illness. And that is consistent with the immunology. If you look at that data presented by people like John Wherry at the University of Pennsylvania here, or by Shane Crotty in La Jolla, I mean, what they show is that at least six months after immunization, the two-dose immunization, you have high frequencies of memory B cells, which is what you care about. And the thing with memory cells is they’re not making antibodies. They’re just waiting, waiting to make antibodies. And when you’re then infected by the virus, then those cells activate, differentiate, become antibody screening cells. That takes time, but so does becoming seriously ill. That also takes time, which can take up to 10 days, two weeks, plenty of time for activation and differentiation of those cells. So all the evidence is that if our goal is to prevent serious illness, we’re doing that, and there’s no need for another dose. Now, some people will argue, Dr. Fauci argues, that for this kind of vaccine, you need to have at least, say, four to six months interval between doses in order to get high frequencies of memory B cells, and he points to the polio vaccine, the hepatitis B vaccine, which are whole, inactivated viral vaccines, because that’s the best way to induce high frequencies of memory cells, and that’s true. The question is, is this vaccine like those vaccines? And I would argue it’s not, because this is not a whole killed virus or a purified protein vaccine. What this vaccine is, is it’s mRNA that goes into your cell, is then translated to a protein. So it’s a little closer, actually, to a live attenuated viral vaccine, where you also make viral proteins in your cells, and where a single dose often can induce long-term memory. So I’m not convinced that at any level, why we would need another dose, but if we put it in that category, I mean, I think Dr. Fauci makes this argument, this should have always been a three-dose vaccine. Had we not been a pandemic, this would have been a three-dose vaccine, because we would have needed that four-to-six-month interval in order to induce good memory, but we’ve induced good memory with two doses. And I think we’re learning about this messenger RNA technology, which is novel. And I think it’s surprising that it induces as high of level as it does of these memory cells, which will protect against serious illness. Okay, so then the second reason, so that’s the third dose. That would go under the third dose category, meaning it was always should have been a three-dose vaccine. The other reason, now we move to booster dosing. So what happens when you give this vaccine, or any vaccine, is over time, the level of neutralizing antibodies in your bloodstream will decline. That is, the level of neutralizing antibodies in your bloodstream directly correlates with symptomatic infection. Asymptomatic infection, mildly symptomatic infection, moderately symptomatic infection, low moderately symptomatic infection, correlates with neutralizing antibodies in the bloodstream. As that fades, then you’re going to be at higher risk of asymptomatic or mildly symptomatic infection. And that’s what you see. When you look at those curves, you see a decline in efficacy against that. And so people will say, okay, now in order to reestablish that neutralizing antibody level, I will give a booster dose. Okay, well, if that’s true, remember after you get this booster dose, levels will also decline over time. And so what are we really talking about? Are we talking about continued booster doses every year for a virus that is certainly nothing like flu? I mean, this is not a virus where natural infection or immunization in the previous year doesn’t protect you. You’re protected against serious illness, I think for years. We’ll see. We’ll see how this plays out, but it certainly looks promising. So if that’s the reason, if that’s the reason, then it’s probably not gonna be just one booster dose, and Albert Bourla, who’s the CEO of Pfizer, has said that. He said, “I think we’re gonna, we need yearly boosters.” And if your goal is to prevent asymptomatic or mildly symptomatic infection, good luck, because we don’t do that with any other vaccine. I mean, rotavirus vaccine, flu vaccine, pertussis vaccine, always there’s gonna be waning neutralizing antibodies, always you’re gonna be at risk of mild or asymptomatic infection. The biggest communication error we have made with this, and I am on record as saying this and will stand by this forever, was using the term breakthrough illness to describe an asymptomatic or mildly symptomatic infection. That’s not a breakthrough. The term breakthrough implies failure. That’s not a failure. When Brett Kavanaugh, who’s fully vaccinated, gets an asymptomatic infection, and then you see him on national TV, and the term used is breakthrough… I mean, he won, he did it. He just, he’s exposed to the virus. He has an asymptomatic infection. Congratulations. And same, Lindsey Graham. I mean, I don’t often quote Lindsey Graham when it comes to sort of medical or scientific issues, but I’m gonna do it here. When he was fully vaccinated, he got a mildly symptomatic infection, which was associated with sinusitis. And he said, and I quote, “This would have been much worse if I hadn’t been vaccinated.” Right. That’s exactly right. He didn’t say, “This is a breakthrough illness,” you know, “The Democrats screwed me.” He didn’t do that. He was right.
– [Zubin] You know, there’s a saying, Paul, never meet your heroes ’cause they’ll let you down, right? That is not true of Paul Offit. That was a beautiful, beautiful rant. Oh, my God. I agreed with every single word. Let me just repackage it very briefly in a one-liner. All right, when you talk about a third dose, what you’re saying is you need at least three doses to generate the memory durable B and T cell response that will give you long-term immunity to severe disease. When you talk about boosters, you’re saying, “No, you just want to top off the tank of those neutralizing antibodies so you can ward off any infection.” And the question is, what should we be shooting for? And how many doses is necessary to get the durable immunity, and how many boosters would you really want when the goal is prevent severe disease, turn the thing into a cold or a mild flu, instead of the deadly plague that it can be for people who are at risk. Right? Is that about right?
– [Paul] That’s exactly right. We’re asking you of this vaccine something that we ask of no other vaccine, and the reason, the difference, is if you get a flu vaccine and then you develop asymptomatic or mildly symptomatic flu, that’s a win. But the difference is there, you don’t get a PCR test and are quarantined if you have an asymptomatic or mildly symptomatic infection, which is true here. So I think that’s why we’ve raised the bar so high for this vaccine. I really wish we’d never used the word breakthrough. It implies failure, and these aren’t failures. And also, you do shed less virus if you’re vaccinated and then have an asymptomatic or mildly symptomatic infection, than if you were unvaccinated. And that misinformation came out of that Provincetown outbreak, where the CDC basically said that if you’ve gotten vaccinated and you have an asymptomatic or mildly symptomatic infection, you will shed just as much virus, you will be just as contagious, as if you weren’t vaccinated and had those same symptoms. And that’s not true. There was a Singapore study that clearly showed that wasn’t true. The way they did that study, I think, the way the CDC had done that study, was they only looked at one early time point, but of course there’s not gonna be a difference in an early time point. It’s the later time points where you see a dramatic reduction in shedding in the vaccinated versus unvaccinated person.
– [Zubin] And that’s something that was really frustrating, because that generates a billion emails, right? Like, “Hey, I was ready to get this vaccine, then CDC said it doesn’t even prevent me from spreading it to someone else. I have just as high a viral load.” Again, misinformation, misunderstanding of the information, mis-parsing and miscommunication on the part of CDC. So now you have people thinking, “Well, I was gonna do this as an egalitarian or a communitarian act, and it doesn’t seem like it’s gonna help. So now there’s only downside for me and no benefit for the community.” None of that is true. Shortening the duration of illness, shortening the amount of viral shedding, shortening whether you’re gonna get infected in the first place is all what happens with this vaccine, whether or not there are boosters are not, from the original doses, correct?
– [Paul] Correct, and that should have been what we… Now, I mean, you do learn as you go here. The CDC certainly is trying to do the right thing. But I think by using words like breakthrough, or saying you’re just as contagious, what it does it make people think, “Yeah, why am I getting this vaccine? It doesn’t even really seem to work.” It was just not, I don’t think we anticipated, heard what we were saying and see how it sounded to people.
– [Zubin] So do you think then that it’s crazy that Israel may be mandating a third dose to be considered fully vaccinated? Is it too early to say that?
– [Paul] Right, so when we met on September 17th, FDA’s Vaccine Advisory Committee, those were the data that were presented. There were two Israeli researchers that presented to us, ’cause for all of us, all the 18 voting members, well, all we saw was that the data presented by the CDC, where that protection against serious illness is holding up, holding up all age groups, holding up the Delta variant. So what’s the problem? And what they presented was that, okay, here, look at our… Here’s our study. And the study was just published, I think, this week in New England Journal of Medicine, here’s our study. And here is the 60 to… Here’s a group of people who we divided in half. Half got a third dose. Half didn’t get a third dose. And let’s see what happened in terms of protection against serious illness. Now, remember, 75% of people in that study were over 70 years of age. And if you looked at that study, there really wasn’t much of a benefit in the 60 to 69 year old. All of that benefit really was in the 70 to 79 year old. That’s where you saw the benefit. I believe that. I mean, I put that in the category of people, basically, who are somewhat immune less competent, immune incompetent. And for that group, there’s already a third dose recommendation. So I didn’t have a problem with that, but to then extrapolate that to the entire community. I mean, do I think that giving a third dose to the 40 to 49 year old or the 30 to 39 year old will make for lesser mild disease or lesser low to moderate disease? Yes, I think it will for some period of time, for maybe for a year. Do I think that that will mean somewhat less contagiousness? Yes. Do I think that that will in any sense move the needle on this pandemic? Not much, because the answer to solving this pandemic is to vaccinate the unvaccinated. I mean, that’s the problem here. That’s the issue, and that’s the hard part. I mean, that’s the hard part right now, how to figure out how to do that.
– [Zubin] I mean, that sounds like exactly what I’ve been telling people. And it’s interesting, ’cause my wife is roughly my age, in the forties, and works at a major academic medical center and went and got a booster because they were offering it to everybody. Because again, part of the thing is anyone in high-risk exposures, whether or not you’re at high-risk yourself. And she got it because she just doesn’t even want to get a mild or an asymptomatic infection and have to be quarantined and all that. But the downside was she had a day of just feeling like she was hit by a truck, fevers, misery. And so there’s even just the symptomatic cost of that trying to avoid the infection. So again, everything has it’s, like you said, there’s no risk-free choice. That’s not much of a risk, but it’s more of a hassle. And the question is what’s the benefit, right? So, Paul, I don’t know what age group you’re in, but would you get a booster yourself, then, based on this data?
– [Paul] I think I fall into three categories for getting the booster: one, I’m over 65, as you can see on your screen, two, I work in a hospital where I take care of patients who have COVID, so I am at increased risk of being exposed to COVID, and three, I’m actually, don’t have a spleen. So that puts me into, all three of those put me in a category of I should get it, but have I gotten a booster yet? I haven’t gotten it yet. I’m in no rush. I suspect I will get a booster, just because I’m in all three categories, and I think that that will offer me something over the next year or so. And it’ll decrease my chance of getting an asymptomatic or mildly symptomatic infection. So somewhat of a benefit, but I think not a dramatic benefit. I hope I’m wrong. I hope that what we’ll learn here over the next year is that giving a third dose to people who are already gotten the first two doses has an impact. But I can tell you this right now, we look at people who come into our hospital over 12, or the hospital next door to us, the Hospital of the University of Pennsylvania, which takes care of adult patients. When we admit kid people to the ICU, it’s not because they haven’t gotten a third dose. It’s because they haven’t gotten any doses. That’s the problem.
– [Zubin] Yeah. Yeah, that’s exactly right. And then that’s what I’m hearing through emails, too, with people who are sick. It’s very rarely that they’re hospitalized having been vaccinated. It’s the unvaccinated that are being hospitalized. So this is one last question on the booster piece. Should we just have spaced that first dose out more? Would that have helped with neutralizing antibody levels?
– [Paul] So have a two-dose vaccine where the second dose is given much later than the first?
– [Zubin] Correct, like 12 weeks like the Brits did.
– [Paul] Yeah, I’m not sure, because what I would like to see data, like to see studies done is to show, as John Wherry has done, what is the frequency of memory cells? ‘Cause that’s the issue. How good are we at inducing memory? Do we need to separate it out in the case of mRNA vaccines by more time? Because right now it looks like the memory responses are pretty dramatic. And we are learning about this kind of technology, the mRNA technology. I think it’s another reason that makes this such an amazing technology.
– [Zubin] Yeah, it’s-
– [Paul] Two doses, relatively short interval, high levels of memory, and that is supported by the epidemiology, at least up to at least six months after that second dose, amazing.
– [Zubin] Got it. Got it. And so relating to that, then, this is an interesting segue into this idea of COVID-recovered patients who have some degree of immunity. You know, we talk about, well, maybe we should measure antibody levels to see were they really infected and are they immune? What’s the deal with antibody level, neutralizing antibody measurements and thresholds? Are they totally useless? What’s going on here? Why don’t we even know what the threshold is?
– [Paul] Well, I think it is a correlate. I think neutralizing antibodies in your circulation is a correlate for protection against infection. It is, but again, it’s not necessarily a correlate for protection against serious illness, because there it’s memory, and neutralizing antibodies may have faded, but you still have your memory cells. Those memory cells are long lived. I mean, I was naturally infected with measles as a nine-year-old in the late 1950s. And I have a high frequency of memory B cells in my body. So when I was taking care of some, we were taking care of immigrants from Afghanistan in our hospital over the past week, We have a number of children who are now in the hospital, some with the question of measles. The occupational health person called me and said, “You need to provide me with evidence that you’ve gotten a measles vaccine.” “Measles vaccine,” I said, “Come on, man, I’m a child of the fifties. I had measles. I am better off than anybody who’s gotten the measles vaccine in terms of my frequency of memory B cells. I’m good.”
– [Zubin] You know, that has so many parallels to people who’ve been COVID infected, who are like, “Man, bro, I’m already there, Dogg.” So let’s actually… God, Paul you’ve said so many anti-vaccine things today. I mean, you’re basically an anti-vaxxer. I mean, I hate to say this. I hate to brand you with the same… By the way, they accuse me for being an anti-vaxxer just for even asking these questions, now. It’s like, there’s almost a dogmatic thing, because everybody’s been so polarized. But so back to the natural immunity thing, natural immunity, like you said, like nature has a great PR agent. Natural immunity sounds really cool. This idea that there probably is definite immunity with previous COVID infection, but what’s the nuance around that? Because I think people see this as, “Okay, well then I have a pass,” but how do you think about this?
– [Paul] No, I think, does natural infection protect you against serious illness associated with re-exposure? Yes. Does natural infection provide a relatively high level of memory B cells? Yes. I mean, if someone says, well, someone could reasonably… Now, that said, there was a study conducted where they took people who were naturally infected, divided them in half. Half got two doses of mRNA vaccine, to show that moving forward, you were 2.5 fold less likely to get infection if you got, as compared to the group that just was naturally infected and not boosted. There’s also studies done showing you really probably only need one dose of mRNA vaccine if you’ve been naturally infected. I wish the CDC actually would make a recommendation on that, because I think the data support that. But I think if somebody says, “Look, I don’t want to get, I don’t want to have to get a vaccine. I don’t want to have to be, say, mandated to get a vaccine, because I’ve been naturally infected,” I think that’s actually a reasonable argument to make. The problem is bureaucratically it’s a nightmare. I mean, in our hospital, we do have a mandatory vaccine policy. And so how would we know that someone was naturally infected? They could hand us their test that says look here, I was PCR positive, or I was antigen positive, which you can buy off the internet. So, I mean, it’s a little hard to do that. The other thing you could do, and it would be approved, would be to get a serology, take the blood and see whether there’s antibodies against the nucleoprotein, the SARS-CoV-2 nucleoprotein, ’cause you can only get that from being naturally infected, and that would be approved.
– [Zubin] And there’s not really an easy commercial test for memory B and T cells against SARS-CoV-2, yeah?
– [Paul] No, it’s all research-provided.
– [Zubin] Right, right, right. So that’s not really a thing. So it just becomes, we’ve talked about this from the beginning, that it’s a bureau, from day one, you were like, yeah, natural immunity is a thing, but it’s very hard from a systematic standpoint. But I think this idea of having CDC say, well, one dose if you’ve been naturally infected might be acceptable if you’re looking at things like mandates and stuff might be helpful. I think it’s generated a lot of mistrust, honestly, Paul. This is more a human thing than a science thing. People are like, “Hey, they’re denying the science that there’s actually immunity,” and then they get very… I heard your debate with Martin Kulldorff about mandates and things like that. I thought it was a good conversation back and forth about both angles on that kind of thing, which, yeah, maybe we’ll link to it, maybe not, but it’s more that that’s the kind of discourse in the country right now. The truth is it’d be nice to just wave a wand and just let everyone get at least one dose of the vaccine, ’cause then we would have such robust community protection against severe disease that we would stop talking about this, like you and I would stop going on and talking about COVID at all, which would be great, right?
– [Paul] Although, two doses. If it’s an mRNA vaccine, I would say two doses. I mean one dose of the J & J vaccine also induces decent memory, so that you could argue for that. Although J & J is now, we’ll review these data on Friday, are looking as a two-dose vaccine, but if it’s mRNA, it’s two doses, because that’s your best chance to have memory. So I wouldn’t go with just one dose, two doses, which is not a big deal. I mean, you can do this. It’s just amazing to me that Kyrie Irving refuses to be vaccinated. And he plays for the Brooklyn Nets. You have to be vaccinated to play in Brooklyn’s arena. Right? I mean, that’s including the people who walk in. So he stands to lose as much as $30 million. If he takes this stance through the whole season, he could lose $30 million in salary because he won’t get two doses of a vaccine. I mean, he’s not being asked to get a heart transplant, but it shows you how dug-in people are on this issue. You know, that how strongly they feel about it. He’s willing to lose $30 million. Wow.
– [Zubin] Yeah, I think you put your finger on it. It’s a psychological reactance people have to being either told what to do or feeling like they can’t trust the authorities. And this is something that I, when I was listening to your discussion with Martin Kulldorff, you talked about Scandinavian countries, how their vaccination levels are quite high in the absence of mandates, but you made a really crucial distinction between Scandinavia and the US, and what is that?
– [Paul] They trust their public health system. They trust their doctors. They believe that doctors and public health people are working in their better interests. And so they’ve never had mandates and they have very high vaccination rates. On the other hand, Saudi Arabia had it where you got your birth certificate at one year of age, and that was only after you’d been vaccinated. So technically you weren’t born until you’d gotten vaccinated. So different countries do different things. I mean, the frustration for me is in a better world, we wouldn’t need mandates. in a better world, you can make the libertarian argument, right? Trust me, I am going to do what’s best for myself and my family, because I’m gonna be well-educated on these subjects. The question is how you get your information, how do you become educated, and there is a lot of bad information out there that causes people to make bad decisions. So now you have 65 million or so people in this country who haven’t been vaccinated, and who are basically saying, “Look, I’m gonna be fertile ground for the continuous spread of this virus, and continued generation of mutations and possibly continued formation of variants, which could be more and more resistant to vaccine-induced immunity and continue to do harm. What are you gonna do about it?” And you can do nothing about it, you can stand back and just continue to let it happen, or you can try and at least do mandates where mandates work. By the way, mandates in schools are not exactly a new phenomenon. We’ve had school mandates since the 1970s. And so you would argue if we have mandates in school for like the polio vaccine, it wouldn’t be unreasonable to have a mandate for this vaccine where the virus is killing like upwards of 700,000 people in this country. And now children, too, more than 500 children. It’s, you know, but it just hits us so wrong. And we were a country founded on individual rights and freedoms. We don’t like to be told what to do. Here, though, you’re not just making a decision for yourself. I mean, if you don’t want to get a tetanus vaccine, great. No one’s gonna catch tetanus from you. This is different.
– [Zubin] Yeah. You know, it’s been such a polarizing, divided time, and you’re right, this country has a kind of different ethos. It’s interesting to see what’s happening in Australia. They have some pockets of severe hesitancy there, and they don’t have the lived experience of COVID like we do, because they’d really shut it down. So they don’t know people who’ve gotten sick and so on. Actually, let’s do a quick, ’cause I know you’re, I want to respect your time. Let’s do a quick misinformation rounds here, just like bang through. Lot of people still hit me with pregnancy questions. Man, I’m this many weeks, I’m that many weeks. Should I get the vaccine? Should I not? I know the Society of Maternal Fetal Medicine recommends it. ACOG recommends it. What’s the latest data that we have that says that we can really reassure women that first of all, it’s dangerous to get COVID when you’re pregnant, and it’s not dangerous to get the vaccine.
– [Paul] Right. So it’s interesting to watch the way this played out, ’cause it’s been in three separate phases. The first thing was the vaccines, let’s take the mRNA vaccines as an example. Those two trials did not include pregnant women. And normally, although there were, I think, three dozen pregnancies that occurred during those two trials, because as Jeff Goldblum said in the movie “Jurassic Park,” life finds a way. So there were a few, and they were equally divided in the placebo, vaccine group, as you would imagine. But what happened, typically what the CDC will do when pregnant women aren’t studied for a particular vaccine, they will say it’s contraindicated in pregnant women, but they didn’t say that here. What they said here, because they knew you were at a two and a half to three-fold greater risk of being hospitalized or being mechanically ventilated or dying if you were a woman who was pregnant as compared to a woman of the same age who wasn’t pregnant, that you were at greater risk of this virus. So they didn’t say it’s contra-indicated, rather, they said that a pregnant woman could reasonably choose to get this vaccine. It wasn’t a recommendation. It was more of a can reasonably choose to get it. And then what happened was thousands and then tens of thousands of pregnant women did choose to get it, which provided a database, which Tim Shapiro at the CDC and others sort of mined through this v-safe system to see, let’s look, let’s compare these tens of thousands of women who were pregnant and got a vaccine, to tens of thousands of women who were pregnant and didn’t get a vaccine, to see if there’s any difference in terms of pregnancy outcome, maternal health, fetal health, neonatal health. Was there any difference? And there were no differences, other than that you were less likely to be seriously infected as a pregnant woman, if you’ve gotten the vaccine, so that was good. And then they changed. The CDC then said that they recommend the vaccine for pregnant women. What’s happened over the last week is because now that there’s been a number of pregnant women who have been hospitalized, who have been put on a ventilator, who have delivered their babies severely prematurely, it’s really urgent now. And so they’ve changed to now they urgently recommend that pregnant women get the vaccine because of this onslaught of pregnant women who are now getting hospitalized.
– [Zubin] Yeah, it’s a crucial distinction, and having that data set, I think we can put a lot of pregnant women’s minds at ease, because that whole, we’ve talked about it in multiple shows, the miscarriage myth, all this other stuff that come up from early misinformation that was spread around, just simply not true. Now, relating to that, people with auto-immune conditions often will message me. I don’t know, I have this, I have scleroderma, I have Sjogren’s, I have this. My immunologist told me not to get the vaccine. What are your thoughts on that?
– [Paul] No, it’s always the fear of the unknown, because what wasn’t study during these trials, we know people who had a variety of diseases, like rheumatologic disease, cardiac disease, et cetera, ’cause they generally selected for more healthy people. So you don’t know, but you know, there’s no reason why it should be a problem, first of all, just biologically, and now, as half the adult population has been vaccinated, or more than half, I think you can feel pretty comfortable at this point that that’s included a variety of people who have had a variety of problems. And if it had been a problem specifically for one group, I think we would have heard about it at this point.
– [Zubin] Yeah, that’s my assessment. And so relating to that, people still seem to be under this impression that mRNA vaccines cause blood clotting, diffuse blood clotting. What are your thoughts on that?
– [Paul] No, I mean, the severe clotting that did occur with both the AstraZeneca replication-defective simian adenovirus vaccine and the Johnson & Johnson replication-defective Ad26 vaccine. So yes, but it’s extremely rare, but that’s where you saw this so-called thrombosis with thrombocytopenia syndrome, but not with the mRNA vaccines.
– [Zubin] Yeah. It’s just not something that happens. And in fact, your risk of blood clotting with natural COVID infection is vastly higher, risk of neurologic complications, et cetera.
– [Paul] Yeah.
– [Zubin] Did you there was some recent data on looking at long COVID symptoms and finding that people who were vaccinated in the setting of long COVID symptoms seem to do better, and there’s no good explanation. Like, is there a persistent viral pool that it’s helping or is it a placebo? We don’t know, but the good news is if you do have those symptoms, you have been infected, you probably might benefit by getting the vaccine. Even if it’s a placebo effect, it’s a real effect on symptoms.
– [Paul] Right, which is why it would be important to do a placebo-controlled study, so then you can see whether it was a placebo effect. By the way, I’m all for placebo effects. Don’t get me wrong. I think there is a physiological basis to placebo effects. I’m all for it. But I wouldn’t like take a placebo instead of like antibiotics for meningitis. I mean, I think that’s where placebos aren’t so good.
– [Zubin] Right. If there were a specialty, Paul, that I could have done, it would have been placebotologist. I would have been, like I devise fancier and fancier and more believable placebos and actually probably saved more lives than the entire medical industrial complex, with the exception of vaccines, right?
– [Paul] Right. They work.
– [Zubin] They work, exactly. So other myths, we’ll leave the other… One of the main things is people say VAERS, VAERS, VAERS, VAERS, so many complications and side effects and deaths in VAERS. What’s your take on VAERS?
– [Paul] Yeah, I mean, so at best, at its best, the Vaccine Adverse Events Reporting System is a hypothesis-generating mechanism, and it worked for myocarditis. I mean, suddenly there were these reports of myocarditis, primarily in boys and young men, primarily after dose two. And so that raised the question, could this vaccine be doing it? The VAERS, however, is not a hypothesis-testing mechanism, ’cause there’s no control group, just got a vaccine, had a problem. So then you went to groups like the Vaccine Safety Datalink and other places where you can look at people who got the vaccine, didn’t get the vaccine, and you could see there clearly was an increased risk for myocarditis, albeit a rare risk, in the sort of one in 40,000 rate for boys of a certain age, 16 to 29, of boys and men of that age. So I think that’s at its best, and rotavirus, when the Rotashield vaccine came onto the market in the late 1990s, it went on the market for about 10 months. And it was VAERS where there were suddenly these reports of intussusception, which is intestinal blockage, which can be a serious illness. And then when it was tested, it was found to be a rare cause, sort of in the one in 10,000, one in 30,000. That’s VAERS at its best. VAERS at its worst is this just noisy system where anybody can report anything. And so you’ll have political pundits who will get on television and say things like 3,000 people have died of VAERS, have died from this vaccine, more than any other vaccine in history. But remember that there’s about two people per hundred thousand in the population who will die every day, and if you’ve given a hundred million doses, as when this particular pundit said that, that would have meant 2,200 people would have died within 24 hours of getting a vaccine, 4,400 within 48 hours. So I mean the vaccines don’t prevent everything else that people die from. And so you can still get this vaccine and die. I mean, this vaccine doesn’t make you immortal. You know, when Hank Aaron died two weeks after getting a vaccine, of stroke in his mid-eighties, I mean, there was all this talk about whether the vaccine could have done it. And this is a problem with vaccines. They’re only designed to prevent vaccine-preventable disease, not everything else that happens in life, and that’s the problem with the VAERS.
– [Zubin] That’s awesome. You know, it’s funny, as you were talking, I was mentally creating a deep fake of you, using different phrases that you just said, to make an anti-vaccine propaganda video. You know, “You can get the vaccine and die.” I’m telling you, that’s my next career is propaganda, anti-vaccine propaganda. So speaking of which, let’s wrap it up with a couple quick things. One is Molnupiravir. Thoughts on this, or is this out of your sort of thing?
– [Paul] No, no, so Molnupiravir is a so-called RNA-dependent RNA polymerase inhibitor. So that’s good. It keeps the virus from reproducing itself, but it has to be given early in infection. This is not an in-hospital drug. It’s a drug you would have to take early on to prevent hospitalization. And it’s about 50% effective at preventing hospitalizations. I think there were about 740 people in the study. There were like 48 hospitalizations in the placebo group, something like 24 or so in the vaccine group, so it was 50% effective at keeping you out of the hospital. There were eight deaths in the placebo group, none in the vaccine group. So with very small numbers, it was 100% percent effective at preventing death. But remember, vaccines are like 99% effective at preventing hospitalization. And as we say, ’cause I work at the University of Pennsylvania, and we have to give a Ben Franklin quote at least once every time we give a talk, an ounce of prevention is worth a pound of cure. You’d much rather prevent something than treat it, because treatments, especially for viruses, are not perfect.
– [Zubin] Yeah, absolutely. And ivermectin?
– [Paul] Yeah, right. I think talk to your large-animal veterinarian to see if ivermectin right for you. Again, it’s all study-able, but to-date, there’s no data. It’s interesting how people who won’t get a vaccine are perfectly willing to take hydroxychloroquine or ivermectin, which can be harmful, and certainly there’s no evidence that it’s helpful. I don’t know why that’s true.
– [Zubin] Monoclonal antibodies. Joe Rogan was like, “Hey I’m not sure I got vaccinated or not, but I basically snorted monoclonal antibodies and took IV vitamin Z.” It’s just crazy stuff, but you know, there’s cognitive dissonance in all of us. I have it myself. Novavax, is it coming anytime soon?
– [Paul] Yeah, it was just reported in the New England Journal of Medicine. I do think… Novavax is an adjuvanted purified protein vaccine, in a manner similar to the hepatitis B vaccine or human papillomavirus vaccine, or yeah. So data look good. I do think the more the merrier, so let as many vaccines be tested and brought to the public as possible, because I think you’re gonna learn about different side effect profiles with different vaccines. And you’re gonna learn about perhaps different duration of immunity with different vaccines. So this virus is gonna be living with us for a while, so the more the merrier.
– [Zubin] The more the merrier, I agree. A lot of people have asked me about that, want to get it, and feel like it’s an older technology and they kinda like that. You know, there’s a psychological benefit to that. So, okay, last thing. Flu. Flu is happening. We’re almost out of time in a couple minutes. Tell me about what do you anticipate is going on with flu this year? Can you get the flu vaccine the same day now as your coronavirus vaccine, because it used to be you couldn’t, and why the distinction?
– [Paul] So yeah. Well, the CDC actually very early on said that you could get them at the same time, which was unusual, because usually in order to get a vaccine, say, onto the schedule, you have to do something called concomitant use studies where you prove that there is no interference in the immunogenicity profile or safety profile when vaccines are given together. Here, because we had such an under-vaccinated population because of the pandemic, we said you can get them at the same time. My feeling about that is, if you’re willing to come back two weeks later to get the other one, I probably would do that, just because if there ever is a safety issue, then you know which vaccine it was, but the CDC’s official recommendation is you can get them at the same time.
– [Zubin] Right, and what do you think is gonna happen with flu this year? You have your eye on that? Are you on the committee that chooses the strain for the flu vaccine?
– [Paul] Yes, I’m on the FDA Vaccine Advisory Committee. We pick those strains in March, and normally what we do when we pick those strains is we look at the strains of influenzas that are circulating in areas usually right before we get them. So Australia, South America, et cetera. There wasn’t much flu that circulated last year. I mean, that’s what happens when you mask, social distance, shut down schools, shut down business, and restrict travel, is you basically have eliminated respiratory disease. Influenza typically kills between 75 and 150 children every year in this country. Last year, it killed one child. I mean, that shows you what it means to do the things that we did last year. And it tells you it would’ve been even worse for SARS-CoV-2 had we not done those things.
– [Zubin] How much of it is viral exclusion from innate immunity due to COVID circulating, and how much of it is all our stuff that we did, do you think?
– [Paul] I think it’s all the stuff we did. I think it’s absolutely all the stuff we did. It’ll be interesting. Remember we always have some level of immunity to flu because we’ve been exposed to flu strains before and there is always some cross-reactivity. But, that’s not true for this one.
– [Zubin] So easier target for our interventions like masking, distancing, closing schools, stopping travel. Yeah. Awesome. Paul, we’re out of time. You have another thing to do. You have a tie on already. I love you so much, brother. It’s such a joy. I always learn something. The audience always learns something. Please come back, if you’re not angry with me for being me. We’ll do it again next time.
– [Paul] Love to. Thanks.
– [Zubin] Aw, thanks, brother. See you next time. Guys, share the video, and we are out. Peace.
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