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Coronavirus Vaccine Update With Paul Offit

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To identify the key insights or developments described in this video
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With the Pfizer and Moderna coronavirus vaccines reportedly under review at the US FDA for Emergency Use Authorization (EUA), Paul A. Offit, MD, of the Children's Hospital of Philadelphia, returns to JAMA's Q&A series to provide an update on what to expect, prospects for vaccine rollout and distribution in the coming months, and ongoing safety surveillance. Recorded December 2, 2020.

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Transcript

This transcript is auto generated and unedited.

>> Howard Bauchner: Hello and welcome to conversations with Dr. Bauchner. Once again, it is Howard Bauchner, Editor in Chief of JAMA. And, once again, I'm joined by Paul Offit. Paul is the Maurice R. Hilleman Professor of Vaccinology at the Perelman School of Medicine at the University of Pennsylvania. Welcome, Paul.

>> Paul Offit: Thank you.

>> Howard Bauchner: Paul, do you get tired of doing these interviews?

>> Paul Offit: Not with you, Howard.

>> Howard Bauchner: You do so many. Remarkable news, Paul, in the last week or ten days. You were quoted over the weekend about how pleased you were with the initial results, acknowledging you hadn't seen all of the data. Have you been surprised by what Moderna and Pfizer have reported out?

>> Paul Offit: I think every scientist on the face of this Earth is probably surprised. I mean, if you said to 1,000 scientists in January, when a paper was published in "Science," that reported the SARS-CoV genome. And you told those 1,000 people that within 11 months you're going to have two clinical trials of a novel vaccine strategy, messenger RNA, naked messenger RNA. That is going to be studied in 44,000 and 30,000 people respectively, using two different constructs of messenger RNA that will induce protection at least soon after the second dose of 95 percent effective against protecting against disease. Including severe disease. Including people greater than 65 years of age. I think no one would have thought that was possible. I certainly wouldn't have thought it was possible. Tony Fauci, who's been sort of a promoter for the mRNA vaccine, I mean, he thought that we could have a vaccine as early as the middle of next year initially. I thought that was really aspirational. So, yes, I'm surprised.

>> Howard Bauchner: Are you pleased that the same mRNA model has worked in a similar fashion in two different vaccines? Is that reassuring to you? Let's try again, Paul. Is it reassuring, is it reassuring that the results are similar between the two different vaccines?

>> Paul Offit: It's exactly what you want to see because they're different in several ways. They have different nucleoside analogues. They have different ways to essentially attenuate the capacity of messenger RNA to induce innate immunity. They have different complex lipid delivery system. That's why one is much more amenable to shipping and storing at minus 20. Whereas the other is shipping and storing at minus 70 to minus 80. You have different groups testing these vaccines. You have different doses. One, Pfizer's is 30 micrograms. Moderna's is 100 micrograms. And with essentially the same results across the board. It's exactly what you would have wanted to see.

>> Howard Bauchner: Now, what do the results tell us? Are, can people communicate disease if they've been vaccinated? How long does protection last? Does it prevent death? There's a series of questions that people have articulated that's unknown. Could you just go through what we do know and don't know, Paul?

>> Paul Offit: What we do know is that soon after getting the second dose, depending on whether it's Pfizer or Moderna's trials. One week or two weeks after second dose, you see vaccine efficacy against disease, mild to moderate to severe disease, of about 95 percent. That's the best time for inducing an immune response is right after that second dose. So we're looking at the best possible data as far as that's concerned. So people worry reasonably. Well, how about six months later? How about a year later? Because you're looking at the best possible immune response. The other thing people worry about a little bit is that, if you look at Pfizer and Moderna's trial, the instance of disease in the placebo group was either 0.7 percent or 0.85 percent. That's low. You would have expected something more 3, 3.5 percent. And when you see it low like that, you worry that you're seeing something, you know, called volunteer bias. Which is that, who volunteers for these trials? It may be people who are more attentive to their health. More attentive to physical distancing. Mask wearing. And, therefore, may be exposed to a lesser inoculum of virus. So you're looking at people who are exposed to a lower inoculum of virus and, therefore, less likely to suffer, you know, moderate to severe disease. It may be easier to protect against a low inoculum disease than a high inoculum disease. So then when it gets out there into the real world that it's not going to be as effective as you'd hoped. That's another thing people are worried about.

>> Howard Bauchner: Do you know enough about the data that you've seen to date about age? Gender? Race and ethnicity? Because those questions have come up repeatedly. Will it be effective in a 40 year old and a 65 year old? Is there any reason to expect that it would be as effective in an obese versus not an obese individual? Who, an obese individual, as we know, is a major risk factor for disease. Have you seen enough data to yet know that?

>> Paul Offit: So as a member of the FDA's vaccine advisory committee, we have received the packet that is going to be discussed a week from now. So I've looked through those data, but I'm not allowed to comment on them until we have our meeting on December the 10th. I will say this. On December the 8th, that packet that I got a couple days ago is going to be available to the public. So we'll all be able to see that. But that's the critical question. Are, when we, as an FDA advisory committee, rule on this vaccine or approve or don't approve this through emergency use authorization, have we adequately represented people who have various comorbidities like obesity? Or diabetes? Or chronic lung or heart disease? Have we adequately represented the, those populations? Either African-American or Latinx populations? Do we, have we adequately represented the greater than 65 year old? I can tell you that all of that is addressed in this document.

>> Howard Bauchner: Now, when I opened up the newspaper this morning on the Internet, England approves vaccine. England approves vaccine. England approves vaccine. How much pressure are you and the FDA going to be under to accelerate the data that you've now seen to move up the December 10th meeting? Or for Commissioner Hahn to approve the vaccine more quickly? Do you feel like there's going to be pressure in the next week building on both you and the FDA?

>> Paul Offit: I don't think so. I mean, you're really talking about a week. You're not talking about, you know, two months from now. So I don't see that as a huge, I mean, the hardest part of this vaccine is going to be getting it out there. I mean, getting it out there into the arms of the people that need it. I think a week is not going to be the critical decision. You want to make sure that people look at these data. I mean, I was fortunate enough to be part of a team at Children's Hospital Philadelphia that created the rotavirus vaccine. When that, that was a 70,000-person prospect, a placebo-controlled four-year trial. When Merck shipped those data down to the FDA for review, all the clinical data, this is Penny Heaton, who was head of the trial at the time, said. If you just take all the papers that we generated and put them one on top of the other, it would exceed the height the Sears Tower. It's a lot of information that has to be digested. You don't want it to go too fast. I mean, you don't want to believe that, you don't want us to just, for example, look at the press releases, say these data look great. And just say, let's go. You want to, you've seen the tip of the iceberg. We're going to look at the base of the iceberg and make sure there's nothing at the base that is cracking and that makes us wonder about whether the tip is really true.

>> Howard Bauchner: Now, Paul, let's get to what are the more difficult questions. Within my own family the debate about safety between my children, my sister-in-law and my wife. I didn't participate. I just listened to the debate. And then I walked in the room, and they said, Howard, can you tell us these vaccines are safe? We believe that they work, okay. We believe that the Dr. Offits and the Dr. Faucis of the world are going to be right. These vaccines work. That's not the issue that's going to persuade people to be vaccinated. It's the concern about safety.

>> Paul Offit: Fair enough. I mean, I think most of the people who are going to be getting this vaccine eventually are healthy young people. And so, who are unlikely to die from this virus. I mean, I think safety is the number one thing people are worried about. What you're going to be able to say now, when these vaccines roll out now, is you're going to be able to say that at least in tens of thousands of people there was no uncommon serious side effect that was seen within two months of getting a dose. And if you look at the serious side effects of vaccines, and there are serious side effects of vaccines. They all invariably occur within six weeks of getting a dose. I mean, whether it's the rare occurrence of Gullian-Barre syndrome following a flu vaccine, which is roughly one in a million occurrence when it happens. The rare occurrence of viscerotropic disease, so-called viscerotropic disease following yellow fever vaccine, which is basically yellow fever following yellow fever vaccine. Which is, again, about a one in a million phenomenon. Obviously, gelatin allergies or latex allergies occurred virtually immediately in this inception, following the RotaShield vaccine occurred, you know, within a couple weeks, obviously, of getting the vaccine. The, or polio vaccine was a rare cause of polio in roughly one per 2.4 million doses. That was found, obviously, very quickly. So Dr. Fauci said this the other day on television, that usually, if you have a serious side effect, you'll find it out quickly now. That said, 20,000 people isn't 20 million people. And you're only going to find out a rare serious outburst event post-approval. That's definitely true. That's always true. But the good news is there's systems in place like the Vaccine Safety Datalink or VAERS or the CISA system to pick that up. So, you know, and there's another side to this. I mean, the choice not to get a vaccine here is not a risk-free choice. It's a choice to take a different risk. And we're, it's, the term "safety" in the medical world means that benefits outweigh what are at this point theoretical risks. That's what the word "safety" means. It doesn't mean absolute safety. It just means, that's what that means. We may find that it causes a serious adverse event post-approval. I hope not. But if we do, we have to be open minded to the fact that that might happen.

>> Howard Bauchner: The other question that crosses my desk, staying with safety, and there's many other questions already, Paul. Is that this is an mRNA vaccine. All of the other vaccines that you mentioned are generally the more traditional, you've taken a virus. You've done, you've manipulated it in some way and inactivated, attenuated. Does the notion that this is mRNA, does that make you more concerned or less concerned?

>> Paul Offit: Well, more concerned. I mean, we have no commercial experience with a messenger RNA vaccine. So what we've done is you take this naked piece of messenger RNA. You encapsulate it into this complex lipid delivery system, which enables the cell then to take it up. I mean, if you just injected messenger RNA, ribonucleases in your body would immediately destroy it. So it wouldn't work. So you're trying to protect it to get it into the cell. So now once it's in the cell, that messenger RNA is self-reproducing in a sense. So, and now you're making a protein. You're making the coronavirus spike protein. Which then for the most part gets inserted onto the cell membrane and to a lesser extent gets excreted into the circulation. What turns it off? What makes it so that it's no longer making coronavirus spike protein anymore? If you look at the animal model studies, mice, for example, you would assume that goes on for about ten days. But what happens in humans, I don't know. I mean, we will find that out, I think, over time. The other thing is that it's also, what's true of all proteins that, foreign proteins, it's going to be broken up into like a 15 or 20 mer [phonetic] piece that's then put on the surface of that cell so that you can stimulate either with MHC1 or 2 glycoprotein to stimulate T-cells. To stimulate the helper cells. Because this mRNA is also going to be also picked up by antigen-presenting cells. So which is more common? Is it picking, being picked up primarily by myocytes? Muscle cells? Is it being picked up primarily by antigen-presenting cells? When it's picked up by myocytes, is it just picked up by the myocytes that are to some extent damaged as you put, as you inject it? I mean, antigen-presenting cells are more likely to act as scavengers and pick it up more easily. What's going on? I, you know, you don't know exactly all of that. So it's always a little uncertain because, you know, I just think you have to be humble in all of this, that there are things I'm sure that we don't know yet. And so we have to be open to the fact that we don't know everything. So keep our eyes open. But on its face, you know, we're dealing with a pandemic that has brought us to our knees. I mean, we have massive joblessness and homelessness and food insecurity. This is, if this vaccine in anyway looks like at the top line data looks, it's a lifesaver.

>> Howard Bauchner: Yeah, I just want to reemphasize what you said about safety. It's not absolute safety. It's in comparison to what would be, what would happen to you as an individual or as a population if you're not vaccinated. There's no such thing as absolute safety. And I've suggested that, if we get to January or February and we're at 2 or 300,000 cases a day and 3 or 4,000 deaths a year, or rather a day. That changes the equation for every single individual. I knew many questions would come in. Pregnant women. Children. Adults with autoimmune disease. Comments about, I know the studies haven't been done in pregnant women or children, but I'll let you comment. And then I know that people with autoimmune diseases and on many different biologics, do we, will there be data about safety in those individuals?

>> Paul Offit: Yes, there's going to have. I'll break it down. The Pfizer initially, when they were just looking at people over 18 years of age. During that trial they dropped it down to 16. Then they dropped it down to 12 so there was.

>> Howard Bauchner: Again, okay.

>> Paul Offit: Eighteen year old. Moderna just announced, I think, today that they are going to do a prospective placebo controlled trial in 12- to 18-years-old children. I think about a 3,000-person trial. Again, prospective placebo controlled. So we'll have data in at least in the older child. Even though pregnant women were not part of these studies or at least they were excluded from these studies, you never actually exclude pregnant women from studies. Because there are women who didn't know they were pregnant that entered the study. So there will be least some data in those. Plus there's something that the CDC directs called V-SAFE, where anybody who got this vaccine who subsequently found out they were pregnant, and that's always true in every trial. They will be then followed up to look at, not only their pregnancy and whether it affected them or, and then whether or not it affected the child when they're born. So we will have at least some data on that.

>> Howard Bauchner: And.

>> Paul Offit: And same with autoimmunity. I think there are people who have a variety of comorbidities, and autoimmune disease was one of them.

>> Howard Bauchner: Now, a number of ethical questions have already come up. You're at the University of Pennsylvania. Presumably a fair number of the vaccines will be shipped to distribute for healthcare workers. I'm assuming it will be optional at your hospital, that you will not mandate vaccination. Do you think that's the right way to go, Paul?

>> Paul Offit: I think it is initially. First of all, just for practical reasons. I mean, there's 40 million doses that are going to be available initially. Which means 20 million people, because it's a two-dose vaccine. If you just look at what the ACIP voted on a couple days ago.

>> Howard Bauchner: Yeah.

>> Paul Offit: Which is that one A group. So long-term care facility residents and staff. Well, that's 3 million people. And then essential healthcare workers, anybody who is has patient care. That's 21 million people. That's 24 million people right there. And we dent even have enough right now for that first group. And we presumably can vaccinate about 2 to 5 million people a week. But, you know, I think that gets the safety issue too.

>> Howard Bauchner: Right.

>> Paul Offit: I think for people that are worried about safety, we are essentially by necessity testing this vaccine with one foot, testing the water with one foot. So we'll have tens of millions of people, frankly even more than that. Because the second tier, other essential workers, is another 87 million. So you'll have tens of millions of people who will be getting this vaccine before the general population gets it. So you'll have a much bigger safety profile than you have when it initially rolls out.

>> Howard Bauchner: Second question is has been 70,000 people, 35,000 have received placebo. What should happen to the individuals who have received placebo? Should they receive active vaccine?

>> Paul Offit: I think they should. I think that ethically they should. If you have a vaccine that's clearly been shown to work, and you are, for example, in the placebo group, and you volunteered for this. And you are over 65 or you have a comorbidity. And there is a product that really looks like it could save your life. I think you should. Now, you can still learn from that trial. Because there are people who then who have gotten vaccine early and then there are people who would have gotten a vaccine say months later, sometimes six months later. So you can follow those two groups. And you, that's probably a good way to see whether or not efficacy fades. You'll see whether or not, how long it is effective in that first group versus second group or early vaccine, later vaccine. So I think there's still value in collecting data. But I think they should be, yes.

>> Howard Bauchner: People who've had disease, these are all the questions that are coming in. People who have had disease or presume that they've had disease, this becomes really quite complicated. So many people with disease that documented, other people think they had disease. Should they be vaccinated?

>> Paul Offit: Well, there will be data on this. I mean, I know in the Pfizer trial that they didn't exclude people who already, who had antibodies detected in their circulation at the time of entry. So you'll see whether or not they, you know, that there's any problems that would come up in somebody, for example, who'd already been infected. And also just programatically, you can't say, okay, this person has antibodies, this person doesn't. So let's say an essential healthcare worker. I'm going to vaccinate the person who's not been exposed and not the person who has been exposed. We don't have a clear immunological correlated protection. We know that people who have relatively asymptomatic infection initially tend to have lower antibody responses. So I just think that we shouldn't try and do that, meaning see who's infected and who's not, before we vaccinate. I just think we should vaccinate everybody who's in those groups.

>> Howard Bauchner: People get vaccine A.

>> Paul Offit: Are you asking me about mandates?

>> Howard Bauchner: Yes.

>> Paul Offit: Sorry.

>> Howard Bauchner: Go ahead, go ahead.

>> Paul Offit: I don't think practically mandate a vaccine that's [inaudible]. But the other thing is just I don't think you can mandate a vaccine that is such a novel strategy. Let a few million people be vaccinated. Maurice Hilleman, who I consider the father of [inaudible] vaccines said it best. Quote, "I never breathe a sigh of relief until the first 3 million doses are out there." Let that happen, then we can start talking about mandates.

>> Howard Bauchner: People get vaccine A, should they stick with vaccine A? Or can they switch to vaccine B if somehow data emerge that vaccine would have been better because of their age or their gender?

>> Paul Offit: So it depends on the vaccines. I mean, for example, if you get an adenovirus vectored vaccine and then you want to get a different adenovirus vectored vaccine, you have to make sure there's no crossreactivity between those two adenoviruses. Because you're just going to neutralize the vector. I think the other question's that come up, has already come up is the, you know, have the Pfizer and Moderna vaccines are both going to be coming out soon. I mean, are they in any sense interchangeable? I think the answer to that question is no. They're different doses. They're different constructs. They have different lipid formulations that surround and encapsulate the naked molecule. So, no, I can't imagine that the ACIP would go for that.

>> Howard Bauchner: Now I anticipate that there will be conversations in social media that people were vaccinated and then became long haulers. You know, we live in a very different type of society than when you and I were younger or 10 or 20 years ago. Can you imagine that being feasible?

>> Paul Offit: I mean, you know, you're being given a protein. You know, you're not, this is not this virus reproduce itself thousands and thousands of times when you're infected with it. When you're given a protein, you're just given that one protein. So I don't, I, unless the ideology at least of some of these long haulers, and I'm sure there's a variety of ideologies to explain in the long-hauler phenomenon. It is based on a aberrant immune response, the SARS-CoV-2 protein that's causing maybe perhaps an autoimmune disorder. I think we'll find that out. But I just don't think that's, what's going to, what worries me about this is the SARS-CoV-2 vaccines are only designed to prevent SARS-CoV-2, not everything else that happens in life. And that's definitely going to happen especially with people that are older who have more medical conditions. That they're going to get a vaccine and then two days later they're going to have a stroke or a heart attack or whatever. And we're going to have to do the kind of epidemiological studies quickly to reassure people that it's occurring at the same rate as background so that people don't worry.

>> Howard Bauchner: Paul, let's say the two vaccines were approved by late December, the Moderna and Pfizer vaccines. I'm not quite sure which one would come up next. So you start January 1 with two mRNA vaccines being available. They will produce a certain number of doses a month. What does January, February, March and April look like? I once asked Tony to comment on Thanksgiving and Christmas, and he said, can we just get through Thanksgiving? And then I'll come back, and you can ask me about Christmas. And this was like a month before Thanksgiving, he was [inaudible]. So just take us through what you imagine happening in January, February and March.

>> Paul Offit: I think we will be able to ramp up vaccine production. I mean, the good thing about the messenger RNA strategy is it's a synthetic molecule. I mean, you just make it in the lab. You don't have to worry about growing it up in cells as is true for, you know, more classic vaccines. And think about it, it's, I mean, the Pfizer vaccine is a 30-microgram per dose. A microgram is a millionth of a gram. I mean, you can make kilograms of this stuff. You can make thousands of grams of this stuff. You really can, I think, in a couple years be able to make enough vaccine to vaccinate 7 billion people. There's no reason to think that couldn't happen. That's the advantage of this kind of strategy. So I think we will ramp up more quickly, especially as we find that the safety profile looks good. Especially as we find that now we're starting to get on top of this virus with vaccination. I think this will be a desired vaccine. And people talk about, you know, the anti-vaccine people being able to kind of squelch uptake. I don't see that happening. This to me is more like the Beanie Baby phenomenon. You know, the attractiveness of a limited edition. Which is really what happened with the flu vaccine in 2004. There was problems with production of flu vaccine in 2004, so there was limited amount. That was a highly desired vaccine. And I think in many ways that may happen here.

>> Howard Bauchner: Do you think the phase one group, which is healthcare workers, essential healthcare workers. Skilled nursing home residents. People who work at skilled nursing homes. Do you think they will have availability of vaccine by the, by April 1, by the end of March? So it takes you through January, February, March? And then the next 100 million will be in the spring?

>> Paul Offit: So if you can make 5 million, if you can make enough vaccine to vaccinate 5 million people a week, then you can vaccinate, in theory, 100 million people in 20 weeks. So that's like five months that you would be able to vaccinate about 100 million people. Which gets you through phase one. It gets you through phase two. And gets you into then phase three. Now, there's overlap in these phases.

[ Multiple Speakers ]

>> Howard Bauchner: Yeah, right.

>> Paul Offit: You know I'm over 65 and healthy. So, you know, there's overlap. But I think in the end you're probably talking about at least 150 million people in phase one, two and three, I mean, 1A, 1B, 1C. Getting through the phase three, which is greater than 65 year old and then high-risk medical conditions. And, which is basically half of the American population. So how many, how long does it take to make 300 million doses? I think that probably gets us into probably late summer, fall before it gets to the population.

>> Howard Bauchner: Yeah, I'm still hoping that somehow next August and September, when we're talking about college and schools and the fall sports, that there's some normalcy returns. That I can imagine that happening next fall, assuming there's no hiccups in production. Side effects. And uptake. I know I'm conscious of time, just two more questions, Paul.

>> Paul Offit: One thing just, I think you'll like this, is that.

>> Howard Bauchner: Go ahead. \

>> Paul Offit: By a reporter. How will I know personally that I have now, feel that we've stopped the spread of this virus? And that I feel comfortable in a setting that I'm not comfortable now? I said, it's when I can go, you know, to Eagles games because I'm an Eagles season ticket holder. Knowing that I don't have to wear a mask because it's hard to boo through a mask, you know.

>> Howard Bauchner: That is very good. I like that one. Somewhere between 10 and 20 percent of people who were vaccinated get a reaction, an acute reaction to it. Now, that could end up overwhelming the healthcare system at the same time that you don't want people coming into clinics. Have you thought through about how to educate people about that? So I'm particularly concerned, and more in the later phases when the vaccination may occur at CVS or Walgreens. I get vaccinated at CVS. And I call my poor primary care doc, and my healthcare system's already overwhelmed. How are we going to have to educate people about that?

>> Paul Offit: Yeah, I think, and actually the CDC in that ACIP meeting yesterday did address some of these issues. This vaccine, the mRNA vaccines do have a, do induce an immune response. And when your immune response is activated, you have certain symptoms. Which can be things like low-grade fever. Headache. Muscle ache. And fatigue. Enough so that you could actually miss a day of work. I mean, that's possible. I wish we had a, I wish the immune system had a better public relations team working for it. Because, I mean, this is just a natural consequence of having an activated immune system. I had a friend who volunteered for the trials, a doctor in North Carolina. And, you know, he didn't know whether he got vaccine or placebo. But he woke up the next morning after getting his second dose, because it seems to be more common actually after the second dose than the first. And he had, you know, headache and fatigue. And he thought, yes, I got the vaccine. And so I just, it's just a natural consequence of this. But I think it does matter, because you're not going to vaccinate your whole emergency department staff.

>> Howard Bauchner: Right.

>> Paul Offit: And have them potentially be out the next day. So I think that's part of it, yeah.

>> Howard Bauchner: And the last question. Paul, you've been, you've done vaccines most of your career. You developed a vaccine that's saved millions of lives. I think there's very few people in the world who can say that. Obviously, we're both pediatricians. I'm talking about the rotavirus vaccine. What is your sense about how long immunity will last from the vaccine? What do your instincts tell you?

>> Paul Offit: Right. I think these kind of viruses, which is to say viruses that have not long incubation periods where viremia's not part of pathogenesis. As a general rule, they induce immunity that is short lived and incomplete. And by short lived, I mean years, not decades. By incomplete, I mean not sterilizing immunity. So protection against moderate to severe disease, but not necessarily mild or, disease or asymptomatic infection. I mean, that's the rotavirus story, which I grew up with. And I think that that's okay. I mean, if you have, all you want to do is keep people out of the hospital and keep them out of the morgue. And I think this vaccine can certainly do that. Even if there is some fading of immunity over that six-month, one-year period, two-year period after people get the vaccine, I still think it will accomplish that. And the way to answer that question and I hope this question will be answered actually when we bring Pfizer up newspaper front of us on December 10th and Moderna on December 17th. Do you have any information about the frequency of memory B- and T-cells? Because if you look at these immunologists like Shane Cronley [assumed spelling] and Stanley Perlman and others that are coronavirus immunologists, that's probably the best predictor. You know, you don't necessarily have to have high titers for circulating antibodies. The incubation period of this disease is about six days. So if you can, if you have high frequency of memory B- and T-cells, you can probably protect yourself adequately against moderate to severe disease. And so that's really the information you'd like to have from these trials. We'll see whether they generate it.

>> Howard Bauchner: There's been more chatter about genetic shift over the last few weeks. Is that a concern with respect to these vaccines?

>> Paul Offit: I don't think so. Remember, it's not, so these, flu is a segmented virus. So you can have that sort of drift and shift. The shift is usually a complete genome change. This virus drifts. I mean, let me rephrase that. This virus mutates. It mutates because it's a single-stranded RNA virus. So far we don't have any evidence, it's only been out for a year. But we don't have any evidence that that mutation has caused it to mutate away from the vaccine. And, remember, the measles vaccine is also a single-stranded RNA virus. We've had a vaccine since 1960s, almost 60 years of that vaccine. And that virus has never mutated away from the vaccine. So I'm going to predict that that will also happen here. Immunity may fade over a year or two that would require a boost, but I don't think you're going to need a booster for the same reason you need a booster for flu, which, you know, mutates constantly. And I know how we say, by the way, flu mutates from year to year to year. No, flu mutates from like minute to minute. I mean, that is one moving target, influenza.

>> Howard Bauchner: Truly the last question. What's the year been like for you, Paul? I mean, you've always been active scientifically. You've always been active in the public domain, in part because you've been a spokesperson for immunizations for decades. And, as I said, we're both pediatricians. What's the year been like?

>> Paul Offit: I've never been busier. I mean, I, every day is just booked with, you know, with either being in the media. Or talking to reporters. Or doing podcasts. Or doing talks. I mean, normally, if you give a talk, in the past you travel to the place to give a talk. You don't do that anymore. You do it from your computer. But I can give three talks in a day. I mean, so it's like the good news, bad news. The good news is I don't have to travel. The bad news is I do far more talks than I ever wanted to do. I mean, I, you know, I say no all the time, and it doesn't matter because when friends ask you to do something, you do it.

>> Howard Bauchner: Right.

>> Paul Offit: And you're happy to do it. But just, it's never, I've before never been busier. It's ridiculous is what's happened to me.

>> Howard Bauchner: Do you take, like over Thanksgiving, did you just say no to everything for two days? Or over the holidays that are coming up, are you just going to say no to everything, it's just family and friends?

>> Paul Offit: No, I still, my daughter was here, and my son was here for Thanksgiving. And it was wonderful having them. I still ended up doing stuff. Although that day, no, I still ended up doing some stuff, but not as much.

>> Howard Bauchner: This is Howard Bauchner. It's been Conversations with Dr. Bauchner. It's one of my treasures to be able to talk to Paul every few weeks. And just to remind people, Paul's on the FDA advisory panel, which will be reviewing the Pfizer vaccine December 10th, you think. And then the Moderna a week later. Paul, I put you up there with Dr. Fauci on the Mount Rushmore of scientists, certainly for this year. Stay healthy. And thanks so much for coming today.

>> Paul Offit: Thank you, Howard. You overrate me, but that's okay. Take care.

>> Howard Bauchner: Take care, Paul. Bye, Paul.

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