Paul A. Offit, MD, of The Children's Hospital of Philadelphia returns to JAMA's Q&A series to provide an update on the emergence of COVID-19 variants and their implications for vaccine development, including the Johnson & Johnson vaccine, scheduled for a US Food and Drug Administration VRBPAC hearing on February 26, 2021. Recorded February 11, 2021.
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>> Howard Bauchner: Hello, and welcome to conversations with Dr. Bauchner. Once again, it is Howard Bauchner, editor in Chief of JAMA and I'm joined by one of my regular guests, Paul Offit. Paul's a physician, The Maurice R. Hilleman Professor of Vaccinology at the Perelman School of Medicine University, Pennsylvania, and certainly one of the world's recognized leaders in vaccinology. Welcome, Paul.
>> Paul Offit: Thank you. Happy to be here.
>> Howard Bauchner: So Paul, I thought we'd start with good news. It's been a struggle the last year. Hospitalizations -- 130,000 to 80,000. The number of deaths are finally coming down. We're vaccinating individuals at about 1.5 million injections a day. Not individuals. I appreciate that. The estimate is that 40 million shots have been given. There's a difference between Bloomberg and the CDC, so I'm splitting the difference. Say 40 million. But at 1.5 million a day, in the next 60 days, that means we will have given 100 million injections in the United States. Essentially all people older than 65, all essential workers, if they will have wanted the vaccine, will have gotten one dose. I think I'm optimistic that we will really begin to see a substantial decline by March and April. What are your thoughts?
>> Paul Offit: I agree, I mean, it's mid-February. This is for the most part a winter virus that, although is transmitted to some extent over the summer, it thrives in the winter. It's spread by small droplets. In the winter, you know it's not as humid, people are gathered together. Yet we have in mid-February a clear drop in cases, a clear drop in hospitalizations. Why? I think the answer is immunity; immunity that's induced been induced by natural infection and immunity that's been induced by vaccination. So right now it's listed that 27 million people have been infected, but that's just 27 million people who've been tested and found to be infected. When you did antibody surveillance studies back in November before there was a vaccine, that number of cases in this country was off by a factor of four. So let's assume it's still off by around a factor of four. If that's true, that 27 million is probably closer between 80 and 100 million people. So you're already talking about at least 25% of the population that has been exposed to this virus. Add to that the 40 million doses that are out there. Now those are our first doses. So this is a two-dose vaccine, and you want to see people get their two doses and probably right now it's about 2 to 3% of people have gotten both doses, but you know that first does provide some immunity. So if you take that 25%, add it to 40 million, then maybe subtract 20% because some people who have already been infected are getting vaccinated. But so now you're up to around 35%. You know, if you look at polio which does have a couple similarities -- so polio, obviously, it's a disease primarily of children. It was a summer disease. But its contagiousness index was roughly similar to this virus and it spread primarily asymptomatically. You started to see a decline in polio cases when you started to get to 35% to 40% immunization rates. So I think you're seeing -- what you're seeing is the consequence of natural immunity and vaccine-induced immunity, and I think it's going to continue to drop. I mean, the two things that stand in the way of that, and we can talk about that are, one, whether variants become a problem, and two, are the anti-vaccine movement, or at least an anti-vaccine sentiment, becomes a problem.
>> Howard Bauchner: We'll return to the variance and the issue about vaccine-hesitant anti-vaxxers, which are -- they're slightly different groups. But I want to go backwards because one of the questions that came up so early on was, how safe are these vaccines? And that obviously is part of the discussion about vaccine hesitancy. Well, internationally, we're well above 100 million people being vaccinated internationally with the two Moderna and Pfizer vaccines. We'll talk about some of the other vaccines. Has any new safety signal come up that you're aware of?
>> Paul Offit: So the Advisory Committee for Immunization Practices about a week ago went through the data they have on possible safety signals. So, in other words, Bell's palsy, which, you know, unilateral facial palsy, which was seen in seven of the roughly 37,000 people that have gotten the vaccine prelicensure as compared to only one in the placebo group. You worry that that might have been a problem, but at least they found that there appeared to be no difference in the vaccinated or unvaccinated population for Bell's palsy. I mean, you've heard about thrombocytopenic purpura as following this vaccine, but when you've seen it, it's been like a day later or two days later. That's too fast. I mean, this is presumably an immune-mediated phenomenon, an antibody-mediated phenomenon, and that's just too fast to see that then. So there are always going to be these temporal associations and you read about them in the newspaper, but at least for right now, those temporal associations have not been found to be causal associations. You know, SARS-COV-2 vaccines are designed to prevent SARS-COV-2 infection. It's not everything else that happens in life, so there's always going to be these temporal associations. And the CDC is right on top of this through the Vaccine Safety Datalink to make sure that those temporal associations aren't causal. But it's amazing, I mean, here you have a virus -- this elusive, difficult to characterize virus that's had a number of clinical surprises and pathological surprises -- which you are meeting with a technology, messenger RNA vaccines, with which we have no commercial experience. I mean, I was -- I think anybody who was paying attention to this was worried that there might have been something unpleasant that we were going to find out eventually that we wish we knew now, but for right now, no. I mean, Maurice Hilleman, who I consider the father of modern vaccines in that he did the primary research and development on nine of the 14 vaccines we give the kids said it best, quote, "I never breathe a sigh of relief until the first 3 million doses are out there." Well, the first 3 million doses are out there. The first 40 million doses are out there in the US, and hundreds of millions of doses are out there in the world.
>> Howard Bauchner: I can't emphasize how encouraging that is because so many people have said they want more data, or they want to wait longer. There's -- at this point, the data are just going to be multipliers of what we already know. You know, great. It'd be nice to have a year of data, but we're out six months from people who initially were vaccinated over the summer, and there is no reported side effects of major concern from the vaccine, and I think it's so important to emphasize that. Let's go on to the other two important issues that you talked about. We've now published a number of viewpoints on variants. We published a research letter just about an hour or two ago about the California variant. No epidemiologic data to describe what the risks from it could be. Tony Fauci, John Mascola have written an accompanying editorial about variants in general. I was struck by the term "variants of concern." It made me think that it was like a TV show or something, but that there's literally thousands of variants and then some emerge as variants of concern, and people are concerned about the variants. Your take?
>> Paul Offit: Yeah, well it's reasonable to be concerned about the variants. I mean, this virus continues to drift at some level and the question is, is it going to drift so far that immunity that's induced by natural infection or immunity that's induced by vaccination is not effective? Now here's the way I see this. Here's when you should worry. You should worry when people who have been either naturally infected or have completed their immunization series are nonetheless hospitalized with one of these variants. That tells you I think that an important line has been crossed. That hasn't happened yet. I mean, it's -- I think certain things are clear. First of all, the virus that initially circulated Wuhan was not the virus that left China. The virus that left China and ultimately spread across the USA -- across Europe and into the US -- was the first variant. This so-called, you know, D614G variant. That was the first variant. And then since then, there's been the UK variant.
>> Howard Bauchner: Right.
>> Paul Offit: [Inaudible] use the country of origin.
>> Howard Bauchner: No, no, I can't remember the numbers. Maybe you can.
>> Paul Offit: P117 variant.
>> Howard Bauchner: Thank you.
>> Paul Offit: That's close enough to the original virus that, what Tony often refers to as the wild type virus. That it looks like immunization or natural infection is going to -- with what we have now -- is going to protect against that variant. The more worrisome ones are the South African and Brazilian variants, which are very close. So to talk about one is to talk about the other. That, if you look at studies, for example -- what you care about, by the way, is not necessarily the studies that are done in vitro where they take sera from people who were naturally infected or sera from people who've been immunized and see whether it neutralizes that virus in a laboratory, because that's looking at just one aspect of the immune response, and what you really care about, the proof in the pudding here, is the clinical response. So for example, when Johnson & Johnson did their trial in South Africa, they found, for example, where they had 72% protection against moderate to severe disease in the US, it was only 57% in South Africa. But they were able to prevent, apparently, hospitalization and death from that virus in South Africa, and South Africa, the strain that's circulating primarily is the South African variant, the B351 variant. So that's good news. I mean, that's what you want. You just want this vaccine to keep you out of the hospital, keep you out of the ICU, and keep you from dying. And right now, that all appears to be true. I mean, you're making a polyclonal antibody response against a variety of epitopes on that virus. And right now, that response appears to be good enough to protect you from severe disease.
>> Howard Bauchner: I just want to re-emphasize something you just said. So when a new variant emerges and it's tested against a sera of someone who's been vaccinated, it's only testing a very small aspect of the immunologic response. And so it is likely that, in real life, in vivo, the vaccine is going to actually be more effective. And as you said, the real test is, does it prevent serious disease? It's nice to get preliminary data from the lab, but what you really want is that epidemiologic data. Now Paul, have you been surprised about the rapidity with which these variants of concern have emerged? I know there's been literally thousands of variants, but we now have the three that you mentioned, we don't know about this California variant that we reported in JAMA today. Have you been surprised about how quickly they have emerged?
>> Paul Offit: No, I mean it's a bat coronavirus. It is adapting itself to growth in the human population, and the way in which it will adapt is it wants to be more easily transmitted. I mean, that's the goal of this virus: to live by being transmitted from one person to the next. So, the UK variant appears to be more contagious. The South African variant sort of took over in South Africa. The Brazilian variant took over in Brazil and the Amazon. That's what the virus does. That makes sense to me. You just want to make it so that there aren't a critical number of mutations in the so-called receptor binding domain or the N-terminal domain of that spike protein that causes polyclonal sera induced by natural infection, or polyclonal sera induced by immunization that it can no longer effectively keep you from being hospitalized. That's what you're worried about, and right now we just had an NIH so-called active group meeting, which is a group that was put together by Francis Collins who talk about these vaccines. We actually thought we were done. But with the variants now arising, we're re-meeting again, but that was the theme of that meeting; that you know, that for right now, although clearly there are mutations in critical regions, it doesn't look like this virus has mutated far enough away from vaccination or natural infection that you are going to be at risk of serious disease. That's where we are right now. Hopefully, we'll stay there. And I do think that as we move into the summer when the weather gets warmer, which makes it even more difficult for this virus to be transmitted, I think as we -- and more and more people get vaccinated -- I feel really good about the fact that we're going to continue to go down. What worries me a little bit is when you hit September and then it gets sort of colder again and there may be a variant that emerges and people are now feeling better, they're not going to wear a mask, they're not going to social distance even more than they're not doing that now. Then you could see an emergence of a variant. The good news is we're much better at sequencing in this country. I think we've increased our sequencing capacity by tenfold according to Dr. Fauci. And so we're looking, and that's the thing we're looking for: Are people going to be hospitalized with these variants who've already been naturally infected or immunized?
>> Howard Bauchner: Yeah. I wanted to ask you a bit more about this timing. So I think you and I are both guardedly optimistic over the next few months, and then we'll get to the summer and just, you know, theoretically two-thirds or three-quarters of the US population will have had disease or be vaccinated by the fall. Wearing your hat of enormous concern, how does NIAID begin to think about a more broadly effective vaccine against all variants, a broadly neutralizing vaccine? I'm sure people are really beginning to think past September of 2021, but when we get into late 2021 or 2022, and that variant emerges that is generally more problematic with the vaccines, does the science begin now, Paul, to try to think about this kind of broadly neutralizing vaccine?
>> Paul Offit: That's already happened. I think that we are certainly paying attention to these variants, and there's one of two ways you can look at this. When you get your second dose of this mRNA vaccine, whether it's Pfizer or Moderna, you get a tremendous boost in neutralizing antibodies, and that appears to be good enough to protect you against, for example, the South African variant or the Brazilian variant, which is not how these vaccines were constructed. They were constructed against that first variant, the D614G variant, so that's good enough. That's a powerful response that's good enough. So then the question, is if this starts to continue, this South African variant, do you give just a booster dose of what you've already gotten which then would be enough for it to cross-react? Or, and I think we're already preparing for this, do you now start to include these variants in what would be, I imagine, either a second-generation vaccine where you get this separate vaccine as a booster later or as a multivalent vaccine where you, which you could do that with an mRNA vaccine where you actually have sort of both mRNA, both of those strands of mRNA within that lipid nanoparticle. That could certainly be done. So we'll see. We're looking. I can tell you I'm certain that the companies are now working with the FDA to figure out what is the path forward on this. Obviously, you're not going to have to do another efficacy trial. It'll be more like the influenza vaccine model where you'll do, you know, some immunogenicity studies prior to allowing that vaccine to be used.
>> Howard Bauchner: I feel like we've gotten a handle on the science when we talk about vaccine distribution, but we've gotten a handle on the science. So it sounds like even if a more virulent variant arises, say, in the fall of 2021 or the winter of 2021-'22, you think there's enough of what we know about the science that we will be prepared for it?
>> Paul Offit: I think so. I mean, if we -- well, if we have to give, say, a second vaccine, meaning, you know, one that contains the South African variant of Brazilian variant or whatever new variant comes up -- there will be more variants. I think you can be sure of that. I mean, the hard part is not constructing those vaccines. The hard part is mass producing them, mass distributing them, and mass administering. That's what we're learning. So if you had to do that all over again, it would be a challenge. But again, we've gotten much better at it. I mean, the thing that was never in place in this country that's getting in place is we never really had a mass immunization system for adults. I think that's getting in place. I mean, the problem initially was administration, right? You had like only 20% of the distributed doses were administered. Then it became 30%, then 40%, then 50%, then 60%. Now it's close to 70%. So we figured out how to distribute it, or at least I should say we're better at distributing it. Now the biggest problem is production.
>> Howard Bauchner: Right. Now, the report this morning was that the ballfield in Los Angeles ran out of vaccine. I thought that was actually good in the sense that at least it's now -- whatever is being produced is being delivered. You know, you don't want to see 20% of the stock being held onto. Paul, it's likely that in the next few weeks, I'm assuming, given what I've read -- you may have more information -- that we may have yet a third vaccine that's approved through emergency use authorization which will be the Johnson & Johnson vaccine. And I'll ask you in a second to compare it to Moderna and Pfizer. As a number of people have said to me, we set the bar so high with Moderna and Pfizer at 95%; people aren't going to feel very good about 60% or 70%, whatever it ends up being. And you know, human nature being what it is, I can imagine people saying, "I want two shots to give me 95%. I don't want one shot that gives me 70%." How do you imagine this playing out?
>> Paul Offit: You know, it's interesting. If the Johnson & Johnson vaccine -- and again, we meet, the FDA vaccine advisory committee meets on February 26th, and so I haven't seen the data.
>> Howard Bauchner: Yeah. Okay, right. And I know it hasn't been released publicly.
>> Paul Offit: Just press release data, but I mean, if you look at that top-of-the-line press release data, it was 72% effective against moderate to severe disease in the US. That's good. And it appeared to be mostly 100% effective in preventing, you know, serious disease. That's good. I think if that had been the first vaccine, everybody would have been ecstatic. As a single-dose, refrigerator-stable vaccine that's stable for months in the refrigerator, people would have thought this is great. This is going to get easily distributed. It can be sent to rural areas where there's sort of less, you know, less support, and everybody would be really happy. But I just think that the messaging here has to be the goal is to prevent moderate to severe disease, and this vaccine can largely do that and has a number of other advantages. Right now, it's a single dose. Now there is -- Johnson & Johnson is doing a two-dose trial in the United States, which presumably we'll have data by April is what I've heard. We'll see. But I mean worst-case scenario, if the two-dose trial shows that it's better, you can just get a second dose down the line. I mean, you don't have to start the series all over again, so there would be that option. But we'll see with the data. Right now we don't know those data.
>> Howard Bauchner: With Moderna and Pfizer having increased production, and say J&J comes available sometime in mid-March and, you know, we vaccinated -- 75 million, 80 million people have gotten an initial dose, can you imagine a system where -- again people have choice. And I want to emphasize that, particularly under an EUA. People will have choice. ACIP will make recommendations -- that Moderna and Pfizer would go to the highest risk individuals? You know, older than 65, under 65 with other complications, and that the Johnson & Johnson vaccine would be used for the remainder of the population? Can you imagine that strategy? Or is that going to be too complicated?
>> Paul Offit: I would be surprised. I mean, again, we haven't seen the Johnson & Johnson data, but let's just say theoretically for the purpose of this discussion that one dose of the vaccine prevents people over 65 years of age 100% of the time from being hospitalized or go to the ICU or die. If that's true, I would be surprised if the CDC then made it differential recommendation on those vaccines. Right now we have so much problem with mass-producing these vaccines, and there are advantages to the J&J vaccine regarding its storage and handling characteristics. So that would surprise me if they did that, but on the other hand, if the J&J vaccine, for example, wasn't as effective in a certain age group or it wasn't as effective with people who have certain comorbidities. That's what the CDC does. Then they do make distinctions. But for right now we don't know what those data are, so we'll have to see.
>> Howard Bauchner: Will the vaccines Moderna, Pfizer, and then J&J eventually move to the traditional approval process? Do you have any idea if the companies are planning to move to the traditional approval process? I'm not sure what they gain from it at this point. I know in the long run there's some gains, but in the short run I'm not sure if there's many gains, but that question has already come in if they're going to move to traditional approval.
>> Paul Offit: It's possible. I mean, that's essentially what happened with Merc's Ebola vaccine when they rolled it out in West Africa. Initially that was all essentially through an emergency use authorization, and then years later they came back and then submitted a biologics license application to get a licensure. It's possible. The biggest thing that they are going to need to generate are sort of longer-term efficacy data. So I think as you get those data, they may go back and do it as a BLA. Certainly possible.
>> Howard Bauchner: Is there any reason to think that the one particular platform vaccine, the adenovector virus, versus mRNA will be more or less effective against a variant? Or the platform itself isn't likely to drive one vaccine being more effective against variants than another?
>> Paul Offit: Well, they all have the same basic ideas in terms of the spike protein. So then the question is -- but it's a perfectly reasonable question -- you know, does the mRNA vaccine drive a better immune response than the replication-defective either simian adenovirus vector, which is the UK Astra Zeneca strategy, or the replication-defective human ad 26, which is the Johnson & Johnson strategy? I mean, to be determined. We don't have a lot of information for that. We don't have a lot of commercial experience with those vaccines. We'll see. I mean, we're going to learn a lot in this process.
>> Howard Bauchner: What would be the three or four kind of -- like if someone gave you an envelope and said, "I have the answer, Paul, to the three questions you really want to know," what would the three questions be, Paul?
>> Paul Offit: Well, so under the category of things that worry me the most --
>> Howard Bauchner: Okay, that's a good category.
>> Paul Offit: Number one is, you know, so number one is, will there be a variant that is generated that escapes recognition by the vaccine to the point that you aren't protected against severe disease, hospitalization, ICU admissions? So that's number one. Will that happen? Do I get to ask that kind of question? Like, is that the kind of question you mean?
>> Howard Bauchner: Yes. Yes.
>> Paul Offit: Okay, that would be one. Number two, the other things that scare me the most -- and it hasn't happened, thank goodness, surprisingly -- there doesn't appear to be any serious adverse side effect with these vaccines. I mean, think about that. Vaccines are our way out of this pandemic, our only way out of this pandemic. If there were a serious adverse event, no matter how rare it was, that would cause a lot of people to not get this vaccine, and that would be a disaster. That hasn't happened, so that's good. Wait, I get one more question.
>> Howard Bauchner: Yeah.
>> Paul Offit: What's the other question I get to have answered? I guess one would be, what will be the impact of sort of the anti-vaccine sentiment? I mean, will it be so great as to not allow us to get to herd immunity? I guess we're going to find out the answer to that question soon enough.
>> Howard Bauchner: Yeah. So that moves us into the next portion of the conversation. You know, we're both pediatricians, and so I think the notion of anti-vaccine-ers versus people who've been vaccine-hesitant, they're different groups of people. Anti-vaccine-ers remain a very small percent. Prior to COVID-19, a very small percent of the population, 1% or 2%. That's very different than vaccine-hesitant, which people WHO reported worldwide had reached 20% or 25%. So how have you begun to think about that given your long history and a champion of vaccines, the politics of the last year, how have you begun to think about that vis-a-vis COVID-19 and vaccine hesitancy? What do we need to do?
>> Paul Offit: Well, people are less hesitant. I mean, if you look at sort of the polls that were conducted, say September, October, and then moving into December and now, each time they do a poll, a progressively larger percentage of people are saying they're willing to get the vaccine. So I think it's reasonable to be vaccine-hesitant. I think you know, it's a frightening virus. A lot of the language that surrounded the development was a little scary, you know? Operation Warp Speed, Race for a Vaccine. Who's going to be the first to cross the finish line? That's a little scary, and it's a novel technology. I mean, I think you reasonably could say, "Wait, let me just see how this plays out initially." Well, it has played out. I mean, once 40 million people have been vaccinated, I think you now have a large platform in which to stand that you can say the effectiveness is remarkable, and the safety, as far as we know, appears to be, you know, reassuring and so, and I think that's why the numbers are going up for people who are willing to get that. So I think we're all vaccine skeptics. I think everybody who sits around the FDA Vaccine Advisory Committee Table is a vaccine skeptic. You want to see the data. Well, now you have the data. I think for the anti -- the true anti-vaccine activists, the conspiracy theorists, I mean, I use the Neil deGrasse Tyson line. I mean, you're never going to talk them out of it. If people reach a conclusion that is not based on science and reason and logic, reason and logic is not going to talk them out of it. So forget that, and that's my fear, is that they will have impact as they have on social media. Interestingly, RFK Junior was just sort of taken off Instagram I think.
>> Howard Bauchner: I saw this morning.
>> Paul Offit: Which is I guess owned by Facebook. So good. I think there's a recognition that you know that free speech has limits and one of those limits is giving people bad information to cause them to make bad decisions that can hurt them or their family.
>> Howard Bauchner: So-called Sputnik, you know, the report came out. On one hand, I think people were concerned about the speed and kind of the secrecy around the way the vaccine was approved. It's interesting, reflecting now in February about what happened at the FDA. The FDA actually did a superb job and has continued to do a superb job around vaccines. I actually think it's an important model for novel therapies, where we see a press release and a preprint but no limited data. I think what the FDA has done by saying, "These are the criteria, we get the data, we produce a 20-page synopsis," it goes to people like you, it enters the public domain, there is a debate, it's public -- I'm not sure what more we could have asked, and actually, there's been almost no criticism. But that was not true with Sputnik. A lot of secrecy around the China vaccines. What's your sense about the kind of international vaccine effort? And you know, people have said, you know, the US has focused on taking care of people who live in the US and there needs to be more of a sense of a kind of global mission around vaccines.
>> Paul Offit: To take the second issue first, that's certainly true. I mean, how much more information do we need that what happens in one country affects another country here? I mean, we're only as strong in this country as countries where it's occurring that this virus is still raging. I mean, we still give a polio vaccine in the United States, even though we haven't had polio in this country since the 1970s. We give it because it's still in Pakistan, and it's still in Afghanistan. And I mean if only one of 200 people that have polio are actually symptomatic, do I think it's possible that people shedding poliovirus walk into LAX or walk into LaGuardia Airport? Yes, I think that's perfectly -- that's why we continue to give that vaccine. So, yes, I think we have to be part of this WHO collaborative that is designed to make sure that every country in this world can get the vaccine. I think it was a shame actually when the last administration backed away from that. We have an obligation. We have economic and technological advances that causes us to have an obligation to all those countries, and just looking at it selfishly, you're only as strong as the weakest country out there. So we need to do that. In terms of other countries, there is sort of a somewhat of a depressing nationalism that's kind of surrounded this effort where, you know, for example, Vladimir Putin very early on, like back in August, said that, you know, that this Sputnik vaccine which is a two-dose vaccine, replication-defective human adenovirus 26 followed a month later with a replication-defective human adenovirus five -- that's their vaccine. He said, we've checked all the boxes when they just finished a phase one trial. They hadn't even started the phase three trial yet. So there was that. You know, the Chinese had come out initially with the replication-defective ad 5. And now it's more of an inactivated vaccine, which they claim to be, you know, highly effective. But then the tested when given in Brazil was found to be much less effective. So, but again, it's all press releases. You just want to see the data. I mean, making a whole killed inactivated vaccine, which the Chinese did, take up the virus grow it up, take the virus, grow it up, purify it, kill it with the chemical beta-Propiolactone, which is the way we make the rabies vaccine, I mean, that's a tried-and-true method. We have a lot of experience with that kind of vaccine. Let's see the data. Publish it. Do what you should be doing. And that doesn't happen. And you know you can see that there is a sort of, you know, Russia will send its vaccine, and as they have, you know to their allies and, and it's just -- it's a little messy.
>> Howard Bauchner: There's a couple of questions that have come in. We discussed on Monday the issues around women who are pregnant. I had a number of guests, and we're certain about the recommendations, not a lot of data yet, but more confident in vaccinating women. But that, but there's four million children in each age cohort, so from birth to 20 is 80 million people or birth to 18. The notion of the trials in adolescents and children?
>> Paul Offit: Right. So that's happening. The initial trials are going to be done down to 12 years of age. They'll involve probably a few thousand children who will get a vaccine to make sure that the dose is right, the dosing interval is right, and then you are consistently inducing a neutralizing antibody response that you will predict, based on the adult studies, will likely protect you. I think you're not going to see efficacy studies in children, these big 30, 40,000-participant trials. You're not going to see that. And I think, I know Jeff Gerber at Children's Hospital Philadelphia is taking the lead on that, and I suspect the next round will be to go down to six years of age. I'm not sure we'll ever get lower than that. But it's worth preventing this disease in children. I mean, although this virus is not a -- obviously -- common killer of children. The number of children who died this past year was roughly the same as died of influenza. And certainly, children can suffer this multisystem inflammatory disease. So any any virus that can cause children to suffer or be hospitalized and even rarely die, if you can prevent it safely, prevent it. So I think we will eventually get there. They just weren't a high priority group because 92% of the deaths in this country are currently people over 55 years of age.
>> Howard Bauchner: Right. Do you anticipate any surprises in children?
>> Paul Offit: Yeah, I guess you should always be humble in this. I'd like to think that we've learned so much from these mRNA vaccines in adults, including very young adults, that I don't anticipate surprises, but you have to be open-minded and humble and keep looking because, you know, there are invariably surprises in medicine.
>> Howard Bauchner: Right. The issue about the ACE receptors changing with age -- I'm curious. So that interaction with vaccines makes me curious about seeing the immunologic response and then the real data, which is what happens in real life. Do they not get either asymptomatic infection, pre-symptomatic infection, or infected at all? Just the last question, Paul. It's going to become more difficult, and that's about mandating vaccine in certain groups or populations: college students, teachers, children going to school when a vaccine is approved. You work at the Children's Hospital of Philadelphia. It's part of the HUP system. Can you imagine how mandated vaccination may play out or will not play out in the US?
>> Paul Offit: I think that it will play out initially in the private sector. I think businesses -- I don't think states are going to mandate this vaccine. It's a little hard to do that. I mean, these are approved through emergency use authorization, which is essentially the equivalent of giving permission to use and investigate new drugs. I think that -- but you could see for example airlines say, "Look, nobody who works on this airline can go into the airline unless they get a vaccine." So I think the business sector, the private sector, would be the first place you see mandates if I had to make a guess.
>> Howard Bauchner: This is Howard Bauchner, editor in Chief of JAMA, and once again I've been joined by a friend and a colleague, Paul Offit. Paul is the Maurice R. Hilleman Professor of Vaccinology at the Perelman School of Medicine University, Pennsylvania, and he's just been a remarkable resource, I think, for guidance and wisdom both in the United States and around the world during the last year. It's been a difficult year. I'm so pleased, Paul, that both you and I are guardedly optimistic about the springtime. Hopefully, the weather will get warmer and you and I will be outside again.
>> Paul Offit: Looking forward to it. Thank you, Howard.
>> Howard Bauchner: Take care Paul. Stay healthy.
>> Paul Offit: You too, Howard. Bye bye. That was fun.
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