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Coronavirus Vaccine Update

Educational Objective
To understand the latest COVID-19 Vaccine developments
0.5 Credit CME

Paul A. Offit, MD, of the Children's Hospital of Philadelphia provides an update on COVID-19 vaccine development. Recorded August 24, 2020.

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Transcript

>> Hello, and welcome to Conversations with Dr. Bauchner. Once again, I'm here with Paul Offit. Paul is the Director of the Vaccine Education Center, and an attending physician at Children's Hospital, Philadelphia, where he is the Maurice Hillerman Professor of Vaccinology at the Perlman School of Medicine, University of Pennsylvania. Welcome, Paul.

>> Thank you Howard.

>> So, I know you're in much demand. A few weeks ago, you wrote a viewpoint for us, developing SARS/CoV-2 vaccine at warp speed. I've told people the 15 minutes that you talk about vaccine development is like an entire book chapter in 15 minutes. It was remarkable, while I've listened to it two or three times. Now, probably a half dozen reports, it's hard to keep up with them, in all the major journals, JAMA published a report about an inactivated vaccine from China last week. What is your sense of where we are, Paul? Then we will run through some of the vaccines. But what is your sense of where we are in vaccine development?

>> Well, we're waiting right now for critical data. Those critical data are going to come from Phase 3 trials. There are a number of companies now, Pfizer, Moderna, with their messenger-RNA vaccine. I think Johnson and Johnson soon to be with their replication defective human adenovirus type 26. The Chinese, with a replication-defective human adenovirus type 5, as well as an inactivated vaccine. There were a number of companies actually who were with a live attenuated viral vaccine. So there has all been--no, I'm sorry, Anova Vacc [phonetic spelling] is moving forward with a purified protein vaccine, similar to the way flu block is made. So we will see. I mean, right now, we're looking at sort of Phase 1 data, minimal Phase 2 data, and we don't really have any idea, just what the safety portfolios are going to look like in larger numbers of people, or whether these vaccines are going to be effective. So right now, we're just waiting to see.

>> Do you anticipate a winner, Paul, or just uncertain?

>> I anticipate winners. I mean, I think there will be several vaccines that will be shown to be certainly at least 50% effective, and hopefully 70 or 75% effective for some period of time. How long that effectiveness lasts over time, I think, we're only going to know frankly post-approval. And I think that these vaccines will be safe in the sense that they won't cause at least serious or permanent adverse event when tested in 10,000, 15,000, 20,000 people, and hopefully that will also be through post-approval when it's tested in, when it's seen in 20 million or 30 million people. We'll see. Here's what--when people ask me the question, what keeps you up at night? Here is what keeps me up at night. What keeps me up at night is the first vaccines we're going to roll off the assembly line are going to roll off first because they were the easiest to construct and the fastest to mass produce. That's really why, I mean, they're just so-called "plug and play" vaccines, meaning you know the protein you're interested in, the spike protein, you know the gene that codes for that spike protein, and so you can plug that gene into messenger RNA, DNA, these replication-defective human or simian adenoviruses. These vector vaccines, like which includes either an Ebola or a measles-containing vaccine. It's easy to do that, and it's easy to scale them up. The problem with those vaccines is there is virtually no commercial experience with those vaccines. So we are going to learn about those strategies as we go, and we're confronting a virus, this novel bad coronavirus, SARS/CoV-2, that has had many surprises, not the least of which is that it's raging during summer months. I mean this is an envelope virus that is spread by small droplets. It should not do well in hot and humid climates, but it seems to thrive in Florida, Texas, I mean, in those climates, so we're going to learn as we go here, over the next two years.

>> Do you anticipate, Paul, that people will need at least two injections or is it just so cloudy until we get more data?

>> It certainly looks from at least the Phase 1 data, that these companies, whether it's messenger RNA, or these replication defective simian or human adenoviruses that those are two-dose trials. But that's the way that this is going to be done. And so we'll see. Now, that may not be necessarily true for say, live attenuated viral vaccines. It probably will be true for the inactivated viral vaccines, we'll see.

>> Now, when I talk to my friends, many of whom are in medicine, but many who aren't, they say I want a vaccine, but don't give me one of those new ones. Let the other people have kind of those new ones that you described and the viewpoint, and you just mentioned. How do you think about that in terms of trying to educate the public?

>> So if these phase 3 trials play out the way you would like them to play out, which is to completion, so that we really have solid data, and we can say in a statistically robust manner that a vaccine is X level, in fact, let's say 70% effective. And you know that at least if it's given in 20,000 people or 15,000 people, that it hasn't caused a serious adverse event, then someone has a choice to make. You have a virus that, let's say, theoretically is still killing 1,000 people a day, and you know that it has been given to 20,000 people, say, and you know if you get the vaccine, you have a three out of four chance of being protected against moderate or severe disease which would cause you to be hospitalized or to die, would you get that vaccine? And most importantly, you know that at least, if you're, say, over 65, that it has been tested in your age group, or you're African American, or you're Latina, that you, that your background has been adequately represented in those trials. Then the right decision is to get it. And newer otherwise, just because it's new doesn't mean it's bad, it just means that there's less experience.

>> If, I knew questions would come in, and we'll get to some that you and I already chatted about. Are people likely to have a choice or in a way in which you anticipate the administration rolling it out if there is a successful vaccine, be it a Trump administration or a Biden administration, will people not have a choice?

>> Meaning in terms of which vaccine?

>> Yeah, which vaccine. Can you imagine that people will have a choice?

>> It depends on the data at some level. For example, like a messenger RNA vaccine works particularly, or more likely a purified protein vaccine, like Novavax's vaccine, because it's [inaudible] works particularly well in greater than 65, we'll much better, say than messenger RNA vaccine, so I think there will be, as we said, in the growing up at the track, which I did as a Baltimore native--

>> Right.

>> [Audio cuts out] there's horses for courses, and I think that may be true here.

>> So you think that, from the Phase 3 trial, there will be enough data to point people, like this is more effective in the older population, this is more effective in men, or women, or people with co-morbid conditions or not.

>> Exactly right.

>> Now you and I are pediatricians, and it always seems like children and pregnant women are left out of vaccine trials. Can you comment on that? It's come up. It has come across my desk multiple times. It has been in the media.

>> Right, so all the initial trials, as I understand them, certainly the NIH back trials, are all going to be done in people who are over 18 years of age. So I think when these vaccines roll out, we won't have data on kids initially. Now, I'm on the NIH active group, which we put together [inaudible] columns, I can tell you at tomorrow's meeting, that's specifically what we're going to talk about.

>> Right okay.

>> Is pediatrics, and when they'll be done, and now they'll be done. Because we can't give vaccines to children until we've proven that they're safe and effective. You can't just give them to adults and assume that's also what you're going to be, what you find in children. So we're going to have to do studies with children. How they get done is going to be tomorrow's discussion.

>> Questions are coming in, but let me start with going through some of them. You know, this Russian vaccine, of which I think there is no peer reviewed publication, any idea what they did?

>> My understanding, the best I can tell, is it's two vaccines in one. That it's a replication effective human ad 26, and replication defective human ad 5. So it's actually two vaccines, that we're giving as two doses. And I did see one piece of evidence regarding the neutralizing antibodies that were induced by that vaccine, and they looked comparable to what we are seeing with messenger RNA or with some of the other replication defective viruses. So just--so your listeners understand, so by replication defective human adenovirus, human adenoviruses cause disease by making them replication defective, the virus can't reproduce itself. So that's good. The virus is also genetically engineered to express the gene that causes a spike protein, so when you're inoculated with this virus, you make a spike protein, then you make antibodies to the spike protein. Because it's replication defective, it doesn't reproduce itself, it doesn't amplify itself, therefore you give a lot of virus. You give about 10 billion virus particles per dose, which is a lot of virus, and not surprisingly then, you have fever, and then the side effects that are associated with fever. I think when Vladimir Putin got on the airways, that was just pure political theater, I mean, where he gets up there and he says, you know, we've checked all the boxes. Near as I can tell, all the boxes are a small, phase 1 trial in 39 people. That's all the boxes, which apparently included his [inaudible], which I guess was a box. But in any case, now we've moved onto he's going to mass produce it, he's going to try to get it out there in September, he's talking to other countries, like Vietnam, about distributing it there. It just all worries me. And I'll tell you one aspect that you never hear about, that you should, is that if you remember Merck made an HIV vaccine a few years ago, where they took a replication defective human adenovirus type 5, and then did express the HIV surface protein, as well as other proteins, and found that people who got that vaccine actually did worse. They were more likely to have the HIV if they got that, than if they didn't get it. So why did that happen? That happened, because if you've already been exposed to human ad 5, and you then are boosted essentially with this replication defective ad 5, you actually increase the number or frequency of CD4 cells. CD4 positive T cells. T-helper cells, that express the receptor for HIV. In other words, you increase your risk for HIV. I am surprised that the Chinese and the Russians both chose this replication defective human ad 5. I would have never chosen that. I can't imagine that that has a future.

>> That immediately leads to two other questions. The first is it's a little hard to know. The CDC has suggested about a few weeks ago in JAMA IM that about 10% of the U.S. population had been infected. So that's somewhere around 30, 35 million. Let's say it's up to 20%. So that would be about 65, 70 million people. Do those people need to be tested for antibodies before they would be vaccinated?

>> No. Uh, I--no. And certainly the trials, the way they're being set up is not to do that, because it's not practical. I mean, when these vaccines roll out, we're not going to test people to see who was previously infected and who wasn't. And I think worst case scenario, you're just going to get a boost to your immune response, so no. No.

>> And now that leads to two other questions. There's an ongoing debate about the percent of the population that needs herd immunity. Some people are guardedly optimistic that with children not getting very sick, but getting infected, if you have 70 million people infected, you know, you need another 50 million to get you to 50% of the population. Do you have a sense? Or is it just all uncertain?

>> I think you're not going to eliminate the spread of this virus by natural infection. I can think of no infection that has burned itself out because everyone got infected, and then was immune. Not smallpox, not measles, not anything. And so I don't think that's going to happen. I do think, though, it's a value to have some population immunity. But I think the only way to get on top of this virus is the dual-pronged approach of one, hygiene. Hygienic measures, you know, wearing masks, social distancing, and two, the vaccine. The question is what percentage of the population needs to be vaccinated in order to stop spread, in other words, to get the or not to less than 1, this index to less than 1, depends on two factors. One is the contagiousness of the virus, and two is the effectiveness of the vaccine. If the vaccine, let's say theoretically is 75% effective, there is actually a formula for this. It's like or not, minus 1, over are not--[laughter]. If it was 75% effective, then you would need to vaccinate about two-thirds of the population to stop spread, roughly.

>> Now, you mentioned one thing about, you know, it sounds like the Russians took kind of a phase 1 study and off they run, in inoculating their population or at least a percent of the population. Yesterday, an emergency authorization was issued for convalescent plasma. I must have 30 emails about it. In part because JAMA has published two articles on convalescent plasma. This was after the pre-print was posted, and there has been criticism or concerns raised about the paper, two senior health officials, I'm assuming, doctors Collins and Fauci, were uncertain if that was the best approach, and you--you've written in the popular press about a concern about the same pressure being put on the FDA, particularly Steve Hahn, the Commissioner, in the fall. How do you think that may play out, Paul, and what advice would you give the scientific community, the FDA, and the public, about how to think about this?

>> Right. So, convalescent plasma has been used, really, to treat infectious diseases since the diphtheria antitoxin in the late 1800s. Not like we don't have experience with convalescent. The--and so it makes sense, if you're given high titers of virus neutralizing antibodies fairly early in your infection, and those are the two critical factors, high titers, and early infections, I mean, early in the infections. So antibodies that are highly avid, have high levels of affinity, are neutralizing and also given fairly early in infection, when viral replication is still at its peak, that you can make a difference. I mean, I do believe, I don't think it's going to be a game changer, even in the best of circumstances. I think it will be--would be, at best, another quiver in the, another arrow in the quiver, for the, you know, for what people can use along with dexamethasone and remdesivir and anti-flavid drugs, and monoclonal antibodies, etc., but the fact is, the Food and Drug Administration's job is to license, or in this case, approve products that had been shown to work, and have been shown to be safe. Now, I think that it's likely that plasma, for the most part, is safe. As to say, from hydroxychloroquine, which wasn't. Which had about a 10% problem with--about 10% of those who got that product could have cardiac arrhythmias. But you have to show that it works. And the data, I think Dr. Fauci and Collins were right. If you looked at those data, they hadn't proven that it worked. Now it's not easy to do those studies. Because you have to control for things to isolate the effect of that one variable. In this case, the variables receiving plasma. So you have to make sure that both groups, the group that got the plasma, or didn't get the plasma, were alike in terms of their degree of illness, in terms of how long they've been infected, in terms of whether they're receiving other things like remdesivir, dexamethasone, so you can look at that one factor. Receipt of plasma. And what you found when you looked at those studies is you couldn't say clearly that that worked. And because you couldn't say that it worked, doctors Fauci and Collins stood up and said no, we're not going to recommend approval until they did. So then, what happened yesterday? Donald Trump got up and in a press conference and said that you know, that now they're going to approve it. So what happened? I mean, what happened between what we knew to be the data that were insufficient and yesterday? And so one thing that could have happened is there's new data. There is a new study that has been done that we haven't seen yet, that clearly shows it's safe and effective. But if that was true, why didn't we hear about it yesterday? I mean, we would have thought that we would have heard about it, but we haven't. We heard about basically this sort of cherry-picked study that Alex Azor [assumed spelling] and Steven Hunt talked about yesterday. So does this concern me? You bet it concerns me! I think that what's happened yesterday is that you saw the FDA being bullied by the President of the United States into approving something that they didn't want to approve earlier, because he wanted them to do that. And certainly it's not the first time. I mean, you've seen the EPA's willingness to take the word, the phrase "climate change" off their website. You saw the National Weather Service being bullied by a supervisory group to basically change exactly how hurricane Dorian hit, you know, the Southeast, when it struck. And you saw what happened to hydroxychloroquine, which should have never been approved. That wasn't shown to work. It had known side effects, and it didn't work to treat or prevent disease so it only hurt people. It either did nothing or hurt people. Those--that's all it could do. So we--I don't think it's going to matter much with the plasma. I mean, people are going to be using the plasma anyway. It probably won't be done in any sort of controlled way anymore. I don't think you're going to increase the use, or decrease the use with this. But what does it mean for vaccines? I mean, you know, you probably saw Donald Trump's tweet recently where he said, and you know this, the deep state, or whoever, over at the FDA is making it very difficult for drug companies to get people in order to test vaccines and therapeutics. Obviously they--the FDA--are hoping to delay the answer until after November 3rd, let's focus on speed and saving lives, at Steve FDA, so what is he saying? He's trying to now bully the FDA into approving possibly through EUA, a vaccine or vaccines before they've been adequately tested. That is a major mistake for a lot of reasons. First of all, as we said earlier, these are novel vaccine strategies. We don't have any information about these strategies. You don't want them tested in only a few thousand people before you are putting them in millions of people. You want to have the biggest safety portfolio you can, and make sure all the sub-groups are represented. And you want to have a statistically robust way to say this is effective. If we don't do that, then we're going to potentially scare an already skittish American public about this vaccine. Because, you know, I think--I don't think I'm alone in this. I think that when Donald Trump speaks, you feel you're being sold something, you know, that he simply declares truths, whether it's hydroxychloroquine, or Oleander flower extract, or you know, Chlorox chewable, or UV light, or whatever he's pushing, you feel you're being sold something. But that's not the way people feel about the FDA. They don't. They think that the FDA is there to protect them. And they are. And there are a lot of great people at the FDA who do their jobs, and I'm on the FDA's vaccine advisory committee, I'm there, you know, a few times a year. Those people are exactly who you want them to be. They care deeply about this, protecting the American public. And I just think that if they're bullied on this for vaccines, there are going to be a lot of people who stand up and say "I wouldn't get this vaccine," and then what you've done is you've scared people, and you only get one chance to make a first impression. And the one thing that will get us out of this mess, in addition to hygienic measures, is vaccines. And if we screw that up, I think we've done an enormous amount of harm.

>> Not surprising, there's lots of questions. Just one follow-up and then we'll move off more of the FDA approval. Do you think the companies could restrain themselves from requesting an EUA? Can the companies exercise some ethical control over what they request? I'm not naïve. I mean, there's billions of dollars at stake. But could they say we don't want to go this approach? Rather than just making it a burden on the FDA? Could the companies behave differently?

>> It depends on the contract that they have with the federal government. Assuming the contract they have with the federal government states that no vaccines will be released to the American public until the company is comforted that the data are adequate, then they could. They could all write--the CEO of every company that is involved could write a letter right now, and say "I promise the American public we are not going to release any vaccines until phase 3 trials have been completed," they could do that. I wish they would do that, really.

>> Yeah, I just think that there may be another approach that sometimes we don't think about, many questions, you and I--right before we came, started, we always chatter, and you mentioned that there is a report that came out, that is beginning to get some pickup in the news. It's about reinfection. And someone is feeding me questions, and he said, oh, that's coming up already. Could you talk about what we'd chatted about before we started the live stream?

>> Right, so there was a man who, I don't know all the details, but I know some of the details. There was a man who was infected with SARS/CoV-2, who had sort of mild to moderate symptoms, fever, including high fever, sore throat, headache, muscle pains, etc., recovered completely from his illness in March. Then in August, so roughly five months later, again was re-infected. This time asymptomatically. So, and with a cladovirus [phonetic spelling], that was different from the virus he was initially infected with. There are a couple of things that need to be made clear here. One, clades are not serotypes. I mean, for all we know still, this is a single serotype virus. That's important for vaccines. This doesn't appear to be at least yet like flu, where the virus mutates away from its original serotype. That's good. Secondly, his second infection was asymptomatic, great, that's what you want. I mean, you want to know that when you're infected, either infected or vaccinated, that you're protected against moderate to severe disease. I mean, you're not going to get the sterilizing immunity, fine with me, it's either natural measles, or measles vaccine, where not only are you protected against moderate to severe disease, you're protected against asymptomatic infection or mildly symptomatic infection, that's not going to happen. It usually doesn't happen with these mucosal respiratory viruses. So I think that's a win, as far as I'm concerned, and it's actually a very good sign. I mean, the most important thing when you're developing a vaccine is to answer this question. Does natural infection protect you against moderate to severe disease associated with reinfection. If that's true, then you can make a vaccine. Then it tells you, this infection induces an immune response, which can be protective, then you just have to mimic that immune response. All good. It's not true of everything. I mean, you get, you can get group-A strep infections of your throat again. You can get gonorrhea again and again. And so we don't have vaccines against that. It's very hard to make vaccines when natural infection doesn't protect. I think that article, which I think could be played by the media the other way, which is oh my god, you know, you get--

>> You can get re-infected.

>> Short-lived, you know, this isn't going to work. Is the opposite. I feel really good about that observation.

>> Is the genetic shift that people periodically comment about, does it impact vaccine development, or worry vaccinologists [assumed spelling] like you?

>> Well so this is a single-stranded RNA virus. And like all single-stranded RNA viruses, it mutates. Every cycle of replication mutates, because it's not very faithful in terms of its replication. But the critical issue is are those mutations functional?

>> Right.

>> In other words, did virus become a different serotype? Did the virus become more or less virulent? Did the virus become more or less contagious? Now, there was some data, or some evidence to suggest that this one mutation has, has caused the virus to be somewhat more contagious. But there are, so no data, clear data, that the virus is more or less virulent, or more or less, or has shifted in serotype. By the way, it's not an advantage to the virus to become more virulent. The virus, the goal of the virus from its standpoint is to live. And so actually it's much better for it to become more contagious and less [inaudible]--

>> I never thought of it, I never quite thought about it that way. So you know, we're both old enough to remember chicken pox, before there was varicella vaccine, and chicken pox parties. And some of it had to do with whether natural immunity was better than immunity induced by a vaccine. Any sense about how that will play out with the COVID-19 vaccine? That if you're infected you're better off than if you get a vaccine?

>> Yeah, so things like chicken pox parties or measles parties, were part of that was that you were more likely to be hospitalized and more likely to die if you had chicken pox or measles as an older person. So the thinking was, let me let my child get chicken pox or measles, and that way they'll be immune when they get older. So that's, that's all fine. But, so the issue is natural--does natural infection induce a better immune response to vaccination and we'll get those examples, I'm a child of the 50s, I'm older than you are, by the way, and I had measles so [laughter], so that made me protected for the rest of my life. And if you look at my children who got a measles vaccine, I probably have a frequency of memory B and T cells that are probably at least three-fold greater than them, and probably have titers of antibodies that are greater than theirs. But that's not the right question. The right question is not is natural infection better than immunization? Is immunization good enough? Because you'd like to be able to get an immune response without having to pay the price of natural infection, which is occasionally hospitalization and death, and the answer to the question is immunization good enough? Yes! We eliminated measles from this country by the year 2000. So without having to make people like my children suffer measles, which was not fun. In the viewpoint you wrote, and then in conversations I've had with other people, people have talked about this enhanced disease. Quite a bit. With vaccination. Could you--one, explain what that is, and would you anticipate it could be better or worse with different types of vaccines?

>> The thing that worries people a little bit about this vaccine is not the Dangy story, remember the Dangy story was sort of antibody-dependent enhancement--

>> Right, right.

>> Which was the dang--dang, vaccine. Vaccine. I don't think that's going to be a problem with this. The one that peo9ple worry about, which I still don't think is going to be a problem, but everybody is paying attention to is that when we took the respiratory [inaudible] virus, and measles virus, in the 1960s, and tried to make vaccines by enacting--activating those viruses with a chemical, formaldehyde, what we found is that when children got an RSV vaccine, they were more likely to develop pneumonia, more likely to be hospitalized, and more likely to die than children who didn't get the vaccine. And I'll tell you why in a second. The same thing is true with measles. But then when we made--and the RSV vaccine never made it to a commercial product. But the measles vaccine did. The inactivated measles vaccine, and again, when children got that vaccine, they were more likely to be the so-called atypical pneumonia and unusual rash, and be hospitalized. And the reason is that the fusion protein, if you critically alter the way it looks on the virus surface, and it doesn't maintain its sort of, so-called pre-fusion confirmation, you induce this aberrant perturbed immune response is actually worse. Now the reason that's relevant here is that the SARS spike protein is also a fusion protein, so people are worried about that, and I know the Chinese group is working on an inactivated vaccine. And so I mean, people will pay attention to that. But people who have been paying attention to making sure that it still has that pre-fusion look, so we'll see.

>> Slightly--off topic. If we have a vaccine, it's approved in November, December, whatever the date, and we have 100 million doses that are available over the next few months after that, because production, I know, is occurring simultaneously. Who should get the vaccine, Paul?

>> Right, so that decision, I think is going to be made by the Advisory Committee for Immunization Practices, the ACIP, yeah, which advices the CDC, in collaboration with the National Academy of Medicine. Now there was a meeting at the ACIP a few weeks ago where there was a presentation where they actually stated who they imagined were going to be getting these vaccines, and so it was people who were over, greater than or equal to 65, essential workers, as yet to be defined. Certainly people who work in hospitals, who long-term care facility residents, people with certain co-morbidities, so, and they estimated the ACIP, estimated that was about 120 million people who likely will be a two-dose vaccine. So you're talking about 240 million people to sort of get that vaccine, just as wave 1, to get out there, which is going to be a tour de force. Also remember for vaccines like the messenger RNA vaccines, but during advisory, those need to be stored at very cold temperatures minus 80 degrees Centigrade, which is like, I don't know 112 degrees Fahrehnheit. So that's dry ice. I mean, you're storing all the dry ice. So there's no real experience with doing that, in doctor's offices or in pharmacies. So that's another challenge.

>> When I spoke to Bob Redfield last week, and then Zeke Emmanuel, they talked about flu vaccine in the fall, and its importance, and I think there is broad agreement about that. But vaccinating 100 million Americans, 100 million people who live in the U.S., when you can't walk into healthcare facilities anymore is not an easy task. And people have suggested that we should use these months to figure out a vaccine delivery system that in some regards is independent of walking into a physician's office. Now, people like their physicians or their healthcare provider, if it's not a physician. How do you imagine vaccinating 100 million people?

>> [Inaudible] put out a piece recently from the CDC, saying, and her initial statements anyway had to do with those points of care being primarily physician's offices, and large chain pharmacies. It may need to be more than that. It may need to be universities or hospitals or, you know, other points of care. And I think, you know, the Department of Defense initially is the one at warp speed that is responsible for implementing and distributing this vaccine, and I think it would be nice to have the plan out there for exactly how they plan to do that, and also to be able to give, you know, states, and localities a chance to figure out how they're going to do it once they get the vaccine in hand. Because we're probably not that far away. I mean, I really do think by early next year, first quarter of 2021, we will have a vaccine or vaccines, and it is going to be really hard to do that. Because remember it's a two-dose vaccine, and you have to identify who those groups are, I mean, how does somebody prove that they are, like sort of co-morbidity, or they're essential healthcare worker, or whatever, I mean, and I'm sure there are going to be many people, as much as we talk about people not wanting to get this vaccine, who are not really going to be in the first group who really want the vaccine. And probably are going to figure out a way to get it, and there could be some ugliness in all this.

>> Well, you can imagine teachers, if they want to bring kids back to school, the teachers who are in high risk but don't want disease, or have someone at home. I mean, can you imagine Good Humor trucks? You know, that can store the vaccine, and they go down the street, and they give the vaccine. I mean, we both laugh about it, but vaccine storage is an art, and you know that because you're a pediatrician. So pediatric offices are very, very good about vaccine storage. But if the storage necessary for some of these vaccines is unique, that is only going to magnify the distribution problems.

>> You're right, you know, it's funny that you say that. This guy [audio cuts out] once, I don't know if you remember this, vaccinate man [laughter] was in a, you know, like one of those Good Humor trucks, you know, everybody--all the kids were happy until the vaccination man came around. Yeah, no. It's going to be, it's going to be really hard, and that's why we now, I think, need to decide exactly how we're going to do all of this. And it's going to be--and that also depends on which vaccines really do roll out first, because obviously the MRNA vaccines are going to be treated differently than the replication defective human or simian adenovirus vaccines.

>> Are there any vaccines out there that you just find scientifically intriguing, that who thought of that? I mean, I know this is your world, but there are other really smart people who are working on it, and you read about it or you spoke to them and you go boy, that is really creative or unique?

>> Well, I'm on the FDA vaccine advisory committee--

>> So you've seen them all. Okay.

>> I'm supposed to check, it says I'm not allowed to express a preference for any vaccine.

>> Okay.

>> No, I think that certainly all the vaccine strategies that have been used before are going to be used to make this one. I think, you know, the messenger RNA and DNA have been talked about before. There's nothing sort of, I think there's no Einstein leaps here, where you know, for like 40 years in the future. I do think, though, in the best case scenario that we will learn a lot about these novel strategies, and as we hopefully, in a good way, but I do think that we'll learn a lot about this, that could then help us with a variety of other vaccines moving forward.

>> I mean you talked about, you know, the October approval through the FDA and your concern, you know, we've talked about, could companies play a different role than they've actually played in the past, when they're trying to market a new product. Is there anything in the vaccine development that keeps you up at night, that you go, you know, people don't really want to talk about this, this is a concern that, something goes awry, Paul?

>> I think, I mean, the [inaudible] group has a sub-committee sort of vaccine-induced immune enhancement, and so we talk endlessly about now coming out with a paper that should be published soon about what it is that we're worried about, and how it is we're going to look for that, once these vaccines roll out. So that is something that the NIH group has considered. So no, I don't--and I honestly think that those aren't actually going to be problems, but I'm glad they're being looked for. So no, not yet, but I mean, the history of medical breakthroughs is that we learn as we go that there are invariably human price associated with that knowledge, and I suspect that this novel, illusive, difficult to characterize bad coronavirus which has already had surprising clinical findings and pathological findings that we're about to meet with vaccine strategies with which we have no commercial experience. I think there is going to be a learning curve over the next two years. I'm sure there are things we're going to learn that we wish we knew now, but we just have to be open and humble to that, and make sure we keep our eyes open. And don't over-promise.

>> Yeah. Now you talked about ACIP and you thought that they would make, along with the National Academy of Medicine, specific recommendations and that, although they've written for us, healthcare systems aren't bound by it from a legislative standpoint, unless I'm wrong, but I don't think people are bound by it, although they generally follow ACIP. Does the vaccine injury compensation program have a role to play in helping people's hesitancy? It has been a hugely successful program. You and I, again, know that as pediatricians.

>> Well yeah, certainly, my understanding is that this, by whatever mechanism, these vaccines will be protected in terms of liability, so that if people do suffer, I mean, what is clearly a consequence of these vaccines, that they would be compensated for that, and that the pharmaceutical companies would not be on the hook, at least initially, because that's the way the vaccine injury compensation program works also. I don't think it's going to be through the vaccine injury compensation program, but I think there will be some liability protection, which was also true of the swine flu vaccine in 1976, which was really, like that was warp speed, too, actually. This is warp speed 3. Warp speed 1 was the polio vaccine.

>> Was polio, right.

>> The swine flu was warp speed 2, this is warp speed 3. So again, mass producing at risk, mass producing without knowing whether it worked or was safe, and then put it out there. So I think, I think that people shouldn't choose not to get a vaccine for that reason. That they feel they wouldn't be compensated were they hurt.

>> Two last questions. We've talked largely about vaccine development, distribution in the United States. How do you think about it globally? I mean, there's 340 million people in the U.S., there's 7 billion people in the world. A lot of other countries are suffering. The U.S. government has put in 10 billion dollars. We'll be first in line for a lot of the vaccines, but there is another six and a half billion people in the world.

>> I think we have a responsibility to the world. I think the fact that we are economically and technologically advantaged means that we have a responsibility to the world. And I mean, how much more information do we need to know that what happens in other countries affects this country. So, I mean, I know a lot of people who are on the inside of this process, who feel the same way I do, and hopefully that's the way we'll act. And despite the President's America First notion that we do have a responsibility to other countries.

>> Do you have a notion that these companies are going to provide some percent of the product that they produce to low and middle income countries? Do you have any idea of how they're thinking about it?

>> I don't know.

>> Okay. And then, this is the last question. So you and I are resuming. We haven't traveled very much. I don't know if you've traveled at all. I have traveled home periodically. The world is a very different place. I call it the great pandemic of 2020, and I think people's memory like many other significant years in people's lives, 63, 68, 1991, going back, 1945, whatever the year, this 2020 will be ingrained in people's memory. Do you see light in 21? Or is it 2022?

>> I think we can wrestle this virus to the ground. I think it will take the combination of hygienic measures and a vaccine. But I think it's going to take a while for vaccines to get out there, and I think that the protection, while I think will be good against moderate to severe disease, I don't think it's likely to protect against asymptomatic infection or mildly symptomatic infection, which means you could still shed, I mean, you see that person for example who had an infection, a natural infection, where you're probably going to get your best immune response, and then five months later, have an asymptomatic infection. The critical question is was he shedding?

>> Right. He did well. But the question is, can he still communicate? Can he still give disease to other people?

>> Which I think that even if you were vaccinated, then you should still wear a mask. One, because you may be one of the let's say 75% affected, you may be [overlapping speakers].

>> Right.

>> And you don't know that. And you're not going to be protected against all, I think, forms of disease. Just moderate to severe. So it's hard enough to get people to wear masks now, as it is. I think it's probably going to be harder to get them to wear masks once we get the vaccine out there. But I think with that dual approach, we can do this. I don't--I think this is at least two years. I think it's 2022, is when we start to see light. But I think it's also going to depend on what level of disease that we're willing to accept. I mean, we do accept 780,000 hospitalizations and 60,000 deaths from flu last year, I mean--

>> Right. Right.

>> I mean, could we have worn masks and socially distanced, and lessened our incidence of that? Yes. What will be interesting to see is what happens with flu this year, because we will still be wearing masks, and we will still be social distancing and I think the incidence to flu probably will drop. So it's, what are we going to accept? What are we going to accept for disease?

>> Yeah, we have published two research letters, at last one, I think two from other countries, where as soon as they began masking, flu plummeted. I mean, there is--I mean, it's always been interesting to me in a "bad flu season," everyone still walks around and comes to work half sick and no one wears masks, and this has totally changed our perception of coming to work ill and wearing a mask.

>> It has been public relations, I think that's it. Because people say the typical flu or the usual flu--it still kills people I mean what's the difference?

>> Right. Paul Offit is the Maurice Hillerman Professor of Vaccinology at Perlman School of Medicine at the University of Pennsylvania. He makes me proud to be a pediatrician. I have to say that, Paul, I've known you for a long time. You're just an extraordinary--you have an extraordinary wealth of knowledge about vaccines. So hopefully I'll have you on--hopefully with Steve Hahn, you know, when they announce the approval of a vaccine, and we can ask him all, all, all about the data, and why they've approved that vaccine. That would be a wonderful--that would be a wonderful conversation to have. Thanks so much, Paul.

>> Alright, take care, thank you.

>> This is Howard Bauchner, Editor in Chief of JAMA, and this has been Conversations with Dr. Bauchner. Stay healthy, Paul.

>> Yeah, you too.

>> Bye bye.

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