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In the midst of rising COVID-19 case rates globally, Derek C. Angus, MD, MPH, and Rochelle P. Walensky, MD, MPH, return to JAMA's Q&A series to update viewers on developments in the pandemic and the critical care management of COVID-19 patients. Dr Angus is Chief Health Care Innovation Officer at the University of Pittsburgh Medical Center, professor and chair of Critical Care Medicine, and a senior JAMA editor. Dr Walensky is Chief of Infectious Diseases at Massachusetts General Hospital and a professor at Harvard Medical School. Recorded November 19, 2020.
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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 two people who I've actually chatted with before but separately, and I thought it would be wonderful to have them together. The first is Rochelle Walensky. Rochelle is Chief of the Division of Infectious Diseases at Mass General and a Professor of Medicine at Harvard Medical School. And the other is Derek Angus. Derek is the distinguished professor at Mitchell P. Fink and now chair Critical Care Medicine. He has a much larger remit than that at UPMC. But most importantly, he's become a good friend since my arrival at JAMA, where he is now a senior editor. This is going to be a wide-ranging discussion. I'm going to start with Derek. But beforehand, I just want to remind people of the numbers this morning around COVID-19. It's a very troubling, frightening story. A hundred and seventy thousand cases yesterday. We've been over 100,000 virtually every day for the last week. Close to 2,000 deaths, which will rival the number of deaths that occurred in March and April, when we peaked at about 2,800. Over 70,000 individuals are in the hospital. Derek mentioned that they have more patients hospitalized at UPMC than since the epidemic began. Derek, beginning with you, for critically ill patients, what's the standard of care now?
>> Derek Angus: So I think the first thing is among all patients who are critically ill with respiratory failure, it's probably the case that worldwide, we've tried to move back our threshold for intubating. And so I think there's been a sort of a broad experiential learning that patients who can get into some hypoxic distress can often be coached through that episode with use of non-invasive ventilation, for example, or high-flow nasal oxygen. And so I think the threshold for intubation has dropped a little bit. And I think there's a brought -- no one has really done -- well, there is a randomized trial addressing early management of hypoxic respiratory distress that's trying to take place in Ireland and United Kingdom. But there's no -- there's no good, randomized evidence to drive this. This has been a sort of a worldwide experiential learning with many groups reporting the same thing. So whether it's truly beneficial or not is less clear. But as best as we can tell, we certainly see that the proportion of intubated to non-intubated has definitely dropped across the world. Those who get intubated are still facing a very severe course. They're still characterized by protracted periods of respiratory failure and ARDS with high mortality rates. But -- so issue number one is when do you intubate? And we've probably backed off a little bit because some episodes of hypoxia can be managed through non-invasive ventilation. And after that, then there's the therapies that we give. I'll pause for a moment and see if you have questions, and then I'm happy to talk about therapies. [Chuckles]
>> Howard Bauchner: Right. Rochelle, has been your experience, the general that -- I mean, I know you often get called in to consult, but that the goal has been to try to avoid intubation at all costs?
>> Rochelle Walensky: Absolutely. I think that's exactly what we're seeing. And maybe not at all costs. But yeah, we're trying to just, I wouldn't say stall, but to try and see if we can get through intermittent episodes if we can, without sort of leaning into a full intubation course because as noted, if they just stay intubated, they're sick for a long time.
>> Howard Bauchner: So Derek, the critically ill patient who isn't intubated or is intubated, you know, we had the three clinical trials. You are an author of one and the meta-analysis from the WHO. There was the recovery trial. Clearly, steroids has emerged as the standard of care. It reduces mortality rates when mortality rates are high. Now mortality rates have come down. So its effect on mortality may be less. But is it steroids and then everything else, Remdesivir, Toci? I mean, how do you think about therapy beyond trying not to intubate?
>> Derek Angus: So I'll start with steroids start by saying we've tried steroids for everything since before I was born. And I think we have a stronger and more consistent signal for the benefit of corticosteroids in sick patients with COVID-19 than we've probably seen in any other analogous condition almost ever. Various forms of community-acquired pneumonia, ARDS, and sepsis have been tried one way or another with steroids on and off for decades. And we've struggled to have a consistent story. So I think corticosteroids, whether it's dexamethasone or hydrocortisone, certainly seem indicated for the clearly sick. In the recovery trial, the hospitalized patients who are not oxygen dependent saw no benefit. And everyone knows these drugs are very pleiotropic. And they do all sorts of things to the host, some of which may be good, some of which may be bad. And so it definitely seems that steroids present a risk benefit, and the benefits outweigh the risk in the clearly sick. The issue then still that borders on exactly how sick is sick enough to give steroids? So the person who's on a fair amount of oxygen but not necessarily intubated, would it be wise to give steroids or not? And there probably is still a little bit of uncertainty around how much oxygen represents how severely ill the person is. And this was alluded to nicely by Todd Rice and Hallie Prescott in their editorial that you either get it or you don't. So there's like a binary flip. But the disease is on a continuum. And so that sort of middle zone is still a little discretionary in my mind. But if I walked in and saw an intubated patient with bilateral infiltrates with COVID-19 that was not on steroids, I would totally have why the hell not? That's steroid. I'll stop there. Then we can [inaudible] --
>> Howard Bauchner: Yeah, no. Let's take them one at a time, and questions are already coming in. Rochelle, how do you -- I mean, you -- I know it's often pulmonologist critical care physicians, but you're a consultant, you know, and your armamentarium may be Remdesivir. So how are you thinking about these drugs, steroids, Remdesivir, Toci? Someone mentioned to me that this is a pleiotropic disease. So maybe those very targeted therapies aren't working because we don't know who to give them to is kind of interesting concept to me. And steroids are, as Derek mentioned, very pleiotropic, which is the disease. But how are you thinking about it when you write your consult? Or your fellow says they want to know what we should do?
>> Rochelle Walensky: Yeah, I think, you know, I sort of feel like there are two things we have to grab based on the data right now. We have steroids, and we have Remdesivir and even Toci now. There was a question of whether we were going to grab it, but we're not grabbing it anymore. [Chuckles] And so, you know, in my mind, the question is how close are you to needing Derek's help? And how close are you to being able to turn this around and go -- and potentially not need an ICU? We are leaning, you know, if people are requiring hospital -- if they're found, incidentally, in the hospital to have COVID, because they had their hip replaced or whatnot, we're not necessarily moving towards Remdesivir. But if they're sick with COVID, they're coming in with COVID, they have some oxygen requirement with COVID, then we're giving them Remdesivir. And then the question is how close are you to needing the ICU? Do you really need Tocilizumab? Excuse me.
>> Howard Bauchner: So you will use Remdesivir prior to steroids in that Todd Rice, Hallie, not quite there with steroids, but you would use Remdesivir in that group?
>> Rochelle Walensky: Yeah, absolutely. Absolutely. And then we sort of watch them carefully and say, "Where are you on this continuum? Do you need steroids today?"
>> Howard Bauchner: Do you have any concern that when you use Remdesivir and steroids together, so Remdesivir, mildly but not seriously ill, and then you give steroids, that you may reduce the effectiveness of steroids?
>> Rochelle Walensky: Yes, I mean, we don't -- we try and not use it in that space. We try and really sort of say we're saving it to the people who we really think are about to downturn and really go into this inflammatory phase, because I think that's really where the data are best that it works. So yes, we do get a lot of calls, especially people who have, I mean, there are a lot of comorbidities associated with this. And we know, you know, the side effects associated with steroids. So we certainly -- we want to give them when they full-fledged meet the criteria for all these trials that look like they benefit. But at an PAO2 of 92%, and it looks like they might turn around the corner, and other comorbidities, we're not necessarily rushing to pick it up.
>> Howard Bauchner: Derek, what's your sense of this Remdesivir to steroids or Remdesivir plus steroids?
>> Derek Angus: So I have -- I have a complicated relationship with Remdesivir. [Chuckles] I feel like a lot of me wants to believe that it's quite plausibly has important antiviral effects in my conceptual model of the disease. And I could imagine if I put someone on Remdesivir, I may shorten the course of shedding. And I may change the arc of the disease. But there have been some RCTs. And they have struggled to nail that that conceptual idea is actually working in practice. I love the act one trial, but that the -- not all the trials have found the same thing. The recovery trial really found very little. And we still see the final published version, but from what we know, you -- nothing about that would make you think I would rush out and give Remdesivir. And it's notable that I don't -- I don't know this for the fact. But my understanding is that it's not being widely used outside the United States. And I would -- it's not -- it's not crazily expensive, but as a worldwide antiviral, it would be an important burden to roll that out globally. And so I personally would still like to see more randomized trials. And I would -- I would still like to understand exactly what patient population do we give it? Maybe we don't have the dose right yet. The interaction with steroids still bothers me. Maybe its best role is in the outpatient. What work are we doing to get a non- intravenous version of it? I'm slightly nervous that people have almost stopped asking questions about Remdesivir. I'm not entirely sure that we're deploying it to its maximum advantage at this point.
>> Howard Bauchner: So this morning, at 5:51 a.m., someone sent me a Tweet on the recommendation of the Data Safety and Monitoring Board recap. REMAP-CAP is declaring efficacy of Toci with an odds ratio of 1.87 for the benefit on a combination of survival and length of time. Patients received organ support in the ICU. That arrives at 5:51 a.m. this morning. I don't, as is often the case, no one will see the data for weeks to months, which, to me, this feels a lot like what pharmaceutical companies do. I understand why this happens. But I think it makes everyone anxious about not seeing all of the data. Two articles in JAMA. I am questioning the value of Toci. One article in Needham questioning the value of Toci. A lead article in New England Journal in a New York Times last week that summarized the three studies, saying where are we with Toci? So Derek, you're -- you participated in this study. Can you say more? Or are you blinded and can't say more?
>> Derek Angus: So I'm happy to talk about it. I don't know whether we're going to circle back to here, Rochelle --
>> Howard Bauchner: Oh, we will.
>> Derek Angus: -- if you want Remdesivir. But we can -- we can talk about Toci if you want. So I, like you, have been very nervous by being on the receiving end of these press releases with no data. And yet here I am part of the steering committee for REMAP-CAP who just issued a press release. So it's totally true that the DSMB called us up about 36 hours ago and said, "Oh, you've hit the statistical trigger for superiority of Toci over control. By the rules of the study design, we unanimously think you cannot randomize the control anymore." Now we have 270 sites live around the world. And we have to contact all of these sites and their IRB's and let them all know. And so we had an emergency meeting of the steering committee and we said, "How do we whisper that to 270 sites [chuckles] while -- and we just realized, we just have to have one clear statement, which is this is what we've been told by the DSMB. So this is now the action of the trial. In the -- we do make the point that we don't have all the data yet. And we fully understand the need to bring the data to bear. And so our plan is to lock the data set and all the patients that have been in this domain up until this morning, get the follow up from the 21 days follow up, and try to have a large data set. You can work the math. It's like right before Christmas. [Chuckles] Try to have people lock the data set. And we will move as quickly as possible to share the data in publication format. But that the press release was because we thought we have thousands of people in this trial. And as soon as we send an email out to it, everyone is, I mean, we've effectively released it all to the public anyway. And so let's just try to have one single centralized statement. I appreciate -- it's hard to know what it means. You immediately have all sorts of questions.
>> Howard Bauchner: So Rochelle, as soon as we finish this conversation, this afternoon, you will get an email. I promise you.
>> Rochelle Walensky: Yep.
>> Howard Bauchner: You're the head of Infectious Diseases at a preeminent institution.
>> Rochelle Walensky: [Chuckles] Absolutely.
>> Howard Bauchner: Someone will consult you. They'll show you the Tweet. And they'll say, "Well, what's your current recommendation for treatment?" Is it -- we know steroids. Let's put them aside. Okay. We're in good -- we're -- thankfully, we're in good shape around steroids. But now you have Remdesivir. Now you have Toci. You have three studies around Toci that showed no difference. You have this press release. How do you -- how do you, as an expert, begin to think about this?
>> Rochelle Walensky: Yeah, it's been really -- it's been an interesting evolution of the times, right? Because early on, we were really thinking about -- and I know Derek's written about -- like, do we do this based on our anecdotes, our cohorts, whatever it is that we can pull together? Or do we really need the clinical trials? And I think we all learned the lesson yet again, we really need the clinical trials, right? But a lot of what we're doing now I'm calling it medicine by press release. And it's really not. It's really hard to practice medicine by press release, especially since for many of the agents where we're doing this by press release, they're scarce. Early on, we got data from the, you know, from the press release that Remdesivir was going to work. We just didn't have enough of it. And so how is it that we take the one pager that gives, you know, a handful of statistics, and allocate something that's so limited? We're here again with the monoclonal antibodies. And so not only are they limited, but they're expensive. And so, you know, in my mind, a lot of what I'm doing is waiting for the NIH guidelines, the HIDSA guidelines, to come out. And because I believe that they're going to see the data before any of us will, I suspect that they will look at those data critically and decide are these -- do we need more data? Who should we be giving it in? Who should we be giving it to? And what's the next best step here? Because I'm really reluctant to sort of take a press release and say we need to move forward and call that standard of care.
>> Howard Bauchner: Yeah, the other issue is the armamentarium gets broader, maybe more difficult to know who gets which drug. You know, there's going to be some challenges. And you're going to have to look at the population in this study to know if it looks like your study. Did they get Remdesivir? Did they get steroids? At what point in their -- in in the disease course did they get it? I want to -- I want to continue with a number of critical care questions and then move a little off of it, because there's already a lot of questions. I am continuing to get quite a few emails about Cyclosporin and Interferon Beta. As both of you know, since I've talked to both of you before, I have a strong belief in trials. I think it -- every non-trial study we saw was polluted in many, many different ways. Different groups, observational data. And we've written about that extensively in JAMA, but both Cyclosporin and Interferon Beta keep crossing my desk. I'll start with you on this case, Rochelle. Any thoughts? I mean, isn't -- do you hold on to just waiting till you see clinical trial data?
>> Rochelle Walensky: You know, we've been -- we've been burned. [Chuckles] You know, I just think we've been burned. And so yeah, you know, there were so many people as in the New England Journal Toci trial was here, right? There were so many people here who initially thought, how could we not give Toci to this patient who is crimping in front of us? Right? Who's really not doing well, when we really believed that this could make them better. And when we really stepped back and didn't give it, because we really wanted to do the trial, those patients sometimes got better on their own. So I really do -- I mean, we learned this in HIV. We've learned this in so many different places. So yes, I think we need to wait for the clinical trial data.
>> Howard Bauchner: Derek?
>> Derek Angus: Yeah, I'm thinking about Interferon Cyclosporin and also about the earlier part of the conversation.
>> Howard Bauchner: Yeah, right.
>> Derek Angus: Mentioned by press release. I really think because we want transparency, and because the whole world is watching, there can be a role in giving rapid updates of each stage of these trials, as long as we know that that can be reason for hope, but not reason to immediately go to the bedside and change what you were doing from last night. And I -- and I would strongly say that if Cyclosporin is legitimate, it should push into trials. Interferon, we have Interferon in REMAP-CAP. But it is complicated because of the earlier trial not in COVID. But the earlier trial in the ARDS suggesting an Interferon-steroid interaction. People are nervous about testing Interferon in the presence of steroids. But I would say steroids do nothing to directly kill the virus. Although they are very pleiotropic, they're broadly in the camp of dampening down a large number of parts of the immune system as well as the cardiovascular effects. We don't know which bits are the most important. But there's a broad panoply of immune modulators that might have a role to play in selectively dampening unwanted parts of the host response. And I would include in that even the things affecting endothelial activation. One might even think of some of the strategies for anticoagulation is really tackling some of the downstream parts of the host response. It's true that the virus is driving some of that, but some of that's the host itself. All of that could feed speculation and theory all day long to produce a laundry list of putative agents. And the only way to get rid of the madness is to try to systematically funnel them into evaluations. These large platform trials seem to be the most efficient way to spool through testing those trials will be randomized, right?
>> Howard Bauchner: I mean, you and I've chatted about this before. The other issue is when you're sitting at the bedside, are you smart enough to know what pathology is dominant in this patient? It may not always be the same. And so for some patients, you may want to block the inflammatory cascade, and in others, you may not. And I'm not sure we yet have the tools to do that. I want to change the focus a bit. Rochelle, I'll start with you. I already gave the numbers. They're frightening. A hundred and seventy thousand cases, 2,000 deaths, 70,000 admissions to the hospital. And I mentioned before we started when I spoke to Dr. Fauci two or three weeks ago, and I asked him about Thanksgiving and Christmas, he said, "Can we just get to Thanksgiving? I'm not sure we even can envision what what's going to happen after Thanksgiving." We're ten days or a week before Thanksgiving. Everyone I know, single digit numbers of people. How did we get to 170,000 cases a day? I don't think anyone anticipated this number of cases in early November.
>> Rochelle Walensky: And it's just extraordinary because, you know, we thought we might be here after Thanksgiving. The fact that there's so much virus out there before people start to gather is just so very scary. You know, what was a cohort of cases in the northeast, and then it moved to Florida, and then it moved to Arizona, and then it moved to California, is now across the United States. And so I think it's pretty easy to see how this could multiply when it's not regionalized anymore. And it multiplied exponentially, right? But what I will say is, you know, I think fundamentally, behaviors are hard to change. It's the reason we have an obesity epidemic. It's the reason people can't stop smoking. And we're asking people to fundamentally change their behaviors, their social behaviors, how they interact with people, what they wear. And so I think those are fundamentally really hard to change. What's interesting is it's actually pretty -- it's pretty easy to prevent. Like, one could just say if you just wear a mask and stayed away from people, but again, you're back to behaviors. So, you know, the thing that worries, of course, the deaths are tragic. The numbers are just crazy. The thing that really worries me, as we head into this, and we see these numbers, there's so much dialogue about the fatality rates are going down, and testing is going up. And we can sort of attribute many of the good things to that. But, you know, our hospital capacities now are just big, full. And they're not just full in a single hospital in a single region, or in a couple hospitals in a single region. There are now like more than 15 states that have more than 1,000 people in the hospital. And ,you know, when you can't -- and I know people, like people are allergic to the words "locked down," and you can't say mask mandate, and there's so many things that are trending politicized. But if we can't fundamentally take care of the health of our public because our hospitals are at and beyond capacity, we can't take care of COVID patients. We can take care of stroke patients and cardiac -- and MI patients and so many other things. And that's, I think, really just what, you know, when I think back to April in Boston, we fundamentally couldn't take care of all the people who were coming in with everything.
>> Howard Bauchner: Derek, you oversee an incredible staff, a large number of ICU beds. You already mentioned that UPMC has more patients in the hospital with COVID now than they that they ever did before. A couple of times a day, I'm sure you get your bed count. How many -- how many beds are empty? How many beds are filled with patients who have COVID-19? How many people in the ICU have COVID-19? How are you even thinking about the next couple of weeks? And there have been some comments. I think people are incredibly concerned now about this, about the health care workers again nationwide. And I want to return to that. But Derek, how are you -- how are you just thinking about the next couple of weeks? I mean, do you want to see a mandate in your state, Pennsylvania? People have to wear masks.
>> Derek Angus: So I mean, it's, you know, this is threading the needle. Everyone can run, but very few people can do a marathon. And so if we were just doubling down for a wave, the way H1N1 came through as a wave, you can -- you can ask society to do almost anything for three to four weeks. But this is about what's sustainable over many months. I think what we're heading into right now is, as Rochelle said, not sustainable at the point that the healthcare system is failing. That's too bad. Having said that, we can't be so draconian that the entire economy halts, or that we ask people to do things that are just totally impractical. I mean, I think I would echo what's been said in the media a lot. It is slightly frustrating that everything is patchwork. It would be nice to have a more coordinated plan. To a certain extent, you even try to wonder why is everyone trying to solve the problem separately? [Chuckles] It's crazy. So when you say should I look at my state to do more, I'm still sort of feeling like for the overall community action, I would still like that to be a little bit more federally articulated. Healthcare systems, to a certain extent, have to handle things -- they have to know what they can do on their own. It's quite hard for healthcare systems to lean into other healthcare systems. It's quite hard for healthcare workers to go from one institution to another. Electronic records don't transfer. I mean, one could envision some future state where everything is much more coordinated. When Hurricane Sandy hit New York, it was almost impossible for the doctors to follow their patients from one hospital to another because they didn't even know how to work on the EHR in the other hospitals. So I still think a lot of healthcare systems can cooperate, but they each have to do -- they sort of have to take care of their own to a certain extent. In our place, we -- we've done a lot to make sure that we've got strong capacity for the hardscape and the number of beds, supplies, etcetera. But we totally worry about our workforce.
>> Howard Bauchner: Yeah.
>> Derek Angus: They're not as replaceable. We have a large number that are out on quarantine. When someone's out in quarantine, we worry that they get sick. But we also worry that the remaining people are now taking on a bigger load. That's not a resource the same way PPEs are resourced. And it's much easier to exhaust and overwhelm the workforce. And so we're looking at things like can we get more data to have a smarter quarantine model so that people who are asymptomatic but have come in, in a low risk or high-risk contact? If they then shelter at home, but they're test negative, is it actually safe for them to come and -- come back sooner than the current CDC guidelines? It would be really useful to have federal guidance that promoted the leanest, most efficient quarantine rules so that we keep as many able bodies contributing as possible. But I think what I've just said there, I think every healthcare system is probably having a very similar thing. Staff, staff, staff.
>> Howard Bauchner: Rochelle, I want to end on a slightly more optimistic tone. Two announcements this week by Pfizer and Moderna, both with messenger RNA vaccines, both with 90-plus percent efficacy, both indicating pull limit -- with preliminary data that it worked across the age spectrum, although again, we haven't seen the data. Both companies are likely to apply for an emergency youth authorization from the FDA in the coming weeks. I want to emphasize I have asked companies not to state they will get an EUA. That is not their decision. That is the decision of the FDA. It is not a company's decision. They will apply for an EUA. The FDA advisory panel on biologics will weigh -- will weigh in. These numbers don't have confidence intervals around them. So we don't actually know if the 90% is 80% to 92%. The confidence intervals are likely to be wide, because the number of cases in both studies are smaller than we had anticipated. And no safety data have been released. What's your sense of the two press releases you've read?
>> Rochelle Walensky: Well, maybe we'll start with the optimistic part and say the -- who would have thought eleven months into this we'd have two vaccines with two Phase III trials that ended to -- with a safe -- with an efficacy endpoint? So like, let's, you know, enjoy that moment for a minute. And then -- and then acknowledge -- and there are several more that are forthcoming, right, coming along the way. Then I think we really need to say that that's the process of getting the public vaccinated is a sequential set of processes. We need the vaccine in order to do so. And then we need it spread across all corners of the United States. And then we need it in people's arms. So I think, you know, if you look at the Operation Warp Speed website, they will talk about the billions of dollars that they invested in the development of the vaccine, and the millions of dollars that they have to put into so far in the distribution of the vaccine. And that they don't talk much about how they have done in terms of gaining public trust and the communication and what needs to happen in order to make sure that people get vaccinated. I'll layer on -- excuse me -- two other issues. One is all that workforce that is now working on trying to take care of the huge volume of patients that we have, new makeshift ICUs, all that workforce is not now being deployed to help in vaccine distribution, right. There is only a finite set of workforce. And so I do think that there are a lot of people who have been overworked and stressed for months and months now who are now actually putting all of their time and energy into patient care and are having a really hard time trying to find the workforce to think through vaccine distribution. And then the other thing is I think we're asking of -- a lot of our vaccine to work really hard when we do -- when we try and introduce it in a setting of 170,000 new cases a day. I do think, you know, you're just asking it to do a whole lot when we know it's not going to kick in efficacy for about five or six weeks from the first day of vaccination. And I think boy, if we could flatten that curve, it would allow the workforce to do a little bit more on the distribution side, as well as, you know, be able to work in prevention rather than trying to play catch up in all this disease.
>> Howard Bauchner: One of the discussions I had with Paul Offit, who sits on the FDA advisory panel, was around safety data. And I think that the committee, there may be robust discussions amongst the committee members. Is two months of data -- safety data sufficient? Do you need four months or six months? You know, people have commented that most adverse effects occur in the first two or three months. But that's with traditional vaccines. These are not traditional vaccines. When I speak to my own family members, they go, "You're putting RNA in my body? I think I'm not so happy about that." How do you think of the safety issue around the vaccines, these two specific vaccines?
>> Rochelle Walensky: You know, I rest a lot in what Paul and his colleagues have been saying about safety, you know. It really -- most of the vaccines that we've seen so far demonstrate, you know, their adverse events in the first two months. I will say, just to, you know, there will be a lot of mild adverse events. And I think from a -- from a trust standpoint, I mean, how many people say every year the flu shot gave me the flu? And the mild adverse events are going to probably be worse than we see with the flu shot. I think we saw that at least in the Phase II data. So but, you know, in terms of the severe adverse events, I don't know how this is going to land because I do think I personally would be happier, from a scientific standpoint, to have a couple of years of safety data, placebos versus, you know, the drug -- the vaccine. H5ow that's ethically going to play out when we have an EUA saying we should vaccinate everybody, you know, I -- it will be interesting to see.
>> Howard Bauchner: I think we'll do reasonably well with the first 20 million doses. They'll go to hospitals. I'm very concerned about the next 100 million doses that have to go beyond the hospital boundaries. Derek, you have a larger remit than just Critical Care Medicine at UPMC. So last words on the vaccines, and then I know both of you have hard stops. This could go on for another hour. But you have a remit larger than just critical care. How have you begun to think about the vaccines and what information you've been seeing, Derek?
>> Derek Angus: So I think -- I think Rochelle summarized it beautifully, that there are multiple steps from the Phase III trial to what actually happens in the community. And there's the potential for degradation in efficacy all the way down. And we don't really -- no one could have imagined being at this point so rapidly. But by definition, we are now at a point where we have less information than we might typically. And so we cannot quantify the potential risks as accurately as we might know the situations. But fundamentally, this is a tradeoff. The alternative is not having a vaccine. [Chuckles] You can either go now with the best information you have. Or you can decide that it was genuinely better to tolerate what we have so far. I think the broadest way of thinking about this is this is by the community for the community. It only works if the entire community engages. And so everything has to be about transparency and trust. We should say to people hey, it's safe. You know, we've done what we can. We think it's probably safe, and we think on balance is the right thing to do. But we're all engaging in this as a community lift for all of us together.
>> Howard Bauchner: Yeah, I do think we're going to have to rethink about the role of the National Vaccine Injury Compensation Program and all of this because it's really protected childhood vaccinations. We moved to it almost 20 years ago. It's been hugely successful. And there's not many federal programs that I would qualify as hugely successful. This is one of them. And there have been questions about whether or not these vaccines should be incorporated into the National Vaccine Injury Compensation Program. We do have to stop. I'm reminded of a viewpoint we had three years ago. And again, it was by Dr. Fauci. Tony wrote it. It was about new vaccine platforms. And I remember he and I were talking about it, and he was writing about DNA viral vectors and mRNA. And he was so optimistic that we could get vaccine development down from five years to four years to maybe two years, but not eleven months. There's not been many major scientific achievements during this time. Care has gotten better. clinicians, nurses, physicians have been extraordinary. But the scientific achievements around vaccine development worldwide, not just in the United States, have been -- have truly been remarkable. What a pleasure. I've had Rochelle on a number of times. Professor of Medicine, Head of Infectious Disease at Mass General. Derek is a good friend, one of the world's leaders in intensive care medicine. He's the distinguished professor in Michael P. Fink, Endowed Chair Critical Care Medicine at UPMC. I wish the two of you a very healthy but small Thanksgiving. And to everyone who is watching or will listen, stay well. Stay healthy. It's a -- it's a very difficult time in the United States. Take care.
>> Rochelle Walensky: Thank you so much, Howard.
>> Howard Bauchner: Bye-bye.
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