Preeti Malani: Hello, I'm Dr. Preeti Malani, JAMA Associate Editor. I'm also the Chief Health Officer at the University of Michigan and a Professor of Medicine in the Division of Infectious Diseases. I'm joined by three guests who recently published a series of viewpoints that describe a national strategy for COVID and the idea of a new normal as we enter the third year of the coronavirus pandemic. First, I have Dr. Zeke Emanuel, who is the Vice Provost for Global Initiatives at the University of Pennsylvania. Welcome Zeke.
Ezekiel Emanuel: Great to be here.
Preeti Malani: Thank you. And then I have Dr. Michael Osterholm, who's the Director for the Center of Infectious Disease Research and Policy at the University of Minnesota. Thank you for joining us, Mike.
Michael Osterholm: Thank you.
Preeti Malani: And then finally I have Dr. Luciana Borio, who's the Senior Fellow for Global Health at the Council on Foreign Relations. Welcome Lu.
Luciana Borio: Thank you so much, Preeti. It's so great to be here.
Preeti Malani: So all three guests are deeply involved in policy efforts around the pandemic and have served as advisors to the Biden transition team from November 2020 to until January 2021. The three viewpoints were published online January 6th and are titled A National Strategy for the New Normal of Life With COVID, A National Strategy for COVID-19 Testing Surveillance and Mitigation Strategies, and third, A National Strategy for COVID-19 Vaccine and Therapeutics. So thanks for joining me. I know it's been such a busy time.
If you had asked me last January what things might look like this January, I would've predicted that things would be a lot better in terms of COVID case numbers than they are, certainly at this moment, but even as efforts are focused on getting us through this most recent surge, most public health experts feel that we are in fact marching towards endemicity and that vision, the idea that transmission will eventually drop from the current very high levels, but COVID is not going away is the premise of these three viewpoints. What I'd like to do is explore some of the practicalities, including how to operationalize some of the strategies presented.
And the first viewpoint outlines the idea that we are moving from crisis to control and the national strategy needs to be updated accordingly. Zeke, you and your co-authors write, “infectious diseases cannot be eradicated when there is limited long-term immunity following infection or vaccination or non-human reservoirs of infection. The majority of SARS-CoV-2 infections are asymptomatic or mildly symptomatic and SARS-CoV-2 incubation period is short preventing the use of targeted strategies like ring vaccination. Even fully vaccinated individuals are at risk for breakthrough SARS-CoV-2 infection. Consequently, a new normal with COVID in January 2022 is not living without COVID 19.” So tell me about the vision for this new normal. And practically speaking, how do we move forward?
Ezekiel Emanuel: Well, I think the “new” there is supposed to emphasize we're not going back to 2019, where there was no COVID, we're going to be in a situation where COVID is going to be around us, it's going to be one of the multitude of respiratory viral illnesses that we face and it's going to wax and wane just like flu does, just like RSV does, just like rhinovirus. And so we need to take that into account. Getting there, we're in far from that situation at the moment with about 1600 deaths a day, but getting there is going to require reducing transmission. And that's mainly going to be done through things like air quality improvements indoors, wearing asks, and some vaccination to get the incidents level low. Then making sure people have fewer complications. That's partially the vaccines, which really are very, very good at reducing hospitalization and death, as well as the new therapeutics we have.
And then it's going to look, COVID should begin looking like a flu, you get it, you stay home so you don't infect other people and your family. When you're feeling better, you can go into work, probably wearing a mask for a few days to again reduce the chance of infection. And that is going to be more common. We're simply going to get back to the life that we've known largely with some modifications.
Preeti Malani: Thank you. So Mike, the US health system does a lot of things well, but public health is not at the top of that list, yet rebuilding public health is a key aspect of the strategy described in the viewpoint. What can be done realistically to build the type of capacity you described? And is this something that should happen nationally or is it more likely to be successful at the state and local level?
Michael Osterholm: First of all, we have to understand that what we have really seen happen over the course of the past two years is our healthcare system has been laid open publicly in a way people can see just the challenges we have in terms of providing care of documenting outcomes and understanding how we bring those data together to make public policies that basically are primarily public health related and as well as treatment related. I think what really is the challenge here is we've lacked creative imagination to understand what a pandemic could do. A year ago, as I think Zeke just pointed out and you did, most people thought that we were out of the woods. Some of us said, "Well, with the variants, maybe we're not, maybe the variants are going to give us some new challenges we hadn't anticipated." I'm not so sure that's not the case in the future. I hope it's not, but hope's not a strategy.
And so I think that we still have to remind the medical care system there is that you'd provide on a day-to-day basis and there's that you provide on a day-to-day basis during the crisis. And that includes public health. And so I think if nothing else, the silver lining, if there is one to this pandemic, is it gives us every reason to go back and reevaluate what are we doing with healthcare or disease care? What are we paying for? What are we not paying for that could make a difference from a public health standpoint? And so I find this as potentially either going to end up becoming a forgotten moment we just want to move on from or it could be a renaissance moment in which we actually go back and ask ourselves these hard questions. And now the lessons learned are right in front of us. They're not imaginary. So to me, I think this is a very critical time to look at how do we improve the public's health.
The final piece, I would say I'm an infectious disease epidemiologist, but I am very aware of all the adverse health outcomes that have occurred because we have deferred medical care, we have deferred many of our public health programs around the world, whether it be HIV or malaria, polio eradication. And the cost that's occurred there has been substantial. And so we're also going to have to understand how to rebalance public health back to a time when basically many of these issues were not forgotten like they have been during COVID.
Preeti Malani: And do you think this could happen nationally or is it going to be more of a local phenomena?
Michael Osterholm: Well, I think it has to have national leadership, but as like with politics, all healthcare is local in a sense, even though it may be paid for by the federal government. And so I think what we have is a balance of how do we bring local related activities. And right now, look at what's happening with our healthcare systems in terms of responding to all these cases of COVID. It turns out in the end, it's local, it's what assets and resources do you have? Which people do you have that can come to work today or can't come to work today? So I think it's going to be a combination of both. It can't be just a top down. And surely, the importance of resources and national planning are going to be critical for any local group or groups to come together and say, what is it that we can and should do so that this doesn't happen in the future?
Great. Let's move on to the second viewpoint. And I'd like to delve into some of the suggestions outlined, with respect to testing and surveillance. Now, a number of concerns come to mind, and we clearly need a convenient, easy-to-access testing infrastructure that also links results to other important data; so the socio-demographics, vaccination status, and certainly clinical outcomes. But we're a long way from this. So, Lu, what do you think testing needs to look like for this new normal, and in particular, how do you build a robust system to deal with the positive results that arise?
Luciana Borio: Yeah. So, that's the hard work. Sometimes we focus so much on developing the task, the vaccine, or the drugs, but linking the assets we have, it's the challenge. And I envision that. First of all, I think it's remarkable that we have now a situation where people are able to do these verily sophisticated tests at home, and understand whether they might be infected or not. That's remarkable. I don't see us going back. I think it's going to open up a lot of novel ways to diagnose diseases at home, at the convenience of the home.
But the key, the work of government I would say, is that they need to... We have to develop a system around this, so that we can adequately capture the data. And it may require some incentives. There must be an incentive to report the test; and then, somebody's going to have to aggregate this data, and create information from this data. I think that in the near future, one of the great urgencies is to get the results of these tests, and link them to an action; whether it's to isolation, or whether it's to access to treatment, as soon as possible. Because we all know that having a result is just the beginning, and not the end.
Preeti Malani: Indeed. It'll be interesting to see how those systems are built. And surveillance goes hand in hand with testing. So Mike, I'm going to come back to you. What does a comprehensive surveillance program look like in 2022? And maybe you could talk about what would be ideal, versus what is going to be realistic.
Michael Osterholm: Well, we don't have to capture every case in disease surveillance to understand what's happening in our communities, both in terms of the actual number of cases, or the impact that it's having. But we've got to have a representative sample, and hopefully most cases, to really make that work. And right now, we have a system that is so broken. It's hard to believe, but there are health departments in this country that still receive their reports on disease cases by fax machine. Right now, I have no sense at all that the numbers we're getting are reliable, in terms of case reports every day. I've been talking to state and local health departments around the country, and some of the health departments are backed up thousands and thousands, tens of thousands of cases, that have not yet been reported out over weeks and months, just because of the backlog.
And so, one of the things we have to understand is, big data means also something to public health, in a way that most people don't think of when they think of clinical medicine. We've got to have a much better way to both document who's infected, when we do document it, and then to be able to aggregate that quickly, just like the clinical information. That has been a priority for public health for the last decade. And yet, it has received little attention.
And I think during this particular couple of weeks with Omicron, it's only become more accentuated. We've had to go to alternative measures to understand what's going on in our community: number of hospitalizations, number of people on oxygen in hospitals, and then unfortunately, even deaths.
So I think again, as we pointed out in the earlier discussion, now is the time for Renaissance thinking, as it relates to public health. What could we do if we had much more timely information, and we had more accurate information. So this is going to be something that is going to be a combined effort of the federal, state, and local governments. And it's got involve the private sector in a big way, particularly our healthcare systems around the country, who in the first instance, are where most of these data come from.
Preeti Malani: Thank you. So, Zeke, in the Viewpoint, you write about encouraging the use of N-95s or KN95s rather than cloth or surgical masks. And, to me, masks have been really, probably the most interesting part of mitigation. And if I think back to the beginning, the message was, "Don't wear a mask. Save the masks." Even, "Masks might transmit virus if you touch the mask."
And then within a few weeks, I also remember in the hospital, healthcare workers going to universal masking; and that was a really extraordinary thing, because we were actually very low on personal protective equipment. And using that mask felt a little bit like a luxury. And we have learned that masks are, in fact, super effective when worn properly, especially with people around you who are masked. But masks are also perhaps the most contentious aspect of mitigation, maybe even more than vaccines. And there's some practicalities around distribution and training, but more simply, I just want to ask more simply, how do you get people to actually do this, especially when they won't wear a cloth mask? Do you think they'll use an N-95?
Ezekiel Emanuel: Well, look. I think this is a case of social norming. What is expected in society, and what are you doing as a responsible citizen? Unfortunately, this has become, as you point out, politicized, and made a matter of a badge of culture; and that is the wrong way to look at it. It really is, as you point out, protective. It reduces transmission substantially. But in 2022, we have to be clear: wearing an N-95, KN-95, KF-94, those are the best masks, and they ought to supersede all others.
How can we social norm that? Well, one thing I have suggested, and we suggested to the government is, what if you sent out a voucher, so people could go to a pharmacy or grocery and get 3, 4, 5 of these masks, so that they could use them free of charge. That would certainly improve the thinking of the public around them. They would make them easily accessible, free, and I think much more used.
I would say the other thing that's very good is a mitigation measure which we have not heavily discussed, is indoor air quality. We don't have an assurance that when we go into a building, the air quality is of a very high standard. And if we are going to really improve for the long term, as Mike points out, the public health around a respiratory viral illness, is upping the air quality indoors to MERV 13 or better, is going to be really important. And in the interim, people can use HEPA filters in school classrooms, in other public places, while we're in the process of getting these better air filtration handling systems.
Can I just make one other point, which is to go to this issue of the healthcare system. One of the things that I think is very, very important, is how we think about telemedicine. We are going to have these crises and these workforce shortages in different places, and the overwhelming of systems. One of the ways we can pretty much not address all of that, because a lot of medicine requires face-to-face contact, especially if you're doing procedures. But there are a lot of things we can do via telemedicine that we have been resistant about adopting.
Medicine across state lines, where people are able to do it if they're licensed in a state, making sure liability insurance covers it, making sure you're going to be paid for. But for many, many things, primary care, a lot of primary care, a lot of mental health; we need to begin to make that standard, and make permanent the changes we did around the regulations for telemedicine. I think that'll help us relieve some of the pressures when a system gets overtaxed.
Preeti Malani: So the third viewpoint focuses on vaccines and therapeutics, and again, as an infectious disease doctor, this is one that I'm thinking a lot about this. In the U.S. at this moment, nearly a quarter of the vaccine eligible population has still not had a single dose of a COVID vaccine. That number has come down a little bit, mostly due to the younger kids getting their first doses. But there's very, very little movement among adults who have not yet been vaccinated.
Lu, regarding variant specific vaccines, you and your co-authors write, "To reduce virus transmission and infections, next generation COVID-19 vaccines that match circulating SARS-CoV-2 variants need to be deployed. Genomic surveillance coupled with nimble vaccine technology allow for rapidly adapting vaccines to emerging variants.” As I read this, vaccines based on the latest variants, they sound really great in theory. But to me, the reality feels different, at least right now. Again, the example that we are in at this moment, in late November, we are still in the throes of a Delta surge, and within weeks, we're now seeing Omicron. Of course, we're not doing sequencing on everything. But again, who knows what's going to come next.
Is variant vaccine something that we could do quickly and short term, especially during this phase of the pandemic where we're still having such large numbers of cases?
Luciana Borio: Yeah, it's difficult to know right now, because the future is a little bit unpredictable, but I think that it's important to be able to plan a parallel approach, or we have planned for variant specific vaccines, because they are the most effective against prevailing variants, and we have a lot of experience with influenza, for example, should the virus become a more seasonal virus. But we also need to pay attention to more broadly neutralizing or universal vaccines. For one, because this is likely not going to be the next pandemic, and it's possible that we have another coronavirus surprise, and it would be really great to have vaccines that would work against several types of coronaviruses. But also because we can't predict completely how this virus will evolve.
But there are trade offs, right? One type of vaccine is quite effective in preventing all infections in addition to severe disease and hospitalization, but very narrow in scope. Others that are broader, there may be trade offs that may be very effective in preventing serious disease, hospitalization, and death, but less effective in dealing with all infections and decreasing transmission.
So at this moment, because there are uncertainties about how this is going to evolve, I think we need to go full steam ahead with this parallel effort, and it's very important, again, for government, for the work of government to help these companies establish a framework for how these decisions are going to be made. Who makes the decision about what variants should be included in the vaccine mix, or how are we going to track that? What are the correlates of protection that would allow us to do a rapid authorization for a strain change, if you will? That work is ongoing.
Preeti Malani: You mentioned the universal coronavirus vaccine, and you write about that in the viewpoint. Is this something that you think is likely in the near future, or do you have an estimated timeline on that?
Luciana Borio: Oh boy, estimated timelines. You're asking somebody who spends so many years at the FDA, and I'll say they should be as fast as possible, but no faster than needed. You have to be very careful because vaccines are given to healthy people, and also, in fairness, what does it mean to have a universal vaccine? We know that it's not truly universal. But I think the science is there for us to develop vaccines that are very good at inducing cell immunity and protecting us from the worst of this virus. I think the science is there also to select the epitopes very carefully that will maximize the desired impacts.
So, there's always a silver lining, right? I mean, I think that vaccinology has dramatically progressed in the setting of COVID, because it was necessary to use all the tools in the box that we have in 21st century science, and I can't think of any other time recently that we had this type of scientific effort around vaccines and immunology and manufacturing, et cetera.
Preeti Malani: Agree fully, and if you just step back and reflect on really what a miracle of science the vaccines have been and the timeline and the safety and all the surveillance for adverse effects, it is truly one of many several silver linings from a scientific standpoint.
Ezekiel Emanuel: Well, I would say we should think about a year ago. A year ago, we just got the vaccines and they weren't deployed, and we've got very effective, the most effective vaccines in the world, and we're in the midst of developing variant specific vaccines very rapidly in just a few months. We've got therapeutics, including oral therapeutics that we didn't have, we've got these lateral flow at home tests, which we didn't have a year ago. I mean, there has been a lot of scientific and diagnostic progress, and sometimes I think in the midst of it, when we are confronting a million cases and 140,000 hospitalizations and 1,600 deaths, we often forget how much has changed over time. That doesn't mean we should pause and be congratulatory, sit on our laurels. We're still in the midst of a terrible pandemic. But we do need to appreciate the rapidity with which those things have come online.
Preeti Malani: Yeah, truly it was unimaginable in March of 2020, so this is really good to reflect on. Zeke, I want to come back to something that's more mundane, which is the vaccine verification methods. Again, this is being used increasingly as an admission requirement to performances, athletic events, restaurants, and it's layered on mandates at workplaces and schools. Do you think we'll move to a national electronic vaccine certification platform?
Ezekiel Emanuel: We've been resistant to it under a lot of pressure. I'm not sure I fully understand the resistance to it. There are platforms out there in a number of states. But we have very, very good certification systems up and running in states, and they do work well. You're not required to get an electronic certificate, you have to access in and download the information, but it is pretty secure, because you have to use your phone and only you have your phone, so I think there is some hope that it'll be widespread, even if it won't be national.
Preeti Malani: Yeah, and for people listening in, I'd encourage you to take a look at the viewpoint. I think it was really laid out nicely in terms of the systems. Having been on the other end of doing some of these vaccine verifications for our students, it's very labor intensive and it would be great if there was an easier way.
Ezekiel Emanuel: We agree.
Michael Osterholm: Can I add? Just I think one of the important considerations here is not what is doable in the sense of science, but what is doable in the sense of everyday life. I for one would love to see some kind of a system where we could know, in fact, what one's immunization, or for that matter, even if they've previously been infected what their status is in terms of being protected. But I don't think that'll ever be a reality just because of the politics. Having served for 25 years of state and local public health, I have a sense of what plays on the ground. This one will not play in Peoria. So, I think we've come to understand what that means. The same reason why we have governors today who refuse to put into place new mandates around public events, masking, and so forth in the height of the omicron, because they'll tell they just can't do it. The public would not accept it. So I think we have to learn from that.
We have to understand what that taught us about what we can and can't do and how we do it. I think the other piece of that is though, and this is the humbling part about these vaccines, remember last year, when the vaccines first were approved, we were euphoric. We had these vaccines that were going to protect us 95% of the time, two doses, we were home free, and then we realized over time what happens, with potential waning immunity and the potential need for additional doses of vaccine, we begin to understand more and more about challenges of what is protection? If you have been previously infected, what does that mean? And so I think, in a sense, it's a moment of great humility also, where we have to say, we still have some really major unanswered questions about what can a vaccine do for us. How often do you have to be vaccinated?
Everyone I think on this screen would agree, if we ended up having to vaccinate people multiple times a year, which I'm not suggesting will be the case, but at least some are hinting towards that, that is simply not doable for the world. It would set up an incredible double standard that I don't think would ever be allowed. More importantly, look at the fact that we almost have two thirds of those individuals who have received two doses of vaccine, they're surely not vaccine hesitant or vaccine hostile, who've not gotten their recommended third dose. Why? We have more and more data showing the improvement and outcomes with that third dose versus the first two, particularly now against Omicron. So I think part of the sociology of this issue, the psychology of this issue, is almost as important as the immunology or the data-driven questions we have and I don't see, right now, that's there, but I think this is another important part of how we evaluate what we've been through with this pandemic.
Preeti Malani: Yeah, those are great reflections, Mike. I think it gets back to that notion too, that the vaccinations are really about protecting everyone around us, not just a intervention to protect us, and that has also gotten lost sometimes, although they do protect us very well too.
Luciana Borio: Yeah, and briefly, I'd like to add that we have about 25 million children under five years of age in this country, and about seven million people that are living with immuno compromising conditions, so even though we'd like to be able to move to the new normal as soon as possible, I think that one of the barriers to get in there is the fact that we have people that yet cannot access vaccine yet, and there are people that, despite being vaccinated, they do not mount a protective immune response, so until we have ample supply of effective therapeutics, a way to link testing to diagnosis, to therapeutics, that is going to slow us down to feeling like this is now a new normal.
Preeti Malani: Yeah, for sure, and that's a great segue to the last topic I want to talk about, which is oral therapeutics, and this is another place where we've seen great progress, and I think in the long term, I am really hopeful that these agents will help decrease the risk of hospitalization and death in those medically vulnerable patients especially, and for monoclonals, we've been doing this for more than a year with a lot of success and there are new data to support outpatient Remdesivir use. That's a little harder, because the logistics in of course.
Just in the last few days, oral antivirals are starting to become available, but the demand is super high, and right now, supply and resources for administration are limited. So not just the supply, but the actual physical ability to get these therapeutics to people. So my last question is really about how to make this work. These therapeutics are most effective, as we know, early, so you need early testing, you need to connect people. So how do we do a better job, just from a practical standpoint, right now, linking the COVID19 testing systems, with an eye on equitable allocation of these limited resources, and Lu, I'll start with you, and then maybe the others can add in some of their thoughts.
Luciana Borio: This is something that the three of us... The six of us, actually, the advisors have talked extensively about, and it'll be very important, I think, as we move forward, to make sure that there is access that is facilitated, whether it's at the infusion center, that somebody can self-refer upon a positive diagnostic test, if they meet criteria, they should be able to self-refer and get assessed and treated right there, without having this need to go through a physician, that, frankly, no, this has taken a lot of time right now for patients, even when the drugs were in more ample supply, the monoclonals, sometimes several days elapsed between a patient being diagnosed and then being referred to an infusion center. So I think that's the key, of course, in addition to increasing supply significantly.
Michael Osterholm: If I could just add a piece here of perspective. We've all, on the screen here, remember, unfortunately, very painfully, those early days in the 1980s, when an HIV diagnosis was in essence a death sentence. Today, we know that we can do amazing things with therapeutics to make HIV much more a long term chronic condition, and that ability to do that can't be lost in what I think can happen with COVID, and the SARS‑CoV‑2 type illnesses. On a global basis, if we could do, just as Lu just pointed out, and we can do it if we put our minds to it, understanding with that creative imagination of just how different the world could be with a one, two punch of vaccines and therapeutics. We could do, I think, a tremendous amount to reduce serious illness, hospitalizations, and deaths, and what more can we want for?
So, I think that this is an exciting time coming up. It's our opportunity. If we miss it, people will die unnecessarily and we will continue to deal with the social, economic and political fallout of this disease. If we do it right, we can do so much to bring this horrible virus under better control.
Ezekiel Emanuel: One of the things that seems to me that would work well, and it's not going to be stood up overnight, but we need a system where someone who tests positive, initially it'll be PCR, but then hopefully, we can get the at home test linked to, if they test positive, they get a robo-call that tells them how they can get the therapy or the number to call, as well as how they should isolate themselves, the mask wearing, what they need to do to take care of themselves. That's not impossible, right? When you go in, at least I recall, when I got vaccinated or tested, I had to leave a telephone number and I had to leave a email, and we could automatically, without human intervention, you've got a positive, you get not just the result, but information about how to get the therapy, as well as what to do in the interim to protect yourself. We haven't built that infrastructure. It's not complicated. We know that. Lots of companies bombard you with emails or text with relevant information, and I think that would be enormously helpful.
Preeti Malani: Yeah, thank you, and again, I think this is one where different states are doing it differently. In Michigan, there is an effort to try and provide these antivirals at point of care with testing. I hope that we can get to the point where we are able to scale this with our community pharmacy partners, sooner than later. So thank you for this great conversation and thank you also for the work all of you continue to do.
Michael Osterholm: Thank you.
Ezekiel Emanuel: Thank you.
Luciana Borio: Thank you so much for having us.