COVID-19: Updates on Treatment and Response

HAMBURG: Thank you very much. And thank you for joining us for this conference call, which is part of the series to look at this evolving COVID-19 pandemic, including the U.S. preparedness and response as the virus spreads, updates on vaccines development and treatment options, and implications for national security. I want to remind all the participants that this call is on the record and recording and transcript will be posted on CFR.org.

We’re going to begin with some discussion from our panelists and then open it up for questions. I am the foreign secretary for the National Academy of Medicine and former commissioner of the U.S. Food and Drug Administration, and the former New York City Health Commissioner. I’m also a member of the board of directors of the Council on Foreign Relations. Our two fantastic speakers also our members of the board of directors of CFR. First, Tony Coles, the executive chairman and chief executive officer of Cerevel Therapeutics. And a very distinguished scientist, physician and entrepreneur. And Janet Napolitano, who is currently president of the University of California, and of course was former secretary of the U.S. Department of Homeland Security.

And as we begin this session, sadly, we are still experiencing the relentless march of this novel coronavirus and the disease that it causes, COVID-19. And we hit a sad milestone today. The death toll has reached over one hundred thousand cases. And tragically, the death toll in this country continues to rise rapidly. The U.S. is now the—now the leader in the world for COVID-19 cases, with over four hundred and fifty thousand. And the death rates in the United States and the U.K. are rising more steeply than they have in any other countries at any other time. So we face a very serious problem.

And I think we all recognize the challenges that we’re seeing of overwhelmed hospitals, of shortages of critical medical equipment—form personal protective equipment, to ventilators, to gaps in testing capacity—that have really hindered our ability to even fully define the nature and scope of this devastating disease as it unfolds, and to help us better manage and control it. And we have huge, pressing tasks before us as we try to reduce infections and ongoing spread, care for the sick and limit death, and do everything we can to minimize social and economic disruptions that are going with these efforts, while managing the public health crisis. Certainly much uncertainty remains. Leveraging science and technology will bring us essential solutions to the problems before us over time, but the path forward, while promising, has many challenges.

And there are so many important issues in terms of what our response looks like, what it means to be, and how we will move forward towards a more normal life. And our panelists, I think, are unusually equipped to talk about all of these many critical issues that are swirling around us. And so with no further ado, I think I will begin with some questions to help us think about these issues before we open it up for questions and discussions.

And I’d like to turn first to Janet Napolitano, wearing her former hat as Department of Homeland Security secretary. And just a general question about how do you think we’re doing with our response? How do you think the federal government, and all of its departments and agencies, is doing in pulling together to combat this devastating disease? Should we have been better prepared? What’s missing now? You had to respond to other crises, nothing like this. But your thoughts and perspective would be much appreciated.

NAPOLITANO: Well, thanks, Peggy.

And I think, in terms of the federal response, we have been slow to the ball. And the federal response is still, I must say, chaotic. We were slow to appreciate the intelligence that we were getting out of China about the coronavirus and to implement the pandemic plans that we do have in the federal government. The CDC was very slow in developing a test that could be used. And that left us somewhat defenseless in terms of knowing where the hotspots were, so that resources could be focused on those hot spots and we could potentially avoid having to shut down entire states, indeed the entire country.

And the supply chain management has been—it’s really the wild west out there still in terms of making sure that masks, and personal protective equipment, and ventilators, and all the other associated equipment are actually making it to the hospitals, to the workforce, and for the safety of the patients.

We were very slow to implement the Defense Production Act, and I still can’t tell the extent to which it has been implemented. That obviously could go a long way to resolving the supply chain issues. And then, finally, the messaging from the White House has been all over the map. And it kind of depends on the day. I must say that I always listened to Tony Fauci. I listened to him when I was secretary. I listen to him now as an extraordinarily knowledgeable individual.

In contrast to the federal government, I think the vast majority of states have coped fairly well. They put in place social distancing. And we’re seeing the effect of social distancing on the incidents of the disease and the slope of the curve. They have helped very much in terms of addressing the supply chain issues. In fact, the governor of California just executed a $1 billion deal to make sure that California has an adequate supply of masks for now and for the months to come. And their messaging, by and large, has been very consistent and very clear.

I’ll just close by saying we’re still in the middle of this and we’re not at the end. And I think we also need to think of this in waves, that we may have some subsidence over the summer but we should be anticipating and planning for another wave in the fall. I think that until there is a vaccine, this coronavirus is going to be plaguing us and challenging us. So we still have a ways to go.

HAMBURG: Well, thank you, Janet; some glimmers of hope in your very thoughtful overview of where we are and how much more needs to be done. And you talked about the importance of scientific and public-health expertise. You talked about, of course, Tony Fauci.

Well, I’m going to turn to another important Tony, Tony Coles. And we all recognize that, you know, when we have some medical tools, some countermeasures against this novel coronavirus, we will be in much better shape. But it takes time. And I thought that maybe Tony could give us some sense of how the biomedical research in the pharma community is really responding in their efforts to develop the diagnostics, the drugs, and the vaccines that we so desperately need.

Of course, these advances in science and access to these products is going to be a big part of the solution in terms of our ability to return to a normal world. But there’s a lot of uncertainty in research and development, and getting a candidate product out into the real world is a challenging process.

So, Tony, you have unique experience in this realm.

COLES: Thanks, Peggy.

And good afternoon, everyone. And, yes, I think it’s fair to say that the life-sciences and biopharmaceutical industries have responded very quickly, have certainly sprung into action and, at least on the therapeutic side of things, because we’ve been living with coronaviruses of different families and forms, have been able to leverage some of that learning and very quickly pivot to what might be helpful for this particular form of coronavirus.

But let me start my comments by addressing the diagnostic testing which you mentioned. And obviously important in any public-health management strategy for an epidemic or pandemic like this is the ability to identify cases very quickly and very early. And for that you need a reliable testing approach.

And once you have this reliable testing approach, then being able to very quickly trace the contacts of infected people is the second most important step. And obviously, in this country and in many others across the world, we’re well beyond the usefulness of either testing to control the pandemic, and contact tracing, of course, is now not something that will be helpful because we now have community spread of the virus. And it is at a stage where these kinds of early interventions ordinarily would be helpful, but we are well beyond that on a number of case bases.

One of the issues—and we’ve all heard about the scarcity of diagnostic tests available—and it really is more complicated than just taking a sample and delivering it to the lab, because once you have the sample retrieved from a patient—that is, their nose or their oropharynx has been swabbed—then you deliver that to a testing facility. There are reagents required to extract the sample from the swab. And then, of course, the specific test is run that will determine whether a patient is positive for COVID.

So there are two or three very important steps. And if any of those steps—getting test kits to patients, collecting the samples, extracting the samples, and then analyzing the samples—if there’s a fault in any of those steps, it’s going to make testing much more difficult.

We are—I think have only completed perhaps two million tests nationwide of the 330 million or so Americans in this country. And that places us in the bottom tier on a per capita basis in our ability to test. But it is important that the industry—and as they are stepping up and as our colleagues on the diagnostic testing side are stepping up as well to rectify this—important to any return to normal will be a very effective, very rapid, and widely available testing system. And we could talk a little bit more about that. So this is a continued area of focus for us, because in managing beyond the current crest of cases, we’ll need very good and effective testing.

Let me talk very briefly about the—on the therapeutic side of things. And we’ll go into much more detail later in the call. I mentioned that we have seen coronaviruses in the past from the pharmaceutical-industry side of things. And we do know something of these families.

This particular coronavirus—and we’ve all heard about the transmission from the various animal vectors to humans—is particularly nettlesome. Not only is it highly contagious; it is also highly lethal. But it also has a complex—a more complex genomic structure than several of the other coronaviruses, making stopping the virus a little more challenging and a little more difficult.

So we’ll talk about vaccinations and we’ll talk, of course, about ways in which we might actually have antivirals that will stop the replication of the virus. But importantly, there are a number of potential therapies. And I think it will be important for us to distinguish what these therapies are designed to do.

So let me end my comments there.

HAMBURG: OK, great.

Well, I think it would also be interesting, if I can impose on you, Janet, to put on your other hat. And you, of course, are the president of the University of California, which is, you know, really a vast network of schools. And also you oversee a huge research enterprise in terms of a network of academic scientists and researchers.

So before we get to the questions, I thought maybe you could talk a little bit about the complexities of managing this unfolding epidemic in this network of universities that you’re responsible for.

You had a lot of difficult decisions early on about sending students home, figuring out how to do teaching at a distance. Now I suspect you’re struggling with how to maintain facilities and core operations, and then, of course, supporting the scientific community as they mobilize to address COVID-19 issues. And you’re also responsible for some hospitals and health care.

So you thought your job as DHS secretary was challenging, but you sit in a very critical and challenging role now.

NAPOLITANO: Thanks, Peggy. Yeah.

And just by way of background, the University of California has ten campuses, five academic medical centers. Those are the big teaching hospitals. Some of those centers have more than one hospital associated with them. And it’s world-renowned for research.

We have about two hundred seventy thousand students and about two hundred thirty thousand employees. We’re actually the third-largest employer in California. So it is an immense enterprise. And the COVID-19 pandemic has caused a lot of immediate change that we’ve had to work our way through.

First, on the academic side, our faculty quickly pivoted to teaching by remote learning or online. And so we are now doing our academic instruction that way. We emptied our campuses to the greatest extent we could so that any student who could leave campus has left campus. So the campuses themselves are fairly empty right now. And we are working our way through, of course, all the fiscal challenges associated with that and beginning to think about how do we reopen the campuses, and when would it be safe to do so?

We quickly changed some of our admission requirements, because high-school students were now themselves getting instruction online and they were no longer, for the most part, getting grades. They were getting pass/no pass, and usually we don’t count those towards the requirements a student must have to apply to the University of California. But we’ve said no, we’ll take and count those pass/no pass classes, and we also suspended the requirement that applicants take the SAT for 2020 and 2021 because of all of the cancellations and displacements of the SAT administration. So that’s on the academic side.

On the workforce side, as I mentioned, we’re the third largest employer in the state, and the number-one thing our employees, you know, wanted to know was whether they were going to get laid off, whether they would have a job, and with the chancellors we decided that we would keep our workforce intact and that all career employees would be assured of no layoffs between now and the end of the fiscal year, which is June 30. But we’re also now turning to workforce planning after that and, of course, that also ties into the financial situation that we find ourselves in.

On the patient care side, we were some of the first hospitals in the state to get COVID-19 patients. We cancelled all elective surgeries and, basically, converted our hospitals into COVID-19 hospitals so that we could care not for current patients but that—so that we would be ready for the expected surge of patients, and the date—there’s no one date for the surge but it’s any day now we expect to have some surge in patients.

And on the research side, we’ve been doing a tremendous amount on testing, on therapeutics, on vaccine. We have three hundred some-odd different research projects underway at the university and, by the way, with that research we have included the national labs that are part of the UC enterprise so that’s Lawrence Berkeley National Lab, Lawrence Livermore, and Los Alamos, and all three of those national labs are now participating in and contributing to research on the—on this coronavirus.

So we are firing on all cylinders and, you know, our goal is to manage our way through this so that the university emerges intact and well prepared for whatever the future holds.

HAMBURG: Well, thank you. I mean, there is no doubt that this unfolding epidemic has brought so many new challenges to all of our critical institutions and activities. And, you know, that leads me to turning to Tony again. You know, we, I think, all recognize the importance of having therapeutics to help temporize our management and care. But everyone is looking to the development of a vaccine to really be transformative.

I keep getting asked questions and I suspect that you do, too, and that our listeners want to know why does it take so long to make a vaccine. But also, you know, if you could, you know, maybe talk a little bit about what you think it’s going to take even with a vaccine to get back to a more normal life. What will be the new normal, what might it look like, and, of course, how will—thinking about it from both being a businessman running a company but also a scientist, how are we going to navigate forward?

COLES: Well, I—thanks, Peggy. I will try to do this quickly because I’m anxious to get to the question and answer period. But in order to answer your question, it involves a little bit of detail and some context.

So we—let’s talk a little bit about the COVID infection, to begin with. We all know that it is spread through respiratory droplets and those respiratory droplets can travel maximum, we think, six feet or so, which is why this social distancing guideline of staying separated by six feet is so important.

There are data to suggest that it is possible for it to be aerosolized—those data haven’t been confirmed—that is, that it can travel in the air. The data there are early and haven’t been confirmed, so I—at the moment, I don’t think that that will be an issue for most of us who are socially isolated and social distancing.

But once taken into the body through the nasal pharynx or the oral passages, the virus rests first, generally, in the throat, and this is one of the interesting things. What we believe is that when it rests in the throat people have very few symptoms. But, unfortunately, they’re highly infectious and that’s one of the reasons that we believe that the infectivity of this is—can be so high because usually as the virus settles in the throat patients might have some mild discomfort but they might not otherwise recognize that they’re ill and all the while they are infectious and able to transmit the virus to other people.

After a short period of incubation in the throat, in the most severe cases the virus then travels to the lungs, settles there, binds to a really important protein, and it’s the binding of that protein in the lungs that causes a massive inflammatory response in the body, and that inflammatory response is what actually incapacitates the lungs, thereby decreasing the body’s ability to send oxygen to the vital organs, and that’s why ventilator support, which replaces the body’s ability to process oxygen, has been so important in those most advanced cases.

I start there because any of our therapeutic options really have to do any one of three things. So there are three different types of therapeutic options, and I want to make this point really clearly because when we are at the height of this we just want anything that will help. But it’s really important to think about this and this will partially answer your question about the length of time.

So the first type of therapy is a vaccine. Now, we’re accustomed to receiving vaccines. MMR, smallpox in previous days, polio in different—in a different era, hepatitis B, these are all great examples of how really worrisome and lethal infections have been controlled. The best vaccine, we think, is an active vaccine, which takes a portion of the virus, attenuates the virus so it isn’t as lethal, and then with the right understanding, the right strain, and the right concentration, we inject that attenuated active virus into patients so that the body’s own immune response can be mounted. So once presented with the virus and an infection, the body has already generated its own antibodies against the virus and the person is, therefore, effectively immunized.

Now, we can sometimes stimulate that process with not an active vaccine but a passive vaccine where we pre-inject or inject into the body antibodies which have been raised outside of the body but which will respond to the COVID virus. This passive immunization, if you will, is also called antibody-directed therapy, and that antibody-directed therapy is what you would do to, on a short-term basis, if you will, provide a quick injection of the antibody and when presented with the infection the patient has not their own antibodies but antibodies that have been manufactured outside of the body, which is what makes it passive.

Now, for full disclosure, I will share with our audience that I am a member of the board of Regeneron Therapeutics, and Regeneron, as many of us have been reading, has a passive vaccine on antibody-directed therapy that is under development. The trial for that particular therapy should begin within the next three to four weeks and we expect to, with a very rapid enrollment period, complete that trial and we should have an answer as to whether we have an effective passive vaccine, or antibody-directed therapy, I would think, by the end of the summer where we might actually have the first signs as to whether this antibody-directed therapy would work.

An active vaccine takes much longer because, of course, you have to figure out the right amount of attenuation of the live virus. You then have to determine whether you can safely administer that and don’t unintentionally give patients a more severe form of the—of the infection than you intend, and that, we think, is probably at minimum twelve months away and perhaps fifteen or eighteen months away. But there are several companies that are already working on an active vaccine. So the first type of therapeutic is to prevent the infection. And you can have an active vaccine or a passive vaccine. The second type of therapeutic is once a patient’s infected, working to control the disease by stopping the virus from replicating or multiplying in the body. So if you go back to those earliest hours or days of the infectivity, when it talked about the virus settling in the upper respiratory tract, if you had a means of stopping replication of the virus in the earliest hours of infection, then you could very quickly eliminate the replication of the virus and the spread of the virus throughout the body.

This is a so-called antiviral approach. And we’re familiar with antivirals through the treatment of hepatitis C, HIV, which all provide therapies that generally are taken by mouth. And they highjack the virus’ ability to use our own bodies are essentially replicating machines or virus reproducing factories. Because the way viruses work in the body is they highjack our own body processes and redirect our own processes to make more virus. So if you can interrupt the replication of the virus, then you can effectively treat and ultimately, as we’ve shown with hepatitis C in particular, cure that particular infection. So there’s great promise being made there. Therapies like remdesivir from Gilead and favipiravir from Fuji, a Japanese company, are examples of antiviral that are currently being tested in hospitals across the country. At Mass General Hospital in Boston, for instance, they have an active trial underway already for favipiravir—I can’t say the word, favipiravir—that is already enrolling patients.

The third type of therapy is designed to, once infected—and we’ve now gone beyond the viruses replication. So we can’t stop it. The virus has settled now in the lungs. The third type of therapy is designed to shut down the body’s immune response that has been mounted that destroys, essentially, the lung tissue and prevents the oxygenation. Now, this is a non-targeted approach, because it’s not a direct antiviral and it’s not a vaccine. We hope this will work, but there are already approved therapies on the market. For example, this is another Regeneron therapy, sarilumab or KEVZARA is already approved for the treatment of rheumatoid arthritis. Some very enterprising physicians and scientists in China started experimenting with this therapy because what it does is to effectively shut down the body’s immune response, to then decease the destruction of the lungs. We don’t know that it will work. It looks very promising. But that particular trial is already up and running. We hope to enroll six hundred patients for that particular study. And we should have those results within the next few months.

And then you have a variety of off-the-shelf options. Hydroxychloroquine is talked about quite a bit. Stem cells are talked about. There’s far less data available for those. I think it’s going to be most important—to get to the last part of your question, which is the return to normal—will be a vaccine which will then guarantee that we have a population that has largely been immunized, and we can then eliminate this particular scourge. Hopefully the passive approach will work, the antibody directed therapy approach. But if not, we’ll have to wait for an active vaccine. And I’m afraid until we have a vaccine—a really good, active vaccine—we will be living with a variety of mitigating measures, including going back to contract tracing should the number of cases fall, rapid testing to then isolate very quickly, and hopefully try to contain it through those kinds of more traditional public health measures, until we have a good vaccine.

HAMBURG: Well, thank you, Tony. That was a masterful overview of the state of the science and our understanding of how this virus causes disease, and the strategies to address it. And of course, Janet, with so many different relevant experiences.

I want to turn now to the question and answer period, because I’m sure that your comments so far have generated questions. So let me ask the operator to begin the question and answer period.

OPERATOR: Thank you. At this time we will open the floor for questions.

(Gives queuing instructions.)

HAMBURG: Thank you. Do we have any questions in the queue?

OPERATOR: And we will take our first question, and that is from Mary McInnis Boies, and that is from Boies Schiller. Please go ahead.

Q: Thank you all.

Is it correct that some countries, such as German and South Korea, have decentralized their approvals for testing and not relied on a single centralized agency? And if that is accurate, what are those models? And would one or more work better in the U.S., even after this virus passes? Thank you.

COLES: Peggy, do you want to—

HAMBURG: So do you want to address—

COLES: Sure. Sure. Well, why don’t you start, because I want to make a point about that.

HAMBURG: OK. Well, I believe that—I mean every country has a different approach to the regulatory review of various kinds of medical products. I have not heard specifically about an active decentralization in response to COVID-19. I have heard about regulatory authorities coming together to try to harmonize standards and approaches, and to really define what studies should be looked—should be developed, what kind of data sets will be requested, so that there can be more alignment of the regulatory review process and approvals, rather than doing separate, discrete, often serial approvals, so that products can get into the marketplace more quickly. The U.S. has modified some of its review strategies, particularly for diagnostics, allowing states to actually take responsibility for tests developed in their state and also allowing products to go out while eventually, after a couple of weeks, after fifteen days, being required to present data to the FDA to support their emergency use authorization.

But Tony may know more about some of the specifics. It sounds like you might know something about Germany.

COLES: Well, I’ll comment first on the U.S., where we do know that the regulatory agencies here, not only the FDA and then obviously the Coronavirus Taskforce, are really working in a highly collaborative fashion with the biopharmaceutical industry, not just on the diagnostic testing side, as Peggy references, but also on the therapeutic side. And I can tell you that across my thirty-year career, I have never seen clinical trials mounted this quickly and begin enrollment as fast as these have. And that really is in direct attribution to the federal government’s relaxing some of the standards because of the lethality of the disease and the impact on society and the economy. So that I think bodes very well for a public-private partnership and how this comes together.

The comment I wanted to make on Germany is many of us have been reading about the effectiveness that Germany has had in answering the outbreak. So this isn’t a regulatory comment as much as it is a public health management comment. And what I hope is that once we crest the number of cases and the number of death start to relax or start to decrease, we can return to learn some of the key lessons that the Germans have learned in the management of these diseases, which have included very aggressive testing, very aggressive contact tracing, and isolating and treating people at home with outside home health care workers who come in and check on the patients throughout their period of illness.

For patients who do then have to go to the hospital, there are COVID taxis that escort patients to the hospital in a secure fashion, so patients are not on public transport or other means trying to get the hospital and infecting people along the way. So there’s a lot that they have done right and well on the public health management side of things. And I think this continued collaboration between governments, regulatory agencies, and companies is going to be essential for us to find a quick and speedy resolution here.

HAMBURG: Thank you. Next question.

OPERATOR: Thank you. We will take our next question. And that is from Leon Kalvaria with Citi. Please go ahead.

Q: Hi. Thanks. Thank you very much for taking the time to do this. This has been extremely interesting from the standpoint of outlining facts as opposed to some of what we read on the news.

My question is relating to the BCG vaccine, a vaccine that some of us had as young kids growing up in Africa or in India I think for TB. And there’s a question about whether some of the places that vaccinated young children have had far lesser outbreaks, and there are some trials going on. Do you have any knowledge or recollection of people looking at BCG as a potential vaccine, or do you think it’s an urban myth?

COLES: You know, I—this is Tony Coles. I, unfortunately, don’t know that data and am not familiar, so I’m hesitant to offer a perspective or a point of view. I’m thinking, as you were asking the question, as to why therapeutically or pathophysiologically that might work, and I’m not sure I have a good explanation. So I wouldn’t call it urban myth, but I think it’s one of the questions that needs a lot more empirical evidence before we can chase that down.

HAMBURG: It has certainly been raised—this is Peggy Hamburg—but I think there isn’t much data. But we will have a chance to at least collect some observational data on it as we watch this epidemic unfold in places like India, where BCG is more routinely used. It will probably give us spotty information, but it will perhaps provide some insights. And I think there may be some studies that are being mounted.

Next question.

OPERATOR: We’ll take our next question, and that is from Sonya Stokes with Mount Sinai Health System. Please go ahead.

Q: Thank you.

Messaging regarding outpatient treatment guidelines for COVID-19 continues to be confusing both for patients as well as providers, leading to erroneous prescriptions with potentially dangerous outcomes. As physicians, we look to the CDC for recommendations. However, as of the last update on April 7, there is still a lack of explicit clinical guidance. Are there any new specific recommendations for outpatient therapies? And how can the messaging about outpatient treatment options be better coordinated or regulated so there are clear, consistent recommendations for us to follow? Thank you.

COLES: Peggy, you might have a public-health perspective to add.

I think the really unfortunate news is that this is largely a matter of supportive care once patients are admitted to the hospital. You yourself, being on the frontlines, will know that many of the cases—this is certainly reflected in the statistics—don’t even make it to the hospital because in the—in one case in particular of a very high-profile person who was COVID-positive, in my recent conversation with this person his comment was the only symptom he had was the loss of smell and taste; no flu-like symptoms, nothing else, and he recovered very quickly after just a few days. So we don’t see many of the cases, but generally by the time they arrive to the hospital they already have compromised pulmonary function, and then it really is largely only supportive care with ventilator assistance, as you well know.

So it’s a long way of saying that there aren’t any very good effective either off-the-shelf or prescription remedies that we can offer here, and I think we just have to wait until we’ve built some of this data and build a body of evidence. But there could be, perhaps, therapies that you’ve thought about or have tried, and I’m sure all of us would be happy to learn about direct frontline experience.

Peggy, would you add anything more on the public-health standards and information-dissemination side of thing?

HAMBURG: Well, I guess I would just make, you know, one comment. Your question does sort of raise, you know, a(n) unfortunate aspect of how this response has been unfolding, which is that I don’t think that as a nation we have mobilized as adequately as we could the expertise that resides within our public-health agencies and also, you know, other organizations.

The Centers for Disease Control historically has, you know, really been able to provide very early and very comprehensive guidance on issues that ranged from public-health management to questions around school closures to some of the kinds of clinical management or guidance. There is a lot of good information up on the CDC website and other websites—the National Institutes of Health, the FDA—and there are organizations that are also putting up, you know, excellent sources for information that builds both on experience and past medical knowledge.

But I think, you know, one of the great challenges is really sorting through this rapidly-evolving stream of information, data, guidance, recommendations, and being able to sort out what’s good, high-quality information and what’s misinformation. And I think that has been really an extraordinary challenge as part of this epidemic, and you know, I really underscore the need to go to trusted, reliable sources of information.

Next question. Maybe we—any for Janet?

OPERATOR: We’ll take our next question—

COLES: Peggy, while we’re—

OPERATOR: Go ahead.

COLES: Oh, go ahead, Operator.

Well, I was just going to say while we’re waiting I think we should address the controversy around hydroxychloroquine and Zithromax, which has been touted by some as a potential effective approach. I have reviewed the studies where this has been used on an empirical basis by Chinese physicians and European physicians, and I will have to tell you that my read of the data is equivocal. What does seem to be apparent is that the viral load or the amount of virus in the body that—in the early stages of infection does seem to decline more rapidly as the result of the hydroxychloroquine administration, and so that does suggest that there could be an opportunity to mitigate the impact of the disease and longer-term infection—although that really isn’t proven out and I’ve not seen any data to connect decline in viral load with either clinical outcome or the need for more aggressive supportive care like a ventilator. So I think it is fair to say that the data really are out.

And this is a really important point to underscore, to Peggy’s last comment, because these therapies are not without their own side effects. We really have to be very thoughtful before we would administer them without fully understanding the potential downside risks of these therapies. But we hadn’t really spent a lot of time on hydroxychloroquine, and I thought we should just mention that briefly.

HAMBURG: Well, and I think it underscores, really, the question that was embedded in the first question, that while we need to be as forward-leaning as possible and as flexible in terms of the regulatory review and the studies that are being done, we also do need to have enough scientific rigor that we can really know what works and what doesn’t for whom, at what time in disease, and at what doses. And you know, there is a belief that if someone is facing a serious, potentially life-threatening disease that anything must be better than nothing, but that isn’t the case. You can make a sick patient worse and you can also prevent them from getting other therapies that might have been more beneficial. We really do need to know for patients today and certainly patients in the future and future pandemics what medical strategies and interventions truly work. Are they effective? Are they safe? How do the risks and benefits weigh out?

Let’s turn to another question now.

OPERATOR: Thank you. And we’ll turn to our next question, and that is from Deborah Amos with NPR. Please go ahead.

Q: I want to ask—I wanted to ask about other kinds of tracking that gets us back to normal. There’s the Kinsa company that has these—you know, temperature tracking. South Korea’s already got a phone app so you know and are given an alert if someone in your neighborhood tests positive. The Europeans are developing an app. The Canadians are developing an app. Do you think that that’s an effective or—a(n) effective strategy for Americans to have phone apps that tell you if there is an outbreak in your community?

HAMBURG: Can I turn to Janet for this question? Because she has to think about how to, you know, really begin to reopen a complex network of universities with lots of different types of activities, employees, critical functions. And I imagine you may not know all the specifics that were just mentioned in the question but that you’ve been thinking about what kind of tools and strategies might you have as you think about this step-wise process of returning to normal or to a new normal.

NAPOLITANO: Right. So, you know, one of the initial questions for us is returning students to dorms and how to ascertain which students may already have immunity and it’s safe for them to return, how many of them may be active, have active disease but be asymptomatic, and then, of course, we have students who are actually ill.

And this is going to pose a lot of complications for universities all over the country as they begin to think about can you have a fall semester and can you have residential colleges reopen where you have, you know, typically two or maybe even three students in a dorm room, not exactly social distancing.

So, yes, those kinds of apps, if they’re available and they work—we’re going to be open to trying everything. One of the things that we are testing now is a wearable device that would go around the wrist and measure things like temperature, et cetera, so—and we’ve got a trial going on with that now. I think it’s at UC-San Diego.

So, yes, we’re going to need to be creative and imaginative to try to get back to a new normal.

HAMBURG: Thank you. I mean, one unfortunate outcome of this unfolding of this pandemic around the world is that so many countries have been affected, but that is an opportunity for us, since we’re coming later in the progression of this disease, we can learn from what has happened in other countries. And we have an obligation to learn. And many of the strategies that have been tried in countries that have already been hard hit are quite interesting and promising. Some would work better in certain kinds of environments than others.

But I think that there’s enormous interest in understanding what has been in use before, and also many, many companies now interested in trying to use the data and analytics, trying to use various syndromic surveillance strategies where you’re looking at symptoms like fever, as Janet mentioned, and trying to think about creative ways to do better case identification and contact tracing and monitoring of individuals as we think about this return to some form of normalcy.

I think we have time for at least one more question. Let’s take one, see where we are time-wise, and maybe we’ll even have time for two. Next question?

OPERATOR: Thank you.

We’ll take our next question, and that is from Martina Hund-Mejean with Mastercard. Please go ahead.

Q: Hi. Thank you very much for this very interesting discussion.

COVID-19, as we know, knows no borders. And we are now seeing that the developing world has more cases. And, you know, these are countries that have already much less resources than the developed world. And you all talked about the work that is being done on testing for COVID, as well as the therapeutic drugs, as well as developing a vaccine, all fairly extensive propositions but that would allow us to get that—

NAPOLITANO: (Inaudible)—that I’m on a conference call.

Q: Can you hear me?

HAMBURG: Yes.

Q: Hello?

HAMBURG: Continue.

Q: OK. So my question really is if the developing countries have these infections and they can’t really spend a lot of resources to arrest those, and those infections can certainly reinfect the developed world, how do you see the poorer countries and people in the world actually getting such tests and drugs and eventually such a vaccine, especially in the—you know, in the era where, from a foreign—there are lots of foreign-relations implications where some of the manufacturing plants might be located in countries who want to hold on to their production of vaccines.

HAMBURG: Well, I’ll quickly begin. This is Peggy Hamburg.

I’ve been quite involved with some of the vaccine efforts. And certainly it is a huge concern about the need to make sure that vaccine is fairly distributed and is distributed in a way that reflects critical public-health need, and that historically we’ve seen how countries can become very nationalistic and keep vaccine in a pandemic-threat situation for their own country. And that, of course, is understandable. We’ve seen situations in other contexts where those with resources can get access to a critical medical resource and others cannot.

You are right that this is a threat that knows no borders. It is one where we will not be safe around the world until we address this devastating disease, wherever it may occur. And one of the things that’s happening to try to accelerate not just the vaccine development as much as can be done, maintaining that scientific rigor that we talked about to get a vaccine that really works and is safe enough for us, but is also to begin the preparations for manufacturing now so that we won’t have to wait while there’s massive scale-up and manufacturing. And that’s hard, because we don’t know for sure which vaccine products will actually be the ones that make it over the finish line.

But there’s been a huge push on trying to think through some of the manufacturing needs. And actually the Gates Foundation has recently announced a very generous, hugely generous contribution to helping to build vaccine manufacturing capability now for a number of different categories of vaccine, not knowing which ones may actually go all the way through manufacture. And discussions need to start now on a global basis about commitments for fair and equitable distribution, because that is going to be very, very challenging going forward, as you note.

We have time for one more question.

OPERATOR: We’ll take our last question, and that is from Donna Shalala with U.S. House of Representatives.

Please go ahead.

Q: Hi.

NAPOLITANO: Hi, Donna.

COLES: Hi, Donna.

Q: Hi.

I had a question that follows on something Peggy started to say about, and that is everybody’s talked about the leadership in the United States and blamed the president. But I’m wondering, Janet—and this puts you on the spot—in your other job whether the creation of the Department of Homeland Security actually weakened places like the CDC and other agencies, not simply in the shift in resources, but in the perception of who was going to respond.

NAPOLITANO: Yeah—

Q: (Inaudible)—too.

NAPOLITANO: Right. So, you know, this administration has managed this pandemic so differently than, say, for example, H1N1 was managed. When H1N1 occurred early in Obama’s first term, DHS was designated the lead federal coordinating agency to coordinate amongst HHS, with CDC, with the Department of Education, with the Department of Commerce, with the Department of Defense, et cetera. But it played a coordinating role, leading to the agencies that had the expertise, for them to do what they do. And so I remember, for example, doing a morning of Sunday morning talk shows with Richard Besser, who was then the acting head of the CDC; and Kathleen Sebelius, who was head of HHS. And it was the three of us talking about the response to H1N1, to show that it was an all-of-government response and that, you know, there was a center of the wheel, so to speak. This administration has—for whatever reason—has kind of discarded that approach. And you know, and it wasn’t really until the formation of the White House taskforce that we saw any kind of all-of-government organization occurring. So you know, I leave it for you to judge for yourself which is more effective.

HAMBURG: Well, I want to thank the panelists. We’ve come to the end of our time. We could certainly talk a for a lot longer. I think it’s been a rich discussion, drawing on the enormous depth and breadth of experience of our two speakers. So thank you, Tony. Thank you, Janet. Thank you to all of our listeners. Let me remind you that this session has been recorded and the transcript will be posted on CFR.org. And with that, I’ll close. And just to all of you, take care and be well.

NAPOLITANO: Thanks, Peggy.

COLES: Thanks, Peggy. Thanks, Janet.

HAMBURG: Thank you.

COLES: Bye-bye.

(END)