Executive Chairman and Chief Executive Officer, Cerevel Therapeutics; Member, Board of Directors, Council on Foreign Relations
Foreign Secretary, National Academy of Medicine; Former Commissioner, U.S. Food and Drug Administration; Member, Board of Directors, Council on Foreign Relations
FASKIANOS: Good afternoon and welcome to the Council on Foreign Relations State and Local Officials Conference Call Series. I’m Irina Faskianos, vice president for the National Program and Outreach here at CFR. We’re delighted to have participants from all fifty states, Guam, Puerto Rico, and Washington, D.C. joining us for today’s discussion which, as you all know, is on the record.
CFR is an independent and nonpartisan organization and think tank focusing on U.S. foreign policy. Through our State and Local Officials Initiative, we serve as a resource on international issues affecting the priorities and agendas of state and local governments by providing analysis on a wide range of policy topics. And we also produce Foreign Affairs magazine. We recognize that many of you are on the frontlines of responding to COVID-19 in your communities. So thank you for your service and for being with us today.
We are pleased to have Dr. Tony Coles and Dr. Peggy Hamburg. We share their full bios prior to the call, so I’ll just give you a few highlights on their distinguished backgrounds. Dr. Tony Coles is the executive chairman and chief executive officer of Cerevel Therapeutics, a biotechnology company specializing in the development of new therapies for diseases of the central nervous system. Previously, Dr. Coles served as co-founder and CEO of Yumanity Therapeutics, where he was instrumental in establishing and advancing potential new treatments for Parkinson’s disease and ALS.
Dr. Peggy Hamburg was the twenty-first commissioner of the U.S. Food and Drug Administration, where she was known for advancing regulatory science, modernizing regulatory pathways, and globalizing the agenda. Dr. Hamburg currently serves as foreign secretary for the National Academy of Medicine. And previously she was founding vice president and senior scientist at the nuclear threat initiative, a foundation dedicated to reducing nuclear, chemical, and biological threats.
Dr. Coles and Dr. Hamburg, thank you very much for being with us today. Dr. Coles, can you begin by giving us an update on where we are with vaccine development for COVID-19, and antivirals that will help with this disease?
COLES: Thanks, Irina. And it’s a pleasure to be with you and with my good friend and colleague Peggy Hamburg.
Let me start by my comments by just saying that I think it’s very important for us to recognize that there are several types or categories of therapies. In the media we’ve heard a lot about a variety of options for treating this horrible disease, but not all therapies are created equally because there are some therapies that are designed to prevent the infection, and there are others that are designed once you have the infection to actually treat it to minimize the side effects. And I want to talk about those two categories.
Obviously, therapies that are designed to prevent a viral infection are commonly known as vaccines. And there are a couple of types of vaccines. There’s the active vaccine format. And we’re accustomed to as children, or for our own children in many instances, having vaccines administered against chicken pox, against measles and mumps. These are vaccines that take a portion of the active virus, attenuate that, then use that to inoculate individuals to generate an immune response within an individuals’ body so that if they are presented with that virus subsequent to the vaccination their own immune system will be able to fight that particular virus and prevent infection.
So the goal of a vaccine is the absolute prevention of infection, and the active form of that is what we’re most accustomed to. We’ve had lots of conversation about how long such an active vaccine might take to deliver. The best estimates, and these are fairly accurate, is that it would take anywhere from twelve to eighteen months. Then of course we’d want to ensure that we had adequate manufacturing capacity of any active vaccine that was found to be useful.
But I do want to talk about another form of vaccination. And it’s called a passive vaccine. This is otherwise known as antibody-directed therapy. And this is where the antibodies against a particular virus are manufactured outside of the body—either from the convalescent serum of those who have the infection and recovered or cloned in the laboratory, having raised the antibodies in mice, for instance—which would be a very safe thing, if we can demonstrate that it’s effective.
This so-called passive vaccination or antibody-directed therapy is the subject of ongoing clinical trials in several biopharmaceutical companies. For full disclosure, I will advise that I am a member of the board of directors for Regeneron Pharmaceuticals, and Regeneron does, indeed, have a type of passive vaccine. The good news here potentially is that the clinical trials for a passive vaccine have already started or will start very shortly.
And it’s quite possible that by the end of this summer or the early fall we’ll have the first results as to whether this particular form of vaccination can be effective. So as compared to the twelve-to-eighteen-month timeline for an active vaccine, we could be looking at something closer in, at three to six months, if these particular antibody-directed therapies prove to be positive. So those are the kinds of therapies in the event that the goal is to prevent infection, which is of course the public health goal when we’re trying to treat a large population.
But there’s another type of therapy, a therapy which would actually once someone has been infected help to control the disease by stopping the virus from replicating or multiplying within the body. Viruses essentially act by hijacking the body’s or the host’s own systems to replicate themselves using either DNA or RNA genomic material, which are required for the various viruses to replicate or reproduce themselves. So they essentially turn the host into a virus factory.
If you can disrupt the hijacking that a virus does and shut down the virus’ ability to reproduce, you can thereby stop the infection or shorten its course. And there are, of course, several antivirals that have been used commonly, for cases such as HIV, for hepatitis C, for hepatitis B, and a variety of other viral disorders. The COVID-19 virus, the so-called coronavirus of type two, is now being tested with several antivirals. And you will know that there are some, such as remdesivir, favipiravir, which is the other one. And these two drugs in particular are thought to potentially be effective.
We have very encouraging, but very early, data from remdesivir, manufactured by Gilead pharmaceuticals, where in the fifty-three patients who were tested in the acute setting, two-thirds of them showed a shortened course or an improvement after they were infected. So that does give us some hope, but of course needs much more data to try to understand the impact of remdesivir and any similar agent.
Irina, let me stop my comments there, because I think we’ve set the frame for the two types of direct or targeted therapies that I’d like to talk about.
FASKIANOS: Wonderful. And, Dr. Hamburg, let’s turn to you about the regulatory aspects of developing a vaccine for COVID-19, what you see as the more global strategy, and the role of WHO in all of this. And I should say, the World Health Organization, just spell it out. Thank you.
HAMBURG: Terrific. Right, right. Well, thank you. And let me first say that I am really pleased to be on this call because early in my career I was actually a local health officer. I was the commissioner of health for New York City. So I appreciate what it’s like to be on the frontlines, although in all honesty I never had to respond to an infectious disease threat quite on this scale or urgency. But my time there certainly reinforced to me that responding to infectious disease outbreaks really is a global undertaking in terms of the interconnectedness of all nations with microbes that cross borders, and also subsequent activities that science is a global enterprise.
Just to follow quickly on what Dr. Coles spoke about, it is critically important as we think about the opportunity to develop and then use medical products, such as drugs and vaccines, that they be made available as quickly as possible. But they won’t do anybody any good if they actually don’t work, and also if their toxicities or side effects are riskier, more dangerous, than the benefits achieved by their use. And that’s why we do have a stepwise process for developing, testing, analyzing, and reviewing products for use.
In the context of a crisis, there is a strong sense of needing to move much more swiftly and doing things in innovative ways. And that we’ve seen in this outbreak and in many others as well. And I think it’s very important to underscore, coming back to the global scene, that one of the things that’s so striking about the response to the unfolding coronavirus pandemic is that there’s been a huge mobilization across institutions, across sectors, and across borders to do the science necessary and to—this includes regulatory authorities, like the FDA, but the authorities in other parts of the world as well, to align to streamline the process as swiftly as possible.
Because, as you all know, the nonpharmaceutical interventions that are currently our tools for managing this epidemic are very challenging. Social distancing, personal hygiene, infection control, et cetera are having an impact on reducing spread and the number of new infections. But it’s also having major consequences in terms of social disruption, and economic implications, and more. So we do need those treatments, which as Dr. Coles said will come sooner. But a vaccine represents our greatest hope for the ability to really move out of our homes and resume something that will be closer to our previous lives.
And vaccines require extra attention to making sure that they work and are safe because you’re actually administering vaccines to people who are otherwise healthy, with the expectation that they’ll be protected. And so that’s why it often takes longer. Beginning with studies in a small group of people—relatively small, usually less than 100, to look at safety issues, and then moving into broader clinical trials. In this case, everyone is trying to sort of telescope the development process as much as possible, but still do rigorous science so that we can actually know whether it works or not.
And it is already been historic in terms of how fast we have moved to develop vaccines against a virus that was not even recognized four months ago. But within nine weeks of posting the genome of the virus from a Chinese scientist, the first vaccine went into human study. There are now three vaccines in clinical study, and there’s over seventy different vaccines that are actively under development. And they fit into about seven different categories. I won’t go into all of that.
But I did want to say that as we are trying to develop these vaccines and thinking about the importance of actually preparing to manufacture whichever vaccines get over the finish line as swiftly as possible in the volumes that we will need—not just for our country but around the world—the WHO plays a very important role. They help to coordinate—both define and coordinate the research agenda, to bring together regulatory authorities in important ways, to help move the process. They put forward norms and guidance for preparedness and response of countries. They do on-the-ground outbreak response. And importantly, they do global disease surveillance and help do technical assistance and support countries to build the surveillance capacities that they need.
So as we respond to this coronavirus global pandemic, and as we think about how to protect ourselves in the future, there is no doubt that WHO is an important partner. And that’s why I think we need to also think responsibility about how our country invests in this unique and essential international health agency.
I’ll stop there, and I suspect there will be further questions on different aspects of all of this. Thank you.
FASKIANOS: Thank you. Thank you, both. That was really terrific.
Let’s now go, Brandon (sp), to the questions. And Brandon (sp) will announce who you are, but if he doesn’t I ask that you do, and tell us what municipality you’re with.
OPERATOR: Thank you. At this time we will open the floor for questions.
(Gives queuing instructions.)
Caller, your line is live. Please go ahead with your question. And if you would please identify your line before asking your question.
Q: Hi. This is Tom Santelli.
And my question is, how do we depoliticize the rhetoric around the virus, specifically with regards to taking responsibility for accurate communication with regards to, you know, China, and particularly where they’ve expelled journalists, where they arrested Dr. Li. How do we get to the next level on that? And so how do we take the propaganda out?
FASKIANOS: And what state are you calling from?
Q: Indiana with Boone County. I’m a commissioner.
FASKIANOS: Wonderful. Thank you very much.
HAMBURG: Do you want me to start with that, since I spent most of my career working at the precarious interface of public health, science, medicine, and politics? You know, I think you raise a really, really important point. And it really is distressing when we see political rhetoric and political pressures start to intrude on the decision making that really does need to be science and data driven. This is first and foremost a public health problem that needs to be addressed with public health solutions that will come from deepening our understanding of the nature of the virus, how it causes disease, the response of the human immune system, and of course applying that to the development of the medical countermeasures we’ve been talking about, and the policies that will make it possible to provide those treatments.
We recognize that all of this is happening in a context that is much more complicated in terms of the impact on society as we know it, certainly the impact on the economy and joblessness, the increasing concerns around civil unrest, and of course the national and international tensions between political leaders and between nations. But you know, I think we all recognize that right now we’ve got a major problem that we have to grapple with. And pointing fingers, causing blame, undermining leadership, is not helpful and, in fact, it can be destructive, and it can also contribute to growing concern about misinformation and lack of transparency.
It was disappointing, I think, that China, you know, was not more open early on. We all were optimistic that after the experience with SARS when they in fact did not come forward on the global stage as they were beginning to recognize and deal with an unusual outbreak out respiratory disease—we’d thought, perhaps, they’d learned from that and we would see better. There were problems at the very beginning, but right now we need to collaborate with China. We need to learn from their experience, as we need to learn from the experience of other countries that have come before us in dealing with this epidemic disease. We need to find ways for open communication sharing of information, collaboration around the science. And we are dependent on China in terms of global supply chains for critical drugs to address COVID and personal protective equipment, as well as routine medical products and devices, and a whole list of other important products as well.
So there are many ways in which this is not the moment to be picking a fight. This is not the moment to cloud the opportunities for insight, and understanding, and action around this unfolding pandemic. And I think it’s something that on a global stage we’re seeing, but also unfortunately on a local and state level some of the political dynamics also are harmful to our ability to respond as effectively as possible.
FASKIANOS: Thank you. I am going to go to the next question.
OPERATOR: The next question will come from Patrice Arent with Utah House. Please go ahead with your question.
Q: Yes. Thank you.
Given the talk from some of the states about soft openings as early as this week and some May 1, what are your thoughts about whether we’re ready to start opening up our businesses this soon?
COLES: Peggy, maybe I’ll start on this one then you can, of course, bring all of your public health experience to bear. Thank you for the question. You know, one of the things—because I have training and a degree in public health—one of the things we always love to go back to is that we should be making decisions that are both evidence and scientifically based. So if we—if we reduce that maxim to the simple data and not dates, I think the data will actually guide our thinking about the reopening of societies. This isn’t to contest any individual state’s decision to do so, but I do think that if we set—if we provided a set of guidelines which suggest that we should wait for a consistent decrease in the number of deaths for a fourteen day period or so, we really should try to understand the context of these decisions through that lens and not rush to judgement, but indeed let the data guide us in terms of thinking about the dates.
There is a belief that this particular virus will wane in the warmer months. That has yet to be substantiated. And we will very soon learn about the experience in the Southern Hemisphere as they now move into their cooler climate time of the year. So we really don’t know whether this particular virus will react on the basis of climate. And additional data is clearly going to be required to guide our thinking. The greatest risk, of course, is that individuals as societies reopen not just infect themselves but, importantly, infect health care workers. And because we rely on health care workers for the continued and consistent care, that puts a strain on the system. So those are just a few considerations and I think they’re, importantly, making sure that we don’t overwhelm an already burdened health-care system before—with a controllable decision about the return to—or, the liberation of social isolation is a really important consideration.
HAMBURG: You know, I think that was an excellent response. I would only say that, you know, one of the great challenges that I think you all recognize is that you inevitably are having to make, you know, very hard decisions in the setting of considerable uncertainty. And there aren’t absolute right answers. But again, you know, we need to look at how this epidemic has unfolded, the nature of the disease it causes, and the experiences of others who have been trying to manage and control it. And I think, you know, one of the clear lessons learned is that if one moves too quickly you will see resurgences. And it is almost inevitable that there will be some waves of infection with this, you know, completely novel virus. But what we want to do is to be sort of open the spigot at the right speed based on the right information so that we can actually manage how we see new infections and cases unfold, we can protect our health-care systems from being overwhelmed, and we can prevent an explosion, again, of new cases, disease, and deaths.
FASKIANOS: Thank you. Next question.
OPERATOR: Caller, your line was not—your information was not captured. Could you please identify yourself before taking your question?
(Gives queuing instructions.)
Q: Hello. This is State Representative Sherry Dorsey Walker from Delaware.
And the question that I have is: Where would we ultimately be doing the testing for the vaccine? Would it be in the epicenter of the epidemic, essentially New York?
HAMBURG: Oh, I’ll jump in first here. There’ll be many centers for vaccine study. You know, for better or for worse, there are cases occurring now in almost every country and territory of the world. And there are some particular hot spots. We would expect that some of the vaccine studies might occur using health care workers, for example, who we know are on the frontlines with significant exposure on a regular basis. There are studies that will go on in other settings as well, and in other countries. One of the clinical studies currently underway—in fact, the most advanced clinical study, it’s in what we call phase II, looking for efficacy as well as safety, is actually going on in China with Chinese-developed vaccine. So there’ll be multiple sites.
And the other thing that will be interesting about how vaccines will likely be studied in this current context is that probably—I mean, I think it is—it is the case that there will be vaccine trial designs where there’ll be multiple different vaccines being studied at once using one control arm, so that, you know, we can move more quickly and examine more vaccines. And also because people are very eager to get access to vaccines that may hold promise, it enables more people to be exposed without having a separate placebo control control arm for each vaccine being studied.
FASKIANOS: Tony, do you want to add to that?
COLES: No, I think that was a perfect response. Thanks.
FASKIANOS: Wonderful. Next question.
OPERATOR: The next question will come from Thomas Abinanti with New York State Assembly. Please go ahead.
Q: Thank you. Yes. I’m Tom Abinanti. I’m from Westchester County. I’m a member of the New York State Assembly.
First of all, I’d like to make comment on the question before about how do we deal with the political rhetoric. I would suggest that the medical societies and the national, state, and local health officers’ organizations have to become united. And they have to speak out, because they command a certain amount of respect with the public. And I think they have to resist whatever political pressure is out there, and say what you guys have said today, basically, about how to respond. And I think they have to take the lead on this, because politicians fighting with politicians just confuses the public.
My question is, are we sure that people who have antibodies from having had the disease are safe from reinfection and cannot carry an infection to someone else? Because there are talks about opening the economy by allowing those who’ve been infected before to go first. And a second part of that question is: Do we have testing yet that is reliable to know who is safe and who isn’t safe, who has the antibodies and doesn’t have the antibodies? Thank you.
COLES: Maybe I’ll start this one. The direct question has to do with what we call seroconversion. And that is a measure of the body’s ability to raise its own antibodies against the virus, which of course would make someone seropositive. This generally happens after exposure to a foreign agent, a virus in this case. And there are readily available tests which can determine whether a particular individual has raised antibodies on their own, and then of course become converted. In most instances, but in not all, seropositive status suggests that a person cannot be re-infected. However, that’s for other diseases. And we just don’t know the answer for the coronavirus.
There are case reports of individuals who have become seropositive from several of the Asian countries, which—where the epidemic beset those populations first—and then having a subsequent infection, or, at least, a subsequent positive diagnostic test for the virus. What we don’t know is whether they became seropositive and then were re-infected, or the virus continues to shed for a period of time after the person has stopped having symptoms when they recover. So the simple answer is, we really don’t know.
Now, this gives us an opportunity to talk about the two kinds of testing as well. Obviously, the testing that we hear most about in the media is the diagnostic testing that is to determine whether a person is infected with the virus or not. And there have been lots of media reports about the availability or the lack thereof of tests and various problems in not only getting the swabs that are used to swab the nasal passages, which is where the test if taken, but the reagents to extract the genetic material from the swab, and then of course the analysis of that particular sample. So there are multiple steps required in the diagnostic test.
And if any of those steps have barriers, it will, of course, delay our ability to administer widespread testing. But that’s only the form of testing that helps us understand or diagnose whether a person has been infected. And the kind of testing that’s implied in this particular question has to do with the measurement of an individual’s ability to raise antibodies. So it’s not a diagnostic test, but it is a test of either seroconversion and whether that individual’s immune response has been mounted against a particular virus. So we’ll all have to stay tuned and study these early case reports coming from Singapore, South Korea, and China very carefully to try to understand whether the virus has continued to shed or whether these individuals are truly re-infected following seroconversion.
HAMBURG: And just to add an additional sort of, I guess, word of caution—I mean, I think we will get scientific answers to the questions that Dr. Coles was just so eloquently discussing. But I think we also do need to recognize—and it goes back to what I was saying about why we do studies, to see if something really works and if it’s safe—with tests it really matters that we validate whether in fact the test is able to detect what it is supposed to with some reliability and reproducibility in terms of when large quantities are manufactured.
And with the so-called serology test, the antibody test, a decision was made, and now I’m putting on my former FDA commissioner hat, by the FDA recently to, what they call, exercise enforcement discretion over those tests for the most part. And so they are not going through the same process of sharing data on validity, and important measures of how sensitive and specific they are in detecting the antibodies. And so there are increasing reports about concerns of whether these tests are reliable.
And I think it’s a very important area that needs to be addressed quickly so that as we come to understand what does it mean to actually have these antibodies and be able to measure them, that those measurements are accurate, especially as many of you on the frontlines are starting to think about strategies, no doubt, where you may use these tests as part of how you think about who is ready to go back into different kinds of settings, whether it’s first responders and health care workers, or people going back into the workplace, or schools, or other social settings or mass gatherings. So this is a very, very important area. And thank you for the question.
FASKIANOS: Thank you. Next question.
OPERATOR: The next question will come from Pamela Pugh with Michigan State Board of Education. Please go ahead with your question.
Q: Hi. As was mentioned, this is Pamela Pugh.
And I’m member of the State Board of Education, but I’ve also served as the chief public health advisor for Flint, Michigan. And a lot of the things that I’m hearing and seeing are so reminiscent of the Flint water crisis, especially as it relates to the interaction with the community and the constant rub and competition between the public health and the economic health. As public health officials and persons we know that the economy is public health. That is one of our big fights is making sure that people, our residents, folks have economic dignity and are able to care for themselves. There’s a lot of data that we can see with COVID, there’s a lot of good qualitative or quantitative data, both on the economic and the health side.
And my question is, how are we monitoring—how are we selecting a qualitative status, and that is the voices of residents, the voices of the people, before we open up America. What is it that’s going to build their confidence? What is that’s going to help their social, emotional health that leads to the confidence in opening America back up, where they’re going to feel comfortable eating at a restaurant again? What is it that’s going to make them feel comfortable taking the vaccine? How are we monitoring that? How are we selecting that information? How do—and I appreciate this session here—but how are we better prepared as the local people to take the pulse of business, because if we produce vaccines or antivirals, how do we make sure that they’re utilized? And how do we make sure that we can get ourselves moving back? And that’s what’s driving that qualitative data, the voices of the people, versus just getting the economy back going? Thank you.
FASKIANOS: Who wants to start?
COLES: Well, let me—let me take a start in answering that. Obviously, one of the additional duties I carry is as chairman of the Black Economic Alliance, which is a political action group that’s devoted to advancing economic opportunity for Black Americans. And we have very much been examining the question you’re raising through that particular lens, since Black Americans seem to be disproportionately affected both in terms of incidents but also in terms of lethality and mortality of this particular virus. In neighboring Chicago, not very far from you, while Blacks represent only 14 percent of the population, they represent about 50 percent of the deaths. And it’s really quite startling what’s happening across the country. So, I’m sorry, that was the data for Michigan. Chicago is 30 percent of the population, 50 percent of the cases, and 70 percent of the deaths. So even worse in neighboring Chicago.
So we are looking at this question about a return to the new normal or the near normal in a number of ways. First of all, everything we said about the widespread availability of diagnostic testing is critical to ensure that we can, indeed, return to some semblance of normal. That would be both the diagnostic testing as well as the seroconversion testing that we talked about a moment ago, because if it is determined that seropositive individuals are safe to return and can’t either be re-infected or transmit the virus, there’s a viable public health strategy there. But it’s really only as good as our ability to test. So good test are going to really be required in, I think, assuring individuals that they can, indeed, get a test anytime they believe, or their provider thinks that they deserve one, is going to be tantamount.
Second, the old-fashioned approach to contact tracing. We may—because we have community spread we’ve lost the opportunity to do contract tracing. But in companionship with the availability of good diagnostic testing, to the extent that we can then implement contract tracing, very quickly identify those who come into contact, some test positive, and then isolate them, gives us a second shot of containment of the virus, if we’re ever able to lower the number of cases sufficiently where a containment strategy becomes very appropriate. I’d say without either widespread availability of tests, the ability to do contact tracing, and some form of therapy—whether it be a passive antiviral, as I talked about a moment ago, or—I’m sorry—a passive vaccine or an antiviral, I think it’s going to be very difficult for anyone, regardless of race or ethnicity, to go back. But of course, I suspect that Black Americans will be very, very thoughtful in terms of their return, unless they have better assurances that they can be treated effectively and quickly.
HAMBURG: And the only thing that I would add to really that, you know, very informed response, is that you talk about how can people, you know, sort of trust their political leaders. And that, of course, ties into our earlier conversation about, you know, trying to limit political infusion into decision making. But I think that probably all of you recognize that, you know the voices of people that are local, state, or regional are very, very important in communicating information and what is known, and what is not known. The importance of really trying to be as open as possible, as you talk about, you know, where we are in terms of our outbreak response, what we know, what we don’t know.
You know, not sugarcoating, not trying to engage in wishful thinking about what might happen. But also, you know, trying to show that there is a pathway towards a return to whatever the new normal will be, that there are actions being taken, and this is what they are. And keeping the lines of communication open, because as you know from your experience with Flint, Michigan, you know, to have had a problem and not been informed that was putting you and your family at risk, you know, it was about as undermining of trust and confidence as anything can be.
FASKIANOS: Thank you. Next question. And also, please feel free to share your—share your experience as well.
OPERATOR: The next question comes from Colleen Garry with Massachusetts State House of Representatives. Please ago ahead.
Q: Hi, folks. Thanks very much for having this today.
I was just wondering, every year we seem to have—we have the new flu vaccine. And it’s always trying to find the right strain to match up. Do you believe that that’s going to be a problem with us going forward with the COIVID vaccine, is it’s going to be mutating and every year there’s going to have to guess at what the newest COVID strain is going to be?
COLES: I think it’s too early to know. I wish I had a better answer for you, but we’re going to need some experience with the vaccine to try to understand its mutability. One of the reasons that the annual flu vaccine changes in its composition of factors is that the influenza virus is always and constantly mutating. However, because there is a sufficient amount of two or three strains that seem to make up most of the influenza strains, we can get a very effective vaccination for the flu. But we just don’t know, unfortunately. And I think some of this answer may lie in the earlier considerations around individuals’ seroconversion and whether antibodies can be mounted that will effectively cover most of the mutations for this particular virus. But we just don’t have enough of a characterization about its potential and its tendency to mutate to be able to answer your question. So we’ll have to stand by for just more evidence there.
FASKIANOS: Thank you. Next question.
OPERATOR: The next question comes from Lawrence Chiulli with Village of Port Chester. Please go ahead.
Q: Hi, how are you today? I have a comment and a question. I’m involved in emergency management. I’m not really medically qualified. But I’ve seen a lot of storms and different things. And when this virus first started I talked to other people in emergency management as we were preparing for it to enter our areas and how to prepare for our staff and essential personnel. And I think the biggest problem that you’re seeing is the fact that the information was not correct. And I think that’s why the public—and this is what I’m getting feedback from the public now—first came out and said that it was just a flu. And masks were not required. And then instead of maybe telling the public the straight answer that we need the mask for our emergency personnel, first responders, and medical, and we’re going to quarantine or ration how much could be provided to the public, that misinformation hurts going forward when then you come bank and then say that masks are important.
And I wasn’t even in the medical field, and at the end of January/beginning of February when it started and we were talking about if it came to our area in New York where it was going to affect us, what would we do? One of the comments I made, based on the information I was getting, was that we should all be wearing a mask because even though I’m not in the medical field common sense tells you if I have a mask on, and you have a mask on, it leads—a proper mask—if it leads from stopping us from giving it to each other, not knowing who’s asymptomatic, would be the proper thing. And I think that misinformation from the beginning hurt us all. And you know, I think going forward that’s what we need to do.
And also, the information coming through was saying how bad it is. Now, I do believe this is a very contagious virus. I do believe there’s a lot of underlying issues with this virus. I do believe we’re still doing a lot of testing to find out exactly how to handle it. And one of the biggest questions I had was asked earlier, which I think was very important, is once you have it are you still contagious is huge before I can put people back into the workplace. Those testings have to be done. So I think—I think that’s where I think our problem is.
Now, I want to ask you the question. When will we have a test that will answer that question, as far as if someone has the virus whether they’re still contagious when they’ve recovered from the symptoms?
HAMBURG: Well, I’ll jump in first, and then let Tony follow. I think, first of all, in responding both to your comment and to your question, is you really do need to appreciate the fact that this is an evolving area of science and understanding that this virus has commonalities with coronaviruses that we have known before. It’s one of the family of coronaviruses. Some just cause the common cold. But we’ve had more serious outbreaks with SARS back in 2003 and MERS more recently. But it is distinct and has distinct characteristics. And I think nobody appreciated early on how there was such a degree of asymptomatic carriage and spread with this novel coronavirus. Generally with viruses, both other coronaviruses and, you know, other viruses, like flu, you don’t spread much until you are actually symptomatic. So this category of asymptomatic spread I think wasn’t fully recognized and, as you point out, you know, it did create confusion and additional recommendations for management.
In terms of when we will find out about, you know, a definitive answer to the antibody test, that work is underway. Some of it involves going back to the other countries that have already been grappling with this epidemic and looking at their data and information. And some of it involves, you know, a much more sort of laboratory-based look at—looking at what are the different types of antibodies and other immune system factors that are mobilized in different people, and what does that potentially tell us when you look at their course of disease? But it’s—you know, there is not gold standard study that we can do to answer that question overnight. But it is one of the most important questions that the scientific community is now deeply looking at.
The good news is that it doesn’t appear—and we’ve now, you know, on a global basis had close to two and a half million cases, it doesn’t appear that the problem of reinfection is a prominent one. And there have been some isolated reports, and Dr. Coles referred to that, but it’s not clear whether that’s actually reactivation of disease that wasn’t fully cleared by the immune system. And the presence—being able to measure the viral genetic material does not mean that that is infectious virus. And so there may be that you can still—when someone’s developed antibodies—you can still swab or isolate viral material from various bodily secretions, but that it doesn’t relate to actual infectious spread. So those studies are being done as well and looking at both the epidemiology and the science to see if we can learn more both about immune protection and the nature of viral shedding.
FASKIANOS: Tony, anything to add or shall we go onto the next question?
COLES: Let’s go on. I thought it was a terrific answer. And I think Peggy’s very last comment about the significance of viral shedding, meaning the presence of virus after the course of the illness, not necessarily predicting an individual’s ability to be infectious is a really important and a very key point in this consideration. And that’s where the tincture of time will be helpful, because we’ll just be more experienced to try to understand whether that’s the body just clearing that virus that can’t infect any further, or whether it’s truly possible for someone to be infected twice. Which would certainly be related to mutation and a number of other things. So it’s a really important distinctions.
FASKIANOS: Thank you. Next question.
OPERATOR: Caller, your information was not captured. If you’d please identify your line before taking your question.
Q: Hi. This is Linda Redmon with the Snohomish City Council in Washington.
And my question was—and thank you for doing this today, by the way. My question was whether we understand if there’s differential response in age groups in antibody production, and whether that changes how we think about how we will vaccinate our population? Thank you.
COLES: I’ll start and Peggy may have more direct experience. I certainly don’t know enough about the presence of viral titers by age, and whether there is a different characterization for younger people who are infected compared to older people who are infected. One of the great mysteries of this disease, of course, is that in the main, younger people tend to have a less severe course and are, of course, less likely to die. But that does not mean zero in either of those cases. There was just a report this morning which I’m sure will be of great interest to the epidemiologists of a five-year-old who is the daughter of first responders who had not left their home, her home, and, of course, contracted the virus and died.
So there’s still a lot about this particular disease that we don’t know. I think that’s why in an abundance of caution, regarding the earlier conversation about reopening venues—public venues, and whole states for business and economy—we have to be very, very thoughtful because there was the misperception at the beginning of this disorder that young people either couldn’t get it or, if they got it, they wouldn’t be very sick. But that, of course, disregards their ability to infect others, which of course has great public health consequence. So this is one of the great mysteries. And I’m sorry I don’t have a better answer for your question.
But, Peggy, are you aware or do you know anything about viral titers by age?
HAMBURG: Well, I don’t know the specific of viral titers by age with this novel coronavirus. What I do know is as a general phenomenon, sadly, as you get older your immune system is not quite as robust in response. And when we look at annual flu vaccination, the vaccine tends not to be as effective in elderly patients. It doesn’t cause immobilization of the immune system and its protections in the same degree. So it wouldn’t be completely surprising if we saw that in this case. But certainly it is a critical question to be asking. And it’s something that the vaccine developers will be looking at because of the demographics of this disease. As was just noted, nobody is completely immune to getting this infectious in COVID-19, and serious, sometimes lethal, consequences of that disease.
But it definitely does seem to predominate in more elderly populations. And that will be one of the groups that we will very much want to be able to target with immunization in settings like nursing homes, I think you said you were from Washington state, certainly have been a source of great concern as well. And again, an elderly population likely to be somewhat immune compromised, simply because of age and the natural advance of systems and, dare I say, deterioration. But, you know, it’s a really important question. And, again, the science is ongoing.
FASKIANOS: Thank you. Next question.
OPERATOR: The next question will come from Robert Nelson, city of—Bay City, Texas. Please go ahead with your question.
Q: Thank you so much, and good afternoon, everyone. The doctors both mentioned about having the right amount of science and the right amount of data. So I have a two-part question. One, do you think we have enough data and science to put people back to work with only 1 percent of the population that’s been tested? And the second part of my question is: Do you think we need to broaden the parameters for those being tested, since the parameters are so narrow and not everyone is being tested?
HAMBURG: Well, I’ll jump in first and then turn it over to my colleague. I mean, I think clearly we need more testing. That is a huge priority. And sadly, from the very beginning of this unfolding epidemic in our country, we have been behind in our ability to test. And that matters both in terms of really ascertaining the nature and scope of the epidemic, the sort of pathway of this virus into our communities and across our country, and it also matters in terms of our ability to apply the public health and medical tools that we have, where you identify people who are infected using a test, you isolate them, you make sure they get appropriate care, you do the contact tracing if you’re early enough that you can actually logistically do that, and you quarantine those who have been exposed. So, you know, we lost time and we, you know, sort of got behind the eight ball because of inadequacies of testing.
Now we’re in a dilemma, although the testing capacity is growing, of still not having enough tests. And as you say, we’ve only tested a small portion of the population. We don’t have the luxury of doing some of the kind of testing in the community to understand the contours of the continuing epidemic, and provide the testing needed to really care for an assess what’s happening in terms of our health care needs. So we are in a state now that we really don’t want to persist in. And we look at other countries, like Germany, that have had strong testing programs in the beginning and are using that testing program now as they look at opening up. And we can see that it really matters. South Korea is another example of a country that, you know, got more rapid control of the outbreak using widespread testing, although they have had, you know, resurgence as they have moved to return people to the workforce and enable less social distancing.
So we need—you know, as we discussed before—both the test for who’s actually infected, and the seroprevalence tests are important. There have been—and then I’ll stop. I didn’t mean to give such a long answer. But there have been some recent studies reported out that have been interesting on the seroprevalence question, where we have been able to learn about background rates of exposure, people that didn’t know that they were sick. They didn’t know they’d be infected, but in fact have antibodies. And of course, you know, you have to put that in the context of the test not being completely reliable, et cetera.
But, you know, we are learning that in communities where they’ve had known outbreaks, someone was on from West Chester before. You know, asked a question earlier. One of these studies was done there, although I actually don’t know the results of that study formally yet. Studies in L.A. that just came out yesterday. I think one in Santa Clara. There have been others as well, Chelsea, Massachusetts, where we have found that, you know, a surprising number of people have been infected, have antibodies, but haven’t been sick. And so that also takes us back to—if that’s protective, that’s great, because we’re moving towards what’s called herd immunity, where you may not have to vaccinate as many people to get protection and decrease spread in a community. But we also need to understand, are those people in fact cleared of the virus and not capable of asymptomatic spreading?
COLES: I wanted to pick up on Peggy’s very last point, because there was recent evidence—there was a random sampling of just over two thousand Californians where testing was done for the coronavirus. And in that random sampling, there were only 4 percent of the individuals who tested positively. Now, it’s an interesting statistic for a couple of reasons. One, that does suggest in this sample that 95-96 percent of those who were screened did not have exposure to the virus or did not have the virus. This wasn’t seroconversion testing. This was diagnostic testing, to test for the presence of the virus. But I think it’s important because if you can extrapolate that, and most people agree, that nationally somewhere between 90 and 95 percent of Americans have not been exposed to the coronavirus, which is, of course, the exact intent of social isolation and quarantine. So it is working, if these numbers do hold up.
But the other way to think about this particular statistic is that if you extrapolate that 4 percent to the entire population of California you, of course, get a much larger number of Californians who might have the coronavirus than the current statistics suggest. Current statistics suggest that only thirty-three thousand or so Californians have tested positive. And you can do the math on thirty-three million. But 4 percent of thirty-three million far outstrips that thirty-three thousand of confirmed cases. And this speaks to the notion that, again, as we’re learning the virus and what it does, that this is virus that has a variety of forms of presentation. For instance, one of our local elected officials where I am only had symptoms of a loss of taste and smell, and nothing else. But it’s clear that that person was probably infectious with that.
So the answer to your question on should we broaden the testing, yes, we should certainly liberalize testing as tests become available. But there should be a good reason or an index of suspicion for testing individuals because we certainly don’t want to deplete that resource and not have it available when the index of suspicion is high for other people. But we are still learning how this disease presents. And I don’t know that we yet have a good handle on its penetration in society to be comfortable with the notion of liberalizing social isolation restrictions or this concept of herd immunity, which we can talk about as well.
FASKIANOS: Thank you. Next question.
OPERATOR: The next question will come from Mary Sterrenberg with Village of Arlington Heights Nursing Services. Please go ahead with your question.
Q: Hi there.
My question has to do more with the vaccines. And I’m curious if you had an educated guess as to what the presentation of the vaccines will be. Seeing as supplies have been a challenge just in personal protective equipment, depending upon the vaccine type—assuming maybe it’s injectable—there are other supplies that are going to be needed. And is that something we should be planning for? Is it being planned for? That’s my question.
COLES: It’s a very good question. And at least the one dimension that I will speak to is the manufacture of the vaccine itself. We’ve talked about the potential of not having sufficient supplies for not just the U.S. population, but for citizens around the world. So this is something that is very much in the minds of both public health experts and philanthropists. Many of you saw the headlines where Bill Gates has agreed to fund the construction of eight manufacturing sites or facilities, all for a different form of the vaccine, not knowing which of those will be the successful combination of elements. And that is certainly one strategy that the private and public sectors are deploying to ensure that we have sufficient supply of the vaccine itself.
But yours is a good question, because I think you’re asking about syringes, and needles, the various administration elements that will be required to deliver the vaccine. And that’s clearly something we should be looking at now on a national level. It’s a very, very good question. Thank you.
HAMBURG: And, you know, just to elaborate a little bit, you know, there definitely are efforts underway. Some think that they are good, others think that they are bad, by our country and by some others, to try to obtain some of the necessary materials in preparation for when we hopefully will have a vaccine. For example, you need to have a certain type of glass vial and stopper for vaccines. And you know, there are variations on the theme, but people are already now buying up those materials for the fill and finish phase of vaccine manufacturing. You know, we have heard—although I haven’t—I don’t know if it’s directly been confirmed—that with the diagnostic test that involve finger-sticks there’s gaps in the supply of alcohol swabs. And, you know, that’s probably another thing that people will start to be looking at supply chains for.
But while some of it is potentially worrisome in terms of we don’t want to have a vaccine that gets distributed solely on the basis of who can pay the most, and we don’t want this to turn into a competition either within our own country of haves and have-nots, rich and poor. We don’t want to have, you know, national nation-to-nation competitions for limited supplies of vaccines or other related materiel. The idea would be to have the capacity needed to meet the overall public health need. But realistically, that is going to take quite a bit of time. And I think we’re going to start to have more and more debates on the public stage about how do we have equitable distribution of vaccine, especially in the early stages, when it will be a very limited and much sought-after resource.
FASKIANOS: Thank you. Next question.
OPERATOR: The next question will come from Susan Hairston, council member. Please go ahead.
Q: Thank you, again, CFR for doing this. I participate in every single one, and you just keep raising the bar. Both doctors, I just cannot thank you enough for the amazing amount of information you are giving our local and state officials here.
With that—all that you’ve said, what seems to be making me nuts is how are we knowing about the folks who do not come into the health—our health-care system and are dying at home? How are you incorporating that into your data? And in the tracing? And I am just so concerned about the number of people and if we’re even recording those people who passed away or even had it back in November, December, January, or February. So I’m just hoping you can shed some light on how that is being incorporated in your data.
HAMBURG: Well, you raise such an important question. And we won’t have full answers. You know, one thing that has happened of later is—you know, going back to November is much harder to ask and answer those questions. But even, you know, as we talk today, there are problems about really identifying all of those, you know, with the infection, because we’re not testing everyone, but also deaths that may have occurred at home or in—attributed to other causes, but where there was COVID infection. And there was a big bump in New York City cases not too long ago, which reflected the fact that they sort of went back—they did a look back and realized that there were a lot of unaccounted for COVID-related deaths. So you know, that is one living example of what you’re describing.
But, you know, I think part of it is that we will have to do a better job going forward. And it will be harder to assess some of what has happened in the past. But, you know, broader testing and building our public health capacity to investigate cases of potential disease will be part of helping us to get better answers going forward.
FASKIANOS: Tony, did you want to add to that, or should we just go on?
COLES: Well, the only thing I would say—it was a great answer. The only thing I would underscore is we may never truly know. Because one of the things that is becoming apparent about this virus is whereas we thought the lungs were the original and the main focus of the virus, in terms of where it interacts with the cells causing the pneumonia, the pneumonitis, the inflammatory response, there’s recent data to suggest that this virus can infect the kidneys, the liver, and, importantly, the heart. So it could be that over time, as any of those organs begin to fail in individuals, we may inappropriately misdiagnose the actual origin and cause. So there’s never going to be a perfect answer. But I think Peggy’s given you a great way to think about the public health implications of the accuracy of the counting. But I just wanted to make that point because that’s a new learning about the virus and expanding our understanding of its involvement of the lungs.
HAMBURG: And I think it’s very, very important—you know, I appreciate Tony saying that. And it reminds me, going back to an earlier comment/question, is that this is an unfolding epidemic. We are learning a lot. There is information that is going to change. And you need to understand that that doesn’t reflect a failure of communication or a desire to hide information under the rug. It’s simply that we are learning a lot. On the other hand, there is misinformation out there. And so, again, you all on the front lines at the state and local level have a great challenge of being able to keep up with new information as it emerges, but also the dissection of what is good information and new scientific insights, versus misinformation. You know, and I hope that our federal agencies can help with some of that as well, with the CDC website, the NIH website, FDA, and the communication from various public health experts at every level of government and other health institutions.
FASKIANOS: We still have a number of questions in queue, but we’re coming to the end of our time. So I’m just going to take one final question. And my apologies to all of you who are still holding.
OPERATOR: Thank you. The final question will come from Kevin Falconer with Carrollton, Texas. Please go ahead with your question.
Q: Yes. Thank you so much for your comments, especially about the science-based approach to reopening.
I guess as we do look to the future, though, and relaxing the social isolation, do you perceive long-term keeping our large groups restrictions for a long period of time, which I’m assuming we may have to do?
COLES: You know, it’s a good question. And none of us have a crystal ball to try to answer it. But I will refer us back to the great epidemic—the pandemic—the Spanish flu pandemic of 1918. And if you go back and look at that as an example—now, a different context, where you’ve got much better sanitation and running water for large parts of the developed world. And there are so many things that are different that don’t make this an exact comparison. But that pandemic lasted eighteen to twenty-four months as it spread around the world, as World War I soldiers returned from the war.
And I just—I raise that because while the environmental context, and the public health and sanitation standards, and the therapeutics, and the health care standards are all so very different today, and we can never, of course, project what might have happened then with the current medical standards we have now, it does give us some sense that this could be with us for a while. And I think the judicious return to—I don’t think life will ever be truly the way we had it—but the judicious return to relaxing these standards and guidelines may take longer than any of us are expecting or predicting. We’re all, of course, hoping that this ends very quickly and that by the fall we are able to resume all of our old routines and normal lives. But that may not necessarily be the case. And I’d just point to that historical fact. Different standards, but of course that historical fact is something that we really have to be very thoughtful about before we relax our guidelines.
HAMBURG: And just quickly, if you go back to the 1918 Spanish flu and compare how different cities managed large-scale gatherings, there were differences. And the burden of disease was in fact less in those cities that limited mass gatherings. Again, a direct comparison: A study was done looking at, I think it was, St. Louis and Philadelphia. And it was a striking differential. So we can learn. But we also are going to have to invent some of our own strategies as we go forward in a very different world now.
FASKIANOS: Well, Dr. Tony Coles and Dr. Peggy Hamburg, thank you very much for spending this time with us. I neglected to mention at the top of our—the opening that both of you serve on the Council on Foreign Relations Board of Directors. So thank you for your leadership at the Council and for all the work that you’re doing. I think we learned from today’s call that it is so important to follow the facts and scientific-based data to make these important decisions as we go forward.
We will be convening again soon. We appreciate, again, all that you’re doing on the frontlines and communicating with your constituents. Also, you can follow Dr. Tony Coles on Twitter at @TonyColesMD. So thank you both and thank you all. If you have any feedback or other specific areas you wanted to cover in future calls, please email us at [email protected]. We look forward to hearing from you and for being a resource for you. And we hope that you all stay well and be safe.