You’re listening to a press conference from the Harvard T.H. Chan School of Public Health with Michael Mina, assistant professor of epidemiology and a faculty member in the Center for Communicable Disease Dynamics. This call was recorded at 12:00 p.m. Eastern Time on Friday, August 28th.
Transcript
MODERATOR: First question.
Q: Hi. Thanks very much. I guess I was hoping you could explain sort of the differences and similarities between these at home point of care and tests that you’ve been talking about versus those the ones purchased by the Trump administration, yesterday, and then the one CMS has been rolling out to nursing homes. I think they’re all broadly antigen tests, but I think the equipment you need and the speed, if you can just kind of explain the differences among those that would be really helpful. Thanks.
MICHAEL MINA: Sure. Just want to ensure you can hear me. Is that correct?
Q: Yes, I can.
MODERATOR: I can, too. For what it’s worth.
MICHAEL MINA: Sure. So they are generally all rapid antigen tests. The first ones that were introduced by Quidel and BD Veritor or Becton Dickinson, they are tests that require an instrument. And so they’re made for medical use and by medical professionals. These are the ones that were introduced by and CMS and the Governors Association pulled together about three million or so of them. They’ve been around for a few months now. They are essentially actually just the same rapid antigen type lateral flow tests. If you were to take one of these BD Veritor instruments, and there’s an instrument itself and that might be a few hundred to a few thousand dollars depending on the instrument. And then there’s these cartridges that are actually what the test itself into the instrument just reads the cartridges. So if you pull all the plastic onto one of those cartridges, actually underneath it all is just a simple paper strip test like I’ve been discussing. So in some ways, it’s a very similar assay and in other ways, because it’s tethered at least based on the approval’s status that it has, it’s tethered to this instrument. It becomes very limited in terms of how many people have access to it. And the throughput of it, if every single cartridge needs to run through the instrument, you can’t easily test 50 people at once. You’d have to have them send in a very long line. So that’s one type. And then Abbott BinaxNOW test, that just came out two days ago, and that’s a very nice assay, which is effectively it’s what I’ve been discussing. It’s not tethered to an instrument. In this case, it looks more like a cardboard envelope rather than just a paper strip. And that’s just form factor. It’s a more expensive paper type of test. And that’s because it’s essentially designed for clinical use that follows in the mold of other BinaxNOW assays that Abbott has produced in the past, which have been for other pathogens.
And so these are generally made to be a little bit more expensive and are intended to go to physicians offices or other health care personnel. That test was given the FDA approval of symptomatic use only. It’s not that it’s a different test. It could absolutely be used for asymptomatic individuals in the home, for example. But to get approval through the FDA, it’s just a much easier, cleaner path if you get an approval just for symptomatic people only. And that’s because it’s a little bit ironic in a way, because you say that for symptomatic people, for a real diagnostic medicine, if the person sitting in your doctor’s office and you probably want to just do a PCR test if you have that available to you. But a lot of people don’t have that available. In any case, it’s really an FDA approval difference where where this test was approved for symptomatic, because it’s an easy claim because you know exactly who is symptomatic. You know how long they’ve been symptomatic. If you ask them and then you only recruit those people who are, for example, within seven days of symptom onset to really provide a sample to do your validation. And it’s not anything below board or anything. It’s a very reasonable approach. But ultimately, what that means is that what they come out with is a test that has FDA approval for symptomatic use only and that is designed specifically for the first week or so symptom onset. Now, that second part is what I’ve been really pushing for anyway. I think having a test that can really find you when your transmissible is the whole goal here. I would just like to see it get an asymptomatic claim and then over the counter claim so that it could be used more broadly. But getting the asymptomatic claims is very difficult because you don’t know who you’re looking for. So it’s a much harder trial to do to actually get the results you need.
Q: Got it. Thanks very much. Appreciate it.
MICHAEL MINA: Sure.
MODERATOR: Next question.
Q: Hi. We were just wondering if you had gotten a chance to see the paper that was published, it’s a preprint, about this twenty five year old who he had a mild illness the first time and then the second time around, he was hospitalized, hypoxic, and they did genomic sequencing and found it was two different strains of the virus. I was just wondering if we can get your general reaction to that if you had a chance to read the paper.
MICHAEL MINA: I haven’t read the paper. But I know about it. This isn’t news, and frankly, it scares people. And I would say that it’s just not surprising. There’s going to be millions and millions of cases. There are people in this world who get hit by busses. There are people who get struck by lightning. They’re people whose immune systems are on the edges. You have distributions of immunological memory and some people won’t respond well the first time. But what really matters to the average person is what happens to most people. If everyone walked around wearing that, they were the great exception, we’d all be worried that we’re gonna get hit by a bus every day. So I think that these papers will get published in academic spheres and that’s fine. You know, they’ll be put out by academics. And it’s important to study these individuals. But I would say it’s not that important to report on these individuals. And it’s no different, for example, then we often see in the media, especially with vaccines and things like that, that we we talk a lot about the rare adverse things because it’s important. But if we were to pay as much mind to all of the times when people aren’t getting reinfected, that would fill up volumes and volumes and volumes of newspapers.
I think that it’s important to keep all of this balanced and mind that and recognize that medicine and things like infectious diseases live on a whole spectrum. And we fully anticipate that a virus like this is going to infect people a second time. I think most people can get infected a second time. That’s the whole way that immunity works. But the whole idea is that the vast majority of people who do get infected a second time, if they do, will not be sick and will not end up in the hospital. And so in this case, it could be that the person just didn’t have a particularly bad first infection, didn’t develop as good of an immune responses maybe their neighbor would have. And and we’re still vulnerable the second time. Or maybe they have some some small problem with their immune system. So I guess the point is, I don’t find the rare exceptions. I don’t think it’s that they should be news because they end up giving the average person completely the wrong idea, because people out in the regular world assume that individual events are generalizable. And what’s generalizable are the generalized events. And then individual events are usually the ones that are not generalizable. And once we start seeing them happen all the time. But, you know, if we have one pop up in Korea and then two pop up in the United States, we have to take all of it into consideration. And maybe what the headline should say is, one in five million chance to get reinfected and end up in the hospital again. So I don’t find it that interesting, even biologically I think it fits exactly along the spectrum of what we would anticipate for a virus like this.
Q: That’s perfect, thank you.
MODERATOR: Next question.
Q: Hey, Michael. How are you? If I just can have a quick follow up. But the first question. So you know me. I like to get predictions. And so we’ve got the flu season coming up. And so I hear Bill Gates saying we got some warm weather effect. I want to know if we actually did, and so as the flu season opens up, does this get a lot worse? That’s the main question. And just a quick addition to that, I’m also hearing reports that in the southern hemisphere, we’re not seeing it get worse as the winter progresses there. So, you know, if you could just hit all those. And I have a quick follow up. Thank you.
MICHAEL MINA: Sure. Well, we did see it. We did see a lot of the cases initially weren’t really happening too much in the southern hemisphere. And then when their winter came on, which was not months go now, we did see cases actually start to really drive in the southern hemisphere, a lot of places. But it’s a good question. It’s really hard, a lot of the southern hemisphere doesn’t have particularly great testing in a lot of countries just because there tends to be a lot of the wealth in this world is concentrated in the northern hemisphere. And so it’s a little bit hard to really get the signal from the noise there. But for example, Australia was initially, not hit very hard, and then has been hit very hard in their winter. So I do think that I would say what we’ve seen doesn’t necessarily show no climate effect. I’m still very, very concerned that we’re going to, you know, we are going to see a climate affect here or a weather effect. And we will see increased transmission when we get into October or November. I hope we don’t, but I think that there’s a very good chance we might. And what we could be experiencing right now is just a just that the force of infection is so, so strong at the moment because there are still so many susceptible is that we’ve seen consistent transmission throughout the summer. But we could find that when we enter into the fall, especially the late fall, that it becomes increasingly difficult to keep transmission at bay.
And so what we’re seeing now might just be sort of a taste of what we might end up seeing later on. And so I think that, you know, unfortunately, we don’t necessarily know what’s going to happen. But I think despite that, we should be at least assuming that it’s going to get worse than that right now. And during the summer months is really our best shot at getting this virus to a point where we are in a much better position to enter into the fall. But unfortunately, we continue to not really do that in a lot of the country, although things happen slowly and moderately improving in places where they were really out of control a couple of months ago.
Q: OK, great. And so, no guess on like, will it be horribly severe or, you know, if you can put it on a scale of one to ten and then just a quick follow, because I want to get off here and et other people. You were the first one to put the 10x idea on my radar screen. As testing is ramped up considerably, is it no longer 10x acts like the real number of cases has it moved down to 8? That’s the other question. So how severe and 10x. Thank you.
MICHAEL MINA: So in terms of severity, I think we don’t know. But if we look at other coronaviruses, we do see that they usually increase dramatically in November and December. They’ll go from very, very few cases being reported at all to then being detected, to really high numbers. It’s possible that that type of seasonality is not as extreme as we as it looks in the literature, because a lot of that comes from passive evaluation of of reported data coming from different instruments. And in general, physicians aren’t usually testing people for coronavirus in the summer months, just because it’s not considered a time to really test people for these types of viruses. So we don’t really know for sure what’s going to happen. It could be, for example, there could be some biological reason. Maybe the transmission doesn’t change, but people become more susceptible to severe disease and symptomatic disease in that in the late winter or in the late fall. So we’re not quite sure what drives the seasonal patterns we’ve seen with coronavirus so far. But it does match what we know of other viruses where flu, for example, will come back in the fall, and usually a little bit earlier, but sometimes overlapping entirely with the kind of viruses. And so there’s been a lot of research over decades to try to understand the biological drivers seasonality. And in general, it’s still not really understood what’s really happening. And so I think that we should plan for the worst, which is if we assume that the worst matches the patterns that we do know exist. It means that the epidemic that spread usually kind of skyrockets, relatively speaking, in October, November, December. In terms of the the other question, when you said 10x were you referring to testing?
Q: Well, the multiple real cases to testing, there was this phantom 10x always in the background that anyway, because there’s more testing has that moved down to 5x or 8x or something?
MICHAEL MINA: Yeah, I think that these days I think there’s probably 10 times more cases than we’re necessarily catching. There are more tests, but they’re not being used necessarily in the most efficient ways. And so I think that in general, I’d be surprised if it wasn’t, you know, but if it was less than 5x, I think I wouldn’t be surprised if it’s more than 10x, frankly. We generally hear this whole pandemic have under estimated that number, I think. And we’re especially seeing it when we go into places like New York City and we’re seeing that some places have 50 percent store positivity. We vastly, vastly under tested. And so I think 10x is still a pretty reasonable number. But hopefully it’s going down.
Q: Thank you.
MODERATOR: Next question.
Q: Hi, so with the recent changes and CDC testing guidelines, I mean, people are just confused. So I was wondering if you’re not exhibiting symptoms, when is it truly appropriate to get a test? And then I have a follow up.
MICHAEL MINA: Well, it really depends on, if you’re not exhibiting symptoms, random surveillance of individuals is generally not particularly effective for a virus like this, unless you’re doing it very frequently in scale. And so I would say that I think that there’s three types of tests. The first type is diagnostic medicine, and that is what it is. It’s diagnosing people when they’re symptomatic when they’re with a physician, for example. There’s surveillance testing, which is really about trying to give public health agencies an idea of where where cases are happening. And it’s a way to get good public health agencies to know where to necessarily pool resources and poor resources and to increase contact tracing and things like that. So that’s diagnostics and surveillance. And the important thing with surveillance is it doesn’t necessarily need to be huge numbers of people because it’s not completely meant to stop all the transmission. It’s really meant to allow public health agencies to know where to sort of increase more testing, for example, maybe increase more diagnostic testing. But if you’re not doing really frequent testing of individuals at scale, then in some ways asymptomatic testing just of a random person in the population isn’t going to be very fruitful.
So I have a number of thoughts about the all the news that happened in the last day or two with the CDC. But just on this same line, I would say that if we really want to use asymptomatic testing to actually serve as a conduit to stop transmission and really get control of outbreaks, then the type of surveillance testing we’ve been doing anyway has been relatively not that useful. I think that our surveillance efforts of asymptomatic is probably gone and has probably been able to detect maybe three percent of all the cases in time to act on them. So our sensitivity using these PCR based approaches and laboratory based approaches of surveillance probably is catching maybe three or four percent of people in time to really make a difference in those transmission chains. And so then there’s the third type of testing which just needs to be on a whole different order of magnitude. And that’s what I’ve been talking a lot about in my writings and in the media and stuff. And that is we can’t have a million tests a day or two million tests a day isn’t going to get us where we need to be. It needs to be like 50 million tests. One hundred million tests a day can really start to make a major impact through asymptomatic testing of individuals, and that’s because they would be testing for it every day or every few days and they would detect themselves even at face and dramatic on the first day that they’re infectious, for example, and pull themselves out of contact with other people. And that would essentially create herd effect to drop the prevalence of the virus.
Just to finish on that thought. I don’t really condone that these types of rapid daily tests would be used for passports. I think that’s been a pretty big misconception that people are thinking that I would want these passports. I think instead that this is really a population level effort to look at asymptomatic and just the average Joe on the street every day so that if they get infected, they know it quickly. And ultimately, the whole goal is to stop transmission chains. And if you can stop one transmission chain from starting from a source, then maybe downstream you prevent hundreds of potential downstream cases. So that’s why it doesn’t even have to be perfect testing. You could you could only be testing half the people not using the test at all and still get herd effects. So I think, you know, the questions a really good one about what is the role of asymptomatic testing. And when I first heard the CDC is changing guidance, I gave the CDC the benefit of the doubt. And I don’t know the truth about what necessarily happened to lead them to change their guidance. I know that there’s been a number of reports that suggest it was pressure from above and if it was not scientifically guided changes, I find that appalling because it is appalling.
But there are reasons why we might choose not to continue it. Asymptomatic surveillance testing of random individuals, given the current constraints on our environment. I do think that we should continue doing asymptomatic testing of contacts, of known positives. As long as those known positives are, there’s good evidence that they might have transmitted to the person. Absolutely. We should be continuing asymptomatic testing of contacts for sure. There’s no reason not to. But asymptomatic testing out in the general population, for example, random surveillance of drive through is of healthy people. These are because we don’t have a huge amount of testing going on. It ends up becoming a pretty low efficiency way to try to contain the virus. And in general, I would say it’s really offering very little overall to contain the virus. But meanwhile, it’s creating a bulk of the testing that’s being done in the clinical laboratories, which is straining the supply chains of our clinical labs. It’s causing clinical laboratories to have to cut down on how much HIV testing or chlamydia testing they’re doing, things like this. So there’s actually Hologic and Roche are actually announcing that they have plastic shortages. The really basic supply chains are getting low and constrained. And so I think that there is a role to rethink what type of asymptomatic tests we’re doing. And I think we need to get it out of the clinical diagnostic world and probably really scale it up if we want it to be useful in a serious way. But scaling it up outside of the clinical diagnostic laboratories and moving to these kind of lateral flow at home kind of care type of tests or potentially other non-clinical big surveillance laboratories that are using a different supply chain.
Q: Thank you, and for a follow up. So I feel like with the HHS, what they seem to imply that people are just waking up and deciding to seek a test for no reason or because someone coughed on them on a grocery store. Right? So but at the same time, some universities are requiring students to have a negative test in some states are requiring a negative test from international travelers. So are those sort of requirements unnecessary with this logic?
MICHAEL MINA: I wouldn’t say they’re unnecessary. I think we have to look at where they fit in the large scheme of things. And so if a university is bringing back thousands of students, it’s an extremely risky endeavor. And so I think it makes sense to test every student as they arrive on campus. And probably if you want to keep outbreaks, because universities are not social distance locations in general, the only way to really keep most universities safe from from large outbreaks happening on their campus is to consider frequent testing as it means. And so I think that university is unlike the general public, they actually oftentimes have the bandwidth and the laboratory capacity to do the type of scale testing that I’m referring to. It’s not going to be 100 million because they’re a smaller community. But if they can cover 80 percent of their campus and get 80 percent tested every few days, and that is going to generally stop outbreaks from occurring or at least from spreading significantly. So I think that it’s different there in those cases because they are actually able to really scale it up if it’s just a one time test. Like, if they were to say, for example, that sometime during the first semester, we want every student to be tested once. It might be OK for as a surveillance effort. Maybe it gives some additional information to public health people on the campus to sort of what’s happening at any given day. They’re going like a cross-section of students every day, but it’s not going to be the tool that will stop the transmission from happening on campus. But it could be the tool that allows public health agencies to recognize that an outbreak is happening on campus and then the campus can kind of go into lockdown mode. So I think that there are avenues where it can be useful in smaller numbers because we have other important tools at our disposal besides just testing everyone that can block transmission chains. It just usually comes at great expense to the economy. But a school closing down classes isn’t going to necessarily bankrupt an economy, for example.
Q: Thank you.
MODERATOR: OK. Next question.
Q: Can you hear me?
MICHAEL MINA: Yeah.
Q: Thanks very much for doing this. I had a question on whether you had had a chance to look at whether a pulse oximeter can be a useful, not substitute, but proxy for asymptomatic carriers in the absence of a test is something which I saw in a report from Apache Nation, I think by The New York Times. It was used in that setting. Is that something you’ve come across?
MICHAEL MINA: I haven’t come across the wide scale use of a pulse ox for asymptomatic. So I think that if somebody is truly asymptomatic, they probably won’t have a real change in their pulse ox that’s meaningful. If somebody is mildly symptomatic, and that would be the symptoms, for example, that, you know, they’re having slightly more difficult time breathing. Maybe they would feel that if they walked a few blocks or something. So I think that can be an adjunct along with things like temperature rates. But I would imagine that it might not be. It takes quite a bit of destruction to the lungs, to actually reasonably reduce a pulse ox to the point where somebody might recognize that it’s really decreasing. But, you know, if somebody is at ninety nine or one hundred percent and then all of a sudden find themselves one day at 97 all day, that could be a sign to get tested for if they’re feeling no other symptoms. But it would be enough to see more data to really see how accurate it is for asymptomatic.
Q: And a quick follow up on a different topic altogether. Is there any sense among yourself and among your community that the sort of production of these agencies, such as the FDA and CDC has been compromised in any way, given recent developments? How do you feel towards that? And I mean, if there is to be an EUA for a vaccine later on this year, can that be trusted without delving the deeper into the data yourself?
MICHAEL MINA: It’s an extremely difficult question at the moment. I wish I had more clarity on exactly what led to the CDC’s changing guidance the other day and then the semi reversal of it. You know, like I mentioned just a moment ago, I think that there are valid reasons why the CDC may have potentially said, look, that asymptomatic testing we are doing just isn’t really doing enough to make it worth the supply chain effects that it’s having and the effects on clinical laboratories in America. But if, on the other hand, that guidance was changed as a result of pressure from above, I think that is one of the most worrying things that can potentially happen in this country in the midst of an epidemic. The last thing we possibly can stand at the moment is to politicize public health. And it’s already been politicized enough.
If decisions start being made that can harm public health and individual health because of political gain in some way, shape or form, I think that that type of compromise in our nation’s institutions can be devastating. And it goes further than our country. The FDA and the CDC, you know, I think still hold a very, very prominent role in the decisions made globally by many countries. Of course, there have been a lot of problems during this epidemic and I think a lot of countries have stopped looking as heavily towards the CDC and the FDA as the arbiters of what maybe is a good approach to tackle this virus. So I think their impact is a little bit less these days. But if they are compromised, I think it’s deadly. And frankly, we need these institutions to be making as well informed decisions as they possibly can and guidance as they possibly can in every decision that they make. These aren’t small decisions. They’re not small decisions in their implications. A small change in guidance at the level of the FDA or the CDC that maybe isn’t based on sound science and might not be the appropriate change, has ripple effects that could end up costing the lives of thousands and thousands of people. And so, you know, the moment we start taking it less than scientific and evidence based decision making process at these organizations and at these agencies, we really do run the risk of the ripple effects, and knowingly not killing tens of thousands of people. And so everything that needs to be done should be calculated based on science, not politics. If a vaccine comes about now, I personally have been a little bit skeptical about what will be the approval pathway for a vaccine.
I think there’s so much political pressure to get a vaccine to market, that I see very few avenues even before any of the phase two and three studies got underway that these vaccines wouldn’t come to market at some point this year in some limited fashion. There’s just so much political momentum to get them there that I think that there is going to be an unfortunate pressure campaign to to approve them. Now, I do hope that they follow the evidence and they’ve made some benchmarks or they said, you know, we’ll deal with 50 percent efficacy, but not less. What exact line they draw for efficacy, I think is, you know, there’s debates that can be had about what’s the best one. But safety is going to be first and foremost. And, you know, it’s unfortunately the case where a safety, it’s fairly easy if somebody dies during a vaccine trial, you can chalk it up to other events oftentimes because a lot of people who might die in a vaccine trial will have other underlying events. And so my hope is that if something like that happens and when you’re testing hundreds of thousands of people, deaths are gone. Deaths from natural causes will happen. But I just very, very much hope that we don’t see any skewing of the data and skewing of the safety signals as a result of pressure from above.
Q: Thank you.
MODERATOR: Next question.
Q: Hi, thanks for taking our questions. I’m just curious, as we think about the next pandemic, if there is anything that this administration or the next administration should be doing to make sure that rapid tests can be developed more quickly and we have the infrastructure in place, you know, when the next pathogen emerges, what are lessons learned?
MICHAEL MINA: Absolutely, yeah. We’ve devalued and defunded public health for so long that we had nothing in place to deal with this virus beforehand. Our nation’s public health laboratories ultimately were not up to the task of dealing with this in any way, shape or form. So I think there’s a few things that we need to do to to get prepared for the next inevitable pandemic, which, you know, people call this once in 100 year pandemic. But that’s not right. And, you know, it might have been right before plane travel. But with all the travel we have now, this is not to be a once in 100 year pandemic. This might become much, much more common. And so I think in the US what we can do are a few things. We can create public health laboratories. These are laboratories that – and they don’t even have to be a statewide public health labs. I think, on the contrary, we should actually have massive laboratories that are able to scale up testing very quickly. And by this, I mean we have bunkers of missiles. We have bunkers of nuclear bombs, of jets. You know, we have hangars full of jets that are rarely used in any meaningful way that cost billions of dollars. The least we can do as a country is spend the money and the time to build bunkers full of laboratory testing equipment and high throughput labs that maybe you have a few regional massive labs that are funded and maintained by the federal government when they’re not in use. They are – sure, they might cost a little bit of money just to have the machines sit there and every once in a while turn them on to keep the gears moving. But they, you know, what we’re seeing is the consequence of not having that type of readiness, despite all of the defenses we have created in the Defense Department to protect ourselves from foreign human enemies on the tune of trillions of dollars. We have not put even a close to a fraction of that type of money into into defending ourselves from something that is potentially much more disastrous to a country and our economy and lives which are pathogens. And so we know that we know what’s going to happen in the future, which is that we’re going to have more inspections and more pandemics.
So why not get prepared and actually have the federal government do something about it, create the bunkers that we need to house this laboratory equipment and run it and have one federal lab for every three states or something like that. That alone would have brought us, you know, if we could spin up labs like that when this epidemic started, we would not be in the position. We could have potentially detected cases before they got out of control in the US and maybe even stopped this epidemic in the U.S. from really happening in any serious way. The other thing is we can create surveillance networks. I think that we should absolutely be creating surveillance systems. And one idea that I’ve had that I published on a couple of months ago and I’ve been trying to trying to develop is an immunological observatory, a global – I would like to create a global system of surveillance networks that kind of like the weather system where there are buoys everywhere in the world that allow us to know what the weather is and pretty much any country in almost any town in the globe right now, you can go on to your your iPhone and type in a zip code or a country name and find out what the weather conditions are. I want to do that for pathogens. I think we should be investing in this kind of surveillance where we use people as our buoys and you have people who are readily donating or giving blood, either in hospitals or just as a donation of the finger prick. You know, maybe every once in a while people it in or you pay them too, or blood donors, for example. Plasma donors has lots of ways to get antibodies from people. And antibodies are like constantly recording whether buoys. They are our body’s way to monitor the environment around us and tell us what pathogens are there.
We know how to tap into these types of of biological information streams. And so what I would really like to do, which Nicole just put it in the chat there is create a global immunological observatory, starting with the United States since we’re here, but then creating this system so that everyone can at any time turn on their phone and say, what’s the flu situation like in my town today or tomorrow? Is my kid’s runny nose because of rhinovirus or because of coronavirus? And get predictions of these things at the population level. So these are some of the ideas that I think could be. We are a well resourced country and we could be putting these big programs that could really change the path of future pandemics into place now. And I just don’t think we’re going to continue, I think, underfunding public health and continue funding diagnostic medicine and insurance reimbursement type of of medical aid.
MODERATOR: Did you have a follow up question?
Q: I guess just quickly to clarify. You think that will be true under a Republican or Democratic administration?
MICHAEL MINA: I mean, I certainly don’t see it changing in any meaningful way in this administration. I haven’t seen any evidence for that thus far, I do hope that this isn’t based on administration, Republican or Democrat, based on party. I think everyone is dying because of this virus. It’s not caring if you’re Republican or Democrat. These are commonsense changes that, you know, the FDA should have pathways that are already in place to evaluate testing strategies and tests that have public health as a primary endpoint. This is just common sense that if we can’t get our country to focus on public health in the midst of a pandemic, I don’t know what we can do. We’re seeing the devastating effects of not putting the type of efforts and resources into public health right now in front of us, killing hundreds of thousands of Americans, crashing our economy, stopping kids from being at school, potentially having devastating impacts for a generation or two to come. And we’re still not talking as much as we should about public health. We’re talking about continuing to increase clinical medicine and individual diagnostic medicine, and not really taking a hard look at at the big picture changes that can be made. So I don’t really know what what will change our country’s ability to focus on public health.
Q: Thank you. That’s it for me.
MODERATOR: Next question.
Q: Hey, Michael, I had a question and a quick follow up. So when these tests, the rapid antigen tests are brought up to the locals, state officials, the response that we hear back is often not accurate. And that’s kind of going back to one level of this. What would be your response to somebody who says that?
MICHAEL MINA: Accuracy is based on what your target is. And if our target is PCR positivity at any time along the spectrum of somebody’s infection, then sure they won’t be accurate. But the important thing is the majority of time that somebody is PCR positive, they are not infectious. So knowing PCR positivity status is really only more useful than antigen testing. If you’re trying to diagnose somebody who is currently sick and that’s just that’s because a doctor is playing detective. They want all the pieces of evidence they can get to understand what might be causing the illness in their patient and understanding if they’re missing something. But from a public health perspective, which these tests are all about, at least the way that I’ve been discussing them, they’re not less accurate. I think in many ways they’re more accurate because for public health use, they tell you when your positives are, that they turn positive when you’re transmitting virus and not during the 70 percent of time that you’re PCR positive and not transmitting virus and don’t need to be quarantined. So from a public health perspective, in many ways, PCR has led to potentially millions of people being quarantined erroneously and because it stays positive for so long after infectivity. The specificity issue is now, I think rightly so. Taking on more of a discussion now, I think we’ve done a good job at getting certain individuals and institutions to understand why a sensitivity shouldn’t be the end all, be all or at least sensitivity against PCR specificity is going to be very important. And I think that with antigen tests, specificity usually does take a hit. And so that’s why one of the approaches that I would say we deal with nonspecific or we deal with specificity issues all the time in diagnostic laboratories. And there are simple solutions. I would say that one solution here would be that every time somebody has an antigen, a pack of tests that they purchase at the store, in that same package, it comes with five confirmatory tests that are targeting a different protein of the virus and maybe have slightly different chemistry. So you wouldn’t expect the fact that a false positive on one test would be false positive on the confirmatory cigaret quiet ball for those to turn positive. And that alone could get specificity to ninety nine point nine percent or so. Pretty readily. And so I think that specificity actually isn’t an issue either, as long as we’re willing to sort of open up our brains to think a little bit outside of the box and say maybe it’s not just one test, maybe it’s two tests, it’s not a big stretch. So I think to the short answer to the questions, I think that they are very accurate for the purposes of stopping transmission and serving as transmission indicators to to stop and lower the prevalence of the virus.
Q: Yeah, just one quick follow up, so at the very beginning of the call you talked about some of the new tests that are rolling out. So how close are we to the sword, the widespread surveillance that you’re saying is the goal here? I think you mentioned 50 million is a number, but how close are we to that actually happening?
MICHAEL MINA: Well, we see that Abbott just got approval for one of these tests, which is essentially exactly the type of tests that I’m referring to. They got approval for it for symptomatic individuals. But again, it’s almost ironic that that’s where it started because some individuals have other assets largely available to them quite often. And they might be people that you really do want the PCR type of sensitivity for because they’re symptomatic. You, again, want to be a detective if you’re a physician saying you want to get every shred of evidence, regardless of whether they’re transmitting or not. But the point is that Abbott out say now that it’s approved, it’s going to be the first one of these really paper strip type of tests. It’s more of a carpet envelope, but it will be out in the wild that we’ll be able to look at its use. We will be able to see doctors absolutely will go off label with it and start using it for doctors and other health care people. We’ll start using it for for asymptomatic individuals and presymptomatic individuals. I’m sure of that. What we do need to do, though, is we need to take very careful care to understand when that happens that people are not then comparing it to PCR positivity and asymptomatic individuals, because, again, people stay positive for much longer on PCR than they do on antigen tests.
So I think now that this Abbott assay will start to become available, it will continue. It’s the first of many assays like this that are going to become available to the public. And I think that if we can get maybe this will be now that it’s available, being produced in the near future, it might start to allow us to build up the evidence bank to go to the FDA and say, hey, look, we want an asymptomatic claim or we want an over the counter claim for these devices. Do I think we should have to be waiting for all of this? No, I think if the test is good enough for symptomatic use, then it should absolutely be automatically considered good enough for asymptomatic use for transmission indication. There’s no good, there’s no scientific reason, I would say, for it not to be automatically approved. That in some ways the symptomatic use should be the the highest bar to jump over. And so, unfortunately, the FDA sees it all differently and they make the highest bar, actually, the over-the-counter use, which does have some reasons, but I don’t necessarily agree with them.
MODERATOR: Next question.
Q: So Reuters is now working on a story about the CDC guidelines that were issued this week. We got in touch with several state departments and we found that 28 states are rejecting the CDC’s new guidelines and have chosen to stick with the existing methods for testing. Now, the question is, how unprecedented is this and what does it do and what the significance of this kind of rejection?
MICHAEL MINA: Well, I think in general, we’ve certainly had instances where individual states decide to do their own thing and go their own way. And in general, they actually go through the CDC and the FDA and they let them know that they are doing that and ultimately like what happened early on in this pandemic where the FDA actually gave states the approval to monitor and evaluate their own laboratory developed tests without going through the FDA. So there has been some precedents for states doing their own thing. But this is a little different for sure, as you say. This is states almost all aren’t rebelling against the new guidelines. And I think it’s another symptom of our fractured governance and the way that our government has been dealing with this pandemic has been very haphazard and it’s not been well coordinated. So in some way, it doesn’t even need to be fractured. It’s already fractured. And I think that it is an important step, it’s showing, unfortunately, that there is becoming a pretty rapid decay in the in the trust that people place in two of the nation’s leading and two of the globe’s leading public health entities, which are the FDA and CDC, or I should say health entities. And as we start to see a decay and trust in these agencies, I think it’s going to make everything more difficult. People will get more and more confused, and this is the opposite direction than we want to go. You know, regardless of how the CDC came to their decision the other day, too, whether it was from a pressure campaign or whether it was based on on actually thinking about limitations and supply chains and the clinical outs, I can’t say.
But what I can say is they didn’t give enough indication to the public and to our state’s public health agency as to let us know what their thinking is and when they’re not being transparent about big changes like this, it erodes trust and it’s going to make everything from here on out increasingly more difficult because the only way to deal with a pandemic that affects every state is to have coordination. And this is just going to really harm coordination. And it’s also, frankly, taking a shining leader out of the global spotlight. The FDA and the CDC have for many decades been held up as the gold standard in many ways. And the world’s agency is to look towards for advice and to know which products are safe, which products are useful, what approaches to public health are crucial, along with the WHO, of course. And so now the globe is going to slowly start losing two of these major entities. And more as a result of this type of lack of clarity and opaqueness from the federal level that’s causing our states to lose trust. It’s going to cost the globe to lose trust.
MODERATOR: Did you have a follow up question?
Q: No. Thank you so much for that.
MODERATOR: Next question.
Q: Hey, thanks for taking my question. I wanted to talk about, again, kind of, you know, this week we’ve seen both the testing guidance change and then the semi reversal from CDC alongside the FDA approval of the Abbott tests and the White House’s purchase of this test. So I’m wondering, how do you weigh the balance of these two kind of conflicting developments in terms of the US’s ability to detect and disrupt new transmissions?
MICHAEL MINA: The conflicting ones being the approval of the Abbott assay and the CDC guidance to not do asymptomatic testing?
Q: Correct, yes.
MICHAEL MINA: Well, I think that pretty much goes in line with the last comment I just made. You know, the CDC comes out with this guidance that says no asymptomatic testing and then the federal government turns around and buys up one hundred and fifty million of Abbott’s rapid tests and say we’re going to deploy them to schools. The only reason schools need that kind of testing is largely for asymptomatic testing. So I think it is confusing. Do they have a coordinated effort? Is there some centralized plan? I mean, the short answer is no. Of course there’s not. We have seen that there is no plan. I think it’s hard to reconcile the two. I think these types of rapid antigen tests that Abbott just came out with, on the one hand, they are FDA approved for symptomatic cases. But then you have the Trump administration buying them up and saying we’re going to be deploying them to all these places where they’re not necessarily going to be used for symptomatic cases. And so that alone is very confusing. Not withstanding the whole effort or the whole debacle at the CDC. So there has been you know, that’s a distinction between EUA approval process and how the how the Trump administration wants to use these tests where they’re not even able to look at, you know, what their own FDA is necessarily saying these are used for at the moment. So I think all of this is just demonstrating that there is no central command here. There is no plan. And, you know, it’s unfathomable that we would be eight months into this pandemic, six or seven months into it on our shores and not have a plan in place and not have really an approach that makes any sense. And I think that this week has been a disastrous week when it comes to communicating any semblance of a plan. And multiple angles have just been have been refuting each other. All coming from the federal level. And we’re seeing the impact of that. The last question I was just asked, which is, you know, we’re seeing like open, you know, we’re seeing states openly go against the regulations that our federal government are putting in place and the guidance that our federal government put in place. And that’s a scary place to be in the midst of a pandemic that’s killing hundreds and hundreds of thousands of people.
MODERATOR: Are you all set?
Q: Yes, thank you.
MODERATOR: Next question.
Q: Hi, thanks for taking my question. I am interested in the University of Arizona making an announcement this week that they were able to potentially stop a COVID outbreak using waste water testing, which is obviously not new. But I saw also a couple days ago that the CDC apparently has launched their own national wastewater surveillance system. I wonder if you know anything about that, if you think this is valuable testing that should be scaled up or not.
MICHAEL MINA: Yeah, I think it’s very valuable. It’s a it’s a really creative and new, true public health approach to this virus. I think it’s a terrific idea. We have seen, for example, early on we started to see cases increase, not early on, but in the last month or two cases started to slowly creep up in Massachusetts. And we saw evidence of that early on from the wastewater data that we were getting. So I think that it’s a terrific approach. I think people have to understand that it’s not the most scalable thing at the moment. You can do it at the level of a university. But then there have to be a lot of resources put in place to know how to act on it. For example, if you have these wastewater robots that are able to test in the wastewater at a pretty large scale, like for a whole neighborhood or even a town, going as the wastewater flows into sort of a central processing facility. It’s a little bit difficult to know exactly where the cases individually are. So you have to couple it to pretty rigorous public health contact tracing or not even contact tracing. It’s more just public health investigations to figure out where the cases are coming from. So it has to be partnered or tethered to pretty robust surveillance at the community level, using things like nasal swabs or saliva in order to really track down where the cases are originating. So I think that it’s a terrific approach. I am completely in support of the use of these. I think that it’s been for the average person. I think many people have misinterpreted this as like something you could put in your toilet or something. And that’s not exactly what it is. It’s really a public health tool. But, you know, maybe it’s for a virus like this. It’s not a crazy thought to create. You know, I was thinking the other day, could we come up with some crisper based compound that you actually do put in the base and above your toilet and then that the toilet turns red or something. Or maybe we don’t want red, blue if you’re positive or something like that. It could be an easy way to you know, I think that there’s really creative ways to think about how these things can be, how we can start testing and whole new ways. And this is a very creative and powerful public health tool that was used in Arizona.
Q: Awesome. Thank you.
MODERATOR: Next question.
Q: Hi. I’m wondering if, you know, I understand that immunology is kind of difficult to pass through quickly and succinctly. But you know, what outstanding questions do you have? As you know, some early vaccine trial results come in, what should we be looking for as the media in some of these results? And what are the critical questions that you’re looking to get answered in some of these studies?
MICHAEL MINA: So at this point, we’re largely into efficacy trials for some of these vaccines, meaning we’re trying to actually understand not just an immunological end point, but also a safety endpoint still, and also actual symptomatic end points. But there is a role for having endpoints of virus load and things like that to to know if these vaccines are going to inhibit transmission. Adam Finn and Rick Maly just had a really nice op ed, I thought it was a nice op ed, in The New York Times a few days ago, talking about the need to ensure that we are not just looking at immunological endpoints and endpoints out the level of symptomatic cases, which is often times what phase three trials will look at, but also to ensure that we are paying attention to whether or not the vaccines and development are going to block transmission, which from population level is going to be one of the absolute most important pieces of vaccination.
You can come up with a vaccine that stops symptomatic disease. But that might not stop transmission at the community level. And these are because you could potentially stop the virus from necessarily doing so much damage that it causes you to end up very sick. But it still my goal to replicate in the nasal pharynx and spread to other people. So there’s a number of end points. So just to summarize that, I think we should be focusing on clinical efficacy to stop symptomatic disease. Transmission blocking, whether or not these viruses stop the virus from growing to high titers in the nose and potentially spreading to others. And then the immunological endpoints, which are going to be very important to measure insofar as they will serve as secondary endpoints and in some cases, premier endpoints to understand what is the role of the vaccine to elicit good long term immunity. So we will be looking at things like T cells and B cell responses. Antibody responses, of course, are the easiest to measure, so they will be the first immunological endpoint that will be measured. But there will be subsets of individuals that will focus on T cells and focus on B cells. They’re just much more difficult to get up. You have to get vials of blood from people and spin those cells down. So I think that those three types of pieces are going to be crucial to keep aware of. The role, the efficacy will generally come out for the first efficacy studies will be all about symptomatic disease. But I would push anyone who’s really wanting to follow it to keep pushing on and ensuring that we know how well this is working necessarily to stop transmission, because that’s going to be very important. And then there’s gonna be a longitudinal studies where we follow people over a numerous potential, numerous vaccine boosters. And over time to find out, you know, we’ll have more results from these phase three trials ongoing now that the results will keep coming out next year and the year after, so that we can keep focusing on how well did people who got vaccinated continue to be protected from this virus for the future. So there is a number of angles that we have to remain focused on as we’re evaluating these.
The thing that we can’t lose track of, first and foremost, though, is safety. You know, for a lot of people, this virus is not killing them. And for a lot of people, it is killing them. Don’t misinterpret what I’m saying, but especially for young people, this virus is not killing a lot of young people at really high rates. And so we have to we will have very low tolerance for safety signals that pop up versus, for example, if this was an Ebola vaccine, you can have a lot more tolerance for it to go awry if you’re really of a high risk of getting Ebola because it’s so deadly. In this case as we start to give the vaccine to the general population who are not necessarily at risk for severe disease, we have to really keep a very close eye on what are the safety signals. Many of these vaccines are pretty new, completely new technology to inject into people. And so I feel pretty confident that they will be fairly safe. But we did see a lot of adverse, mild adverse events even within a couple of hundred people in the phase one two trials. And when you start to get fringe effects there, there might be more severe adverse effects that we just have to keep an eye on and make sure that we’re not putting people at greater risk than they would otherwise be.
MODERATOR: Did you have a follow up?
Q: I did just a brief follow up. I’m wondering what we can take away, I guess we being members of the media, on studies that talk about viral load, because I’m thinking of a study from last week that talked about the level of viral load in kids and that kind of got misinterpreted to be that kids because they had a high viral load, at least through nasal swabs when they were asymptomatic, that they might be super spreaders, even though the study didn’t talk about transmission at all. So what can we gather from information about viral load at different stages in positive cases?
Well, I think, since this epidemic started, it’s been kind of an interesting epidemic over the whole course of it, because people have generally believed that you can only believe what you’re seeing and you only see what you’re testing for in this case or really looking at. And so because kids were asymptomatic, the initial thought was that kids didn’t transmit. I’ve never believed that. We published paper back in April of preprint saying that, you know, of course, kids are probably transmitting just like they always do. This isn’t a super strange virus for kids or somehow not transmitting just because they’re not getting sick. So I think that probably kids are transmitting and their viral loads are now showing it. And the more the younger and younger age groups that we test with any rigor, we’re finding that the more we test, the more we find out that, hey, surprise, surprise that these children at the younger age groups are transmitting initially with Diamond Princess, we thought, well, you know, that the community thought, oh, it’s just older people. And then the age has continuously crept down. And I think when all is said and done, we’re going to realize that this virus is just like many, many other viruses that are often transmitted primarily through children. But the only reason that primarily transmitted through children is because by the time the adults become adults, they’ve already seen most of the viruses. And so they’re not you know, they’re already mostly immune. And so they’re not going to be super spreaders or, you know, major contributors to transmission, whereas kids still need to build up their immunity and so they’re still liable to transmit. That’s how viruses work. It’s been this long evolutionary dance between our immune system and and pathogens.
And so I think that the data that’s coming out that’s now showing that children have very high viral loads, I think that’s exactly what we would have anticipated. That children have high viral hits and are very similar to other people and they’ll probably transmit just as much, if not more, given there once they go back to school and start really socially interacting with other children as their baseline would, as they normally do a baseline.
MODERATOR: Next question.
Q: Hi. Thanks for doing this. Question on Texas and several other states, antigen tests are not included in the official case count. So Texas says we know we just do confirmed cases by PCR. Should states be including antigen positives in their official counts? Why aren’t they? And does that affect the the ability to understand the full scope of COVID cases by state and by nation?
MICHAEL MINA: Yeah, I think there’s no good reason to not use an antigen test in the case counts. That’s as far as I’m concerned, just a way to suppress your cases or your ID number, rather. So I don’t know why they wouldn’t unless there is a policy that they are reflecting every positive to PCR, for example. And then you don’t want to double count, of course. But short of that, I think, you know, these are tasks that even if you know that they are diagnostic tests that they’re approved by the FDA. There’s no reason why they shouldn’t be counted in the case counts. And I can’t really think of any good reason why they should.
Q: And then a quick follow up. Is that going to become more of an issue as we see more antigen tests being used?
MICHAEL MINA: It could be again, I don’t think that these new Abbott tests, they won’t be hooked up necessarily tethered, hardwired into any sort of system. There is piece of cardboard that can be uploaded into an app. But they should certainly be recorded and documented. And that’s the whole idea of keeping them in in the kind of view approval process that all of these antigen tests so far are really approved just for healthcare use and by trained personnel. So and part of that is to ensure that they are being documented. As we start to see tests go out into over-the-counter use, for example. And there is rapid antigen tests that I would really like to see get put out to the population. I think there will need to be some there will need to be some flexibility on how tests are reported. And I don’t think they should be mandated to be reported. But in return, what we get is a huge increase in the number of tests that we’re performing. And then public health agencies, for example, could either set up Web sites that people could volunteer their results or they could be, for example, public health surveys that are sent out over two weeks to the communities that are using these tests and say, you know, have you used these tests? Have you used them the last two weeks? How many were negative, how many were positive? And that’s a really good way to get data that otherwise is not tethered directly into the public health infrastructure to give public health agencies a really good, solid idea of what the surveillance efforts and really understand where to where cases are ongoing. So I think that there’s different ways that these will be used. But as long as these are being used by health care professionals with tests that have died, true diagnostic claims as these do. There’s no good reason to have them not fully documented, just like any other test.
MODERATOR: Next question.
Q: Hi. Thanks, Dr. Mina, for taking my question. My question is really more about we’re seeing a decline in demand for testing. There’s also low participation rate and contact tracing in Miami-Dade. And they seem like signs that maybe people are reaching COVID fatigue. And last night, the county mayor even issued a statement asking people to please not get complacent and continue testing and social distancing and masking. So I’m wondering, are you seeing signs of COVID fatigue or complacency, too? And if so, what do you think is causing it and what can be done about it?
MICHAEL MINA: Sure, it’s not even just fatigue. We have active, groups speaking out against paying attention to COVID and appropriately dealing with it. And so I think it really crosses the whole spectrum of things. And I do think that we will have COVID fatigue. It’s an extremely difficult thing to deal with. I think there is an immense amount of activity and energy that’s happening at all spectrums. Scientists are getting sick of it. You know, at the beginning, everyone wanted to work on COVID who normally studies anything else. And the public is getting tired of it. Everyone’s tired of it. Everyone wants their life to go back to normal. I think that there are some ways to improve this situation, and one is to decrease the barriers to testing. And having to go get a diagnostic test and drive through or buy a health care professional is a barrier to testing. If you can make it as simple as putting in your contact lenses, then that really reduces the barrier and a lot of it could potentially make tens of millions or hundreds of millions of people much more willing to do this on a daily basis. Then it’s something that they’re getting immediate results for. They’re getting their data back in real time. And we know that the quicker you can give results back to people, not only is it good for public health and decision making, but it also is a gratifying activity where you get immediate gratification that keeps people hooked into it. So I think this is completely expected. And I think the best way to deal with this is to try to make everything simpler, but still keep up the importance, keep it very well-known, known just how important it is to keep social distancing. Keep wearing masks and make masks. You know, just keep socializing them and normalizing them so that it’s not a toll on people to actually wear them. And you know that it’s just a thing that you do in the same way that these kind of rapid up on tests would just be a thing that you do on a routine basis. You know, in the privacy of your house before you eat dinner or even whatever it might be. But I think it just speaks to how much we have to stop using this like this big diagnostic infrastructure and all of the effort that goes into testing people, of course. People are not going to want to go and go to a drive through frequently and things like that. It’s just, it’s a headache.
Q: Thank you.
MODERATOR: Next question.
Q: Thank you so much. And I’ll be quick, but we just had a comment made by our governor today at a roundtable on the Fort Lauderdale Airport saying that air travel was not, in his words, a considerable vector. He said air travel was safe and it wasn’t a vector for a spreading coronavirus. This was in the context of encouraging tourists to travel down to Florida, to go to Disney World and things like that. You know, I know the CDC just came out with a study on this recently. I just kind of wanted to get your thoughts on what have we learned about air travel and and how much of a risk that is or spread?
MICHAEL MINA: Yeah. So I haven’t followed it closely. There were some reports early on and I admit that I’d put my focus on my biggest concern this whole time, though, it’s really been more on the airports and moving through, I think. It is possible to get pretty high airflow in an air exchange in planes. And so in the flight, it could very well be that that they don’t become huge victories on in the in the flight vessel itself. Although my colleague, Joe Allen, would be able to speak much more intelligently about that aspect. But my concern has really been in the airports funneling people through hallways and jetways and metal detectors and the whole process of airports or lines and squishing people together. And we know that this virus can be airborne and it can linger for a little bit. And so I think it’s a dangerous place to be. If I were, well, I personally make the decision not to travel. I haven’t flown anywhere. I used to fly once every week or two. And now I just haven’t flown since. Since February. So I do believe that they can be areas where transmission is as possible as anywhere else. Like a restaurant or something like that. But the flight itself, I think other people would have more expertise on just what the risk level is in the plane itself.
MODERATOR: Do you have a follow up?
Q: No, thank you so much, I really appreciate your time. Thanks a lot.
MICHAEL MINA: Absolutely.
MODERATOR: Dr. Mina, do you have any final thoughts before we go?
MICHAEL MINA: No, that was it.
This concludes the August 28 press conference.