You’re listening to a press conference from the Harvard T.H. Chan School of Public Health with Michael Mina, assistant professor of epidemiology. This call was recorded at 12 p.m. Eastern Time on Friday, October 30th.
MODERATOR: Do you have any opening comments you’d like to share with us?
MICHAEL MINA: No.
MODERATOR: OK, now I guess I’ll go straight to the questions. First question.
Q: Hi, Dr. Mina. Thank you for making time for us. I appreciate it. I am wondering about Thanksgiving in particular with regard to colleges and universities. It seems that there’s a potential issue here where colleges and universities that have students on campus are going to be releasing them to go home around the country. And I wonder if you have any thoughts on what the risk is of that whole sort of migration of students from campus to around the country. And what are the best practices for colleges and universities to minimize any potential risk?
MICHAEL MINA: Well, certainly there is quite a bit of risk, I would say, but it depends on where that risk lies, isn’t all the same. So to some universities, the risk is going to be more on the back end when individuals come back from Thanksgiving, for example, and. I might have to just change my Wi-Fi really quick. I’ll be right back. It’s giving me problems.
So I think the question is, when is that risk going to be greatest? Is it going to be the students coming back from campus and going home? Or is it going to be coming back to school from home? And certainly, at these massive sorts of rearrangements of people, are times when this virus can spread and can shift really dramatically. For example, I’ve been discussing with a number of institutions around the country and suggesting to them that they try to work with their governors. A lot of governors have now been allocated rapid tests from the Abbott, BinaxNow purchase of the federal government. And, you know, there could actually be, although they’re not being prioritized for colleges and universities, at least not that I know of in any real way, that is a potential place where we might want to utilize these, because when people come back to school, especially in states that maybe don’t have a ton of cases, that’s going to potentially be something that brings cases in into a state. I think that if a school has done a very good job at keeping cases low, then really the risk of going home is pretty minimal. But it doesn’t tell travel and just massive people movement and influx and efflux from locations. But it’s not just schools. I mean, our whole country tends to start moving around Thanksgiving and Christmas time. So I don’t think there is, unfortunately, a particularly good solution at the moment. The best solution is to ensure that your negative, when you go to travel, if you can test yourself shortly before actually traveling. I think that would be greatly beneficial. But many people won’t necessarily be able to do that, at least not with ease. Hopefully, institutions are trying to offer that to their students so that before the students go back home to their families, where there might be many different age categories, hopefully these institutions are trying to make sure they’re sending the students off in the safest way possible. From talking to them, most of the concern from the administration of these institutions is largely already on bringing them back into campus. And so it’s unclear to me how much effort is really going to ensuring that when they leave the campus that they are COVID-free. Certainly, the institutions that are doing very frequent testing right now generally don’t have a lot of cases. The higher ed at academic institutions, at least in the Northeast, have actually done a pretty tremendous job at keeping cases low. So those students moving back home for the holidays might actually pose relatively little risk compared to the community risk that’s already surrounding their families.
MODERATOR: Do you have a follow up?
Q: You think, Dr. Mina, that it would be wise for schools to have a policy that you must be tested before you go home? And if you’re positive that you must quarantine before you go home or isolate before you go home?
MICHAEL MINA: I think it would in the same way that many institutions have not necessarily encouraged and hopefully have discouraged students from if they become positive, and the school is offering them to be isolated on campus, I know many students have chosen, given that its 10 day period, to just go home instead. But from what I know is that many institutions that I’ve spoken to have largely discouraged this primarily for the sake of the family. And I do think that if a school has the means, they should absolutely try to offer testing to students as close as possible to the time that they’re leaving campus, ideally within a couple of days. And they can use the infrastructure that they’ve already built up around testing to make that happen. So I think it would be a good piece of advice and something that probably they should be considering doing.
Q: Thank you.
MODERATOR: Great. Next question.
Q: Thank you, Doctor. I guess just stepping back and looking at these pretty alarming numbers in this vertical looking trend line with cases a lot of people think about, do we go back to a lockdown or do we keep things open? It’s a pretty black and white kind of question. What steps can states take that maybe would be effective, even if it’s not what we saw in the spring in terms of a lockdown?
MICHAEL MINA: Well, we’re running out of options. That’s for sure. If the goal is to safely reopen things and without cases skyrocketing, we have truly painted ourselves into a corner at this point. We don’t have many options. We had a lot of options in the summer. We had a lot of options leading up to this. But now we’re in the throes of it. We’re in the thick of a third spike, or second spike depending on where you are. And I think that the options now are short of closing everything down, and I’m not a particular fan of that, I think that we do have other options besides serious shutdown, but we need to immediately be doing something different. And the things that we can do different are, if you’re a state that is not advocating for a wide use of masks and attempting to social distance as much as possible, then you should start doing that immediately. And if you’re not doing that, then you’re just asking for trouble. Essentially, at any state that is not completely advocating for abrogating the virus as much as possible, is really pushing themselves up against a wall where they’re going to be forced, whether they know it or not, and whether they want to or not, they’re going to be forced to shut down. And it’s going to get out of their decision-making hands once their hospitals start to overflow. They won’t have options. So I think for any state that’s not already pushing rules, you know, whether they’re laws or they’re just some sort of advice to communities, but to get everyone on board with continued to social distance and really limiting the numbers of events, you know, we continue to see rallies and things along those lines that have thousands of people, despite being in the midst of exponential increases in this virus. Why that is persisting is just completely beyond anything I can understand. And so we need to limit gatherings. Marc Lipsitch recently, I forget where he was quoted, but he brought up a very good point. And that’s that for every case, risk of transmission increases exponentially with the number of people that are gathering.
It’s not a linear increase, and that’s because with more people, you have more risk of somebody actually being infected. And with more people, you have a greater number of people who might end up being exposed if somebody actually does show up there. So it doesn’t increase linearly the increase exponentially. That’s one of the best things we can do. And then finally, I think I’ve harped on it for months now, and the manufacturing and deployment of simple rapid paper strip type tests can serve to step in and actually stop transmission. It can serve as something that is as effective, if not potentially more effective than a vaccine when it comes to controlling this virus. And so at this point, you know, I don’t know how the election is going to go. Certainly, if the election goes towards Trump and nothing changes in the decision making at the White House, I think we’re left with almost no choice except that state’s governors have to take the reins and start building up manufacturing capacity in a way that the federal government just isn’t doing. As a country, despite all the radix and things along those lines, we’ve put actually extraordinarily minimal numbers of dollars into to testing, despite it being one of the most important things to stop spread. And so I think eventually states are just going to have to take it upon themselves to start producing these tests, which can be produced relatively simply. We just continue waiting for startups to build them. And that continues boggling my mind as well. This is something that state’s governors and can kind of push their manufacturing in their states to actually produce and even make money out of it if they want. I would recommend instead that everything be given out for free. And I think that’s something that states should also be doing right now. There shouldn’t be a single person in this country who pays for a test. That should just be a no brainer. We don’t need to be charging three hundred dollars for tests. All of these tests, every company can potentially charge twenty-five to fifty dollars, if not ten dollars for a test. And not a single American should be paying for a test right now. And so those are some of the pieces that I really worry, though, that we’re painting ourselves into a position where we have no just no options except to shut down.
Q: Thank you.
MODERATOR: OK, great. And I’m going to put the quote that you were talking about, Dr. Mina, that was from Web M.D. I’ll put that into the chat in a second and send it to everybody. Next question.
Q: Hi. Thank you for taking the time. So, I just want to ask, the last-minute overview of the pandemic for before the election. And basically, you know, this is maybe a very general question, but sort of for something a layperson can understand, could you explain why the pandemic is specifically worsening now, whether this is earlier than expected for a so-called winter wave that some have been expecting? And if there’s any sense for exactly how bad it could get in the next few months.
MICHAEL MINA: Well, I think that it’s increasing now because of the same seasonal forces that are normally at play in this case. Like I’ve said in the past, the summer months where we continued to see transmission during the summer, not because this isn’t a seasonal virus, but because the force of infection is so high, because there’s so many susceptible people that it was able to overcome the seasonality barriers that would normally have it very limited in the summer. And so what we’re seeing is as it becomes even just slightly cold, more and more people go inside in much of the country as the humidity starts to decrease slightly and we start to see that the transmissibility of this virus probably is starting to go up. And there’s some nice data that shows things like lower absolute humidity, lowers the amount of viral clearance that people have in their trachea, for example. And so I think what we’re seeing is a confluence of biological factors, as well as social and behavioral factors that are normally driving seasonal dynamics for viruses like this. This is acting as intended. It is a little bit early, which I think, again, is a reflection of just how high the force of infection, or the momentum that this virus has. You could think of it as if you have a small stream and you built a dam and you start to start to poke holes in it. If it’s not particularly high flowing down, it might take quite a few holes before it really just kind of breaks through that wall. In this case, we have a massive river that’s just been pushing on this wall and one small crack is just allowing it to sort of blow through that wall and really accelerate its path. That’s what this virus is doing right now. We’re seeing it a little bit earlier, but that’s because it’s particularly sensitive at the moment to just any initiative it can take, any avenue it can take. It will take advantage of that. In this case, it might just be small changes in people’s behavior. Schools going back into session, call it, you know, all of this essentially, people are aggregating more. Sunday will be November 1st, so we’re actually not that early compared to the seasonality of these viruses.
And we could end up seeing this thing continue to skyrocket for the next two months. I honestly wouldn’t be surprised if we start to detect two hundred thousand cases a day, a month from now. This is just going up and up and up. And it is accelerating. And so and I don’t think that’s going to be just because of increased testing. You know, we’re increasing our testing capacity a single digit percentage points if this thing is increasing much, much faster or not. So unfortunately, I think we are certainly in for a long winter. I think in much of the country, there still has not been too much behavioral change despite the skyrocketing cases. And we might end up finding ourselves at truly extraordinary numbers.
MODERATOR: Do you have a follow up?
Q: Yes. So I guess could you speak a little more, you know, there are seasonal factors just with the biology of the virus. But you’ve also been mentioning behavioral factors, and I’m sure policy factors are related to that as well. So I guess, to what degree is the timing and severity of this spike inevitable versus something we’ve brought on ourselves by not getting it under control earlier?
MICHAEL MINA: Yeah, well, I think it is back in the middle of the summer, I was saying or even the spring, I think I was saying we had to start think about the fall. And we had the best opportunity we had to control this virus and get cases down to low numbers was in the summer. It was in June, July, August, when cases are generally at their minimum for a virus like this. And from everything we know of this virus that kind of matched, but we didn’t take advantage of it. And so what happened was I used this analogy many times, but I think of this virus and what we’re seeing right now, this is actually something I think I was talking about in April, that come fall, what we’re seeing is you could think of this country as a forest and a lot of dry leaves are sitting on the ground. And you can either have a few sparks started on fire and you can hopefully contain each of those fires as it as they come about. Or you can have tens of thousands or hundreds of thousands of sparks that all light simultaneously on that forest floor. And there’s very, very little avenue to really contain it besides, you know, extraordinarily serious shutdowns, things like that.
And so I think we could have gone into this fall in a much better position, had we actually paid attention, particularly in the center of the United States and the South, where cases continue to spread. You know, generally, unabated throughout the summer, those were states that generally weren’t taking this virus seriously. And had we, as a country, been able to control it, and then come into the fall, not with 40 or 50 or 60 thousand new cases every day that were being detected, but 6 thousand new cases, that would have put us in an extraordinarily different position and could have bought us the entirety of the fall and maybe into December before we really started seeing spikes get out of control. And by that point, we would have had other options to really control it. And, you know, I think either way, we would have seen increases right around now. But the magnitude of that, we wouldn’t have been starting with sixty thousand cases and going up from there. We would you know, if we could have had this 10-fold lower or 100-fold lower, that would have been ideal. And we’ve seen other countries do this. We’ve seen a number of countries keep cases at extraordinarily low numbers, primarily through acting and just maintaining action to keep cases low. They are now enjoying the fruits of that labor where they can go into the fall with very, very few cases.
MODERATOR: Are you all set?
Q: Yes. Great. Thank you so much.
MODERATOR: Next question.
Q: Hi, Dr. Mina. Good to be speaking with you again. In the next couple weeks, probably before the end of the year, we’re expecting to see the FDA issuing a EUA the first fully home self-test for COVID-19. Obviously, we don’t know exactly who’s going to get there first or, you know, which company. But I think you’re familiar with the technology that’s out there right now. I wonder if I can get you to just preview for a story, what are those initial home-based consumer tests going to look like? And how far or not far will they get us towards really ramping up the type of mass screening that you’ve been advocating?
MICHAEL MINA: Well, the first ones to come out probably won’t be massively produced. They might be. But I mean, it could be a Roche test or something like that that really does have major capacity. Of course, we’ve seen, for example, of BinaxNow, that’s been authorized as well. And these are being produced at around a maximum of a million a day. And that’s not anywhere really what we need for the type of mass screening. So given that type of production, it’s just that if it’s a hundred thousand plus a day, we just apply that out to random people’s homes. It’s going to do almost nothing. So I think what needs to be done is when these tests first become available, we need to identify places that are being hit the hardest and try to understand can these types of tests really be used to stop spread? So some of that, maybe it’s picking some school systems, maybe it’s picking some nursing homes. But before any of that happens, unfortunately, what I have not seen so far is any real effort on the CDC’s part or the FDA’s part to provide serious guidance about how best to use these. I haven’t seen any real effort from the federal government to determine how best to deploy them. If what happens with the BinaxNOW happens with any future tests, then the government just purchases them. You know, it’s not necessarily a bad thing. The government could then help allocate them in the most appropriate fashion, actually do something useful with them versus just having them become diluted out into the population and not useful.
I think that these tests hold immense power and you can scale them to incredible numbers, even not just their production, but through very strategic use. You can actually get them to stop spread across massive swaths of the population with only a fraction of the tests that you’d expect that you’d need. And so I worry that we are going to have a haphazard rollout of them, that they’re just going to either come to market and we’ll have random folks buy them. Maybe it will be a few businesses will buy them. But I think the important thing is some of the best uses of these is through serial testing of individuals to stop them from spreading to others and to actually develop public health strategies around them. And until that happens, I don’t have a lot of confidence that the first ones that come out are really going to make much of a dent at all.
Q: Great, thanks. Just one follow up. How important is it that they be FDA labeled or indicated for asymptomatic screening? And is FDA comfortable with that? You know, that these antigen tests can be used for asymptomatics? Are they onboard with that now?
MICHAEL MINA: I think that they are warming up to the idea. I do think that they are, unfortunately, missing the biology of how these tests work. And it’s led to massive amounts of confusion, and it’s based on sort of the regulatory landscape of how the FDA does its work. If the FDA is not in a position to give claims that aren’t requested and if somebody is requesting a claim, they usually demand the data. So these companies, in order to show sensitivity metrics that match what the FDA requires, they have to find people early in their infection. The easiest way to find people early in their infection is to focus on symptomatic people. And that’s because you actually have a symptom to go on and you can say, oh, have you been symptomatic for less than seven days? And if so, then they’ll use one of these tests and say, OK, this is actually concordant. But if you have somebody who is just off the street who turns out to be PCR positive, they’re very likely to actually be negative on an antigen test because they might have already cleared the virus and just have some lingering RNA. So that means that it’s very difficult for the companies to recruit enough people into an EUA authorization sort of study to put their data together, to actually give it a claim of asymptomatic. Now, what I’ve said to the FDA in the past is biologically, there should be no difference if we’re not using these for clinical diagnostics, but we’re using these to identify people at the greatest risk of transmitting the virus to others. Then all that matters is that you can detect the virus in the nose, regardless of symptoms. It says in a clinical test this is a public health screening test. And so given that, it really shouldn’t matter if somebody is symptomatic or asymptomatic, the metrics of the test will be the same. If you have a virus and regardless of symptoms, it will detect it. If you don’t a virus, regardless of symptoms, it won’t detect it. There are some nuances there when it comes to specificity, but that can be dealt with. The real holdup here is that the FDA has failed continuously to create a new pathway for approval of these devices. The FDA only has a pathway for clinical medical testing devices. So they’re having to make decisions around clinical diagnostic medicine, but that means that they’re authorizing these tests with that in mind, despite knowing that these are planning to be used as public health tools, the system is too archaic to create a new authorization pathway.
Now, I look at the FDA and I say they’re an organization that approves drugs. They approved prosthetic limbs. They approve tests. There is no reason why the FDA can’t make a new pathway that approves tests in light of public health. But it’s not their charge, apparently. And they have been unable to do it. And so what that means is they will continue just authorizing these for symptomatic use case because it’s too difficult to necessarily find the asymptomatics. Now, they are really lowering the bar and saying, OK, we only need 10 asymptomatic people and we need to show sensitivity there. But that still means you have to find 10 asymptomatic people who are early in their infection when they’re actually likely to be transmitting. And so I think that there’s a lot of different choices that the FDA could be making to facilitate the authorization of these and in particular. If they would create a public health authorization pathway, it would allow them to more readily sort of be labeling these for symptomatic or asymptomatic public health screening, for example. And importantly, it would not necessarily start to erode the metrics that are trying to be achieved for a true clinical diagnostic medicine. One of my real concerns is that because we need these tests for public health use, because we only have one lens or pathway to approval, we are going to start approving these. We’re lowering the bar for authorized tests for medical purposes just so that we can squeeze public health tests through a medical lens. And that’s a real problem. And so that’s why we’ve seen so many clinical pathologists and laboratory directors, rightly so, fight back against some of these and say these aren’t appropriate because largely they might not be the most appropriate for a medical diagnostic test. But absolutely, they’re appropriate for a public health test. And the FDA, for some reason that I just can’t really grasp, has been unwilling to separate the two. And instead, they say public health tests are not our purview. So if you’re trying to get a public health test, we don’t even want to evaluate it. But then at the same time, they define these particular types of rapid tests as medical diagnostic tools because they give results back to the individual. So it’s this weird catch 22. And frankly, the last thing we want is for the FDA to not regulate these. That could become disastrous. Kind of like what we saw with the antibody tests.
Q: Thank you, really helpful.
MODERATOR: OK. Next question.
Q: Hi. Thank you very much. It’s good to talk to you. I’m not sure if you had a chance to look at the weekly report here in Massachusetts. It had some new information from the state’s contact tracing, which was interesting. In particular, it really highlighted that the bulk of the clusters were coming from household transmission, wasn’t from social events or schools or anything like that, usually household transmission. I mean by the factor of thousands, and it leaves the question open about where somebody got the virus and brought it into that household where the community transmission is. And I’m just wondering if you could address that at all in terms of if you had any thoughts about the new information from the state and really what that household transmission tells us.
MICHAEL MINA: Well, I think that’s always the number one place to look if you’re trying to see if people have transmitted, the built in contacts, if you will, are the household numbers. And so this makes perfect sense. And it would be astounding if, for example, we had a lot of community transmission and that didn’t transmit in the household because people go home and the one place, they definitely don’t wear the masks is inside the house. So this is not surprising in the least. I think what it shows is that we need to stop the virus from getting to that household. We need to stop the virus from any community transmission. Can it quickly splinter out? You can have one node. And even if it’s just going to three people in the community that can very quickly spread to nine or fifteen people in the various households that they go back to. And so, I mean, that would be pretty high. But it can happen because people in households are close together. And so I think what we really need to do is figure out where are the notes that are most likely to transmit in the community and stop this from happening. It is extraordinarily difficult, though, to do that. Now, Massachusetts, I think, in general has done a pretty good job at social distancing and mask wearing and things like that since the start of this pandemic. There has been a pretty diligent effort towards it. Of course, we’ve seen even in Massachusetts that people are getting tired. People are going back to work. People are going back to school. And so community transmission is increasing again. And that will cause exponential increase through the households. Then each household, those aren’t unlinked. You spread it within a household and then somebody in that household goes to a community in the next few days. And so these are highly linked. It just happens to be that the place where you might have one, you know, individual cases spreading out of the households are coming back in. But it’s always within the households that you have the potential for quite a bit more spread. So just mathematically, it works out. Not every transmission, for example, is super spread around the community, but every transmission event in the community that gets brought back in the household has potential to spread to maybe everyone in the house or half the household. So I think I don’t have a good answer for how to necessarily stop it in the community. We haven’t quite pinned down what are the most likely places. And that’s a problem because there is no pinning that number down. And it will flux as we keep different types of establishments closed versus open. Different businesses will have different practices. It’s really going to be around how people are behaving socially in these different contexts. And we have to focus maybe more on thinking about how to adjust people’s behavior even if they are at work, rather than just thinking about, is it this kind of workplace or that kind of workplace?
Q: Thank you.
MODERATOR: Next question.
Q: Hi, Dr. Mina. So the federal government has left so much of responding to the pandemic to states. And here in Ohio, Governor DeWine yesterday has kind of doubled down on the strategy of building community up responses and leaving a lot of policy decisions to counties and to individual communities. We have 113 health districts here and kind of letting them each take a charge. So who should be responding here in your eyes? You know, the state or the federal government? And what do you make of this patchwork approach?
MICHAEL MINA: I happen to be in Ohio at the moment in a small town called Archbold visiting my fiancé’s family, and it’s been interesting to see the epidemic as it has progressed in places like this farmland and sort of these much more rural areas. I think what we’re seeing is that this patchwork approach cannot work. People are really struggling in this country to recognize that an epidemic is entirely different than more or less anything we’ve really had to deal with. In any other situation, people are able to say, you know, we’ll deal with recycling at the county level. We’ll deal with whatever it might be on a county level. And that works usually because, you know, it’s just for the most part, it’s usually if you’re doing this just with your ten thousand constituents or whatever might be, then that’s great that those ten thousand constituents are enjoying the benefits of it or are reaping the consequences, whatever it might be. A virus, on the other hand, just doesn’t care. It really, really doesn’t care about borders. And I think that what we’re seeing is not having a concerted effort, not just within Ohio and the different districts, but within the United States as a whole, control cannot work if it’s asynchronous, period. We’ve seen that in the most devastating way at the national level so far, where the Northeast did a really credible job in getting cases very, very low. However, in many parts of the country, cases did not get low and stay low during summertime. And so they continue to see new cases across the country and continue spread. And so now what we end up seeing is that we never really had a chance in New England to drive cases towards zero and really get this under control long term, because to really get it towards zero takes an enormous amount of effort. And you can do that for a little while, but then eventually you do have to open up like we did in New England. But if everyone didn’t do that at the same time, then there’s still going to be a flood of cases that are going to hit you as a result. And we’re seeing the same thing in individual counties and districts in Ohio, for example, where just the other day, I was speaking with a family member who works at a shop in cases where I am at the moment have been fairly low. But she is extremely concerned because that shop gets people that come in from some of the bigger towns around here. And so as long as we’re doing this in a haphazard individual district by district way, I can all but promise that it will not work.
MODERATOR: Did you have a follow up?
Q: OK, for one, hello and welcome to Ohio. And two, so I appreciate you’re saying that it sounds like the county to county approach will not work. What’s the answer? Does the federal government need to step up or is it states that really need to take the lead?
MODERATOR: I really believe that the federal government has to step up. This is again, in the U.S. we enjoy an amazing advantage versus other countries that we have two big oceans on the side of us. And that gives us some level of isolation. But within our borders, we are a single country. And there is a lot of movement across borders. This virus doesn’t try to travel on its own and it travels through hitchhiking on humans, and humans move. That’s just a fact. And so it just needs to be a coordinated national response. I think anything short of that, like I said, is just not going to cut it. There’s more or less no way to have a lot of cases happening right here and have this place really get cases low and work hard at doing it and then start to open back up because they have gotten their cases low enough without these cases coming over and causing this area to have to close down again. And so I don’t think it’s in my hands. So it needs to be a national coordinated response and it needs to frankly, you know, I don’t want to make this political, but we absolutely need a president who is going to rally everyone together to stop transmission. And thus far, we have not had it. And there is just no way to stop this virus from continuing its march towards infecting more or less everyone unless we control it. And, you know, we just don’t have a good way to keep. Sixty-five, seventy-five, eighty-five-year-old, ninety-five-year old’s safe. There is a lot of people in this country who are in those age categories and they’re all at very, very high risk.
Q: Thank you, Doctor.
MODERATOR: Next question.
Q: Hi, thanks for your time. Another question related to testing. One of the main takeaways from this research letter Nicole flagged in the call earlier, the one circulated by JAMA today from some of your colleagues was that the vast, vast minority of nursing home staff and residents who were tested get results back within 24 hours, which is pretty critical to outbreak control. I know you weren’t an author on this study, and the report was just published. But I wondered if you had any thoughts on this, either about the study, if you are familiar with its findings or just the overall idea of having a more coordinated rapid testing strategy when we’re talking about infection control for residents and staff of nursing homes and Long-Term Care Facilities, given they’ve been hit so hard by this?
MICHAEL MINA: Yes. So I’ve done a lot with nursing homes over a number of months and we have a paper that’s coming out that we’ll be submitting very soon, looking at this particular question specifically for nursing facilities. You’re absolutely right. And in fact, many places, many, many nursing homes in this country are getting results back three or four days later, still with PCR tests. It is horrendous. It’s unconscionable how bad it has been. One of the best things that we could possibly do is frequent testing in all nursing homes. And that is because nursing homes need people to work in them. And those people can potentially bring the virus in, especially today when we have massive cases. There will be asymptomatic people who will be very likely to bring the virus into the nursing home. And having even having a 24-hour turnaround time is not good enough. Because if you’re a staff member and you go and you want to walk into the nursing home, you might get a swab today and spend your whole day with some of the residents and then find out tomorrow or in two days that you’re positive. That’s, of course, terrible, because night potentially infected them at the peak of your infection. Or you take a test yesterday so that you can enter today, and you never know. You could have you could have been negative yesterday and have turned positive today. So that, of course, if it’s everyone gets a test, maybe 24 or 48 hours before walking into work and it takes that long, you know, it’s better than nothing. But what the best approach is, to get people tests as they’re entering. And I’m trying to develop the language surrounding this type of testing. And I want to start using different words for these two types of screening tests.
We have entry screening, which is for things like this, where to enter into a building for work or other reasons, you have a screening method, that’s entry screening, and then you have public health screening, which is a lot of the massive deployment of tests to the whole population to mitigate outbreaks. For nursing homes, we’re really talking about entry screening. We need decent tests. We need a very fast turnaround time. And we also need very fast confirmatory testing. But that can be a little bit slower than out in the overall population because it will be in a controlled setting, and ideally, you’re not getting a lot of staff that are positive at any given time. And we have these tests. They could be available today and they could serve to greatly reduce the number of cases. Some of what our research is also showing is that we should be really thinking not about how we’re cohering the patients, although we have to keep doing that, but also cohering the staff based on who’s been infected already and who’s not been infected, for example. And we want to start really getting people to think both about the immunity of this virus and also frequent testing to work closely together to create sort of a forcefield around nursing homes. But at the moment, we are failing still at this point in time to really benefit the nursing homes and keep them protected. And in large part because we have failed to progress with getting testing out of the clinical realm and into the public health and entry screening realm, which demands much faster turnaround time, even if it is at the expense of some small levels at the limit of detection of the virus, the sensitivity is a bit worse. That is fine. If what you’re getting in return is frequent testing, every single time somebody wants to walk into a nursing home, maybe it’s twice a day for some people, for the staff, for example, we can do this. We just have to scale these up.
MODERATOR: Do you have a follow up?
Q: I do not. That was really helpful. Thank you.
MODERATOR: Great. Next question.
Q: Hi, thanks for taking the question, Dr. Mina. I’m sure you’re aware of the fact that the FDA has decided it will not do EUA reviews of lab developed tests stemming from the executive order regarding the authority to regulate such things. I’m sure you’re also aware of the fact that any test that is not processed through the EUA program enjoys no product liability immunity via the PREP act? I don’t know whether you talk to anybody in the laboratory community for want of a better term, but do you have any sense as to whether labs that have tests available that did not get through in time, whether they’re still practicing those tests? Or, you know, is there sort of a mass shift away from practicing non-EUA tests because of the liability question?
MICHAEL MINA: Yeah, I think it’s becoming an increasing issue. Not so much for the labs that already existed. Most of them already had their EUAs or had the applications in. But it’s hugely damaging to our ability to continue scaling up laboratory testing. And I think that for better or worse, the EUA has become the stamp of approval. I don’t know if it should necessarily be, it’s not exactly a high bar. But the EUA has become a stamp of approval that anyone who is going to partner with a laboratory to do their testing, wants to see that. And so that automatically removes market share for any new lab trying to enter into the market and provide new tests. At the same time, like you said, the PREP act is not covering individual laboratories that do not have an EUA. It is contingent on that. And this, I think, needs to change maybe more than the EUA status. EUA is a new thing. It’s not a common thing for laboratories to have to get an EUA for the testing that they do in their own domain, in their own walls. As a laboratory director, I want to create a new lab test, I don’t normally have to go to the FDA to get approval. In this public health emergency, they made that a thing. But, you know, so they can potentially separate these two. They can say you still get PREP act coverage without having an EUA. And that would be hugely beneficial because a lot of laboratory directors that we’re going to get set up maybe won’t at this point. Maybe the country felt like we were already saturated with laboratory tests and we don’t need them. And in some ways, you know, that argument could be made in the fact that we could just shuffle around. We have a lot of open capacity in this country still for lab tests. But I think it’s extraordinarily important that we continue to get the lab testing out of the clinical laboratories and into sort of more specialized high throughput CLIA laboratories that are not also in charge of running all the other tests that they do for a hospital.
Q: You sort of raised an interesting point there, though, because a lab that is practicing a test with a CLIA certificate presumably has some sort of regulatory oversight. So, you know, if you removed the question of FDA’s capacity to review additional EUAs, and that was the pretext that they offered. You know, they didn’t come out and say we just don’t have the capacity. But Tim Stenzel did say on the town hall, the day that that was announced, that they’re struggling to keep up with the volume of EUA applications they’ve got. I don’t want to drag you into this whole CLIA versus FDA review discussion because it’s flying first central. But, is there any reasons that CLIA certification for a lab, generally speaking, is insufficient to grant that test some sort of coverage under the PREP act? Or is that one of those things that would require Congress to attach to the PREP act in order to provide it? I know that is a long question.
MICHAEL MINA: Yeah, no, there is no reason that that can’t be changed and provide legal protections to a CLIA laboratory certified through CMS as a CLIA laboratory that is performing an assay that is not CLIA approved or authorized, that can be done. And I’ve actually been talking with Brett Giroir to try to get him to change this. He does have, to a large extent, power to place the PREP act coverage where it needs to be. And so I’ve been texting and talking with him in various ways to try to get clarity on this. And he’s been fairly responsive to at least try to approach the subject. But, you know, it’s been a few weeks now, and I checked in with him every once in a while, and it continues to be with general counsel. And so it’s unclear why it’s taking a long time. For example, he did very quickly change PREP act coverage for off label use of point of care testing in companies for, it’s off label. It’s not for symptomatic use, for example. And they provided PREP act coverage for that. So it is a flexible coverage type that can be provided.
Q: So that can be done administratively, there’s no need to tweak the statute, correct?
MICHAEL MINA: Absolutely. It could definitely be done administratively.
Q: Thank you very much. I appreciate it.
MODERATOR: Next question.
Q: Yes, hi. Thank you very much. I just wanted to get your perspective on some of the trends in Maine. I can kind of kind of give you the low down here, there’s some interesting things happening. One is that our testing capacity, PCR testing capacity, just over the past week has really increased. We’re now doing 519 tests per 100,000 population, that’s roughly 15-25 percent increase over the past month. It’s fluctuated a little bit over the past month. So that’s why I say 15-25 percent. But at the same time, our cases have more than doubled compared to a month ago. So seven day average of daily new cases, have gone from thirty, which I understand is really low to sixty-eight and our positivity rate has gone from zero point four nine to zero point eight three over the past few weeks. And I know like in comparison to the country that still really low. But does this suggest some really bad times ahead or do you think we have a pretty good chance for suppression considering our testing volume? I’m just wondering what you think of those various trends.
MICHAEL MINA: So I think that there’s a confusion about the role of testing in this epidemic. Testing alone will not suppress this virus. And I think this has been such a confusing point that it’s actually obscured our ability to control the virus. People have thought that that type of testing will do it. It will not do. It will not control this virus, period. Just won’t. Where in this country are we doing the type of testing that can actually be used as a control effort? We’ve kind of fooled ourselves into thinking that will be possible. Testing in the way we’re doing it now is really about surveillance and clinical testing. And the type of testing that I’ve talked about demands orders of magnitude more testing than we are currently doing in order to actually identify enough people early to really stop their transmission chains. Of course, surveillance testing can work if you have cases at extraordinary low numbers or very, very low numbers so that contact tracing can actually keep up with it. But I am hesitant to even necessarily say that contact tracing is really making a huge dent. I worry that we’ve just been kind of fooling ourselves in this country, thinking that we are making a dent with contact tracing and testing in the way that we’re doing it. So what it can do, though, is the testing and the increased testing can continue to provide better and better resolution for policymakers and public health officials in Maine and elsewhere, of course, to determine how best to act and react to cases that are increasing. And I think that that’s one of the most important parts of the testing programs that we have right now. It’s really to inform public health on as high resolution basis and temporal resolution as possible to know where to act and where the cases are emerging. And can we actually have targeted closures or targeted interventions in different ways to stop spread? But I think testing alone and scaling it up will not be what’s needed to really drive this virus down unless we are following more of along the lines of the path that I have laid out multiple times now, which is a whole different type of testing that I call public health screening testing.
Q: Really super quick. Just yesterday, the state of Maine announced a partnership with Walgreens for the rapid tests, rapid antigen, Abbott BinaxNow and allowing anybody to come in and get a rapid test. Plus, they’re doing some things with schools and first responders, etc.. What do you think of that strategy, partnering with the major drug chain?
MICHAEL MINA: I think it’s great. I think that partnering with Walgreens and those companies is really a good way to potentially create some level of some programs around these tests. What I hope to see is that, you know, I don’t know that the most beneficial way to use them in Walgreens is just to say, hey, these are now available at Walgreens come and get the test, if you think you want one. I think that we can use the footprint that Walgreens stores have to make testing much more accessible, especially something like the BinaxNow quicker and accessible. But at the same time, do it in a more organized way, have strategy. We need to be thinking about every step of this as strategic in the same way that we think of why we would never just send a bunch of guns overseas and say, do what you will with them. We would end in the same way. We’d never send a bunch of soldiers overseas and say, do something. You know, if you want to go fight today, do it. There is strategy in war. And why we continue to not have a strategy about how we’re deploying the test, that’s not smart. I think Walgreens is really well situated to work with the Department of Health in Maine and in other states, for example, to create those strategies and help identify what are the best strategies forward and how Walgreens or any other institution could potentially best facilitate the use of these BinaxNow cards without them just sort of disappearing through a sort of haphazard use.
Q: Great. Thank you very much.
MODERATOR: Thank you, Dr. Mina, is there anything you’d like to say before we end the call?
MICHAEL MINA: No, I don’t think so.
This concludes the October 30th press conference.