You’re listening to a press conference from the Harvard School of Public Health with Michael Mina, assistant professor of epidemiology. This call was recorded at 12:00 p.m. Eastern Time on Friday, February 5th.
MODERATOR: Hi, Dr. Mina, do you have any comments for us today?
MICHAEL MINA: Not at the moment. I’m OK.
MODERATOR: All right. So first question.
Q: Hey, can you hear me?
MICHAEL MINA: Yes.
Q: Thanks for taking my questions. I wanted to get your thoughts on B.1.1.7 in Florida, specifically using the helix platform, which they’ve flagged the vast majority of the B.1.1.7 cases that we’re seeing here. The last estimate, based on a percentage of the S gene drop out, was that it was five percent of all cases. But I’ve had a couple people reach out to me and say that it could actually be much higher than that. And I was curious, just to get your perspective, Dr. Mina, on how to interpret the sequence information that we have right now and how to get an idea of the prevalence of B.1.1.7 in Florida.
MICHAEL MINA: I’m not familiar with the helix, is that using the thermo TaqPath assay?
Q: I believe so, yeah. And what they have is a five-day moving average of a daily percent of SGTF of positive samples. And so the latest data that we had on that and I actually haven’t checked it since then, was their estimation was five percent of all cases. But that’s based off some back of the envelope math that they do there. So I might send you the details offline to get you to respond to that. But I’m just curious, kind of is there, given the lack of sequencing or the relative lack of sequencing, is there a way to really accurately tell how prevalent the B.1.1.7 strain is here in Florida at the moment?
MICHAEL MINA: Well, certainly the labs that are using the TaqPath assay, this is a test that’s a PCR laboratory-based test built by Thermo Fisher. It identifies three different targets. One of those, as it would happen, drops out. Given this mutation, there’s some biological correlation there. But in any case, it was more just a stroke of good luck that some people saw it as bad at the beginning, but it’s actually turned out to be extremely fruitful for our understanding of the transmission and biology, this particular strain. In general, it seems to be doing well as a marker of the spread of B.1.1.7. So I would have to look more at the data you’re referring to better understand why if we’re seeing five percent of all positive cases currently. With an S drop out relative to the other two primaries, why we would necessarily expect it to be much more than that? I do think that the writings on the wall, though, that once B.1.1.7 comes in, it generally sweeps through and takes over pretty well and fast. So I think the data might show five percent now, but it might be 15 percent very shortly and increased from there in pretty rapid speed.
Q: And just a quick follow up, as far as how do we read into the situation at large? We have cases, positivity and hospitalizations are all kind of falling right now in Florida pretty consistently over the last few weeks. How do we square those two things? Are we just in a moment where we’re not seeing the effect of B.1.1.7 yet? Or is partial population immunity playing a role here, considering just how much spread there’s been in Florida? I’m just curious how to read those two things.
MICHAEL MINA: Well, this has been a mystery. I look at this as it’s just another chapter in the textbook of we just already know what’s happening and we just aren’t going to look at it. And now if you look at coronaviruses in general, they have very short transmission peaks in terms of population level peaks, and they’re generally two to three months long in duration. And so you can look at some of the incidence curves over the last decade that have monitored prior coronavirus strains. And you can see that each one of them, although the overarching peak of the coronaviruses is maybe five months or more, if you look at each individual strain, you see that there may be two or three months in terms of their real peaky-ness. And so I think what’s happening here is that we might already be seeing the seasonal effects. This was a virus that really took off as expected back in November. We expected it to take off in the fall last spring, frankly, and some of us did anyway. And I think now what we might be seeing is it took off in November and now we’re actually seeing it’s natural decline and decay falling back down. And so my hope is that that’s actually what we’re seeing. I do think that the estimates of immunity might be under in terms of preexisting numbers of cases. They’re definitely off by a long shot right now, we have twenty-seven million in the US, probably at a minimum. We have one hundred and twenty-five million people, and I don’t think it’s completely out of the question that we might even have more than that. The CDC suggests that we have undercounted by about five-fold, so twenty-seven million, that immediately brings us up to one hundred and twenty million or so people who have been infected in the United States. That’s based in part on serology. If we then account for how serologies can under count individuals as well. Because a number of factors, we might even have more than one hundred and twenty-five million people in the US having been infected. So those while they don’t achieve the herd effect threshold, we’re well on our march towards herd immunity thresholds. And just like anything, it’s a continuum. So we start to feel the benefits of that the closer and closer we get. Once you pass the threshold, that just means that the virus can’t persist at the population level. And so I think we’re seeing seasonality and potential some herd immunity plan to this overarching picture. I think B.1.1.7 is the wild card here as it starts to take off. Is it as a strain going to have a different seasonal pattern? Is it going to be sufficiently transmissible that it’s force of infection, meaning how well it can transmit between people, just overwhelms the seasonality and can continue transmitting like we saw given the high number of susceptible in the South during summer, we saw that the virus is able to continue transmitting despite its seasonal patterns? So it’s a complex ecosystem and environment right now. But I think those three pieces are at flight.
Q: Thank you so much that answers my question. I really appreciate it.
MODERATOR: Next question.
Q: I wondered, you’ve sort of started to answer this question, but I wondered what causes seasonal coronaviruses and possibly this coronavirus to peak and then drop when the weather is still cold? The behavior, as far as I can see, is pretty similar to when it was rising a few months ago. So I wondered, is there any understanding of what factors besides some level of population immunity might be causing the infection levels to fall the way they are?
MICHAEL MINA: We don’t exactly know, and this is speculative in many ways, we don’t exactly know why seasonality of viruses or bacteria occur. There are some pieces that we do know. For example, part of our immune system, are these little cellular structures called cilia. They need to work in concert with each other. And when we are in a low humidity environment or absolute humidity, the cilia stop working as well, so our immune systems don’t clear the virus as well, could allow a virus to build up, transmit across each other. There might be immune responses that we just aren’t sufficiently attuned to really understand why people’s immune systems might not do as well to defeat the virus during winter versus summer, for example. The ability for the virus to survive outside of the body changes between seasons. So this has been an area of intense research for a very long time to understand the seasonal patterns of pathogens. And we just don’t fully appreciate or understand why they occur the way that they do. But we do know that they exist, and they exist in very striking patterns that are repeatable.
Q: Do you think that public health officials have overemphasized the idea that human behavior is everything and that, you know, it’s all about policy and what we do?
MICHAEL MINA: I think that there’s two ways to look at that. I think that we can’t control the seasonality of the virus, but we can control our human behavior, and we can figure out ways to challenge this virus and to get it to stop spreading so readily. So in that sense, I think the human behavior component of this can’t be overstated. I think it would be a mistake to assume that all increases and decreases are driven primarily by human behavior, that would be forgoing everything we know about viruses and bacteria in many ways, no, I would say that much of human much of the seasonality in general is related to human behavior as well. For example, with any virus, if you’re spending more time indoors, you’re more likely to spread to other people than if you’re spending more time outdoors. But that being said, I would say that in North America or at least in the United States, human behavior in terms of time indoors versus outdoors is an exceptionally distinct between summer and winter. People still work indoors most of the time. And so in that sense, I would say that there are seasonal patterns that are out of our societal control, per say, but we could try to hijack them or use them to our advantage and using human behavior. So right now, for example, cases are falling, and they continue to fall for a while. We should absolutely be using this to our advantage right now. Get the virus when it’s not exponentially increasing and try to do everything we can to suppress spread as much as we can right now to actually get control over it. We failed to do that this past summer when cases were low. We did nothing effectively. We just crossed our fingers and hoped that obviously failed. And I do think that this is another opportunity that cases may well continue to fall, especially in the context of B.1.1.7. We should use this as an opportunity to try to get control over the virus through behavioral change, of course, through rapid testing. If we ever find our way to understanding how to evaluate rapid tests appropriately, I think we would find that they are extremely effective to control spread and it’s probably the most powerful tool we just continue to fail to use. So I think human behavior can stop this virus if we want it to.
Q: Thank you.
MODERATOR: Next question.
Q: Hello, thanks for calling on me. The White House coronavirus response team just announced that the Biden administration will announce six more companies will surge manufacturing of at home test kits with the goal of by summer having millions of Americans being able to access at home tests. I wondered if you welcome that development or do you think more, even more should be done?
MICHAEL MINA: We have tests that are available today that can be made in the millions today. They could have been made in the millions yesterday, months ago. We don’t have to wait till the summer to get these tests out to people, we could be doing this today. There are test companies that are not being authorized right now for no good reason, except that the way that the US chooses to evaluate antigen tests, assuming that the PCR test is correct, is confusing everyone, including our own CDC. And it is hindering these tests from being available. So I think that if we could change something, we can have these tests tomorrow. We could have them today. There’s at least one company that’s able to make almost 10 million tests per day right now in America that just is not getting authorized because the way that we evaluate and authorize these tests today is against PCR, so that an antigen test like this one in my hand, the company or the government sees this as not sensitive. That’s the wrong way to look at a test like this. It’s not that this test is not sensitive enough, it’s that the PCR test is not specific. And what I mean by that is the PCR test is not specific to infectious virus. So this test is going perfectly well, it’s almost one hundred percent sensitive to catch people in their infectious. But it won’t catch you after you’re no longer infectious, a PCR test will catch you after you’re no longer infectious. That’s not a public health test. We don’t want to isolate people. After they are infectious, that is a burden on society, but that’s the policy that we have right now in the FDA and our government is to assume that if you’re a PCR positive, you are infectious. And that makes us isolate the wrong people and it makes these tests appear to be less good than they are. So it’s an extremely simple concept that is holding back what I think and have thought for a long time as one of America’s best and most powerful tools. The notion that we would wait until summer to get these tests to people to scale it up is ludicrous. We could have them yesterday, I mean, we’ve done surveys, we know that the American people want these tests, we want to open up schools, have people test themselves at home before they go to school. You know, there’s no reason that this test should be illegal. That is insane. And so, you know, I’m frustrated at this and I’m happy that this administration is really pushing forward with rapid tests. I think we need to be more aggressive. We need to do a root cause analysis to understand why isn’t this particular test in my hand right now that can be made 10 million per day in America, why does America not have access to this test yet? There is a problem there, especially in the context of B.1.1.7. And we need to stop transmission. We continue to just close our eyes to the tools in front of us and not use them and evaluate them incorrectly when the science is so clear. So no, I don’t think that waiting until the summer is good. I am encouraged that the Biden administration is making multiple steps right now to try to signal that they are going to be pushing for speedier access to testing. But I think that we have the test in front of us at the moment. We just need to listen to the science a bit more.
Q: Thanks very much.
MODERATOR: Next question.
Q: So to follow up, I felt like I had missed an FDA email and they made that announcement that they’re investing in six more rapid at home tests. And so I was thrilled that you were doing this call today, because I know you talk to these companies all the time. And do you happen to have any details? Who are these tests? What manufacturers are making these tests and what’s the likely price point going to be? Because they’re also investing in the Ellume test, which is about thirty dollars, the kit. And you’ve said before, I think that Ellume is just too expensive for all the ways that we need to be using them. And then finally, as a second part to the question, I’m hoping you could go over one more time for those of us in the cheap seats in the back that haven’t reported on this in a while. How do you envision these tests being optimally used in our daily lives? What can they do for us?
MICHAEL MINA: There’s a lot of confusion on the announcement about these six tests. I don’t have the details of what six tests. What I can say is that there are a few companies that can scale up today. And at least in the company that can scale to the greatest number today is one that is currently being held back from being authorized for reasons that are inappropriate, I think. I just don’t have the details. The way that we need to use these tests. Tests have to be used frequently. The more we learn about this virus, the more we recognize that the transmission window, the period of time when people will do almost all of their transmission of the virus is three to four days. That’s it. The moment you get outside of that window, you might still have residual virus left for a few more days, but almost all of the transmission that’s going to happen is going to happen in a three- or four-day window of time. So the only way to use testing in any effective way is it has to be frequent. If it’s not frequent, you’re just not likely going to find people during that period of time. If you don’t get results back quick, then even if you’re doing it frequently, by the time you get results back two or three days later, the test has already lost 50 plus percent of its effectiveness to stop transmission. And they have to be accessible and equitable, this test, this one that I’m holding is this company and this is a company we have been trialing it, it’s working really well. It’s the one from the U.K. and they can scale to a huge number of tests. And these kinds of tests, these paper strip tests, but just to be clear, this is made in the US. The UK is using it. We’re exporting it to the UK because the FDA is not authorizing it. It’s a mistake not to authorize this test. It’s the highest scaling test we have. And this is almost one hundred percent sensitive when people are in that infectious window. What does that mean? That means that you can actually take somebody, test them in the morning and say you’re infectious. Let’s pull you out of society for a moment. And if we can just get people even to isolate just for three or four days, we would do an amazing job to slow the spread because the transmission window is very short. And so this test is as powerful as it is because it will find when you’re positive. It won’t tell you that you were positive two weeks ago. Like PCR will tell you that you’re positive right now and it would give it to you in a time that is actionable 15 minutes later. So before you go to work, you can test yourself twice a week, three times a week. We have seen amazing success in all of the New England colleges and universities that are using fast PCR testing because they’re wealthy. They can do that.
The average American can’t get PCR testing. And when they do, it’s delayed. It’s delayed two, three days. So that makes it almost useless to stop transmission even when you find positive people. This test is like a great equalizer. It can actually get the average American and the average American company to be able to have their employees, everyone schools use these tests two or three times a week, just like the universities. What we’ve seen in New England universities is that you could have raging outbreaks across the city and across the community. And then each of these colleges, which should be the petri dishes for infections, have actually been little oases of not having outbreaks. And that’s because they’ve all been doing frequent testing. So what I think needs to happen is the CDC should issue guidance around exactly how to evaluate this test. Unfortunately, so far, they have themselves been evaluated incorrectly, which we’ve seen with a couple MMWR reports recently, as well as the just bad media reports. But the CDC can issue guidance around this the same way that the CDC issues guidance around other things like masks and distancing and can actually provide the US with a road map of how to best use testing two or three times a week is a very, very powerful way to stop outbreaks. You can do entrance testing and entrance screening before you walk into a location like a sports arena, for example. Right now, we have people testing themselves three to five days before they go to an event that is useless, that I can’t say it enough. That is a pointless waste of money. The best thing you could possibly do is test yourself the moment right before you’re walking into whatever it is, whether it’s work or school or an event or the grocery store or whatever it might be, have a test every day, have a test twice a week, twice a week will stop outbreaks from continuing to expand daily, might stop even every single infection. So it depends on how aggressive you want to be. The goal for public health testing should be not to stop every single case, but to stop every single outbreak. And twice a week or three times a week testing with a simple paper strip test would actually do that.
And then reporting is another issue that a lot of people talk about. This thing doesn’t have any electronics. So instead, people are so up in arms about reporting that we end up with something like an Ellume test. Ellume is not a public health test. It can’t scale. It’s going to add 3000 new tests a day. That is nothing to the US market. That’s nothing. We have wasted money on it. It’s a total waste of money. We don’t need the test itself to do the reporting. The CDC is making a really simple reporting tool that you can log into on your iPhone or on your computer. We could have text message-based reporting, just really simple ways to make reporting wholly accessible without tethering it to this and to keep it voluntary, so people use these tests on a voluntary basis. And that is absolutely crucial for public health because we just want people to know, are they positive? We will get enough people to volunteer their results for public health metrics, but we don’t want to tell somebody you can’t know your results if we can’t know what that is a bad policy. We would rather the person who just doesn’t want to participate in government oversight and is too poor to be asked to not go to work and too poor to be asked for their family to not go to work. We don’t want to force them to not know the results just because we want to know the results. We want them first and foremost, you know, the results that they can make small behavioral changes. And if they want to volunteer their results, then they can do that. So I think there’s a lot of ways that we can make these tests work. We are unfortunately currently doing none of them.
Q: Nicole, can I ask one last follow up?
MODERATOR: Real quick one, because it got a lot of other folks go through.
Q: I understand. Do any of the companies have data yet, Dr. Mina, on how well these tests work against the variants?
MICHAEL MINA: This is a misconception. The tests, especially these antigen tests, they will work just fine against the variants. The variants are under selection by a different protein on the virus. It’s a specific part of the spike protein. Almost all of these looks for the nuclear capsid, same way as a lot of like the CDC assay does, the PCR and such. And so these tests should not have any problem as a result of the variants, just the places that the molecules that these tests are looking for are not under any sort of immunological selective pressure.
Q: Thank you.
MODERATOR: Next question.
Q: Hi, thank you for taking my question. I wanted to ask about the preliminary AstraZeneca trial results that say their vaccine prevents transmission as well as disease. Could you talk a little bit about those results, how that studied and how it compares to the vaccines we have approved currently?
MICHAEL MINA: So the basic way that study it is just looking at whether or not there is virus detectable in people. Unfortunately, the studies of the mRNA vaccines did not consider swabbing people as part of the readout of those trials. And so we didn’t really get a chance to understand anything about whether or not those vaccines were able to prevent viral replication in the nose. We were only looking at do the vaccines prevent symptomatic disease. So the AstraZeneca results and further trials of other vaccines are going to be swabbing people’s noses to essentially understand do people who get vaccinated have any virus compared to people who didn’t get vaccinated? And regardless of symptomatic disease, so it’s just another readout. So it’s not necessarily looking directly at transmission, but it’s looking essentially viral replication and with the expectation appropriately that if you don’t have any virus that’s detected in the nose or if it’s very minimal, it’s very unlikely that you’re going to be transmitting to other people.
Q: OK, just to be to be completely clear, they were not studying necessarily whether they were spreading it to other people, but whether their participants were testing positive?
MICHAEL MINA: I believe so. I would need to confirm this, but I do not believe that they were doing household transmission studies, which would be the other approach. But to be honest, I didn’t look closely enough at that data to say that for certain. But that would be what you’d be looking for. If a study wants to really do kind of the gold standard, does this vaccine prevent transmission? You can take people’s household members and you can ask of those households where somebody got a vaccine, do you see differences in transmission patterns in the household? Those generally are very, very labor intensive, difficult studies to run.
Q: Great. Thank you so much.
MODERATOR: Next question.
Q: Thanks, Nicole, can you hear me, Dr. Mina?
MICHAEL MINA: Yes.
Q: Hey, thanks as always for your insights into rapid testing. But today, I have a question for you about taking over the counter painkillers before the vaccine. There’s been some reporting about it’s not wise to take Tylenol, ibuprofen, acetaminophen, I mean, just all those before you get the vaccine because it might lessen the efficacy. I don’t know if you have any thoughts on that or if you could give advice about can you still take something after if you have some post vaccine symptoms, just help us clear that up a little bit for our viewers.
MICHAEL MINA: Sure. Yeah, actually that was some of my work years ago with flu. The short answer is that there is a chance that COX-2 inhibitors, that essentially painkillers and anti-inflammatory can reduce your immunological response. I mean, that’s essentially what they are designed to do, and so you might not want to, I would say, use them very judiciously, don’t use them beforehand, don’t use them prophylactically. That’s not the appropriate use of them. And in general, try very hard not to unless you really are in need. I don’t think it’s going to be the end all be all if you use it or don’t use it. In any case, I don’t think it’ll be the end all, be all, but I would suggest that if people can avoid it, not to bother attempting to use them unless you really need to. But there is a chance. It’s a very hard thing to study, to really be able to say, are they really having an effect or not? I think at the end of the day, it’s better to give people’s immune responses the absolute best chance that they have, and that’s to sort of let it do what it’s going to do in the absence of painkillers, killers. But if needed, it’s not going to be horrible to take them.
Q: Can you explain, though, why that might affect the efficacy of the vaccine? And also, if I’m having issues afterward, is it OK if I take something after the vaccine? I’ve just sort of trying not to do that for the first day or so. Any thoughts on it?
MICHAEL MINA: Yeah, it’s because for a vaccine to work, you want to elicit immune response, like you want a fever. People don’t generally want fevers, but if you’re getting mild symptoms, that generally means that your immune system, the immune system, doing what it does causes the symptoms. And that’s usually how, you know, that it’s actually responding usually to a pathogen, but in this case, to a vaccine. So you don’t want to suppress it from doing what it is evolutionarily sort of trained to do, which is to expand inflammatory markers and try to build immunological memory. The way that we build immunological memory is to actually have the cells that are holding that memory and changing to sort of expand and create as many memory cells as possible quickly and with the expectation that as the immune response subsides, you have as good a shot as possible to keep a bunch of those memory cells around. So you don’t want to dampen your overall ability to expand those cells in general. And so whereas painkillers are generally intended to suppress the immune response, you want to as much as within reason, you want to allow the immune response to flourish, not suppress it, because that immune response which will direct your memory, immune response to develop. It’s sort of like, let’s say you’re exercising. You wouldn’t want to suppress your ability to go for a run when you’re supposed to be in the middle of a training regime for a marathon. And you need to get muscle memory to really do a marathon well. And so you wouldn’t want to do something that is suppressing your ability to actually get out and run. It’s the same thing for an immune response.
Q: Thanks so much.
MODERATOR: Next question.
Q: Thanks for taking my question, Dr. Mina. Have you seen the release that the Rockefeller Foundation put out yesterday? This is regarding K through 12 pilots conducted in six cities involving Abbott BinaxNOW.
MICHAEL MINA: I know of it; I haven’t read it through yet.
Q: I just wanted to highlight it for you. I mean, there’s some good things about BinaxNOW that came out in particular in the Mathematica report. There’s also a RAND report. But the mathematical one specifically focuses on early findings from these school districts that have implemented BinaxNOW. And basically, if I can just run through this quickly here, there’s some barriers that they found in this study, and this is in no particular order, there’s some limitation of Abbott’s associated app that’s used with the test. And there’s also significant cost beyond just the five dollar per test cost. There’s a whole bunch of ancillary costs that school districts found, which essentially takes the cost of operating the test up to eighty-eight dollars per test. There’s also been some pushback because of the frequency of tests, both from staff as well as parents and kids. And obviously, the more that they test, the more effective it is at finding infection. Do you just have some comments on those points there? The other thing, and we’ve talked about this previously, I don’t know you have concerns about this, is that in cases where the BinaxNOW test is positive, they use a PCR test to confirm it. And so, again, I know that’s an area of concern that you had in the past.
MICHAEL MINA: Yeah. So I’ll just get the confirmation out of the way quickly. So these antigen tests have come a very long way since the early ones that had instruments and things like that. The BinaxNOW, as well as the Sanova tests have been performing pretty similarly in terms of false positives, meaning we really haven’t seen any. We’ve run thousands and thousands and thousands of this particular test. And it’s similar to the BinaxNOW. And we just aren’t seeing false positives. Meanwhile, we are seeing false positives on PCR, you know, one in five hundred or so, false positive PCR results. So I think that the point is, there’s many easier ways, much more efficient ways to confirm a rapid test than sending out the PCR. Doing that is ridiculous. Just confirm with another rapid test, if you have two companies, even better, but you could even just use the same rapid test twice that will immediately get the false positive rate to one in ten thousand or so. So it’s really not an issue at all.
To the other points, I feel strongly that the best way to test using these tests is not to put more of an onus on the schools. But to use these tests at home in order to make the schools safer. Testing at home can be a part of school testing. If for some reason a kid can’t test at home, then you could have a smaller subset of students get tested in the nurse’s office if that’s needed. But in general, we can ameliorate these excess costs by doing the test by distributing that effort into the households, this can be part of keeping families safe. You can even pool tests. If a family has these tests, have different have two or three people use a swab at once and they can all use the exact same test on a given day. And so I think that, you know, this is no different than what’s happening with screening already. We have students getting screened at home. They’re getting temperature checks at home and then going to school. And people are trusting that their student or their child doesn’t have symptoms. This is just a really, really powerful way to do that. And they’re so simple to use. The first time somebody uses it, maybe it’ll take them 5 or 10 minutes to learn how. But once you’ve used it once, the next time, it takes you 40 seconds to use. So it’s not too onerous for individuals to use. You do not need to pour tons of money into the logistic chain of these tests if we just use them the most appropriate way possible. So I’m not I think that there are, again, many ways to use them. And I think we should just be mindful of what are the most appropriate ways. And I think the home testing approaches is probably the most powerful, not just for schools, but to get these tests out into the people going to work as well. Essentially, back to the Rockefeller report, I think it’s great that they are being used in schools and it’s great that they’re really pushing on this. We want to work with the White House. We want to work with the Biden administration. Biden has made rapid testing one of his top priorities as a way to tackle this pandemic. And that is good thinking, it’s using science, it’s basing decisions on science, I commend the administration very much for pushing on this. And now we just have to ensure that we are using them in the most efficient way possible. And I think home testing and getting tests like this one scaled and through the FDA as quick as possible or the way that we can do all of this.
Q: OK, thank you.
MODERATOR: Dr. Mina, just really quickly, you had talked about pool testing with antigen test, do you mean multiple people should use the same swab or the same paper strip?
MICHAEL MINA: Please don’t have multiple swabs.
MODERATOR: Thank you. I just wanted a clarification on that.
MICHAEL MINA: Different swabs. The swabs are easy to make. Different swabs. But this is a test. I would normally take a swab and stick it into a little tube swirling around in that tube, and then pour a couple of drops from the tube on to the test, you could have three swabs. For example, go into that one tube, all three get swirls around and then pour it on to the test.
MODERATOR: OK, great, thank you. Next question.
Q: Morning, I have two. The first one, I hope is real simple, and I think you’ve addressed this before, so I apologize. I just don’t recall for the benefit of all the journalists who might report on the rapid test, give any financial ties to Enova or any of the other companies that are developing this?
MICHAEL MINA: No, I do not have any ties to any of these antigen test companies.
Q: The question I really wanted to ask was going back to the painkillers, is there any difference between in relation to the vaccine efficacy or if you want to speak to it, taking painkillers when a person has COVID symptoms, when they know or presumed, they have COVID. So kind of two separate parts there. Does it matter if they take acetaminophen, ibuprofen or aspirin?
MICHAEL MINA: I would say for the purposes of this, I would say no. There are slightly different reasons why one might have a slightly different effect, but we don’t have the evidence base to really make a claim in any real way.
Q: OK, thank you.
MODERATOR: Are you all set?
MODERATOR: OK, next question.
Q: Hi, thanks for doing this call. I think you alluded to this earlier, but, you know, there’s one test that the US government is purchasing so far. Rapid test. Given the limited supply like the vaccines, how do you get the biggest public health effect with the limited supply of rapid tests to begin with?
MICHAEL MINA: Well, you don’t unless you scale up. Like the Ellume test, for example, there’s just no public health benefit there. The Abbott BinaxNOW is a test that the government has invested in and that one can scale to a high enough level to start having an impact. I believe that Abbott is now making something like one point five million per day or so or is able to do that. So I would say that there are a few ways that we currently are not using these test, but we should be. So Abbott, I believe, is making 50 million per month right, this month. So one of the best ways to use these tests is not to dilute them out. These are really nice because they’re distributable. But if you distribute them too widely, you can dilute the entire effort. You can just make these a one-off useless test, and so one of the best things to do with the BinaxNOW, if you have a million and a half or so of them being built every day, is to identify hotspots, for example, and say, OK, we know that the best and most efficient use of rapid antigen testing is to do it frequently. So it’s better, for example, to take a group of people and have them test frequently rather than test a whole lot of people once. You can easily just deplete the whole utility of these tests by just having people use them once. We have to stop thinking about them in terms of medical one time use testing. That is a pointless type of testing for public health. Getting a test here and there randomly is not going to stop transmission. That’s all we’ve done so far. We have still not created a policy around the frequent systematic use of testing except in the university settings, not surprisingly, and in things like Hollywood and other places where they’re using it as interim screening.
So I would just suggest that as we continue to have a limited supply for a country that’s 330 million people, we use them with strategy and we decide, OK, now at some point life isn’t fair and we have to start somewhere. And so pick a city, pick a few cities, pick a few hot spots and say we are going to get these tests that we do have available to us right now into these particular hot spots to help slow spread. The other option is to use them all, not to try to stop community spread. I think the most powerful way to utilize these tests is to suppress community spread, outbreak suppression, and that’s to get our below one. But the other option, which in the case of where we are right now, which is unfortunately very limited numbers of these antigen tests in the United States, would be to get them at the at the door of every senior living center and every nursing home. Have nursing homes and senior centers of the employees use them before they walk in every single day, use a test before you walk in. That would be an appropriate use of these tests at the moment because they are not in really a large enough quantity to really be used for outbreak mitigation.
Q: Thanks. And just to follow up, it looks like in the Biden administration’s communication, it was referenced schools as a potential spot for these rapid tests. So it sounds like you’re talking long term care and hotspots, but you didn’t mention schools. So if you’re developing a policy, is that the pecking order you would recommend?
MICHAEL MINA: I want to be very clear that public health is not just about suppressing the virus and blocking transmission. School and getting kids back to school is a huge part of community public health that should not be undercounted at all. And I think in this case, like if we look only through the lens of viral transmission and mortality, then the pieces that I was just mentioning are the number one way to go with limited supply. But if we take a step back and we say what else is important to us as a society and to the public good and public health, the mental well-being of kids is absolutely paramount. And their parents, of course. And so getting schools back is a decision that I think is absolutely appropriate. And these tests, using them as entrance screening to help safely reopen schools, having them done at home before kids go to school two or three times a week, for example, is absolutely an appropriate way to use these tests while they’re in limited supply. It will help a different it will have a primary outcome that’s helping in a slightly different way than an infectious disease centric view. It allows schools to reopen, which brings a different element of public health to the fore. And I think these myopic views that its suppression of the viral transmission alone has been damaging, and so I’m actually glad that Biden is placing a priority that is well in line with suppressing the virus but is looking at this through a lens that says, you know, what else is important in our society. And certainly, from a public health perspective, keeping schools closed is one of the most disruptive things that society can possibly do. And opening them back up is therefore one of the most helpful.
MODERATOR: Next question.
Q: Thank you, Dr. Mina. I just wanted to sort of circle back to what you were saying earlier about needing to do a root cause analysis of why America does not have access to these tests. You know, you’ve indicated that the Biden administration is really, you know, in favor of them, but it’s being held off till the summer. But yet we have the capacity to do this tomorrow or yesterday. So I’m really struggling to understand, like, what’s the barrier? Is that the FDA and if there was going to be a point to push on, where would it be?
MICHAEL MINA: I would say that 90 percent or more of the reason is the FDA. The FDA has not kept up with the science of testing in any way. The in vitro diagnostics division of the FDA continues to mandate that this test be compared to PCR. I’ll give an example. I mean, if you have an MRI, if you break your bone, your femur is broken. An x ray will pick up that broken femur. Same as an MRI will. But you put that bone back together and it heals. Now, let’s say that this is the heal. It heals, the x ray will no longer detect it. But a year later, an MRI can still see the scar. You do an x ray, the x ray says no broken bone. An MRI says, but there was one. We wouldn’t ever fault the x ray and say that it’s wrong. It picked it up when it was broken. It’s no different with these tests. The FDA is treating this as though it’s supposed to pick people up weeks after they’ve been infectious. That means it’s not the sensitivity of this test, it’s that the FDA is unwilling to recognize that the PCR test, which I have nothing against PCR, I run PCR labs. I’ve started the highest throughput PCR lab in the country. But it is not the public health test we need. It is causing erroneous isolations. It’s causing contact tracers to go down the wrong paths. It’s causing damage. It’s putting extra onus on our populace because people stay positive on the PC for so long. And part of that damage it’s doing is it’s that continued comparison by the FDA is making these tests look like they’re not working. It’s misleading. It’s misguiding everyone. And then you see scientific reports. Unfortunately, people take their cue from the FDA. They say, oh, we should compare an antigen test where the virus is cleared very quickly after infection versus the RNA, which persists on the PCR test. Scientists then think that that’s the right comparison to make. So then it leads to this cycle of bad science.
And so we had the CDC come up with two different papers recently saying that the Abbott BinaxNOW is only 30 percent sensitive against asymptomatic people. Absolutely not true. The CDC was wrong. They are comparing people post infectious on the BinaxNOW and the BinaxNOW should not turn positive when people are post infectious. It’s a contagiousness indicator test. So I think that the FDA is simply misunderstanding the science and nobody is correcting it. And it is detrimental, and I would say that it is costing lives. The testing needs to be in the context of what is the goal. And as long as we continue to pretend like the goal is finding every shred of RNA week after somebody’s been infected and asking them to isolate as a result, that’s a failure. That’s a failure of our government. That’s a failure of our ability to tackle this virus. If you’re going to do a public health testing to stop transmission, you need a test that’s detecting people who are at risk of transmitting. And so honestly, this test here that could be scaled to 10 million per day on American soil right now is being held up right now by the FDA just because it’s not detecting people long after they’ve been infectious, that is. It’s just, frankly, a failure of our government to keep up with the basic science here.
Q: Wow, that’s sobering. Thank you very much.
MODERATOR: Next question.
Q: A lot of my questions have been answered, but I have one, which is what about the ELISA antigen tests that have been approved? And they’re not at home, but is there a way to use them to scale up testing in the interim until the at home testing issues get resolved?
MICHAEL MINA: When you say, ELISA, do you mean the antibody tests?
Q: No, I meant the antigen tests.
MICHAEL MINA: So I would say there are other tests like the Mesoscale Diagnostics and some other antigen tests for ELISA. If you’re going to do that, I would say that it’s not even close to work that like when you have an antigen test that’s working extremely well for point four right there in the moment, because the moment you add in, for example, every day delay that it takes to get a result back, your test loses 20 to 30 percent effectiveness. And so my concern is that if you’re having to send out a result, send out a sample, you’re not going to do it daily or you’re not going to get rather day and then it’s going to require a day. So, you know, there’s a very simple answer. And that’s sort of every day you wait. The sensitivity of the test is zero percent effectively during those days. And so I’m trying to back away very strongly from laboratory based testing as a means to fight this pandemic. I think the antigen tests would be very good and very powerful. The laboratory-based antigen test, those are what we should be using in the hospital when we’re choosing how much effort we need to put into isolate keeping people in isolation rooms and quarantining them away from other patients. If you get a positive PCR, maybe a reflex that to an antigen test, a high sensitivity antigen laboratory test in the lab, you’re getting results back very quickly. And if that’s negative, but the PCR is low, positive, you can then go, hey, this patient doesn’t require isolation. They’re not infectious. So I actually think there’s a role there, but it’s really more in the hospital domain.
MODERATOR: I think that’s our final question. Dr. Mina, do you have any final thoughts for us now?
MICHAEL MINA: I really will just continue imploring the media to stop you know, I continue to read in The New York Times and elsewhere, you know, in every media report, any time that these are reported, they’re always referred to as “although the antigen test is less accurate”, we need to stop that narrative. I mean, if you want to be real about it, if your goal is testing people for infectiousness, the PCR test is highly inaccurate. More frequently than not, a positive PCR test in asymptomatic person is wrong if your goal is to find contagiousness. I’m distressed. I take some blame for it because back in May, I called these crappy tests and the more we’ve learned about them, there were headlines then that said frequent crappy tests are better than infrequent high-quality tests. But I’ve really changed. The science has caught up to a point where these are not crappy. These are actually working exceedingly well. And the more we learn about PCRs downfalls, it is the PCR that is inaccurate as a public health test. It’s not specific for infectiousness. It is a low specificity, high sensitivity test. It’s sort of by the definition of sort of when you go to really high sensitivity, you lose specificity. In this case, we’ve really lost our way and we’ve lost specificity for contagiousness. So I just really would like to see new media reports that come out and stop saying that because it’s no longer accurate. These are high accuracy when they’re needed. And they’re low and they turn negative when they’re not needed. It’s a basic story at this point. We just finished a big trial where we found that we monitor people daily with PCR. And we found that by the day after the day after they turned PCR positive, these were approaching 100 percent sensitivity and they stayed nearly a hundred percent sensitive for the four to five days. And then they start to wane. And that means that transmission starts to wane. But that PCR just kept being positive for weeks. And it’s keeping people in isolation from long time, quarantining the wrong people. So I guess I’ll just stop there.
This concludes the February 5th press conference.