You’re listening to a press conference from the Harvard School of Public Health with Michael Mina, assistant professor of epidemiology and a faculty member in the Center for Communicable Disease Dynamics. This call was recorded at 11:25 a.m. Eastern Time on Thursday, April 1st.
MODERATOR: Do you have any opening remarks for us?
MICHAEL MINA: Sure. So I wanted to just reflect on a few pieces that have happened. Yesterday was a massively important day, I think, on the testing front, we saw the FDA offered at home over the counter testing for two different tests for the Quidel Quick Vue and Abbott BinaxNOW, which I have here, it’s this two-pack test. But the crucial thing is that this is a major milestone, in my opinion, where the FDA has essentially authorized these rapid strip type of antigen tests for at home use that will not require a physician, not require a CLIA waiver. That will eventually be the type of test that people can walk down the street or order on Amazon or whatever it might be and be able to have access to a high-quality rapid test in their home. The important thing about the way that this authorization was created is that it’s for screening and so that the pack comes with two tests and they’re supposed to be used to the first one is negative. They’re supposed to be used within 36 hours of each other with the intention that if you happen to be in that early phase of infection and not yet positive on an antigen test, that you’d pick it up the next day when you use it, when you use the second one, if you are actually infected and positive.
So this is just the beginning of what we’ll probably see as a massive switch in our testing programs and the possibilities for people to get tested, the equitability and accessibility of testing that is removing the need for doctors, and it’s removing the need for extra costs that have been essentially limiting people’s ability to get tests and has been limiting people and institutions abilities to test and keep their communities safe. This all happens on the heels of an announcement earlier yesterday that the NIH and the CDC are rolling out a massive experiment in two American cities to evaluate the use of rapid at home tests at scale, giving tests to individuals who want to participate in the community, to effectively as many individuals who want to use them to be used three days a week, people’s decision, which days. To be able to evaluate if the widespread use of free rapid at home testing is going to actually limit and reduce spread in these communities and they’ll be comparing them to other communities. So this is a massive effort that the NIH director, Francis Collins, as well as Bruce Kromberg, who has been in charge of RadX, have been working on for about three months. I was lucky enough to be in some of the early calls to think through what a program like this might look like. And then, you know, after a lot of silence, we got this wonderful announcement yesterday that this experiment is now moving forward very, very quickly. So I think that those are both extraordinarily exciting advances that came yesterday. And all of this is really on the heels of and being made possible because the FDA a little over two weeks ago created a new template that has actually turned out to be an incredible advance where they have effectively created a new template for at home screening tests that allowed a company like Abbott to take their prescription based test that is only for asymptomatic people and apply for an asymptomatic over the counter test claim to be able to immediately start selling it over the counter without having to go through any more onerous trials to show that it works. And that’s because these tests do work in asymptomatic people. There’s been a lot of confusion about that because of how the trials are done, but they work very, very well in asymptomatic people on a very high sensitivity when people are infectious. And the FDA has recognized that, that now the CDC and the NIH and then the White House are all sort of simultaneously recognizing this is a very powerful tool over the last two, two and a half weeks. And this is all in the context of new variants coming about and a recognition that while vaccines are incredibly important, they are not the end all be all to this pandemic. They will hopefully be the most powerful tool that we have. But we need other tools in our arsenal and the widespread availability and scaling up of rapid antigen tests for people to use in the privacy of their home without a need to report, but with voluntary reporting. Is going to just be an extraordinary game and a powerful tool, I think, to help slow spread, particularly, as variants are arising and we’re seeing a resurgence of cases across the US, which is starting to eat away at many of the gains we’ve made recently. So I will stop there and I’m happy to take questions.
MODERATOR: Thank you, Dr. Mina. First question.
Q: So my question is, are the rapid tests as accurate at picking up a case if the person has a variant? And of course, I’m not talking about identifying which variant it is. I’m just talking about how reliable is it that the person will get a positive result if they have a variant?
MICHAEL MINA: Yeah, absolutely. Every test, PCR or antigen or rapid test, whatever it might be. Every test, the way the tests work is they have to have targets. And if a target mutates, then you run the risk of that test not picking it up. But the good thing is that the rapid tests don’t target the molecules and the proteins that our immune system is necessarily targeting to neutralize the virus. So the virus doesn’t have any good reason to mutate, it’s really important to note the variants are often one point mutation, meaning one nucleotide out of a huge genome, relatively huge genome that these viruses have. And so the antigen test or the rapid tests or the PCR tests are looking for one small part of that virus. Meanwhile, the variations and the mutations are over here in this other region. So they are very, very low risk of losing their effectiveness to detect a virus because these variants, there are different molecules that are mutating on the virus or detecting one thing, but the virus is mutating a different part of it. You could think of it as if the variant is akin to I don’t know, let’s say I have a detection system to detect your ears, but you close your eyes, you know, I’m still going to be able to detect you based on your ears, even if your eyes are closed. So that’s, you know, they’re different pieces. And so, yes, they will still be effective at detecting the variants. But these companies will have to keep monitoring because they are a lot of viruses and small mutations are happening just randomly all the time. So there is always a chance that any one of the tests, laboratory based tests, we’ve already seen some drop out for the lab, PCR based tests, but as well as rapid test, there is always a chance that we’ll get a new variant and the companies will then have to quickly readjust and change things. But we haven’t seen any evidence of it.
Q: Thank you.
MODERATOR: Next question.
Q: Thank you and thanks for that great analogy on eyes and ears. And I was just laughing and listening to the crane analogy. So my question is, on the cost and scale up right now, Abbott specifically is talking about being able to be a more affordable option than the ones that we’ve already seen and that you’ve discussed in the past are out there. So those are like in the twenty five thirty dollars range. They sold this one to the U.S. government for five. So it is going to be one of the more affordable ones. And Abbott is a company that can scale up relatively quickly, but we’re still at a shortage. And I know coming from where you have in the past year the race that you’ve been running, this seems like closer to the finish line. But are you worried at all about the availability and access? Because we’re just at the start of this right now?
MICHAEL MINA: Yes, I’m trying to have a day of positivity here. So I am extremely concerned about the access and scalability because still it’s two tests, Abbott and Quidel that now have over the counter use that are reasonably scalable. The other ones are expensive and not so scalable, meaning Ellume and Lucira. And this this test will be, you know, it will be scalable to a large extent, but it’s going to be they’re going to be competing forces trying to get at this test. We already know that the US government is that this will probably be a test that’s going to be picked up and used for school openings and sort of being used for that. In Massachusetts, for example, businesses wanted individuals are going to want it at home. So how Abbott and Quidel choose to balance out where they place their tests for which ones are going to go to the home over the counter use versus which ones are going to continue being packaged in the packs of 40 and used for congregate settings in a CLIA waiver environment. I don’t know the answer to how they’ll decide what fraction to put where. Certainly, the individual tests that come in a two pack over the counter will probably be more expensive than the 40 packs because of packaging and then market retail markups like in CVS and Walgreens. I’m sure that they’re going to increase the cost. So my expectation is that once they get to that, by the time a consumer’s purchasing these new tests, they’ll be somewhere around twenty dollars for a box of two. But I don’t know what the actual cost of that will be, but that’s my guess. So it’s not the two dollar tests that I have been really pushing for, and it’s not the scale Abbott is still at 50 million per month and not planning. From what I know, I haven’t heard anything more about them scaling up beyond 50 million a month. And Quidel also is at a lower scale than that and is planning to bring on new factories later this year. But what all of this means is this is great news that we’ve had some regulatory hurdles come down.
Now we need to get more companies in the space that can actually produce these tests so that people can actually access them. I worry that very much, you know, for example, Ellume had a big announcement that they had an over-the-counter claim, but not a single American has used a test yet, despite hundreds of millions going to that company months ago. That’s not going to be this. I think Americans can expect to see these tests on shelves probably in the next few weeks. I again, don’t have any real information on it, but that’s my guess. But I think they will be limited. There’s going to be a short supply of them and that will hopefully drive market demand. And we’ll see new companies come on board and maybe Abbott and will choose to scale even to even greater numbers.
Q: Thank you. Sorry to bust your positive news.
MICHAEL MINA: Oh, no, no, it’s totally fine.
MODERATOR: Next question.
Q: All right, Dr. Mina, thanks for doing this. I want to get your opinion at this point the pandemic with of all these different tests, supposedly widespread access to testing, notwithstanding the scalability issues you just talked about at this point, do we need a national testing strategy? And if so, what sorts of things should the strategy address, considering how different the pandemic looks now versus a year ago when we were first started talking about this?
MICHAEL MINA: Yes, absolutely. We need a national testing strategy. I think it’s being formed now to a certain extent. And this is really one of the major reasons why the NIH and the CDC are undertaking this big trial in these two cities to evaluate would this be a strategy that Americans can use? Can we give Americans free tests at scale and if we do that and get them into their homes to use in the privacy of their own home, will they use it and will it prevent spread? Will it prevent surges? And sure, had we had these tests in a widely scalable at home, simple to use fashion last summer, we could have prevented hundreds of thousands of deaths. We could have prevented surges of cases. And now we’re finally getting there, and some people might say that’s a little too late, but it’s not, we’re seeing a resurgence of cases right now. And frankly, my feeling is if there’s still a thousand people dying a day in the United States almost with COVID, which we’ve become numb to, but this is still a massive tragedy every single day.
And if we can use these types of tests to mitigate spread moving forward and if we can use these tests from an economic perspective and a social perspective to prevent a resurgence of outbreaks that might happen in a school here, there, just because people are spending 30 seconds in the morning, three times a week to use a test that alone might be enough to ensure that outbreaks don’t grow. And when an outbreak does start, it fizzles out very fast. That means if we get that in place, that means when an outbreak starts in a school or a nursing home or wherever it might be in the future, we don’t have to close things down. We don’t have to take extraordinary measures in order to prevent the spread of new variants. We can keep trotting forward as a society, even in the context of ongoing, limited spread, as long as we are preventing every outbreak from growing, even in the context of cases still existing. And so I think that getting these tests out is a huge step towards that. Getting a national strategy together is taking shape right now. One of the greatest barriers to actually creating a strategy. I can imagine that the White House wants to create a very serious strategy around testing. The problem is we don’t have the supply of tests to make a massive strategy. There are a lot of companies waiting to get an EUA. And if there was a pathway to get those over the finish line, then we would all of a sudden have millions more tests every single day. And that would give the White House the latitude to actually create a strategy, along with NIH and CDC, to create a strategy surrounding the real robust use of these tests across communities everywhere. Right now, with limited supply, there is a hodgepodge of strategies somewhere, including rapid tests somewhere, including PCR based tests. But certainly, what we can see, at least from my vantage, is the strategies are starting to form. And really its foundation is in the CDC’s new guidance surrounding screening tests. I think that was a huge step forward that the CDC put the guidance out on how these tests could be used to limit spread at the same time that the Biden administration helped to allocate billions of dollars towards testing for this type of reason. And now we see a new FDA regulation breaking down barriers. So we’ve really come a long way in the last three weeks. And I think that we should consider this sort of a pivotal change in the in the testing landscape in the US.
Q: Thank you.
MODERATOR: Next question.
Q: Dr. Mina, are you still anticipating a November surge?
MICHAEL MINA: Sure am. You know, I’ll answer in two parts. If we don’t do things now to ensure that we don’t have a November surge, yes, I do think that we will have a resurgence of cases even among vaccinated people. Sorry, even with the vulnerable people being vaccinated, we’re not going to have all the kids vaccinated. We’re still going to have ongoing spread. When it becomes seasonal again, we’re going to see increases. I feel pretty confident that the surge is going to be a lot smaller than last year. But my concern is that the most vulnerable in our communities will have then been vaccinated almost a year earlier. Unfortunately, the most vulnerable are the most elderly and elderly people don’t hold on to their immunological memory very well. And so I think we can anticipate that there will be a gradient of people who, despite having been vaccinated in January and February, who are vulnerable, will no longer retain a very strong immunological responses. In that case, then ongoing spread, even just among kids, will lead to increased case counts. And I’ve been saying that if its only increased case counts with no hospitalizations or no massive increases and massive increases in deaths, then we should you know, we don’t want to get into just been counting cases. But if those cases start to translate into deaths among the most vulnerable people who have now been vaccinated almost a year earlier, I think that’s going to make everyone get very uneasy. And it would cause a clampdown again on society. So my whole effort here with really trying to push preparations that are not simply vaccine mediated, like rapid tests is to ensure that those outbreaks don’t happen. The real problem with public health, though, is short of having a placebo-controlled trials, it’s exceedingly difficult to measure beneficial public health efforts. For example, if we do get all of these tests out to communities between now and the fall and people are using them and we never see outbreaks emerge, you’ll have a large number of people who will say, why am I bothering to use this test? There’re no cases, but it might be the very use of those tests at the population level that’s preventing the cases in the first place. So this is a tension that public health always has. And I’m hoping that we don’t see this resurgence in cases. But I’m hoping that rapid testing and other mitigating strategies will help prevent them from occurring, but I’m concerned also that if we’re not smart about how we discuss it and think about it and monitor it, we may end up in a situation where people essentially say that there was no purpose to it, even when the purpose was to essentially prevent something from happening. I don’t know if that made sense, it’s a tension that’s always existing in public health, where the more effective the approach, the more people feel that it’s a useless approach because it’s actually effective in preventing something noticeable.
Q: Thank you.
MODERATOR: Next question.
Q: First of all, congratulations, Dr. Mina, you’ve worked so hard on this. Congratulations. I just wanted to ask you about that. A lot of people still push back on the accuracy and performance of these tests and the things that I’m hearing them talk about and that I know my tests where they were only 40 percent sensitive polymer poll tests where there wasn’t a difference in the two communities. And then some are referring to that in a statement that’s come out because you’re always talking about them being contagiousness tests and really being able to detect virus early. But to answer your statement imminently, you sense that CT thresholds can’t formulate with the viral load. How can you help me with this?
MICHAEL MINA: I can. I’m so tired of it. But I mean, the problem is I’ve been trying just so, so darn hard to understand why scientists and physicians across the world are having so much trouble with something so simple. I think what’s happening is we have the science behind using totally different tests that detect two different molecules with different clearance rates from the body and which mean different things, the idea of using a gold standard that looks for one thing to evaluate a test, looks for something else, is somewhat out of the ordinary. And frankly, the science surrounding how to evaluate these tests has never been attempted to be created. The science of understanding how to evaluate a public health test, every test that we’ve ever created for the most part, is about diagnostic medicine. And I think it’s just been extraordinarily difficult for people in the world around, including our own CDC at times, to understand these massive differences.
The short answer is this, and I’ll try to keep thinking one of the best ways to explain it. We have a new manuscript that we’re writing that we’re trying to say, OK, let’s take values out of the picture, let’s take transmissibility out of the picture. Let’s just focus on what we know epidemiologically that the infectious duration is less than 10 days. And that’s why CDC says isolate for 10 days. We know this. This is not a question anymore. The infectious duration for almost everyone is less than 10 days. It’s probably more like five or six. OK, so we start there less than 10-day infectious duration PCR stays positive for on average 20 to 25 or 30 days. So if you have an infectious duration and you have a picture duration, that’s this long. And you have a test which is specifically meant to only detect you during this period of time when you only expect. That a perfect test, meaning one that is 100 percent sensitive and 100 percent specific to people, to catching people during the isolation window during that 10-day period of time, if you have a test that is perfect during the 10-day period of time and you compare it in asymptomatic people to PCR. The theoretical maximum sensitivity is only going against PCR is only going to be somewhere between 30 and 40 percent. And that’s just simply because you’re literally taking a test that’s supposed to detect people over a 10-day window and you’re comparing it to a test that’s detecting people over 25- or 30-day window, and that’s a massive problem here. So we can get rid of CT values. We can get rid of viral loads. We can get rid of all of the stuff and just use what we know from the epidemiology to show that a 40 percent sensitivity of a rapid test meant to be specific to the infectious period, specific to the 10-day window of time should only have a theoretical maximum sensitivity of around 40 percent when you compare it to Q PCR. The problem, and I want to be careful, but I’m going to just say bluntly, you know, the problem with these analyzes is that the world has assumed that PCR is the gold standard. It is for diagnostics. But for knowing who needs to isolate PCR is horribly not specific, it is not a specific test, meaning that a large number of people who are detected, who are asymptomatic and detected as PCR positive don’t need to be isolated because and it’s not because they weren’t sick, it’s not because they didn’t have the virus in them, but it’s because they had the virus in them last week and now, they just have remnant RNA in them. So this is not a public health test. A public health test should not be isolating people who no longer need to isolate themselves. And this has been the problem with these analyzes, everyone assumes that the PCR test is the gold standard, but you can’t take a test that’s meant to be specific to the infectious period and make a gold standard against it. That is totally not specific to the infectious period. It’s a massive mistake. And study after study after study and physician after physician after physician have continued to repeat this mistake. And it’s been really damaging because it’s been confusing to people, you know, and I think we just need very clear guidance that, hey, this is not this is this is in a lot of people say this is like we don’t know enough, but we do. We know that 10 days is less than twenty-five period. We need nothing more than that to understand what the problem is here. And I don’t know. Does that help clarify? I’ve tried so many different ways to explain this in so many different avenues and forums. And does that make sense to people?
Q: It definitely makes sense. Any ideas why it didn’t make a difference in the Liverpool versus Manchester community? Can they just not test enough?
MICHAEL MINA: Can you remind me of what you’re referring to?
Q: Yeah, there was a UK study where they use the test in the Liverpool community, but not in the Manchester community. There was still a second wave in both communities, so they didn’t think the tests really helped that much.
MICHAEL MINA: Oh, sure. Sure. Yeah. The Liverpool studies. So just because rapid test exists doesn’t mean they’re being used in a way that’s going to bend the arc of r. So the science that I’ve been pushing it for, I know at the NIH and CDC are doing, is recognizing how aggressive if we actually want to use tests to limit community spread, it’s not enough to just make tests available and tell people to come grab one here and there, which is what generally was happening in Liverpool. What you really need is you need aggressive at home testing. And by that, I mean it can still be very, very simple. But two to three times a week for everyone who’s using these tests and you need a large fraction of the population, say 50 percent, to be willing to do that. So you have to make them free of need to make them accessible. And you need to get people to want to use them truly two to three times a week at 50 percent of a community. So that sounds like a lot and it’s much more than what Liverpool was doing. Liverpool is now changing. They’re recognizing, hey, this wasn’t quite what the science suggests is really needed to keep r below one. And they’re actually starting a new program now, which is giving people similar to what the CDC and NIH are doing. They’re giving people many more tests to use at home. People don’t have to now show up to get a test at a site like they did in Liverpool. They can now bring the test and use them much more frequently. So people are very quick to say, hey, Liverpool didn’t work, this testing program doesn’t work, but they weren’t doing the testing program that is needed. They were making the first strides into it, I would say.
MODERATOR: Dr. Mina, it is noon. Do you have a couple more minutes or do you need to go?
MICHAEL MINA: I think I’m fine, actually. I had on my calendar that this is going to 1230. So it’s fine.
Q: Hi, thanks for taking the question. I want to ask about Stuntz remarks yesterday on the industry call where he basically said that they only made this change because to their standards, because they didn’t have validated home-use tests being submitted. And I know that there’s a few manufacturers that basically have no interest in pursuing the OTC indication. Do you have any sense why? And do you think that the authorizations yesterday for this serial screening indication will actually encourage them to get off the sidelines?
MICHAEL MINA: Do you mean the test companies get off the sidelines of the FDA to get off the sidelines?
Q: Test companies not submitting for that indication?
MICHAEL MINA: I think that we have to do a sort of a root cause analysis of that comment. Many companies want OTC, but many companies recognize that OTC is hard to get. And these companies are they’re scrambling because they haven’t been able to get even a symptomatic claim yet. So there’s a clear pathway here and in fact, now the FDA has almost formalized that pathway, get symptomatic prescription claim first and then get out. See, don’t just try to jump to OK, because if you’re not able to get symptomatic prescriber claims, then it’s going to be very hard to get OTC. So I think we have to be a little bit careful how we interpret the comments. It’s easy to say we haven’t had test manufacturers apply for OTC, but that’s not because that’s not their full intention. It’s just because the step away, the stairway to getting there is first get a prescription claim. Get yourself situated to be able to do that and then get your OTC claim. But these companies that are making very high-quality tests are getting stuck even with the symptomatic. So, you know, no test company in the world is going to be like, oh, we can’t. Well, there are some reasons why they might now. But in general, they’ve just been struggling to get through that first barrier for months and months and months, months now. Since last summer, they’ve been applying and applying and going around in circles and trying to get the symptomatic use claim with a prescription. So I think we have to be really careful about what it means to not have the applications and also we have to be very careful about why the companies that could like Abbott and Quidel before the FDA created this new template, why didn’t they go after an OTC claim? And the reason they didn’t like obviously they wanted to them took advantage of this pathway immediately once the FDA came out with it. So why didn’t they do it months ago? They didn’t do it months ago because the previous template for OTC use and still the current template, unless you package to test together is. It’s like essentially theoretically impossible to achieve. And that’s because they have a piece of it, if you want to get it over the counter claim with a test like Abbott BinaxNOW, you have to show in a representative sample of asymptomatic people, you have to show 80 percent or 90 percent sensitivity. That was before I’m talking about before this new template came out. But what I just described is the theoretical maximum sensitivity you’d ever get in a representative group of asymptomatic people is like 40 percent or so of a follow up at this point.
Q: So obviously, part of the FDA’s promise to put in this new pathway and was a follow up study to be completed in that population. Do you think that the FDA will be inclined to take these tests off the market once those studies are completed and don’t show the performance that you’re describing?
MICHAEL MINA: We already know that they’re not going to show it. Look, I mean, it’s been on the market for a while now. We have lots of papers from CDC and others that show 40 percent sensitivity in our safety concerns in a few months from those studies are completed and submitted. Well, I think I’m hoping that by that point we’re going to see science prevail. We’re going to see simple biology and simple math prevail, which will make this phenomenon known that 10 days is less than 80 percent of twenty-five days. It’s not a hard mathematical equation. So I think it’s going to be very, very interesting what the companies are good at doing and what the you know is. Figuring out ways to show that to you, using the exact same the exact same test, you can manipulate who you recruit into your studies, which is essentially what the test companies have had to do. Abbott was the first one to do it where they said, OK. We wanted a symptomatic claim early on and before, before Abbott got their first authorization for the BinaxNOW, everyone was just doing any time comparison against any time PCR Abbott came along and said, we’re going to show a symptomatic claim that this works within the first five or seven days of symptoms. And that was just skewing. They got approval by just skewing the patient population they recruited into their study. So my guess is they’ll figure out some way to get asymptomatic people, probably pre symptomatic people into their study to enrich the study with, you know, people they know will be positive on the BinaxNOW who just haven’t developed symptoms yet, know something like that. That is the only way that you can get an asymptomatic group of people to achieve an 80 percent sensitivity on these tests is, you know, to essentially know when they were infected and try to target just those people with the highest viral loads who haven’t yet developed symptoms. If you truly get a representative sample of asymptomatic, we’ve shown mathematically now that it’s not going to be possible. So I don’t know what’s going to happen in a few months when they actually do try to create the studies.
Q: I guess the last question I have on those, are you hopeful that the real-world evidence will come from these pilot studies that will augment submission for, you know, EUA application?
MICHAEL MINA: I hope so. I mean, the NIH and CDC studies are really the only two that are happening now. Other studies can be done to I think that there’s whole different ways to do this study is. Where you can follow people there, their owners, but you have to follow people saying quarantine who have a good risk of becoming positive and ask the question, how sensitive is the test during their quarantine? Once they from the moment they become positive PCR, how sensitive is the test if you’re taking the test every day? So rather than using this sort of one tough test process is they could have a whole different pathway that really evaluates the sensitivity against PCR doing to detect infectious people during their course of like the first 10 days that they are PCR positive. That would be a really good approach, that maybe it would be a different approach to what is happening currently. I do think that the real-world examples will help, but FDA generally doesn’t use real world examples as part of their decision-making process. If they did, they would have a lot of other data sources, but they generally don’t use real world examples in their thinking, or at least not in their in their templates for authorization.
MODERATOR: You all set?
MODERATOR: Next question.
Q: Thanks for sticking around to answer my question. So we know with the Pfizer news that its vaccine is effective against the B1351 variant first identified in South Africa. We know from real world data from Israel and more recently here with the health care workers that these vaccines impede transmission, including asymptomatic infection. So is there any other arguments to be made for why vaccinated individuals should be wearing masks? Or do you think that there may be some revisions in mask and guidelines in the future?
MICHAEL MINA: Well, we know that vaccinated people can still have virus in their nose. We’ve seen that plenty. So it’s a little bit of a difficult question. We know that the viral loads tend to be lower. And I have to point out the amazing thing here. This isn’t answering your question, but when it comes to measuring vaccine responses and transmission, everyone is OK thinking about CT values as a measure of viral load and transmissibility. But when it comes to measuring tests, nobody is OK with thinking about CT values as a measure of transmissibility. It’s a very strange dichotomy between the vaccine world and the test world. But in any case, the data does show that CT values are generally higher among vaccinated people who do have the virus, but they can still get to decent, decent numbers. So I think I would be reticent at this point to necessarily suggest that vaccinate people can’t transmit.
But I do very much think to vaccinate people will have much reduced transmission. So it really depends on the context. Part of this is why the CDC is recommending that if all parties have been vaccinated, then the risk is just so low that if you happen to be somebody who’s been vaccinated and who’s transmitting, you know, the person you’re likely transmitting to is ninety five percent protected. And so in general, I think that that’s very good advice, but it’s very confusing at the same time, because then how does society function? Is everyone asking each other, you vaccinated, are you asking all of your friends before your dinner party if everyone’s been vaccinated? That is generally what’s happening now. So I think that it’s going to be complex for a while. Who needs to wear masks where you need to wear masks? How sure are you that you know that you’re not transmitting if you have been vaccinated at low levels? Like, I wouldn’t recommend, for example, that somebody who may live in an environment that is that has transmission ongoing. Even if they’ve been vaccinated, I wouldn’t recommend that they go into a nursing home without a mask and all of the data so far that we’ve seen with regard to potential reductions in transmission from reduced PCR, viral loads measured, that’s all in the acute phase after vaccination within the first few months. And we do know that the power of the vaccine in terms of the immunological memory form does win over time. And so I think we have to keep monitoring it over time to see will people start sort of losing some of the real magnificent power of the vaccine and certainly to have a reduced efficacy to prevent transmission or disease. So we’ll have to just keep monitoring it. But at the moment, I would say it’s kind of a mess and it’s a little bit complex for the average person to know, like, why do I have to wear a mask? When do I have to wear a mask? How do I make those decisions?
Q: When do you think that that question will be a little simpler? Do you think we need to get to a certain point in terms of how many people are vaccinated at the present population is vaccinated or immunized, or when do you think that would happen?
MICHAEL MINA: Well, I personally think it should happen when cases stop surging and cases are very low, which I think, again, not to bring it back to test, but I think rapid tests out to the population can really greatly help it. Vaccines are obviously going to help it, but probably, you know, if for no other reason, but from an ethical equity, not trying to create a two-class structure, which is definitely going to be unfortunately divided not just on vaccine status, but on socioeconomic and race status. You know, we don’t want to facilitate those ethical quandaries in our society either. So I feel that we should probably wear masks pretty diligently until we get cases low. It’s you know, we’ve gone through hell to get to where we are today. And the last thing we want to do is keep going through hell. We want to get out of this. And we are seeing resurgence cases. We have the CDC director shedding tears on camera because of the resurgence in cases, pleading for people to be careful wearing masks is still pretty simple. Testing is still pretty simple. And unless you know that you are in a small space with everyone being vaccinated, I would say air on the side of caution for a little bit longer. Let’s see if we can stop this resurgence of cases before, they get out of control and, you know, and really get a handle on this.
Q: Perfect, thank you.
MODERATOR: Next question.
Q: I just want to clarify your point that the tests, the new test, the Abbott and Quidel. Now they’re the same tests that were already approved for symptomatic use within prescription. But now they’re just over the counter for asymptomatic use without a prescription and used serially, correct?
MICHAEL MINA: Exactly. Identical tests. This is one of them, same identical test.
Q: Is that a simple test? Because you always talk about the paper strip that can be tens of millions in a month. Is that simple enough to mass produce like that?
MICHAEL MINA: Well, this one, if you look at it, it’s actually this piece of cardboard. And that’s the test right there. It’s literally just that little thing. So, yes, it is exactly the kind of test. And the way that it works is you use a swab and then the swab goes into one of those holes. You literally just take a swab out of your nose and you stick it into that hole and then you pour a little you have a drop or buffer; you pour it into that other hole and then you close it. And then the result shows up in a little window there. So I think that there is even easier ways like take this strip off of the cardboard and just drop it into, like, the buffer with the swab. That would be that’s essentially what the quickfire does. The Quidel test is really simple. It’s just the paper strip that you drop into a tube. And, you know, I think if more companies made just the paper strip, get rid of any of the plastic casing, that we could really then you can really scale up very, very huge to Fauci.
Q: And you think they’re going to be around twenty dollars or ten?
MICHAEL MINA: So this is how they’re being sold now or how they will be sold. Just to be clear, this is just a box that doesn’t it was just a camera. So it’s going to have two in it. I don’t work for Abbott. They just send me it’s going to have two in it. And I think that I mean, I can’t say, what I can say is that the packs of 40, so each test is five dollars each. So this is a lot more packaging and then there’s going to be the retail markup. So my guess is they’re going to try to keep it at the price of like for the two tests combined. They’ll probably try to keep it at the price of a normal over the counter type of test, like a pregnancy test or something. So hopefully the box of tissue will cost somewhere like twenty dollars. I would love to see it at four dollars for the box of two, but I’m not going to push my luck at the moment.
Q: And then any idea what the CDC plan might be for screening asymptomatic people that they’re working on?
MICHAEL MINA: Yeah, well, they’ve essentially come out and they’ve said, like repeat, frequent screening of asymptomatic people is a very powerful way to identify transmissible people, to identify people who are infectious. And so this is, you know, is this going to be the test in this format that’s going to allow people very frequent testing? No, that might be still the boxes of authority in a clear way of environment. But essentially, CDC said K through eight. It’s great to test on a frequent basis that that’s what the science shows. Our own CDC director, Rochelle Walensky, published one of the earlier papers last year showing frequent use of testing is one of the most powerful ways to mitigate spread. And so that’s really what their guidance now is showing. I think that this is all working together. And as we get more market forces, if more tests come on the market, it will drive prices down for all the tests. And I hope that we can get to three dollars test in due time. And even if not, I think the government you know, this is one thing that I would say, and I really feel very strongly that, no, during a pandemic like this, no person should need a prescription. A person should need to go to the doctor to get a test if they don’t want to. And I don’t think a test should be the cost of the test should not fall on the user. Taking a test to help you prevent transmission is for the benefit of the public. And it can only be in the US’s best interest to buy these tests for the public. And this is where it’s such a difficult thing for people to get their minds around during this pandemic. This is not a diagnostic test. People aren’t taking a frequent paper strip test to help their own health. They’re taking it to ensure that they are safe if they go out of their house, that don’t infect their neighbors. It’s a public health utility. So to ask individuals to pay for their ability to not harm their neighbors inadvertently is really missing something here. And we really have to remember that these are public health tools. And they you know, the more people are using them, the better for everyone. And almost the last person that it’s actually really effective for is the person using the test, because if you’re positive, you’re positive the test isn’t going to change that. And, you know, so I would really like to see the government, they’ve put a lot of funds towards just paying for these tests. And ideally, then they can use their leverage to drop the costs even more.
Q: Thank you.
MODERATOR: Dr. Mina, I have a couple of questions for you. Do you have any conflicts of interest that you want to tell us about?
MICHAEL MINA: No, I work not with rapid antigen tests. I work with a company called Detect and they make molecular tests, but not for this rapid antigen tests.
MODERATOR: Right. Thank you. And what was your reaction to the FDA announcement when it first came out?
MICHAEL MINA: I mean, I think just I’ve had a hard time with it. A little bit, but now I think I just excitement, frankly. I mean, I’m just really, it’s been such a long, long road to, you know, create the science. A year ago, we started developing the science around rapid testing and how rapid testing could work. At that time, I was setting a PCR laboratory and realizing that, you know, the PCR laboratories weren’t going to be sufficient for actually mitigating spread. I set up massive PCR labs at the Brigham and Women’s Hospital at the Broad Institute and then developed a whole, you know, in some ways, kicked off this field of science around rapid testing, along with some other folks and it’s just been a year of trying to build that science, build the lexicon for it, just build the language around it, there wasn’t even a language for how to how to describe that. The transmission blocking test and a public health test versus a diagnostic test was published. Lots of papers on it now to try to create a new ecosystem, a new language, to even just give it a framework to think about it. And so to go from there and frankly, to have an extraordinarily fraught year in terms of trying to advance policy and trying to describe scientific findings to policymakers and regulators to finally get to this point where the FDA is actually recognizing it and overtly recognizing it. And in the same way, the CDC, the White House and the NIH are also recognizing that, I think it feels. I don’t know, like at least I tried to accomplish something and have moderately succeeded.
MODERATOR: So screaming into the void worked?
MICHAEL MINA: I suppose so.
MODERATOR: Eventually. So how are you doing today then?
MICHAEL MINA: Today has been just like any other COVID day, it’s been extraordinarily busy.
MODERATOR: I want you to be happy!
MICHAEL MINA: I know, you know, there’s still so much to do. There’s still you know, I do want to be happy, but it’s really hard when I recognize that, you know, these announcements are coming up, but the supply is still going to be lacking. Most people still aren’t going to get their hands on one of these tests. You know, the some of the barriers are coming down, but there’s still barriers and. To really give the White House the tools that they need to be able to follow the science, I think is, you know, it’s still on the agenda. But I do feel very relieved. And I think that after this week, I will probably take a big step back from advocacy and I’ll let the companies figure it out on their own. How to get there is I’m probably going to step away back from testing and just go back to my research life. And the global immunological observatory as well. Yeah, that’s part of what I would really like to focus on, getting set up the Human Immunomics initiative at Harvard as a big initiative that we’re trying to start to understand human immunology, the global immunological observatory, to create a weather system, a global weather system for viruses, to track and monitor pathogens across the globe using people’s immune repertoires to do so. These are all very, very exciting to continue studying the immunological impacts of measles on kids and understanding the importance of measles vaccines and other childhood vaccines. I’m so incredibly tired of testing and just want to get back to my immunology and public health research outside of this particular domain.
MODERATOR: I can understand. Well, congratulations and thanks for all your hard work on this and just from me, thank you. Does anybody else have any questions out there? Looks like that may have been the last one. Anything else you’d like to tell us before you go?
MICHAEL MINA: No, I think that’s it for now.
This concludes the April 1st press conference.