Coronavirus (COVID-19): Press Conference with Michael Mina, 12/11/20 | News


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 2 p.m. Eastern Time on Friday, December 11th.

Transcript

MODERATOR: Dr. Mina, do you have any opening remarks?

MICHAEL MINA: No, not right now.

MODERATOR: OK, let’s see what happens by the end. All right, first question.

Q: Thanks for the call. Appreciate it. Dr. Mina, thanks as always. Nice backdrop, by the way.  

MICHAEL MINA: Thank you, I made a lot of it.

Q: I’m working on a story on whether it’s advisable for businesses now that the vaccine is starting to roll out to require their employees to get the vaccine. From a medical standpoint, is that something that makes sense?

MICHAEL MINA: It’s such a fraught question. I think it can’t make sense at the moment because it’s not up to people if they have access to the vaccine yet. If we get to August, that question might be more reasonable to ask. But I think we certainly cannot anticipate that in any time in the very near future that the vaccine is going to be widely available. I think that if, for example, there started to be laws made that started to discriminate based on age, for example, because these will be rolled out, first will be to first line medical professionals and eventually it will get to vulnerable individuals and eventually to sixty-five year old’s and up. And so I think that requiring a vaccine would start to get into the territory of discrimination because there’s not going to be equal access to the vaccine. So I think it starts to get a little bit outside of my domain of expertise, to be honest. But I do believe that it’s a question for a medical ethicist, and B, I have a feeling that it won’t be appropriate to require it any time soon.

Q: Thanks, appreciate it.

MODERATOR: Next question.

Q: Hi, curious, Pennsylvania just announced increased closures, including indoor dining and gyms, which were already operating at a quarter or half of capacity. Curious on your thoughts on the value of closures of things like gyms and restaurants and also kind of how that crosses paths, if that makes sense, with testing that you’ve been pushing for.

MICHAEL MINA: Yeah, it’s extraordinarily frustrating to me that we are back in this position, completely predictable months ago, predictable in March. I think certainly, congregate settings like restaurants and gyms are potentially places where transmission can unfortunately occur, and it does occur. So we have put ourselves into a position where we don’t really have another choice if our goals are to try to slow transmission. I think we do have other choices right now, which, of course, you all know what I’m going to say, which is to scale these tests up, get these into everyone’s home, put these at the door of a restaurant, put these at the door of a gym. We change the balance. If we had these in front of every restaurant, I don’t think that we would say restaurants need to be closed. If we had them at the front of every school, I don’t think we’d say schools have to be closed because this little piece of paper has the potential to drop the probability of somebody walking in being a transmitter by ninety-eight, ninety-nine percent. And so if we could say, look, the risk of opening this restaurant is already not huge in terms of will somebody with COVID who’s spreading it right now, walk in the next two hours. But if we could then cut that risk by ninety eight percent, that really changes the balance of the risk benefit ratio to keeping the economy closed down.

And this is at the heart of everything I’ve been talking about for so many months, which is we have this tool. It doesn’t look like a PCR tool. It’s a piece of paper. But the more data we get on it, the more we find that this little piece of paper is ninety-nine-point nine percent sensitive and specific. Actually, really formally, I’m talking about this paper, the Abbott BinaxNOW. New data showing that this one is is ninety-nine-point nine percent sensitive. This one is just about that. And so we have all of these tools that we could scale up if we just use them. And I think we wouldn’t have to be closing everything down. The point is they actually work. So not only could they get community transmission under control by giving them to everyone in their homes, but let’s say we actually put these into everyone’s home, we scaled them up. We already are building about eight million of them a day in the United States, but we’re sending most of them overseas because the FDA is not willing to really recognize them as public health tools. And that’s part of the reason. But if we could get them out to everyone’s home, we could get population transmission down. Let’s say we dropped overall incidence by 70 percent. So then the average person walking around on the street has a reduced risk of 70 percent. And then you put these little tests at the entrance to every restaurant and you require that somebody has taken a test within the last five hours if they’re going to come into your restaurant. Then you’ve had a 70 percent community reduction plus 90 times a 90 percent individual sort of entrance risk reduction. And that would completely change the balance and allow us to start opening up our economy. It’s very simple. We know how well these work now, and that’s why I have been such an advocate for these. It’s not because I enjoy talking about these tests. I hate talking about these tests at this point. I just want to get back to my other research in my life. But these are the only tool we have at the moment that we could roll out today and actually not be running into the problem that you are bringing up.

Q: And really quick follow up on that, when I ask people, the response I get is the report and I’m sorry to beat a dead horse with these questions, but the reporting part of it is that, you know, that a positive test needs to be reported. That seems to be what the response I get from from lawmakers that I talk to.

MICHAEL MINA: Yeah, it’s really short sighted, I think this is just a symptom of us not thinking about what the heck we’re doing and not thinking about why we want reporting. We want reporting not to have control, although that’s debatable. But we want reporting so that we can get the epidemic under control. If there was no epidemic, we wouldn’t care about reporting of the epidemic. So the point is reporting helps us define where the cases are so we can enlist sort of public health help. That is a process called surveillance testing. This is a different type of testing. This alone can get the epidemic under control without the reporting. And so people who are saying that are really missing the point. And I think that we’re just so ingrained with this idea that we must be reporting it really has to do with this very paternalistic supervisory governmental kind of approach when we need to empower the people. This is a tool that empowers everyone. It allows them to make the right decisions without somebody calling them up and telling them to go get a test. The only options we have on the table right now besides this are PCR tests, which generally are taking days and days to get back from public health transmission perspective. They are purposeless. If it’s taking days to get back, by the time you get it, you’ve already done 90 percent your transmission. So people are unfortunately missing the point. They’re missing the opportunity to step back and say what is our goal and what’s the best way to get there? And reporting is just a structure to allow somebody to call up somebody else and tell them to get a test. In this case, we’d already have all those people using tests much more frequently and much more rapidly than the contact tracers ever could get them to.

MODERATOR: Next question.

Q: Thanks again for doing this and excuse my noises here of my water heater died this morning and there’s a plumber walking in out. So I have two questions. The first one is kind of a sweeping question. What do you think about the significance? It looks like we’re going to get a vaccine authorized in the next day or so. What do you think about the impact of that? The benefits of that?

MICHAEL MINA: Well, first, do you remember that you were the first person to interview me about COVID? Do you remember that? It was back in January.

Q: I didn’t realize I was the first, but I know I’ve been doing it for a while.

MICHAEL MINA: Yeah, it was like January 21st. So the question that you asked was?

Q: What does this do to our fight? What significance does it have to have a viable vaccine, knowing it will take a while to roll out?

MICHAEL MINA: To to be honest, I’m really worried about it, about what it’s actually going to do today, I think that we have so focused on the vaccine, this whole pandemic that we have lost track of the tools that are sitting in front of us and now more than ever, we need them. We are in the thick of it right now. We are at the peak of transmissibility of this virus. It’s probably going to last for another couple of months in terms of being in the coronavirus season. We knew this again; we knew it back in March. This isn’t surprising. And so my real concern is that we’re going to have a few people get vaccinated, relatively speaking. It will hopefully be millions, but it’s going to be a very small fraction of our population. And so, on the one hand, I think it’s giving the public some hope and I’m very, very grateful for that, I think the results have been positive. We still don’t know how well they’re going to block transmission. We don’t know how long the vaccines are going to last. We know the last two months, but we know that there’s a good biological reason that the efficacy could fall dramatically after two months. And so my real concern in the immediate term, and I’ve heard I’ve heard it from policymakers. I’ve heard it from governors. And that is well, why should we bother with anything else? Why should we even try at this point? Vaccines are here. Well, every day, three thousand people are still dying. That’s why we should try right now. That’s why we should be putting efforts into new approaches today, every single day we wait, we have thousands of people die. We have tens of thousands of people injured and get long COVID and other problems and every single day. I don’t think we realize this as a country, but this virus is costing us about 16 billion dollars every day. Every single day, and that is, it’s horrible. I mean, when you couple all of those together so that now is not the time to step back and say the vaccine is here, let’s not worry anymore.

I think now is the time more than any time that there has been to say we have to do everything in our power to figure out how to stop this virus today and set ourselves up for the best success so that as the vaccine continues to be rolled out, we can really give it its best chance to additionally stop spread. The incoming CDC director, Rochelle Walensky, just had a nice piece in Health Affairs, I think it was in Health Affairs, and said very clearly, that vaccines work best when incidence is low and when you start rolling out vaccines, you want incidence to be low. That’s how they can be the most beneficial. And so I think we’re unfortunately not going in that direction. So I hope that the vaccines and all the news surrounding it doesn’t take away from our our recognition that we have thousands and thousands and thousands and thousands of people continuing to die daily. So my concern is that it’s backfiring a little bit in terms of where people’s focus should be.

Q: Do you have concerns that we’ve been hearing that some health care workers even are reticent to take the vaccine because they’re first in line, I guess, and they’re concerned about safety? Are you hearing that, and do you have similar concerns?

MICHAEL MINA: Sure. I don’t have particular concerns about the safety at a population level at this point. I do have concerns, the moment you take a vaccine that’s been trialed in tens of thousands of people and you start giving it to potentially tens of millions, I’m sure people will hate me for saying it, but there’s not a zero percent chance that will somebody die of some complication. But that’s a very, very, very small risk relative to the benefits and the gains that can come from a vaccine. And this is always the trial and tribulation of vaccines, it’s one of the few things we have a duty to healthy people, which makes the bar so incredibly high in the midst of a pandemic. We, of course, have to be a little bit more liberal in terms of what our risk threshold is. But I do think that I’m not surprised. In fact, health care workers, especially in the nursing community, and I don’t know why, but there’s been a large push back for years against vaccines. And I think it’s just for some reason, it’s been more in that community than the physicians. But it’s easy to forget how much vaccines do for us. And so it’s very easy to slip into a vaccine hesitant role because we don’t see the benefits of vaccines every day because it’s very difficult to see how much you’re benefiting by something that is not in front of you because of the vaccine they’ve been benefiting from. And now, when we think about just how accelerated the trials have been, how much media attention has been placed to, is the Trump administration being honest with the vaccine, the vaccine trials, or are there cover ups and things like that, which I will say very much that I don’t believe that there have been cover ups, I think, or at least I think that the vaccine trials have gone quickly but safely. But it makes sense that we’ll have health care workers who are a bit reticent about getting a vaccine.

Q: And I owe you a coffee, January 21st, 2022 in a restaurant without mask? Thank you.

MICHAEL MINA: Great.

MODERATOR: Next question.

Q: Hi, thanks for taking the question, Dr. Mina. One of the things that occurs to a horribly uneducated layperson about availability of the vaccine is that it might change what might be perceived to be the best deployment of diagnostics. That is to say, if you were to concentrate vaccinations in a given geographical area where you see a fairly significant incidence, you might then reasonably conclude that you can shift some of your diagnostic and surveillance testing to other areas. Maybe that doesn’t make any sense, but I figured it’s a question. And if it is a dumb question, I can just explain that I’ve got a bachelor’s degree in communication and that’s it. So what’s your reaction to that?

MICHAEL MINA: Not a dumb question at all. It’s a real concern. This happens, for example, it’s been a concern of mine that when we look at communities and where cases are right now, we’ll use places in New York City, for example, some places in New York City were hit very, very hard. So hard that 30, 40 percent of people were infected. That doesn’t necessarily mean that those places don’t need the same type of support today because they were hit very hard early on. But they might have some level of herd effects at this point. And so they might end up, that population, if we were to do a study today, we might certainly think that, hey, that population somehow is avoiding the wrath of this virus. But really, it’s just because we missed the opportunity to see how much devastation it has already played. And so it kind of gets into the same sentiment where we have to be very careful when we’re allocating resources to understand what’s actually going on on the ground where we’re trying to allocate those resources. Should vaccines be a replacement for improving, like should we assume that if we’re getting vaccines into a community, that we can forego our other attention? I would say absolutely not. If we could vaccinate enough people and then see that, hey, that whole community is now safe from this virus and we can actually benchmark that, I would say then that becomes a different story. But for the time being, anyway, we are going to be vaccinating a very small fraction of people. And in general, it’s not going to be the people who are the greatest transmitters. There will be people who are putting themselves in the front line and might be at risk. And I think it should not take away from all of the other public health programs that are taking place.

Q: Super, thank you very much.

MODERATOR: Next question.

Q: Hi, doctor, thank you so much for doing this call. I had two quick questions for you. I hope they’re quick. The first is we’re seeing some chatter online about Bell’s palsy. The question being, does the COVID-19 vaccine cause Bell’s palsy? And then my second question has to do with whether or not the participants in these COVID-19 vaccine trials will ever get to know that they got the placebo or they got the real vaccine?

MICHAEL MINA: I’ll be completely transparent. I haven’t seen that about Bell’s palsy in this vaccine. Of course, vaccines can on occasion, in the same way that infections they can elicit reactions that are bizarre. We see this with both infections and vaccines, they can elicit, for example, autoimmune antibodies. And it’s essentially any time you stimulate your immune response. This happens after regular infections. It happens after vaccines. So is that maybe what people are recognizing? I would say that when it comes to vaccines and things like Bell’s palsy, there is a long history of vaccine hesitancy and some outright anti-vaccination media, which tends to place things like Bell’s palsy, which often are what we call idiopathic, meaning we don’t have a defined sort of root cause for somebody’s condition. I would say that there’s some level of wanting an answer, especially if it’s parents with their kids or just individuals on their own, people want answers to what’s happening. Sometimes you can actually make very clear temporal connections, but sometimes the connections are very loose, but our minds want to find a reason. And a vaccine is often that reason. So I don’t know about this case, if there’s any truth to this. An immune inflammatory reaction is what elicits a Bell’s Palsy reaction, which is for anyone who doesn’t know it’s when half of your face, kind of gets a little bit paralyzed and jerks. So I’m not quite sure about that. And I am interested to look into what the current concerns are about it. You had a second question, but I can’t remember it was.

Q: Sure, and I’ll give you a follow up to that. I haven’t been closely following the FDA hearing, though there were murmurs that there were four participants from the Pfizer group that developed Bell’s palsy. So I think people are seeing those four participants and saying maybe, perhaps this is proof that people should not take it.

MICHAEL MINA: So I didn’t I didn’t actually get a chance to read yesterday what the actual reaction was, these are the allergic individuals who ended up with Bell’s Palsy, is that the story from yesterday?

Q: I believe this information came out yesterday as to whether or not this was the allergic reaction you were thinking of, I’m not sure.

MICHAEL MINA: OK, yeah, there is a story yesterday that I also have, and I’ve just been working far too hard, I haven’t had a chance to get caught up on everything. But there are certainly concerns that came up yesterday with the Pfizer vaccine trial that individuals with severe allergies, ended up having some sort of response. And I haven’t looked at it. But, anyway, I wouldn’t be able to say much, much more than that at the moment of that issue.

Q: Sure, and the second question that I had was regarding the vaccine group participants, the volunteers, whether or not it’s going to be unblinded, they’ll be able to know whether or not they got the placebo or the actual vaccine?

MICHAEL MINA: Yeah. Certainly, at some point they will be unblinded. I think there’s a lot of questions and I am not quite sure exactly how and when it’s going to happen. But certainly, the questions, for example, are what is ethical at this point? Do people who joined into the vaccine trial have a right to get to be unblinded and get a vaccine right now because they were willing to join and sign up early? And how do we weigh the ethics of not giving them a vaccine despite the fact that they chose to join into the vaccine trial versus the benefit of continuing to monitor these two arms of each of these vaccine trials to understand what are the longer-term efficacy metrics of this vaccine? Do we want to preserve the two arms as they are, for example, or do we want to unblind them and allow everyone to get a vaccine? I have a feeling that I mean, I don’t know. But certainly, the tides are likely going to go in the direction of unblinding and allowing people to get a vaccine. But the question is when? And certainly, I think that in particular, for people who are not necessarily in line to get the vaccine first. I hope that there is an option for people to remain in the trial without knowing their status so that we can actually understand a little bit more about the durability of the infections, even just another few months would give us a lot more information right now.

Most people were only sort of in the trial and vaccinated during the phase three for about two months or so before the results. And my real concern with that is during that period of time, about two months is essentially the exact same timescale as when people’s immune systems are really energized from the vaccine. They have a huge number of antibody secreting plasma cells that are floating around their blood. But ultimately, those plasma blasts will die off after about two months in entirety. But during that period of two months, that’s what’s turning out the vast majority of somebody’s antibodies. And so my real concern is that we have now gotten these extraordinary results from phase three trials for at least two of the vaccines. But we don’t actually know what it’s going to do between months two and five, even. We really only measured months one and two for the most part across people, and some of them a little bit longer. And I think we have to really be cognizant of the fact that the early effects of the vaccine might be much grander and more efficacious than the effects. Even three months after vaccination, when all of the plasma blasts that are produced, most of the antibodies that are protective, they all have to die. And so then you really you have to focus on all of those small fraction of cells that are remaining. How well are they protecting people at month six, for example? And so that’s the type of information we don’t yet know that we really need to know. We can’t just blindly go into this and say, hey, the efficacy of this vaccine is ninety-five percent when we’ve only measured up to two months. That’s like I think I’ve given the analogy before, it’s like going to war and putting all of your troops at the front line and saying we’re holding the line really well. It’s a ninety-five percent efficacy. And then assuming that after you remove all of your troops from that line and you just have some snipers in the towers, that you’re going to hold that line as well. That’s not a great way to view these results. I think we have to be much more cautious than that. And so keeping these people in the vaccine trial arms blinded, perhaps on a voluntary basis could give the world a lot more information.

MODERATOR: Are you all set?

Q: That sounds good. Thank you so much for your time, Dr. Mina.

MODERATOR: Next question.

Q: Thanks so much for doing this. So I’m the NFL reporter, and I have a little bit of a off the beat question here. The NFL since August, they’ve been doing daily testing of a population of eight to ten thousand people, a full system of contact tracing, and they’ve performed over seven hundred fifty thousand tests over the last few months. Has that been helpful at all for the medical community, just in understanding some aspects of the virus and how this spreads and how the testing can all work?

MICHAEL MINA: Well, the data is not being made particularly public, from what I know. I think that people should be livid. People should be in an uproar. We have the FDA being a gatekeeper to the average person, getting access to these tests at their home. We have doctors saying these tests giving error prone responses because they don’t know enough about these tests to understand just how effective they are. We have a lot of people saying these tests can’t be trusted in the hands of the average American. But then we have the rich and wealthy and famous of our country. We have Hollywood using these, the NFL is using these, the White House is using these. The important people in our communities. And by that, I mean the rich and famous are using the tests. But then we have a system that is stopping the average person from getting these very tests and in fact, causing them to not know what to do, what to trust.

And so I think we should really look no further than exactly what you just said to recognize, you know, the rich and famous don’t use the tools that don’t work, they just don’t do that. And I can tell you that these work, we’ve seen them work extremely well. And so I think I would love to, you know, to be able to look at the data from the NFL. But we have a lot of other data that shows just how well these work. There are universities, colleges that are using it, there’s countries that are using it. They are being used here and there in cities. And then internationally, we have a lot of data. There is a beautiful paper in The Lancet showing just how well this worked. Another group in San Francisco that’s coming up with new data that’s showing that these are over ninety-nine percent sensitive and specific. And so we have a lot of data that shows frequent testing works to keep places safe. It’s being used as an entrance screening. So we have Hollywood studios are back in session, football is back in session, all of this is back in session. But then we have Main Street’s closing down. We have restaurants closing down and staying closed. We have schools closing down and staying closed because these tests aren’t being made to the regular person, to everyone in the community. And that is I just think that the United States should be in a completely you know, people should be pissed off that this is not available to them, but it’s available to everyone with wealth. You know, I use these all the time. I have them in my house and everyone else should be allowed to have them in their house.

MODERATOR: Do you have any follow up questions?

Q: I mean, I understand they’re not sharing their data and I’m sure you have it’s not easy to follow everything that they’re doing. But they’ve had some interesting findings that there haven’t been any new cases that have been shared on the field. Teams aren’t sharing it from one team to the next. You’d think in a sport like football, there’s a lot of contact that something like that would happen. So what the NFL is doing, has that at all been helpful to understanding this virus?

MICHAEL MINA: Oh, sorry. Yes, absolutely. It’s been helpful to understand the metrics surrounding this test. We know a lot about how the virus spreads, but we know that the teams are stopping spread both within their ranks. Sure, you’re going to get outbreaks once in a while, but by and large, they’re really stopping most outbreaks from occurring because of this rapid and frequent testing they’re doing. They’re stopping it on the field because they’re not having players go out onto the field if they test positive. And so really what it’s showing us is just how narrow the window for transmissibility is, how well that we can find people with these tests when they’re transmitting, and we can isolate them and have them not go and infect others. So I would say certainly the sports teams like the NFL are showing us that the virus will turn these tests positive when people are really at risk of transmitting to other people. I would say that we’re learning a great deal from the lack of news in a way about outbreaks in the NFL, because we know that the only way that they’re realistically keeping themselves safe and stopping whole teams every day from having to to shut down because of this virus, which is so immensely prevalent at the moment, is because of this real rapid testing programs that they’re doing.

Q: Great, thank you for that.

MODERATOR: I will also just interject really quickly; Dr. Yonatan Grad is also a colleague of Dr. Mina’s and he has worked with the NBA. So if you’re interested in that, I’m putting a preprint that he was working on, that may be helpful, a different sport. If you’d like to talk to Dr. Grad, just let me know and I can try and set that up.

Q: Great. Thank you so much for that.

MODERATOR: Sure. Next question.

Q: Good to talk to you again. One question specifically about all the effort that you’ve been putting in, it’s clearly paying off. You have a lot of people paying attention. You’ve got the Biden administration talking about this. And even recently, I believe Secretary Azar mentioned it. So keep the ball rolling. But when it comes to actually getting this done, is it something you anticipate the Trump administration doing before leaving? Or are you relying more on the Biden administration and are you still talking with them about this? That’s my first question.

MICHAEL MINA: Yes, I think both. I think Congress is about to pass a nine hundred- and eight-billion-dollar bill on that. And so what we’re working very hard to do before we can really I mean, there’s a lot of these in production, but we need to scale it up maybe about double or triple what we have, which isn’t very hard for this country. Tony Fauci said it perfectly the other day. If you watched him at Harvard the other day, I think his direct words were, “we have done things infinitely more difficult than scaling up these tests. We can do this.” But to do it, we need Congress to appropriate the money. And in this almost trillion-dollar package that they’re trying to put together right now, I think one of the most important things that, frankly, they could do to curb spread instead of just cleaning up the mess, we really want to curb the spread and stop the mess from happening in the first place is they could allocate one billion dollars specifically to the manufacturing scale up of these tests. Once we have the tests available, then policy can be made.

The tests are sort of available right now, but they’re getting pushed. Most of the tests being produced by US companies are getting sent abroad to other countries. And that’s a shame for the United States. That’s good for other countries. I think what we really need right now, the most immediate thing is to have Congress appropriate a billion dollars in this next spending bill for COVID relief, specifically dedicated to building these tests at a greater scale. Once that happens and we have been speaking with members in the Trump administration, I give a lot of accolades. I’ve been a little bit harsh on some people, but I give a lot of accolades to Brett Giroir, who is in a very difficult position, I would say. But he has been really very proactive about working with us to try to build pilot studies, large pilot studies on these tests. He clearly is somebody who wants to see this kind of vision brought to life. He wants to see if it works. The US government did invest quite a lot into these BinaxNOW tests. And he has been trying to work with us and work with others around the country to see how we can best and most efficiently utilize these tests. So I would say that that’s one avenue. But at the same time, we have to recognize that in just over a month we will have a change in leadership. And so certainly I think the real heavy lifting for all of this is going to fall on the new administration.

I have certainly been in contact with Biden’s COVID task force. And we’ve discussed this. And I think that there is interest for sure. I think it’s very notable that one of the greatest champions for this approach for months, who is published as much as I have on this particular issue is Rochelle Walensky. She is the incoming director of the CDC that Biden has announced. And so I think that there are a lot of reasons to feel that there is potential here to see frequent testing become much more utilized as a tool to combat this virus. But I do also think that there are differences of opinion, which unfortunately mostly come out come from not really understanding the science around these tests, which has continued to limit the availability. And there’s also serious regulatory hurdles, which I believe every day that goes by, I think that what we really might end up needing is some sort of presidential order to release these tests, to not declare them as medical devices so that we can have some sort of the FDA regulate them. We can have the CDC or the NIH really take the helm and sort of evaluate this and sort of put a stamp of approval on which tests can and cannot be used as this public health screening tool, because the FDA just isn’t really in a great position to evaluate public health tools. So I think there’s a lot of activity that’s happening now. I think we can be optimistic that we might actually have tests in our home, and we don’t have to go and wait in long lines to get a test back days later, that’s not useful. But it’s still a little bit of a road to get there.

Q: Thank you. You kind of jumped the gun in answering my second question, but I’m going to ask it anyway. Looking at the regulatory issues. I know you’ve said this, and I’ve heard this actually the same exact phrase from multiple people, which is we’re more focused on getting it perfect than getting it done. I just wonder, has the hurdle been identified? It seems like there is a way around this and even outside of just shifting it to how quickly could we potentially get these tests into the homes?

MICHAEL MINA: I mean, they could start getting into the homes tomorrow if we if we knock down the barriers. It’s frustrating. We see now that the FDA just announced that LabCorp has a PCR test that they’re making over the counter. I don’t know where they’ll sell them. But if you have the means and you have the money and you can get to a Walgreens or wherever, they’re going to sell those or if it’s going to be by mail, I’m not sure. You can now get a COVID test from LabCorp without a prescription, without anyone telling you that you need it, but it’s going to take a while. You got to get the thing delivered. You have to use it to mail it back the next day and you get a result back three days later. So you’ve already wasted your entire transmission period. It’s never going to work for public health. But that said. Now, it raises the question the FDA has now conceded that COVID testing doesn’t require a medical prescription. So the real question now, is how can they continue to hold back these tests and require medical prescriptions for some tests, but not others? These are all COVID tests. There’s no reason to have this dichotomy existing now. We have over the counter COIVD tests, but still 90 percent of the tests or however many percent, are by prescription only. And that doesn’t add up. So if we can get to a point where the FDA can say, OK, these are all over the counter and you can go and buy this on your own, you can go buy a pack of ten of these for thirty dollars or whatever and go buy a pack of 20 of these for 15 dollars. Or better yet, have the federal government mail them to you and you get them for free. We could start doing that tomorrow if we could release these regulatory hurdles. But because the FDA is only in a position to evaluate a product based on its utility as a medical device, it really drives a stake through it. It stops us from getting these to everyone because they have really high bars, and they continue to compare a test that looks for protein. They made the gold standard a test that works for RNA. It’s not compatible. And for some reason, they’re unwilling to understand that these are very different types of tests with very different uses. And so I think that the only way that we’ll get there in a very fast amount of time is if, frankly, if somebody takes the pressure off of the FDA, says, look, this isn’t on you and I don’t know exactly how that can happen. Maybe that’s CMS. Maybe that’s a presidential order. Maybe it’s back in discussions with the CDC and the NIH. I’m not quite sure. But technically, it could happen tomorrow, if we wanted to.

Q: Thank you.

MODERATOR: Next question.

Q: Like everyone else said, thank you so much for doing this. I had two quick questions here. For one, I wanted to ask, nationally that sort of peak, here in Ohio were just kind of getting there, how do you interpret death hitting a peak just now and matching the death of the spring, but huge case increases compared to what we were seeing in the spring versus what we’re seeing now. And I was wondering if you’ve looked at any data as to how people of the world rank as a leading cause of death in the US?

MICHAEL MINA: So sorry, just to better understand your first question, are you asking about the delay in deaths relative to the cases now, or are you asking to compare the deaths in the spring in Ohio to the deaths today in Ohio?

Q: I guess I’m asking both nationally and at a state level, why are we just seeing deaths hit the threshold that we saw it in the spring, that we’re seeing it as a byproduct of so many more cases, like more than one hundred thousand cases a day now versus whatever that figure was in April?

MICHAEL MINA: Well, there’s two reasons for that. The first is that we didn’t have the kind of testing in the spring, so there were probably quite a lot of cases occurring that went completely unnoticed. And so on the one hand, that’s just a fact. On the other hand, the death rate has certainly come down. We have a different demographic of people who are getting infected today. We have actually done an OK job trying to keep cases out of nursing homes. Not a great job, unfortunately, but certainly better than we saw at the very early days of spring. So we’ve actually seen fatality rates drop, both because of the difference in demographics, we know that younger people have orders of magnitude lower mortality rate than elderly. But also we have actually made medical advances to better understand how to protect, to keep people alive in the hospital. So I think all of that combines to get at the pattern you’re describing.

Q: And have you reviewed any data that might be able to gauge where COVID will rank as the leading cause of death in the US?

MICHAEL MINA: Well, I haven’t been paying attention to the rankings lately, but I imagine it’s in the top two at the moment. And I think that’s very notable. It’s devastating. We have this, frankly, preventable disease that we could have prevented from spreading and ideally, it’s not going to continue being in the top two or three causes of death in the country. Who knows, maybe it might even be the top cause of death right now. I am looking forward to a few months from now when it starts to come down again, hopefully it will just be in a few weeks from now, but I think Christmas will end up leading to another big burst of cases. And it might not be until February or so that we start to see cases really start to decline, maybe not until March or April. We’re just not sure. Depends on a lot of factors. But I hope that it doesn’t remain as elevated as it is right now. It’s really a national travesty and it’s just sad.

MODERATOR: Jake, I don’t know if it’s helpful, but the WHO came out with the leading causes of death and disability worldwide yesterday and it’s through twenty nineteen and they have a little bit in there, about COVID as well. So put a link to that in the chat.

Q: Yeah. Thank you to both of you. That’s a huge help.

MODERATOR: Sure. Next question is Kyle Midura from Gray TV.

Q: Hi, Dr. Mina, thank you for making the time today. In chatting with lawmakers on the Hill, some of the pushback I’ve heard to the widespread rapid testing approach is that they frankly don’t believe that these tests are accurate enough to the same degree PCR tests are, and they question the efficacy of an approach, relying on, quote unquote, less accurate tests, given the White House was using an Abbott antigen test prior to super spreader events. Was that a flawed test? Were they using a flawed approach? Was it just a suboptimal outcome? Or is that a fundamental misunderstanding of the macro level approach versus the micro level approach?

MICHAEL MINA: It is a fundamental misunderstanding of the macro level approach versus the micro. No thing that we can do can stop every outbreak. My real opinion is that our president was the super spreader at that event and probably was not tested. His physicians failed to really confirm ever that he was being tested. And it was everyone in the front rows that ended up getting sick. And there’s a lot of evidence for that, in my opinion. But it’s a very poor interpretation of that event because it’s easy in public health to look at the one event. But public health is not about taking the numerator and just forgetting what the denominator is. This is demonstrating that unfortunately, some of these folks you’re referring to just don’t know the basic properties of how to evaluate risk. The denominator, there should be the number of days that the White House went without any outbreaks and frankly, they went all the way from March through October, flagrantly disregarding essentially every public health tool except for a rapid and frequent test. And they didn’t have any outbreaks against all odds from March through October. And so to point a finger at the Rose Garden event and say, look, testing doesn’t work is the most misguided approach you can take to that event. What you have to do is you have to point a finger at the White House from March through October and you have to say how many outbreaks did they have and how many would they have had if they weren’t doing frequent testing?

People with tests, I don’t understand this at all, when we have a ninety-eight percent or ninety-nine percent sensitive test, people only focus on the one percent risk. But then when we have a seventy percent effective vaccine, people only focus on the seventy percent benefit. And they don’t say we shouldn’t give a vaccine because it’s not going to work. And thirty percent of people, they don’t say we’re not going to use a vaccine, which is not going to work, and five, if we can cut risk by ninety-nine percent when people walk into an event, then that is a major benefit. I don’t know why anyone is even arguing this at this point. The question about the accuracy of these tests is done. There are so many publications now that are out there. They’re from the best groups in the world, from the Netherlands, they have one of the best labs in the world on this topic from Germany, Christian Drosten, from Joe Derisi in San Francisco, from all over the world, we are seeing the serious benefits and just how accurate these tests are. And the reason that they have become so accurate is because the science has caught up. It’s unfortunate. It’s what I’ve been saying for many months. But now everyone is realizing, hey, comparing just to PCR positivity is not the right thing to do. That’s like, you know, faulting a security guard for not seeing a crime that’s no longer being committed. But there’s blood on the floor. A PCR test can detect that DNA on the floor, but that’s not on the security guard to find that blood that’s on the forensics. Detectives go and find that these are two totally different topics, unfortunately, in our country. Everyone’s looking at the FDA. The FDA is not a scientific body, they’re a regulatory body. And unfortunately, the regulations haven’t caught up yet to the science. And the science is that an antigen test works exceedingly well to catch people with live virus, or PCR test works exceedingly well to catch people with live or dead virus who were infected weeks ago. And so we just have to stop making the PCR test the gold standard for an antigen test. They’re just different tests and boom, all of a sudden, we actually see the real power of these tests. And it’s that they are exceptionally sensitive to catch infectious virus. So unfortunately, it’s a question that continues to circulate. It continues to be perpetuated by our federal government, by the FDA, who for I just don’t understand why it will not budge on this issue. But this is a serious issue, it’s an issue that is literally causing thousands of lives a day right now because of the confusion it’s causing, the rest of the world is figuring it out. They’re saying, hey, we need a PCR value of a CT in less than 30 is reminiscent of a live virus we can compare it to that is the gold standard. Or we can go to culture positivity or we compare this test to this test because this has been shown to work exceptionally well, whatever it might be. Comparing to PCR is continuing this this false narrative.

Q: Thank you, Dr. Mina.

MODERATOR: All right, Dr. Mina, I have a question. She’s in Greece. She has a series of questions about the vaccines. And she was wondering, what would you say to those who believe that the vaccines are unsafe?

MICHAEL MINA: I would say that for absolutely, for the vast, vast, vast, vast majority of people, the vaccines have proven very effective and safe at this point. We’ve now given in phase three trials over one hundred thousand people these vaccines. We’ve seen very, very, very few severe attacks. We are going to learn. I think we have to be right and we have to be up front with the media and the people of the world about this topic, that when we move from a Phase three trial of thirty thousand people to vaccinating millions, we very well might find new things that were not uncovered during the trial. This issue of severe allergic reaction of people having some response could be one of those things. We might even have a fringe case where somebody gets too high a fever and has a seizure. But those are going to be rare. They’re probably going to be less than one in one hundred thousand, if not one in a million. And so it’s sort of like the same question about the Rose Garden. We have to in public health, we have to not just look at the denominator and say, look, this person had a severe reaction. We have to look at this person out of how many had a severe reaction. And in this case, if it’s one person out of a hundred thousand vaccinated, well, your risk of dying today is quite a bit more than that from the infection or of getting severely ill. And so the risk benefit ratio really is favoring getting the vaccine as long as what we have seen thus far continues to hold, which is across these tens of thousands or hundreds of thousands of people that have been vaccinated across the various vaccines, we’ve seen exceedingly low, serious adverse events.

MODERATOR: Another one of her questions, how close are we in winning COVID-19?

MICHAEL MINA: Depends on what country we’re talking about, I suppose. I think we’re going to see an unfortunate disparity in vaccine rollout both within this country and abroad. We will probably see the wealthy nations get vaccines much more quickly than the poorer nations. The US decided not to sign on to the COVAX agreement, which I think is a stain on us. That’s just terrible, in my opinion. That’s an agreement to help ensure equitable distribution of vaccines across the globe. So I think COVID-19 isn’t going away, it’s going to continue persisting across the population, but it will become a seasonal virus, it will become something that sticks with us, but it won’t be as serious. It won’t be as bad over the coming years after people have already received one vaccine or two vaccines or have been infected. If they get exposed again, maybe they’ll get a little bit of an infection, but it will actually serve to boost your immune system. So re-exposure shouldn’t be seen as a bad thing. They should, to a certain degree, be seen as a natural thing with immunity. But I think we shouldn’t expect things to go back to normal in the United States until at least the summer. I think we could accelerate it a lot with these tests. But for the rest of the globe, I think it’s going to really be enormous in terms of which country you’re in, what type of resources they are provided. And we’re going to see a real challenge, an extraordinary challenge of some of these vaccines that require cold chains and minus 80 freezers. There are large parts of the world that just are not going to be able to get the freezers to those locations. And so it’s going to slow down vaccines quite a lot.

MODERATOR: And going back to the vaccine and people boosting their immunity, do you think that we will need to be immunized every year or is it just going to be as we pick up the virus?

MICHAEL MINA: I think we have to wait and see. We don’t have enough data at all to know how durable the vaccine responses are. We don’t have enough data at all to really know how durable the responses to the infections are. But we do know from the immune responses to have seen so far with the infections that they seem to be persisting for six, seven months. And that’s good. That’s good news. We don’t have that same data from the vaccines. And the immune responses between the vaccine and the virus totally differ. So we can’t place what we know about the infection on to the vaccine response. But there’s a good chance for a little while we might need vulnerable people to be vaccinated. In general, somebody who’s in their 70s or 80s doesn’t have the immune system’s memory is no longer very good, same as our sort of regular memory start to go down with age. And so we might see that vulnerable people need to be revaccinated. Young people might turn out, will do just fine. Maybe you’ll get a vaccine once and then we can actually bank on the seasonality and the end, meaning that the propagation of the virus in the population after it’s done with these massive outbreaks to actually keep exposing people, given that they have already built up some immunity so that by the time somebody like myself becomes 70 years old, I will have seen the virus maybe 30 times and I won’t be vulnerable to its severe effects in the same way that seven or eight year old’s today are not vulnerable to the effects of age you want or any of the other seasonal coronaviruses. So even though it sounds scary that this might stick with us, I think we have to be recognized that the worst is going to be behind us once this year and a half or so is done.

MODERATOR: Thank you, Dr. Mina. That was the last question, do you have any final thoughts for us before we go?

MICHAEL MINA: No, I think I’ve got everything out of my system.

MODERATOR: Well, good. Then you can have a nice relaxing weekend. I hope.

MICHAEL MINA: I’m not sure I know what that is.

MODERATOR: When does the pandemic end again? That’s when you get a weekend.

MICHAEL MINA: Right.

This concludes the December 11th press conference.

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