Coronavirus (COVID-19): Press Conference with Michael Mina, 12/18/20 | 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 12:00 p.m. Eastern Time on Friday, December 18th.

Transcript

MODERATOR: All right, Dr. Mina, I’ve gone through all of my introductory remarks, so do you have anything you’d like to say?

MICHAEL MINA: No, we only of a shorter time today, so I’ll keep it short.

MODERATOR: Excellent. First question. He’s referring to an op-ed that came out in The New York Times. Let me just put that in the chat right now for everybody who hasn’t seen it yet. Yesterday at the FDA Advisory Committee meeting, Moderna suggested that the initial immune response from the first inoculation was due to innate immunity, and the second shot is what provides adaptive immunity. If I understand this correctly, innate immunity is a general ramping up of immune response, not specific to any particular antigen. Your op-ed today doesn’t address this directly. If this is indeed the mechanism of action, how long would you expect innate immunity to offer significant protection against COVID-19? And if that is indeed the mechanism, how about a push to vaccinate a bunch of people for other vaccines that would stimulate innate immunity?

 MICHAEL MINA: So the question is referring to an op-ed that I wrote today with Zeynep Tufekci in The New York Times suggesting that we should be immediately starting single dose trials. We saw such good responses after a single dose and before the second dose was given, that it really warrants an immediate investigation and beginning of new trials to see can we vaccinate twice as many people by using only a single dose? So far, we are like testing. We’re taking this very individual centric approach to a public health problem. We’re trying to optimize to add all expenses, the individual level response while forgoing the optimization at the population level. And so we need to be focusing on how to best optimize at the population level and frankly, just achieve herd immunity the quickest. And so the suggestion in the op-ed is that we need to start trials. We need to look to see does a single dose vaccine offer sufficient protection to allow us to reasonably and safely vaccinate individuals just once instead of twice? Ideally not the most vulnerable, but people who have very robust immune systems, younger people. And we could start these trials today. The question then asks suggests that, I don’t know who it was who said it, but that the suggestion is that the effect is fully mediated by an innate immune response and not an immune memory response, meaning a single dose might lead to protection, but it’s only an extremely short-lived response that is due solely to an innate immune response that would degrade after a few weeks. Now, I’ve been the first to say that even the two-dose vaccine might not last. And that’s why we need contingency plans. That’s why we need to get these rapid tests built as soon as possible. A lot of different pieces there. But the suggestion that this is an innate immune response alone, it does not hold true to the data. The data shows that people begin to develop a very robust protection at about 12 to 14 days after they get the first dose of the vaccine. That is not in line with it being driven wholly by an innate immune response. So I would say that the suggestion that it’s purely an innate immune response that’s leading to that early protection before the second dose is given is just not correct. I would caution that vaccine manufacturers have a lot riding on keeping a two-dose regimen in place. It’s just the fact there is a lot of money on the table and there is no reason why a vaccine manufacturer wants a single dose over a two-dose regimen. So that’s my cynical side suggestion that we need to let data drive this discussion. We need to start the trials. We need to get these trials done as quickly as possible because there is a possibility, we could get to herd immunity through vaccination twice as fast, if we find that a single dose regimen of a vaccine is sufficient, even if it’s only sufficient for a year and we need to give a booster dose a year later, that will get us through the next five or six months in a much better position than we are currently in.

MODERATOR: Thank you, Dr. Mina. Next question.

Q: Hi, I appreciate it. Thank you both for setting this up. Doctor, you’ve been a proponent pushing hard for testing. You just talked about the vaccines. Are we falling into a false sense of security that, hey, we’re coming down the homestretch? And if we are, what argument would you make to people who have that feeling that we’re not there yet and testing still needs to be a priority?

MICHAEL MINA: Absolutely. We are absolutely falling into a false sense of security. I mean, the media attention alone, the attention by the NIH, I mean, the moment the vaccine was authorized, it was as though everyone forgot that every single day, we are having over three thousand people in this country die every day and we’re OK with that. That’s twenty thousand people every week. That’s a town’s worth of people is dying every week. And so I think we are definitely having a false sense of security here. Most people are not going to get a vaccine for many months. We’re giving the vaccine to medical professionals who are in low risk or low health risk. And I worry very much that we are not going to get the vaccine to the people who need it the most for quite a while, and especially the people who are disenfranchised, people who live in poverty, they are going to be the hardest to reach. We have simple solutions in front of us. Testing is an approach that would help us tremendously. Getting the vaccine out is going to be beneficial. But there are a lot of problems or a lot of speed bumps. Even just at Harvard, we’ve seen difficulties getting, you know, just things as simple as the sign-up sheets that are online crashed. And there was some news about that. So the vaccine rollout is not going to be as peachy as everyone hopes. I certainly hope it goes OK, but it’s going to be a while. There’s a very serious cold chain that needs to be put in place. But beyond that, we don’t know exactly, this kind of goes back to what I was just mentioning, we still, even with a two-dose vaccine, we do not know the durability. It’s possible that the durability of the immune response might be the efficacy might be ninety five percent and then fall down to 60 percent after four months. We just don’t know. And there’s good biological reason to think that the two-month window in which it has been studied so far might be much better than the three, four or five, six-month window later on. And we need contingency plans. This is an experiment on a global scale we’re about to undergo. We are rolling out a vaccine in a period of time when the virus is transmitting in millions and millions, millions of people across the globe. That opens the door for the possibility for a virus somewhere in the world to mutate and be able to get around the immune response elicited to the spike protein that’s in most of these vaccines. If that happens, we need a contingency plan. We need another opportunity in front of us. And that’s where getting these simple paper strip tests out, these can slow spread, these can stop spread in communities if we want them to. If we want to scale them up. And we need them. Frankly, they are a different way that will only benefit the vaccine program and it can put the vaccine in the best place to also slow the spread once it really gets rolled out to everyone.

MODERATOR: Great. Next question.

Q: Hi Dr. Mina, I’m writing a story about whether employers should or will put out a mandate for employees to be vaccinated with the vaccine, and I’m wondering if you can tell me what the public health argument would be for a mandate, if that’s where you stand.

MICHAEL MINA: I’ve worked on vaccines for a while, pre-COVID I’ve worked on vaccines. I try to stay away from giving an opinion of whether mandates, mandates are a policy issue, they’re based on decisions that are outside of my area of expertise with regard to law and sociology and social structures and things like that. But from a public health perspective, I think that mandating anything is dangerous in our country where we essentially say that nothing should be mandated, so it immediately has the potential to backfire and elicit a lot of concerns about infringement of rights and freedoms and such, especially when it comes to health. But from a public health perspective, getting as many people vaccinated, vaccination and testing is a public health good. It’s not about the individual. I mean, it is on the one sense, but it is much more about stopping that individual from spreading to other people, whether that’s testing or vaccination. Vaccination has the dual effective also benefiting the individual from a health perspective, and so it’s a very difficult question, should you mandate something that exists that will have as one of its primary purposes, the protection of others around you? I think my personal opinion is that getting as many people vaccinated as quickly as possible benefits everyone. But I am very much in the camp where we should have universal health care and we should all be supporting each other in every way possible as a society. But that’s not how the US functions. And so the US functions very much on an individualistic basis. That’s what we’re taught. That’s our country. We have almost no sense of community in this country. And that’s what we have decided as a society. I don’t agree with it, but I think we have to take that into consideration very deeply when deciding whether or not in our society we should mandate something like a vaccine.

Q: But wouldn’t that help achieve herd immunity faster, if employers did, in fact mandate?

MICHAEL MINA: Oh, I mean, from a purely transmission of this virus perspective, absolutely. The more people we can get vaccinated, especially as we vaccinate clusters of people, surely that would help. Yes. That being said, I don’t think that we’re going to see the supply outstripped the demand. So if employers don’t require it, I think we’ll still see just as many people get vaccinated. So I’m not sure that it’s needed at the moment. We’re not trying to find people to vaccinate. I would say that people are trying to find the vaccines at the moment.

Q: OK, thank you.

MODERATOR: Next question.

Q: Dr. Mina, thank you for making time today. I’d like you to reflect on the approvals for both the Ellume Test and the BinaxNOW test that came or the additional approval, I should say, for the BinaxNOW test that came this week from the FDA with the BinaxNOW obviously requiring a medical professional to guide the patient through the swab. Secondarily, with these approvals, what are the biggest obstacles, in your opinion, to achieving the widespread cheap testing regime that you’ve been promoting and calling for?

MICHAEL MINA: Well, the best thing about the Ellume approval, I like the Ellume test as a clinical device, I’ll just be honest, I don’t like it as a public health tool because it’s not. It’s not going to be scalable to the type of massive testing that I’ve been calling for. But it is a very, very nice test that people would go out and buy if they’re symptomatic and it’s instead of going to the doctor. So as much as we can get people to not have to go out into the community when they are symptomatic, that is great. And so this is the Ellume test, I don’t work for Ellume or anything. I think it’s a really nice test. But what I really want is this test right here. And the problem with the Ellume test, if you turn it around, this is what it is. It’s got circuit boards and batteries and it actually runs on a paper strip test that’s pretty similar to this one. But this whole thing is disposable. So this isn’t something we want to try to get into every household to use twice a week. The nice thing about it and the thing that excites me the most is the FDA authorization for at home over-the-counter use. And that suggests that at least the FDA is willing to have to make that decision, that COVID test can be over the counter without a physician’s involvement. What it does, though, is it opens up this Pandora’s box, in my opinion, that is a good box to open, but it means to me that the FDA, there is no reason for any of these other tests to remain as prescription only. We need to figure out how to distribute them equitably, which I don’t think this this thing will be a luxury item for the rich, or at least the middle class. And now that the FDA has authorized this test, they’ve essentially said it’s OK for somebody to know their COVID status without a physician involvement. Of course, that’s the case. I mean, the FDA should have made this decision long ago. Unfortunately, the FDA is only in a position to make a claim for a company based on what that company wants. And so we saw Abbott also get authorization this week for at home use, but with physician involvement with an E medical consult. So that immediately, unfortunately, took this simple paper strip test, which just has a paper strip in it and brought it not from a five-dollar test, that it should be maybe even be less than that, but brought it to twenty-five dollars out of the accessible range for many people in our country. And so that’s because so it was very odd to have on the one hand, a test like this go and get a claim for over the counter, no physician involvement. And this one, you go from five dollars, where it should be, to twenty-five dollars just because they’re now demanding physician involvement, you know, it doesn’t make sense. You’re essentially paying twenty dollars or twenty-five dollars just to have somebody watch you swipe your nose when this one doesn’t require that. This one’s actually more complicated because you have to download an app to link it to Bluetooth. You have to do all of those parts. Right. So this is very complicated to use from a technical perspective, and it requires a phone and all that. So I would say that the FDA is not making a lot of sense, but unfortunately, they’re not in a position to make these calls. They make the claims based on what the companies want and what the companies ask for and applied for, which is why we have to change the system. We have a system where the executive branch or whoever it might be, it might say, look, great that Abbott wanted to get a claim for this that requires an E-consult. I’m sure that E-consult would make millions and millions of millions of dollars based on it. However, we need this today as public health tools. They should be authorized as public health tools, not requiring a twenty-five-dollar purchase, but requiring a five-dollar purchase by governments or whomever else. So I’m frustrated that we still don’t have this very simple device or this one, these are essentially the same. That’s what we need right now, and we need to be accelerating, we need the FDA to be recognizing that now that they have said that people don’t need to have physician involvement based on the Ellume test, I think all of the dominoes should fall and none of these tests should be required to have physician involvement and maybe what it needs because the manufacturers don’t necessarily need or have any real market incentive to go and get that claim. We need public health to step in with the CDC or the executive branch or Congress for something to step in and say, look, we’re grateful for these companies building these and suggesting that they need medical oversight, but we recognize that they don’t. And we’re kind of going around the FDA to say, although the companies are not asking for it, we’re saying that they can be used without physician oversight. And that’s something HHS could do, for example.

Q: Thank you, Doctor.

MODERATOR: Next question.

Q: Hi, thanks. I wanted to go back to your New York Times op-ed about the one dose. I just wonder how long, you know, if we started that new trial to test one dose today. I mean, how long would that take? And if it’s going to be a few months, is it possible it would be moot by the time the trial is over if, you know, in February, we have plenty of vaccine, even with two doses.

MICHAEL MINA: I think you’re way overestimating the availability of vaccines, particularly at the global level. Most people won’t be getting a vaccine across the globe for a long time until the latter half of this year or even into 2022. This is something that we could do as a service to humanity at the moment. If we start these trials today, most of the world doesn’t have A, access to the vaccines or B, the ability to really run these large trials. The US can. If we could do that, if we found after a two-month period of time that the benefits are persisting, that would greatly increase the accessibility of these vaccines to the rest of the world, getting the cold chains in place and having them sit there for a month while a second dose sits in a freezer, know that’s going to make everything much, much more complicated, particularly in low resource settings. So, no, I don’t think it would become moot at all. Two months from now, most people will not have a vaccine yet. If we were to start this trial today, which frankly, we could if we wanted to, we could start it. And in two or three months, we would know, are people with a single dose vaccine still seropositive, are they still showing reduced symptomatic cases relative to their unvaccinated control groups? Or we could even compare it to the two vaccinated. We take individuals who are willing to just get one vaccine and we compare them to people who end up getting two vaccines and we show what we call noninferiority. Or in this case, even if it’s slightly inferior from a public health perspective, it might be superior. And so we have to take a slightly different approach. I think we can do that. And I definitely think that if we start today, so far, the phase three trials were only two months, for the most part in their entirety. Some people went out to three so we could start the same thing now and it would not be for a while.

Q: Thanks.

MODERATOR: Next question.

Q: Thank you, I’m sorry, this is a very general one. We’re still in the midst of this pandemic, but looking towards the next one, what is the single thing that would be at the very, very, very top of your list for what must be put into place at a systemic level before the next pandemic?

MICHAEL MINA: A plan. We should have a strategy and a plan for any kind of pandemic that can come about. Respiratory pandemic, bio threats, pandemic that causes diarrheal disease, you know, whatever it might be, massive Ebola pandemic that transmits through aerosols or these types of things. We should have a plan for it. So that should we ever find ourselves in a position again with a president like the one we currently have, we don’t have to rely on the current administration to come up with a whole new plan. We would have a plan already right now that we can lay that textbook or whatever it is, the binder in front of the president and say, do this. This is what has been developed. So I think that that is the number one thing that we should be doing today to prepare for future pandemics. I will say that there are three other things that I’ll mention. One is, we should have a global surveillance program. And when I say that, I mean, what I would like to see is a weather system for viruses, a way that we can monitor the globe for pathogens. That’s something that I’ve been pushing for. It’s something that I’m trying to get started, what I call a global immunological observatory so that we would have passive systems constantly monitoring for current and new threats. We could scale up testing in the United States, testing infrastructure, so that when the next pandemic comes, we don’t have to go and build a huge number of new laboratories and do everything we’ve done. We should just have bunkers of laboratories. We should have factories that can make these in the millions and flip the switch within weeks. So we can actually prepare physically for this with infrastructural changes today. We should be treating this like a Department of Defense project. We have bunkers of missiles and bombs and planes and there’s no reason why we shouldn’t be learning from this threat and recognizing the serious need to prepare in that sense. And that goes into the third piece, which is we need to bolster our public health. We don’t have any sense of public health in our country. We have found that the public health networks, the state laboratories, the State Department of Public Health have been largely ineffective because they have been underfunded and devalued for so many decades. And so we need to get away from just having a medical centric capitalistic approach to health. And we need to bolster public health and preventative health care at the community level. And if we do that, I think we’d be in a much better position.

Q: Thank you.

MODERATOR: Next question.

Q: OK, can you hear me?

MICHAEL MINA: Yes.

Q: Oh, hi, professor. So my question is also very general. Now we are in the vaccination age, so we all know that it’s totally different with the world before. So what factors will determine the future of the United States in terms of ending the epidemic, and what are the possible variables?

MICHAEL MINA: Well, I would say that we can either accelerate the end of this outbreak in the US, we can’t do too much at this moment in time to accelerate the vaccines much more than we already have. I’ve put out a suggestion that we should be trialing a single dose to do that. We should be bolstering our testing program. I think more than anything that is available immediately, these small little paper strip tests, if we get these out into the communities, into people’s homes, into schools, workplaces, we could decrease community transmission and make each individual location safer. We could do that today. We have millions and millions of these tests, we can be accelerating their authorization with the government to get them out to the community. What we need to do, and it looks like we’re not going to, unfortunately, but Congress needed to add in one billion dollars into these nine hundred or a thousand dollars billion package that they’re putting together right now, a trillion-dollar package. They could have taken one one-thousandth of that and put it into bolstering the manufacturing capacity of these tests. That is one of the very concrete steps that we should have taken. And I don’t know that the Congress is doing it. We should be outraged by it because it’s one one-thousandth of the bill specifically appropriated for bolstering the manufacturing of these simple tests could alleviate the woes that everyone in this country is having from a testing perspective. It doesn’t seem like we are able, as a Congress and as a country, to do anything that is in our benefit. We’re just mopping up the mess rather than just stopping the mess from happening. If we were to do that, we could accelerate greatly the end of transmission. We would put the CDC, especially the new CDC director, Rochelle Walensky, and other people, we would give them the tools so that when they start in January, that they would have the tools in front of them to actually create policy and strategy in a way that hasn’t been possible yet, despite the best efforts of some people in the administration. And so I think that that’s what we should be doing right now. Those are the features that would greatly help stop the spread, of course, wearing masks and continuing to do that. Everyone is aware of masks at this point. So I don’t feel like I have to really be pushing on that angle.

Q: And what about the one, because after the first round of vaccination, when the vaccine begins to cover a larger part of the population, what about the vaccination strategy? I think different vaccination strategies will have different impact on our timetables of going back to normal life.

MICHAEL MINA: So we should be trying as hard as we can to ensure that we are vaccinating individuals who are most likely to be transmitting and participating in transmission chains or who are most vulnerable. So, of course, getting the vulnerable people vaccinated is priority number one. Well, in our case, it’s priority number two, unfortunately. Party number three, I suppose I should be targeting the places where transmission is occurring at the greatest pace and that would help us the most to be able to alleviate transmission and achieve herd immunity the quickest.

Q: Thank you.

MODERATOR: Next question.

Q: OK, I’ll try to make this quick. I wanted to backtrack and talk about the accuracy of at home tests. So what in your stance is the best or most accurate at home tests people should be taking, whether that’s one’s where you’re doing the collection at home and sending it out versus doing the entire test at home? And what is your stance on the accuracy of nasal swabs versus saliva tests?

MICHAEL MINA: I would say the nasal swabs are as good or better than saliva tests. The saliva tests are very variable just because of the medium, how do you collect the saliva and things like that. So my personal favorite, nasal swabs, the soft collected ones that are just in the inside of the front of your nose are very good for capturing infectious virus that’s at high viral loads. I was reading an email when you started speaking. I apologize. Can you repeat the first part of that question?

Q: Yeah, I just wanted to know basically what your stance was on the accuracy of at home tests. So do you think the ones where you’re collecting them at home and sending them out to labs are better than ones where you’re doing it entirely at home yourself? Or do you think they’re both relatively the same and accuracy?

MICHAEL MINA: They have different benefits. So the ones that you’re sending out to labs, they are potentially more accurate and they’re using PCR testing. So I don’t want to say accuracy, but I want to say they’re potentially more sensitive to find RNA, but they might find RNA after you’ve already been infectious. And so they are going to have a better job at finding very, very, very low amounts of RNA in your nose. But it’s not necessarily better or more effective than having an immediate rapid test available. So I would take, for example, a rapid test that is 20 percent less sensitive, but gives me an immediate result any day over a PCR test that I have to order, send back in and get a result three days later. That PCR test is very ineffective versus a rapid test if your goal is effectiveness. And so that’s where I think we’ve really lost our way with evaluating these tests. We should be exploring and asking the question, what’s more effective? Not which is more sensitive because you can have a very sensitive test, but if it gives you a result five days later, it’s not a useful test.

Q: Thank you.

This concludes the December 18th press conference.

 

Source link

Random Posts