You’re listening to a press conference from the Harvard T.H. Chan 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 4 p.m. Eastern Time on Wednesday, October 6th.
MODERATOR: Dr. Mina, do you have any opening remarks?
MICHAEL MINA: No, I’m happy to start. If you’re done, then I’ll start talking, sure.
MODERATOR: I am done. Please do.
MICHAEL MINA: Alright. Well, thanks everyone for joining. I was getting a lot of requests, so I figured I’d just do this, which is the first one of these I’ve done in a very long time now. We just had a baby a couple of days ago, so I’m a little tired. So, the first I want to point out for on to an article that we published the other day in the New York Times. Myself and folks in the COVID collaborative authored it with me, and it was essentially laying out an idea about how we can scale up rapid testing very, very quickly. And so, the president’s announcement, the White House announcement today, that probably everyone on the call just heard is around the scaling up of rapid tests a bit more. And while this is a great step forward, in my opinion, I think that it unfortunately will still fall short, both in terms of the timeframe needed to get these tests into Americans hands, especially given that this is by definition a public health emergency which has time as a part of that, and we need to be doing everything we can as fast as we can to get these tests into people’s hands at home. But it’s also an issue of scale. Now, I think that the president’s initiative here, both in the COVID-19 action plan that was released a couple of weeks ago and the announcement today of the billion dollars going towards testing is all, I think commensurate with what needs to be done with this pandemic. We need to be able to give people the tools to know if they’re infectious. This is the exact same story that’s been told now for essentially 20 months now that COVID doesn’t have to be an information problem. We don’t need to have quarantines and shutdowns again. Quarantining somebody because they are potentially exposed to somebody, especially in the school systems, is purely an information problem. It’s because we don’t know whether or not your child was infected by their peer who was positive. So, the fact that we actually have a tool that would enable us to be able to know whether or not you’re actually infectious and not just have to have this sort of rogue quarantine practice is, on the one hand, a sign of being an industrialized country. It’s a sign of using the tools that are at our disposal. But unfortunately, we still have not made these tools widely available. I think that that that we can do better. One of the things that we’ve pointed out in the New York Times piece last week is that there is the greatest bottleneck in Americans getting access to affordable, high quality, rapid tests that to the extent that people just have them in their homes in the same way that we have Band-Aids or Advil. There’s no reason not to have rapid tests when this pandemic weighs so heavily on society, the best way to get them authorized and thrown into the hands of Americans is to change how they’re regulated. Right now, they continue to be regulated as medical devices. But that means that we’re applying the wrong metrics to them when the FDA evaluates them. The best way to rapidly scale up, not by December or February or March, the number of tests that we have and still, even with the president’s announcement, it’s still going to be woefully insignificant, insufficient rather to really be able to curb spread is to call them public health tests for the president to take presidential action and executive action to do something that’s very sensible and simple. And that’s to say that any tests used for public health testing during this public health emergency will be designated as public health tools. What that does is it enables a new pathway to be built to get these tests into the hands of Americans. It follows in the footsteps of what the UK and Germany and a number of European countries have done, which changes how we’re evaluating them. We start to evaluate these tests on the right with the right metrics to ask does it detect infectiousness? Is it specific for people who are infectious so that we’re not isolating people who are no longer infectious? And it also would enable us to not have to have onerous clinical trials and would be able to take the best tests from all around the world and say if a certain country that we trust has already had a lot of experience with a particular test, then we immediately grant them certification to use in the United States. So, then we’re not waiting until February to actually scale up to 200 million tests. We’re actually opening America’s doors to a huge number of additional tests almost immediately, which would, of course, help drive down costs. You can go to Germany right now, and every person in Germany can buy a box of 50 tests for under 35 dollars- that’s under a dollar a test. And here in the US, we are still charging 10-15 dollars per test. We still have just this slow trickle of authorizations coming through, which is, on the one hand, heartening to see that they’re actually able to get through the hurdles. But effectively what’s happening is they’re just having to get authorization. These companies are essentially having to contort their clinical studies to find the right people to join into the studies so that they can even meet the FDA as benchmark. Instead, we should just be actually evaluating these tests based on their public health utility, getting them out very quickly. The best of the tests can be in every American’s hands very, very quickly. And ideally, the government should be subsidizing the full cost. I’ve said many times that Americans should not be on the hook out of their pocket to pay for public health. These tests are public health tools, they’re not medical devices, and by asking people to pay for them really shows a lack of understanding about what the actual role of tests like these are. They are public health. They’re for the benefit of people’s neighbors, not for the test user. And so individuals should not be on the hook for paying for them. The government should be subsidizing, which is what we see in other developed countries. Most of our peer nations are barely charging or giving this out for free to individuals, and that’s smart public health in the same way that we’re not charging people for vaccines and many times people can get masks for free, we should be doing the same thing with tests. And then we should also really focus on making sure that we’re giving companies and schools and businesses and all the entities that are going to be putting testing programs in place. In particular, in the wake of the president’s COVID-19 action plan, which has vaccination or testing as one of its pillars. Then these tests should be verifiable. We should be propping up software platforms and companies that actually enable verified results that get reported to public health so that we don’t have to be making a tradeoff between a rapid test and public health reporting, we can do both. So, I think that there’s major things, major themes that come out of this. I’m very happy that the president is pushing forward on rapid tests. I think it’s a great step forward. This announcement is a great step forward. For a country our size, it might sound to the average person that 100 million tests or 200 million tests per month is a lot. But at the end of the day, that’s probably not going to come about until the end of this year or early next year. And it still means that it’s less than six tests per year per American given at that rate. And so, we really need to figure out how to massively scale up these tests, drive down costs and do it in a timeframe that’s actually commensurate with the continued problems that are associated with this pandemic today.
MODERATOR: Thank you, Dr. Mina. Alright, first question.
Q: Hi, thanks so much for doing this. And Dr. Mina, congratulations on the baby, wonderful journey you’ve just embarked on. My question is, I feel like I’ve been hearing you say this now for almost two years, as you say, 20 months. Why is it taking us so long to do this if this is as simple as you describe? We know that this has been a need since the beginning. Why do you think it has just been something that we have slowly, slowly come to recognize?
MICHAEL MINA: I think it’s two reasons. On the one hand, we have had a vaccine only approach, but that’s really only been in since this last December. So yes, we did need these last year and we could have had them last summer to avoid the fall shutdowns and deaths associated with the fall and winter last year. I think the greatest reason is unfortunately still the same reason, these tests have been available, they’ve been available around the world, they just haven’t been available until recently. We heard Jeff Zients on a call at 3:00 in the White House say that these are a new technology that only came about since the president. This administration that’s been in place, but that’s not actually true. It’s just in the United States it’s been that case. I think the reason is actually the same. It’s that the FDA has only authorized this as medical devices and effectively created an impossible barrier to entry. The only way to get an authorization, an EUA for these rapid tests, which are specific to being to the infectious period, is to skew the clinical trials appropriately or to skew the clinical trials but I would argue it may be considered an inappropriate fashion against what the FDA is actually asking for so that the only participants that are in your trial are currently infectious. And that way you can actually achieve the 80 percent bar because in reality are only positive on a rapid test for about 30 percent of the time they are positive on a PCR test, and that’s because you’re only infectious for about 30 percent of the time they are otherwise PCR positive. So, I would argue that it is all been about the barriers set up at the FDA and the unrelenting sort of requirements by the FDA to authorize these only as medical devices against PCR using onerous clinical trials. And in some ways I actually would argue that maybe this isn’t even the FDA’s fault. Maybe it was never on the FDA to take on this role. They’ve very publicly state over and over and over that they do not care or evaluate public health tests, and they don’t. And so at some point, somebody had to recognize that this was a bottleneck and they had to say, look, these are public health tests designed for different metrics. They’re fast, they’re inexpensive. They can be done at home frequently, and they are specific to the infectious period of somebody’s infection. That’s a public health tool, and somebody at some point had to say to the FDA, look, if you don’t have a pathway to evaluate this for its public health merits, then we need to find somebody else who would evaluate it appropriately. And in fact, I would argue that by forcing everything through a medical pathway, we’ve actually effectively eroded the medical sort of the way that we authorize these medical devices and use prescriptions. We should have much earlier on just said, look, this is a CDC response or CDC tool, the CDC will be in charge of figuring out how to evaluate it based on public health metrics. And if we do that, we still can, I think that would immediately released a logjam of these tests, but ultimately the FDA just held them all to an incredibly high standard, but not an appropriate standard. People keep confusing high standard with better. It’s actually been a standard that they’re holding it to is not appropriate for public health, and we don’t want to isolate people, for example, who are not infectious. That’s bad public health. And so, it’s been a real problem and I think that we’ve asked the FDA to take on an impossible task of evaluating a public health tool when they are only charged with evaluating medical devices.
MODERATOR: Next question, she has two questions, the first one, she says for fun, congrats on being a parent and has this changed how you think about testing? I’m feeling no. And the second one is more serious. This issue is once again putting federal dollars into a strategy that appears to not have a timely impact, where is the best outlet for these tests to be once tests become more readily available for the biggest impact. Would that be pharmacies, testing sites, mail order? What are your thoughts?
MICHAEL MINA: I think some of the greatest impact we have to look at is what are the entities that are the greatest, that have the greatest impacts of COVID that are struggling the most as a result of COVID? And certainly, I think in the country at the moment we have breakthrough cases happening all over the place, which is not unexpected in any regard and especially in nursing homes, we have schools that continue to shut down and we have vaccinate or test mandates that the president is putting out. And then we have a lot of different entities like prisons and things like that where spread can happen very quickly. And so I think getting these, focusing on those types of entities, finding where is this virus the most problematic for society, and let’s just use schools as one example, I think that schools, we need to be keeping kids in school. We can’t keep quarantining kids because Johnny in their class is positive. We don’t want to ask 20 other kids to go home for 10 days. That’s that information problem I was discussing. We have these tools to be able to solve that. We want to give these tools to people to use at home before they go to school and say instead of quarantining, use your test in the morning. If you’re negative, go to school. If you’re positive, don’t go to school. It’s that simple, and we can partner that with verification if needed and all these different things that all exists. I think using these tests for what they’re worth, they can be made very inexpensive. They can be distributed so that there’s no sort of centralized area that’s performing them. That’s very good for underprivileged communities, for poor communities, for communities that are undocumented. These people in these communities are generally unable to afford many of these rapid tests. We need to get the price to essentially free. And we need to give people the tools to be able to deal with their slice of this pandemic on their terms. And if it does go to the public health agencies for reporting great, if it doesn’t, then at least people are keeping themselves and their neighbors safe. So I think those are some of the, there’s a whole slew and I’ll actually be giving a keynote or not a keynote sorry a Grand Rounds lecture tomorrow for the UCSF Grand Rounds seminar series, which maybe many of you have joined over in the past year about this tomorrow.
MODERATOR: Thank you. And I think this might be our last question, because we’re at 4:20 already, is that OK?
MICHAEL MINA: Five more minutes. OK.
Q: Hi, Dr. Mina. So, let’s see, where to start. So FDA updated its templates for all its COVID-19 test applications right today, but they maintained that 80 percent sensitivity or specificity, one of the two, for these antigen test and the outline. I wanted to ask slash pushback on your definition of what a public health test would be, or at least the mechanism through which you imagine the administration to utilize, to create this pathway. Are you advocating for the creation of a new FDA pathway? And if so, does that not require legislative action from Capitol Hill?
MICHAEL MINA: No, the FDA does not regulate or authorize public health tools, so what I’m arguing for is for the CDC to create some sort of certification process that would enable particular tests to be able to be used without an EUA as long as the CDC, and of course, that might have to be done in collaboration with FDA, for example, to say you can either go through the EUA process as has been done or you can go through the CDC public health emergency process.
Q: Do you think that the CDC has the expertise to evaluate these types of tests, especially given the challenges developing a test and maintaining sterile labs at the beginning of the pandemic?
MICHAEL MINA: Absolutely. I think this is not a difficult thing. The UK has demonstrated how it can be done. We actually demonstrated how it can be done with the COVID-19 Rapid Test X Prize last year. And the reality is we don’t need this convoluted and onerous clinical trial system to offer as these tests. We need to know which tests are specific. So we need to know which tests are sensitive for a given viral load.
Q: So last Friday, Ellume, which I believe got the first EUA for an at home test in December of last year, so I think Zients got that wrong today, had to issue a recall of several of their tests as I’m sure you are aware, lots of people are complaining on Twitter or, you know, to public health departments that you know, this is a problem. Do you think that the characteristics of that type of test, especially if it was flooded into the US market, would not create the same reaction?
MICHAEL MINA: Sorry, I’m not I’m not following the question,
Q: If a test is not accurate enough and you have this type of problem and you have so many people complaining that they’re getting false positives or worse false negatives, whatnot can be detrimental to the pandemic response.
MICHAEL MINA: Oh no. Well, I think that if we give if we treat these tests like the public health tools they are and we go through a different public health pathway, we would be identifying the right metrics we wouldn’t be, for example, the FDA has an oddly, extraordinarily low bar in terms of evidence that needs to be put forward to get an EUA, but an extremely high bar in terms of how that evidence has to be gathered. So, you end up getting essentially useless information is what’s given to the FDA. It takes 30 positives to get an EUA. But finding the right positives takes months and millions of dollars.
Q: Two more questions. Germany removed about over 20 tests that they were using rapid tests from their market in the last few weeks. Do you have any comment on that since you have been advocating for the German approach?
MICHAEL MINA: It sounds like it’s working then if they’re finding the ones that aren’t working, I would say.
Q: Even though they’ve been used for months now?
MICHAEL MINA: Well, I think that what we should do is, you know, whether we follow the exact German approach or follow the UK approach, which I think has actually been extremely successful, the UK has done a great job at selecting really very, very highly accurate ones.
Q: Yeah. I apologize asking so many questions, but this is my last one. Are you still involved with ANOVA and their efforts to get a COVID-19 test onto the market in the United States?
MICHAEL MINA: No, and I wasn’t really involved with them, I was I ran the clinical trial with Citibank, and that was sponsored by Citi and so, but no I haven’t had any interaction with them. But I would say that they continue to demonstrate that their test is actually quite robust and totally third-party independent studies that have come out in the last couple of months.
Q: Did you or your nonprofit get any reimbursement for that work?
MICHAEL MINA: No, not from an ANOVA at all.
Q: OK, thank you.
MODERATOR: One more question.
Q: Yeah. Hi, Dr. Mina, a congrats on your new baby. My question is, aside from the shortage in testing supply, what role does the availability of testing sites and to actually find and get these COVID 19 tests play in the decline of testing, like especially with parents whose kids are in school and need tests, they can’t find available testing appointments within 30 miles of them.
MICHAEL MINA: Yeah, I think that that is a true travesty of this pandemic in the United States. I think having access to these rapid tests in the house and being able to have, frankly, the government should just be, I think, should really just be producing these tests and giving them out to people. There should be no place in the United States where somebody has to drive a half hour to get a test, which is actually very common in a lot of the United States at this point. A lot of the policy makers are in D.C. or New York City and things like that. And so people are a little bit under the impression that getting even a PCR test is fast and simple. But not having access to a test during a pandemic like this is, I think, really massively detrimental. And I certainly hope that part of this initiative, the president’s putting together is going to really try to address that head on and say and maybe allocate more tests to the rural areas, for example.
MODERATOR: Are you all set?
Q: Yeah, thanks so much, Doctor.
MODERATOR: Doctor Mina, do you have anything else you’d like to say before we go?
MICHAEL MINA: No, not right now.
MODERATOR: OK. And if anybody is looking for the information on the grand rounds, I’ll see if I can find that to send me an email and see what I can do. Thank you very much, Dr. Mina, and thanks to everybody for participating in today’s call, and we’ll see you again sometime soon. Bye.
MICHAEL MINA: Thanks.
This concludes the October 6th press conference.