This transcript is auto generated and unedited.
Preeti Malani: Hello, I'm Dr. Preeti Malani, JAMA Associate Editor, and I'm also a professor of medicine at the University of Michigan. I'm delighted to be joined today by a longtime friend and colleague, Dr. Ashish Jha. Dr. Jha recently took a break from his day job as Dean of Brown University's School of Public Health, to serve as the White House Coronavirus Response Coordinator, helping oversee the pandemic response for the entire US government.
Ashish, welcome and thank you for joining me today.
Ashish Jha: Preeti, thank you for you having me here.
Preeti Malani: To start our conversation, I wanted to reflect on the current state of COVID. We're now well into the third year of the US pandemic. We've gone from March of 2020, when the goal was preventing every case, to using masks and social distancing, to get back to essential activities, to the availability of highly effective and safe and vaccines, to the Delta and Omicron variants, and the recognition that protection, either from vaccination or prior infection is not durable against symptomatic infection.
And in the background of all of this is the essential need to get back to the things that matter most. We've now shifted from preventing every case to preventing hospitalizations and deaths in high-risk individuals and preventing disruption. With that long background, my question for you is, what comes next? Where are we headed?
Ashish Jha: You're absolutely right that our views on what the goals are have shifted for good reasons. If you go back to May of 2020, so two years ago, a case, somebody who got infected, almost invariably had a pretty high risk of leading to hospitalization, leading to death.
That is much less true now than it was two years ago, right? Because even though we have waning immunity against systematic infection, what we know is that people who were vaccinated and boosted, have a very high degree of protection against the severe illness. Obviously, we've developed new therapies that also make an enormous difference.
And if you take a step back and ask the question, why isn't preventing every infection still the goal, there's only one country that's still trying to do that, and that's China. And we've seen the very difficult time they are having with the highly, highly contagious variant of Omicron. It's very difficult, I would argue nearly impossible to suppress all infections. So what our goal has got to be is, obviously if there are the things that we can do to keep infection numbers low, we should do those things, but what we really need to be focused on is preventing those infections from turning into hospitalization, into death, into severe long-term disability.
And that has got to be the strategy moving forward, and that has been a view I've held now for probably nine to 12 months. It certainly has been the plan that the president has put out, that says protecting Americans is about really making sure that we continue to do everything we can to prevent severe illness and death. And that's I think, the landscape we're looking at as we move forward, not giving up on infection, continuing to do things that we can to keep infections low, but having as our primary goal, making sure that people are not getting particularly sick.
Preeti Malani: Thank you. So let's talk a little bit about vaccine. In recent months, we've seen rapidly evolving recommendations around boosters, which are now recommended for most people, really basically everyone 12 and up, and more recently an additional booster dose has been recommended both for individuals who are immunocompromised, and then for older adults, the 50 plus group. And there are lots of opinions on this one, and I personally get a lot of questions on timing, especially since so many people had symptomatic infection in recent months.
And so, I have a couple related questions. The first is, who should be getting an additional booster now? Who should maybe wait a little bit, perhaps in the fall? And speaking of fall, should people expect to be getting boosted again in the fall, and will that vaccine be a different formulation?
Ashish Jha: There are about two or three questions in there. So let's break them apart. First and foremost as you know, we always want to be driven by evidence, the data of this, right? So what I would start with in terms of who should get that third shot, the booster, I think the evidence at this point is overwhelmingly clear that everybody benefits from a booster as long as you're five months out from your second shot. We've certainly... The data on adults is overwhelming.
There's now increasingly good data on kids, that that third shot doesn't just raise your antibody levels, which it clearly does, but it causes a lot of affinity maturation. Your antibodies get better. You get a more robust T cell response. You just are far, far better protected with that third shot. So in my mind if the question is who should get a third shot, it's every adult. And again, I don't want to get ahead of the FDA on kids, and they're still looking at third doses for kids, and then five to 11 is being looked at right now but the FDA.
So that's where we are with the third shot. Now your question of fourth shot, and then the question around next generation vaccine, let's go back to the evidence, right? So the best evidence on fourth shot comes from Israel, and as you know, the data from Israel was very clear that people over 60 who were, I believe in the study, four months out, but four or five months out... The data was very clear that those people had dramatic reductions not just in infection, but in mortality by getting that fourth shot.
Now, when we think about clinical studies and our endpoints and outcomes, and we often think about, what are the surrogate outcomes? Death is not a surrogate outcome, right? That is the hardest outcome we have. It is the most important outcome we have, and we saw the fourth shot dramatically lower mortality rates for people over the age of 60. This is why I think the FDA and CDC have come out in favor of allowing people over 50... We'll come back to 50 to 59 in a second. But to me, the evidence is overwhelmingly clear.
People over 60, if you're four or five months out from your first booster, you would benefit from getting that second booster, and that's what I recommended to my elderly parents. That's what I recommended to my friends and family. 50 to 59 is an age group where we just have less data. We don't have... The Israeli studies didn't look at it. There are a lot of high risk people in that 50 to 59. I think this is why FDA and CDC said, "You should consider it in that age group. Up to your provider."
If you're a higher risk person, I would probably consider getting it, but that becomes some more customized decision. Talk about the fall and what we might expect. So first of all, no decisions yet. FDA Advisory Committee expert... Advisory Committee is going to be meeting about this in June. There are clinical trials going on right now, being run by the pharmaceutical companies. Both Moderna and Pfizer are looking at bivalent vaccines, different combinations. So maybe the original strain plus Omicron, or original strain and Beta. There are different formulations.
My guess... And this is a guess because again, we haven't seen the data, and the FDA is going to make the call, but my expectation is, we're going to see a new generation of vaccines this fall that will probably be a bivalent vaccine, and obviously we want to make sure we have the resources to buy enough for every American. Again, conjecture here because we haven't seen the full set of data. Probably going to be more effective against Omicron. Probably going to be more effective against whatever subvariant of Omicron is circulating at that time.
And so, that's my expectation, but we'll see what the data shows.
Preeti Malani: You mentioned kids, and any word on vaccine availability for the little kiddos, so the under five group?
Ashish Jha: I have a lot of friends who have kids under five, and so maybe the question I get asked the most. Where we are right now is, Moderna has submitted their application, and that is being reviewed by the FDA, and FDA has said, and I've spoken to leadership of FDA... They've been very clear to me, and I think it's been very clear in the public that they're going to through the data, they're going to do it expeditiously, and as soon as this meets their standards for a decision, they will make that decision.
And the good news is, we have plenty of vaccines ready to go as soon as the FDA makes this decision. So we're ready from a kind of operational point of view, of getting these vaccines into kids' arms once FDA makes the decision. But obviously, we don't want to pre-judge that decision. And this is really a decision that the FDA scientists are going to have to make. And then of course, CDC and their advisors will look at the data and make their own recommendation. I hope all of that happens in relatively short order.
Preeti Malani: It would be nice as a back-to-school gift for families. I know that this has been an exceptionally difficult time for parents of very young children, for lots of reasons, not just COVID.
Ashish Jha: Yeah. It has. And what I say to folks is we obviously want to move really quickly on this, but we really, really want to get it right. And so what's important here is that ... Okay, this is the last group of Americans who are not yet eligible. I know parents have been waiting a long time. My hope is it happens reasonably soon. What I will say, it's very clear to me, is that the folks at the FDA both understand the urgency. They're working to try to get this done as quickly as possible. And I suspect we'll see it sometime soon.
Preeti Malani: Speaking of vaccines, we still have large numbers of people who are eligible but unvaccinated for a variety of reasons, different concerns, misinformation, safety. Can you comment on any new efforts that are being done to help nudge some of these unvaccinated individuals to being vaccinated?
Ashish Jha: Yeah. I came into this role about four weeks ago and thought, "Well, with a fresh pair of eyes, I can kind of look at this set of issues." Obviously, it's complex why Americans ... why some chunk of Americans still have not gotten vaccinated. We've been doing a pretty deep dive trying to understand why are people who really need to be boosted, not boosted? Why have people not gotten their second shot when they got their first? And obviously, why did many people who would benefit ... Pretty much everybody would benefit. Why have they not gotten their first shot?
And then we're trying to create a lot more targeted programs, trying to reach out to trusted voices in the community. One group that I think can be doing even more, and I know that they've been on the front lines on this, is primary care physicians and other physicians who are trusted by patients for their health. Right? So this is an area where I think it's incredibly important. If you're a physician, understanding which of your patients has been vaccinated and not, and having frank conversations with them about what's holding them back, if they're not vaccinated or boosted, and offering the kind of assurance that comes from only somebody's physician or their primary provider.
So I think that's an area where we probably have not done enough, I think, to engage providers in this effort. We've seen this as a public health thing, which of course it is, but going into the clinic and helping doctors advise their patients about what's right for them, I think is going to be another important tactic, another important strategy for getting more people vaccinated.
Preeti Malani: I appreciate you saying that. Both of us, we're physicians ... I'm not sure. You're probably not seeing patients right now.
Ashish Jha: Not right now. Not right now. I'm a hospitalist, I was in the hospital a few months ago on clinical service, but in this current role, that would be difficult.
Preeti Malani: Yeah. I do think it's an all-hands-on-deck, all these clinicians. And even just creating lists of people through the health record of who hasn't been vaccinated, and giving them a call or bringing it up during appointments. I've seen at least an opening to have a conversation, and maybe that's at least a starting point.
So let's shift to testing. This is something that has also evolved relatively quickly. It's easy to forget, you mentioned the spring of 2020. At that time, getting people tested at all really required that they were seriously ill in the emergency department. And today, testing is widely available. Unlike the December, home tests are actually pretty available. They're plentiful now.
At the same time, there's been less routine asymptomatic testing. It feels like we're moving away from that, especially in schools and college campuses. But one group that is still required to test is people returning to the US after international travel. And now that mask requirements on planes have been changed, will routine testing to return home also be eliminated?
Ashish Jha: It's true. Routine testing, in general, has declined a lot. I mean, we see this, right? During surges, you get a lot more testing. Everybody needs and wants a test. And then during kind of quieter times, that people pull back on testing. It makes total sense that that's what happens.
I still think there's a really important role for routine testing in many parts of our lives, just as a way to keep infection numbers low. We talked earlier about the goal of preventing severe illness, hospitalizations, and death. But there is still a goal of keeping infection numbers low. I actually think routine testing could make a big difference there.
On the issue of pre-departure testing for people coming back to the United States, I know this is an area of a lot of debate and discussion. This is really a decision that the CDC makes around travel safety, and so CDC's looking at this, as it is at all times. I mean, every time they have travel policies in place, CDC's constantly evaluating whether that still makes sense, how it aligns with others, what the benefits and the costs are. So I know that kind of evaluation is ongoing.
I don't know where the CDC scientists are going to land on this, and I don't know where the CDC director's going to land on this. So I have nothing new to report on this, I will just say. It is a topic that I know is getting ongoing looks.
Preeti Malani: Of all the advances we've seen in two years, the ability to offer treatment on scale is perhaps the most remarkable. I say that as someone who’s been on the clinical the front lines since the beginning of the US pandemic. And as case numbers are rising, I'm getting a lot of calls and emails about oral antivirals, and one of the things I emphasize to people is that treatment works best if given early. Yet, so many people with COVID, including some of our most vulnerable, are simply not connected to medical care. The Test and Treat program was designed with these access and equity issues and mind. Can you explain a little background around Test and Treat for people who are not familiar with the program, and also tell us how it's working, and where and how it might be improved?
Ashish Jha: Yeah. Test and Treat is an idea that was first articulated by the President in the preparedness plan that he laid out earlier this spring. But the idea is very simple. Which is what we know is that these new treatments that are coming out, these new oral anti-virals, they work fast when you give it early in the disease course. And so what you want to do is you want to tie testing to treatments. And you want to create a seamless experience where people who test positive if they develop symptoms or if they're testing it symptomatically, they test positive, that they immediately get evaluated for treatment. And that these two acts of testing and treatment really get brought together, because we know that the benefits of treatment are optimal when it happens early.
Yeah, so let me start off by talking about where most Americans, who are getting Paxlovid ... Paxlovid being the major oral antiviral. There's also Molnupiravir from Merck, but Paxlovid really is the one that has the best efficacy data. Most of that is still being done as prescribed by physicians to patients they know, getting filled in a pharmacy that patients may use on a regular basis. So that still remains the primary way that people are getting it.
But you're absolutely right. There are plenty of vulnerable people who don't have a regular source of care, who don't have a primary care physician that they can turn to. So what do they do? And Test and Treat was designed, in large part, for them. It was also designed for other people who may have a primary care physician, but let's just say, for convenience sake, they need to find an alternative method.
So right now, there are about 2200 Test and Treat sites across the country. That's good. We want to keep working on expanding more of them. And so we are looking at actually setting up in some places where a demand may be high, and Test and Treat sites may not be as widely available, actually setting up federal sites. There are a lot of federal sites that do testing already, where you can go get a test, especially if you're uninsured, you can get it covered, but if you have insurance. And we're looking at setting up a treatment site right next door to it.
So you can imagine a place where you go get a test. It's positive. You go next door. You get a provider who looks at your medication list, looks at who you are, looks at your risk profile and prescribes. And then you can get your Paxlovid dispensed and head home all in one shot. We're working on that.
We're talking to other pharmacy chains, looking at what kind of providers. Right now, the FDA has authorized only physicians and nurse practitioners and PAs to prescribe this, so there are a lot of people who are looking, how do we expand access to that across the country.
In my mind, we want to get to a point certainly by the fall and winter, if we end up seeing a surge of infections, which many of us worry we might, especially if we're not fully prepared. I want to get to a point where Test and Treat is available widely for people who don't have access to their primary care physician. And obviously for people who do, it's always great to be able to go to see the doctor that knows you and that you trust to get vaccinated.
Preeti Malani: So I wanted to talk a little bit about post-COVID conditions, often referred to as Long COVID. As you know, there are large numbers of people who have symptoms that can persist for weeks to months after acute infection. But Long COVID remains very poorly understood. And the approach to management varies a lot. I know this has emerged as a high priority issue for the Biden Administration. What's being done to improve our understanding and really to inform management of Long COVID?
Ashish Jha: Yeah, it's a great question. And you're right, Preeti. The problem with this clinically is that it's such a range of conditions. I mean you have some surveys that ask people at four weeks, "Do you still have a cough or do you still feel not quite well?" And of course we know from lots of viral syndromes that people can feel not quite back to 100% four, six, eight weeks later.
But then there are people who are truly debilitated by this. Who months later, some people up to two years later continue to suffer substantial debilitating symptoms. And so the range of conditions that are Long COVID fit within that whole pocket. And part of it is just we need to clinically understand what's going on. For some people, this is clearly immunologically driven. For other people it may happen with viral reservoirs that have not gotten fully cleared. There may be combination. There's a lot of work to be done just clinically in sorting out different types of patients, what's driving it, et cetera.
Because obviously if we don't do that, it's going to be very hard to study them. It's going to be very hard to come with effective interventions. As you might imagine, if it's immune remediated, you're going to need a different set of interventions than if it's because of a viral reservoir. I think we've got to get tighter on our definition and cleaner in understanding the categorization of different types of patients with Long COVID.
The next thing is again, the President put out a presidential memorandum on this. There's a lot of funding now going into building cohort studies. Because one of the things you want to do is you want to track people over time so this is happening both through NIH, it's happening at many institutions. Where really they're trying to create cohorts of patients with Long COVID to understand the natural history of Long COVID and where it goes.
And then I do think that there's a lot of work being done to look at potential therapeutics. If you're talking about people with dimensional viral reservoirs, then potential anti-virals, oral anti-virals may be a really important tool. Again, these are things all being studied right now. What I would say is Long COVID is serious. It is for some proportion of people, it's quite debilitating. We have to find a way of both understanding the disease, trying to come up with therapy. And then supporting people have them. Supporting them in whatever ways they need to get back to their lives.
Preeti Malani: Yeah, hopefully lots of good information coming out on this issue because this feels like that next piece that we're starting to understand. I think as you know it actually, the evidence is really sort of everywhere. Whether anti-virals help, whether vaccination, it decreases risk. I guess it's just one more reason why we still need to be careful.
Ashish Jha: I do think there is some reasonably good evidence that if you're vaccinated and particularly if you're boosted and you have a breakthrough infection, you may still get some persistent symptoms, but generally those people tend to have a lot lower likelihood of getting Long COVID and it tends to be less severe. That is also I think an important way of understanding the mechanism of what might be going on. And then we get one more reason to make sure people are getting vaccinated.
Preeti Malani: Indeed, indeed. In your prior life, you studied prevention and population health, big picture issues around health equity. Really I wanted to just end our conversation by asking you what we've learned during the pandemic and how can that be applied going forward to improving health in general?
Ashish Jha: Yeah, it's a great question. If you take a step back and look at the history of medicine and public health, and you and I are both physicians. We also, I think, think of ourselves as public health people who care about that broader public health perspective. There's been over the last 50 years, almost an attempt to separate the two. And this idea that medicine is over here, public health is over here. One thinks about the patient, the other thinks about the population. I have been, and maybe this is just because as a doc who cares about public health, maybe this is just my view, but I've always found that separation a little bit artificial. And I've always thought well, population health begins by thinking about the individual in mind and you can't really think about the individual's well being unless you understand that broader social context.
And so I've always thought this separation between public health and medicine, between public health schools and medical schools felt artificial. I think this pandemic has really made that very, very clear, that you can't separate out public health and medicine. That they really are intrinsically linked to each other.
And one of the lessons I'm hoping we learn from this is obviously we've got to invest in a much stronger public health infrastructure. If not, it's the health system that really suffers. But that we have got to find ways of getting both public health and medicine to work more closely together. Whether that's about information sharing and data. Whether that's about work force and using the clinical work force as a back up for public health emergencies. There's lots of ways in which these two communities that have been heading in slightly different directions I think have been brought back together in the pandemic. And my hope is that that change sticks and it's here to stay. Because for people like me and you who are both docs and public health people, bringing these two communities back together I think will be a welcomed change.
Preeti Malani: Doctor Ashish Jha, thank you for joining me today. This has been a great conversation. And thank you for all you do.
Ashish Jha: Dr. Malani, it was a pleasure. It's great to see you. Great to be back on this forum and thank you for having me here.