Toolkit: Everything You Need to Know About Vaccines
It’s the Monday Toolkit episode of In The Bubble that people have been waiting for. Today, Andy and Zach get answers to the most important questions we all have about vaccines from two of the world’s foremost experts, Drs. Mark McClellan and David Agus. There is incredibly promising news and some news that is likely to be fairly surprising. You’ll learn when we can expect to see a vaccine and how life will — and won’t — be different with a vaccine.
Keep up with Andy on Twitter @ASlavitt and Instagram @andyslavitt.
Follow David Agus @DavidAgus on Twitter and on Instagram @davidbagus.
In the Bubble is supported in part by listeners like you. You can become a member, get exclusive bonus content, ask Andy questions, and get discounted merch at https://www.lemonadamedia.com/inthebubble/
Take a brief listener survey and get a chance to win a $100 Amazon gift card at https://www.lemonadamedia.com/survey
Check out these resources from today’s episode:
- Read more about the Oxford University vaccine: https://www.economist.com/britain/2020/07/02/oxford-university-is-leading-in-the-vaccine-race
- Learn about one person’s experience in the clinical trial for Moderna’s vaccine: https://www.washingtonpost.com/nation/2020/07/06/coronavirus-vaccine-trial-patient/?arc404=true
- The World Health Organization keeps track of COVID-19 candidate vaccines here: https://www.who.int/publications/m/item/draft-landscape-of-covid-19-candidate-vaccines
- Check out the National Institute of Health’s new clinical trials network to test COVID-19 vaccines and other prevention tools: https://www.nih.gov/news-events/news-releases/nih-launches-clinical-trials-network-test-covid-19-vaccines-other-prevention-tools
- Here’s more on the FDA guidance regarding the development of safe and effective COVID-19 vaccines: https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-takes-action-help-facilitate-timely-development-safe-effective-covid
- Curious about the human challenge studies? Here’s an article from the New England Journal of Medicine: https://www.nejm.org/doi/full/10.1056/NEJMp2020076
[00:01] Andy Slavitt: Hey, it’s Andy Slavitt. And you’re listening to In the Bubble, which is Lemonada Media original podcast. We have a super short listener survey open right now. We’d love to hear from you. So go to LemonadaMedia.com/survey and tell us about you, your feedback about In the Bubble, which will be anonymous, and get a chance to win a $100 gift certificate.
[00:43] Andy Slavitt: Welcome to In the Bubble. This is Andy Slavitt. This is a Toolkit episode. It’s our second Toolkit episode because you liked our first Toolkit episode on how to talk to each other about masks so well, we clearly solved that problem, that we are doing our second one. And our second Toolkit is about vaccines. What do you need to know about vaccines? Is it coming? Are they gonna be safe? How will they work? How many people will they work on? We got a ton of voicemails and emails from you on this topic. And rather than read them all, they all seem to group into some pretty specific categories. So I’m going to just ask the questions that I took away from your voicemails and emails. And my hope is that that’s the best way to answer as many of them as possible. So thank you for sending those in. Those absolutely informed the way we’re going to conduct this interview. And just like last time, we went out and searched far and wide and found the two experts who I think are going to do an amazing job. And the two of them together are going to be fascinating, and we’re going to answer these questions.
[02:12] Andy Slavitt: We’ve been doing this very cool thing we just started called Monday Toolkit episodes for listeners of In the Bubble. And what we do is we get the two most expert people we can find, and we talk to them about something that you really need to know. And today’s episode is on vaccines. And I couldn’t be more fortunate to have two really great people — not just people who know this topic incredibly well — but two really good human beings. David Agus, we have some personal history. But David has become a very well-known author, TV spokesperson. But he’s an incredible researcher in all areas of medical science. And he’s up on everything. Maybe at some point I’ll tell the audience about our connection. But I owe David a debt of gratitude my entire life for the circumstances under which we met. And then Mark McClellan, Mark was the head of the FDA in the W. administration, was also the head of Centers for Medicare and Medicaid Services. He has a big job at Duke overseeing a lot of things in health policy. And thanks both for joining you. Ready to talk about vaccines?
[03:21] Dr. David Agus: I’m pro-vaccine.
[03:24] Mark McClellan: Andy, good to be on with you and Zach and David.
[03:27] Andy Slavitt: We’ve got a lot of questions from emails, voicemails, etc. I thought, though, the best way to start was just kind of one to two minute overview on what to expect, when to expect a safe vaccine in this country that can be broadly used, and what impact that will have on the game? David, Dr. Agus, let’s start with you.
[03:54] Dr. David Agus: So I’ve been fortunate to see much of the vaccine data that’s ongoing now, and there’s no question in my mind that we will have vaccines in the fall. So the real question is, how well will they work and how long will they work? It is very easy to measure antibody responses. It is very difficult to measure T-cell responses in order to measure, you know, the T-cell response — remember, the immune system has two arms to protect you against a virus and have a memory, both the T-cell part, which is turning out to be critically important for this virus, as well as the antibodies. Everybody’s talking about antibody tests now. There’s some quality issues we could talk about later. But the T-cell hasn’t been measured much. And so that’s going to be critical. The Oxford vaccine has been in development for a decade. It was originally developed for SARS and they took the spike protein off and just put the spike protein of COVID-19 on, and it is showing impressive responses both at the antibody and the T-cell level. And, you know, the world is lucky that a couple of entrepreneurs in Brazil brought this in to a randomized placebo controlled trial in the country of Brazil, where the number of cases is at a very high level. So we should have results relatively shortly in a random I study and then we’ll see challenge studies later this summer, which will give us some more information about the immune response and about how well they work and how long they work.
[05:13] Andy Slavitt: Got it. And just as since you talked about the Oxford, people may also be familiar that there are other candidates, one called Moderna, and then a couple of others from some of the bigger pharmaceutical companies. Can you give just a little bit of the landscape?
[05:24] Dr. David Agus: There are five or six real candidate vaccines out there. And they range from being RNA vaccines, which are basically the instructions that are injected into the body and then the cells take them up and make them themselves. And that’s new. We need a little bit more testing because we’ve never done that before. It makes total scientific sense, but it’s new. And then there are a couple of other vaccines, some of the pharmaceutical companies are being rather slow to getting to phase one and then escalating from there. And they’re, you know, on purpose being very conservative because this is going to be a long ball game. And so, you know, most of these vaccines are two-part shots. That is day one and day 21. So week one and week three. And we’ll see how long they last. And there will be booster vaccines coming afterwards. But the immune system likes to be primed and then given another shot several weeks later. And that’s how you make most of your optimal immune responses. So we’re encouraged by many of them. The United States has gone on and is doing at-risk manufacturing of five of them. So if the data are positive — and the big question is what does positive mean? And that’s a separate issue — then we can actually start distribution of these vaccines in the U.S.
[06:37] Andy Slavitt: OK. So we may have enough data in the fall to know that a few of them are working, for how long they work and how many people they work for still would be unknown. But sounds very promising. Is that a fair summary?
[06:50] Dr. David Agus: No question about it. And remember, “working” is a funny word. I mean, we have to define it. Does it mean that it totally eliminates the virus? That ain’t going to happen with Coronavirus. But what we hope it means is that a down-modulates the virus in many people so that people don’t go to a hospital, don’t end up in an ICU, and in some people who would have gotten sick, they don’t get sick at all. To me, that’s a win. It’s not a binary all or none. It’s going to be, you know, giving your immune response something so you don’t have these, you know, hospitalizations like we’re seeing now.
[07:18] Andy Slavitt: Got it, makes it safer. So, Mark, what would you add to that? What are you seeing?
[07:22] Mark McClellan: Very important points that David made. I just want to emphasize a few things. First of all, because of the huge health impact and economic impact of this virus, what’s underway now with vaccines is truly an unprecedented effort. So there are a number of different kinds of vaccines in development. You mentioned RNA, there’s DNA, there’s some of the more traditional ones that have good track records in both the humoral immunity, the antibody immunity that David mentioned, and the T-cell immunity, the cell-based immunity. And many of those are going to be completing good clinical tests by fall or into the late months of 2020. And that’s just an unprecedented speed of process, not because so much corners are being cut, but rather because several things are happening at once. Regulatory agencies like the FDA, my old agency in the U.S., and similar regulatory agencies in other parts of the world have tried to work with experts and a line on what exactly we need to show for these vaccines to be effective. And that enables development and clinical testing to be done in multiple parts of the world at the same time.
[08:38] Mark McClellan: In addition, there are major efforts underway to get the trials done in places where there are actual outbreaks happening. And Brazil, unfortunately, right now in many parts of the United States, some in England and other parts of the world, so that we can roll lots of people in these clinical trials. And that’s needed, because you’re giving the vaccine to people who are healthy. So you want to make sure they are not side effects or make sure that there really is a significant immune response. And I would agree that that means we’re likely to see vaccines that are at least somewhat effective available at a significant scale by fall. The only thing I would emphasize, though, is that it’s really hard to convey the scale that’s needed here. So we’re talking about, for each of these vaccines, manufacturing hundreds of millions of doses that would be available very quickly after these clinical tests are done. Usually that takes months to years after clinical testing, and it is happening early now. And even that level of doses may not be enough for everyone to get access to the vaccine in late 2020. This is probably going to be a process, especially from a global perspective, that’s going to take well into ‘21 or ‘22, depending on how effective all of these vaccines seem to be. There’s this pandemic scale that is something that’s unprecedented, it’s been really important at every stage in responding to the COVID-19 emergency.
[10:15] Mark McClellan: And then the last thing I’d add is that, just like David said, working doesn’t necessarily mean perfect. People are probably familiar with flu vaccines that, you know, some seasons seem to work better than others, but they do really help in terms of reducing severity of cases and preventing some cases. And the standards that the regulatory agencies, at least in the U.S. and many other parts of the world are imposing, would require the vaccines to be pretty effective before they’d be approved for widespread use.
[13:08] Andy Slavitt: We have a whole set of questions that I think are asking about vaccine safety. And the question is, is there a trade-off between speed and safety? And there’s a couple of angles to this question. So I want to get all those angles out and then and then give it to David to respond to this. Someone says it’s not just anti-vaxxers, but there is a political problem given the FDA using its emergency use authority for drugs that haven’t been ready for prime time or for some of the tests that are ready for primetime. So there’s a lot of questions on who is it that we can trust to tell us that this vaccine is safe? And then maybe talk a little bit about challenge trials and explain what those are, and some of the ways that you think we’ll get to be comfortable. David, you want to start with that?
[14:01] Dr. David Agus: So there’s no question, I mean, safety is a big issue. The Oxford vaccine, which is the lead candidate right now, has over 11,000 people injected, and there is yet to be one — that is zero adverse significant adverse events. And I still remember the day when I had a call from one of the investigators literally in tears that night and I thought it was over. There was a big effect. It was that he had vaccinated an 80-plus year old and they had a fever. And so that’s the greatest thing in the world because, I mean, an 80-plus year old is having an immune response, which is positive. So we have with a very high degree of certainty, we can say that it will be a safe vaccine. Some of the other effects are, I mean, vaccines are very new and they need further testing in order to get there. But when you’re talking about 10-plus thousand patients already administered, we know that significant adverse events may come up, and they always will. But right now, no. When some of the vaccine efforts use an adjuvant, which is something that’s given to make the immune response really potent, like the shingles vaccine shingrix does, there’s more side effects. But you know, the downside, right, is loss of life. The downside is loss of our way of life. Downside is loss to the economy. But we are very vigilant. Most of these efforts are global efforts. And so we can trust the data are what the data are. And they’ll be very transparent. In terms of financial transparency, the beauty of the Oxford vaccine is there’s no profit, they are selling it for-cost through AstraZeneca, and AstraZeneca cannot make a profit on it. And I think that’s a very powerful statement. People making profits of COVID-19 does not make intuitive sense to me by any regard. Some of the other efforts are for-profit and we’ll see what pricing or charging coming in in those regards.
[15:39] Andy Slavitt: So would you feel differently if the Moderna vaccine was here first?
[15:43] Dr. David Agus: I think the Moderna vaccine, the big issue I have is lack of transparency with data. They did a press release and they reported eight patients. And I don’t think that’s appropriate. I think that, you know, many of the patients weren’t reported. We still don’t know anything about the T-cell responses. And I think we have to have true transparency with data, and where we are with these, because these trials are being supported almost 100 percent by the U.S. government. And many of them don’t have that yet. And I think we need some more transparency there.
[16:11] Andy Slavitt: So, Mark, should we trust the FDA?
[16:13] Mark McClellan: I think we should trust the FDA. Trust, but verify. So just picking up on some of David’s comments. I do think that there are some very good processes under way to demonstrate that these vaccines really are safe and effective. And as David said, for many of the vaccines, not all of them — the Moderna one, that MRNA one is new. That hasn’t been used before. But the Oxford vaccine and some of the others are based off platforms that have been used in tens, if not hundreds of thousands of patients already for previous viral infections where the vaccines have turned out to be both safe and effective. So that’s a good track record to build on. And then these are going to be large trials. As I mentioned, the U.S. government, the FDA is aiming for trials that are 30,000 or more people, and that’s both to make sure we can detect that the vaccine really does have a significant effect, but also to detect rare side effects. And some of those are already done, as David mentioned, in so-called phase one testing or early testing and people to make sure you don’t see things like the vaccine causing an increased response to the virus rather than tamping it down. And again, so far, the results look pretty good. In addition, in the guidance that the FDA has put out for what all the manufacturers need to do, it’s not just a matter of doing a test over a period of months to show exactly as David said, that the body mounts a strong immune response and it leads to fewer and less severe chances of infections. But also, the people who are in the trials are going to be followed for a long time period after the approvals just to make sure there aren’t any very rare side effects that don’t show up late. So I think putting it all together seems like that the benefits are very likely to outweigh the risks. I know you’ve asked about emergency use, too.
[18:16] Andy Slavitt: Well, yeah. So let’s say it’s October. It’s two weeks before the election. And we don’t have a complete phase three set of data on, say, that Moderna trial, and the FDA issues and emerges the use order which people might find parallel to hydroxychloroquine, which was also done under EUA and it turned out possibly to be a mistake, although, I’m sure opinions differ. But that may or may not have been politically motivated. But October, we’ve got a very politicized country, and if something came out under the EUA, would you take the vaccine, Mark?
[18:54] Mark McClellan: I think I would depend, as David said, on what the evidence shows. But based on what FDA has said so far, they do not intend to make a vaccine available for emergency use until there is clear evidence on effectiveness as well as safety. FDA wrote about this recently, and this is not the political leadership of the agency or the White House, it was the career FDA staff, the experts in their biologic center that oversees vaccine regulation in the same documents that they talked about what they want to see in well-designed clinical trials. As we’ve just talked about and what they said was they could see an emergency use being approved before the formal vaccine approval happens, but only after the clinical trials have shown significant impact on outcomes that matter. And that’s kind of what happened with our remdesivir, that antiviral drug that’s now being used and is on track to do more widespread use and approval. FDA waited until the important clinical trials, the so-called pivotal clinical trials, showed a significant benefit. And then an emergency use would probably only be available if we don’t have good options and we are facing serious outbreaks in the fall. And probably only for some quite narrow populations, at least initially, like frontline healthcare workers or other workers at very high risk.
[20:24] Mark McClellan: All that said, I think this is an area where FDA needs to be extremely transparent and encourage and support the availability of data, not by press release, as David said, but by more complete release of the supporting information that would be the basis for an emergency use authorization. That could be, for example, a pre-publication print of the actual academic study that’s being developed about the vaccine, but something more significant than a press release. And it is important, given the day and age, that we work to be as transparent as possible about the evidence underlying these important decisions.
[21:04] Andy Slavitt: It’s so hard. You can’t really blame people for being confused, even with that good explanation. People who’ve had no business having to know what a pre-print was and an EUA are now learning this language real-time. And how did people know who to trust, given that people are suspicious, as you said, David, they may be going to take risks every day anyway, and this is a different type of risk. I think people really want to know how to think through making the decision. Is there an authority? Is it Anthony Fauci? Is it you guys? Is it someone speaks out for, someone speaks out against, how do people make sense of it?
[21:40] Dr. David Agus: It’s a critical question. And I think in today’s time, you know, obviously we’re lacking leadership in the healthcare space. And it’s shocking to me that we never really had leadership. And now it’s obviously showing. There are some pivotal events coming. The side effects — I think the biggest side effect is not going to be, you know, getting an adverse event from the vaccine. It’s thinking you’re immune and hugging grandma and potentially harming grandma. So do we know it worked in you. I think, you know, the challenge studies that will start next month are very powerful. They are two separate challenge studies being planned. The first is people who already had the virus, they’re going to give them the virus again. They can put them up in a self-contained community, a hotel, and they will stay there during the course and we’ll define what immunity is. I’m not going to say where it is, but it’s in a European country. It will help to define what immunity is, because despite all of this, all of the great science for the last four and half months, we don’t know what immunity is. We haven’t defined what immunity is. And there is no immunity test. The second, we’ll take people and give them a vaccine, and then part two of the vaccine, and then several weeks later, introduce the virus, or challenge. And again, we’ll start to define what happens in an elderly, what happens in a young person, what immune response is enough to actually block the virus. And those are two critical steps. When it was announced they needed 600 people to participate, there were 25,000 people that volunteered in the first two days. Heroes that stepped up and said, I want to be part of the process. You’ll see tomorrow, they’ll announce the first 30,000 patients, as Mark alluded to in the Moderna study. They’ll screen a million people to get to 30,000 because it has to be diverse. It has to be every ethnicity, every age, every weight, every preexisting condition.
[23:22] Dr. David Agus: So we can really know with fine granularity who should get it and who will be protected when they do get it. That’s hard to do. And this is new science here. Because it matters if you get it and it works versus if you get it and it doesn’t work. Your behavior is going to be different. And so we need leadership here. And you know where to get that information, I don’t even know how to answer that. But I do think the right studies are being done. And the challenge is everything is political. Listen, I’ve gotten death threats. I’m a little cancer doc in Los Angeles and I’m getting death threats. I mean, what the hell? Because I had, you know, talked about hydroxychloroquine, I had talked about vaccines. An anti-vaxxer literally had a gun. They caught, you know, her. I mean, it was a wealthy individual here in Los Angeles. Because they get very emotional about these topics. And these are religion. It’s very hard to argue against people’s beliefs, rather than arguing scientific facts. And so and social media gives everyone a voice. And it’s very intimidating, as I’m sure Mark will attest to and you will attest to, you get attacked on social media. And it’s scary. I ain’t used to it. People used to like me.
[24:31] Andy Slavitt: Yeah, well, everybody who knows you loves you. And I can attest to that. For anybody out there who has a bad thought about David Agus, he extended my dad’s life for a number of years and is one of the warmest, kindest people and one of the smartest. Zach has a question that he wants to ask both you guys.
[24:50] Zach Slavitt: Yeah. I’m wondering, what are the chances you think that we find a vaccine and the virus mutates and comes back seasonally, or like reaction isn’t able to be top of the vaccine.
[25:02] Dr. David Agus: So over a million years, the human genome evolved one percent. It changed one percent our DNA. This virus can change up to a percent in a day. So there’s no question it’s changing. The good is most of the treatments in development now as well as the monoclonal antibodies in the vaccines are targeting a part of the protein, the virus, that actually engages with our sensor, our receptor called ACE-2. So if it mutates or changes, it won’t bind to the human receptor. And so the good is we’ll benefit from a mutation in that regard. Historically, viruses get weaker over time, not stronger. But you’re right, they do change, which is how they went from animals to us, and being able to grow in us. But I don’t think that’s going to be a major issue, at least we hope, on the vaccine side or the more exciting therapy side.
[25:51] Mark McClellan: I don’t think it’s going to be a big issue for the vaccines. On the other hand, people should be aware that they may need to get boosters down the road. We don’t know how long immunity is going to last, but both for the vaccine and for a lot of the other treatments in development that are based on the principle of building an antibody that can neutralize the virus, I think those are all very promising therapies despite the these changes in the viral genome.
[26:26] Dr. David Agus: So, Mark, if you were FDA commissioner today, what would you set the threshold for approval to be? I mean, what do you think it has to be in order to go into the market?
[26:37] Mark McClellan: Well, I think where FDA is setting the bar is pretty reasonable, and that’s 50 percent. That means a 50 percent reduction in how likely you are to get infected, or how severe the infection is. A 50 percent reduction having to go into the hospital if you get it. And that’s done with trials that are big enough that you won’t make a mistake. So you could be absolutely sure it’s going to be at least, you know, 20 or 30 percent effective. As you said, I don’t think we should expect this first round of vaccines to be effective in everyone, but they can make a really big difference, and they’re still worth taking. I would take it, if it met the standards that the FDA is aiming for now, which is really at least a 50 percent reduction.
[28:30] Andy Slavitt: So I want to clear up something that I think you guys have made quite apparent, that I think is different than how people think about when they hear the word vaccine. A lot of sentences either begin or end with the phrase, “until there’s a vaccine.” Like we’re not going to have this sports league until there’s a vaccine. Schools won’t be normal again until there’s a vaccine. I can’t see my mom again until there’s a vaccine. So in some respects, we are giving a lot of power to one word to be transformative. And I think one of the things that you’ve both made clear is that vaccines don’t work on everybody. We don’t know how many people they’ll work for. We don’t know how long they’ll work. And it may be, in fact, that the type of people that most need the vaccine — immunocompromised, older or whatever — maybe those are some of the people it doesn’t work on. So that’s on the one hand. On the other hand, I want to also make the point and see if you all agree with this, that it actually doesn’t need to work on everybody. And here’s why: what we’re trying to do is give the virus no place to go. We’re trying to prevent the virus from spreading. And it’s quite possible that by the end of this summer, 15 percent of people or so will have had the virus. Now you’re going to explain, hopefully, whether that means that if they’ve got some antibodies that gives them some protection or not or that we don’t know. There’s also some probably observational evidence that some people are not as susceptible, either because they’ve got some sort of cross immunity or there’s some gap in our knowledge or something about their T-cells or who knows what. But my point is just that once you have a certain portion of the population that is either vaccinated, or has some other form or protection, the virus begins to die down and becomes less of a threat. So all of that is to lead up to say: if you picture the world three years from now, David, how much is Coronavirus likely to be a factor in our lives? How many of the normal things will we have gotten back to, etc.?
[30:42] Dr. David Agus: It will always be in the back of our mind and it’s going to change our behavior. There will be a new normal. I mean, the one thing I would comment on is that I don’t think pinning all our hopes in a vaccine is everything. I think, you know, what a vaccine does is it makes you make an immune response against the virus who can’t get inside of your cells. Well, we can recapitulate that with something called monoclonal antibodies, is that we’re able to take B-cells, which are the cells that make antibodies, out of patients that have recovered, and found ones that are able to target that spike protein right where it’s required to get into the cell. And they’re in drugs now and they are in clinical trials now and they look tremendously exciting. So if we have a treatment that works, our shoulders come down. If we can get to what we call herd immunity, which is enough people in the population that you alluded to so that the virus doesn’t have anywhere to go. It doesn’t have to be everybody, because a lot of people won’t make immune responses. But that number is probably in the 80-plus percent range. I say probably because there’s something called R-naught, how infectious the virus is, and with this virus, because so many people are asymptomatic, we don’t really know what that number is, like with most viruses where everybody is symptomatic. So it’s difficult.
[31:48] Dr. David Agus: But I think we’re going to be able to take — we’re asking Zach’s generation to change their entire lifestyle today to help not themselves, but to help other people. And that’s a new concept for our country. What a vaccine will do is enable us to have our shoulders down. It’s not going to eliminate disease. We’re still going to have many of the precautions that we do. You know, we talk about is it building LEED certified for energy? Well, pretty soon we’re going to say, does it have good ventilation? Just in the same words as we say, is it good for the environment? So it’s going to change many of the aspects. My hope now is that anytime you’re sick, you wear a mask in our country. Like it’s been normalized in many the Asian countries. That’s a freakin’ new concept here. And we can actually change that. So I do think it’s going to change some behaviors to a new normal.
[32:31] Andy Slavitt: Yeah. So, Mark, will I be hugging my mom a year from now, year and a half from now?
[32:37] Mark McClellan: I sure hope so. I think by three years from now, as David said, you know, the world is going to be different. Work will be different. Healthcare will be different. And I think in many ways, those are actually good things, steps that the pandemic has actually encouraged to make things more convenient and potentially safer, more focused on prevention. But the next three to six months are still going to be very challenging for the reasons we’ve talked about. I’m optimistic that we’re going to have better treatments in the next few months, and even better a few months after that. David mentioned the monoclonal antibodies. There are studies underway now that have shown for people who are sick enough to get hospitalized, there are things that we can do that actually significantly improve their outcomes, we’re going to learn more about those over the coming months. I am concerned, back to my point about the scale of a pandemic, that we really need to be planning now to manufacture many of these treatments at a very large scale. So those monoclonal antibodies, the neutralizing antibodies that could be available well before a vaccine and help bridge to it, or help people who don’t mount a strong immune response to the vaccine on their own, can be very helpful. But we don’t have that much capacity in this country or in the world to manufacture monoclonal antibodies that the level needed for, say, prophylaxis for protecting you if you’re at high-risk, or if you’ve been exposed and you want to avoid complications.
[34:02] Mark McClellan: And then as we find our way to something like containing the virus, as you said, you know, these medical treatments are going to make that easier and easier over the coming months, even before we get to a vaccine. But until then, for the coming months, it really is on us. The steps like wearing a mask and paying attention to distance is very disruptive. It’s not like something we’ve had to do before. But I would emphasize, I think that’s just a matter of months. By six, seven, eight months from now, I think we’ll be able to ease up on some of those kinds of requirements. And by a year from now I sure hope you’re hugging your grandma.
[34:53] Andy Slavitt: So let me try to sum up, because I know that you both have tight schedules and you’re amazing to do this. I think we’ve all learned a lot. A couple of things I’m hearing, one is there is no one silver bullet. However, if you combine a bunch of the different things that people are working on, they get together and they get at this. You’ve both emphasized that along with that will probably still continue to be some kind of personal responsibility for our health if we’re sick, masks and some new norms. You know, you’ve also made the point that there’s a light at the end of the tunnel. Am I wrong to say that you both sound optimistic, and that you think that notwithstanding the fact that there are going to be questions about safety, that in the near term, whether it’s a few months or sometime next year, we’re going to have a safe vaccine? And then I think final, the final thing I heard is that there will be more questions to answer. Manufacturing, distribution, how long it lasts, whether they need to be renewed and so forth. What would you change about that summary? What would you add about that summary that people should be taking away?
[36:00] Dr. David Agus: There’s not going to be one winner. They’re going to be several winners. And the first vaccine that goes to the market may not be the best. You know, some of the ones that are in development that haven’t even entered patients yet, I think are scientifically even more exciting. But that’s OK. I want one that’s effective, and then over time, we iterate and we get better. I think that’s critical. I think we’re going to need a method to not just the supply chain, as you alluded to, which is going to be a major one, but also to know who’s been vaccinated. We’re talking a two-part vaccine here. We’re talking about probably regular booster shots at some point. We’re talking about monitoring to know when you need a booster shot. So we’ve never had a surveillance system like that ever in this country. And privacy advocates are going to say, I don’t want you to know. But the other side is I don’t want you to harm anybody. You know, the way we decreased smoking in our country pretty dramatically is we said, hey, second-hand smoke can kill others. You could do what you want to yourself, but you can’t harm others. And I think the same is going to happen here, is that you can not get a vaccine, but then you probably shouldn’t get on a plane. You shouldn’t go to a sporting event. You shouldn’t go to a restaurant if you don’t have a vaccine. And I think we have to think differently as a community, rather than only as an individual.
[37:07] Andy Slavitt: Wow, big societal questions. More fodder for this podcast. I think this podcast is not going anywhere.
[37:15] Mark McClellan: Just quickly. I think we do have some cultural issues ahead for all the reasons that you’ve just discussed. And thank you for the podcast and bringing those up. It really is impressive how the response to this pandemic depends so much not just on science, which it does, and it’s really impressive to see the level and the speed of scientific response here. I mean, this pace for a vaccine is just unprecedented by scientific standards. And I think there’s good reason to believe it’s actually going to work pretty well. But also the extent to which how the pandemic does depends on the decisions that we all make, both individually with our decisions about masks and how we interact with others and collectively through our political leaders. And I hope people will not underestimate just how important those parts of the pandemic response are, too.
[38:14] Andy Slavitt: That’s great. Well, I deeply respect you both. I really thank you both for coming on and sharing all this. And hopefully everybody’s knowledge has been a bit of further pushed down the field. Like everything, the topic isn’t clean and simple, as we all would like it to be. But in that complexity, there’s a real richness, a possibility, and that makes me optimistic.
[38:40] Andy Slavitt: I first met David Agus when he was my dad’s physician. My dad had late stage cancer and was not given very long to live. He was 60 years old. And David was someone who is at the forefront of research and cancer and oncology. And as a result of all of this — I think he was diagnosed before you were born, Zach, and you were a couple years old when he died. But he lived much, much longer at a much, much higher quality of life than I think he would have otherwise. And so you heard me refer to that. I hope you enjoyed this episode. We have a spectacular episode coming up on Wednesday. I might even say a brilliant episode coming up on Wednesday, as we continue to give you the facts you need to know, with an interview with Larry Brilliant. And if you don’t know who Larry Brilliant is, he was the advisor on the movie Contagion. He is an amazing scientist who is probably as much as anybody else, even as much as Anthony Fauci, kind of the leading authority on what’s going on right now. He cured smallpox. And he and I worked on a number of things together. And I think you’re not going to want to miss that episode. In the meantime, go listen to some old ones and we’ll talk to you on Wednesday.
[40:33] Andy Slavitt: Thanks for listening to In the Bubble. Hope you rate us highly. We are a production of Lemonada Media. Kryssy Pease is our producer. Ivan Kuraev is our editor. Jessica Cordova Kramer and Stephanie Wittels Wachs executive produce the show and run our lives. My son Zach Slavitt is my cool co-host and onsite producer. Music is by Dan Molad and Oliver Hill. You can find out more about our show on social media @LemonadaMedia. And you can find me at a @ASlavitt on Twitter or @AndySlavitt on Instagram. If you liked what you heard today, please, please, please tell your friends to come listen, but from a distance. And for now, stay safe. Share some joy. And we will get through this together. And #StayHome.