Vaccines: FDA Approval, Kids Under 12, Boosters & Side Effects Explained (with Mark McClellan)
Andy and former FDA commissioner Dr. Mark McClellan detail the next big moves in the COVID battle including FDA approvals, what’s happening with clinical trials for kids, boosters, mandates, and what the adverse reporting system really says about vaccine safety. Plus, they discuss the #COVIDSafeZones initiative launched with 30 other public officials.
Keep up with Andy on Twitter @ASlavitt and Instagram @andyslavitt.
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Check out these resources from today’s episode:
- Read Kayla Chadwick’s article that Andy mentions in today’s episode: https://www.huffpost.com/entry/i-dont-know-how-to-explain-to-you-that-you-should_b_59519811e4b0f078efd98440
- Learn more about the plan for COVID-19 booster shots: https://www.cdc.gov/media/releases/2021/s0818-covid-19-booster-shots.html
- Here’s the website for the COVID Collaborative: https://www.covidcollaborative.us/
- Read what Andy, Mark, and John Bridgeland wrote about #COVIDSafeZones in Yahoo! News: https://news.yahoo.com/former-government-officials-issue-national-142600426.html
- PoltiFact debunked a viral TikTok video that claimed VAERS data showed 6,000 deaths from the COVID-19 vaccine: https://www.politifact.com/factchecks/2021/aug/09/tiktok-posts/no-truth-vaers-system-shows-6000-died-because-covi/
- Find a COVID-19 vaccine site near you: https://www.vaccines.gov/
- Order Andy’s book, Preventable: The Inside Story of How Leadership Failures, Politics, and Selfishness Doomed the U.S. Coronavirus Response: https://us.macmillan.com/books/9781250770165
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For additional resources, information, and a transcript of the episode, visit lemonadamedia.com/show/inthebubble.
Andy Slavitt, Dr. Mark McClellan
Andy Slavitt 00:19
Welcome to IN THE BUBBLE, I’m your host, Andy Slavitt. So, we’re gonna take a look at what’s going on and what’s about to happen. In some pretty important areas over the next couple months, there’s a lot of activity relative to just the pandemic alone. And that activity is going to change the way we do things. Mark McClellan will be here today we’re going to talk about what some of those things are. They relate to kids, they relate to schools, they relate to booster shots, they relate to the FDA, Mark used to run the FDA, used to run CMS, he’s a Republican, who I have collaborated with a lot. And I think you will really learn a lot from this conversation. So when we ask what’s going on, it’s, I have to admit, it’s something I’ve been asking myself with increasing intensity over the last few weeks. And not really just with respect to COVID-19. But if we zoom out and look at all of the things around us, in our world, they’ve come at us, some of which, you know, we really can’t touch and feel like what’s happening in Afghanistan, like what’s happening with the climate change, although I think we can all agree that we can touch and feel that one, it just causes me to want to zoom out a little bit.
Andy Slavitt 01:45
And at some risk of not hitting the points exactly the way that you can relate to them. I’m going to try, I’m going to try my best to communicate a little bit before we start this episode of, you know, what it is we’re seeing, and what it is that it says, there are a lot of things going on that feel beyond our control, individually, and are only in our control collectively. How much carbon we put into the air? Well, I don’t know how much time you spend thinking about how much carbon you put into the air? But if you do, you probably are conscious of it. In the some of the activities you do, but sort of if you’re like me, not in ways that give you major disruptions to your life. Only in ways that are things you can do when you can do them. Oh, sure. I can not take a plastic bag, Oh, sure. I can do something that’s slightly more fuel efficient. Maybe even I can put a solar panel on my house, if it pays for itself. And you know, if there’s a government subsidy, I mean, that’s the kind of behavior that the countries are expecting, at best from people that with financial incentives, maybe they’ll do what they think is the right thing for their fellow man and for people that they haven’t met. And it’s hard.
Andy Slavitt 03:12
It’s a recognition that, you know, we just do a pretty lousy job when it comes to caring about others, and about the impact of things on others. Now, when I say care, I don’t mean that we don’t care. I mean, we care about girls and women in Afghanistan. But do we care enough that we have a solution to that problem? No. Do we care about people who are going to be born in 2040 and 2050, and live on this planet, with the mess that we left them? We care, but we don’t know them. And so we don’t alter our actions that much certainly, as societies, we have all kinds of reasons and all kinds of rationale why that’s the case. And you know, we’d rather have our bird in the hand is really what a lot of it comes down to then worry about some potential outcome in the future. And part of it is because we don’t take collective action. And so we don’t see our neighbors, we don’t see other countries taking action.
Andy Slavitt 04:20
So we feel like why should we be the only ones to suffer? Why should we limit our freedom, our rights, things we enjoy things that are important to our family. And that puts us in a state where things just drag and we never quite do the right thing and look to a point where this week we just read the news that it has, for the very first time in history, shown rain in Greenland. And for the first time in history, we are seeing the planet change in ways that will never change back from we’re experiencing some of the hottest temperatures ever were recorded in the history of our planet. And that’s, you know, fundamentally, those are things that none of us feel we can control. But, in fact, we’re all needed to play our part to control those things. And how do we do that?
Andy Slavitt 05:15
And, you know, I wrote a little bit about this, in my book, Preventable. In the last chapter. You know, I wrote about an article that started with an article that Kara Chadwick wrote, in 2017, which is called I don’t know how to explain to people that you should care about other people. And I read from that you said, if making sure your fellow citizens can afford to eat, get an education, and go to the doctor isn’t enough of a reason to fund a higher minimum wage, public education, universal health care. I have nothing left to say to you. So she’s made it fundamentally clear in that article, how difficult that is to have an effective policy conversation if you can’t even fundamentally agree that we owe each other something. And so that’s a real question, do we owe each other something? Why are we so lousy at caring about other people and thinking about other people, it is been such the case during this pandemic. And I write as another part of this book, I’ll just read it to you really quickly. When there’s a pandemic, we blame scientists, when they’re raging fires, we blame the forest, in the crisis, we try to protect ourselves, and even a neighbor too.
Andy Slavitt 06:30
But for all the people we don’t know personally, we suggest that a lack of quote, individual responsibility is the culprit. If this crisis didn’t harm us, we decide the next one won’t harm us either. And so we never make the modest investment to prevent it. Instead, we chalk up massive losses to the cost of doing business. But every choice we make that ignores the suffering of others, means that we are much less prepared for the next adversity, when it arrives. Does that ring true? Does that ring true to what we see around us? Does that ring true to how we feel about others? Does it ring true to some understanding of our impact on the world? I think that pandemic is really offering us a lesson, a lesson on what happens when we just don’t care enough about other people, when we think our own individual right to not wear a mask is more important than other people’s rights. That’s fundamentally a flaw that exists in our system right now, because we are so interdependent. Maybe when we were in the hunter gatherer stage of things, centuries and centuries ago, you know, that interdependence didn’t matter very much, or it provided opportunity for us to do things better.
Andy Slavitt 08:01
But right now, perhaps our greatest risk, the greatest risk we have is that we can’t seem to get it together and do things that benefit all of us, if they cost us a little bit. And that’s a kind of profoundly sad statement. And what it can suggest here is that we think about our next generation, think about what the kids are going through today and what they’re witnessing. They’re witnessing the cost of this excess, the cost of this not caring, and just maybe they want to do something about it. Maybe they want to do something about it. Maybe we shouldn’t raise kids in our own image. Maybe we shouldn’t raise kids to think so much about their world until they think about the broader world. I don’t know how we do that. I don’t know how we do that. But I know that we all have some sort of obligation here to figure this out. Because we’re kind of in a moment that a lot of crises are happening and they’re not happening by accident.
Andy Slavitt 09:12
And you may not agree with my diagnosis of how we got here, or you may not agree with my conclusions about what needs to be done, or what we need to work on. But boy, we need to talk about it. But that needs some space and need some safe space and we need to be able to talk about it with people who don’t see eye to eye with us in a safe way. Or we’re never going to make real progress. All right. sermon over, done with that sermon. Let’s get to McClellan. Dr. Mark McClellan. Former head of the FDA, former head of the CMS, partner in crime, and he’s gonna illuminate us on the challenges to get at right now.
Andy Slavitt 10:03
So, I think there’s a few things we should talk about Mark McClellan, former important person, and then another time a former important person, and that time for a person, and that is a term that still a very important and charming person. Welcome back to the show.
Dr. Mark McClellan 10:20
Hey, it’s great to be back. This is my favorite bubble.
Andy Slavitt 10:23
Oh, your favorite bubble? I love that. I mean, maybe just as like, if people are out there listening and thinking about the throughput of stuff that’s about to change. That’s got to go through some sort of policy apparatus, and then hit them, we can combine that we can create this list together. It’s like, there’s gonna be final approval of the Pfizer vaccine, at some point to get approved vaccines for kids under 12. They’re going to prove booster shots for first Pfizer, Moderna, then Johnson&Johnson, who, what am I missing? I feel like I’m missing like 10 other things.
Dr. Mark McClellan 11:01
Those are all, yeah, I think those are all good. There may be some therapeutics coming along this fall for people who have been infected..
Andy Slavitt 11:11
Like an oral antiviral?
Dr. Mark McClellan 11:13
Oral antivirals. We’ve got better testing than we’ve ever had. And now with that spread of Delta, people are really taking that up more, taking a more serious look at how we integrate testing and what we’re doing. The list goes on, Andy.
Andy Slavitt 11:31
How about the use of monoclonal like, if you could do a real time test, and say that someone has COVID Is there something structural to do there as well?
Dr. Mark McClellan 11:42
Could be, especially if the tests are good to combine for people having the vaccinated tests and vaccination. If the test turns out, especially the test turns on negative. But I think part of the challenge with monoclonal is we’re just having trouble getting enough to people who are actively infected, so 200,000 doses delivered in the past week, which is way up from what it was before. And that sounds great, except that we had five times that many infections and people who are at risk and would benefit. And the monoclonal’s can now also be used for prophylaxis, meaning for people who have been exposed, who are high risk, and we’re not really close to reaching all of those individuals.
Andy Slavitt 12:27
Right, because we got to save them for governors like Governor Abbott.
Dr. Mark McClellan 12:31
Well, I’m glad he got it.
Andy Slavitt 12:34
Yeah, if he was wearing a mask, he wouldn’t have gotten infected, you know that. So there’s an array of that stuff. And then there’s an array of other changes, having to do with that sort of policy related stuff having to do with masks, schools, and then something that you and I have been working on, which is what’s going to be the posture of different people, businesses, schools, sports teams, etc, on whether or not they require vaccinations, or at least some sort of proof that people aren’t infectious before they get admitted?
Dr. Mark McClellan 13:09
And that’s really important that and the full approval of the vaccines and going to be the two biggest things for getting our vaccination numbers up.
Andy Slavitt 13:18
So broad horizon changes. It’s so as it turns out, there is a big agenda for fighting Delta. There’s a number of these pieces. Oh, by the way, we’re only just talking about the domestic stuff. Massive, massive amount, baby as important as anything on the global.
Dr. Mark McClellan 13:33
Yeah, and happy to talk about that, too, is you know, we’re doing a lot, globally, some that you helped us with back when you were in the administration.
Andy Slavitt 13:41
That’s right. And we have Jeremy Farrar episode coming up right after this one. phenomenal, phenomenal episode. So your job is to be more interesting than him and you don’t have a British accent, you don’t have a British accent. And I think there’s an unfair advantage. So where should we start? Like if you think about this cluster of activity, help us all make sense of it. What’s most important, what happens when maybe even say something simple? Like when should the public be expecting certain of these things to happen?
Dr. Mark McClellan 14:14
Well, I think these things are gonna be happening right away. The FDA has said that they’re aiming to get the full approval of the Pfizer BioNTech vaccine done by around the end of this month, very beginning of September. So that’s within the next week or so I would expect the guidance from the federal government out just today. And these were talking is aiming to set up booster programs beginning on September 20. For the people who got vaccinated early and are at highest risk. That’s eight months after they finished their second dose. There also will be information coming soon for those who are listening who got the J&J vaccine. As you know, one of the things I do is on the J&J board as an independent director, J&J is finishing a study very soon on the effects of the second dose and potentially a need for a booster there that’s coming seem top. Where re-opening schools and a lot of schools are taking Delta very seriously with a comprehensive approach that includes distancing, reasonable distancing for kids. Mask use, better ventilation, testing and vaccination in the teachers and staff. So we’ll get to see how well those programs work, I think they actually are probably going to provide better rates of controlling COVID spread involving kids. And what we’re seeing right now are a couple 100,000 cases of COVID. And kid this past week alone that were reported. So watch the things coming up.
Andy Slavitt 15:50
Did you say a couple 100,000 cases of COVID, in kids alone?
Dr. Mark McClellan 15:53
In children and that those are just the ones that we’re counting. Remember, most kids fortunately have very mild or no symptoms, with COVID. So we’re probably missing a lot more than those. But we’re at peak levels of hospitalizations for kids in the United States today, with COVID highest level of levels we’ve ever seen.
Andy Slavitt 16:13
This just brings a lot of stress to people, right to parents, to teachers, to young people themselves.
Dr. Mark McClellan 16:20
It does. But I think the good side of it is that while Delta has made everything tougher for getting beyond the pandemic, we’ve got so many more tools and so much more knowledge to protect ourselves despite delta. So we’ve seen in some of the schools that are starting to reopen now, programs that do all the kinds of things that I said, you’ll know one of these steps is perfect. But they all help vaccinated teachers and staff and for the kids that are over 12, vaccinations in kids, and while that’s all for the kids, that’s a voluntary program, there are a growing number of schools that are requiring vaccination to participate in school sports extracurricular activities, so that keeps the other kids in the group safe. So vaccination really important for protecting schools, even though kids under 12 can’t be vaccinated.
Andy Slavitt 17:18
When do you think kids under 12 will likely be interested to get vaccinated?
Dr. Mark McClellan 17:22
So FDA is trying to be very thorough with those studies, because people understandably have questions about safety. There are some early results and process it seemed to show some important benefits. But I’d expect that to be Andy still a few months off late this year before all the data is reviewed. And there’s a decision unless things get significantly worse with COVID. Hopefully, that’s not gonna be the case, because of these other steps that matter, vaccination and people who are eligible and the masks the testing in schools and there are lots of schools that are doing this effectively. Now, things like that.
Andy Slavitt 17:57
Is there anything people are seeing that’s causing concern in the data? The under twelves?
Dr. Mark McClellan 18:02
Not that I know of. But again, that’s why FDA is asked for these studies to be enlarged. That’s why I’ve asked the companies to follow the kids for longer just to make sure they’re not missing anything.
Andy Slavitt 18:16
Okay, so we’ve got a high bar to make sure. And so parents should feel like, even though I’m exposed, if the FDA could make a decision that they felt highly confident with, they would do it earlier. And so this time really benefits us and then to make sure that when and if they do make that recommendation, it’ll be because they feel like they’ve got it confident got it right. And there’s a lot of questions like dosing or other things that need to be worked out.
Dr. Mark McClellan 18:47
Dosing, very rare side effects, you can’t assume that kids are going to respond just like they’re not little adults, they differ in important ways. So it’s important to check all that out. And you know, unfortunately, you just need to watch and wait as these clinical trials are underway. So it is going to take a little bit more time.
Andy Slavitt 19:33
So when you think about, Mark, the combination of things that should encourage vaccination, you mentioned the final what people talk about as BLA. This is when people say there’s a final approval, it’s called a Biological License Agreement. Between that and some of the requirements that some employers and colleges etc are pushing for its 72% of the public has had their first shot today in the US. How far do you think we can get by, you know, say the end of the year through this BLA and through some of these other initiatives in different parts of society.
Dr. Mark McClellan 20:10
Well, I’d like to see us Andy get over 80%, I think we can do even better than that. But you’re seeing examples of that. Now, as you know, we’ve worked together on some initiatives to help businesses, colleges and universities, entertainment venues, take steps to make use of vaccination to educate people and to get their questions answered, to get the vaccination rates up. And if you look around the country, there are now a number of sports teams that have reached 100% vaccinations. That’s young, healthy people a number of college athletic programs that have reached 95% or higher. And that’s not by just it takes work. It takes listening to people’s concerns that takes making clear what the benefits of vaccinations are, take steps to make it easy to get vaccinated. But we can do significantly better than renewing while still making sure we’re answering all the questions and addressing the concerns that people understandably have about getting vaccinated.
Andy Slavitt 21:12
So do you want to give a kind of a minute or two overview of this initiative? I don’t think I’ve talked about it here on the podcast. So that would be great if you would give people a sense of what the goal is.
Dr. Mark McClellan 21:24
Yeah, well, the COVID collaborative working with you Andy, me and a lot of other public health experts and former government officials. And in both parties, I think Andy has covered all five of the past presidential administrations, including people like Jerome Adams, Surgeon General under President Trump and Scott Gottlieb, who was the FDA Commissioner in the in the last administration, have all come together to get behind some common-sense recommendations based on the science that we think the private sector can take to help make workplaces, schools, other places that people come together safer in this era of Delta. And, you know, I wish it was more straightforward. I wish we could just go back to you know, be vaccinated, some of us being vaccinated and go forward. But it takes a bit more than that. What we’ve laid out in this collaboration is some simple clear steps to help make that happen. That includes getting vaccination rates up in settings that are really high risk, or people are coming together a lot, that includes vaccination requirements, with appropriate exceptions for religious reasons, or medical reasons.
Dr. Mark McClellan 22:42
It includes the use of additional steps for individuals who choose not to be vaccinated to help make sure people around them are protected as businesses get back to work or as people come together for, let’s say, sporting events or other kinds of entertainment. It includes using other steps to promote vaccination and to support safer workplaces, like testing programs, and the other things that we know can be implemented. So this is some additional work. It is temporary until we get COVID in our community back down to levels where it’s not a threat, which is very achievable, I think it’s a big opportunity to augment what the government can’t and you know, perhaps, frankly, shouldn’t be doing is relying on the private sector and people who are working together to create safe workplaces to create safe places to go to school to create safe places to enjoy being together in this era of COVID.
Andy Slavitt 23:46
Well, to say it’s been really great working with you on this. And I really enjoy the depth and knowledge and skills you bring to this conversation. And, you know, I think people would be really encouraged to see, you know, a bunch of people who many of whom, as you said, have served in different political administrations. So they have there’s some political affiliation there somewhere, kind of all very much saying the same thing, in a way that I think it really, I don’t know what you think Mark, is very meaningful for a CEO or someone who runs a sports league or team or university to say, you know, despite what may be going on in a state or two, there’s a broad consensus here, that, as you say, it’s thoughtful, it balances, the lot of concerns people have. But it also says, look, just because there’s no perfect answer, doesn’t mean we shouldn’t do something. And I don’t know, I think it’s really powerful when people see the kinds of people coming together like this, to provide support.
Dr. Mark McClellan 24:56
You know, some of the conversations I’ve had, you know, when I went into government, I first serve actually in the Clinton administration. And then in a number of roles under President George W. Bush, I turned to some of these individuals who had worked earlier in the Clinton administration or other administrations to get advice. And, you know, the nice things about that was you can tell how much they cared about the country and cared about what mattered to people around them and in their communities. And, you know, I haven’t had an experience and he really liked that sense until this until COVID, has really brought everybody together and to look closely at what the facts are to find areas where we should be able to get to common ground and work together, it’s just been great to see that commitment to the well-being of the country. And, and a willingness to think about how we can work together not to raise the decibel level around, you know, political debates, but focus on what can really help us all do better together.
Andy Slavitt 25:59
It feels like, if what you wanted to do was be critical, just go out there and find things that people have done wrong, and use that to get yourself on cable TV, or get some clicks, or some tweets or what have you. It’s not really that hard to do. I mean, it’s a pandemic, for grants, there’s a lot of stuff that is just by definition going to go wrong. One of the things I admire about you and always have been, there’s plenty of opportunity to take shots at people, but they don’t really do as good, they don’t move the ball forward. And you always seem to find a way to help people see perspective of how challenging This is, and how much we need to come together and do some of these things.
Dr. Mark McClellan 26:39
Well, I appreciate it. If you keep going on like this, I’m going to tear up or something. To get back to the point of all of it, you know, what does really seem special to me with this is, is just how broad the support is for taking steps like getting helping people find out about getting vaccinated and getting vaccinated, taking some other common-sense steps like masks where we really need them in workplaces, in schools, just to get through this crisis period, so that we can really get on with our lives. It’s great to be a part of that with you, Andy and with so many other people, so many diverse backgrounds who are coming together in the public and private sector to try to make this happen.
Andy Slavitt 27:20
Well, just so you know, I took that as a challenge to try to make you cry. So now I’m going to be relentlessly looking for weak spots. How do you think about this decision that was just announced on the third shot of the boosters? And people who have a global view like you do? certainly see all sides of the issues. So maybe you could comment on both the couple elements. One is that what’s the scientific rationale for making this decision? Is it the right decision? And secondly, you know, what are the political forces that are surrounding this decision? And third, you know, are there are tradeoffs, both scientific and humanitarian, relative to the first world countries continuing to enhance their, you know, immunity levels, while there are people still waiting for their first shot?
Dr. Mark McClellan 28:14
Yeah, I definitely want to spend a few minutes on that. That’s a critical question. But let’s start with the US situation. And you know, I know in the pandemic, like you said, things are changing. Nobody is able to manage something like this perfectly. It’s such a big and dynamic set of issues involved. But if you take a step back, and again, just trying to lower the decibel level a little bit there, this really isn’t a surprise, the decision to advise the use of boosters for people have had the Pfizer and Moderna vaccines for several reasons. One is we’re now several variants further along the way in the virus that we’re facing. So the Delta variant has really become incredibly advanced in terms of its ease of transmission, it’s easily airborne. It’s probably four times two to four times as transmissible as the first virus that we were dealing with last year. And so that makes it easier for people to transmit it and probably easier for people who have been vaccinated to get at least mild, moderate symptoms, but the vaccines do seem to be holding up pretty well and very effective vaccines, but it’s a much tougher variant.
Dr. Mark McClellan 29:31
Second thing that happens, we’re getting further out from when people were vaccinated. And if we were in normal times the way that a vaccine typically works and they remember this you’ve got kids, you don’t have the two doses that close together. So within three or four weeks of each other, it’s usually one dose, maybe three months later, time for the second dose. It’s kind of to make sure your body gets the thinking that hey, it’s really facing a threat that could come back. So that close together that’s really helpful for getting immunity up fast, which we definitely needed last winter is perhaps not as good for making immunity that’s really going to be memorable for your body, for your system. And so this booster is likely to be able to add to immunity in important way. Since the immunity we have so far does seem to be fading over time. You can see this in some of the data from other countries.
Andy Slavitt 30:29
The immunity is fading or is it that the antibodies are fading? And I want just draw the distinction between the immunity and the antibodies and sense of the B cells and T cells that are..
Dr. Mark McClellan 30:40
That’s right. So Dr. Slavitt. Excellent point. And that is, you know, there are three components of immunity, there are the antibodies in the blood, these are the little proteins that can latch on to the virus and effectively help take it out. There are cells called T cells that manufacture those antibodies, and those have memory of what they’ve seen before. But over time, they may diminish in number and so it may take them a little while to ramp back up. And there also are a T cells that tells that kind of more direct killer function and attacking infected cells have been infected by the virus, and it’s totally normal for antibody levels to go down over time. And then a boost back up if people are infected. And I think that’s why you’re seeing because we have effective vaccines. There are relatively few, very few cases of serious infections. Even for people who are, you know, five, six months or more out from their second dose, they’re having substantially lower rates of hospitalization, way lower rates of death than people who are unvaccinated.
Dr. Mark McClellan 31:50
So from that standpoint, still looks like the vaccines are really effective, but in terms of maybe preventing the very mildest cases and potentially down the road losing some more of that protection against the serious cases. Those are the things that are behind the recommendations recently for going ahead and getting a booster. What I think is going to come out of this, you know, we don’t know yet we’re living through this pandemic in this virus for the first time, is that if you get a booster after that six-month interval, that’s going to provide strengthening of all three parts of that immune system, especially the memory cells to keep and make it possible to get antibodies up fast if you’re exposed to the virus again, and those cellular immunity components. And what that will hopefully mean is that unless we get a really bad variance in the future, that you’ll be protected for a significantly longer period of time, I don’t think just because we’re getting a booster here at six months, that you’re going to be getting a dose, especially if you’re not immune compromised, elderly, otherwise at very high risk.
Dr. Mark McClellan 33:00
I don’t think that means you’re going to be getting a dose again and in six months or so. But that does bring me to your to your last question. Probably the most important one is what do we do for the rest of the world? You know, we’ve had tremendous progress here, most of the first world’s gotten most of the doses so that the pandemic just isn’t what it was Before. If we were facing Delta now with an unvaccinated population versus a population where more than 70% of those eligible who’ve had at least 70% of adults have had at least one dose, we seen something much worse than we saw on December. Unfortunately, that’s what much of the rest of the world is experiencing with the Delta variant in India and Malaysia in many parts of South America. in sub–Saharan Africa. We’ve seen huge surges, very high rates of hospitalization to the point that hospitals and health systems are overwhelmed, and much higher rates of death in what we’re seeing.
Dr. Mark McClellan 33:56
And this is a real challenge, Andy on two points. Number one is just the moral challenge of this. We can’t stand by and let this happen in the rest of the world. I had the privilege of working with President Bush in 2000 to 2003, when he led a global program, the President’s Emergency Plan for AIDS Relief to bring the medicines that had at that point transformed HIV and AIDS in the United States and other high-income countries to the rest of the world. We need something like that now on moral grounds. But we also need it on public health grounds. The variance that we’re facing now didn’t start in the US. They started in places like India, or Peru, where there were large amounts of uncontrolled spread because people were unvaccinated, giving the virus an incredible number of opportunities to mutate and figure out something that works. We’ve been lucky Andy, in that the Delta variant came along maybe six months or so ago is incredibly transmissible. But we really haven’t seen anything worse since then.
Dr. Mark McClellan 35:07
I think, you know, hopefully, that means the virus can’t figure out how to really evade the vaccines any better. It’s hard to imagine it being easier to transmit and it’s become, hopefully, we’re not going to face something worse. But the biggest threat from a public health standpoint, for the world getting beyond the pandemic, is all of the uncontrolled spread that’s happening because we have not made vaccines widely available. And this is the last point, I don’t think it’s either or, you know, we have 100 million excess doses of vaccines in the United States right now. And we’re pumping out millions more every day. We have enough vaccines to make sure everybody who needs a dose, who’s not vaccinated now, or who needs a booster to stay protected can get it. We just need a more systematic approach, like we did with PEPFAR, like is taking place in other global health challenges like Polio decades ago, to get those vaccines out. The problem right now isn’t so much the number of vaccines available, we’ve got extra doses, it’s that many countries aren’t well set up to get the vaccines delivered.
Dr. Mark McClellan 36:15
Remember what happened in the United States back in December and January, and February, we weren’t set up to get vaccines out with cold storage and the other conditions needed. We didn’t have enough people set up to be vaccinators, it took a huge amount of work. And you were directly involved in standing a lot of that up well imagine, you know, maybe we can send you to Asia or Africa to help but imagine the challenges in standing up programs like that and the rest of the world. Imagine the challenges and needing to educate and engage people and helping them understand the why they should believe that these vaccines are safe and effective when you know, it’s a totally new kind of program. It’s exactly the kinds of things that we went through here, that are going to mean that in the months ahead.
Dr. Mark McClellan 37:02
The problem with global vaccination is not going to be inadequate number of vaccines, we’re going to have a glut of vaccines, relative to the capacity to get those shots in the arms and to engage the public and people around the world to get the vaccination rates up. When we did PEPFAR getting the drugs was a was a significant challenge, the bigger challenge was getting the infrastructure, helping countries develop their health systems, you know, most these countries have never done a large-scale vaccine program for adults before, it’s a great capacity to have for protecting the whole world in the future and for strengthening their health systems. But it doesn’t exist now. And it’s something that we really need to step up together to try to address and I hope the US will do more to lead on.
Andy Slavitt 37:48
And the principal agency that you think is best suited to make that happen across the globe?
Dr. Mark McClellan 37:53
I think the principal agency is the one where you were working recently is the White House. And the I mean; this is really kind of an all of government approach. The lead agencies for this are places like the State Department, USAID, State Department can help manage through their embassy, figure out what’s needed locally in terms of what resources are available on the ground. What resources the US have across USAID and state and maybe some scenario where the Department of Defense could potentially help as well. And also the private sector. You know, we have a lot of companies in the US that have a global presence that would like to do more to help, including companies like Coca Cola, Pepsi, others have a lot of experience with things like cold storage and distribution and engaging the public. There needs to be some organizing force to bring that together. And I think the US embassies can do that there are multinational agencies that definitely have a critical role to play here, including the World Health Organization and GAVI and others.
Dr. Mark McClellan 39:00
Now you’re talking to some people who are involved with that. They don’t have nearly the infrastructure that the US does in many parts of the world, thanks to PEPFAR, thanks to USAID program. So we all need to work together on this. And I do think it takes some very high level us leadership by been part of an effort with a number of other organizations to call on the White House to have a summit to host a summit on global COVID response in conjunction with the upcoming UN General Assembly next month. It’s time to do this.
Andy Slavitt 39:35
Needs to be done.
Andy Slavitt 40:05
There’s one more topic I want you to help us understand before we let you go. And it’s one of those topics that sounds really nitchy. But the stuff that like, you probably spend a lot of your career working on the leg only, you know, a handful of people understood are now things that like the general public is like, okay, now I get one more thing I got to understand. And that’s this VAERS system, which is this that I’ll have you explain, because you’ll be able to do better than I will. But it’s certainly it’s the one that people have heard I’ve in the context of reporting of people having adverse reactions to the vaccine. And the reason I think it’s so important for people to understand this as it’s being misused, to put it mildly, put it politely. There’s this sort of shadow, various things that people who really want to mislead the public about vaccines are using. So can you help clear up just for simpler people? What is VAERS? How does it work? How should the data be interpreted? How should that be interpreted?
Dr. Mark McClellan 41:01
Yeah, so VAERS stands for Vaccine Adverse Event Reporting System, and it’s a system we’ve had in place for decades. That’s intended to get information reported into CDC and FDA on adverse events, and things that aren’t normal good health events that happen for people who have taken vaccines, it is meant not to make any definitive conclusions about anything, but to help look for potential issues that do need further investigation, involving vaccines. And to put that in context Andy, I need to back up a minute to just remind the people with us today, what it takes to get a vaccine onto the market, including the COVID vaccines in this emergency use authorization period, and that is very large scale randomized clinical trials where you might get the vaccine, or you might get so called placebo. And the reason to do that is because there are all kinds of things that happen to people in a way of adverse events that may or may not be related to the vaccine that you care about. So that’s why we had clinical trials, 40,000, 50,000 people or more, to bring these vaccines to the market so that we can answer some questions pretty clearly.
Dr. Mark McClellan 42:26
One, most importantly, was do the vaccines really work? And the answer there is a resounding yes as we’ve been talking about. Two is, are the vaccines safe? And do we understand the adverse events that can be associated with the vaccines on any kind of common basis, and what a 50,000-person clinical trial will tell you is whether there’s any common event that could occur associated with a vaccine that would make you think, well, maybe this vaccine shouldn’t be used. So we were able to find things like, you know, people get sore arm, so people get headaches, they get a flu like symptoms for a day or two, all of those symptoms resolved within a limited period of time. So all that happens before a vaccine, it’s market and those people continue to be followed for longer and longer time periods. What’s hard to detect in the clinical trials is very rare events that may be serious. So where there’s helped a bit, but it was even the main story was in finding some of the rare side effects that you all may have heard about, that we know now or that appear to be associated with a vaccine.
Dr. Mark McClellan 43:35
These are things like in the J&J vaccine, certain types of individuals, especially women aged 20, to around 20 to 50, have a low risk, maybe, you know, 10 per million cases of getting a rare blood clotting disorder temporarily. And it’s one that is treatable now that we know about it. And so that can be identified and managed, it’s still a very, very low risk compared to the protection that you get from COVID. And the very serious complications, including clotting and death, and so forth from serious COVID cases that happen a much higher rate. But we understand that well, for the Pfizer and the Moderna vaccines, there’s a bit of an association with an inflammation of the heart muscle, but again, looking closely at that doesn’t cause death goes away. It’s transient, and it’s also very rare compared to the benefits of the vaccine. So that’s how rare event reporting can help, what rare event reporting doesn’t tell you what their system doesn’t tell you is just because somebody had a common event, like a hospitalization or death. These are things that happen a lot and people especially those at higher risk and happen and they’re going to happen in people who were vaccinated. It doesn’t tell you anything about whether the vaccine caused that complication or not. That takes the further kinds of statistical analysis that I’ve been talking about.
Andy Slavitt 44:59
Sure. If someone were to enter something into the VAERS database, do they need to have sign off from some authority that says this is the kind of event that it is..
Dr. Mark McClellan 45:09
They don’t, it’s that anybody can call in, there’s a standard form to fill out. And then FDA and CDC use this as their very preliminary screen to see if there could be, you know, what’s called a signal underlying that could be, there could be something that merits further investigate, and when that, yeah, I was just gonna say one other thing is that is there, lots of studies going on now a very large populations that can get a better handle on whether something’s real or not. And Israel in England and populations here in the US, there’s a Mayo study published today, 1000s, and 1000s of people get followed, and you can look carefully in a much more systematic way where you know, the denominator in the population to figure out whether something’s really going on here.
Andy Slavitt 45:55
So the way to think about it, if you put an analogy to crime, is it’s not the cases that the judges have decided it’s not even the number of arrests. It’s a tip line. It’s like, Hey, Mark, I saw some guy walking around my neighborhood. And he looks suspicious. That’s VAERS, right?
Dr. Mark McClellan 46:15
Yes. And it’s, it’s even could be even broader, less of a clear signal than that there’s a whole lot of noise as he’s saying that and statistical analysis out there, and the challenge is getting through all of that to figure out what’s really..
Andy Slavitt 46:31
So when someone says, and some people who are trying to discourage people from taking the vaccine say, Oh, my God, there are 7000 things entered into VAERS. What they’re saying is, there’s a bunch of people that have called a tip line with a variety of their own using the right of their own judgment, and a variety of definitions that are we want, because we want to investigate everything, because we want to be thorough, but it’s not the same thing as saying, put someone in jail. Because you’re guilty. That’s really important. That’s really helpful. Well, Mark, I know you pressed for time, and, as always, incredibly, incredibly helpful to go through this array of issues we’re facing. And we’ll come out the other side.
Dr. Mark McClellan 47:18
We will, great working with you, Andy, And great to be here today.
Andy Slavitt 47:34
Let me tell you about the two episodes coming up. And I hope you enjoyed that conversation with Mark. He just is just a fount of knowledge and just as a great way of explaining things. Okay. Here we go. Wednesday, a great episode with Jeremy Farrar, director of the Wellcome Trust, we’re going to talk about the many things that are happening in different parts of the world that you’re not seeing every day that are affecting us. And I […] in my theme to begin this podcast, we need to know about those things. I really believe it. I really believe it a lot of times, like, oh, it’s not happening in the US or my community, I’m gonna pay a little less attention. I’m really hoping we don’t do that. I have been negligent in not spending enough time on this, but he is great. I think you’re gonna love it.
Andy Slavitt 48:22
I would never drag you through something that I didn’t think was interesting as well. And then next Monday, we’re gonna have a really hot episode, really hot. Everybody remember David Hogg. The activist from Parkland, David Hogg, a very smart, young guy, dude. I don’t know what he is. But he just very admirable young man, who has been incredibly outspoken about gun violence and gun safety. He’s living in Florida. And he and I have an intense conversation about Ron DeSantis, what’s happening in Florida, and how this sort of ignoring what’s happening with kids is really, really hurting us badly. Let us get to that next week. But please, please, please enjoy the next couple days. Be good, be safe.
Thanks for listening to IN THE BUBBLE. Hope you rate us highly. We’re a production of Lemonada Media. Kryssy Pease and Alex McOwen produced the show. Our mix is by Ivan Kuraev. Jessica Cordova Kramer and Stephanie Wittels Wachs still rule our lives and executive produced the show. And our theme was composed by Dan Molad and Oliver Hill, and additional music by Ivan Kuraev. You can find out more about our show on social media at @LemonadaMedia. And you can find me at @ASlavitt on Twitter or at @AndySlavitt on Instagram. If you like what you heard today, most importantly, please tell your friends to come listen and please stay safe, share some joy and we will get through this together.