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Americans will soon have access to several new COVID-19 vaccines. The FDA is expected to finally approve Pfizer and Moderna vaccines for children under 5 as well as the protein-based Novavax vaccine. Looking ahead, the FDA is meeting in late June to discuss a vaccine targeting multiple variants of the virus, which may be available in the fall. How do all these shots compare to our current ones, and how do you know what’s right for your family? Andy gets answers from epidemiologist Katelyn Jetelina and New York Times health reporter Apoorva Mandavilli.

Keep up with Andy on Twitter @ASlavitt.

Follow Katelyn Jetelina and Apoorva Mandavilli on Twitter @dr_kkjetelina and @apoorva_nyc.

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Check out these resources from today’s episode: 

• Read Katelyn’s explainer on predicting the fall’s vaccine formula: https://yourlocalepidemiologist.substack.com/p/predicting-the-fall-and-boosters?s=r
• Find vaccines, masks, testing, treatments, and other resources in your community: https://www.covid.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.

Transcript

SPEAKERS

Andy Slavitt, Apoorva Mandavilli, Katelyn Jetelina

Andy Slavitt  00:17

Welcome to IN THE BUBBLE. This is your host, Andy Slavitt. Wednesday, June 15th. I hope you enjoyed Monday’s episode with Larry Summers, a very solid, comprehensive take on the economy. And of course, we watched the stock market continue to gyrate. Today’s episode is about COVID-19. And it’s really a state of play in the state of affairs with two of the very best people that we could possibly have on the show. And so I think you will enjoy it in a moment. But before I did that, I wanted to give my view of kind of where we stand today, and a little bit of context on the different phases of fighting COVID that we’ve gone through. And I would argue that we are in phase three of at least four phases of this battle, and how we ought to be thinking about things. You know, the first phase that started 2020, was a novel virus that had a substantial lead on anything we could do to respond. And of course, you know, the best things we could do were to get testing out rapidly to try to contain the virus to try to prevent variant from spreading, to take public health measures, like masks seriously. We didn’t do a great job of that as we know. But we were also battling something where our bodies had no experience and no immunity built up to COVID. And we lost a lot of people in that phase. And that was a very scary phase. I think that phase ended with the first vaccines coming to market at the end of 2020, and the beginning of 2021, which I would call phase two. Which is where we really made substantial progress, beginning with the approval and rollout of some very effective vaccines, they reduced the number of deaths pretty significantly. And it included the later rolling out of new therapeutics, which also took a big bite. And you could argue that the that progress has been substantial, even though we lost a lot of ground still continuing, because in that next stage, we also had a couple of other things happening, we had the Alpha variant, we had the beta variant, we had the Delta variant. And then you know, we even had the Omicron variant at the very, very end of last year. And we had a lot of people that didn’t get vaccinated, both in the US and around the world. And the virus really showed us that it could change what we were building towards. The third phase, to me really has been this phase we’ve been at since Omicron, has been on the scene. And if in the second phase, we really relied on science and we relied on this rollout and we had some remnants of public health measures to help us phase three is been a bit more of death by 1000 cuts. It has been the rapid evolution of these new Omicron variants which started with what we call BA1, BA2, and now, be BA4 and BA5 are hitting the country and it’s almost like a never ending relenting assault, the same way a common cold circulates around the world, we’re now seeing COVID-19 just continue to find ways to try to do the only thing you can do to survive, which is get around our immune system capability.

Andy Slavitt 

Otherwise, it really has no place to go. And it’s doing that four times as rapidly as the flu does. It’s doing it four times a year. And I’d say in this phase in this third phase, which we’re currently find ourselves in, the virus is changing more rapidly than our sciences. And there are virtually no public health measures saved maybe in China, that are really being put to use. They’re really in a very much of a best effort basis. And I would say that in the third phase, we’re kind of progressively losing the battle. We’re not losing the ground we’ve made in phase two, we’re not seeing death rates go up. But we’re not keeping up as quickly with the virus and its mutations as we need to be. It’s just the job has gotten too hard. And this episode today is gonna be a lot about the response we need in order to just keep up and I think what we will talk about is what can we do improvements in the vaccine for 1, vaccines for kids 0 to 5 finally, the introduction to some new vaccines but as I think you’ll hear, we are still chasing it. And we’re not even chasing it with full force because we don’t have congressional support to financially do those things. The big question that we’ll get to at the end is What does phase 4 look like? And I think phase 4 is going to be either a very significant innovation in the way we attack this virus, or a very significant turn from the virus to render our current approaches, much, much less effective. I think we need to be thinking about what this phase four has and what it has in stock for us. There are a couple big tools, when you think about kind of what would be a significant way for us to turn the tables on the virus that are doing things that are not doing today, it would really be with a different type of vaccine, maybe a nasal vaccine, something that could attack all variants, something different than I think we’re going to see now because I think what we’re going to see over the course of the next year, as we continue this phase is, we’re just going to continue to get out run. Hopefully, that even with all that you can stay safe. Even with all that we can do many, many normal things. But still, this is far from a place where we’re not affected by the evolution of this pandemic. So on the show today, you will find the one, the only, Katelyn Jetelina, she is your local epidemiologist, I encourage you if you don’t for you to be reading her sub stack, or her newsletter, or her Twitter, she’s got probably the best most current up to date takes on what’s happening with the virus. And Apoorva Mandavilli, who is a reporter for the New York Times, she covers science and global health, she is one of the most authoritative sources on what’s happening. And the two of them are paying a lot of attention to what’s going on at the FDA. We are seeing today and later this week. Finally, after 18 months of waiting, kids zero to five, get vaccines approved, that’ll be the last age group to have make that finally happen. That is a long time coming. And we’re going to start to see kids getting vaccinated as early as next week in all likelihood. So we’ll talk about that as well as other things the FDA is going to consider and adapt and other ways we’re going to evolve to fight this virus over the course of the next few months. I’m excited for the conversation. I hope you enjoy it.

Andy Slavitt  07:29

Apoorva, so good to see you.

Apoorva Mandavilli 

You too. Nice to meet you. I don’t think we’ve talked before.

Andy Slavitt 

I don’t think so I’m so grateful you’re on the show. And Katelyn, as always. Your newsletters getting better and better, Katelyn, if that’s even possible?

Katelyn Jetelina

I’m glad to hear it. It’s a labor of love. I will say that.

Andy Slavitt

Katelyn, let’s start with you. Maybe you could tell folks where we are in the race between Omicron variants, and science and vaccines and our ability to keep up with them to sort of set the stage for the work we’ve got to do over the next 6 months.

Katelyn Jetelina  08:06

Yeah, so the virus continues to throw us into loops. And that’s really because it’s mutating real quickly. It is mutating about four times faster than the flu right now. And currently, the path that the virus is taking is to chip away at our immunity to try and escape our antibodies, our neutralizing antibodies, which is our first line of defense. And so because of that it’s getting incredibly difficult to mount this proactive instead of this reactive response. Right? How do we anticipate where this virus is going is an incredibly challenging question to answer right now. But that is what we’re trying to answer right now, as we prepare into the fall and for the winter.

Andy Slavitt 

It feels like the challenge is as you describe it as like a wholesale different than coming up with a vaccine and creating one major impact that you might have by introducing a new vaccine, or introducing a new therapeutic, which can have kind of a big take, a big bite out of the current trajectory. But now it seems like what you’re talking about is almost like an arms race. Like there’s a behavior that we’ve got to figure out how to attack from a scientific standpoint. How’s it scientific challenge being met in a different way?

Katelyn Jetelina

It is incredibly challenging. And that’s the reason why is because believe it or not, this is still a novel virus and it feels like it’s been around forever. And it’s been around for two years. And because of that, we don’t know where it’s going next. We have don’t have enough time to see what pattern or what path this is really going to take. And so all we can act on as public health officials, as vaccine manufacturers, as us as a team, is the probabilities, what is the probability that Omicron will continue to mutate or completely jump to another Omicron like event? And the challenge with probabilities is sometimes you’re wrong.

Andy Slavitt  10:18

Do we see anything in the latest variants coming to the US, which would basically BA5, BA4, that is different from what we’ve gotten used to with prior Omicron variants?

Katelyn Jetelina

Yeah, so BA4 and BA5 have actually many different mutations, but two in particular, we’re really keeping an eye on the spike protein. And the reason for those two mutations, and our knowledge of it is because it’s been seen on other variants of concern. And so we know that it’s getting better and better at escaping our neutralizing antibodies. And pretty soon, it’s going to be fully escaping eventually. And so that’s what we’re really keeping an eye on.

Andy Slavitt 

Okay, so Apoorva, if that’s the state of play. We have the FDA Advisory Committee coming together this week. And there’s a whole bunch of work going on in science. Can you update us on who’s getting together? What’s being discussed. and how. we, the big we, are facing up to the kinds of challenges that Katelyn laid out?

Apoorva Mandavilli 

Yeah, so the advisors for the FDA are meeting later this month, to essentially try and guess what variant we might see circulating in the fall. And as Katelyn was saying, it’s, you know, it’s just a gamble at this point and try to figure out, will it be a variant that looks just like BA4, BA5? Will it have some other mutations? How much farther will we have gone in terms of evading our neutralizing antibodies? This is something the advisers do even for the flu, which in some ways is not reassuring at all, because as we know, the flu vaccine doesn’t always have a very high success rate. You know, in that case, they meet in the spring, and they try to guess what’s coming around in the fall based on what’s been going on in the southern hemisphere. This time we’re meeting at the end of June, I heard from Dr. Peter Marks at the FDA that they wanted to make a decision by July 1 at the very latest. But July 1, is not anywhere close to when we would actually be getting vaccinated, which is September October, you know, forget it at the same time as the flu vaccines. So a lot can happen. In those two months, as we’ve seen, we’ve seen new variants come and take over in much less time than that.

Andy Slavitt  12:34

Can you talk about the decision they’ll be making at that meeting, and then I want to go back to a meeting that they’re having this week about kids zero to five, but let’s, since you brought up the one at the end of the month, which is focused on, as you said, predicting what we should be developing a vaccine in favor of, what are they going to be deciding on? Where do you think we should be paying attention to?

Apoorva Mandavilli 

Yeah, one of the things they’ll really be deciding is which vaccine to roll out. So based on what they think might be the variant that’s circulating, should it be just another dose of the vaccine we’ve already all been getting. Should it be one that’s specific to Omicron? And, you know, Moderna just announced that that seems to do better against the current variants than the original vaccine. So will it be that will it be a combination of the two, which I think is the leading horse at the moment in the race, but you know, it’s those are all the things that they were going to decide. And one thing that the advisors have said, I will see how closely they actually stick to this is that they won’t approve any updates to the vaccine unless they are really convinced that it is much better than the original.

Andy Slavitt 

So let’s take a look at and Katelyn, maybe you can help us. We have a little bit of science by press release. Moderna has released their own information, which to their defense they’ve tended to be. I don’t always tell the whole story. We haven’t seen a lot of inaccuracies; I should say and what companies have released. We of course want to see that reviewed by the FDA. But what have we learned in what do we know and then to a porpoise point, what can we intuit about, you know, the work that was done on that vaccine, which was against the original Omicron strain and the fact that as you just pointed out, we’re going to be dealing with BA4 and BA5, which are different.

Katelyn Jetelina  14:20

Yeah, so Moderna was answer of what to do this fall was basically that we need this by Vaillant vaccine, which is a formula that covers two variants. One is it covers the Omicron variant as well as our original virus variant, the what came out of Wuhan, and they found they randomized a couple 100 people and found that this combo vaccine works really well. It increased neutralizing antibodies; it had a higher impact than just the original booster. It was seize, we don’t know the durability of it, and this is a huge question, because to the FDA, if we will be producing and distributing another vaccine, we need to make sure it’s something that lasts at least 6 months to get us through the winter wave. Moderna did include a quick between the lines saying that they’re beta bi-vaillant vaccine. So, they already also tested a beta, an original vaccine a few months ago, and that one is staying durable for 6 plus months. So we would expect this Omicron, bi-vaillant vaccine to last at least six months. But that’s a kind of a hypothesis and proxy.

Andy Slavitt 

Can you tell us by comparison with the current vaccine against Omicron is a factor for about how long?

Katelyn Jetelina 

So officially, it’s about 5 months. But what we’re seeing is as Omicron mutates and mutates and mutates, that timeline is getting shorter and shorter. And so, currently, I’m honestly not sure how quickly our protection lasts against BA4 and BA5 but it will be shorter than what we’ve seen previously.

Andy Slavitt  16:46

Okay, so one benefit, it sounds like if we’re going to hopefully see a more durable vaccine. Now they talk about this eight time tighter response, which I know the first time Tony Fauci started talking to me about titers, I was like, just telling me the effectiveness percentage, I’m so used to just understanding the vaccine percentages. What does this 8 times response translate into? Does it translate into increased protection? Does it translate into decreased communicability? does it reduce hospitalizations? What does it do for my T-cells, I want to use all this newfound knowledge. Anything we know about any of this? Either Katelyn or Apoorva.

Apoorva Mandavilli 

I mean, it really only tells us about neutralizing antibodies, right? That titer is just about antibodies is not about T-cells, it’s not about severe disease. What it does tell you though, is that the vaccine might be more powerful at preventing infection because those are the antibodies, we really need to stop the virus from even causing an infection. So 8 times more is good. But also it’s not as good as it sounds. I mean, 8 times and neutralizing antibodies is not the same as 8 times as powerful.

Andy Slavitt

Okay, so it takes in antibodies, neutralizing antibodies that circulate in my, you know, throughout my body, and what multiplies them by 8 fold in comparison to what, and then you take the current vaccine. Does that give you 8 times? Or does that give you less than 8 times?

Katelyn Jetelina  18:12

So that’s a really important question, Andy, because it is eight times higher than baseline. So all of these people in the randomized control trial already had their three shots. They tested this bi-vaillant as their fourth dose. And so 30 days after they took that vaccination, they’re neutralizing antibodies, are our first line of defense increased 8 fold, which sounds amazing, because it is amazing. However, the original booster also increases neutralizing antibodies a lot in the first 30 days, the bi-vaillant increase that more statistically significant than the original booster, but how big of a difference what that change or difference means and how valuable that means is the question, I think that the FDA really needs to answer at the end of the month. Because a new vaccine, it’s also expensive. We have to distribute it, we have to, we have to do a lot. And if the original boosters doing just fine, then what’s the added benefit?

Andy Slavitt 

Okay, so it’s got to prove itself to be not only more durable, but more effective. And of course, with the same very, very favorable side effect profile that we don’t really know the answer to any of those questions yet, it sounds like.

Apoorva Mandavilli

I don’t think we expect it to be any less safe than the previous vaccines, but so much just really depends on which variant we’re going to see. Because if we see the same trend continue, you know, with BA4 and BA5 being significantly different from BA1 and BA2, enough that the immunity is not holding up then it won’t matter if this is a times more antibodies if the variant that comes along is very good at evading those antibodies. So a lot is going to really going to depend on what the enemy is in the fall.

Andy Slavitt  20:03

Sounds like this group has got a tough job to do, Apoorva, what do you expect out of this, this meeting?

Apoorva Mandavilli

You know, I wonder if the FDA advisors will stick to what they originally said that they’re really going to need to be convinced. If I had to bet I would say that they will say okay to the bi-vaillant vaccine, and that we will see that rolled out how widely it will be rolled out whether it will be for everybody, or just some people or whether it will be you know, whoever wants it, that I’m not sure about that. But most likely, it will be rolled out just like the flu vaccine, like everybody should get it, and especially people who are most at risk.

Andy Slavitt

Okay, so maybe not a homerun category, but in the category of I don’t know, I don’t think we should take the sports analogy too far. But we’ve got a Novavax vaccine, a fourth potential vaccine to be improved. Tell us about that. Is that significant? Why should we care about that?

Katelyn Jetelina 

Yeah. So it’s actually really great news. Novavax uses an entirely different platform. It’s called a protein based vaccine. And we’ve used this type of vaccine before, for example, or we currently use it for like hepatitis B. And there’s a lot of people who said that, you know, if they’re hesitant with the mRNA technology or biotechnology, they could potentially feel more comfortable with Novavax. I think that it’ll be really interesting to see how many people stick to their guns saying that, yeah, it was because of the mRNA or just because of the vaccine altogether. I’m actually not convinced that we will be getting lines of people out the door for Novavax. We didn’t see this, for example, in the UK, which rolled out Novavax a couple of months ago, it really just didn’t change the dial that much, unfortunately. I think we’re Nova Vax may make a really big impact is among vaccine hesitant adults. So potentially for kids vaccines, parents may feel a little more comfortable with their kids with this vaccine. and we have a lot more room in which we can change the dial of vaccination status among kids, for example, 5 to 11 year old’s, only 30% of them are vaccinated right now. And the other place that this could change the dial is with those that are allergic to some things and mRNA vaccines like PEG, and then third, and we’re really waiting to see the data on this, but the potential for Novavax as a booster. Mixing and matching Boosters is becoming pretty clear that when we present the spike protein to the immune system in a different way, it produces extra benefit, compared to repeatedly boosting the same product. And so we may be also able to optimize our booster strategies to help with durability to help with breath, against other variants. And so we just have to anxiously wait those results. So I’m very excited about Novavax, I think it’s great to have another option on the market, how much it changes the game in the grand scheme of things in the United States, will to be determined.

Apoorva Mandavilli 

I mean, I agree in principle that I think it is great to have another candidate, but Novavax in particular has had so many manufacturing problems that I’m not sure they will actually get their act together enough to give us enough of the vaccine and that people will then trust it enough to take it.

Andy Slavitt

Why have they had so many problems?

Apoorva Mandavilli 

Good question. I mean, they’ve been dogged with manufacturing problems from the very start, you know, they’ve been manufacturing in other parts of the world. And the FDA has these very strict rules that if you are going to manufacture another country, you have to show that the standards are the same, etc. And they’ve had delay after delay. So even now, even after the adviser to the FDA have in theory said, you know, we would authorize this, the Novavax came back and said, you know, you’d have more sort of manufacturing issues that he was dealing with. So it’s still up in the air exactly when that’s going to get rolled out it won’t be or it may not be anyway, like the mRNA vaccines were, you know, the second it was authorized, was like available to everybody, maybe that it gets authorized, and then it takes several more weeks for us to actually get the doses.

Andy Slavitt  24:19

It’s worth pointing out that when people think about what the FDA is job is to look at a vaccine in the lab or even in you know, with 1 or 200 or 300 or even 3000 or 30,000 people is one thing, but what they have to be assured is that when Kaitlyn gets the 100,000 vaccine or the 1 million vaccine off of the line somewhere that it works exactly the same way as the first one does. Can you just think about what that takes, you know, to show you could do something in the lab or even with a set of people is one thing, to show you can do it consistently every time when you’re hiring people to produce this vaccine and fat and you know, some factory that’s not even been hired yet and to get the process and procedures, it’s a much higher bar

Katelyn Jetelina 

Andy, that’s where experience comes to play a lot with these to the experience of the manufacturer. And that’s what was happening with Novavax. right? So the FDA requires that the vaccines pass a purity test, they have to pass at least 90% of contaminants are not in the vaccine to make it. You know, we want to make sure the vaccine continues to be effective and continues to not adversely react to people. And Novavax is having a was having or it is having a difficult time passing that purity test with their levels hovering around 70%. So it takes work and I think, I guess I’m a little more optimistic. And I think that they will figure out those processing eventually, it just takes time. And we will have another option for Americans.

Apoorva Mandavilli 

I agree with that. I don’t want to completely diss Novavax here. But I think the US government that’s so big on them, I think they got they got more money than any other company. It was 110 million doses preorder, and I’m not sure that we’re going to use all those.

Andy Slavitt  26:08

That’s a really good perspective. I guess before we go away from Novavax, I’m just stuck on one thing. Katelyn, you pointed out the benefit, principally as providing another choice for Americans, people who are uncomfortable with the arm mRNA vaccine, maybe they’re allergic to Bernie vaccine? I guess I’m curious. And I think people, other people are as well as, is there anything different about how it works? That having another weapon in our arsenal helps? Is there anything about how the vaccine mutates, that another platform approach might give it another a different benefit. Are there other types of benefits? Is there anything about the way this vaccine works? That we’d say, hey, you know, I’ve had the mRNA vaccines, but maybe I ought to look at the Nova vaccine. Is there anything more promising? Or is this just another incremental choice?

Katelyn Jetelina 

So, I know that there’s hypotheses, like I said, before, there’s hypotheses and that mixing these different platforms does have benefits, how big those benefits are, and how long lasting they are is yet to be determined? Will it be a massive game changer? I don’t think so. But it will change and incrementally I don’t know if you disagree or agree.

Apoorva Mandavilli

I do agree, actually. Yeah, I think it’s good to have another option just for that. I mean, we’ve seen cases, studies in the UK, combining AstraZeneca and Pfizer, and those did way better than AstraZeneca alone. So, I do think it would be good to have another one just to mix and match. And I agree with you, Katelyn earlier you were saying that you think Novavax’s main purpose will be as a booster, and I can absolutely see it going that way.

Andy Slavitt  28:20

So, 18 months after the first EUA for the first vaccine, we have some exciting news this week is it appears that we’re finally, after all this time, after 18 months, going to have a vaccine to cover every age group in the country with approval of the vaccines for kids 0 to 5. And I know for so many people, that has been such a long time coming. Apoorva, can you give us a rundown of what we see happening this week?

Apoorva Mandavilli 

Yeah, so the advisors to the FDA are meeting to discuss the Moderna and Pfizer vaccines and part of the Moderna vaccine conversation will just be about the vaccine for all kids, you know, through age 17. But they’re also going to be talking about vaccines for the youngest kids. And you know, I’ve been writing about vaccines since the beginning and oh my god, the parents are so desperate for this vaccine, or at least some parents are. And it’s been so hard for them to see the vaccines get authorized for group after group, you know, age group after age group and their age group gets closer, and then you know, they get all these setbacks. So I think there are a lot of parents really waiting for the decisions on Tuesday and Wednesday. And honestly, I don’t expect any surprises. I think the data from those studies seems reasonable. And I think the advisors will authorize those vaccines. You know, it’s clear that those vaccines will provide some sort of protection even if it’s not 100%. Again, I think we’re not going to see those kinds of crazy levels that we saw at the beginning. So it’s probably not even a reasonable expectation to think that they should perform at you know, 90-100% efficacy, but people have been waiting for these vaccines for a long time. And yet we went through these massive Omicron surges. And I know, we know, that the CDC came out with that study a couple months ago saying they think they estimated 75% of kids have been infected with the virus. So there may be some number of parents who just decide, you know, my kids already been infected, maybe I don’t want this vaccine. So we’ll see what the uptake looks like. I think that’s sort of the big question, but from the conversations that the advisors are going to have on this week, and then the CDC’s advisors will meet on Friday and Saturday to put their rubber stamp on it. I’m not expecting any surprises from any of those conversations.

Andy Slavitt  30:40

It’s this whole trial and tribulation with vaccines for kids under 0 to 5. Is it one that’s a success story for the FDA and how they do things? Or is it? Conversely, a story of kind of failure dropped balls and missed opportunities? How do you look at it?

Apoorva Mandavilli 

I mean, you know, it’s easy to blame the FDA in the situation. And I think they, there are a lot of things they could have done differently. And I’ll explain what I mean by that in a second. But also they are operating with a new virus and a new vaccine. And it’s not that unusual for companies and for the FDA to move cautiously, when we’re talking about really little kids, you know, you do have to be careful. One thing I think they could have done differently. And I’ve spoken to a lot of immunologist who actually wrote to the FDA saying this, they could have looked not just at antibodies from the start, you know, we I think we’ve all heard now that antibodies are great for preventing infection, and maybe also for preventing severe disease. But that kind of leaves out an entire part of the immune system that’s actually very important, you know, T-cells, and B-cells, these parts of the immune system that are great for preventing severe disease, and we don’t know exactly how important they are for COVID. But all circumstantial evidence points to yes, they are actually quite powerful. And yet, we haven’t really required the companies to evaluate those data, you know, I think the companies have collected some data on those other parts of the immune system. But in theory, if we had done that, from the start, if we had looked at T-cells and said, Okay, T-cells work, even if the antibody levels are low, that would have been very different, because the FDA essentially made the decision to not look at these vaccines, because the trial showed that antibody levels in the kids, you know, 2 to 4, were not as high as they were in young adults and that was the way that we’ve been evaluating the vaccine for all kids. But in this particular age group, that didn’t really seem to show any enough of a response, let’s say, but if they’ve been looking at other parts of the immune system, we very well could have had these vaccines a lot sooner.

Andy Slavitt  32:38

I think the criticism from some parents, some very informed parents, is that we didn’t treat this approval with the same sort of tradeoffs of urgency versus sort of just harm reduction. In other words, if there were harm reduction benefits that we could get immediately, we sort of lost that, then it felt like, at least early on with the FDA. That was not the case, it feels like they got more considered, more careful. And I suppose in their defense, they would say, hey, you’re dealing with healthy kids, with a lower fatality rate. And putting something into otherwise healthy kids is a different story. And they would also say that we know the science of how babies and toddlers bodies works is not, they’re not just tiny adults they have there’s a bunch of differences.

Apoorva Mandavilli 

I think that’s actually absolutely appropriate to say that the risk benefit conversation for kids has to be very different, because the risk to kids is lower. And therefore, you know, the benefit has to be much higher in order to clear that bar of harm reduction. So, I think that’s one of the reasons that they did act slower.

Andy Slavitt

Katelyn, you’re in full, both informed and an interested party here.

Katelyn Jetelina 

I know, I’m a little bias.

Andy Slavitt 

So well, how do you think your bias helps you with your point of view here? How do you see it?

Katelyn Jetelina

How do I see it? As a mom, I’ve been incredibly frustrated. It does feel that it has been pushed to the side. And is there things that could have helped that? Yes, I think that the biggest thing for me is learning about what happened and how are we going to fix that for the future. I mean, just like these bi-vaillant vaccines, if the FDA doesn’t change the way we evaluate vaccines, kids will never have access to up to date boosters, for example, we can’t continue with a process that leaves kids continuously two years behind. Maybe it made sense for these first vaccines. Maybe we could have done age de-escalation a lot quicker. But I think going forward, this is incredibly important conversation and I don’t see people offering solutions either. So I’ll be curious to see if that discussion comes up, or maybe that’s more of a conversation for ACIP at the CDC who really determines policy around this. But to me as what to what aligns under five, I recognize that the level of severity is lower for them, but there’s still my kids. And if I know that there’s something out there that could help them. And we’re not getting it quick enough, then it’s incredibly frustrating.

Andy Slavitt 

You know, you raise a really interesting point, which is, as you and Apoorva both just said, we may be about to roll out these shiny new and improved vaccines for the fall, for adults, that work, at the very least, somewhat better. But maybe they’re even a lot better than the current vaccine. And we’re yet, we’re about to give you the four year old kids. yesterday’s version, we’re about to give him the Honda Prelude from, you know, 2004. Well, we’re all getting the updated model, which has, you know, hybrid. electric gas, you know, et cetera, et cetera. Are we about to just be in the same spot all over again?

Katelyn Jetelina  36:09

You know, whatever vaccine we give the kids, it’s gonna be really great for severe disease and death, we’re starting to talk about very little incremental changes, I think, the bigger question that I have really been trying to wrap my head around is that that really only matters to about 25% of us parents that are gonna get our under 5 year old kids vaccinated. That means there’s 75% of parents out there that are not getting vaccinated period. And while we have such strong, amazing, breakthrough science, bench science about these vaccines, we really need to leverage more of our social science and the ways that we can increase effectiveness of vaccine rollouts, and how do we meet parents where they’re at. How do we start answering questions. So the vaccines can help whatever formula it is, and again, a conversation I haven’t really seen happen on a national federal level.

Andy Slavitt 

In the absence of that, and I agree we could do more. There is something that’s interestingly rational about vaccine take up rates by age, I mean, show me a 90-year old and I’ll show you someone who’s vaccinated. Show me, you know, a 5 year old and soon to be, you know, less than that, I’ll show you someone who probably isn’t. But you know, if you overlaid the kind of the likelihood that someone’s going to get COVID and die. And look, I think there’s a lot of complications to this whole little random going on, including long COVID and unknown effects. But for at least for what the public knows, there is appear to be somewhat rational response, which is to say the riskier it is for people, the more likely they are to get vaccinated. And given you know, a vaccine, that’s been, you know, we’ve only had for a couple of years. And we know how long science takes to adapt. You know, is it all that surprising?

Apoorva Mandavilli  38:11

I don’t think it’s all that surprising. But I think it’s also pandemic fatigue. I mean, age is a very big part of it, for sure. You know, you said there’s a difference. And there really is, I mean, if you look at young adults, I think it’s, you know, very high rates, you get to the kids 12 to 17, it’s 60%, you get to kids, 5 to 11, it’s 30%. So what are we looking at for kids under 5? So age, definitely one part of it. But I think the other really big part is because we’ve done the sort of age de-escalation thing, the vaccines have come later and later for those groups. And by the time the vaccines are coming out for these really young kids, a lot of people have decided that the pandemic is over and that the virus doesn’t matter anymore.

Andy Slavitt 

But, look, I don’t think people be confused about where I stand on whether people should get vaccinated or not. But we save pandemic fatigue, like it’s a thing that’s plaguing us. But the truth is, people have gotten vaccinated and then gotten COVID. A lot. And so it’s not that like this is irrational fatigue, if people were able to, as they originally believed, get vaccinated in the […] COVID, I think you’d see very different take up rates. But I think for people who don’t feel like they’re going to die if they get COVID And who feel like it’s not going to prevent them from getting COVID or at least, you know, you could say to who follows the durability, the variability, the variance, all they know is it’s not it’s not protective. You know, I don’t think that it’s an entirely irrational response. And so I say this because Katelyn, you just started with, we need a better rollout strategy, communications, etc. As someone who was accountable for rollout and communications. It began with listening to people, and they’re very, very often, that there are a lot of very informed people who are saying, yeah, I’ll get one or two for me. I’m not sure I’m gonna get every booster. And as far as my kids go, you know, this is a risk that arguably, you know, is a very close call. And I don’t know how you message around that.

Katelyn Jetelina  40:19

Yeah, you know, I guess what I compare it to is, and I know we all have PTSD around this is comparing it to the flu vaccine every year 60% to 70% of kids get the flu vaccine. So why is that such a difference between the COVID-19 vaccines, I also think we have to be really careful in our messaging. And Andy you brought this up is, you know, a 90-year old person has different risk than a 9-year old person. And that is true for severe disease and death. But also kids aren’t supposed to die either. And COVID-19 is a leading cause of death for kids. And so we have to be careful the comparisons as well, what denominators are we using? And, you know, yeah, there’s a lot of informed people out there and a lot of people making their own decisions. All I hope is that people are making evidence-based decisions. And if they have the information that is reliable and credible, and we’re all staying so you know, starting from the same baseline, I think I am fine with parents deciding no. What my worry comes in as we’re not all starting from that same foundation.

Andy Slavitt 

No question. What I’m trying to get at is even the next level question, which is how do you do effective communications, when you have a situation where I think people feel like the vaccine was represented to them originally as something that that really, it hasn’t been level set. And then they look at the data and the risk, and for them in their daily lives, they don’t see the benefit as strongly. I don’t know, I just don’t know how you get substantially higher participation levels.

Apoorva Mandavilli  42:09

I think the messaging is going to be different than it was for flu, because flu is risky for kids in a way that COVID isn’t, I mean, I’m not saying COVID is not risky at all, and I’m totally pro vaccine. But I do think that, you know, because for flu, the risk groups or older people and kids, that messaging has been easier. Whereas for COVID, because we see this huge difference with age, we think that with decreasing age, I think a lot of parents have had a lot of trouble convincing themselves that they need it. You know, I’ve spoken to a lot of parents of kids under 5, and I know, Katelyn, you are one. But I’ve spoken to a lot of them who say, you know, my kid had COVID already, and it wasn’t a big deal. Why do I want the vaccine, or I read a lot about this, and it’s a new vaccine, and I got vaccinated, but I’m not sure I want this for my kid. So there’s just a lot of different kinds of hesitation. One thing I’ll say that may actually work in favor of getting vaccines for those kids is that they do go to the doctor a lot to get vaccines. You know, for me, I have 13-year old and a 10-year old and I had to take them out of school and find a time to take them and it was a pain. But if you have a really young kid, you know who’s already going to the doctor a few times a year maybe to get other vaccines, then it’s a lot easier to just have that be another one. I think they’re mentally also more prepared to give their kids vaccines.

Andy Slavitt 

Well, all I’d suggest is it let’s just start right folks off who aren’t vaccinating their kids as either fatigued or misinformed. I think we got to understand them a little bit better. And then just try to figure out a very hard problem. I want to close up asking you each kind of where we need to go from here. What should we be doing as we look around a very murky picture. But understand and you know, you’ve written about this, you both have and pretty, I think compelling ways about our need to just be able to do things differently, whether it’s more rapidly, whether it’s emphasizing certain parts of science, whether it’s other ways of making sure that we’re keeping up and staying ahead of this. I think what you describe Katelyn as this sort of this horse race, arms race, it’s going on now between a very rapidly mutating virus and science, which can only go so fast. So, what do you think the priorities ought to be?

Katelyn Jetelina  44:29

I’ll start, and just from I guess from an epidemiological perspective, we need to prepare. We need to really, really be able to leverage our tools right now, and maybe people don’t want them right now. I think a lot of people still are using antigen tests. And I do think people are still using masks, but we need to understand what may be coming this winter and maybe there’s never going to be another wave of SARS-CoV-2, but we need to be able to arm people if there is. And unfortunately, a lot of that preparation is getting stopped right now, because we just do not have the funding to initiate, innovative science, for example, there are options, we do have the science to find a variant proof vaccine, but we need the ability to test it and see the value in it going forward. And not just for SARS-CoV-2, but we’re seeing you know, more infectious diseases. We have monkey pox right now, how can we learn about our communication? How can we get that communication better and going forward. And so I guess that’s where my really big push is right now in the understanding and how we move forward.

Andy Slavitt

I want to dig in on something you said, because I found it very intriguing, which is that we do have the ability to create a vaccine that is variant proof. Say more about that, and what you’d like to see here and how we’d like to direct our investment, and also just how high level or conceptual of a comment is that versus something you think is potentially quite real.

Katelyn Jetelina  46:15

Yeah, so we have several vaccines within clinical trials right now, different stages, most of them was phase 1, some at phase two. Looking at the effectiveness of a variant pre-vaccine, it’s basically a soccer ball with multiple faces of spike proteins. And so no matter how SARS-CoV-2 mutates, this vaccine, will train our bodies to recognize and fight it. And there’s a lot of value to that. And not just again with SARS-CoV-2 but for future emergencies as well. So we don’t have to play this arms race that we can finally get into this proactive approach. But innovation and research and science at all takes investment. We saw after the SARS epidemic in 2003, that all research just stopped after that epidemic. And if it didn’t stop, we would have had a vaccine for SARS-CoV-2 so much faster. Be if we continued that research. And I think that is the larger picture that I want people to see is that even if it’s not for SARS-CoV-2, it will help in the future, we are going to get more and more viruses. And so thinking again, I know I always say this, but thinking proactively rather than reactively.

Andy Slavitt 

So, that’s yet another reason to compel Congress to act and put forward at least some or hopefully all of the $22 billion that’s been requested of it. I mean, a very approved vaccine, those are three pretty nice sounding words together, this sort of goes to the kind of conversation we were having earlier portrayed as we close up, I do think this plays in the horizon. And maybe you can also speak to what you’re seeing and hearing about a deal getting done in Congress to get some funding.

Apoorva Mandavilli  48:13

I don’t have any insight into that part. But one thing I will say is that there is something that we could have been doing in terms of the vaccines, and it sort of piggybacks off of what Katelyn was saying about the very improved vaccines, and that’s nasal vaccines. And I’ve been shocked over and over at why we have not invested at all in research into that. I mean, we’re good two to three years away from having one of those. And, you know, that’s the kind of vaccine you need to prevent infection, I think arguably, that would have convinced a lot more people, first of all, to get the vaccine, if we’d had a combination that actually prevented infection, we’re also looking at a potential massive, massive epidemic of long COVID all over the world, and a nasal vaccine would prevent that because it would stop people from actually getting infected. And it would be a better booster, it would be easier. I mean, I could go on, but there are a lot of advantages to having a nasal vaccine. And you know, I asked Dr. Peter Marks this, you know, why do we not have one. And pretty much all the candidates that are farther along in development are in other countries, not here in the US where we seem to have put all our eggs into the mRNA basket. And he said, we were sort of blinded by the light by the end of the mRNA vaccines. So I think it’s really time for the whole vaccine conversation to not be blinded by the light, to think about these other candidates, which is you know, one of the reasons that Novavax is exciting, right? Just alternatives. Having options is good. And, you know, even the mRNA vaccines, I think we didn’t do a fantastic job of letting people know why they’re good or evil. It was easy for people to say this is new technology. We don’t know how this works and I’m not taking it and there were a lot of missed opportunities in terms of letting people know actually know, actually, there’s been this you know, 20 year research leading up to this, this is your tax dollars at work. There were ways we could have actually empowered people to think very highly of the vaccines. And I think those are all things that we could still do. And really, I want to say actually, as a journalist, I’m kind of stunned by the lack of conversation around what happens in terms of a plan of action for when we have the next wave, which I feel like is inevitable, maybe not this fall. But you know, at some point, when the virus does mutate enough to get around our current immunity, there will be one and I don’t, you know, I hear the dial up, dial down. But that means almost nothing if people aren’t going to listen. So, what is our plan if something else comes along?

Andy Slavitt  50:39

Well, for both of you, I think my belief is one of the reasons why we are so focused on the science now is that there’s very little juice that anybody is willing to squeeze out of alternative public health measures, at least at a policy level, doesn’t mean that individually or at the level of a store or a restaurant or a ballgame that there won’t be people who are taking this more seriously than others, particularly during different waves. But I think, you know, we’re counting on science now, in part, because I think people have given up other elements of the fight. And if I were gonna summarize what I heard from the two of you today, it would be that we’ve got some incremental progress ahead, certainly, significantly, if you’ve got a kid 0 to 5. And, you know, between Novavax and a bi-vaillant, we can expect to see some marginal benefits, but nothing earth shattering, nothing, nothing game changing. And with a virus, it’s changed the game on us continuously. Nothing that says we’re keeping up with it. But as we ended, you both gave us two really important areas to focus on a very approved vaccine, and a vaccine delivered through nasal, directly the nasal passageway or maybe even some alternative like that, which can be game changers, and that we really need to just be playing the short game. But we’ve got to play the long game if we’re gonna say, how did this thing.

Katelyn Jetelina  52:05

Amen.

Apoorva Mandavilli 

I agree with that.

Andy Slavitt

Great, well, thank you both. It’s such a delight to talk to you both. And you both contribute so much to everyone’s knowledge in this space. I’m a big fan.

Katelyn Jetelina 

Thank you very much. It’s been a pleasure.

Apoorva Mandavilli 

Thanks for having me, Andy.

Andy Slavitt 

All right, what are we turning to next in the bubble? We have some absolutely amazing guests coming up. This team has just done a great job of booking some great people, Beto O’Rourke, we’re going to talk about Texas and the country and a little bit about what he’s doing. He’s running for governor, Dan Pfeiffer. We’re going to talk with Dan, who was part of the Obama administration has just written a book on The Big Lie. We’re going to talk to him about January 6th hearings that are ongoing. Nick Kristof, who is the columnist of The New York Times, he’s also may be running for governor in Oregon. Jason Kander, former presidential aspirant, who is someone who many know have suffered from PTSD and talk publicly about it. Adam Conover, who is got a show about, called the G-word on Netflix about the government with Barack Obama and show favorite Michael Mena and Patrice Harris, the latest testing. So as we get through the next few weeks, you’re gonna hear all those people on in the bubble. Plus, on Fridays, you’re gonna continue to hear our great Friday conversations. And in fact, we’ll have one coming up on what is it? Two days, two days from now, unless you’re playing this on Thursday, in which case tomorrow, or in case you’re playing this on Friday, you can listen right away. Thanks, everybody. Appreciate you listening. We’ll look forward to talking to you again in a couple days.

CREDITS

Thanks for listening to IN THE BUBBLE. We’re a production of Lemonada Media. Kathryn Barnes, Jackie Harris and Kyle Shiely produced our show, and they’re great. Our mix is by Noah Smith and James Barber, and they’re great, too. Steve Nelson is the vice president of the weekly content, and he’s okay, too. And of course, the ultimate bosses, Jessica Cordova Kramer and Stephanie Wittels Wachs, they executive produced the show, we love them dearly. Our theme was composed by Dan Molad and Oliver Hill, with additional music by Ivan Kuraev. You can find out more about our show on social media at @LemonadaMedia where you’ll also get the transcript of the show. And you can find me at @ASlavitt on Twitter. If you like what you heard today, why don’t you tell your friends to listen as well, and get them to write a review. Thanks so much, talk to you next time.