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Andrew Egger
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Jonathan Cohn
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Andrew Egger
Buy and Drive today@discounttire.com Let's get you taken care of. Hey everybody. Welcome to Bulwark Takes. I am Andrew Egger, this is Jonathan Cohn, our policy reporter, here to talk about some crazy stuff, stuff that's going on in the world of vaccine approvals over at the Food and Drug Administration. So you may have heard of these MRNA shots that companies like Moderna and Pfizer have been messing around with the last few years. They kind of helped lift us out of the COVID pandemic pretty much single handedly. They're a technology platform that has a lot of applications. One person who does not really like these mRNA shots is Robert F. Kennedy Jr. The anti vax quasi crank who runs the Department of Health and Human Services. He has been kind of putting a lot of pressure on and his people who work for him have been putting a lot of pressure on MRNA vaccines and their developers for quite some time now, for about a year. And we got maybe one of the most shocking developments in this respect last week when the Moderna, the MRNA vaccine company, submitted an application to the FDA for an MRNA flu vaccine to try to get FDA approval. And the FDA fired right back saying they not only did not approve this application, but they were not actually even going to look at the application because they did not think that Moderna had put together a sufficient sort of data package to send to them in the first place. In terms of early trials, that was last week, made a huge splash. Jonathan Cohn wrote about it in his breakdown newsletter on Sunday. The new development today is the FDA seems to be walking it back. Moderna announced this morning that they're actually going to look at the application. After all, we're all kind of running around with our hair on fire trying to figure out exactly what's going on here. Fortunately, Jonathan is here to walk us through. So Jonathan, first of all, just sort of, just sort of talk us through why it was such a big deal last week that Moderna said that the FDA had spiked this, this application. Kind of. How unusual was that? And then how unusual is this, this new development that we're getting, that we're getting today?
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Jonathan Cohn
Yeah. So the quick answers, they're both extremely unusual. The background here is Moderna, like you said, they do the MRNA vaccines like we saw in Covid, they'd been developing one for the flu. Now, you know, we have flu shots out there, but they are far from perfect. They do a really good job at reducing disease severity, keeping you out of the hospital, which is a big deal. You know, flu, it kills tens of thousands of Americans every year and puts 10 times that in the hospital. So a vaccine, having a good vaccine makes a big difference. And there is the hope, still unproven, but the hope that an MRNA vaccine could be even a little better. Partly because you can construct it more quickly based on, you know, you can scale it up quickly. And one of the issues with the flu vaccine is that the virus mutates so quickly. And it's. Every year it's a new strange. The scientists have to guess basically what it's going to look like based on the best data. So in theory, an MRNA vaccine would let you wait a little longer and get the vaccine. Right?
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Andrew Egger
We don't know, sort of like a more flexible. Flexible modular vaccine development platform, basically.
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Jonathan Cohn
Yeah, exactly, exactly. And plus, you know, it's good to have extra, you know, platforms for all kinds of reasons. Among other things, you know, the current flu vaccine, mostly it's made using chicken eggs, which, you know, if you can imagine a world where there's a supply shock because, you know, avian flu is wiping out poultry farms, things that, so having the ability to, to, to, to. To make this kind of shot, you know, has advantages. So Moderna, you know, they develop their shot and they do what companies do, which is along the way they meet with the FDA and they say, hey, we're developing this shot. We want to know what kind of data you're going to want, what kind of tests you're going to want. We want to go over our plan with you, make sure we're all on the same page, because we're investing, you know, hundreds of millions or they actually at one point said more than a billion dollars in this shot. We're, we're going to test it on 40,000 people. We don't want you to come back and say, hey, you got it wrong. So they meet with FDA and they propose a way of doing it. And there's some back and forth and.
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Andrew Egger
We can get into the details of what it was in a minute if you want.
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Jonathan Cohn
But basically at one point, FDA says, well, could you actually run an extra kind of test? And Moderna's like, ah, we, you know, we don't really think we need to. And they go back and forth and FDA says, fine. They say, it's acceptable. You can do this. You might later on want to add some of that extra data. It would be useful, but okay, we'll take it. So they run the test and they run the trials. They get pretty good results, at least in terms of how the shot works, in terms of reducing the risk of hospitalization, et cetera. They meet again with the fda. They say, okay, we're getting ready to submit this. This is what's going to look like. FDA says, again, gee, it would have been nice to have that other data, but okay, we'll work with this. And so they submit it. And then FDA is like, nope, we're not going to take it. And that is just not the way these things are done. For it to change its opinion at the last second, like that is basically unheard of. And then on top of that, we find out through reporting and a shout out to reporters at STAT and the Wall Street Journal have done amazing coverage of this. We find out through reporting, and I later heard this also, that, you know, there's the fda, normally they have senior scientists who make these decisions. Know it was Vinny Prasad, who was Kennedy's guy in the division that oversees vaccine safety, who overruled them and said basically, actually, that extra test we said we wanted, we, well, you didn't do it, so we're not even gonna look at this. And again, FDA wasn't rejecting the application, as you said. They were refusing to look at it, which is an extreme step. They rarely take that The FDA only does that typically if there's like a big piece missing from the application or they have some reason to suspect data integrity. So that's where we were a week ago, and there was a huge outcry because it was so unprecedented because drug companies among them were like, wait a minute, how are we supposed to develop the drugs if we're going to do what you told us to do? And then at the last minute, you're going to pull the rug out from under us? So there was a big pushback, we now know. Again, thanks for reporting. I think I saw this in the Journal that the White House met with FDA officials. FDA then went to and met with Moderna, and now they have agreed to. The FDA said, okay, we'll look at it. After all, we're so, you know, we're going to. We're going to backtrack. Moderna did make one really important modification, which is they're going to kind of ask for sort of. They're splitting their request, in effect, you know, looking at one. So they're going to seek approval for people who are under 65, and then separately for people who are over 65. And it's that over 65 group where the issue had come up about what kind of testing they're doing. So that's how we've gotten to where they are. This whole thing is just chaos. This is not how a government agency is supposed to run. And again, the big issue here isn't it's not. It's not the flu shot. It's not Moderna. It's like, what kind of environment are we creating, you know, for the future development of vaccines and other kinds of drugs?
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Andrew Egger
Yeah, yeah. So I want to drill down on this a little bit. The point you just mentioned about this, this concession, this extra concession Moderna has offered, because this is what's unclear to me about this whole thing, is this. Was this essentially a situation where the FDA maybe didn't anticipate the blowback, didn't realize how much of a. Of a kind of hornet's nest they were going to kick by rejecting this Moderna application. And then this Moderna change is sort of like a fig leaf that lets the political leadership of the FDA sort of walk that back without looking even sillier than they already do? Or is this like a. Like a really pretty significant concession from Moderna that that, like, you know, interferes with Moderna's own model for testing this drug in some way?
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Jonathan Cohn
Yeah, I am not, you know, look, we'll have to See in the next few days what everybody says and we learn more. To me, this does not look like a major concession from Moderna. And in fact, you know, one of the things that was said right away when FDA refused to look at the application and they said, and they explained why, they said, well, you didn't do this test on the over 65 population. It would have been completely normal for FDA to say, okay, we're going to take the application to review it and then come back and say, hey, this your testing looks good for under 65. We think you need to do more testing for over 65. So come back to us with that. That would have been a, you know, that would have been a. FDA does that. So I mean, where they have landed is, is. Is where this process might have landed if they had taken the application in the first place. So I don't really see this as a walk back, a major concession from Moderna. I think this is chaos at the FDA playing out with all kinds of different forces going on.
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Andrew Egger
Yeah, I mean, it's so weird even to talk about these things ever, right? Because I mean, there are sort of like degrees of sort of craziness and lunacy and chaos to all of these things. You know, you talk about all of this taking place under the political leadership of people RFK Jr. Has installed at the FDA who share certain of his, you know, different heterodox views about MRNA or the technology or just, you know, the need to put vaccines through far more stringent testing period, just kind of as a general principle. And yet, you know, the gap even between, you know, many of RFK lieutenants and RFK himself is also quite large. Right. I mean, you have a guy who is running the entire show right now who is pretty routinely getting blowback from his own biggest anti vax fans because they're like, hey, whatever happened to your whole history of saying that, you know, MRNA vaccines led us to like the deadliest vaccine, the COVID shots being the deadliest vaccine in history. And all that stuff you used to say about you know, the possibility of a plan Demic and about just, I mean, just real life lunatic conspiracy theory stuff that RFK used to traffic in. And so it's just, it's so weird to sort of try to pick through these stories and be like, well, you know, is there, is there a steel man case to be made for this thing that the FDA is doing? Is there a steel man case to be made for that thing that the FDA is doing? And yeah, maybe there's some chaos over here. But, like, is there really, like some nice motive or at least some like, understandable motive buried in all this, or is it just pure, like Robert F. Kennedy Jr. Style mania that is motivating these things? This, this Moderna story is, is not really the only story of its kind that's playing out in sort of the vaccine industry right now. Obviously this is, this, this has been a major flashpoint, but we are also seeing lots of reporting just about chilling effects across the vaccine industry more broadly. Can you talk a little bit about what the, what the vibes are like out there?
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Jonathan Cohn
Yeah. So it's not, you know, if it was just this one decision.
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Andrew Egger
Right.
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Jonathan Cohn
Okay, whatever. Agencies have hiccups, you know, there was a miscommunication. You, you wouldn't be such a big deal. The reason this has gotten so much attention is because it is part of a much broader story, as you say. Right. So you just look at the last year, what have we seen, you know, on mRNA specifically? Right. Kennedy pulled hundreds of billions of dollars in, in government support for research that was supposed to go to companies like Moderna to help them develop MRNA vaccines for future pandemics. And again, this gets back to why we care about MRNA technology. It's just, it's quick, you can scale it up fast. And, you know, you imagine a world where five years from now, 10 years from now, there's a new avian flu running around, something worse than Covid. The ability to get a shot in production quickly and in large quantities can be the difference in millions and tens of millions of lives. But, you know, the vaccine industry, you know, you know, needs to get financial support and it needs, you know, the government support was going to help it develop and kind of get a head start on that. But that's also a signal to investors, right, who, you know, are weighing their own bets like, well, am I going to invest in Moderna or some other company to develop this kind of shot? Well, that depends on whether I think that shot's going to be welcomed in the future. The government's going to support it. And so we're seeing this chilling effect. Actually, Moderna has pulled back on some of its investments in research into vaccines for other kinds of diseases. And of course, this is all taking place against an even broader background where we see, for example, CDC this year dramatically scaled back the recommendations for childhood vaccines. And there's all kinds of reports that they're going to start to mess with the vaccine liability system. And we have language on the official CDC website saying, actually, we don't know if vaccines lead to autism, which is a theory that has been tested a gazillion times and never found to have validity by any sort of, you know, by mainstream scientists. And so, you know, this creates this sort of, this, this headwind on vaccines. And again, in that headwind, at some point there are companies that have to develop this. And I say this is someone who's frequently critical of the vaccine industry. You know, I'm coming at this as someone thinks, you know, we need to sort of scrutinize treatments more and there should maybe be, you know, more pressure on prices from the drug industry and you know, where, you know, where, you know, most of the sort of groundbreaking science probably comes from NIH backed research, not from the pharmaceutical industries. But you still need the pharmaceutical industry to develop these shots. And they, you have to convince them and their backers this is a worthwhile investment. And you look at this, you look at this sort of resistance to vaccines and then you add on the chaos and they're just not going to want to spend the money. And you know, that's where we're going to end up, you know, five, ten years from now. We're, we lose out on innovations and new vaccines that really could have been helpful.
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Andrew Egger
Yeah, yeah. So I guess sort of in the short term it's good, it's good that there seems to have been a walk back from last week's really remarkable kind of jump forward in the campaign against vaccines and vaccine development by the Health and Human Services by the fda. It's nice that I guess even though the decisions over there are happening in a political politicized environment, at least that politicized environment is responsive to political pressure. It appears that's better than nothing. And yet this remains an ongoing story. Robert F. Kennedy Jr. Has not reassessed his general feelings about vaccines. There's gonna be a lot more where all of this came from. We'll keep our eye on it. We'll be back here to talk about the next story when the next story comes along the pipe. Thanks Jonathan for hopping on to explain all of this. And thanks to you guys all out there, those of you who, who are listening to the end, you know, wading through all of this talk of MRNA and, and vaccine development and, and, and liability and all these sorts of things. We appreciate you. We hope you will subscribe to the feed subscribe on YouTube. Head over to the bulwark.com or to substack to subscribe to us over there. Get my newsletter Get Jonathan's newsletter. There's so much good stuff we're pumping out every day. Thanks and we'll see you all next time.
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