How does a vaccine get developed, studied, approved, distributed, and administered, and then just … disappear? On Episode 34 of The Politics of Everything, hosts Laura Marsh and Alex Pareene explore what happened to LYMErix, a vaccine for Lyme disease that has been called the only safe and effective vaccine ever to have been voluntarily withdrawn from the market in the United States. What does the story of LYMErix tell us about vaccine hesitancy, liability, and how pharmaceutical companies decide what to sell? And can we expect another Lyme vaccine anytime soon? Guests include Rebecca Onion, who wrote about LYMErix for Slate, and Andrew Zaleski, who wrote about new prophylactic treatments for Lyme for Outside magazine.
Andrew Zaleski: Every time I’m walking through grass, I’m just high-stepping it, like a football player, just knees to the chest the entire time, checking my ankles when I come back—is there anything crawling on me?
Laura Marsh: That’s the writer Andrew Zaleski. He recently reported an article about Lyme disease, and he’s talking about an experience I think we’ve all probably had, of trying to avoid disease-carrying ticks.
Alex Pareene: Today on the show we’re talking about Lyme disease.
Laura: There is no vaccine available for the disease, which affects about a half a million people every year.
Alex: But once upon a time, there was a vaccine. It was called LYMErix, and it was available starting in 1998.
Laura: So there was a vaccine—but now there isn’t.
Alex: LYMErix was the only effective, FDA-approved vaccine in the U.S. ever to have been voluntarily withdrawn from the market.
Laura: So I wanted to know, how does that happen? How does a vaccine disappear?
Alex: I think that there’s one sort of simple answer that has something to do with vaccine skepticism, which we’ve all been thinking about this last year. But in looking into it, the answer is really more complicated than that. The story of LYMErix does tell us about vaccine skepticism, but it also tells us about how medical research and drug approval and our health care system work in general.
I’m Alex Pareene.
Laura: And I’m Laura Marsh.
Alex: This is The Politics of Everything.
Alex: Our first guest is Rebecca Onion, who wrote an article for Slate in July about how the Lyme vaccine disappeared from the market.
Laura: So I’ve always loved hiking, and over the last year or two, during the pandemic, it’s been one of the activities that I’ve felt most comfortable doing. You don’t have to worry about being close to people, it’s incredibly socially distant, and the only part of hiking that I’ve felt uncomfortable with has been this pervasive fear of ticks and of catching Lyme disease. So I was thinking, idly, wouldn’t it be great if there was a vaccine for Lyme disease, and I googled this. Rebecca, I found out from your article that there was a Lyme disease vaccine. I had never heard of it, and no one I spoke to had ever heard of it. Can you just tell me, how did it work?
Rebecca Onion: It was made by SmithKline Beecham—now it’s GlaxoSmithKline, but then it was SmithKline Beecham. The way it worked, it caused a human body to create antibodies, which then, if a tick were to latch onto them, would go into the tick’s body and neutralize the bacteria that causes Lyme, which is called Borrelia burgdorferi. The tick would keep on biting you, but they couldn’t do anything to you.
Alex: How effective was the vaccine?
Rebecca: In trial, it showed 78 percent effectiveness, but you had to take three doses over the course of a year. Three doses over a year is kind of tough. But, as I said in the article, I’d still take it. I’m like, sure, sign me up!
Laura: That was also my reaction learning that this existed—I would get this tomorrow. Even if it were three shots, I would happily get this vaccine. It would be amazing to go out into the country and be able to walk around or do whatever it is that you want to do without worrying about getting Lyme disease. What went wrong?
Rebecca: It’s such a complicated story. I thought, before I looked into it a little bit more, that the answer to that was just your basic, “Vaccine skepticism caused the withdrawal of the LYMErix vaccine.” And I sort of thought that because of Paul Offit, a pediatrician who’s been involved with the development of several vaccines. He wrote a really good book on the Cutter incident, which was something that happened when the polio vaccine was getting rolled out in the 1950s.
Laura: The Cutter incident—people got sick from taking the polio vaccine, is that what happened?
Rebecca: The Cutter incident was this terrible thing where a lab out in California did not follow protocols perfectly in producing the Salk polio vaccine. Because of that, some of the lots of the vaccine were contaminated, and some people got polio from the vaccine.
Laura: Since then, there’s been a fear around vaccines that they could make you sick. Were people worried that the Lyme disease vaccine was going to make them sick?
Rebecca: Some people even were bringing suits about it. So this whole story is complicated by the existence of so-called chronic Lyme. Some people who had been suffering from Lyme for a long time, when the vaccine was out, they took it and thought that the vaccine had reactivated the bacteria in their body and created arthritic conditions in them. This caused them to turn against the vaccine. And they were an important part of the groups of people who were lobbying for the vaccine to be taken off the market—they believed that they had been harmed by it.
Alex: So we should point out that these concerns were contradicted by an FDA study, which found no evidence of elevated rates of arthritis in vaccine recipients. In other words, the rate of arthritis for people who got the Lyme vaccine was no higher than the rate for people in the general population or the rate of arthritis among people who got a placebo instead of the actual vaccine.
Laura: But the manufacturer was still worried it would be vulnerable to loss.
Rebecca: So Paul Offit, who wrote the book about the Cutter incident—the book is a lot about the way that liability worked after polio, how things have developed on that front. His perspective was that the withdrawal of LYMErix, which happened about four years after it was approved, was because the company felt that it was not going to be sufficiently covered because the shot wasn’t covered by the National Vaccine Injury Compensation Program.
Alex: I think we need to explain something about vaccine approval and liability here, because the LYMErix vaccine—there’s a list of vaccines that are approved that manufacturers cannot be sued over, and this was not on that list.
Rebecca: Yeah, that’s right. So it was given what I believe is called a “permissive” classification. They were basically saying, “If you feel that you would benefit from this, by all means, go ahead.” But it was not a recommended vaccine in the way that the MMR shot is, which is a really different classification. So the stakes for liability are really different.
Alex: And it left them open to the lawsuit you were talking about. And then that gets at the fact that LYMErix was never unapproved. It was voluntarily withdrawn from the market for liability, because it was only ever treated as sort of an optional vaccine—“Eh, if you want this, you should get it”. It wasn’t treated as seriously as a vaccine like MMR or the others that are required.
Rebecca: Which is kind of interesting, because in 2021, I feel like I see Lyme as a huge problem. The incidence has tripled since 2000—in part because of shifting climate conditions, in part because of houses being built closer and closer to the woods—so our perspective on how necessary a shot would be is really different now.
Laura: You started your article asking how much you’d pay for the vaccine, and you said it would be like $1,000.
Alex: I don’t know if that exact dollar amount is what everyone else would hit on, but there would definitely be a lot of demand for the Lyme disease vaccine now. But back when it was first authorized, it was treated as something only a few people would even care about.
Rebecca: When it was first authorized, some of the people on the advisory committee on immunization practices at the CDC—doctors, public health people—called LYMErix “the yuppie vaccine.” I’m totally paraphrasing right now, but this one doctor said, “Oh yeah, I think the only people who are interested in this vaccine are the people who want to get a quick shot before they dash off to Cape Cod.” I believe the words “L.L. Bean” and “Esprit” were cited in relationship to the kind of person who would be paying for this vaccine. So, in a way, all of these things combined to bring about LYMErix’s downfall—the fact that it was seen as something so optional, where the disease was not really that big of a problem, also led, I think, to a depressed market for it. So they just didn’t sell as many shots of it as they thought they were going to.
Laura: Going back to the anti-vax sentiment that you originally thought might have something to do with this: Is it the case that there is an element of that, but it’s also the fact that the authorities didn’t take Lyme disease seriously enough?
Rebecca: Yeah, it’s interesting—even in reading some of this older history, a couple of these articles were written 10 or 15 years ago, and they would say things about Lyme like, “This is really just not a disease that’s a big problem, like if you see it, if you realize that you have it, you take a course of antibiotics and it’s it’s OK.” And I think now, from everything I’ve read, it seems like public health actually is sort of recognizing not only that cases have gone up but also that it can be a dramatic thing in people’s lives. And I think that that is recognized a little bit more, but in 2000 it was an unusual, new thing.
Alex: If you could go back to the late 1990s and tell everyone how much more widespread it would become in a few decades, how it would spread geographically, it wouldn’t just be a New England problem for yuppy hikers, it would spread across much of the country, I do wonder if, on the one hand, the FDA would have treated it differently, and, on the other hand, if they would have marketed it differently.
Rebecca: In marketing the vaccine, the company did direct-to-consumer pharmaceutical ads for it, and they marketed it as a way to sort of avoid the anxiety of going outside. And the images were of, like, a well-dressed white lady in her backyard, that kind of thing. But it’s a misnomer to consider Lyme something that only hits Northeastern liberals. And of course, now it’s spreading—they found it in the Bay Area, they found it all over everywhere. So more and more it’ll become a question of, like, are you required to be outside for your job? Then this might be something that would affect you.
Laura: How many people ended up actually getting the vaccine in the period when it was available?
Rebecca: One number that can say a little bit about how few people were getting the shot by the time the four years had ended: In 2001, the company earned only $5 million from the shot and only 93,000 people bought doses. And then in 2002, right before it was gone, in the first two months, only 10,000 people bought doses. So things were really starting to dwindle by the time that the vaccine was pulled off the market.
Laura: Wow. That’s really low. So among every person I’ve mentioned this Lyme disease vaccine to, a lot of people who’ve lived in the Northeast for many decades, no one remembered it. Every single person I mentioned this to was just shocked it had ever been available. They had the same reaction I have, which was like, if they’d known they would have gotten it. Why do you think it’s just disappeared from memory?
Rebecca: It’s so interesting. I feel like it’s only recently that—I mean, for obvious reasons—we think about vaccines a lot. I always have just gotten all the vaccines I’m supposed to get and given my child all the vaccine she’s supposed to get and been happy about it, but not felt like it was solving a huge problem in my life, because those problems were all hypothetical. I think that might be part of it—that we’re a little bit unaccustomed to thinking about vaccines as something that are immediately helpful to our lives, as opposed to a sort of background advantage to living in a country that’s pretty technologically advanced and has tried pretty hard to get rid of certain infectious diseases.
Alex: You described the marketing of this, and I think there was some sense, probably, in which the marketing made people think, “Well, they’re trying [to make] me scared of this disease, they’re inventing something for me to be worried about so I take their medicine,” and then it sort of disappeared without leaving much in the memory.
Laura: Do you think there’s anything that we can learn from the story of the Lyme disease vaccine in this moment?
Rebecca: It’s funny, because when I was writing this piece, I tried to find vaccine politics people who might be willing to hazard a guess as to whether new vaccines like this would have an easier or a harder time coming to market, someone who would say, “Oh yeah, this madness over the Covid vaccine is going to make it so that vaccines can’t be approved, people will be too up in arms about it,” or “The appreciation of the Covid vaccine among some parts of society will be so strong that people will have a renewed investment in the vaccine approval process and will lobby or be more aware of it,” and everyone that I asked was just like, “I’m not going to say, I have no idea,” which is classic—that’s like a classic Covid-politics expert thing.
Alex: Yeah, I feel like that has been a recurring theme on the show—me especially, saying, “I’m just not going to predict things anymore, no idea.”
Rebecca: To me it’s sort of like, I don’t know—I don’t think the government is perfect, and I don’t think pharmaceutical companies are perfect, but I feel a little bit more inspired by the story of LYMErix to actually be a little bit more active in—I hate even saying this—supporting pharmaceutical companies in our valiant efforts to bring the magic juice to us that will cause us to be able to go into the woods again! Like, no, obviously, but in a way, sort of? I don’t know.
Laura: Well, I feel like this is also a story about the conditions that enable a vaccine to be successful. It’s a story about how do you get people on board if they’re hesitant about vaccines? How do you create the regulatory infrastructure to allow their manufacturers to succeed and allow it to be viable? Did you feel that when you were working on the story there were things that you pulled out that were also relevant to thinking about the Covid vaccines? Like understanding that there are these other reasons that aren’t necessarily obvious about why people don’t get a vaccine.
Rebecca: One thing that some of the historians of medicine did say about the permissive designation—LYMErix, again, was designated as “You can take this if you want, but you don’t have to”—was that physicians didn’t know what to say; it was unclear who would be a good candidate. At that time, people in the government weren’t doing as much tracking of which parts of the United States had more Lyme ticks in them. And so it does seem like individual doctors being able to identify candidates and try to talk them into it would maybe have helped get this to more people, and maybe would also help get the Covid vaccine to more people. But that kind of infrastructure is hard in our country because a lot of people don’t have individual doctors, or easy access to them, or health care to pay for them.
Alex: Well, it’s funny, the feelings toward our health care system and our pharmaceutical companies that we have during this pandemic era, because this is a story where a Lyme vaccine is not available because the company that developed it is choosing not to sell it, and they’re choosing not to sell it because they were afraid of liability, because it’s not profitable—it wasn’t profitable to keep selling LYMErix.
Rebecca: Yeah. And saying that makes you sort of give them a little bit of a side-eye.
Alex: That, I think, speaks both to some of the skepticism people have about the motives of the pharmaceutical companies, but it also leads me to wonder, will this just happen all over again with some future treatment for Lyme or other diseases?
Rebecca: Interesting you should say that. Paul Offit—remember, the historian/pediatrician/pro-vaccine guy who wrote the book about the Cutter incident—his whole thing is that the government needs to figure out ways to structure liability so that companies will be incentivized to make vaccines. So at the time that he wrote that book, he was in despair about the potential for a lot of lawsuits about various vaccines to make it, so that American pharmaceutical companies would just not do it. I remember reading stories about these very pre-pandemic fears that America was losing its edge in terms of the number of companies that we had that were willing to produce. So for somebody like Offit, the answer to the question would be, what do you expect? If they’re going to get slammed with all these lawsuits, and there’s no reform of the system, if government doesn’t protect them, what do you expect from them? I’m not a hundred percent sure that I agree with that perspective—I think, well, can we nationalize them? I don’t know!
Alex: I mean, that would be where I would go. My own feeling would be like, the government could have just made its own Lyme vaccine—like, just have the government do it.
Rebecca: And then we’d come up with all kinds of problems, like how would they choose which ones to do? But at least we would have some sort of democratic control over it—question mark, possibly?
Alex: I always like to end any discussion with a question mark.
Rebecca: Nationalize, question mark?
Laura: No, I think that “nationalize” is always a good note to end on— probably one we’ve hit on previous episodes, too!
Alex: Well, thanks so much, Rebecca. Rebecca Onion’s article, “Where’s My Lyme Vaccine?” was published in Slate in July.
Laura: After the break, we’re going to talk with the writer Andrew Zaleski, whom you heard at the beginning of the show, about how much more widespread Lyme has gotten since the vaccine was last available, and whether any preventive Lyme treatments are on the horizon.
Alex: So Laura was wondering about a Lyme disease vaccine, and discovered there was one that has been withdrawn from the market. At this point, that was about 20 years ago. Since that vaccine was withdrawn, Lyme has gone from being something that was isolated to the Northeast and parts of the upper Midwest to being nationwide. Andrew, thank you so much for joining us. Can you tell us the scope of Lyme in the U.S. and how much worse or more widespread it has gotten in the last few decades?
Andrew: You’re correct, Alex. It used to be this weird regional infection; since then it’s just exploded. There are about a hundred million people in the U.S. who live in an area where they can get Lyme. The number of Lyme infections about a decade ago was around 300,000, which itself is a very large number. It’s ballooned. Almost half a million people, at least according to CDC figures, are diagnosed and treated for Lyme disease every year now.
Laura: So we were also talking about the period when the Lyme disease vaccine was available. Lyme disease was not particularly well understood, it wasn’t really considered a serious illness. What is the worst-case scenario for someone who contracts Lyme?
Andrew: It’s not caught early, and because it’s not caught early, it’s not treated, so it can start spreading. It could spread to the brain, it could spread to the heart, it could spread to other major organs. And from that point on, it just causes this never-ending cascade of symptoms and problems. Bart Yasso, this famous marathon runner, always has swollen joints, can never run without feeling arthritis of some sort.
Laura: Definitely something you do not want to get. You wrote your story for Outside magazine, which is a magazine that focuses on outdoor pursuits. Obviously Lyme disease is a big reason not to go out onto a trail. What have been the effects of Lyme on outdoor culture?
Andrew: There was this study conducted by some researchers at Yale a little while back that found that in order to avoid possibly contracting Lyme, people will take a billion fewer trips outside.
Laura: It’s pretty big numbers.
Alex: I would imagine, to go back to what I said at the beginning, that number would have been a lot smaller 20 years ago, when we had this Lyme vaccine. I know that when I was a kid, we gave basically no consideration to the threat of Lyme when we went outside—which is probably how I ended up contracting it! I’m fine now. But now if I’m doing certain stuff with my kid, I’m like, “All right, we’re going to tuck pants into the socks, we’re going to check you”—all these things that wouldn’t have occurred to my parents to do for me. And so, now that we have this awareness of it, awareness with no vaccine anymore, what do we do? Is there anything on the horizon that will save us from the huge spread of Lyme disease?
Andrew: The thrust of this Outside story was talking to Dr. Mark Klempner, who devised, along with a larger team, this pre-exposure prophylaxis that he calls Lyme PREP, PREP being the acronym. Basically, it’s a monoclonal antibody. The idea is you would get this annual injection. When a Lyme-carrying tick bites you, it sucks in your blood, and it would suck in this antibody that would immobilize the Lyme-causing bacteria, Borrelia, within its gut, which means it wouldn’t transfer to you, and presumably you would not get Lyme disease. He began a Phase I trial in February of this year and is hoping maybe this will be out in the market sometime in 2024.
Alex: This is a preventive Lyme treatment, but it’s not a vaccine.
Andrew: That’s right. It’s a preventive treatment that gives you an antibody. The difference is that a vaccine normally stimulates an immune response that will generate an antibody; this is the antibody itself.
Laura: When this eventually comes onto the market, do you foresee it encountering some of the problems that LYMErix had, with people not wanting to get vaccinated or having concerns about taking a treatment for this?
Andrew: Perhaps. Mark Klempner said that he thinks it’s going to fight some kind of acceptance battle because of the problems that emerged around LYMErix.
Alex: How far along is it in trials?
Andrew: The Phase I trials started with 60 participants in February 2021. That’s a dosage study: figure out how much of Lyme PREP people need in order to protect them. And then you gradually expand the participant population and start doing studies of the safety: How many people could take it safely? Does it work? Is it actually doing the thing that it’s supposed to do, which is prevent Lyme disease? I think Mark Klempner seems to think that all of this will progress at a reasonable clip and it will be able to go to market in a few years.
Alex: So this is interesting, because I feel like we’ve been highlighting the ways that PREP is different from a vaccine. We were talking with our previous guest, Rebecca, about LYMErix being withdrawn not solely because of anti-vax sentiments—also, in part, it was a story of a drug company not knowing how to market this vaccine, and not feeling like there was enough of a consumer base for it. I think that … the consumer base has grown since then, but also, do you expect that the fact that this is not a vaccine will be a selling point, if and when it is approved?
Andrew: I would imagine so, if you can very objectively and easily explain the difference between a vaccine, which would generate an immune response to create antibodies, versus here’s the antibody, you’re just getting the antibody, and if you have it in your body, it should presumably prevent your getting Lyme. You would think it would, but I don’t know.
Alex: Well, one thing that I found interesting is that I no longer have to be introduced to the concept of injecting antibodies—now that we know of that as a treatment for Covid-19 in this post-Covid world, like, oh, OK, one therapeutic treatment for Covid is directly injecting these antibodies. And even the concept of PREP, the other usage of prep for disease prevention that I know of is HIV, which is completely well-accepted. So I do wonder if, societally, we are more ready for this kind of treatment now than we would have been a decade or two ago, because we’re more familiar with these concepts.
Andrew: Hopefully. I mean I’m one guy, who cares about me, but if this is out there and I could take it, I would take it.
Laura: I have one last question about the way in which this is a public health issue, because the main subject of vaccine conversation in the last couple of years has obviously been the Covid vaccine. And it’s important with the Covid vaccine that everyone in the community gets it because you can spread Covid from person to person. Lyme disease is a little different because ticks spread Lyme disease to humans, but I’m not aware of any human to human transmission of Lyme. So is it a public health issue in the sense that there isn’t community spread, but that it is still a disease that is at large in many parts of the U.S.?
Andrew: Sure, in a way. Sam Telford, the Yale professor that I quote in the story, will give you a great diatribe about the spread of deer, the fact that the deer population has just exploded and deer are carriers, but it’s also just this growing suburbanization in America—the more you begin spreading where people live out into places in nature where they perhaps weren’t found before, you can come into contact with different types of diseases and infections. That’s been the story from the entirety of almost the last two years, zoonotic diseases or vector-borne diseases. And so that’s a piece of it too, if that fits into public health.
Alex: The more we talk about Lyme, the more I’m feeling that it has parallels to everything else that’s going on. It’s like this skeleton key—it’s about climate change and where these ticks are found, it’s about development patterns, it’s about the sort of sociological and economic reasons why drug companies develop the treatments they do and how they market them and what gets approved. It touches on so many other things. Andrew, thank you so much for taking the time to talk to us today.
Andrew: Sure. Thanks for having me on.
Laura: Andrew Zaleski’s article, “Finally, a Shot to Prevent Lyme Disease Could Be on Its Way” appeared in Outside magazine in August.
