When will there be a vaccine for Lyme disease?
To answer this question from Robert Small of Stannard, Brave Little State takes stock of not one, not two but three pharmaceuticals currently in development.
In the last 30 years, the incidence of Lyme disease in this country has almost doubled, and because of climate change, ticks are expanding their range. So why isn’t it easier to prevent this tick-borne illness?
That’s what Robert Small of Stannard asked Brave Little State. VPR’s people-powered journalism project answers questions about Vermont that have been asked and voted on by you, because we want our journalism to be more inclusive, more transparent and more fun.
Robert asked us this: "When will there be a vaccine for Lyme disease?"
We’re not just going to answer Robert’s question, we’re also going to explain why he even needs to ask it in the first place.
Note: Our show is produced for the ear. We recommend listening to the audio above if you can! But we also provide a written version of the episode below.
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Meet our question-asker
Robert Small’s curiosity about a Lyme vaccine stems from the fact he himself was diagnosed with Lyme disease nearly a year ago. He says his journey has been “interesting, to say the least,” beginning with the fact that he's not sure how he got it.
“I never saw a tick. I never got the bull's eye [rash],” Robert says. “And I know not everybody gets that.”
Robert’s story might sound familiar to you. He was having some weird joint pain, and it was difficult to diagnose. He saw different specialists over the course of several months, and eventually ended up doing a blood test.
“And sure enough, Lyme popped up,” he recalls. “And so that was kind of a bummer.”
Antibiotics helped, and Robert also saw a Lyme specialist. These days he mostly feels OK, but every once in a while he’ll get a really intense pain in the middle finger of his left hand.
“[I] pick up a bucket of water or something where you have to really grasp on, and that finger just locks in,” he says. “So overall, I mean, compared to what I know a lot of people have to suffer through, I feel pretty fortunate that it's nothing more than that.”
Robert says this whole experience — getting Lyme, but not knowing for months that he had it, finally being diagnosed and going through treatment, and then still having some lingering symptoms — really made him wonder: Shouldn’t there be a way to avoid this whole ordeal?
“What the heck? … Why is it taking so long to get a vaccine, and what's the status?”
“To be honest, I spend a lot of time outdoors. And I know people that do, and then I hear sometime in the summer that folks say, ‘Well, no, I don't want to go in the woods because I don't want to get Lyme disease,’” Robert says. “And I'm like, wow, that's a bummer. If people aren't able to enjoy what Vermont has to offer in terms of outdoor recreation ... I just thought, wait a minute, we've got to do something.”
Maybe you know someone who’s had a brush with Lyme. Maybe that person was you. And it’s scary. Sometimes the symptoms are really bad, and some people struggle for a really long time. There’s so much we still don’t know about Lyme. But in this story we’re not talking about the disease itself; we’re talking about how to prevent it. And there are some very smart people working on this.
Because — and I know this will sound strange in 2021 — the answer to Robert’s question actually contains some potentially good news.
‘Two to three years, if we’re lucky’
So when will there be a Lyme vaccine?
“That is such a good question,” says Sue Halpern, a staff writer at The New Yorker magazine and a scholar in residence at Middlebury College. “And it’s the question that I asked when I started to do my research. And the short answer to that is probably two to three years, if we're lucky.”
(Full disclosure: Sue is the mother-in-law of Brave Little State producer Josh Crane. “Josh is wonderful,” she confirms.)
Robert’s question about a vaccine won in a public voting round, where we ask you, our audience, to direct our reporting. And right when that round was running, Sue looked into this very question for The New Yorker. And she found out about not one, not two, but three pharmaceuticals currently in development that could help you avoid Lyme.
And, spoiler, one of them is similar to those monthly chewables that you might give to your dog or cat. (However, it will not taste like beef.)
The blacklegged tick
But first: Our question-asker Robert had an additional request for this story. He’s a retired wildlife biologist (he used to work in Alaska) and he wants to make sure everyone gets some basic info about the ticks that cause Lyme. Just in case you’re not totally aware.
“What do we know about the tick? Is it indeed found in denser concentrations as you go south in Vermont? Is that range expanding? ... How might climate change affect that?” Robert asks. “So, you know, to me, that would be kind of interesting. If there's a tick specialist in Vermont.”
For that, I got in touch with Natalie Kwit. She’s the state public health veterinarian with the Vermont Department of Health.
“Lyme disease is a bacterial disease transmitted through a tick species called the blacklegged tick, which is definitely here in Vermont,” she says.
Note that Natalie said Lyme is transmitted through the blacklegged tick. To infect you, the tick itself has to be infected with a bacteria called Borrelia burgdorferi.
("There are other strains elsewhere," Natalie notes.)
“If [left] untreated or not diagnosed in a timely manner it can proceed on to more severe manifestations of disease that can affect the neurological system, the cardiac system — particularly the heart — and the joints as well,” Natalie says.
So how likely is it that you’ll encounter a tick with Borrelia burgdorferi?
“Anywhere you live in Vermont, you have a risk for contacting an infected tick,” Natalie says.“Although the risk is higher in certain areas of the state than others.”
Historically, the risk was higher in southern Vermont. But Natalie says that over time, it’s expanded northward.
To track statewide case counts, the health department does what’s called “passive surveillance,” meaning that they rely on health care providers and labs to share their data. Natalie says that means the state’s numbers are likely an underestimate.
“Every year we get between 500 and around 1,000 cases reported to the health department,” she says. “But the order of magnitude is likely 10 times higher than that.”
Nationwide, the Centers for Disease Control and Prevention estimate that close to half a million people may be getting Lyme each year.
“It's a public health problem, in that we are going to see more of it as the climate is changing,” says René Najera, an epidemiologist and the editor of the History of Vaccines project by the College of Physicians of Philadelphia.
“So you have seen reports of Lyme disease, originally from Lyme, Connecticut, right?” René says. “That's how it got named. [But] it's been moving west and south more and more.”
And, René adds, warmer winters mean a longer season for tick-borne illnesses.
“During the winter, it used to be that as soon as we had our ... first [hard freeze] of the season, we would stop doing tick-borne disease and mosquito-borne disease surveillance. And now, over the last few years, we have continued those surveillance programs into the winter because we just don't seem to get that hard freeze anymore.”
Lyme is definitely more prevalent than it used to be. But it’s not exactly a new disease. So what’s the holdup on a vaccine?
The Lyme vaccine that wasn’t
“It’s a kind of horrifying story, actually,” says The New Yorker’s Sue Halpern.
It turns out that we can’t talk about a future vaccine for Lyme until we talk about one that used to be available.
“There was a Lyme disease vaccine about 20 years ago,” Sue says, “made by a company called SmithKline Beecham.”
It was called LYMErix. (SmithKline Beecham is now GSK.) You’d get a series of three shots over the course of a year, and eventually your body would be able to make antibodies that would kill Borrelia burgdorferi. Not when it was inside your body, but before the tick even transferred it to you.
“So the tick attaches to you and starts feeding off of you,” says René Najera, from the History of Vaccines Project. “And the antibodies attack the bacteria in the tick's gut and begin destroying it there before it even gets into you.”
LYMErix was almost 80 percent effective at preventing Lyme disease. It first became available in 1998. When we announced Robert’s question, some of you pointed this out — that we’ve had a Lyme vaccine before. But I had literally never heard of LYMErix. Maybe because I was in elementary school in the ‘90s, and it wasn’t available for kids to take. But about 1.5 million doses were sold for adults.
Jack McCullough, of Montpelier, got two doses of LYMErix. He and his family used to vacation on Martha’s Vineyard, which was, and still is, a Lyme hot spot.
“I got it pretty early after it came out. I got it at the doctor’s office,” Jack remembers. “For some reason I never never got the third shot. And I don't remember why that was.”
Jack says getting LYMErix was no big deal, and he doesn’t recall having any sort of a reaction. But there was a group of people who did have a reaction to the vaccine, or rather, who believed they did. And they mounted an opposition campaign against LYMErix that they’d eventually win.
“The people who had what we're going to now call “long-haul” Lyme disease — a certain percentage of them, not every one of them — believed that the actual vaccine was causing a kind of Lyme arthritis,” Sue explains.
In other words, some people who had already gotten Lyme disease then got the LYMErix vaccine and reported having side effects: headaches, and symptoms similar to arthritis. (Long-haul Lyme, or chronic Lyme, is a pretty fraught topic, because the medical community is split on whether or not it actually exists. But that’s a story for a different day.)
“And so they started very seriously trying to get this vaccine eliminated from the shelves,” Sue says.
The FDA had approved LYMErix as a “permissive” vaccine, meaning that it wasn’t required, or recommended — it was just available for people who wanted it. Which opened the drug manufacturer up to this big class-action lawsuit, which got a lot of press.
“There were some news articles that came out with titles like, “Concerns Grow Over Reactions to Lyme Shots,” or “Lyme Vaccine May Cause Problems,” or “Lyme Disease Vaccine Safety is Questioned,” recalls René Najera. “This is around the same time that the fraudulent study on the MMR vaccine came out claiming that the MMR vaccine caused autism. And there was the beginning of the modern era of anti-vaccine activism. And so anti-vaccine activists latched on to this vaccine as well and just attacked it relentlessly — attacked the manufacturer, and so on and so forth. So by 2002, the manufacturer said, you know what? We are done.”
According to Sue Halpern, it was the first time an FDA-approved vaccine was removed because of a "concerted public-opinion campaign" — even though the complaints that people were making about side effects were never medically proven.
Sales of LYMErix dropped. And by 2002, the manufacturer pulled LYMErix from the market.
“And as a consequence of those lawsuits, and that bad press, no other pharmaceutical company wanted to touch a Lyme vaccine for humans for a very long time,” Sue says.
This is the reason why Robert Small is still waiting for a vaccine, and asking Brave Little State what the prospects are.
René Najera says the whole LYMErix kerfuffle is a cautionary tale. It’s certainly one with many COVID parallels:
“It's a cautionary tale for vaccine manufacturers that optics are going to matter. It is a cautionary tale to regulators and policymakers that even though you might hear a very loud segment of the population claim that something is harmful, or that something is beneficial when it's not, you still need to stick to the science,” Rene says. “And the other cautionary tale for us as a society is that yes, you know, things are not 100 percent safe, they're not 100 percent effective, but when they do the most good with the least harm we should give it a shot. Because not doing it causes even more harm.”
So what does the future of Lyme prevention look like? Sue Halpern told question-asker Robert and me about three different Lyme pharmaceuticals currently in the pipeline. They all work in totally different ways: One is an annual prophylactic, one is a long-term vaccine, and one is basically a monthly pill.
The first one we’re going to talk about is in some ways a direct response to what happened with LYMErix, and the anti-vaccine sentiment. Because it’s not actually a vaccine.
“The idea here is, it would be an annual shot — the way they've engineered it, it would last for about nine months,” Sue says. “And the thing about it that is kind of cool is that it works right away. Whereas with a vaccine, often you have to have a kind of lead time for it to work. And that's why Dr. Klempner and his colleagues think it might be a better route to go than a vaccine.”
“Dr. Klempner” is Mark Klempner, of MassBiologics, a nonprofit vaccine manufacturer at the UMass Chan Medical School, where Mark is also a professor of medicine. He was involved in the effort in the 1990s to develop the first Lyme vaccine. (He didn’t technically work on LYMErix; he worked on a different drug that didn’t get licensed. But he saw everything that went down.)
“And when I talked to him, he was still pretty upset and sad about the fact that they had worked so hard on this, and then it just sort of went away,” Sue says. “So they have this new idea.”
It’s called Lyme PrEP, and Mark Klempner took some time to explain it to question-asker Robert and me.
“It is a single monoclonal antibody … I probably gets easier to explain this in the age of COVID, because now everybody's heard of monoclonal antibodies,” he says. “Monoclonal antibodies have been around to prevent infectious diseases for a very long time. So [the method] has been shown to be very safe.”
Rather than prompting your body to make the antibodies to kill the Borrelia, like a vaccine would, Lyme PrEP just gives you a big stash of them. And then, when the tick bites you, your antibodies go into the tick’s gut and neutralize the Borrelia before it makes it into your bloodstream.
“And we call it Lyme PrEP, because it is for pre- (Pr), exposure (E), prophylaxis [P],” Klempner says. “In other words, before you go out there and get exposed, you should take this medicine. And it differs from the original question about a vaccine in several very important ways.”
One, Mark reiterates that it works right away, with just one shot. And two, it gives your body the exact antibody needed to kill the Borrelia, rather than prompt the creation of multiple antibodies, some of which aren’t necessary.
“And that's why I started with drawing this important distinction between Lime PREP, a monoclonal antibody to prevent Lyme disease, and a vaccine to prevent Lyme disease,” Mark says. “Does that answer your question more thoroughly, Robert?”
“Yes, it does. And that makes good sense,” Robert replies. “I appreciate that distinction. That's great.”
Robert also asked if Lyme PrEP would help people who already have Lyme. Mark’s answer to that — and this goes for all the pharmaceuticals we're talking about today — is, unfortunately no. These are preventatives, not therapeutics.
Sue Halpern puts it this way: “Once you’ve been infected by the bacteria, all bets are off.”
MassBiologics started Phase 1 trials for Lyme PrEP this past February. If all goes well in future phases, Mark Klempner figures Lyme PrEP could be available by 2024. Since MassBiologics is a nonprofit based at a university, the plan is to partner with a pharmaceutical company to run the larger trials and bring the drug to market.
Which brings us to a second type of Lyme prevention that’s in development. It is a vaccine. It’s a little farther along. And it’s gotten picked up by a company you’ve definitely heard of.
It’s called VLA-15, and the early phases of its development were so promising that Pfizer bought into it.
”It's a vaccine that was developed by a French company called Valneva,” Sue Halpern explains. “And it kind of works off of this concept of getting to the tick before the tick can get to you.”
VLA-15 actually uses similar science to LYMErix.
“[Valneva and Pfizer] have gone through a number of clinical trials. I think they have one more to go,” Sue says. And once that one is in the bag, then they will apply to the FDA for approval, which it seems likely that they will get just because it's shown to be effective and safe.”
"I think [Pfizer's investment in a Lyme vaccine] is kind of a vote of confidence on the part of the pharmaceutical industry, that there's something here that is going to fly."
Right now the companies are in their third Phase 2 trial, working to confirm that the vaccine is safe for children.
It’s notable that one the world’s largest pharmaceutical companies is investing in a vaccine whose predecessor got torpedoed just 20 years ago. But Sue Halpern says that’s a good sign:
“I think that is kind of a vote of confidence on the part of the pharmaceutical industry, that there's something here that is going to fly.”
Maybe the public reception will be different this time. And the third and final Lyme preventative Sue told us about might have a head start on that front.
This third drug may answer a question “that anyone who has a dog and probably a cat has asked themselves over and over again,” Sue says.
The question being: How come my pet can take a chewable to prevent Lyme disease, and I can’t?
Sue says there’s a small California company, Tarsus Pharmaceuticals, that primarily works on eye care. They were trying to develop a drug for these mites that some people get on their eyelids. And they were working with an ingredient, lotilaner, found in a veterinary brand called Credelio.
“And they found that this particular drug killed the thing that they were trying to kill, which was mites on your eyelid, which apparently is a big problem,” Sue says. “And in the course of doing that, they realized that it also had the potential to do what it does for your dog or your cat, which is [to] kill the tick.”
A circuitous way to begin this kind of research, to be sure. But better late than never.
“A person would take it, let's say every month or two over the Lyme season," says Bobby Azamian, the CEO of Tarsus. "And they could take it even potentially the day before they were worried about being exposed."
Bobby notes that this drug, TP-05, doesn’t target the Borrelia inside the tick: It targets the tick itself, paralyzing it before it can transmit the Borrelia.
“It doesn't mean we want Vermonters to drop everything and stop protecting themselves against tick bites and go roll in the woods."
“[Tarsus is] at the very beginning of their work, they are just starting their first clinical trial,” Sue says. “So they are ...probably a couple years behind the others. But potentially, if they succeed, it becomes a very simple way of protecting yourself against Lyme ticks.”
TP-05, would definitely be different from Lyme PREP or the Valneva-Pfizer vaccine. Instead of getting jabbed, you’d pop a tablet every month or two. And while it’s still too soon to say, it might help prevent tick-borne illnesses beyond Lyme. Like anaplasmosis. Because after all, ticks can carry multiple diseases.
“That is one of the potential advantages of a chemical in contrast to a biologic or a vaccine that's really only targeted to the Borrelia bacteria,” Bobby says.
Tarsus’ marketing director, Maaza Martin, joined our interview. And she stressed the flexibility of this kind of Lyme prevention.
“This is something that could be used for folks who live in endemic areas. And then as well as [by] people who work outdoors, as well as those traveling … to an area where there may be a lot of ticks,” Maaza says.
“I do think the convenience of this — not having to go into a doctor's office, but get a prescription for this, and take a simple pill on demand ... I think that profile has a lot of appeal,” Bobby Azamian adds.
If you can sense some sales pitch here — well, of course you can. This is a California startup. But even Mark Klempner, of MassBiologics, was making the case for Lyme PrEP. I think one reason is obviously competition: with Lyme on the rise, this is going to be a growing market. But there may also be some cautious customer assurance going on here.
“A lot of the people who are working on this stuff now were working on it 20 years ago, and feel that they got burned in a very large way,” Sue Halpern observes. “But you know, 20 years ago, Lyme disease was really not that prevalent, and therefore, people didn't necessarily really know a lot about it. And now of course, we all do know about it.
“And I'd say that the chances are, more people will want it than people will protest against it. And, again, because it's not something that anyone is going to mandate that you have to take ... it's a personal decision. If you want to have it, you have it, if you don't want to have it, you don't have it.”
Sounds ideal. Even if people are hesitant, René Najera figures their thinking could change.
“If Lyme disease severely affects children, as it makes its way into playgrounds, as it makes its way into backyards and neighborhoods — if that is the case, and that has shown to be the case, then people might change their tune,” René says. “[They] might be more open to a new Lyme disease vaccine.”
But even if or when we have a pharmaceutical method for preventing Lyme, we won’t be invincible. I think that truism is one of the many enduring lessons of this pandemic.
“It doesn't mean we want Vermonters to drop everything and stop protecting themselves against tick bites and go roll in the woods,” says Natalie Kwit, with the Vermont Department of Health. “We want them to continue to keep up with your other preventive methods. We want you to check, protect, remove and watch.”
Wear long sleeves and pants in light colors; spray your clothes with permethrin, if that’s your thing; check your body and shower when you come in from the woods and fields. And few years from now — again — you might have the option of getting some extra protection from Lyme.
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Thanks to Robert Small for the great question, and for joining some of the interviews for this story.
This episode was reported and produced by Angela Evancie, with help from Josh Crane. Mix and sound design by Josh Crane, and digital production by Myra Flynn. Ty Gibbons composed our theme music; other music by Blue Dot Sessions and Myra Flynn.
Special thanks to Lexi Krupp, and to those of you who wrote in on this topic: Annie, Nessa, Andy and Karen. You can send us a note any time at email@example.com.
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