First Do No Harm: Lyme Disease Vaccination May Present More Risks Than Benefits
Meryl P. Littman, VMD, Diplomate ACVIM
When veterinary clinicians decide whether to recommend a particular vaccine for a particular patient, risks and benefits are weighed. The vaccinometer tool, developed by Larry Glickman, was designed to help practitioners determine whether or not to recommend a vaccine.1
As we investigate Lyme disease vaccination, the questions posed by the vaccinometer help highlight many unanswered questions and potential risks related to this vaccine. With these concerns in mind, I choose first do no harm. In other words, if we use proper tick control, vaccination is unnecessary.
Question:What is the prevalence and risk of exposure/infection in your area ?
Answer: Risk of Lyme disease exposure/infection is high in my area, but proper tick control lowers the risk greatly.
The CDC website2 shows that 95% of human Lyme disease is found in 12 endemic states in the Northeast, Mid-Atlantic, and Upper Midwest U.S. In some endemic areas, seroprevalence in healthy dogs is as high as 70% to 90%.3 In high-risk areas, risk of exposure can be lowered dramatically with adequate tick control, which also decreases the risk for other tick-borne diseases, such as anaplasmosis, babesiosis, bartonellosis, ehrlichiosis, and Rocky Mountain spotted fever.
Question:How great is the risk of severe disease once the dog is infected ?
Answer:Risk of Lyme disease becoming severe is low, but possibly somewhat higher in retriever dogs.
Question:How effective is the vaccine?
Is There A Immunization Against Ticks Or Lime Disease For
Is there a immunization against ticks, or lime disease for humans???
There is currently no human vaccine for Lyme disease. The best way to avoid the disease is to protect against tick bites. You can find more information about Lyme disease and how to protect yourself against tick bites on the BCCDC and Government of Canada websites.
– Immunization Nurse
Combating Concerns About Vaccination
There are still some who believe that Lyme disease is not a disease worth vaccinating against or the vaccine causes more harm than good. This is despite the:
- Extremely large number of clinical Lyme disease cases and nonclinical Lyme infections seen in small animal practice in endemic areas in the U.S., including the often fatal syndrome of Lyme nephritis
- Millions of dogs that receive Lyme disease vaccines annually with no data to suggest any resulting harm from the vaccine.
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The Rise And Fall Of Lymerix
Part of the industrys reluctance to develop a new vaccine dates back to the 1990s, when two pharmaceutical companies, SmithKline Beecham and Pasteur Mérieux Connaught , were going head-to-head developing Lyme disease vaccines. A few days before Christmas in 1998, LYMErix won the race and received FDA approval.
It would prove to be an inauspicious time to bring a new vaccine to the market.
Initially, the vaccine fared well, with 1.4 million doses distributed by July 2000. One early issue was that LYMErix required three shots over 12 months and it wasnt clear how long immunity would last. Another was that it wasnt approved for anyone under age 15. And some people felt that it should have been more effective, since it worked in just about 80% of those who got the vaccine.
Theres A Vaccine For Lyme Disease So Why Cant We Get It
Thanks to vaccines, the number of COVID-19 cases has plummeted in the U.S. and restrictions are being lifted across the country. But as we return to our normal activities, we face a more familiar summertime scourge. Were in the thick of Lyme disease season the two-month run from early June to the end of July when 85 percent of infections take place. Surprisingly, vaccines may have allowed us to avoid this epidemic, too. As I learned during my own recent bout with Lyme disease, a vaccine has existed for decades, but its no longer available.
Its yet another frustrating aspect of this mysterious disease. One bite from a tiny, hard-to-detect tick can lead to a host of odd symptoms, including arthritis, serious cardiac issues, and neurological damage in the most severe cases. The disease is easy to treat once you get a diagnosis, but that can be elusive. And while work is underway to develop a new and better vaccine, it may take years to come to market. Heres what we know about how the disease works, and what you can do to stay safe.
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Before Lyme Disease Vaccine Approval
A month before vaccine approval, the Lyme Disease Association, Inc., published LDAs Vaccine Position Paper. LDA was following the development of the vaccine and was concerned that safety and efficacy had not been fully established. The Steere research pointed to a potential link between OspA and a possible unstoppable immune cascade. LDA suggested that individuals considering vaccination should get answers to the questions posed by the paper before getting vaccinated. Before the LVs approval, Dr. Patricia Ferrieri of the University of Minnesota, who chaired the FDA advisory panel, chose to summarize the committees sentiments: Its rare that a vaccine be voted on with such ambivalence and a stack of provisos.Join or login below to continue reading.
What Still Isnt Known
While guinea pigs were able to develop tick immunity, weve found that animals like mice do not. We plan to test this mRNA vaccine model in other animals, such as rabbits, to better understand how tick immunity varies in different tick hosts. We also plan to develop vaccines for other tick-borne pathogens and test for whether immunity extends to different tick species as well.
Our hope is that vector-based mRNA vaccines targeting the disease carrier can be applied to other vector-borne diseases. However, the feeding strategies of each disease vector is different tick bites are not the same as mosquito bites, for instance. Because the way disease-carriers transmit pathogens may be different, vaccines may need to be modified for each vector.
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The Vaccine Was Pulled From The Market Despite Evidence Finding It Was Safe
But it was too late. Already, there was significant media coverage, sensationalism, the development of anti-Lyme vaccine groups … who urged withdrawal of the vaccine from the market, Poland explained in his 2011 article. A class-action lawsuit targeted SmithKline Beecham, claiming the company did not do enough to warn people of potential autoimmune side effects.
The FDA continued to follow up with an additional drug safety trial to try to settle the matter for the public. The trial was supposed to last four years. But sales of LYMErix had plummeted from about 1.5 million doses in 1999 to a projected 10,000 doses in 2002, the National Institute of Allergy and Infectious Diseases explains on its website.
Falling sales, combined with the mounting lawsuits from patients, led the manufacturer to pull it from the market, although early data from the additional safety trial found no differences in any significant adverse reactions noted between control subjects and vaccinated persons, Poland writes.
Concerning side effects sometimes do emerge after a drug comes on the market. But you need hard data to establish them. And the FDAs investigations into LYMErix never found any evidence of autoimmune side effects.
In the 2000s, Lyme still didnt infect that many people, and the public was more concerned about the Lyme vaccine than the disease itself. But now infections rates are rising and were left without a crucial tool to stop its spread.
A Safe And Effective Vaccine Exists But You Cant Get It
After Borrelia burgdorferi was identified in 1983 as the cause of Lyme disease, researchers went to work developing a vaccine, and in short order they found success. SmithKlineBeecham tested its three-dose LYMErix vaccine on some 10,000 volunteers and found that it was 76 percent effective, with no significant side effects. In 1998 the FDA approved it, and areas where the vaccine was widely administered showed sharp drops in Lyme disease.
In a perfect world wed still be using LYMErix today, and hundreds of thousands of people might have been spared the disease, including me. But it was not to be. Within a year of the vaccines introduction, anecdotal reports began circulating about possible side effects. The media reported on the plight of vaccine victims, and a Philadelphia law firm filed a class-action lawsuit against SmithKlineBeecham. The furor prompted the FDA to review the safety data it concluded that the concerns were unwarranted. But the damage had been done. Demand for the vaccine fell off so precipitously that the manufacturer simply pulled it from the market.
Thats not the end of the story, though. Pfizer has teamed up with the French pharmaceutical company Valneva to develop a new Lyme disease vaccine called VLA15 that will target a broader range of Borrelia subspecies, meaning that it will, hopefully, have a significantly higher overall efficacy. Currently undergoing phase 2 trials, the vaccine is unlikely to see approval before 2025.
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Are Lyme Patients At Higher Risk For Covid
Many Lyme patients believe that they are in a high-risk category for a more severe disease . A majority of patients believe that their chronic Lyme disease places them in a high-risk category for severe disease .
Approximately 13% of survey respondents have contracted COVID-19 and 14% say that a member of their household has contracted the illness.
To date, approximately 26% of the US population have been vaccinated since vaccine distribution began in mid-December 2020.In our survey, 33% of Lyme patients report having been vaccinated.
Of those, 53% received the Moderna vaccine, and 47% received Pfizers. Close to 59% had received one dose of vaccine, and 41% had received two doses.
These numbers are likely to increase over time as the vaccines become more readily available.
Valneva And Pfizer Start New Phase 2 Study For Lyme Disease Vaccine Candidate
Related tags:Valneva, Pfizer, Vaccine
The study builds on previous Phase 2 studies: incorporating new dose regimens and now including children aged 5-17 years old. It will determine whether the candidate proceeds to Phase 3 studies.
Kathrin Jansen, Senior Vice President and Head of Pfizer Vaccine Research and Development, said: We hope this Phase 2 trial, with a simplified schedule, will provide evidence that the investigational vaccine can be used in populations that are at risk of contracting Lyme disease, potentially including children age five years and older.
Lyme disease is a systemic infection caused by Borrelia bacteria burgdorferi sensu lato transmitted to humans by infected Ixodes ticks4. It is considered the most common vector borne illness in the Northern Hemisphere. According to the U.S. Centers for Disease Control and Prevention , approximately 476,000 Americans are diagnosed and treated for Lyme disease each year with at least a further 200,000 cases in Europe.
The effects of climate change such as warmer winters – means that ticks are spreading to new areas and the medical need for vaccination is steadily increasing, note the companies.
Valneva and Pfizer entered into a collaboration agreement in April 2020 to co-develop the multivalent protein subunit candidate VLA15. The program had previously been granted Fast Track designation by the US FDA in July 2017.
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The Lyme Vaccine That Wasnt
Its a kind of horrifying story, actually, says The New Yorkers Sue Halpern.
It turns out that we cant 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. Youd 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 Roberts question, some of you pointed this out that weve 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 wasnt 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 Marthas Vineyard, which was, and still is, a Lyme hot spot.
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The History Of The Lyme Disease Vaccine
Borrelia burgdorferi bacteria, the cause of Lyme disease, is transmitted to humans via the bite of an infected tick. CDC / Janice Carr
Lyme disease, a bacterial infection spread by certain types of ticks, is a growing problem in the United States. First described in 1977 as Lyme arthritis after a cluster of cases was reported in Old Lyme, Connecticut, the disease is most common in the Northeast and upper Midwest, but has been reported from every U.S. state. Each year about 20,000 new cases are reported, while experts note that the true incidence may be three times higher or more. In 2014, the number of cases of Lyme disease ranked 7th on a list of the leading nationally notifiable diseases reported to the Centers for Disease Control and Prevention , despite more than 90% of cases being found in only 10 states.
The first and only licensed vaccine against Lyme disease was developed by SmithKline Beecham . Given in a three-dose series, the vaccine had an unusual method of action: it stimulated antibodies that attacked the Lyme bacteria in the ticks gut as it fed on the human host, before the bacteria were able to enter the body. This was about 78% effective in protecting against Lyme infection after all three doses of the vaccine had been given.
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Some Vaccinated For Covid While Actively On Antibiotics
16% of patients who report having been vaccinated were actively on antibiotic treatment for Lyme disease when they received their shots. Nearly 93% of those vaccinated recommend that their friends and family receive the vaccination when able.
Of those who have not been vaccinated, 35% intend to get the vaccine when it is available to them and 39% do not intend to receive the vaccine. The remainder are unsure. For patients who do not intend to get vaccinated, 49% cited safety concerns and worries about potential COVID vaccination side effects.
A large majority of patients report that they take precautions to reduce their risk of exposure by wearing a mask in public , washing their hands and/or using hand sanitizer often , sheltering in place , or limiting contact to a small group of people with low risk .
Yale Researchers Develop Mrna
Yale researchers have developed an mRNA vaccine that targets the antigens found in tick saliva in order to alert individuals to tick bites as well as prevent the tick from feeding correctly, thereby reducing its ability to transmit pathogens.
12:45 am, Dec 02, 2021
Contributing Reporter
Cate Roser
Yale researchers have developed an mRNA vaccine against lyme disease that triggers an immune response at the site of a tick bite and provides partial protection against the disease-causing bacteria.
In a paper published on Nov. 17 in the Science Translational Medicine journal, scientists studied specific ticks called Ixodes scapulari that carry a lyme-disease-causing bacteria called Borrelia burgdorferi.According to Gunjan Arora, one of the co-first authors of the paper and an associate research scientist at the Yale School of Medicine, lyme disease is the fastest-growing vector-borne illness in the United States, with close to half a million people affected every year. Currently, there are no commercially available vaccines for lyme disease. This novel vaccine is unique in that it targets the vector of transmission, the tick, rather than the actual pathogen itself.
Traditionally, vaccines are developed to target specific viruses or bacteria that can cause disease. However, this new lyme disease vaccine is designed to target tick salivary proteins, according to Matias dos Santos.
Ticks are classified as arachnids and are closely related to spiders and scorpions.
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Gene Editing To Stop Lyme Disease: Caution Is Warranted
Theres a lot of worry about Lyme disease, to the degree that some parents are telling children they shouldnt play outside or limiting hours, Nigrovic said. Theyre behaving differently because of that worry. So vaccines are attractive.
The Food and Drug Administration gave VLA15 fast-track designation in July 2017. Valneva completed initial safety studies in a Phase 2 clinical trial and, according to a company press release, VLA15 had no associated safety concerns. The company is now working to determine the dose. Based on current estimates, Lingelbach said Valneva plans to test the vaccine in a clinical trial of at least 15,000 people, and it should be available in four or five years.
The FDA approval process is long. But Telford said it may be easier for VLA15 than it was for LYMErix, given how many more people today know about Lyme disease and may enroll in trials.
Finding people is going to be a cinch compared to what it was like in the 1990s, he said. I dont see why they couldnt have it benefiting people by 2024.
A different approach, being developed by the University of Massachusetts Medical School, is called Lyme pre-exposure prophylaxis . Unlike a vaccine, Lyme PrEP delivers a single defensive antibody, said Dr. Mark Klempner, the executive vice chancellor for MassBiologics and a professor of medicine at the university, who is leading efforts to develop the product.
