Why Theres Still No Lyme Vaccine For Humans
False starts and fear have kept such a drug off the market for two decades.
Jessica Reeder worries about ticks and the diseases they carry. She had Lyme disease, her brother had Lyme disease, and every fall her children come home from school with notes reminding parents to do a nightly tick check. Even in Philadelphia, where Reeder lives, the bloodsuckers lurk in the woods around the playground. Her family used to go tent camping with friends, but they stopped after a few people in the group contracted Lyme.
It just got to the point where people were too stressed out about it, she says.
Reeder made sure that her shih tzu, Rory, got the canine Lyme vaccine, but she must protect the human members of her family the old-fashioned way: bug spray, long pants tucked into socks, and frequent tick checks. Theres no Lyme vaccine on the market for humans.
Valneva, a French biotech company focused on developing vaccines for infectious diseases, hopes to change that. Six years ago, the company began working on a vaccine against Lyme disease, which is now part of phase-two clinical trials in the United States and Europe.
Valnevas Lyme vaccine isnt the first designed for people. Twenty years ago, Reeder could have been immunized. From 1999 to 2002, SmithKline Beechamnow GlaxoSmithKlinesold a Lyme vaccine called LYMErix. But the company pulled LYMErix off the market after public backlash and a spate of lawsuits.
Until Now It Was Not Immunologically Feasible To Address Ospc Variability Via Vaccination
The OspC chimera in VANGUARD crLyme is a single engineered protein that contains antigenic material from seven different types of OspC
Provides targeted immune response to the seven types of OspC
Why both OspA and OspC?
OspA antibodies can help kill B. burgdorferi inside ticks
OspC antibodies can help kill B. burgdoferi inside the tick and dog
The Gathering Storm: The Fda Meets
With lawsuits pending and questions from the public and the media, and facing an increasingly complex and explosive situation, the FDA reconvened its advisory panel on 31 January 2001 to discuss the future of the Lyme vaccine. The participants included the FDA scientific advisors, the LYMErix manufacturer, independent experts, practising physicians, the vaccine victims and their lawyers.
This panel, described by one participant as raucous and riotous , provided a forum for all of the stakeholders . In support of the vaccine, the FDA summarized the VAERS data and concluded that the evidence did not support a causative association. The vaccine manufacturer, now GlaxoSmithKline following a corporate merger, assured the assembled parties that the LYMErix vaccine did not cause harm to its recipients. They reviewed the status of their phase IV post-marketing surveillance. Practising physicians spoke of vaccine efficacy by describing the dramatic reduction in Lyme disease cases in their own practices.
Others raised concerns about the vaccine’s safety. Scientists argued a potential role for genetic susceptibility and OspA-related autoimmunity in vaccine complications. Poignant presentations by several vaccine victims described in detail their suffering. The prosecuting lawyers for the largest class action suit claimed that manufacturers suppressed reports of adverse events from the licensing trial and provided inadequate warnings to genetically susceptible individuals.
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How Is Lyme Disease Prevented
Its not comforting to understand that such a small insect can have so much control when it comes to Lyme disease. A vector is an organism that transports and delivers an infectious organism from one host to another. In this case, the vector of Lyme disease is the deer tick in the Northeastern United States. Female ticks lay about 2,000 eggs in the spring. The tick will transmit the disease to a new mammal host. However, this process requires a minimum of 48 hours, and if the tick can be removed within that time frame, the dog or human will not get Lyme disease. This gives us control in the fact that we can vaccinate our dogs against Lyme disease and take preventative measures such as checking them for ticks after being outdoors.
For Animals That Have Not Been Vaccinated Can Osp A Values Be Positive How Should This Be Interpreted
Antibodies to OspA have previously been interpreted as markers for vaccination. Non-vaccinated animals usually have low values for antibodies to OspA, while vaccinated animals develop these antibodies. OspA antibodies have been shown to protect from infection with B. burgdorferi.
However, there is accumulating evidence that antibodies to OspA can occur without vaccination. First, residual OspA is present on the bacterial surface at the time of transmission to an animal. This causes a low and transient OspA antibody response early after infection. Second, antibodies to OspA have also been associated with treatment-resistant Lyme arthritis and with development of autoimmunity in human patients. Similarly, OspA antibodies in non-vaccinated dogs or horses can be considered as markers of chronicity and disease severity.
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Results Of Individual Studies
A summary of study results for included observational studies is presented in Table . Only 1 observational study assessed clinical signs, but because these were grouped together, data for individual clinical signs could not be extracted. This observational study did not assess seroconversion after vaccination therefore, raw data could not be extracted for that noncritical outcome. The other 2 observational studies provided raw data for seroconversion between vaccinated and unvaccinated dogs.
A summary of study results for 17 included challenge trials from 13 publications is presented in Table . At least 1 critical outcome was assessed in 16 of the 17 trials. Sixteen challenge trials assessed lameness, 7 evaluated anorexia, 5 assessed pyrexia, 6 assessed depression, and none assessed lymphadenopathy.
What Are The Risks Of Puppy Vaccination
As with any medication and vaccines, whether for animals or humans, there’s always some risk of potential side effects. However, studies show that all core puppy vaccines on the essential puppy shot schedule, like the DA2PP or rabies vaccine, are completely safe.
Most today’s core vaccines for dogs were developed over 50 years ago. After decades of scientific discovery and testing, enough effort has been put into making these vaccines safe and reliable for animals.
In very rare instances, some vaccines may cause adverse effects in puppies that are typically unpredictable. Fortunately, most of those negative reactions dogs have to vaccinations are minor and easily managed.
Your vet will ask about the health of your puppy prior to vaccinations and, if necessary, may perform some tests. If your dog is sick, the vaccine may have to be put on hold due to a dog’s compromised immune system. If given during that time, the vaccine could be ineffective or cause side effects.
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Is It A Good Idea For Dogs To Get The Canine Lyme Vaccine Even If They Already Had Lyme Disease
You ask about the benefits of the canine vaccine against Lyme disease. That is a great question. Unfortunately, veterinarians do not have a complete answer when it comes to the vaccines effectiveness. Some research suggests that vaccination appears to be fairly good in preventing infection in dogs not previously exposed to the Lyme organism. I word this carefully, though, because your dog already has been exposed, and theres no known benefit of vaccination after an initial exposure to the Lyme-causing bacteria.
You also ask about the risks of the vaccine. We have a bit more information about that, because veterinarians have been using it for several years. There is a very low incidence of side effects, less than 2 percent. As with most vaccines, reactions might include facial swelling, hives, itchiness, swelling at the vaccination site and, less commonly, collapse.
So what is my best advice? I do not routinely encourage vaccination against Lyme, even though I practice in a region where the disease is endemic. That said, I do not hesitate to administer the vaccine when a pet owner requests it, because I believe it is safe.
Types Of Lyme Disease Vaccine Available For Dogs
Two types of Lyme disease vaccines are available for dogs:
Both work to prevent transmission of Borrelia bacteria from the tick to the dog during a tick bite. Lyme disease vaccines do not cause Lyme disease, and they do not prevent disease development in dogs already infected.
It is important to know that both types of vaccines are only about 80% effective in preventing Lyme disease. In other words, about 20% of vaccinated dogs can still become infected with Lyme disease. Some scientific studies indicate that Lyme disease vaccines for dogs may only last about six months, although many more studies are needed to determine if this is true.
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Vaccinations For Adult Dogs: Boosters And Titers
There is a difference of opinion about having your adult dog vaccinated every year. Some vets believe too many vaccinations in adult dogs pose health risks. But others disagree, saying that yearly vaccinations will prevent dangerous diseases such as distemper. Talk with your vet to determine what kind of vaccination protocol works for you and your dog.
Many dog owners opt for titer tests before they administer annual vaccinations. Titer tests measure a dogs immunity levels, and this can determine which, if any, vaccinations are necessary. One key exception to this is rabies: a titer test is not an option when it comes to the rabies vaccine. This vaccination is required by law across the United States. Your vet can tell you the schedule for your particular state.
And its all worth it. For your effort and care your puppy will lavish you with lifelong love in return. This critical first year of her life is a fun and exciting time for both of you. As she grows physically, the wonderful bond between you will grow, too.
Dont miss crucial information when it comes to raising your puppy. Get personalized training, nutritional, veterinary, and everyday advice sent straight to your inbox. , a weekly email newsletter with customized content based on your puppys breed and age.
Disease Transmission And Symptoms
Lyme disease is caused by the Borrelia burgdorferi bacteria, passed to humans through the bite of infected black-legged ticks , which initially get the disease from mice. The transmission of the bacteria from an infected tick to a human can take hours often more than a day but the ticks small size makes them easy to overlook on the body, allowing time for this transmission to occur unimpeded. They are typically about the size of the head of a pin, and can bite without being noticed.
The most commonly known symptom of Lyme disease is the bulls-eye or target rash, which appears in most cases. The rash begins at the site of the tick bite between three and 30 days after exposure and usually grows in size for several days. When Lyme disease is diagnosed, antibiotics are prescribed for treatment. If the disease is left untreated, other symptoms can develop in the weeks following exposure: additional rashes joint pain and swelling shooting pains dizziness and heart palpitations severe headaches and loss of muscle tone in the face .
If the disease remains untreated beyond this point, arthritis can develop. This occurs in about 60% of patients whose infections are not treated, and can cause swelling and severe pain in the joints. In addition, as many as 5% of patients whose Lyme infections are not treated develop chronic neurological problems. These can occur months or even years after transmission.
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Symptoms Of Lyme Disease Can Be Very Serious
A dog may also test positive for Lyme, but have no symptoms at all. In fact, this is most commonly the case! Clinical signs only develop in 5-10% of infected dogs, but they can be very serious.
Symptoms of Lyme disease in dogs include:
- Joint inflammation and pain
- Lethargy or ADR
- Shifting leg lameness
- Swollen lymph nodes
With Tick Control & Vaccination In Endemic Areas Lyme Disease Is Preventable
Richard E. Goldstein, DVM, Diplomate ACVIM & ECVIM
Lyme disease, its causative tick-borne agentBorrelia burgdorferi, and Ixodes ticks are all on the rise. In August 2013, the Centers for Disease Control and Prevention increased their estimate of the number of new human cases of Lyme disease from 30,000 to 300,000 annually.1
Tick removal and control is an important part of prevention of Lyme disease, but so is Lyme disease vaccination. No vaccine is completely without risk, but when weighing the risks versus the benefits, I believe the evidence strongly supports the following:
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What Are The Clinical Signs
Many people with Lyme disease develop a characteristic bulls-eye rash at the site of the bite within three to thirty days. If this occurs, the disease can be easily diagnosed at an early stage.
Symptoms of Lyme disease are more difficult to detect in animals than in people. The characteristic rash does not develop in dogs or cats. Because the other symptoms of the disease may be delayed or go unrecognized and because the symptoms are similar to those of many other diseases, Lyme disease in animals is often not considered until other diseases have been eliminated.
Affected dogs have been described as if they were walking on eggshells.
Many dogs affected with Lyme disease are taken to a veterinarian because they seem to be experiencing generalized pain and have stopped eating. Affected dogs have been described as if they were walking on eggshells. Often these pets have high fevers. Dogs may also begin limping. This painful lameness often appears suddenly and may shift from one leg to another. If untreated, it may eventually disappear, only to recur weeks or months later.
Some pets are infected with the Lyme disease organism for over a year before they finally show symptoms. By this time, the disease may be widespread throughout the body.
The Lyme Vaccination For Dogs Isnt Foolproof
The shot isnt 100 percent effective, says Dr. Mengel.
But, Dr. Mengel adds, anecdotally, many practices report seeing lower numbers of dogs testing positive for exposure to the bacteria that causes Lyme since using the vaccine in practice over several years.
The Lyme vaccine cannot replace good tick control, because it is not completely effective at preventing Lyme disease, and it does nothing to protect against the many other tick-borne diseases, such as ehrlichiosis and Rocky Mountain spotted fever, says Dr. Brevitz.
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Lyme Disease Exposure In Dogs Is Cheap And Easy To Diagnose
What do I mean by Lyme disease exposure? I say exposure here because the tests we use to diagnose Lyme disease actually detect antibodies in dogs, proving that they have been exposed to natural Lyme infection and their immune system has responded. However, most of these dogs are what we call assymptomatic90% will never develop clinical signs. While that is great news, recognizing that a patient has been exposed is super helpful to me in caring for their health . One of the reasons is that dogs with Lyme disease can develop joint inflammation and arthritis that is not readily apparent. Knowing a dog has tested Lyme positive puts me on guard to be hypervigilant about subtle clinical signs.
In veterinary medicine, we are lucky to have whats called the SNAP 4Dx test. This inexpensive test is run with just a few drops of blood and the results are ready in the office within minutes. Additional tests, such as one which measures the dogs antibody levels to a special peptide , are great tools for veterinarians seeking to diagnose and track Lyme positive patients.
Incidentally, nothing like the SNAP 4Dx test exists for humans, so the road to a human diagnosis is often more complicated.
What Is The Bordetella Vaccine For Dogs
The Bordetella vaccine is a preventative measure created to protect dogs from the illness.
Unlike most other vaccines, the Bordetella vaccine doesnt always have to be injected.
There’s two forms of the vaccine, Dr. Schwartz said. There’s one that’s injected. And there’s one that’s intranasal.
Both forms of the Bordetella vaccine are effective, but according to Dr. Schwartz, the intranasal option which is administered in the form of nose drops should be your first choice.
The intranasal is better, Dr. Schwartz explained. It gives a better immune response, and it goes directly to the point of entry, most of the time, of the virus. So, that one is preferred, but the subcutaneous one is effective as well.
Its important to remember that even though the vaccine will protect your dog from Bordetella, it wont provide guaranteed protection from kennel cough, since that can still develop from other illnesses.
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What Is The Lyme Disease Vaccine
Although the syndrome now known as Lyme disease was first identified in human patients in 1975, Borrelia burgdorferi was not identified until 1981. The first canine Lyme vaccine was introduced in 1992 .
The Lyme vaccine for dogs is available at most veterinary clinics, especially in areas where Lyme disease poses a significant threat. Even in low-risk areas, many veterinarians carry this vaccine in order to protect dogs traveling to Lyme-endemic areas. If your veterinarian does not carry this vaccine, they may be able to obtain it for you or direct you to another clinic where you can receive it.
This vaccine does not require a specialist visit and can often be administered with your dogs other vaccinations at a routine wellness visit.