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.
Vla15 Valnevas Lyme Disease Vaccine Candidate
- VLA15 is currently the only active vaccine program in clinical development against Lyme disease.
- VLA15 is a multivalent recombinant protein vaccine that targets six serotypes of Borrelia representing the most common pathogenic strains found in the United States and Europe.
- Valneva has completed recruitment and reported initial results for two Phase 2 clinical trials of VLA15 in over 800 healthy adults and in which Valneva observed high levels of antibodies against all six serotypes.
- Valneva announced a collaboration with Pfizer for late phase development and, if approved, commercialization of VLA15 .
- As part of its collaboration with Pfizer, Valneva accelerated the pediatric development of VLA15 with an additional Phase 2 clinical trial initiated in March 2021. In July 2021, Pfizer and Valneva announced recruitment completion for VLA15-221 with a total of 625 participants, 5 to 65 years of age .
- The VLA15 program was granted Fast Track designation by the U.S. Food and Drug Administration in July 2017 .
Additional information about Lyme disease:
Mayo Clinic Minute: Will There Be A Lyme Disease Vaccine For Humans
Lyme disease is the most commonly reported tick-borne illness in the U.S. Depending on the stage of infection, it can cause a wide range of symptoms, ranging from a fever and rash to neurological problems. Lyme disease also affects dogs. You can schedule a visit to a veterinarian to get your pup vaccinated against the disease.
Journalists: Broadcast-quality video is in the downloads. Read the script.
“You can protect your dog in the U.S. against Lyme disease, but you cant protect you or your children with a vaccine,” says Dr. Gregory Poland, director of the Mayo Clinic Vaccine Research Group. He says there was a vaccine for humans, but it was withdrawn.
“The primary reason is there was immense anti-vaccine sentiment about the vaccine, much like we had with measles vaccine. It’s illogical.”
Its the bite of an infected black-legged tick or deer tick thats responsible for making so many people sick with Lyme disease. “There are probably about 300,000 new cases a year,” says Dr. Poland.
There are no plans at this time for a new Lyme vaccine in the U.S., but there is good news. A vaccine, VLA15, is being developed in Europe.
The company has been through phase 2 testing. “Now theyll do phase 3 clinical testing, which means they go to the FDA, get approval, and theyll do very large studies,” says Dr. Poland.
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So Will The Vaccine Work In Humans
The Yale team warns that this vaccine isnt a finished product and they need to do more testing to see if it protects people.
Similar experiments in mice showed that the vaccine did not confer resistance to tick infections. The study authors believe part of this is because the skin of guinea pigs and humans has more layers than that of mice. Ticks may also have evolved new ways to feed on mice, which scientists say are a natural host of I. scapularis ticks.
The study appears in the journal Science Translational Medicine.
Stop The Saliva Prevent The Disease
Researchers explain that the black-footed tick species Ixodes scapularis transmits the Lyme disease pathogen Borrelia burgdorferi. This disease contains multiple proteins and the team focused their research on 19 different types.
Working with the University of Pennsylvania, they analyzed pieces of mRNA that produce all 19 of these tick saliva proteins. Scientists who developed the COVID-19 vaccine used the same strategy to create a formula that protects against the SARS-Cov-2 virus.
In guinea pigs, the team discovered that vaccinated animals quickly developed redness at the bite site after encountering a disease-carrying tick. As long as the researchers removed the ticks as soon as the reddening began, none of the guinea pigs developed Lyme disease. Conversely, about half of the unvaccinated group of guinea pigs were infected with B. burgdorferi bacteria, even though the researchers removed the ticks.
Interestingly, the vaccine successfully protected immunized guinea pigs from a single tick bite, even when the researchers left the tick on the animals skin. On the other hand, a single tick bite led to Lyme disease in 60 percent of unvaccinated guinea pigs. The vaccine also prevented ticks from aggressively feeding on their hosts and caused them to shed their skin more quickly.
The vaccine has its limitations. The results show that protection against Lyme disease decreased when three ticks remained attached to the vaccinated guinea pigs.
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Has A Vaccine For Lyme Disease Been Fda Approved
Yes. In 1998, the FDA approved LYMERix, the first and only Lyme disease vaccine. Another vaccine, called ImuLyme, was also being studied at the time but never applied for approval
LYMERix was recommended for people ages 15 to 70 with exposure risk who lived or worked in areas with high rates of Lyme disease . It wasnt recommended for people in low risk areas, children under age 15, or adults over age 70.
The vaccine was given as a three-dose vaccine. You would receive your first shot, followed by your second dose one month later. Your third dose was 12 months after your first shot.
LYMERix worked by targeting a protein on the outside of the bacteria that causes Lyme disease. It triggered the immune system to make antibodies against this protein, which is found on the bacteria in the ticks gut as it starts to feed on your blood.
In clinical trials, the vaccine was found to be 49% effective against Lyme disease after two doses. And it was 76% effective after three doses.
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.
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Discovery And Basic Science
Nonprotein targets are also being assessed for potential utility in Lyme disease vaccine development. The Borrelia do not produce lipopolysaccharide, but do produce glycolipids on their outer surface that may be unique to the Borrelia. During infection, a strong immune response is mounted against some of these nonprotein antigens . One glycolipid in particular, acylated cholesteryl galactoside , has been the focus of investigation as a vaccinogen because of its immunogenicity during infection . ACG induces an IgM antibody response when administered to mice or rabbits in micellar form in PBS, or in DMSO, squalene, or Freunds adjuvants . A protein conjugate of ACG has been synthesized, and is currently being tested for use as a Lyme disease vaccine .
L.H. Sigal, in, 2014
A New Option To Stop Lyme Disease
Tick populations show no signs of shrinking and the spread of tick-borne illnesses are likely to continue increasing, so a Lyme disease vaccine could be big business.
Wendy Adams, research grant director at the Bay Area Lyme Foundation, said the real number of Lyme disease cases is likely much higher than the reported number.
Due to reporting requirements, only about 30,000 cases are reported to health authorities, which the CDC has acknowledged is likely less than 10 percent of actual cases, Adams said. There are 329,000 or more new cases of Lyme disease diagnosed each year in the U.S.
That puts new cases of Lyme disease higher than almost any other reportable infectious disease, including HIV and AIDS.
Different groups suggest that the global market for a vaccine against Lyme disease is estimated at approximately $1 billion annually, based on current estimates of the cost of treating patients with acute and more chronic Lyme disease, said , PhD, professor of medical microbiology and immunology in the College of Medicine and Life Sciences at The University of Toledo.
With that in mind, in 2017, the Food and Drug Administration approved a Fast Track designation for a new Lyme disease vaccine.
French company Valnevas vaccine for Lyme disease, VLA15, completed initial trials in early 2018 and is currently in phase II of clinical testing, Thomas Lingelbach, the companys CEO, said.
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Vaccine Licensure Recommendation And Initial Use
In response to growing reports of Lyme disease cases in the United States from 1982 to 1996, the number of reported cases increased by 32 times SmithKline Beecham developed LYMERix, which was licensed in 1998. The licensed product was a recombinant vaccine containing an outer surface protein from theBorrelia burgdorferi bacteria. Before licensure, 6,478 people received a total of 18,047 doses of the vaccine during clinical testing. The most common adverse events noted within 30 days of receiving at least one dose of the vaccine included pain or reaction at the injection site, joint pain, muscle pain, and headache. Of these, only pain and reactions at the injection site occurred much more frequently in the vaccine recipients than in those who received a placebo.
The efficacy trial for the vaccine showed that it was 78% effective in preventing Lyme disease after all three doses were given. It was also shown to be 100% effective at preventing asymptomatic cases, where an individual would get the disease and develop antibodies against it but never develop any symptoms.
The Lyme disease vaccine was considered for use in individuals between 15 and 70 years old living or working in areas with high rates of Lyme disease. People with very little exposure to areas with heavy tick infestations were not recommended to receive the vaccine.
Between the time of its licensure in 1998 and July 31, 2000, about 1.5 million doses of the vaccine were distributed.
Four Safe & Effective Vaccines
Compared to humans, dogs are lucky. There are currently 4 extremely safe, effective, and reliable vaccines7-9 on the market that have all been through the United States Drug Administration licensing requirements for safety, efficacy, purity, and potency.
All available canine Lyme disease vaccines produce borreliacidal antibodies in the dog in response to vaccinal outer surface protein A . These antibodies work in the ticks gut to bind the bacteria during the blood meal, sterilizing the gut of the tick and preventing transmission of bacteria into the dog.
OspC is the main immunogenic protein exhibited by Borrelia in the ticks salivary glands and in the dogs body during natural infection. Three of the current Lyme disease vaccines contain 2 strains of inactivated Borrelia isolates1 OspA producing strain and 1 unique OspC producing strain, which perhaps adds an additional layer of protection.
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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.
How The Lymerix Lyme Disease Vaccine Was Pulled From The Marketpatricia Smith President Of Lda Identifies Lessons We Can Learn From The Lymerix Lyme Disease Vaccine Story And Pitfalls We Can Hopefully Avoid In The Future
T he LYMErix Lyme disease vaccine by SmithKlein Beecham was approved by the Food and Drug Administration in December 1998 after completing a clinical trial of 10,936 peoplethe manufacturer concluded it was to be most effective in preventing the disease in people under age 65. Half the trial participants received an initial injection, then booster shots 1 month and 12 months after. Uncertainty about the length of vaccine immunity implied that recipients might need more boosters as often as every year to prevent waning immunity. The panel unanimously endorsed the vaccine for use in people ages 15 to 70. Safety and efficacy testing data for young children who were at high risk of developing Lyme disease was not available.
Six months before the Lyme disease vaccines approval, lead researcher for the Lyme disease vaccine, Dr. Allan Steere, New England Medical Center, Boston, was among the researchers who published results of a test tube study that showedthat OspA could cause a cross-reaction with a human protein in people positive for the HLA-DR4 gene, which comprised 2030% of the population.1 The immune system could attack the bodys own protein, thinking it was an invading bacterium there was not proof of this reaction in humans, but it indicated a possible connection. The LYMErix Lyme disease vaccine had an OspA base.
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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.
Yale Researchers Develop Lyme Disease Vaccine
Clinical trials have not been done, but it does hold promise.
Researchers from Yale University have developed a messenger ribonucleic acid vaccine against Borrelia burgdorferi, commonly known as Lyme disease, according to Yale Daily News. The vaccine has been tested on guinea pigs, but has not undergone clinical trials yet, so its effectiveness on humans remains uncertain.
The paper was originally published in the medical journal Science Translational Medicine on Nov. 17. The study focused on human diseases particularly Lyme disease from black-legged ticks, otherwise known as deer ticks. The scientific name for deer ticks is Ixodes scapularis, which was shortened to I. scapularis in the paper.
According to the paper, the hypothesis was that acquired resistance to I. scapularis due to repeated tick exposure has the potential to prevent tick-borne infectious diseases. One part of the tick that is thought to contribute to the disease delivery process is salivary proteins.
The researchers analyzed the lipid nanoparticles ability to enhance the host bodys capability to recognize a tick bite. These lipid nanoparticles contain nucleoside-modified mRNAs encoded with 19 types of deer tick salivary proteins. Vaccinated guinea pigs developed erythema, a reddening of the skin from injury or irritation, on bite locations shortly after the ticks bit them. This caused the ticks to feed poorly, and hindered the transmission of Lyme disease to the guinea pigs.
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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.