Lyme Disease Vaccines 2023
The U.S. Food and Drug Administration (FDA) has not approved a preventive Lyme disease vaccine as of January 18, 2023. Ongoing vaccine research includes early-stage discovery and novel vaccine formulations, including tick saliva-based approaches.
The U.S. National Institutes of Health (NIH) Strategic Plan for Tickborne Disease Research prioritizes research needed to detect and prevent tickborne diseases.
The only vaccine previously marketed in the United States was LYMERix®, which the manufacturer discontinued in 2002.
Lyme Disease Vaccine Candidates
VLA15, a multivalent Lyme Disease vaccine candidate produced by Pfizer In. and Valneva SE, targets Borrelia's outer surface protein A. It is designed for prophylactic, active immunization against Lyme disease, aiming for protection against most human pathogenic Borrelia species. In addition, a sponsored study for healthy adults and children age 5+ who live in or often visit outdoor areas that may expose them to ticks is conducting a late-stage clinical trial.
TP-05 is a novel investigative oral therapeutic TP-05 for potentially preventing Lyme disease. TP-05 is an oral systemic formulation of lotilaner, a well-characterized anti-parasitic agent that selectively inhibits parasite-specific GABA-CI channels.
The National School of Tropical Medicine at Baylor College of Medicine and Texas Children's Hospital's Center for Vaccine Development received an $860,000 grant from the U.S. Department of Defense (DoD) to develop a recombinant protein vaccine for Lyme disease. This work is supported by the Congressionally Directed Medical Research Programs through the DoD Tick-Borne Disease Research Program under Award No. W81XWH-20-1-0913.
Lyme Disease Diagnostics
Most tick-borne infections are misdiagnosed because these nonspecific symptoms mirror other illnesses. In addition, there are several Borrelia sub-species and strains, and researchers continue to discover new species. This variety is why patients can receive false negative test results because the test they took was not designed to detect the species of Borrelia causing their infection.
FAIR Health examined a statistically significant cohort of individuals in its private insurance claims database from 2017 to 2021, The analysis found that diagnoses such as malaise and fatigue, and soft-tissue-related issues were more common among Lyme patients than among the total patient population.
Lyme disease is typically diagnosed by a 2-tiered serological testing approach involving an enzyme-linked immunosorbent assay (ELISA) followed by a Western blot test. However, the sensitivity of commercially available tests is limited, meaning they can miss active infections. However, IGeneX, a commercial company, offers several Borrelia burgdorferi tests that detect and speciate the B. burgdorferi group.
Lyme Disease Overview
According to the U.S. NIH, Borreliosis is an infectious disease caused by spiral-shaped bacteria known as Borreliae, often carried by ticks. The species of Borreliae known to cause disease in humans are split into the following two groups: B. burgdorferi sensu lato, which causes Lyme disease, and Relapsing Fever Borrelia, which causes Tick-Borne Relapsing Fever.
Lyme disease can present a variety of symptoms similar to a wide range of illnesses, including chronic fatigue syndrome, fibromyalgia, and autoimmune disorders such as RA and Multiple Sclerosis, says the U.S. CDC.
Lyme Disease Vaccine News For 2018 - 2023
December 15, 2022 - Tarsus Pharmaceuticals, Inc. announced positive topline results from the completed Phase 1b study and enrollments in the Phase 2a clinical trial.
December 1, 2022 - Pfizer Inc. and Valneva SE reported antibody persistence data six months after completing a three-dose or a two-dose vaccination schedule with their Lyme disease vaccine candidate VLA15.
October 10, 2022 - It is estimated that 476,000 people in the U.S. and 130,000 people in Europe are impacted by Lyme disease each year.
April 26, 2022 - Juan Carlos Jaramillo, M.D., Chief Medical Officer of Valneva, said, "Lyme disease affects all age groups, but with their affinity for being active outdoors, the pediatric population is at the greatest risk of Lyme disease. Therefore, these first pediatric results are significant and support the inclusion of pediatric participants in our planned Phase 3 trial. In partnership with Pfizer, we are excited to further investigate our VLA15 vaccine candidate, which will hopefully help protect both adults and children against Lyme disease."
April 19, 2022 - A recent Michigan State University study found a 43% increase in ticks submitted for disease testing since March 2021.
April 13, 2022 - The U.K. stated that 'European studies estimate 1-5% of tick bites can lead to Lyme disease. On average, between 2.5–and 5.1% of ticks are infected in England and Wales, although this range can fluctuate in different areas and across years.
March 15, 2022 - Tufts University announced that when people are exposed to Lyme bacteria, the potential host produces a substance the bacteria use to grow. The investigators believe a testing mechanism that detects these autoantibodies could be the fastest and most accurate way to test for Lyme disease.
February 4, 2022 - Valneva SE and Pfizer Inc. reported other positive Phase 2 data for their Lyme disease vaccine candidate, VLA15. Valneva and Pfizer plan to proceed with a three-dose primary series vaccination schedule in a planned Phase 3 clinical trial based on these new results. The trial will evaluate VLA15 in adults and pediatric subjects five years of age and above and is expected to be initiated in 2022, subject to regulatory approval.
December 23, 2021 - MassBiologic's Lyme PrEP (2217LS) has begun a phase 1 clinical trial to test for the safety of Lyme PrEP and to determine how long it lasts in the human bloodstream. Lyme PrEP uses a monoclonal antibody.
December 2, 2021 - Yale researchers are developing an mRNA vaccine against Lyme disease.
January 13, 2021 - The U.S. CDC published Estimating the Frequency of Lyme Disease Diagnoses, United States, 2010–2018. Using commercial insurance claims data; we estimated that Lyme disease was diagnosed and treated in about 476,000 patients in the USA annually during 2010–2018. The CDC said these results underscore the need for accurate diagnosis and improved prevention.
January 13, 2021 - The U.S. CDC's Report Volume 27, Number 2—February 2021: Borrelia burgdorferi Sensu Stricto DNA in Field-Collected Haemaphysalis longicornis Ticks, Pennsylvania, United States. 'We collected questing Haemaphysalis longicornis ticks from southeastern counties of Pennsylvania, USA. Of 263 ticks tested by PCR for pathogens, one adult female was positive for Borrelia burgdorferi sensu stricto, yielding a 0.4% infection rate. Continued monitoring of this invasive tick is essential to determine its public health role.'
December 2, 2020 - France-based Valneva SE announced its plans to accelerate the pediatric development of its Lyme vaccine candidate, VLA15, in collaboration with Pfizer Inc., with the planned initiation of study VLA15-221 in the first quarter of 2021, subject to regulatory approval. In addition, a phase 3 pivotal efficacy trial is scheduled to commence in 2022.
November 19, 2020 - The National School of Tropical Medicine at Baylor College of Medicine, along with Texas Children's Hospital's Center for Vaccine Development, has received an $860,000 grant from the Department of Defense (DOD) to develop a recombinant protein vaccine for Lyme disease, the most common vector-borne disease in the general U.S. population and the U.S. military. In addition, researchers from Baylor will partner with Lyme disease experts from the Wadsworth Center, New York State Department of Health.
July 22, 2020 - Valneva SE stated the VLA15 vaccine candidate was found immunogenic across all dose groups tested. And the VLA15-201 study's results did not indicate that prior exposure to Lyme (seropositivity) impacted immunogenicity or safety.
July 9, 2018 - "New Effort for Lyme Disease Vaccine Draws Early Fire," by Sumathi Reddy, appeared in the Wall Street Journal. The article, which includes a quote by LDA President, Pat Smith, reports that a European company, Valneva SE, is in clinical trials for a vaccine for Lyme disease, which has been fast-tracked by the FDA.