Lyme disease is a tick-borne infection caused by Borrelia bacteria and transmitted by blacklegged ticks. Clinical manifestations can involve skin, joints, nervous system, and heart if untreated.
Valneva withdrew its U.S. BLA and IND for chikungunya vaccine Ixchiq after an FDA clinical hold tied to a serious adverse event. The company reported a wider FY2025 net loss of €115.2 million, while its Lyme vaccine VLA15 showed over 70% efficacy in Phase III.
Two new studies advance Lyme disease research: anti-lipid antibodies may enable earlier diagnosis and detect persistent symptoms, while cell wall changes in Borrelia burgdorferi offer insights into Lyme arthritis pathogenesis and potential treatment targets.
Recent studies highlight progress in monoclonal antibodies against measles, Lyme disease, and Epstein-Barr virus. A Phase I Lyme antibody trial showed lasting protection, while preclinical antibodies blocked EBV and measles infection.
January and March 2026 drug pipeline updates included Phase 3 results, Fast Track designations and Priority Review decisions across multiple disease areas. Mavacamten, teplizumab-mzwv, anifrolumab, AXS-05, gedatolisib and AFTX-201 were among the programs with notable milestones.
Pfizer and Valneva said their investigational Lyme disease vaccine candidate showed more than 70% efficacy in the phase 3 VALOR trial. Pfizer plans regulatory submissions after the study, which reported no safety concerns at the time of analysis.
Pfizer and Valneva said their investigational Lyme disease vaccine showed more than 70% efficacy in the Phase 3 VALOR trial with a favorable safety profile. The companies plan regulatory submissions despite the trial missing its primary statistical criterion due to fewer Lyme cases than expected.
The FDA agreed to review Moderna's mRNA flu vaccine application after initially rejecting it, reversing course within a week. The agency will now consider full approval for adults 50-64 and accelerated approval for those 65 and above, with a decision expected by August 5.
| NCT ID | Title | Status | Phase |
|---|---|---|---|
| NCT07703787 |
Flow Cytometric Immune Monitoring of B. Afzelii-Specific T Lymphocytes |
NOT_YET_RECRUITING | |
| NCT07562087 |
A Study to Evaluate Safety and Efficacy of TP-05 in Healthy Participants With Tick Exposure |
ACTIVE_NOT_RECRUITING | PHASE2 |
| NCT07561294 |
A Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of mRNA-1982 to Prevent Lyme Disease in Healthy Participants (18 to 70 Years of Age) |
ACTIVE_NOT_RECRUITING | PHASE2 |
| NCT07500506 |
A Study to Learn About the Safety, Tolerability, and Immunogenicity of a Fifth Dose of 6-Valent OspA-Based Lyme Disease Vaccine |
RECRUITING | PHASE3 |
| NCT06397794 |
Navigating Pregnancy and Parenthood With Lyme Disease |
RECRUITING | |
| NCT06045416 |
Borrelia B-cell Diagnostics |
RECRUITING | |
| NCT06026969 |
Pregnancy and Early Neurodevelopmental Outcomes Following In Utero Lyme Disease Exposure |
RECRUITING | |
| NCT05975099 |
A Study to Evaluate the Safety and Immunogenicity of mRNA-1975 and mRNA-1982 Against Lyme Disease in Participants 18 Through 70 Years of Age |
COMPLETED | PHASE1/PHASE2 |
| NCT05634811 |
Safety Study of a Vaccine to Help Protect Against Lyme Disease in Healthy Children |
COMPLETED | PHASE3 |
| NCT05477524 |
An Efficacy, Safety, Tolerability, Immunogenicity, and Lot-Consistency Clinical Trial of a 6-Valent OspA-Based Lyme Disease Vaccine (VLA15) |
COMPLETED | PHASE3 |
